# EDGAR Filing Document

**Accession Number:** 0001283259
**File Stem:** 0001493152-26-010642
**Filing Date:** 2026-3
**Character Count:** 1289214
**Document Hash:** a023074e06e00ff60c2802769bb1ec3f
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-26-010642.hdr.sgml**: 20260318

**ACCESSION NUMBER**: 0001493152-26-010642

**CONFORMED SUBMISSION TYPE**: S-1/A

**PUBLIC DOCUMENT COUNT**: 27

**FILED AS OF DATE**: 20260318

**DATE AS OF CHANGE**: 20260317

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** BIOVENTRIX, INC.
- **CENTRAL INDEX KEY:** 0001283259
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 200372415
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** S-1/A
- **SEC ACT:** 1933 Act
- **SEC FILE NUMBER:** 333-293418
- **FILM NUMBER:** 26764322

**BUSINESS ADDRESS:**
- **STREET 1:** 120 FORBES BLVD.
- **STREET 2:** SUITE 125
- **CITY:** MANSFIELD
- **STATE:** MA
- **ZIP:** 02048
- **BUSINESS PHONE:** (925) 830-1000

**MAIL ADDRESS:**
- **STREET 1:** 120 FORBES BLVD.
- **STREET 2:** SUITE 125
- **CITY:** MANSFIELD
- **STATE:** MA
- **ZIP:** 02048

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** BIOVENTRIX INC
- **DATE OF NAME CHANGE:** 20121121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CHF TECHNOLOGIES INC
- **DATE OF NAME CHANGE:** 20040310

**As filed with the Securities and Exchange Commission on March 17, 2026.**

**Registration No. 333-293418** 

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

 **AMENDMENT NO. 1**

 **TO**

**FORM S-1**

**REGISTRATION STATEMENT**

**UNDER**

**THE SECURITIES ACT OF 1933**

**BIOVENTRIX, INC.**

(Exact Name of Registrant as Specified in its Charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **3841** | **20-0372415** |
| (State or other jurisdiction of<br> incorporation or organization) | (Primary Standard Industrial<br> Classification Code Number) | (I.R.S. Employer <br> Identification No.) |

---

**120 Forbes Blvd., Suite 125<br> Mansfield, MA 02048 USA**

**(925) 290-1000**

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices)

**David Richmond**

**Chairman and Chief Executive Officer**

**120 Forbes Blvd., Suite 125<br> Mansfield, MA 02048 USA**

**(925) 290-1000**

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

**with copies to:**

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| | |
|:---|:---|
| **Richard I. Anslow, Esq.**<br> **Lawrence A. Rosenbloom, Esq.**<br> **Ellenoff Grossman & Schole LLP**<br> **1345 Avenue of the Americas**<br> **New York, NY 10105**<br> **Phone: (212) 370-1300**<br> **Fax: (212) 370-7889** | **Stephen E. Older, Esq.**<br> **Carly E. Ginley, Esq.**<br> **McGuireWoods LLP**<br> **1251 Avenue of the Americas, 20<sup>th</sup> Floor**<br> **New York, NY 10020**<br> **Phone: (212) 548-2100**<br> **Fax: (212) 548-2150** |

---

**Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.**

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ <br> Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. ☐

**The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the U.S. Securities and Exchange Commission, acting pursuant to Section 8(a), may determine.**

**The information contained in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.**

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| | |
|:---|:---|
| **PRELIMINARY PROSPECTUS** | **SUBJECT TO COMPLETION, DATED MARCH 17, 2026** |

---

![](formdrs_001.jpg)

**Shares of**

**Common Stock**

This is the initial public offering of shares of common stock, par value $0.0001 per share, of BioVentrix, Inc., a Delaware corporation, on a firm commitment basis.

Prior to this offering, there has been no public market for our common stock. We anticipate that the initial public offering price of our common stock will be between $ and $ per share with a $ assumed initial public offering price (which is the midpoint of the $ and $ per share range; this assumption is used throughout this prospectus). We have applied to have our common stock listed on the Nasdaq Capital Market ("Nasdaq") under the symbol "BVXX." No assurance can be given that our application will be approved by Nasdaq. If our common stock is not approved for listing on Nasdaq, we will not consummate this offering.

The initial public offering price of our shares of common stock in this offering will be determined between the underwriters and us at the time of pricing, considering our historical performance and capital structure, prevailing market conditions, and overall assessment of our business. Therefore, the assumed initial public offering price used throughout this prospectus may not be indicative of the final offering price.

We are an emerging growth company under the Jumpstart Our Business Startups Act of 2012 and a "smaller reporting company" as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and, as such, may elect to comply with certain reduced public company reporting requirements for this prospectus and future filings. See "*Summary — Implications of Being an Emerging Growth Company" and* "*Summary — Implications of Being a Smaller Reporting Company*."

***Investing in our common stock is speculative and involves a high degree of risk.* Before making any investment decision, you should carefully review and consider all the information in this prospectus**, **including the risks and uncertainties described under "Risk Factors" beginning on page 10.**

**Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.**

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| | | |
|:---|:---|:---|
|  | **Per Share** | **Total** |
| Initial public offering price | $| $|
| Underwriting discounts and commissions<sup>(1)</sup> | $| $|
| Proceeds to us, before expenses | $| $|

---

(1) Represents
 underwriting discounts equal to seven percent (7%) of the gross proceeds from sales of shares of common stock in this offering. For
 a description of the other terms of compensation to be received by the underwriters, see "*Underwriting*."

We have agreed to issue warrants to the underwriters to purchase a number of shares of common stock equal to five percent (5%) of the total number of shares of common stock sold in this offering (including any shares of common stock sold pursuant to the exercise of the underwriters' over-allotment option), at an exercise price equal to the initial public offering price of the shares of common stock sold in this offering. The registration statement of which this prospectus is a part also registers the offer and sale of the underwriters' warrants and the shares of our common stock issuable upon exercise thereof.

We have granted a 30-day option to the underwriters to purchase up to additional shares of common stock at the initial public offering price, less underwriting discounts and commissions, solely to cover over-allotments, if any. If the underwriters exercise the option in full, the total underwriting discounts and commissions will be $ and the additional proceeds to us, before expenses, from the over-allotment option exercise will be $

The underwriters expect to deliver the shares of common stock to purchasers on or about , 2026.

 **Benchmark, a StoneX Company**

The date of this prospectus is , 2026

**TABLE OF CONTENTS**

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| | |
|:---|:---|
|  | **Page** |
| [Prospectus Summary](#ar_001) | 1 |
| [Risk Factors](#ar_002) | 10 |
| [Cautionary Note Regarding Forward-Looking Statements](#me_001) | 57 |
| [Use of Proceeds](#me_002) | 58 |
| [Dividend Policy](#me_003) | 59 |
| [Capitalization](#me_004) | 60 |
| [Dilution](#me_005) | 61 |
| [Management's Discussion and Analysis of Financial Condition and Results of Operations](#me_006) | 63 |
| [Business](#me_007) | 70 |
| [Management](#me_008) | 86 |
| [Executive and Director Compensation](#D_001) | 92 |
| [Principal Stockholders](#D_002) | 101 |
| [Certain Relationships and Related Party Transactions](#D_003) | 103 |
| [Description of Capital Stock](#D_004) | 104 |
| [Shares Eligible for Future Sale](#D_005)<br>| 110 |
| [Material U.S. Federal Income Tax Consequences to Non-U.S. Holders](#D_006) | 112 |
| [Underwriting](#D_007) | 116 |
| [Legal Matters](#D_008) | 125 |
| [Experts](#D_009) | 125 |
| [Where You Can Find More Information](#D_010) | 125 |
| [Index to Consolidated Financial Statements](#D_011) | F-1 |

---

Neither we nor the underwriters have authorized anyone to provide you with any information or to make any representation other than those contained in this prospectus and in any free writing prospectus prepared by or on behalf of us and delivered or made available to you. Unless otherwise indicated, information contained in this prospectus concerning our industry and the regions in which we operate, including our general expectations and market position, market opportunity, market share and other management estimates, is based on information obtained from various independent publicly available sources and other industry publications, surveys and forecasts, which we believe to be reliable based upon our management's knowledge of the industry. We assume liability for the accuracy and completeness of such information to the extent included in this prospectus. We are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus or any free writing prospectus is accurate only as of its date, regardless of its time of delivery or of any sale of shares of our common stock. Our business, financial condition, operating results, and prospects may have changed since that date.

**For investors outside the United States**: Neither we nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, this offering of the shares of common stock and the distribution of this prospectus outside of the United States.

i

**INDUSTRY AND MARKET DATA**

Unless otherwise indicated, information in this prospectus concerning economic conditions, our industry, our markets and our competitive position is based on a variety of sources, including information from third-party industry analysts and publications and our own estimates and research. Some of the industry and market data contained in this prospectus are based on third-party industry publications. This information involves a number of assumptions, estimates and limitations.

The industry publications, surveys and forecasts and other public information generally indicate or suggest that their information has been obtained from sources believed to be reliable. None of the third-party industry publications used in this prospectus were prepared on our behalf. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in "Risk Factors" in this prospectus. These and other factors could cause results to differ materially from those expressed in these publications.

**TRADEMARKS**

We own or have rights to trademarks or trade names that we use in connection with the operation of our businesses, our corporate names, logos and website names. This prospectus contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the® or <sup>™</sup> symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies' trade names, trademarks, or service marks to imply a relationship with, or endorsement or sponsorship of us by any other companies. All other trademarks are the property of their respective owners.

ii

**PROSPECTUS SUMMARY**

*This summary highlights certain information appearing elsewhere in this prospectus. Because it is only a summary, it does not contain all of the information that you should consider before investing in shares of our common stock and it is qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in this prospectus. This summary contains forward-looking statements that involve risks and uncertainties, such as statements about our plans, objectives, expectations, assumptions, or future events. These statements involve estimates, assumptions, known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from any future results, performances or achievements expressed or implied by the forward-looking statements. See "Cautionary Note Regarding Forward-Looking Statements." Before you decide to invest in our common stock, you should also read the entire prospectus carefully, including "Risk Factors" beginning on page* 10*, "Management's Discussion and Analysis of Financial Condition and Results of Operations" beginning on page 63, and the financial statements and related notes included in this prospectus.*

*Unless the context indicates otherwise, as used in this prospectus, the terms "we," "us," "our," "our company," "BioVentrix" and "our business" refer to BioVentrix, Inc. and its consolidated subsidiaries.*

*The following terms, as used in this prospectus shall have the following meanings:*

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| | |
|:---|:---|
| ejection fraction | The percentage of blood the heart's left ventricle pumps out with each beat calculated as the ratio of stroke volume to end-diastolic volume. |
| mini-thoracotomy | A less invasive surgical procedure using a small incision between the ribs in the chest wall, typically to access the heart or lungs, that avoids the need for a full sternotomy (i.e., open heart surgery). |
| ST Elevated Myocardial Infarction <br> (or STEMI) | A severe type of heart attack caused by a prolonged blockage of a coronary artery, characterized by ST-segment elevation on an electrocardiogram (ECG) and resulting in damage to the heart muscle. |
| win-ratio | A statistical measure comparing outcomes between two groups, typically in clinical trials, by pairing participants and counting how often the treatment group has a superior outcome (a "win") versus a worse outcome (a "loss") based on a pre-defined hierarchy of endpoints (i.e., the primary and secondary endpoints, or measures, of the trial). |
| PEEK | Polyether ether ketone. A high-performance, biocompatible polymer commonly used in medical implants and devices due to its strength, stability, and radiolucency. |

---

**Overview**

We are a medical device company focused on developing, manufacturing and commercializing proprietary devices to restore left ventricular function in heart failure patients with reduced ejection fraction ("HFrEF").

Our lead device program, the **Revivent System**, has a CE mark in Europe and is in its pivotal trial in the United States. In Europe (where we have obtained approval but are currently not commercially operating in order to preserve capital) or through an authorized U.S. clinical site (as we have not received FDA approval), heart failure specialists refer HFrEF patients with left ventricular dilation due to large anterior heart attack scars to cardiac surgeons who elect to utilize our product to restore left ventricular function by reducing the size of the left ventricle. The Revivent System accomplishes this reduction by folding the scar onto itself and fastening it together in a less invasive mini-thoracotomy procedure.

Based on our analysis of publicly available data and according to a 2016 New England Journal of Medicine article, patients with heart failure with HFrEF continue to face poor outcomes under the current standard of care, with multiple studies reporting an approximately 50–60% five-year mortality. Our goal is for the Revivent System to be the new standard of care for these patients.

We also have ownership rights to **Alginate**, a hydrogel-based device treatment for HFrEF patients without anterior scarring.

**Our Past and Current Clinical Trials in the United States**

In November 2024, we received an investigational device exemption ("IDE") from the U.S. Food and Drug Administration (the "FDA") under a Breakthrough Device Designation ("BDD") to begin a pivotal trial of the Revivent System (called the "RELIVE Trial"). We began enrolling patients in the RELIVE Trial in September 2025. An IDE authorizes the use of a significant-risk investigational medical device in a clinical study in order to collect safety and effectiveness data but does not constitute FDA clearance or approval to market or commercialize the device. The FDA grants BDD if preliminary clinical evidence suggests the procedure may improve substantially upon at least one clinically significant endpoint for a serious or life-threatening condition compared to existing therapies.

Our company, under prior management, previously conducted a clinical trial of the Revivent System (called the "ALIVE Trial"), which ended in 2023. The ALIVE Trial achieved statistical significance upon secondary analysis on functional status and Quality-of-Life ("QoL") measures, three of the five measures in the trial's primary efficacy endpoint. The functional status and QoL endpoints included change in 6-minute walk test ("6MWT"), change in Minnesota Living with Heart Failure questionnaire score ("MLHF"), and change in New York Heart Association ("NYHA") functional classification assessed at 12 months. However, as reported in the Journal of the American College of Cardiology ("JACC") ALIVE Trial publication, the failure of the other two measures, cardiovascular mortality and heart failure hospitalization, were in part a result of the comparison of our trial results with a control group that was healthier than the treatment group. This was a result of prior management's decision to not randomize the ALIVE Trial. In the JACC ALIVE Trial publication, the authors noted that (i) the control group was healthier than the treated group as evidenced by heart failure treatments and hospitalizations in the twelve months prior to the trial and better baseline left-ventricle function; and (ii) the external anchor placement (surgical only approach) produced fewer major adverse events than the internal right ventricle-left ventricle (RV-LV) anchor placement (hybrid procedure). The composite primary safety endpoint through 30 days was met. Major adverse events occurred in 15 of 84 patients (17.9%) of which 12 out of 60 patients (20%) were in the hybrid procedure and 3 out of 23 (13.0%) were in the surgical only approach. In one patient, the device procedure was attempted but aborted before device anchor placement. While the ALIVE trial met its safety endpoints inclusive of the hybrid procedure and surgical only approach, we have decided to test the surgical only approach only in the RELIVE trial due to the fact that fewer major adverse events could indicate that it has a more favorable safety profile, which would ultimately be determined by the FDA.

Our current management team is following the JACC article authors' recommendations by designing a randomized control trial using the external anchor placement approach. We proposed and were approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition) to support our Revivent Therapy Pre-Market Approval ("PMA") application. We are actively engaged with 16 sites, providing confidence to management on their estimates on site initiation, recruitment rates, heart failure specialist referral rates, surgeon experience, and trial expense.

The Revivent System is classified by the FDA as a Class III medical device and requires PMA approval. In the event we receive FDA PMA approval for our Revivent System, which we believe could be by mid-2028, we intend to expand from the 20 or more cardiac surgery centers participating in the trial to the top 336 United States cardiac surgery centers which represent approximately 30% of hospitals performing cardiac surgeries and 51% of cardiac surgery volume according to data published in The American Journal of Accountable Care. Ultimately, through the approximately 1,545 U.S. heart failure specialist and 1,120 U.S. cardiac surgery centers, our goal is to deploy the Revivent System in the market to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. based on our estimations. We believe that hospitals are eager to increase elective surgeries, such as ours, to utilize the fixed costs of their surgical suites and their surgeons and reduce bed utilization by deteriorating heart failure patients. Multiple studies highlight that untreated heart failure imposes substantial burdens on hospitals and payers due to expensive hospitalization and declining patient health (Nair et al. *Impact of Outpatient Diuretic Infusion Therapy on Healthcare Cost and Readmissions*, International Journal of Heart Failure 2022 Jan 11;4(1):29–41; *Projecting Hospitals' Profit Margins Under Several Illustrative Scenarios.* Working Paper Series, Congressional Budget Office. 2016; Milhailoff et al. *The Effects of Multiple Chronic Conditions on Adult Patient Readmissions and Hospital Finances: A Management Case Study*. Inquiry. 2017 Sep 1).

While our priority is conducting the RELIVE Trial, we intend to support post-market surveillance to maintain our Revivent System CE mark and may build a small European commercial organization if funding from this offering or otherwise becomes available in excess of our trial expenses. In addition, we expect to conduct post-approval studies to support marketing and to satisfy any ongoing regulatory requirements.

There is no guarantee that the RELIVE Trial will be sufficient for FDA approval, and in such case, we may be required to conduct additional trials for the Revivent System. *See* "*Risk Factors – If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.*" and "*Risk Factors – The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable."*

**Background on ST Elevated Myocardial Infarction ("STEMI")**

Each year in the U.S., approximately 805,000 patients experience an acute myocardial infarction ("AMI"), according to the American Heart Association's 2025 Heart Disease and Stroke Statistics. Approximately 322,000 (or 40%) of these individuals experience a STEMI event according to 2010 data published in the Journal of the American College of Cardiology. About 35% of these patients who have experienced a STEMI event develop anterior wall scarring according to data published in the Journal of the American Heart Association in 2020, and 25% of that group (approximately 28,000 patients) have severe scarring affecting greater than 30% of the anterior wall according to data published in the Journal of the American College of Cardiology in 2016. These patients face the prognosis of 50-60% five-year mortality rates (or 40-50% survival rates), the prospect of frequent hospitalization due to their HFrEF and represent our primary target market for the Revivent System.

Based on this information, and a 45% five year survival rate (implies 85.2% annual survival rate compounded over five years) (such mortality found in the 2002 *Framingham Heart Study*), we estimate that approximately 192,000 patients in the U.S. live with heart failure induced by a large anterior scar. While percutaneous coronary interventions ("PCIs"), such as stents, restore blood flow post-MI, they do not prevent scar formation in necrotic heart muscle damaged prior to blood flow restoration. As a result of the scarred tissue, the heart enlarges, the left ventricle remodels, pumping ability becomes impaired, and heart failure progresses – even with guideline directed medical therapy.

**Our Market Opportunity and Key Assumptions**

We estimate the U.S. addressable patient population for our Revivent System as follows:

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| | | | |
|:---|:---|:---|:---|
| **Step in Derivation** | **Step Percent** | **Percentage of Population** | **U.S. Annual Patients (approx.)** |
| AMI |  | 100% | 805000 |
| STEMI (40%) | 40% | 40% | 322000 |
| Anterior Wall Scarring (35% of STEMI) | 35% | 14% | 112000 |
| Severe Anterior Scar (>30% wall involvement; 25%) | 25% | 3.5% | 28000 |
| Prevalence (5-year survival midpoint, ~45%) 1 / 14.8% annual mortality rate suggests average life of 6.7 years for 28,000 patients indicating a prevalent population of approximately 192,000 |  |  | 192000 |
| Reimbursement assumption (based on reimbursement levels for comparable advanced heart failure device therapies, including implantable HFrEF interventions and mechanical circulatory support procedures) |  |  | $50000 |
| Total U.S. Opportunity |  |  | $~10 billion |
| Leading cardiac surgery device companies (Based on 2024 Form 10-K disclosures for Boston Scientific and Edwards Lifesciences) US revenue as a percent of total revenue averages approximately 60% of revenue from the U.S. market, which we apply as a proxy to estimate implied global total addressable market. | 60% |  | $~16 billion |

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Based on these data, we estimate a U.S. prevalent target market of ~192,000 patients with severe scar-induced heart failure following STEMI and a US and global total addressable market of $10 billion and $16 billion, respectively. Approximately 28,000 addressable patients, or an estimated $1.4 billion of market opportunity are added each year due to a new AMI, and approximately 28,000 addressable patients are lost to mortality each year. However, these estimates may not be accurate. See "*Risk Factors –We manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable market for our product candidates. The sizes of the markets for our current product candidates have not been established with precision and may be smaller than we estimate."*

**The Revivent System**

The Revivent System is a less invasive surgical device designed to treat ischemic heart failure by excluding scarred anterior wall tissue in the left ventricle. The Revivent System uses titanium anchors connected by PEEK tethers to plicate or fold non-functional myocardium scarred tissue onto itself, reduce LV volume and restore cardiac function. The Revivent System can be implanted on a beating heart through a mini-thoracotomy in under 90 minutes, offering a less invasive alternative to heart transplants, ventricular assist devices, and other open-heart surgical approaches. CE Marked since 2016, the Revivent System is being evaluated in the U.S. through our pivotal RELIVE Trial.

**Our Industry and Market Opportunity**

We are targeting what we believe is a large, underserved global heart failure population with anterior wall scarring post-STEMI. We estimate the total addressable market for the Revivent System, following approval by the FDA, at approximately $16 billion globally and $9.6 billion in the U.S., based on prevalence and expected reimbursement levels, similar to Barostim and Impella, which are both FDA-approved HFrEF devices being used in the market. Barostim is an implantable device that provides baroreceptor stimulation to reduce sympathetic activity in patients with HFrEF, and Impella is a percutaneous ventricular assist device that provides temporary mechanical circulatory support. By contrast, the Revivent System is designed to achieve durable left ventricular volume reduction through exclusion of scar tissue in patients with ischemic cardiomyopathy.

In the U.S., the Revivent System has the potential to address 28,000 new cases annually and 192,000 existing monitored patients, as noted above. Current treatments like ventricular assist devices (known as VADs) and heart transplants are highly invasive, costly, and, according to the Society of Thoracic Surgeons Intermacs 2025 Annual Report, are used in less than 3% of eligible patients, creating an unmet need for other options such as the Revivent System. Innovative single commercial product medical device companies have historically been acquired around approval or when revenue is meaningful and accelerating. We received reimbursement authorization in Germany, in the ALIVE trial, and the RELIVE trial, however, we cannot guarantee that our product will receive reimbursement in the United States assuming an FDA approval, nor what rate might be applied if reimbursement is granted. See *"Risk Factors – We manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable market for our product candidates. The sizes of the markets for our current product candidates have not been established with precision, and may be smaller than we estimate."* and *"Risk Factors – If hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they will gain further acceptance."*

The cardiovascular medical device industry has experienced consolidation in recent years as large medical technology companies have expanded their product portfolios through acquisitions of companies developing innovative structural-heart and heart-failure therapies. These acquisitions, which we believe can be part of the life cycle for cardiovascular device companies, have occurred across a range of development stages, including prior to FDA approval, following the obtaining of a CE Mark in Europe, and after early commercialization.

Many of the companies acquired were developing novel or first-in-class device platforms addressing significant cardiovascular disease markets, which we intend for our Revivent System. We believe these acquisitions illustrate value creation and resulting strategic activity in the structural-heart and adjacent cardiovascular device sectors as large medical technology companies seek to expand their therapeutic offerings. As we continue to develop our products and strategy, our management considers these representative transactions to be useful examples of companies who are developing novel therapeutic devices in the cardiovascular space, similar to us.

Selected examples of publicly reported acquisitions in the structural-heart and adjacent cardiovascular device sectors are summarized below. Readers are cautioned that the transactions cited illustrate industry activity and are not intended to be strictly indicative of the current or potential value of our company or our technology. Moreover, we are not presently in discussions for the sale of our company or all or any portion of our assets. Further, no assurances can be given that we will sell our company or assets, nor do we commit to enter into any such discussions, following this offering on terms similar to those set forth below, or at all.

*Selected Illustrative Structural-Heart and Cardiovascular Device Industry Transactions*

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| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **Announcement Date** | **Acquirer** | **Target** | **FDA Development Stage at Acquisition** | **Product / Technology** | **Capital Raised Prior to Acquisition ($MM)<sup>2</sup>** | **Upfront Consideration ($MM)<sup>1</sup>** | **Potential Milestone Consideration ($MM) <sup>1</sup>** | **Total Potential Consideration ($MM) <sup>1</sup>** |
| Feb 2026<sup>2</sup> | Medtronic | CathWorks | Early Commercial | FFRangio / angiography-based FF | Not disclosed | 585 |  | 585 |
| Mar 2025 | Boston Scientific | SoniVie | Pre-Approval | Intravascular Ultrasound System | 63 | 400 | 200 | 600 |
| Aug 2024 | Johnson & Johnson | V-Wave | Pre-Approval | Interatrial Shunt Device | 132 | 600 | 1100 | 1700 |
| Jul 2024<sup>5</sup> | Edwards Lifesciences | JenaValve<sup>4</sup> | Pre-Approval | Transcatheter Aortic Valve System | 364 | 1200 | 445 | 1645 |
|  |  | Endotronix | Post-Approval (June 2024); Pre- Revenue | Cordella Pulmonary Artery Pressure Monitoring System | 155 |  |  |  |
| Apr 2024 | Johnson & Johnson | Shockwave Medical | Commercial | Intravascular lithotripsy |  | 13100 |  | 13100 |
| Nov 2022 | Johnson & Johnson | Abiomed | Commercial | Impella heart pump platform |  | 16600 | 3500 | 20100 |
| Jun 2021 | Boston Scientific | Farapulse | Pre-Approval | Pulsed Field Ablation System | 36 | 295 | 92 | 387 |
| Dec 2018 | Boston Scientific | Millipede | Pre-Approval | Transcatheter Mitral Repair Ring | 49 | 325 | 125 | 450 |
| Jul 2018 | Boston Scientific | Claret Medical | Early Revenue | Cerebral Embolic Protection | 51 | 220 | 50 | 270 |
| Mar 2017 | Boston Scientific | Symetis | Early Revenue | Transcatheter Aortic Valve System | 57 | 435 |  | 435 |
| Nov 2016 | Edwards Lifesciences | Valtech Cardio | Pre-Approval | Transcatheter Mitral Valve Repair | 70 | 340 | 350 | 690 |
| Aug 2015 | Medtronic | Twelve | Pre-Approval | Transcatheter Mitral Valve Replacement |  | 408 | 50 | 458 |

---

**Sources:** Company press releases, SEC filings, and publicly available transaction announcements

**Notes:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) Consideration
 values reflect publicly reported upfront and potential milestone consideration where disclosed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) Capital
 raised reflects approximate venture funding prior to acquisition announcement based on publicly
 accessible PitchBook information and company disclosures.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3) Medtronic
 announced an intent to acquire CathWorks on February 3, 2026; the transaction was still pending
 regulatory clearance and expected to close by the end of Medtronic's fiscal 2026

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(4) Edwards
 announced on January 9, 2026 that it would not acquire JenaValve after a court blocked the
 transaction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(5) Edwards
 Lifesciences disclosed total potential consideration of approximately $1.645 billion for
 the combined acquisitions of JenaValve Technology and Endotronix, including approximately
 $1.2 billion upfront and up to $445 million in contingent milestone payments.

**Our Strategy**

Our strategy focuses on clinical validation, regulatory approval, and targeted commercialization of the Revivent System. We are advancing the pivotal RELIVE trial using only the external anchor approach and intend to seek PMA from the FDA by mid-2028. Assuming FDA approval, we expect to market the Revivent System to our RELIVE trial clinical sites and the top 30% (or approximately 336) cardiac surgery hospitals in the U.S., which provide over half of cardiac surgery procedures. We will also seek new procedure codes and reimbursement rates.

We also plan to expand our portfolio with Alginate, a hydrogel treatment for HFrEF patients without anterior scarring. We intend to access public capital markets as needed to support clinical, regulatory, and commercial expansion of Alginate.

**Our Competitive Strengths**

●  ***Serving Large Unmet Medical Need*:** No alternative device addresses severe anterior LV scarring post-STEMI. We believe this represents a $16 billion market available based on prevalence and a $2 to 3 billion market based on incidence.

●  ***Providing Hospitals and Cardiothoracic Surgeons a High-Volume and High-Value Procedure within Their Capabilities*:** Most cardiac surgery device innovation over the last two to three decades supports catheter-based procedures performed by interventional cardiologists, not surgeries performed by cardiothoracic surgeons. Hospitals typically seek to increase high-revenue elective surgeries, such as ours, and also seek to reduce bed utilization by deteriorating heart failure patients, such as our eligible patients.

●  ***Utilizing Breakthrough Device Designation to Obtain Accelerated FDA Review*:** We expect the RELIVE trial to demonstrate both adequate safety and efficacy, as determined by the FDA, and hope to receive accelerated FDA review under Breakthrough Device Designation of its RELIVE trial safety and efficacy data. However, the process of medical device development is inherently uncertain and there is no guarantee that this designation will accelerate the timeline for approval or make it more likely that the Revivent System will be approved .

●  ***An Efficacious and Patent Protected Less Invasive Therapy*:** We believe our Revivent System procedure offers a novel, less invasive procedure for left ventricular reconstruction in patients with severe anterior wall scarring following myocardial infarction.

●  ***Prospect for Achieving the Same or Better Safety and Efficacy Outcomes in Our RELIVE Trial that we Demonstrated with Statistical Significance in the ALIVE trial*:** We expect to achieve the safety and efficacy endpoints based on the ALIVE Trial evidence and potentially achieve better results than the non-randomized ALIVE Trial given that the treated and control patient populations in the RELIVE Trial should have equal health characteristics due to randomization.

●  ***Access to a Large Market Driven by Potential Healthcare Savings and Quality of Life Improvements*:** If the RELIVE trial indeed demonstrates a significant improvement in the hierarchical composite endpoints which include death, heart failure hospitalization, quality of life, and functional measures and meets its safety endpoint (as it did in the ALIVE trial), we expect the FDA to approve the Revivent System thus allowing us to provide a significant new treatment for patients. However, the results of the ALIVE trial may not be replicated or ultimately accepted by the FDA as part of our PMA submission.

●  ***Demonstrated Trial Progress*:** We are engaged with 16 sites needed for our RELIVE Trial of which eight sites have been activated. Activated sites include: Saint Luke's Hospital of Kansas City (part of Saint Luke's Health System), Oklahoma Heart Hospital (part of Ascension St. John Health System), Penn State Health Milton S. Hershey Medical Center, Baptist Health South Florida, Banner University Medical Center Phoenix, Duke University Hospital, University of Chicago Medical Center, and Tampa General Hospital.

●  ***Experienced Clinical Trial and Manufacturing Management across Cardiovascular Devices and Specifically Running the Needed Trial*:** Our Chief Medical Officer and Co-CEO have played major roles in running many cardiovascular trials. Complemented by a team of industry consultants, our leadership team brings deep medical affairs, clinical trial management, regulatory, and manufacturing expertise and established relationships with leading clinical investigators and trial sites.

●  ***Expanding Product Portfolio and Product Synergies*:** In addition to the Revivent System, we hold ownership rights to Alginate, a therapeutic device designed to treat heart failure patients without myocardial scarring. This device was CE-marked in Europe, had received an IDE in the U.S. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the FDA regarding a proposed plan), and represents a significant opportunity for expanding our addressable market and diversifying our product offerings.

●  ***Robust IP Portfolio*:** Multiple U.S. and international patents, some of which extend through 2041.

**Management**

Our management team is made up of experienced executives and medical professionals. In January 2024, we appointed David Richmond, our Chairman, Co-Chief Executive Officer, and Chief Financial Officer. Mr. Richmond restored senior management running the clinical, manufacturing, and regulatory functions, including Steven Chartier, our President and Co-Chief Executive Officer since January 2025 and Dr. Ori Ben-Yehuda, who rejoined as Chief Medical Officer in January 2024. As of this filing our management team led the RELIVE Trial design, secured the regulatory approvals necessary to start our trial, activated eight sites, maintained manufacturing and regulatory compliance, secured German reimbursement, attracted clinical trial sites, recruited three board members, and recruited two national principal investigators.

**Summary of Risk Factors**

***Investing in our common stock is speculative and involves a high degree of risk***. These risks are discussed more fully in "Risk Factors" and elsewhere in this prospectus. We urge you to read "Risk Factors" beginning on page 10 and this prospectus in full. Our significant risks may be summarized as follows:

**Risks Related to Our Industry and Business**

● We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever generate revenue or achieve profitability (of which no assurances can be given), we may not be able to sustain it.

● We will require substantial additional capital to finance our planned operations, which may not be available to us on acceptable terms or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or eliminate our product development programs, commercialization efforts or other operations.

● If we are unable to establish an effective network for commercialization, including effective distribution channels and sales and marketing functions, it may adversely affect our business, financial condition, results of operations, and prospects.

● We will initially depend on revenue generated from a single product and in the foreseeable future will be significantly dependent on a limited number of product candidates.

● The commercial success of our product candidates will depend upon attaining significant market acceptance of these product candidates among physicians, healthcare payors and the medical community.

● We manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable market for our product candidates. The sizes of the markets for our current product candidates have not been established with precision and may be smaller than we estimate.

● Even if we are able to launch our pipeline portfolio successfully, we may experience material delays in our commercialization program relative to our current expectations.

● If hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they will gain further acceptance.

● Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.

● Clinical trials may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to develop new product candidates or seek new indications.

● We depend on a limited number of manufacturers and suppliers in connection with the manufacture of the Revivent System, which makes us vulnerable to supply shortages and price fluctuations that could have a material adverse effect on our business, financial condition, results of operations, and prospects.

● The report of our independent registered public accounting firm for the year ended December 31, 2025 includes a "going concern" explanatory paragraph.

&nbsp;&nbsp;&nbsp;&nbsp;

● We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.

● Product liability claims could damage our reputation and adversely affect our financial results.

**Risks Related to Our Intellectual Property and Technology**

● If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, or if customers, patients and other partners are reluctant to use our devices because of concerns about the privacy or security of their data, we may face additional costs, loss of revenue, significant liabilities, harm to our brand, decreased use of our platform and business disruption.

● We will be required to comply with our obligations in our intellectual property licenses and other agreements with third parties.

● If we are unable to adequately protect our proprietary technology or obtain and maintain issued patents that are sufficient to protect our product candidates, product candidates, and methods others could compete against us more directly, which could harm our business, financial condition and results of operations.

● We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.

● Intellectual property rights do not necessarily address all potential threats.

**Risks Related to Regulatory Approval and Other Governmental Regulations**

● We intend to expand sales of any approved product candidates internationally in the future, but we may experience difficulties in obtaining regulatory clearance or approval in the United States or in successfully marketing our product candidates internationally even if approved. A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.

● If we fail to obtain and maintain necessary governmental approvals for our product candidates and indications, we may be unable to market and sell our product candidates in certain jurisdictions.

● Our product candidates are subject to extensive regulatory requirements, including continuing regulatory review, which could affect the manufacturing and marketing of our product candidates.

● Our product candidates may be subject to extensive governmental regulation in foreign jurisdictions, such as the European Economic Area (EEA), and our failure to comply with applicable requirements could cause our business, results of operations and financial condition to suffer.

● The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable.

● While BDD allows for increased interaction with FDA reviewers and prioritized submission review, it does not guarantee product approval, faster approval, or commercial success.

**Risks Related to Our Securities and this Offering**

● The trading price of our common stock may be volatile, and you could lose all or part of your investment.

● Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.

● Our management will have broad discretion in how we use the net proceeds from this offering and might not use them effectively.

● You will experience immediate and substantial dilution as a result of this offering and may experience additional dilution in the future.

**Implications of Being an Emerging Growth Company**

We qualify as an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). For as long as we remain an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies. These provisions include, but are not limited to:

● being permitted to have only two years of audited financial statements and only two years of related management's discussion and analysis of financial condition and results of operations disclosure;

● an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, as amended (the "Sarbanes-Oxley Act");

● reduced disclosure about executive compensation arrangements in our periodic reports, registration statements, and proxy statements; and

● exemptions from the requirements to seek non-binding advisory votes on executive compensation or golden parachute arrangements.

In particular, in this prospectus, we have provided only two years of audited financial statements and have not included all of the executive compensation-related information that would be required if we were not an emerging growth company. Accordingly, the information contained herein may be different from the information you receive from other public companies in which you hold stock.

In addition, the JOBS Act permits emerging growth companies to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are not choosing to "opt out" of this provision. We will remain an emerging growth company until the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues exceed $1.235 billion, (ii) the date on which we first qualify as a large accelerated filer under the rules of the Securities and Exchange Commission (the "SEC"), (iii) the date on which we have, in any three-year period, issued more than $1.0 billion in non-convertible debt securities, and (iv) the last day of the fiscal year following the fifth anniversary of the completion of this offering.

**Implications of Being a Smaller Reporting Company**

Following this offering, we will be a "smaller reporting company" as defined in Rule 12b-2 under the Exchange Act. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that our voting and non-voting common stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter.

**Corporate Information**

We are currently a Delaware corporation. Our predecessor, CHF Technologies, Inc., was incorporated under the laws of the State of California on October 15, 2003. On June 8, 2012, we incorporated BioVentrix, Inc. under the laws of the State of Delaware, which subsequently merged into CHF Technologies, Inc., with BioVentrix, Inc. as the surviving corporation in the merger. Our principal executive office is located at 120 Forbes Blvd., Suite 125, Mansfield, MA 02048. Our telephone number is (925) 290-1000 and our website is *www.bioventrix.com*. Information contained on, or available through, our website does not constitute part of, and is not deemed incorporated by reference into, this prospectus, and investors should not consider any such information as part of this prospectus.

**THE OFFERING**

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| | |
|:---|:---|
| **Common Stock Offered by Us** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;shares of common stock on a firm commitment basis (or shares of common stock if the underwriters exercise their over-allotment option in full). |
| **Common Stock Outstanding Prior to This Offering** | 5,712,645 shares of common stock outstanding as of December 31, 2025. |
| **Common Stock to Be Outstanding Immediately After Completion of This Offering <sup>(1)</sup>** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;shares of common stock (or shares of common stock if the underwriters exercise their over-allotment option in full). |
| **Over-allotment Option** | We have granted the underwriters a 30-day option to purchase up to an additional shares of our common stock at the initial public offering price, less underwriting discounts and commissions, solely to cover over-allotments, if any. |
| **Use of Proceeds** | We estimate that the net proceeds to us from this offering, after deducting the underwriting discounts and estimated offering expenses payable by us, will be approximately $ million, or approximately $ million if the underwriters exercise their over-allotment option in full, based on the assumed initial public offering price of $ per share.<br>The net proceeds received by us from this offering will be used primarily to fund the RELIVE clinical trial and the associated manufacturing activities required to support such trial. The remaining portion of the net proceeds will be used to fund working capital and general and administrative expenses. See "*Use of Proceeds*." |
| **Underwriters' Warrants** | The registration statement of which this prospectus is a part also registers the offer and sale of common stock purchase warrants to be issued to the underwriters (the "Underwriters' Warrant") to purchase shares of our common stock (or 5% of the shares of common stock sold in this offering), including any shares of common stock sold pursuant to the exercise of the underwriters' over-allotment option, and the shares of our common stock issuable upon exercise of the Underwriters' Warrants. The Underwriters' Warrants are being issued to the underwriters as a portion of the underwriting compensation payable in connection with this offering. The Underwriters' Warrants are exercisable at any time, and from time to time, in whole or in part, from the first day of the seventh month after the closing of this offering, to the date that is five years from the date of commencement of sales in this offering, at an exercise price equal to the initial public offering price of the shares of common stock. Please see "*Underwriting — Underwriters' Warrants*" for further information. |

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| | |
|:---|:---|
| **Listing** | We have applied to have our common stock listed on Nasdaq. No assurance can be given that our listing will be approved by Nasdaq or that a trading market will develop for our common stock. We will not proceed with this offering in the event that our common stock is not approved for listing on Nasdaq. |
| **Proposed Nasdaq symbol** | "BVXX" |
| **Risk Factors** | ***Investing in our common stock is speculative and involves a high degree of risk***. See "*Risk Factors*" beginning on page 10 and the other information in this prospectus for a discussion of the factors you should consider carefully before you decide to invest in our common stock. |
| **Lock-Up** | In connection with this offering, we, our executive officers, directors, and our existing stockholders have agreed not to offer, sell or otherwise transfer or dispose of any shares of our capital stock for a period of six (6) months following the closing of this offering. See "*Underwriting*" beginning on page 116 for more information. |
| **Transfer Agent** | The transfer agent and registrar for our common stock is Issuer Direct Corporation. |

---

(1) The
 number of shares of our common stock to be outstanding upon completion of this offering will be 
 shares assuming no exercise of the over-allotment by the underwriters, which is based on 5,712,645 shares of our common stock outstanding
 as of December 31, 2025, and 7,664,988 shares of common stock being issued upon the closing of this offering in connection
 with the conversion of: (i) 1,565,000 shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock (assuming
 an initial public offering price of at least $10.00 and an assumed conversion price of $10.00) and (ii) $11,333,146 of
 our existing convertible notes into 6,099,988 shares of our common stock (assuming an initial public offering price of
 at least $10.00 and an assumed conversion price of $10.00), and excludes, as of the date of this prospectus:

● shares of common stock issuable upon the exercise of the Underwriters' Warrants;

● 950,500 shares of our common stock reserved for issuance under stock option agreements issued pursuant to the BioVentrix 2024 Equity Incentive Plan (the "2024 Plan"); and

● 549,500 shares of our common stock (which is equal to % of our issued and outstanding common stock immediately after the consummation of this offering) reserved for future issuance under the BioVentrix, Inc. 2026 Equity Incentive Plan (the "2026 Plan"), which will become effective as of the closing of this offering.

Unless otherwise indicated, this prospectus reflects and assumes (i) no exercise by the underwriters of their over-allotment option and (ii) no exercise of the outstanding stock options described above.

**SUMMARY OF CONSOLIDATED FINANCIAL INFORMATION**

The following tables set forth summary financial and other data for the periods ended and at the dates indicated below. Our summary financial information for the years ended December 31, 2025 and 2024 and as of December 31, 2025 and 2024 has been derived from our audited financial statements included in this prospectus. The financial data set forth below should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the financial statements and notes thereto included elsewhere in this prospectus.

---

| | | |
|:---|:---|:---|
|  | **For the Year Ended**<br> **December 31, 2025** | **For the Year Ended**<br> **December 31, 2024** |
| **Statement of Operations Data:** |  |  |
| Gross (loss) profit | $- | $- |
| Operating expense | 6270430 | 3562516 |
| Operating loss | (6270430) | (3562516) |
| Other expenses (income) | 1397241 | 288158 |
| Net loss before taxes | (7667671) | (3850674) |
| Income tax expense (benefit) |  |  |
| Net loss | (7667671) | (3850674) |
| **Net loss per share of common stock:** |  |  |
| Basic | $(1.35) | $(0.72) |
| **Weighted-average shares of common stock outstanding:** |  |  |
| Basic | 5696603 | 5355663 |

---

***Balance Sheet***

---

| | | |
|:---|:---|:---|
|  | **As of December 31, 2025** | **As of December 31, 2024** |
| **Balance Sheet Data:** |  |  |
| Cash | $1838121 | $2637635 |
| Working capital (deficit) | $(11592497) | $(4989308) |
| Total assets | $2568861 | $3279249 |
| Total liabilities | $15134042 | $8318384 |
| Additional paid-in capital | $218675435 | $218533820 |
| Accumulated deficit | $(231241344) | $(223573673) |
| Total stockholders' deficiency | $(11965181) | $(5039135) |

---

**RISK FACTORS**

***An investment in our common stock is speculative and involves a high degree of risk.*** *You should carefully consider the risks described below, which we believe represent certain of the material risks to our business, together with the information contained elsewhere in this prospectus, before you make a decision to invest in our shares of common stock. Please note that the risks highlighted here are not the only ones that we may face. For example, additional risks presently unknown to us or that we currently consider immaterial or unlikely to occur could also impair our operations. If any of the following events occur or any additional risks presently unknown to us actually occur, our business, financial condition and operating results may be materially adversely affected. In that event, the trading price of our securities could decline and you could lose all or part of your investment.*

**Risks Related to Our Industry and Business**

***We have a history of net losses, and we expect to continue to incur losses for the foreseeable future. If we ever generate revenue or achieve profitability (of which no assurances can be given), we may not be able to sustain it.***

We have incurred significant losses since our inception and expect to continue to incur losses for the foreseeable future. We have reported net losses of approximately $3.9 million and $7.7 million for the years ended December 31, 2024 and 2025, respectively. As a result of these losses, as of December 31, 2025, we had an accumulated deficit of approximately $231.2 million. To date, we have financed our operations primarily through debt and equity financings. We expect to continue to incur significant research and development, regulatory, sales and marketing and other expenses as we expand our marketing efforts to increase adoption of our product candidates, expand existing relationships with our customers, obtain regulatory clearances or approvals for our planned or future product candidates, conduct clinical trials on our existing and planned or future product candidates and develop new product candidates or add new features to our existing product candidates. In addition, we expect our general and administrative expenses to increase following this offering due to the additional costs associated with being a public company. The net losses that we incur may fluctuate significantly from period to period. We will need to generate significant revenue in order to achieve and sustain profitability. Even if we ever generate revenue or achieve profitability (of which no assurances can be given), we cannot be sure that such revenues will continue or that we will remain profitable for any substantial period of time.

***We will require substantial additional capital to finance our planned operations, which may not be available to us on acceptable terms or at all. Our failure to obtain additional financing when needed on acceptable terms, or at all, could force us to delay, limit, reduce or eliminate our product development programs, commercialization efforts or other operations.***

Since inception, we have incurred significant net losses and expect to continue to incur net losses for the foreseeable future. Since our inception, our operations have been financed primarily by net proceeds from the sale of our equity and debt securities. We have ongoing clinical trials, and expect to continue to make substantial investments in these trials and in additional clinical trials that are designed to provide clinical evidence of the safety and efficacy of our product candidates, which would ultimately be determined by the FDA. We intend to continue to make significant investments in our sales and marketing organization by increasing the number of U.S. sales representatives and expanding our international marketing programs to help facilitate further adoption among existing hospital accounts as well as broaden awareness of our product candidates to new hospitals. We also expect to continue to make investments in research and development, regulatory affairs and clinical studies to develop future generations of our product candidates, support regulatory submissions and demonstrate the clinical efficacy of our product candidates. Moreover, we expect to incur additional expenses associated with operating as a public company, including legal, accounting, insurance, exchange listing and SEC compliance, investor relations and other expenses. Because of these and other factors, we expect to continue to incur substantial net losses and negative cash flows from operations for the foreseeable future. Our future capital requirements will depend on many factors, including:

● the cost, timing and results of our clinical trials and regulatory reviews;

● the cost and timing of establishing sales, marketing and distribution capabilities;

● the terms and timing of any other collaborative, licensing and other arrangements that we may establish;

● the timing, receipt and amount of sales from our current and potential product candidates;

● the degree of success we experience in commercializing our product candidates;

● the emergence of competing or complementary technologies;

● the cost of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights; and

● the extent to which we acquire or invest in businesses, product candidates or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

We will require additional financing to fund working capital and pay our obligations. We may seek to raise any necessary additional capital through a combination of public or private equity offerings and/or debt financings. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. If adequate funds are not available on acceptable terms when needed, we may be required to significantly reduce operating expenses, which may have a material adverse effect on our business and/or results of operations and financial condition. If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders' rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through strategic collaborations or marketing, distribution, licensing and royalty arrangements with third parties, we may have to relinquish valuable rights to our intellectual property or technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us or issue equity or convertible debt securities, which may result in dilution to our stockholders. Additional capital may not be available on reasonable terms, or at all.

***If we are unable to establish an effective network for commercialization, including effective distribution channels and sales and marketing functions, it may adversely affect our business, financial condition, results of operations, and prospects.***

Our limited commercialization experience and lack of approved or cleared product candidates in the United States make it difficult to evaluate our current business and assess our prospects. We also currently have limited sales and marketing experience. If we are unable to establish effective sales and marketing capabilities or if we are unable to commercialize any of our product candidates, we may not be able to effectively generate product revenue, sustain revenue growth and compete effectively. In order to generate future growth, we plan to continue to expand and leverage our sales and marketing infrastructure to increase our customer base and grow our business. Identifying and recruiting qualified sales and marketing personnel and training them on our product candidates, applicable federal and state laws and regulations, and on our internal policies and procedures requires significant time, expense and attention. It often takes several months or more before a sales representative is fully trained and productive. Our business may be harmed if our efforts to expand and train our sales force do not generate a corresponding increase in revenue, and our higher fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand for our product candidates. Any failure to hire, develop and retain talented sales and marketing personnel, to achieve desired productivity levels in a reasonable timeframe or timely leverage our fixed costs could have a material adverse effect on our business, financial condition and results of operations. Moreover, the members of our direct sales force will likely be at-will employees. The loss of these personnel to competitors or otherwise could materially harm our business. If we are unable to retain our direct sales force personnel or replace them with individuals of equivalent technical expertise and qualifications, or if we are unable to successfully instill technical expertise in replacement personnel, our revenue and results of operations could be materially harmed.

Our ability to increase our customer base and achieve market acceptance of our product candidates will also depend to a significant extent on our ability to develop and expand our marketing efforts as we plan to dedicate significant resources to our marketing programs. Our business may be harmed if our marketing efforts and expenditures do not generate a corresponding increase in revenue. In addition, we believe that developing and maintaining broad awareness of our brand in a cost-effective manner is critical to achieving broad acceptance of our product candidates and penetrating new customer accounts. Brand promotion activities may not generate patient or physician awareness or increased revenue, and even if they do, any increase in revenue may not offset the costs and expenses we incur in building our brand. If we fail to successfully promote, maintain and protect our brand, or if we incur substantial expenses in an unsuccessful attempt to promote and maintain our brand, we may fail to attract or retain the physician acceptance necessary to realize a sufficient return on our brand building efforts, or to achieve the level of brand awareness that is critical for broad adoption of our product candidates, which would have an adverse effect on our business, financial condition and results of operations.

These factors also make it difficult for us to forecast our financial performance and growth, and such forecasts are subject to a number of uncertainties, including our ability to successfully develop additional product candidates that add functionality, reduce the cost of product candidates sold, broaden our commercial portfolio offerings and obtain FDA 510(k) clearance or premarket approval ("PMA") for, and successfully commercialize, market and sell, our planned or future product candidates in the United States or in international markets. See "*Risks Related to Regulatory Approval and Other Governmental Regulations — The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable*." If our assumptions regarding the risks and uncertainties we face, which we use to plan our business, are incorrect or change due to circumstances in our business or our markets, or if we do not address these risks successfully, our operating and financial results could differ materially from our expectations and our business could suffer.

***We have limited experience marketing and selling our product candidate.***

Our limited commercialization experience and limited number of approved or cleared product candidates make it difficult to evaluate our current business and predict our future prospects. These factors also make it difficult for us to forecast our future financial performance and growth, and such forecasts are subject to a number of uncertainties, including our ability to successfully complete clinical trials and obtain pre-market approval or 510(k) clearance by the FDA for our current investigational and future planned product candidates in the United States or in key international markets. Our commercialization efforts will depend on the efforts of our management and sales team, our third-party suppliers, physicians and hospitals, and general economic conditions, among other factors, including the following:

● the effectiveness of our marketing and sales efforts in the United States and internationally;

● our success in educating physicians and patients about the benefits, administration and use of the Revivent System, if approved;

● the acceptance by physicians, patients and payors of the safety and effectiveness of the Revivent System, including the long-term data;

● our third-party suppliers' ability to supply the components utilized in the Revivent System in a timely manner, in accordance with our specifications and in compliance with applicable regulatory requirements, and to remain in good standing with regulatory agencies;

● the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing therapies;

● our ability to obtain, maintain and enforce our intellectual property rights in and to the Revivent System;

● the emergence of competing technologies and other adverse market developments, and our need to enhance the Revivent System or develop new product candidates to maintain market share in response to such competing technologies or market developments;

● our ability to raise additional capital on acceptable terms, or at all, if needed to support the commercialization of the Revivent System; and

● our ability to achieve and maintain compliance with all regulatory requirements applicable to the Revivent System.

If our assumptions regarding the risks and uncertainties we face, which we use to plan our business, are incorrect or change due to circumstances in our business or our markets, or if we do not address these risks successfully, it will negatively affect our business, financial condition and results of operations.

***We will initially depend on revenue generated from a single product and in the foreseeable future will be significantly dependent on a limited number of product candidates.***

In the event we are able to successfully develop, gain regulatory approval for and commercialize our Revivent technology in the United States (of which no assurances can be given as to any of these matters), we will initially depend on revenue generated from our Revivent product for the foreseeable future and will be significantly dependent on a single or limited number of product candidates. Given that, for the foreseeable future, our business will depend on a single or limited number of product candidates, to the extent that a particular product is not well-received by the market, our sales volume, prospects, business, results of operations and financial condition could be materially and adversely affected.

***We may expend our limited resources to pursue a particular product or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.***

Because we have limited financial and managerial resources, we focus on specific product candidates, indications and discovery programs. As a result, we may forgo or delay pursuit of other opportunities with others that could have had greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial product candidates or profitable market opportunities. Our spending on current and future research and development programs for specific indications may not yield any commercially viable product candidates. If we do not accurately evaluate the commercial potential or target market for a particular potential product, we may relinquish valuable rights to that potential product through future collaborations, licenses and other similar arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such potential product.

***The commercial success of our product candidates will depend upon attaining significant market acceptance of these product candidates among physicians, healthcare payors and the medical community.***

Our success will depend, in part, on the acceptance of our product candidates as safe, effective and, with respect to providers and third party payors, cost effective. We cannot predict how quickly, if at all, physicians will accept our product candidates or, if accepted, how frequently they will be used. Our product candidates and planned or future product candidates we may develop or market may never gain broad market acceptance among physicians, the medical community or third party payors for some or all of our targeted indications. Healthcare providers must believe that our product candidates offer benefits over alternative treatment methods. The degree of market acceptance of any of our product candidates will depend on a number of factors, including:

● whether physicians and others in the medical community consider our product candidates to be safe and cost effective treatment methods;

● the potential and perceived advantages of our product candidates over alternative treatment methods;

● the prevalence and severity of any side effects associated with using our product candidates;

● product labeling, product insert or marketing and advertising requirements by the FDA or other regulatory authorities;

● limitations or warnings contained in the labeling cleared or approved by the FDA or other authorities;

● the cost of treatment in relation to alternative treatments methods;

● the convenience and ease of use of our product candidates relative to alternative treatment methods;

● the availability of coverage and adequate reimbursement for procedures using our product candidates from third-party payors, including government authorities;

● the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors, including government authorities;

● the size of the market for such product, based on the size of the patient subsets that we are targeting, in the territories for which we gain regulatory approval;

● our ability to provide incremental clinical and economic data that show the safety, clinical efficacy and cost effectiveness of, and patient benefits from, our product candidates; and

● the effectiveness of our sales and marketing efforts for our product candidates.

Additionally, even if our product candidates achieve market acceptance, they may not maintain that market acceptance over time if competing product candidates or technologies, which are more cost effective or received more favorably, are introduced. Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition and results of operations.

***We manufacture and sell product candidates that are used in a limited number of procedures and there is a limited total addressable market for our product candidates. The sizes of the markets for our current product candidates have not been established with precision, and may be smaller than we estimate.***

The Revivent System, in the event it achieves FDA approval or clearance, intends to target an identifiable U.S. patient population of approximately 192,000 monitored individuals suffering from STEMI induced heart failure, with an additional 28,000 patients added and 28,000 patients lost each year. With approximately 192,000 monitored individuals, the potentially addressable U.S. patient population for the Revivent System remains substantial. We believe that we are well-positioned to serve a substantial, underserved global addressable market of $16 billion in eligible and appropriate patients (prevalence) and once served, $2.4 billion of annually recurring patients (incidence); the U.S. could potentially represent a $10 billion addressable market. However, the total addressable market for our product candidates is subject to change from year to year and geography, and may be further limited by FDA restrictions, limitations on use or more narrowly defined indications, any of which could have a material adverse effect on our business, financial condition and results of operations.

Our estimates of the annual total addressable markets for our current product candidates are based on a number of internal and third-party estimates, including, without limitation, the number of individuals suffering from STEMI-induced heart failure treatable by our product candidates and the assumed prices at which we can sell our product candidates in markets that have not yet been fully established. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, our estimates of the annual total addressable market for our current or future product candidates may prove to be incorrect. If the actual number of patients who would benefit from our solution, the price at which we can sell our product candidates, or the annual total addressable market for our product candidates is smaller than we have estimated, it may impair our sales growth and negatively affect our business, financial condition and results of operations.

***The estimates and projections that we may make from time to time are subject to inherent risks and may prove incorrect in the future.***

The estimates and projections we describe in this prospectus and may provide from time to time in the future (including, but not limited to, those relating to addressable market sizes, target patient populations, procedure costs, insurance reimbursement levels and other financial or operational matters) reflect numerous assumptions made by management, including assumptions with respect to our specific as well as general business, economic, market and financial conditions and other matters, all of which are difficult to predict and many of which are beyond our control. For our company in particular, since the condition we are targeting with the Revivent System (restoring left ventricular function in heart failure patients with reduced ejection fraction) is a subset of overall heart failure and heart disease, we are required to extrapolate different data to reach conclusions regarding certain of our estimates and projections (for example, see the section of this prospectus captioned Business – Market Opportunity Assumptions). Accordingly, there is a risk that the assumptions made in preparing our estimates and projections, or the estimates and projections themselves, will prove inaccurate. There will be differences between actual and projected results, and actual results may be materially different from those contained in our estimates and projections. The inclusion of such estimates projections in this prospectus should not be regarded as an indication that we or our management or representatives considered or consider the projections to be a reliable prediction of future events, and our estimates and projections should not be relied upon as such.

***We may be unable to continue to successfully demonstrate to heart failure specialists, surgeons, or key opinion leaders the merits of our product candidates and technologies compared to those of our competitors, which may make it difficult to establish our product candidates and technologies as a standard of care and achieve market acceptance.***

Heart failure specialists and surgeons play the primary role in determining the course of treatment and, ultimately, the type of product candidates that will be used to treat our patient phenotype. As a result, our success depends, in large part, on our ability to effectively market and demonstrate to heart failure specialists and cardiovascular surgeons the merits of our product candidates and methodologies compared to those of our competitors. Acceptance of our product candidates and methodologies depends on educating surgeons as to the distinctive characteristics, clinical benefits, safety and cost-effectiveness of the Revivent System and our other product candidates and technologies as compared to those of our competitors, and on training surgeons in the proper use of our product candidates. If we are not successful in convincing heart failure specialists and surgeons of the merits of our product candidates and methodologies or educating them on the use of our product candidates, they may not use our product candidates or may not use them effectively and we may be unable to increase our sales, sustain our growth or achieve and sustain profitability.

Additionally, since the Revivent procedure is a new procedure, some heart failure specialists and surgeons may be reluctant to change their treatment practices for the following reasons, among others:

● lack of experience with our product candidates and procedures;

● existing relationships with competitors and distributors that sell competitive product candidates;

● lack or perceived lack of evidence supporting additional patient benefits;

● perceived liability risks generally associated with the use of new product candidates and procedures;

● less attractive availability of coverage and reimbursement by third-party payors compared to procedures using competitive product candidates and other techniques;

● costs associated with the purchase of new product candidates and equipment; and

● the time commitment that may be required for training.

These reasons may affect the pace of adoption of the Revivent System and future product candidates and techniques that we may offer.

In addition, third party payors, including private and government healthcare programs, would need to understand the costs and benefits of our product candidates compared to existing standards of care, if they are to provide reimbursement for the cost of our product candidates and the procedures to implant our product candidates. We believe recommendations and support of our product candidates and technologies by influential heart failure specialists, surgeons, and key opinion leaders in our industry are essential for market acceptance and establishment of our product candidates and procedures as a standard of care. If we do not receive support from such heart failure specialists, surgeons, and key opinion leaders, if long-term data does not show the benefits of using our product candidates and procedures or if the benefits offered by our product candidates and procedures are not sufficient to justify their cost, heart failure specialists, surgeons, and hospitals may not use our product candidates and we might be unable to establish our product candidates and procedures as a standard of care and continue to achieve market acceptance.

***The training required for clinicians to use our product candidates could reduce the market acceptance of our product candidates and reduce our revenue.***

Clinicians must be trained to use our product candidates proficiently. It is critical to the success of our business that we ensure that there are a sufficient number of clinicians familiar with, trained on and proficient in the use of our product candidates. Convincing clinicians to dedicate the time and energy necessary to obtain adequate training in the use of our product candidates is challenging and we may not be successful in these efforts. If clinicians are not properly trained, they may misuse or ineffectively use our product candidates. Any improper use of our product candidates may result in unsatisfactory patient outcomes, patient injury, negative publicity or lawsuits against us, any of which could harm our reputation and affect future product sales. Furthermore, our inability to educate and train clinicians to use our product candidates may lead to lower demand for our product candidates.

***Even if we are able to launch our pipeline portfolio successfully, we may experience material delays in our commercialization program relative to our current expectations.***

Even if we are able to complete development of our pipeline portfolio and obtain regulatory clearance or approval, commercial market acceptance of our product candidates in the healthcare community, including among physicians, patients and third-party payors, will depend on many factors, including:

● our ability to provide incremental clinical and economic data demonstrating the safety, clinical effectiveness and cost-effectiveness of, and patient benefit from, our product candidates, and any perceived inadequacy of evidence supporting clinical benefits or cost-effectiveness over existing alternatives;

● the availability of alternative treatments;

● whether our product candidates are included on third party payor coverage plans;

● the willingness and ability of patients and the healthcare community to adopt new technologies;

● customer demand;

● liability risks generally associated with the use of new product candidates;

● the training required to use a new product;

● the convenience and ease of use of our product candidates relative to other treatment methods;

● the pricing and reimbursement of our product candidates relative to other treatment methods; and

● the marketing and distribution support for our product candidates.

There is a risk that we may be unable to address any of these criteria or any additional criteria that might affect the market acceptance of our product candidates. If our product candidates achieve market acceptance, they may not maintain that market acceptance over time if competing product candidates or technologies are introduced that are received more favorably or are more cost-effective. Failure to achieve or maintain market acceptance would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition, results of operations and prospects.

***Our employees, independent contractors, consultants, commercial partners, distributors, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.***

We operate in a highly regulated industry. We are exposed to the risk that our employees, independent contractors, consultants, commercial partners, distributors, and vendors may engage in fraudulent or illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the laws of the FDA and other similar foreign regulatory bodies, including those laws requiring the reporting of true, complete and accurate information to such regulators; (ii) manufacturing standards; (iii) healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or (iv) laws that require the true, complete and accurate reporting of financial information or data. These laws may impact, among other things, future sales, marketing, and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

We plan to adopt a code of business conduct and ethics in connection with the closing of this offering, but it may not always be possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, additional integrity reporting and oversight obligations, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results of operations. Whether or not we are successful in defending against any such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which could have a material adverse effect on our business, financial condition, and results of operations.

***We may be unable to compete successfully with larger companies in our highly competitive industry.***

The medical device industry is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants. We compete or plan to compete with other providers of cardiovascular procedures. While we believe that there are currently no direct substitutes to our product candidates available or in clinical development, a competitor may develop a comparable product in the future. Many of these competitors are large, well-capitalized companies with significantly greater market share and resources than we have. As a consequence, they are able to spend more on product development, marketing, sales and other product initiatives than we can. We also compete with smaller medical device companies that have single product candidates or a limited range of product candidates. Some of our competitors have:

● significantly greater name recognition;

● broader or deeper relations with healthcare professionals, customers and third-party payors;

● more established distribution networks;

● additional lines of product candidates and the ability to offer rebates or bundle product candidates to offer greater discounts or other incentives to gain a competitive advantage;

● greater experience in conducting research and development, manufacturing, clinical trials, marketing and obtaining regulatory clearance or approval for product candidates; and

● greater financial and human resources for product development, sales and marketing and patent litigation.

We believe that our intellectual property, technology and organization will be critical to our future success. Our competitive advantage is driven by our ability to safely and effectively treat patients with left ventricle heart failure while improving outcomes and reducing procedural costs. To sustain our success, we will need to:

● develop innovative, proprietary product candidates that can cost-effectively address significant clinical needs;

● continue to innovate and develop scientifically advanced technology;

● obtain and maintain regulatory clearances or approvals;

● demonstrate efficacy in our sponsored and third-party clinical trials and studies;

● apply our technology across product lines and markets;

● attract and retain skilled research and development and sales personnel; and

● cost-effectively manufacture and successfully market and sell product candidates.

In addition, competitors with greater financial resources than ours could acquire other companies to gain enhanced name recognition and market share, as well as new technologies or product candidates that could effectively compete with our existing product candidates, which may cause our revenue to decline and would harm our business.

Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, as well as in acquiring technologies complementary to, or necessary for, our product candidates. Because of the complex and technical nature of our product candidates and the dynamic market in which we compete, any failure to attract and retain a sufficient number of qualified employees could materially harm our ability to develop and commercialize our product candidates, which would have a material adverse effect on our business, financial condition and results of operations.

***Technological change may adversely affect sales of our product candidates and may cause our product candidates to become obsolete.***

The medical device market is characterized by extensive research and development and rapid technological change. Technological progress or new developments in our industry could adversely affect sales of our product candidates. There can be no assurance that other companies will not succeed in developing or marketing devices and product candidates that are more effective than the Revivent System or that would render the Revivent System obsolete or noncompetitive. Additionally, new surgical procedures, medications and other therapies could be developed that replace or reduce the importance of our product candidates. Our product candidates could be rendered obsolete because of future innovations by our competitors or others in the treatment of cardiovascular diseases, which would have a material adverse effect on our business, financial condition and results of operations. Accordingly, our success will depend in part on our ability to respond quickly to medical and other changes through the development and introduction of new product candidates. Product development involves a high degree of risk, and there can be no assurance that our new product development efforts will result in any commercially successful product candidates.

***If hospitals, clinicians and other healthcare providers are unable to obtain coverage and reimbursement from third-party payors for procedures performed using our product candidates, adoption of our product candidates may be delayed, and it is unlikely that they will gain further acceptance.***

Growing sales of our product depends on the availability of adequate coverage and reimbursement from third-party payors, including government programs such as Medicare and Medicaid, private insurance plans, and managed care programs. Hospitals, clinicians, and other healthcare providers that purchase or use medical devices generally rely on third-party payors to pay for all or part of the costs and fees associated with the procedures performed with these devices.

Adequate coverage and reimbursement for procedures performed with our product candidates is central to the acceptance of our current and future product candidates. We may be unable to sell our product candidates on a profitable basis if third-party payors deny coverage, continue to deny coverage or reduce their current levels of payment, or if our costs for the product increase faster than increases in reimbursement levels.

Many private payors refer to coverage decisions and payment amounts determined by the Centers for Medicare and Medicaid Services ("CMS") which administers the Medicare program, as guidelines for setting their coverage and reimbursement policies. Private payors that do not follow the Medicare guidelines may adopt different coverage and reimbursement policies for procedures performed with our product candidates. Future action by CMS or third-party payors may further reduce the availability of payments to physicians, outpatient surgery centers, and/or hospitals for procedures using our product candidates.

The healthcare industry in the United States has experienced a trend toward cost containment as government and private insurers seek to control healthcare costs. Payors are imposing lower payment rates and negotiating reduced contract rates with service providers and being increasingly selective about the technologies and procedures they choose to cover. There can be no guarantee that we will be able to provide the scientific and clinical data necessary to overcome these policies. Payors may adopt policies in the future restricting access to medical technologies like ours and/or the procedures performed using such technologies. Therefore, we cannot be certain that the procedures performed with each of our product candidates will be reimbursed. There can be no guarantee that, should we introduce additional product candidates in the future, payors will cover those product candidates or the procedures in which they are used.

***Conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.***

Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability of appropriate clinical trial investigators; support staff; and the proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our product candidates or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive product candidates.

***It may be difficult to identify and enroll patients due to clinical trial inclusion-exclusion criteria or other factors, which has in the past, and may in the future, lead to delays in enrollment and in generating clinical data for our trials.***

Our clinical trials have had, and may have in the future, strict inclusion criteria for patient enrollment. These criteria could present significant obstacles to the timely recruitment and enrollment of a sufficient number of eligible patients into our trials. We may experience slower than expected patient enrollment in our existing or future clinical trials. Any inability to successfully enroll the number of patients meeting the criteria for any of our clinical trials could cause significant delays in the trial and increase the costs associated with the trial, which could materially harm our business and prospects.

Patient enrollment in a clinical trial may be affected by many factors, including:

● the severity of the disease under investigation;

● the design of the study protocol;

● the eligibility criteria for the study;

● the perceived risks, benefits and convenience of administration of the product candidate being studied;

● the existence of infectious disease outbreaks;

● the competitive disease space with many trials for patients to select from;

● the availability of approved alternate treatments; and

● the proximity and availability of clinical trial sites to prospective patients.

We and our investigators may also face challenges in enrolling patients to participate in our clinical trials due to the novelty of procedures. Some patients may have concerns regarding our procedure that may negatively affect their perception of our therapies and their decision to enroll in our trials. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, and our inability to enroll a sufficient number of patients for any of our current or future clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.

***If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.***

Clinical development is a long, expensive and uncertain process and is subject to delays and the risk that product candidates may ultimately prove unsafe or ineffective in treating the indications for which they are designed. Completion of clinical trials may take several years or more. Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a trial, in reaching an agreement on acceptable clinical trial terms with prospective sites, in obtaining institutional review board approval at each site, in recruiting patients to participate in a trial or in obtaining sufficient supplies of clinical trial materials.

We cannot provide any assurance that we will successfully, or in a timely manner, enroll our clinical trials, that our clinical trials will meet their primary or other endpoints or that such trials or their results will be accepted by the FDA or foreign regulatory authorities.

We may experience numerous unforeseen events during, or because of, the clinical trial process that could delay or prevent us from receiving regulatory clearance or approval for new product candidates or modifications of existing product candidates, including new indications for existing product candidates, including:

● enrollment in our clinical trials may be slower than we anticipate, or we may experience high screen failure rates in our clinical trials, resulting in significant delays;

● our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and/or preclinical testing which may be expensive and time-consuming;

● trial results may not meet the level of statistical significance required by the FDA or other regulatory authorities;

● the FDA or similar foreign regulatory authorities may find the product is not sufficiently safe for investigational use in humans;

● the FDA or similar foreign regulatory authorities may interpret data from preclinical testing and clinical trials in different ways than we do;

● there may be delays or failure in obtaining approval of our clinical trial protocols from the FDA or other regulatory authorities;

● there may be delays in obtaining institutional review board approvals or governmental approvals to conduct clinical trials at prospective sites;

● the FDA or similar foreign regulatory authorities may find our or our suppliers' manufacturing processes or facilities unsatisfactory;

● the FDA or similar foreign regulatory authorities may change their review policies or adopt new regulations that may negatively affect or delay our ability to bring a product to market or receive approvals or clearances to treat new indications;

● we may have trouble in managing multiple clinical sites;

● we may have trouble finding patients to enroll in our trials;

● we may experience delays in agreeing on acceptable terms with third-party research organizations and trial sites that may help us conduct the clinical trials; and

● we, or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed to unacceptable health risks.

In addition, changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes, which could impact the cost, timing or successful completion of a clinical trial. If we experience delays in the commencement or completion of our clinical trials, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenues will be delayed. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also lead to the denial of regulatory approval of a product candidate.

Failures or perceived failures in our clinical trials will delay and may prevent our product development and regulatory approval process, damage our business prospects and negatively affect our reputation and competitive position.

***Clinical trials may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to develop new product candidates or seek new indications.***

We may experience delays in our ongoing or future preclinical studies or clinical trials, and we do not know whether future preclinical studies or clinical trials will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. The commencement and completion of clinical trials for future product candidates or indications may be delayed, suspended or terminated as a result of many factors, including:

● the FDA or other regulators disagreeing as to the design, protocol or implementation of our clinical trials;

● the delay or refusal of regulators or institutional review boards ("IRBs") to authorize us to commence a clinical trial at a prospective trial site;

● changes in regulatory requirements, policies and guidelines;

● delays or failure to reach agreement on acceptable terms with prospective clinical research organizations ("CROs") and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

● delays in patient enrollment and variability in the number and types of patients available for clinical trials;

● the inability to enroll a sufficient number of patients in trials to observe statistically significant treatment effects in the trial;

● having clinical sites deviate from the trial protocol or dropping out of a trial;

● negative or inconclusive results from ongoing preclinical studies or clinical trials, which may require us to conduct additional preclinical studies or clinical trials or to abandon projects that we expect to be promising;

● safety or tolerability concerns that could cause us to suspend or terminate a trial if we find that the participants are being exposed to unacceptable health risks;

● reports from preclinical or clinical testing of other similar therapies that raise safety or efficacy concerns;

● regulators or IRBs requiring that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or safety concerns, among others;

● lower than anticipated retention rates of patients and volunteers in clinical trials;

● our CROs or clinical trial sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a trial;

● delays relating to adding new clinical trial sites;

● difficulty in maintaining contact with patients after treatment, resulting in incomplete data;

● the quality of the product candidates falling below acceptable standards;

● the inability to manufacture sufficient quantities of our product candidates to commence or complete clinical trials; and

● exceeding budgeted costs due to difficulty in accurately predicting costs associated with clinical trials.

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or the Ethics Committees of institutions at which such trials are being conducted, by the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements, including the FDA's current Good Clinical Practice ("cGCP"), regulations, or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate safety and effectiveness, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

If we experience delays in the commencement or completion of any clinical trial of our product candidates, or if any of our clinical trials are terminated, the commercial prospects of our product candidates may be harmed, and our ability to generate revenue from sales may be delayed or materially diminished.

We do not know whether any of our future preclinical studies or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence sales and generate associated revenue. Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial, suspension or revocation of expanded regulatory clearance or approval of our product candidates. Significant preclinical study or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring product candidates to market before we do and impair our ability to successfully commercialize our product candidates.

***We may be required to suspend or discontinue clinical trials due to side effects or other safety risks that could preclude approval of our product candidates.***

Our clinical trials may be suspended at any time for a number of reasons. We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants. In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to participants.

***Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.***

From time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the top-line or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, top-line data should be viewed with caution until the final data are available.

From time to time, we may also disclose interim data from our preclinical studies and clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease. As a result, interim analyses should be viewed with caution until the final data are available. In addition, the data received from an interim analysis could prompt us to alter the trial design, or even to halt the clinical trial altogether. Finally, we may report interim, top-line or preliminary data of only certain endpoints rather than all endpoints. Adverse differences between preliminary or interim data and final data, or between the initially planned trial design and any subsequently altered elements of the trial design due to our analysis of interim, top-line or preliminary data, could significantly harm our business prospects.

Others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the ability to initiate further clinical studies, the approvability or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically a significant volume of data and other information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. If the interim, top-line, or preliminary data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain clearance or approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

***Even after receiving regulatory clearance or approval, our product candidates may be subject to product recalls, which could harm our reputation and divert our managerial and financial resources.***

The FDA and similar governmental authorities in other countries have the authority to order mandatory recall of our product candidates or order their removal from the market if the government finds that our product candidates might cause adverse health consequences or death. A government-mandated or voluntary recall by us could occur as a result of component failures, manufacturing errors by us or our suppliers or design defects, including labeling defects, or unanticipated safety problems. Any recall of our product candidates may harm our reputation with customers and divert managerial and financial resources.

***We depend on a limited number of manufacturers and suppliers in connection with the manufacture of the Revivent System, which makes us vulnerable to supply shortages and price fluctuations that could have a material adverse effect on our business, financial condition, results of operations, and prospects.***

We source and rely upon components and sub-assemblies of the Revivent System, as well as manufacturing services from approved manufacturers and suppliers, some of which are single-source suppliers.

These components, sub-assemblies and services are critical to us, and there are relatively few alternative sources of supply. Our suppliers generally are not under long-term contracts with us, and may experience delays or issues, stop producing our components or sub-assemblies, increase the prices they charge us, or elect to terminate their relationships with us. In any of these cases, we could face a delay of several months to identify, perform appropriate testing and qualify alternative manufacturers and suppliers with regulatory authorities, as we currently have transition plans for some but not all of our manufacturers and suppliers. In addition, the failure of our third-party manufacturers and suppliers to maintain acceptable quality requirements could result in quality issues, including recalls of our product candidates. If one of our manufacturers or suppliers fails to maintain acceptable quality requirements, we may have to identify and qualify a new manufacturer or supplier. Although we require our third-party manufacturers and suppliers to supply us with materials, components, and services that meet our specifications and comply with applicable provisions of the Quality System Regulation ("QSR") and other applicable legal and regulatory requirements in our agreements and contracts, and we perform incoming inspection, testing, or other acceptance activities to ensure the materials and components meet our requirements, there is a risk that they may not supply components that meet our requirements or supply components in a timely manner.

The number of third-party manufacturers and suppliers with the necessary manufacturing and regulatory expertise and facilities to produce our device components is limited and the certification of a new manufacturer or supplier may be complex and time consuming. Any delay or interruption would likely lead to a delay or interruption in our manufacturing operations. The inclusion of substitute components must meet our product specifications and could require us to qualify the new manufacturer or supplier with the appropriate regulatory authorities, including the FDA. The added time and cost to arrange for alternative manufacturers or suppliers could harm our business. New manufacturers of any planned product would be required to qualify under applicable regulatory requirements and would need to have sufficient rights under applicable intellectual property laws to the method of manufacturing the planned product. Obtaining the necessary FDA or international approvals or other qualifications under applicable regulatory requirements and ensuring non-infringement of third-party intellectual property or other proprietary rights could result in a significant interruption of supply and could require the new manufacturer to bear significant additional costs that may be passed on to us.

***The report of our independent registered public accounting firm for the year ended December 31, 2025 includes a "going concern" explanatory paragraph.***

The report of our independent registered public accounting firm on our consolidated financial statements as of and for the year ended December 31, 2025 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a going concern. If we are unable to raise sufficient capital when needed, our business, financial condition and results of operations will be materially and adversely affected, and we will need to significantly modify our operational plans to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. The inclusion of a going concern explanatory paragraph by our auditors, our lack of cash resources and our potential inability to continue as a going concern may materially adversely affect our share price and our ability to raise new capital or to enter into critical contractual relations with third parties.

***We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.***

We are highly dependent on our senior management and other key personnel. Our success will depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including sales and marketing professionals, scientists, clinical specialists, engineers and other highly skilled personnel and to integrate current and additional personnel in all departments. The loss of members of our senior management, sales and marketing professionals, scientists, clinical and regulatory specialists and engineers could result in delays in product development and harm our business. If we are not successful in attracting and retaining highly qualified personnel, it would have a material adverse effect on our business, financial condition and results of operations.

Competition for skilled personnel in our market is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms, or at all. To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have issued stock options that vest over time. The value to employees of stock options that vest over time may be significantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies. Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employment with us on short notice. Our employment arrangements with our employees provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice. We also do not maintain "key man" insurance policies on the lives of these individuals or the lives of any of our other employees.

***David Richmond, our Co-Chief Executive Officer and Chief Financial Officer, also holds certain management positions and directorships of other companies and may allocate his time to such other businesses, thereby causing conflicts of interest in his determination as to how much time to devote to our affairs. This could have a negative impact on our ability to implement our plan of operation.***

David Richmond, our Co-Chief Executive Officer and Chief Financial Officer, is engaged in other business endeavors for which he may be entitled to compensation, which may result in a conflict of interest in allocating his time between our operations and his other businesses. Pursuant to Mr. Richmond's employment agreement that will be effective as of the consummation of this offering, Mr. Richmond shall be employed with us on a full-time basis, but shall be permitted to participate in certain limited business activities, including serving on boards, committees or similar bodies of charitable or nonprofit organizations (subject to prior written approval from the board of directors), fulfilling limited teaching, speaking and writing engagements (subject to prior written approval from the board of directors), and managing his personal investments, in each case, so long as such activities do not individually or in the aggregate materially interfere or conflict with the performance of Mr. Richmond's duties and responsibilities under his employment agreement. Accordingly, although Mr. Richmond is employed with our company on a full-time basis, he may hold certain management positions and directorships of other companies, and may allocate his time to such other businesses, thereby causing conflicts of interest in his determination as to how much time to devote to our affairs.

Mr. Richmond may also have competitive fiduciary obligations and pecuniary interests relating to his other business ventures that conflict with our interests. Mr. Richmond's employment agreement contains certain restrictive covenants while they are employed by us. These restrictive covenants, generally, restrict Mr. Richmond from engaging in any other activities that materially interfere with or conflict with the performance of Mr. Richmond's duties and responsibilities under his employment agreement. Mr. Richmond is further subject to general restrictions regarding the use or disclosure of any confidential information, of our business. Notwithstanding the foregoing, to the extent that these additional activities may have a conflict between their interests and ours, this could have a negative impact on our ability to implement our plan of operations.

***Our management team has limited experience operating a public company, which may require additional time and resources as we transition to public company reporting and governance requirements.***

Our current management team has not previously operated a public company and therefore has limited experience with public company accounting, reporting, compliance, and governance processes and procedures. In particular, while we have strengthened our finance organization by hiring accounting and financial reporting personnel with significant public company and technical accounting experience and by engaging experienced external advisors, our Chief Financial Officer does not have direct experience with the ongoing requirements of operating as a public company.

We are continuing to enhance our internal controls, systems, and reporting processes to meet public company standards. However, we cannot assure you that these efforts will be sufficient to prevent delays, errors, or increased costs associated with public company compliance. Any failure to effectively transition to public company operations could adversely affect our business, financial condition, and stock price.

***We intend to expand sales of any approved product candidates internationally in the future, but we may experience difficulties in obtaining regulatory clearance or approval in the United States or in successfully marketing our product candidates internationally even if approved. A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.***

While we believe that if the Revivent System receives FDA approval, most of our revenue will be generated in the United States, we intend to increase our sales outside the United States as well, including the EU, where we have obtained a CE Mark. Currently, other than through an authorized U.S. clinical site, the Revivent System is only available outside the United States. Sales of our product candidates outside of the United States are and will be subject to foreign regulatory requirements governing clinical trials and marketing approval. We will incur substantial expenses in connection with our international expansion. Additional risks related to operating in foreign countries include:

● differing regulatory requirements in foreign countries;

● differing reimbursement regimes in foreign countries, including price controls;

● unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

● economic weakness, including inflation, or political instability in particular foreign economies and markets;

● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

● foreign taxes, including withholding of payroll taxes;

● foreign currency fluctuations, which could result in increased operating expenses, reduced revenue and other obligations incident to doing business in another country;

● difficulties staffing and managing foreign operations;

● workforce uncertainty in countries where labor unrest is more common than in the United States;

● potential liability under the U.S. Foreign Corrupt Practices Act of 1977, as amended (the "FCPA"), or comparable foreign regulations;

● challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;

● product shortages resulting from any events affecting raw material or finished good supply or distribution or manufacturing capabilities abroad; and

● business interruptions resulting from geopolitical actions, including war and terrorism.

These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations, which would have a material adverse effect on our business, financial condition and results of operations.

We received our European CE mark for the Revivent System, indicating that we affirm our product's conformity with European health, safety and environmental protection standards. We will also need to obtain regulatory approval in other foreign jurisdictions in which we plan to market and sell our products. The time required to obtain registrations or approvals, if required by other countries, may be longer than that required for FDA clearance, and requirements for such registrations, clearances, or approvals may significantly differ from FDA requirements. If we modify our products, we may need to apply for additional regulatory approvals before we are permitted to sell the modified product. In addition, we may not continue to meet the quality and safety standards required to maintain the authorizations that we have received. If we are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable product in that country.

In addition, there can be no guarantee that we will receive approval to sell our product candidates in any market we target, including the United States, nor can there be any guarantee that any sales would result even if such approval is received. Even if the FDA grants marketing approval for a product, comparable regulatory authorities of foreign countries must also approve the manufacturing or marketing of the product in those countries. Approval in the United States, or in any other jurisdiction, does not ensure approval in other jurisdictions. Obtaining regulatory approvals could result in significant delays, difficulties and costs for us and require additional trials and additional expenses. Regulatory requirements can vary widely from country to country and could delay the introduction of our product candidates in those countries. Clinical trials conducted in one country may not be accepted by other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. If we fail to comply with these regulatory requirements or to obtain and maintain required approvals, our target market will be reduced and our ability to generate revenue will be diminished. Our inability to successfully enter all our desired international markets and manage business on a global scale could negatively affect our business, financial results and results of operations.

***Our future growth may depend, in part, on our ability to continue to operate or expand in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.***

Our future growth may depend, in part, on our ability to continue to develop and commercialize our planned and future products in current and additional foreign markets. We are not permitted to market or promote any of our planned or future products before we receive regulatory approval from applicable regulatory authorities in foreign markets, and we may never receive such regulatory approvals for any of our planned or future products. To obtain separate regulatory approval in many other countries we must comply with numerous and varying regulatory requirements regarding safety and efficacy and governing, among other things, clinical trials, commercial sales, pricing and distribution of our planned or future products. If we obtain regulatory approval of our products and ultimately commercialize our planned or future products in foreign markets, we would be subject to additional risks and uncertainties, including:

● different regulatory requirements for approval of medical devices in foreign countries;

● reduced protection for intellectual property rights;

● the existence of additional third-party patent rights of potential relevance to our business;

● unexpected changes in tariffs, trade barriers and regulatory requirements;

● economic weakness, including inflation or political instability in particular foreign economies and markets;

● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

● foreign currency fluctuations, which could result in increased operating expenses, reduced revenue and other obligations incident to doing business in another country;

● foreign reimbursement, pricing and insurance regimes;

● workforce uncertainty in countries where labor unrest is common;

● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

● business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, typhoons, floods and fires.

***To the extent we enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances.***

The rapid pace of technological development in the medical technology industry and the specialized expertise required in different areas of medicine make it difficult for one company alone to develop a broad portfolio of technological solutions. In addition to internally generated growth through our research and development efforts, we expect to make future investments where we believe that we can stimulate the development or acquisition of new technologies and product candidates to further our strategic objectives and strengthen our existing businesses. Collaborative arrangements and strategic alliances in and with medical technology companies are inherently risky, and we cannot guarantee that any of our previous or future investments or investment collaborations will be successful or will not materially adversely affect our business, results of operations, financial condition and cash flows.

Any collaboration arrangement or alliance we have or may have in the future could be terminated for reasons beyond our control or we may not be able to negotiate future alliances on acceptable terms, if at all. These arrangements and alliances could result in us receiving less revenue than if we sold our product candidates directly, place the development, sales and marketing of our product candidates outside of our control, require us to relinquish important rights or otherwise be on unfavorable terms.

Collaborative arrangements or strategic alliances will also subject us to a number of risks, including the risk that:

● we may not be able to control the amount and timing of resources that our strategic partners/collaborators may devote to the product candidates;

● strategic partners/collaborators may experience financial difficulties;

● the failure to successfully collaborate with third parties may delay, prevent or otherwise impair the development or commercialization of our product candidates or revenue expectations;

● business combinations or significant changes in a collaborator's business strategy may adversely affect a collaborator's willingness or ability to complete their obligations under any arrangement;

● a collaborator could independently move forward with a competing product developed either independently or in collaboration with others, including our competitors; and

● collaborative arrangements are often terminated or allowed to expire, which would delay the development of, and may increase the cost of developing, product candidates.

***If we fail to obtain and maintain necessary governmental approvals for our product candidates and indications, we may be unable to market and sell our product candidates in certain jurisdictions.***

Medical devices such as ours are extensively regulated by the FDA in the U.S. and by other federal, state, local and foreign authorities. Governmental regulations relate to the testing, development, manufacturing, labeling, design, sale, promotion, distribution, importing, exporting and shipping of our product candidates. In the U.S., before we can market a new medical device, or a new use of, or claim for, or significant modification to, an existing product, we must generally first receive PMA from the FDA. This process can be expensive and lengthy, and can entail significant expenses, primarily related to clinical trials. It generally takes between one to three years to receive approval, or even longer, from the time the PMA application is submitted to the FDA. Regulatory clearances or approvals, either foreign or domestic, may not be granted on a timely basis, if at all. If we are unable to obtain regulatory approvals or clearances for use of our product candidates under development, or if the patient populations for which they are approved are not sufficiently broad, the commercial success of these product candidates could be limited. The FDA may also limit the claims that we can make about our product candidates. Any significant modifications to the design, materials, or intended use of those devices require FDA approval through PMA or humanitarian device extension ("HDE") supplemental applications.

If we do not receive FDA approval for one or more of our product candidates, we will be unable to market and sell those product candidates in the U.S., which would have a material adverse effect on our operations and prospects.

We also plan to market our product candidates in international markets, including the European Union. Regulatory approval processes differ among those jurisdictions and approval in the U.S. or any other single jurisdiction does not guarantee approval in any other jurisdiction. Obtaining foreign approvals could involve significant delays, difficulties and costs for us and could require additional clinical trials.

***Our product candidates are subject to extensive regulatory requirements, including continuing regulatory review, which could affect the manufacturing and marketing of our product candidates.***

The FDA and other regulatory agencies continue to review product candidates even after they have received initial approval. If and when the FDA or another regulatory agency clears or approves our product candidates under development, the manufacture and marketing of these product candidates will be subject to continuing regulation, post-approval clinical studies, including compliance with the FDA's adverse event reporting requirements, prohibitions on promoting a product for unapproved uses, and QSR requirements, which obligate manufacturers, including third-party and contract manufacturers, to adhere to stringent design, testing, control, documentation and other quality assurance procedures during the design and manufacture of a device.

Any modification to an FDA approved device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a supplemental PMA, HDE or Emergency Use Authorization ("EUA") approval. The FDA requires each manufacturer to determine in the first instance whether a modification requires approval, but the FDA may review and potentially disagree with any such decision. Modifications of this type are common with new product candidates. We anticipate that the first generation of each of our product candidates will undergo a number of changes, refinements, enhancements and improvements over time. If the FDA requires us to seek approval for modification of a previously approved product for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval and we may be subject to significant regulatory fines or penalties, which could have a material adverse effect on our financial results and competitive position. We also cannot assure you that we will be successful in obtaining clearances or approvals for our modifications, if required. We and our third-party suppliers of product components are also subject to inspection and market surveillance by the FDA and other regulatory agencies for QSR and other requirements, the interpretation of which can change. Compliance with QSR and similar legal requirements can be difficult and expensive. While we continue to monitor our quality management in order to improve our overall level of compliance, our facilities are subject to periodic and unannounced inspection by U.S. and foreign regulatory agencies to audit compliance with the QSR and comparable foreign regulations. Enforcement actions resulting from failure to comply with government requirements could result in fines, suspensions of approvals or clearances, recalls or seizure of product candidates, operating restrictions or shutdown, and criminal prosecutions that could adversely affect the manufacture and marketing of our product candidates. The FDA or another regulatory agency could withdraw a previously approved product from the market upon receipt of newly discovered information, including a failure to comply with regulatory requirements, the occurrence of unanticipated safety problems of other defects in product candidates following approval, or other reasons, which could adversely affect our operating results.

***Consolidation in the medical device industry could have an adverse effect on our revenue and results of operations.***

Many medical device companies are consolidating to create new companies with greater market power. As the medical device industry consolidates, competition to provide goods and services to industry participants will become more intense. These industry participants may try to use their market power to negotiate price concessions or reductions for our product candidates. If we reduce our prices because of consolidation in the healthcare industry, our revenue would decrease, which could have a material adverse effect on our business, financial condition and results of operations.

***We are subject to various U.S. and international bribery, anti-kickback, false claims, privacy, transparency, and similar laws, any breach of which could cause a material, adverse effect on our business, financial condition, and profitability.***

Our relationships with physicians, hospitals, and other healthcare providers are subject to scrutiny under various U.S. and international bribery, anti-kickback, false claims, privacy, transparency, and similar laws, often referred to collectively as "healthcare compliance laws." Healthcare compliance laws are broad, sometimes ambiguous, complex, and subject to change and changing interpretations. Possible sanctions for violation of these healthcare compliance laws include fines, civil and criminal penalties, exclusion from government healthcare programs, and despite our compliance efforts, we face the risk of an enforcement activity or a finding of a violation of these laws. While our relationships with healthcare professionals and organizations are structured to comply with such laws, it is possible that enforcement authorities may view our relationships as prohibited arrangements that must be restructured or for which we would be subject to other significant civil or criminal penalties or debarment. In any event, any enforcement review of or action against us as a result of such review, regardless of outcome, could be costly and time consuming. Additionally, we cannot predict the impact of any changes in or interpretations of these laws, whether these changes will be retroactive or will have effect on a going-forward basis only.

***If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our product candidates. The expense and potential unavailability of insurance coverage for liabilities resulting from our product candidates could harm us and our ability to sell our product candidates.***

We face an inherent risk of product liability as a result of the marketing and sale of our product candidates. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during manufacturing, marketing or sale. Any such product liability claim may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. In addition, we may be subject to claims against us even if the apparent injury is due to the actions of others or the pre-existing health of the patient. For example, we rely on physicians in connection with the use of our product candidates on patients. If these physicians are not properly trained or are negligent, the capabilities of our product candidates may be diminished, or the patient may suffer critical injury. We may also be subject to claims that are caused by the activities of our suppliers, such as those who provide us with components and sub-assemblies.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or halt commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

● decreased demand for our product candidates;

● injury to our reputation;

● initiation of investigations by regulators;

● costs to defend the related litigation;

● a diversion of management's time and our resources;

● substantial monetary awards to trial participants or patients;

● product recalls, withdrawals or labeling, marketing or promotional restrictions;

● loss of revenue;

● exhaustion of any available insurance and our capital resources; and

● the inability to market and sell our product candidates. We believe we have adequate product liability insurance, but it may not prove to be adequate to cover all liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain or obtain insurance at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our insurance policy contains various exclusions, and we may be subject to a product liability claim for which we have no coverage. The potential inability to obtain sufficient product liability insurance at an acceptable cost to protect against product liability claims could prevent or inhibit the marketing and sale of product candidates we develop. Assuming we obtain clinical trial insurance for our clinical trials, we may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts, which would have a material adverse effect on our business, financial condition and results of operations. In addition, any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, harm our reputation in the industry, significantly increase our expenses and reduce product sales.

We carry product liability insurance for our clinical trials covering $10 million, subject to certain deductibles and exclusions. Although we believe the amount of our insurance coverage is typical for companies similar to us in our industry, we may not have adequate insurance coverage or be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. If and when we obtain marketing approval for product candidates, we intend to expand our insurance coverage to include the sale of commercial product candidates; however, we may be unable to obtain product liability insurance on commercially reasonable terms or in adequate amounts. On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects. A successful product liability claim or series of claims brought against us could cause our stock price to decline and adversely affect our reputation and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business.

Some of our customers and prospective customers may also have difficulty in procuring or maintaining liability insurance to cover their operations and use of our product candidates. Medical malpractice carriers are withdrawing coverage in certain states or substantially increasing premiums. If this trend continues or worsens, our customers may discontinue using our product candidates and potential customers may opt against purchasing our product candidates due to the cost or inability to procure insurance coverage.

***Product liability claims could damage our reputation and adversely affect our financial results.***

The clinical use of medical product candidates, even after regulatory approval, poses an inherent risk of product liability claims. We maintain limited product liability insurance coverage, subject to certain deductibles and exclusions. We cannot be sure that product liability insurance will be available in the future or will be available on acceptable terms or at reasonable costs, or that such insurance will provide us with adequate coverage against potential liabilities. We may be subject to product liability claims alleging defects in the design, manufacture or labeling of our product candidates. Claims against us, regardless of their merit or potential outcome, may also hurt our ability to obtain physician endorsement of our product candidates or expand our business. As we continue to expand use or our existing product candidates and introduce more product candidates, we face an increased risk that a material product liability claim will be brought against us.

Some of our product candidates are designed for patients who suffer from late-stage or end-stage heart failure, and many of these patients do not survive, even when supported by our product candidates. There are many factors beyond our control that could result in patient death, including the condition of the patient prior to use of the product, the skill and reliability of physicians and hospital personnel using and monitoring the product and product maintenance by customers. However, the failure of our product candidates used for clinical testing or sale could give rise to product liability claims and negative publicity.

The risk of product liability claims is heightened when we sell product candidates that are intended to support a patient until the end of life. The finite life of our product candidates, as well as complications associated with their use, could give rise to product liability claims whether or not the product candidates have extended or improved the quality of a patient's life. If we are forced to pay product liability claims in excess of our insurance coverage, our financial condition will be adversely affected.

***Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.***

We do not carry insurance for all categories of risk that our business may encounter. Although we carry product liability insurance in the United States, we can give no assurance that such coverage will be available or adequate to satisfy any claims. Product liability insurance is expensive, subject to significant deductibles and exclusions, and may not be available on acceptable terms, if at all. If we are unable to obtain or maintain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we could be exposed to significant liabilities. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could have a material adverse effect on our business, financial condition and results of operations. Defending a suit, regardless of its merit or eventual outcome, could be costly, could divert management's attention from our business and might result in adverse publicity, which could result in reduced acceptance of our product candidates in the market, product recalls or market withdrawals.

We do not carry specific hazardous waste insurance coverage, and our insurance policies generally exclude coverage for damages and fines arising from hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended.

We also expect that operating as a public company will make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified people to serve on our board of directors, our board committees or as executive officers. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would negatively affect our business, financial condition and results of operations.

***Our long-term growth depends on our ability to enhance our product candidates, expand our indications and develop and commercialize additional product candidates in a timely manner.***

The market for our product candidates is highly competitive, dynamic, and marked by rapid and substantial technological development and product innovation. New entrants or existing competitors could attempt to develop product candidates that compete directly with ours. Demand for our product candidates and future related product candidates could be diminished by equivalent or superior product candidates and technologies offered by competitors. If we are unable to innovate successfully, our existing product candidates could become obsolete and our revenue would decline as our customers purchase our competitors' product candidates. Developing our current and new product candidates is expensive and time-consuming and could divert management's attention away from our core business. The success of any new product offering or product enhancements to our solution will depend on several factors, including our ability to:

● assemble sufficient resources to acquire or discover additional product candidates;

● properly identify and anticipate physician and patient needs;

● develop and introduce new product candidates and product enhancements in a timely manner;

● avoid infringing upon the intellectual property rights of third-parties;

● demonstrate, if required, the safety and efficacy of new product candidates with data from preclinical studies and clinical trials;

● obtain the necessary regulatory clearances or approvals for expanded indications, new product candidates or product modifications;

● be fully FDA-compliant with marketing of new devices or modified product candidates;

● produce new product candidates in commercial quantities at an acceptable cost;

● provide adequate training to potential users of our product candidates;

● receive adequate coverage and reimbursement for procedures performed with our product candidates; and

● develop an effective and dedicated sales and marketing team.

If we are unable to develop or improve product candidates, applications or features due to constraints, such as insufficient cash resources, high employee turnover, inability to hire personnel with sufficient technical skills or a lack of other research and development resources, we may not be able to maintain our competitive position compared to other companies. Furthermore, many of our competitors devote a considerably greater amount of funds to their research and development programs than we do, and those that do not may be acquired by larger companies that would allocate greater resources to research and development programs. Our failure or inability to devote adequate research and development resources or compete effectively with the research and development programs of our competitors could harm our business.

In addition, we may choose to focus our efforts and resources on potential product candidates or indications that ultimately prove to be unsuccessful, or to license or purchase a marketed product that does not meet our financial expectations. As a result, we may fail to capitalize on viable commercial product candidates or profitable market opportunities, be required to forego or delay pursuit of opportunities with other potential product candidates or other diseases that may later prove to have greater commercial potential, or relinquish valuable rights to such potential product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to retain sole development and commercialization rights, which could adversely impact our business, financial condition and results of operations.

***Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.***

Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results. These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to:

● the level of demand for our product candidates and any approved product candidates, which may vary significantly;

● expenditures that we may incur to acquire, develop or commercialize additional product candidates and technologies;

● the timing and cost of obtaining regulatory approvals or clearances for planned or future product candidates or indications;

● the rate at which we grow our sales force and the speed at which newly hired salespeople become effective, and the cost and level of investment therein;

● the degree of competition in our industry and any change in the competitive landscape of our industry, including consolidation among our competitors or future partners;

● coverage and reimbursement policies with respect to our product candidates, if approved, and potential future product candidates that compete with our product candidates;

● the timing and success or failure of preclinical studies or clinical trials for our product candidates or any future product candidates we develop or competing product candidates;

● the timing of customer orders or medical procedures using our product candidates and the number of available selling days in any quarterly period, which can be impacted by holidays, the mix of product candidates sold and the geographic mix of where product candidates are sold;

● seasonality, including the seasonal slowing of demand for our product candidates we have experienced in the fourth quarter and summer months based on the elective nature of procedures performed using our product candidates, and which we expect to become more pronounced in the future as our business grows;

● the timing and cost of, and level of investment in, research, development, regulatory approval and commercialization activities relating to our product candidates, which may change from time to time;

● the cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements with third-party suppliers and manufacturers; and

● future accounting pronouncements or changes in our accounting policies.

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, it could have a material adverse effect on our business, financial condition and results or operations.

***Litigation and other legal proceedings may adversely affect our business.***

From time to time we may become involved in legal proceedings relating to patent and other intellectual property matters, product liability claims, employee claims, tort or contract claims, federal regulatory investigations, securities class action and other legal proceedings or investigations, which could have an adverse impact on our reputation, business and financial condition and divert the attention of our management from the operation of our business. Litigation is inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect how we operate our business. We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change the way we operate our business, or both. There may be an increase in the scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could have a material adverse effect on our business, financial condition and results of operations. Adverse publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers' confidence and reduce long-term demand for our product candidates, even if the regulatory or legal action is unfounded or not material to our operations.

***If we experience significant disruptions in our information technology systems, our business may be adversely affected.***

We depend on our information technology systems for the efficient functioning of our business, including the manufacture, distribution and maintenance of our product candidates, as well as for accounting, data storage, compliance, purchasing and inventory management. Our information technology systems may be subject to computer viruses, ransomware or other malware, attacks by computer hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, damage or interruption from fires or other natural disasters, hardware failures, telecommunication failures and user errors, among other malfunctions. We could be subject to an unintentional event that involves a third party gaining unauthorized access to our systems, which could disrupt our operations, corrupt our data or result in release of our confidential information. We address these data security concerns in more detail below. Technological interruptions would disrupt our operations, including our ability to timely ship and track product orders, project inventory requirements, manage our supply chain and otherwise adequately service our customers or disrupt our customers' ability use our product candidates for treatments. In the event we experience significant disruptions, we may be unable to repair our systems in an efficient and timely manner. Accordingly, such events may disrupt or reduce the efficiency of our entire operation and have a material adverse effect on our business, financial condition and results of operations. Currently, we carry business interruption coverage to mitigate certain potential losses but this insurance is limited in amount, and we cannot be certain that such potential losses will not exceed our policy limits. We are increasingly dependent on complex information technology to manage our infrastructure. Our information systems require an ongoing commitment of significant resources to maintain, protect and enhance our existing systems. Failure to maintain or protect our information systems and data integrity effectively could have a material adverse effect on our business, financial condition and results of operations.

***If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, or if customers, patients and other partners are reluctant to use our devices because of concerns about the privacy or security of their data, we may face additional costs, loss of revenue, significant liabilities, harm to our brand, decreased use of our platform and business disruption.***

In connection with various facets of our business, we may collect and use a variety of personal data, such as name, mailing address, email addresses, mobile phone number, location information and clinical trial information. Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our data or consumers' personal data could result in significant liability under state, federal (e.g., HIPAA and the HITECH Act and international law (e.g., the European Union's General Data Protection Regulation ("GDPR")). Such an incident may also cause a material loss of revenue from the potential adverse impact to our reputation and brand, affect our ability to retain or attract new users and potentially disrupt our business. We may also rely on third-party service providers to host or otherwise process some of our data and that of users, and any failure by such third party to prevent or mitigate security breaches or improper access to or disclosure of such information could have similarly adverse consequences for us.

Because the techniques used to obtain unauthorized access, disable or degrade service or sabotage systems change frequently and often are not recognized until launched against a target, we and our service providers may be unable to anticipate these techniques or to implement adequate preventative measures. Our servers and platforms may be vulnerable to computer viruses or physical or electronic break-ins that our security measures may not detect. Individuals able to circumvent our security measures may misappropriate our confidential or proprietary information, disrupt our operations, damage our computers or otherwise damage our reputation and business. We may need to expend significant resources and make significant capital investment to protect against security breaches or to mitigate the impact of any such breaches. If we are unable to prevent or mitigate the impact of such security breaches, our ability to attract and retain new customers, patients and other partners could be harmed, and we could be exposed to litigation and governmental investigations, which could lead to a potential disruption to our business.

***If we are unable to develop additional, high-quality manufacturing capacity, our growth may be limited and our business could be seriously harmed.***

To be successful in the long-term, we will need to increase our manufacturing capacity to support continued demand for our product candidates. We may encounter difficulties in scaling up manufacturing of our product candidates, including problems related to product yields, quality control and assurance, component and service availability, dependable sources of supply, adequacy of internal control policies and procedures, ability to automate certain manufacturing processes and lack of skilled personnel.

If we cannot hire, train and retain enough experienced and capable scientific, technical, and manufacturing employees, we may not be able to manufacture sufficient quantities of our existing or future product candidates on time and at an acceptable cost, which could limit market acceptance of our product candidates or otherwise damage our business. In order to meet the expected demand for our Revivent System, we have continued to implement process improvements on the production line at our manufacturing facilities in Mansfield, MA to increase the output that we can produce at these facilities. We continue to work on initiatives to expand our Revivent System manufacturing capacity. We are also working with our existing suppliers and new suppliers to ensure we are able to have sufficient inventory as we increase our manufacturing capability to support growing demand. We are and will continue outsourcing certain sub-assembly production to third-party suppliers. We are also working on process improvements to allow us to manufacture our product candidates more efficiently as much of our manufacturing process is labor-dependent. If we are unable to implement these process improvements on a timely basis in order to meet customer demand, it could inhibit our future revenue growth.

***Each of our product candidates is currently manufactured utilizing a combination of in-house manufacturing and outsource manufacturing, and any significant disruption in production could impair our ability to deliver our product candidates.***

We currently utilize a combination of in-house manufacturing and outsource manufacturing to assemble our Revivent System. In-house manufacturing occurs at a 1,200 square foot ISO 13485 certified facility in Mansfield, Massachusetts. Events such as fire, flood, loss of electricity or other disasters could prevent us from manufacturing our product candidates in compliance with applicable FDA and other regulatory requirements, including current Good Manufacturing Process ("cGMP") and QSR, which could result in significant delays before we restore production or commence production at another site. These delays may result in lost sales. Our insurance may not be adequate to cover our losses resulting from disasters or other business interruptions. Any significant disruption in the manufacturing of our product candidates could seriously harm our business and results of operations.

If we cannot obtain FDA authorization to utilize product candidates manufactured from our cGMP manufacturing center on a timely basis or at all, we could experience supply constraints that could delay our clinical trials. Any disruption in the supply of our product candidates could result in delays in our clinical trials, which would materially adversely affect our business, financial condition, results of operations and growth prospects.

***If we fail to identify, acquire and develop other product candidates, we may be unable to grow our business.***

As a significant part of our growth strategy, we intend to develop and commercialize additional product candidates through our research and development program or by licensing or acquiring additional product candidates and technologies from third parties. The success of this strategy depends upon our ability to identify, select and acquire the right to product candidates and technologies on terms that are acceptable to us.

Any product we identify, license or acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval or clearance by the FDA and applicable foreign regulatory authorities. All product candidates are prone to the risks of failure inherent in medical device product development, including the possibility that the product will not be shown to be sufficiently safe and effective for approval or clearance by regulatory authorities. In addition, there is a risk that any such product candidates that are approved or cleared will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace.

Proposing, negotiating and implementing an economically viable product or technology acquisition or license is a lengthy and complex process. Other companies, including those with substantially greater financial, marketing and sales resources, may compete with us for the acquisition or license of approved or cleared product candidates. We may not be able to acquire or license the rights to additional approved or cleared product candidates on terms that we find acceptable, or at all. If we are unable to develop suitable potential product candidates through internal research programs or by obtaining rights from third parties, it could have a material adverse effect on our business, financial condition and results of operations.

***We may acquire other businesses which could require significant management attention, disrupt our business, dilute stockholder value and adversely affect our results of operations.***

As part of our business strategy, we may in the future make acquisitions or investments in complementary companies, product candidates or technologies that we believe fit within our business model and can address the needs of our customers and potential customers. In the future, we may not be able to acquire and integrate other companies, product candidates or technologies in a successful manner. We may not be able to find suitable acquisition candidates, and we may not be able to complete such acquisitions on favorable terms, if at all. In addition, the pursuit of potential acquisitions may divert the attention of management and cause us to incur additional expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated. If we do complete acquisitions, we may not ultimately strengthen our competitive position or achieve our goals, including increases in revenue, and any acquisitions we complete could be viewed negatively by our customers, investors and industry analysts.

Future acquisitions may reduce our cash available for operations and other uses and could result in amortization expense related to identifiable assets acquired. We may have to pay cash, incur debt or issue equity securities to pay for any such acquisition, each of which could adversely affect our financial condition or the value of our common stock. The sale or issuance of equity to finance any such acquisitions would result in dilution to our stockholders. The incurrence of indebtedness to finance any such acquisition would result in fixed obligations and could also include covenants or other restrictions that could impede our ability to manage our operations. In addition, our future results of operations may be adversely affected by the dilutive effect of an acquisition, performance earn-outs or contingent bonuses associated with an acquisition. Furthermore, acquisitions may require large, one-time charges and can result in increased debt or contingent liabilities, adverse tax consequences, additional stock-based compensation expenses and the recording and subsequent amortization of amounts related to certain purchased intangible assets, any of which items could negatively affect our future results of operations. We may also incur goodwill impairment charges in the future if we do not realize the expected value of any such acquisitions.

Also, the anticipated benefit of any strategic alliance, joint venture or acquisition may not materialize, or such strategic alliance, joint venture or acquisition may be prohibited. Additionally, future acquisitions or dispositions could result in potentially dilutive issuances of our equity securities, the incurrence of debt, contingent liabilities or amortization expenses or write-offs of goodwill, any of which could harm our financial condition. We cannot predict the number, timing or size of future joint ventures or acquisitions, or the effect that any such transactions might have on our operating results.

***General economic conditions may adversely affect our business.***

Adverse worldwide economic conditions may negatively impact our business. A significant change in the liquidity or financial condition of our customers could cause unfavorable trends in their purchases and also in our receivable collections, and additional allowances may be required, which could adversely affect our business, financial condition and results of operations. Adverse worldwide economic conditions, including tariff and trade wars, may also adversely impact our suppliers' ability to provide us with materials and components, which could have a material adverse effect on our business, financial condition and results of operations.

***Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.***

Our operations could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or man-made disasters or business interruptions, for which we are predominantly self-insured. We rely on third-party manufacturers to produce our product candidates. Our ability to obtain clinical supplies of our product candidates could be disrupted if the operations of these suppliers were affected by a man-made or natural disaster or other business interruption. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.

**Risks Related to Our Intellectual Property and Technology**

***We will be required to comply with our obligations in our intellectual property licenses and other agreements with third parties.***

If we fail to comply with our obligations in our intellectual property licenses and other agreements with third parties, we could lose license rights that are important to our business. We are not currently party to any intellectual property license agreement with any third parties, but we anticipate that in-licensing and co-development will be strategies that we utilize as we continue to pursue our growth strategy. We expect to enter into licenses and co-development and other agreements in the future, and we expect these agreements to impose, various diligences, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with these obligations, the licensor may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed patents.

We may need to resort to litigation to enforce or defend our intellectual property rights, including any patents issued to us. If a competitor or collaborator files a patent application claiming technology also invented by us, in order to protect our rights, we may have to participate in an expensive and time-consuming interference proceeding before the United States Patent and Trademark Office. We cannot guarantee that our product candidates will be free of claims by third parties alleging that we have infringed their intellectual property rights. Third parties may assert that we are employing their proprietary technologies without authorization and they may resort to litigation to attempt to enforce their rights. Third parties may have or obtain patents in the future and claim that the use of our technology or any of our product candidates infringes their patents. We may not be able to develop or commercialize combination product candidates because of patent protection others have. Our business will be harmed if we cannot obtain a necessary or desirable license, can obtain such a license only on terms we consider to be unattractive or unacceptable, or if we are unable to redesign our product candidates or processes to avoid actual or potential patent or other intellectual property infringement. Obtaining, protecting and defending patent and other intellectual property rights can be expensive and may require us to incur substantial costs, including the diversion of management and technical personnel. An unfavorable ruling in patent or intellectual property litigation could subject us to significant liabilities to third parties, require us to cease developing, manufacturing or selling the affected product candidates or using the affected processes, require us to license the disputed rights from third parties, or result in awards of substantial damages against us.

There can be no assurance that we would prevail in any intellectual property infringement action, will be able to obtain a license to any third-party intellectual property on commercially reasonable terms, successfully develop non-infringing alternatives on a timely basis, or license non-infringing alternatives, if any exist, on commercially reasonable terms. Any significant intellectual property impediment to our ability to develop and commercialize our product candidates could seriously harm our business and prospects.

***If we are unable to adequately protect our proprietary technology or obtain and maintain issued patents that are sufficient to protect our product candidates, product candidates, and methods others could compete against us more directly, which could harm our business, financial condition and results of operations.***

Our intellectual property and proprietary rights are important to our ability to remain competitive and for the success of our product candidates and our business. Patent protection can be limited and not all intellectual property is or can be patented. Our commercial success may depend in part on our ability to obtain and maintain patents and other intellectual property rights in the United States and elsewhere, and protect our proprietary technologies. If we do not adequately protect our intellectual property and proprietary technologies, competitors may be able to use our technologies and erode or negate any competitive advantage we may have, which could harm our business and profitability.

We have filed patent applications for our product candidates and related intellectual property with the U.S. Patent and Trademark Office and in other jurisdictions. As of September 1, 2025, we have been granted over one hundred (100) patents including over 50 patents in the United States, and we have another 7 pending applications in various stages of review.

Our patents may not have, or our pending patent applications that mature into issued patents may not include, claims with a scope sufficient to protect our product candidates, product candidates, or methods. Other parties may have developed technologies that may be related or competitive to our product candidates, product candidates, and methods, may have filed or may file patent applications for those technologies, and may have received or may receive patents that overlap or conflict with our patents or patent applications, either by claiming the same product candidates or methods or by claiming subject matter that could dominate our patent position. The patentability of devices and methods in our technical field may involve complex legal and factual questions, and, therefore, the scope, validity and enforceability of any patent claims that we may obtain cannot be predicted with certainty.

Though an issued patent is presumed valid and enforceable, its issuance is not conclusive as to its validity or its enforceability. Patents may be challenged, deemed unenforceable, invalidated, circumvented, or found not infringed. Proceedings challenging our patents could result in either the loss or reduction in scope of one or more of the claims of the patent. Furthermore, an adverse decision in an interference proceeding or a derivation proceeding could result in a third party receiving the patent rights sought by us, which in turn could affect our ability to commercialize our technologies. Any successful challenge to our patents could deprive us of exclusive rights necessary for the successful commercialization of our product candidates and methods. In addition, defending such challenges may be costly.

Patents have a limited lifespan. In the United States, the natural expiration of a utility patent is generally 20 years after its effective filing date and the natural expiration of a design patent is generally 14 years after its issue date, unless the filing date occurred on or after May 13, 2015, in which case the natural expiration of a design patent is generally 15 years after its issue date. Further, if we encounter delays in our development efforts, the period of time during which we could market our product candidates and methods under patent protection would be reduced and, given the amount of time required for the development, testing and regulatory review of planned or future product candidates and methods, patents protecting such product candidates and methods might expire before or shortly after such product candidates and methods are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing product candidates and methods similar or identical to ours.

Furthermore, patents may not provide us with adequate proprietary protection or competitive advantages against competitors with similar product candidates. Competitors may be able to design around our patents. Other parties may develop and obtain patent protection for more effective technologies, designs or methods. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the United States, and we may encounter significant problems in protecting our proprietary rights in these countries. Competitors may export otherwise infringing product candidates to territories where we have patent protection but enforcement is not as strong as that in the United States. These product candidates may compete with our product candidates, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. If any of these developments were to occur, they each could have a negative impact on our business and competitive position.

Our ability to enforce our patent rights depends on our ability to detect infringement. It may be difficult to detect infringers who do not advertise the use of infringing product candidates, the practice of infringing methods, or the incorporation of infringing components in their product candidates. It may be difficult or impossible to obtain evidence of infringement in a competitor's or potential competitor's product, or infringing uses or sales by a customer of a competitor. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded if we were to prevail may not be commercially meaningful. In addition, third parties may attempt to commercialize competitive product candidates or methods in foreign countries where we do not have any patents or patent applications and/or where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations.

In addition, proceedings to enforce or defend our patents could put our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Such proceedings could also provoke third parties to assert claims against us, including that some or all of the claims in one or more of our patents are invalid or otherwise unenforceable. If any of our patents covering our product candidates, product candidates, or methods are invalidated or found unenforceable, our financial position and results of operations could be negatively impacted. In addition, if a court finds that valid, enforceable patents held by third parties cover one or more of our product candidates, product candidates, or methods, our financial position and results of operations could be harmed.

We rely upon unpatented trade secrets, unpatented know-how and continuing technological innovation to develop and maintain our competitive position, which we may seek to protect, in part, by entering into confidentiality agreements with our employees, suppliers, vendors, collaborators, and/or consultants. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, suppliers, vendors, former employees and current employees. If parties to any such agreements breach or violate the terms of any such agreements, we may not have adequate remedies for the breach or violation, and we could lose our trade secrets through the breach or violation. Also, it is possible that technology relevant to our business will be independently developed by a person that is not a party to such an agreement. Further, our trade secrets could otherwise become known or be independently discovered by our competitors, which could diminish the value and competitive worth of those trade secrets.

***If we fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business.***

We have licensed and may enter into or may be required to enter into intellectual property license agreements that are important to our business. These license agreements may impose various diligence, milestone, payment, royalty and other obligations on us. For example, we may enter into exclusive license agreements with various universities and research institutions, we may be required to use commercially reasonable efforts to engage in various development and commercialization activities with respect to licensed product candidates, and may need to satisfy specified milestone and royalty payment obligations. If we fail to comply with any obligations under our agreements with any of these licensors, we may be subject to termination of the license agreement in whole or in part, increased financial obligations to our licensors or loss of exclusivity in a particular field or territory, in which case our ability to develop or commercialize product candidates covered by the license agreement will be impaired.

In addition, disputes may arise regarding intellectual property subject to a license agreement, including:

● the scope of rights granted under the license agreement and other interpretation-related issues;

● the extent to which our processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

● our diligence obligations under the license agreement and what activities satisfy those obligations;

● if a third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements, we may be required to sublicense rights in that area to the third party, and that sublicense could harm our business; and

● the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us.

Disputes over intellectual property that we have licensed may prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, and we may be unable to successfully develop and commercialize our product candidates.

***Obtaining and maintaining our patent protection is a complex process that requires compliance with various procedures, documentation requirements, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.***

The patent prosecution process is expensive, time-consuming and complex, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output in time to obtain patent protection. Also, filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing product candidates made using our inventions in and into the United States or other jurisdictions.

There can be no guarantee that any patents will issue from our pending patent applications or future patent applications that we file, if any, and there can be no guarantee that any issued patents will adequately protect our intellectual property. We cannot be certain that we were the first to make the inventions claimed in any of our patents or pending patent applications, or that we were the first to file for patent protection for such inventions. Defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example, with respect to proper priority claims, inventorship and the like. If there are material defects in the form, preparation or prosecution of our patents or patent applications, such patents or applications may be invalid and unenforceable. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

The legal standards relating to the validity, enforceability and scope of protection of patent and other intellectual property rights are complex and often uncertain, and are subject to change that can affect the validity of patents issued under previous legal standards. The U.S. Patent and Trademark Office, or USPTO, and various foreign governmental patent agencies further require compliance with a number of procedural, documentary, fee payments (e.g., maintenance and annuity fee payments), and other provisions during the patent procurement process as well as over the life span of an issued patent. Noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market or compete more directly at an earlier time than would otherwise have been the case.

***We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.***

Our commercial success depends in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties. Our business, product candidates, and methods could infringe the patents or other intellectual property rights of third parties. Our competitors may seek, or may already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, sell, offer to sell, and license our product candidates and technologies either in the United States or in international markets. It may be difficult or impossible to identify, prior to receipt of notice from a third party, the patents, trade secrets, or other intellectual property rights of a third party, either in the United States or in foreign jurisdictions, that relate to our business, product candidates, and methods. We have not conducted an extensive search of patents issued or assigned to other parties, including our competitors, and no assurance can be given that patents containing claims covering our product candidates, parts of our product candidates, technology or methods do not exist, have not been filed or could not be filed or issued. In addition, because patent applications can take many years to issue and because publication schedules for pending applications vary by jurisdiction, there may be applications now pending of which we are unaware and which may result in issued patents which our current or future product candidates infringe. Also, because the claims of published patent applications can change between publication and patent grant, there may be published patent applications that may ultimately issue with claims that we infringe.

Our industry is characterized by frequent and extensive litigation regarding patents and other intellectual property rights. Many companies in our industry with substantially greater resources than us have employed intellectual property litigation as a way to gain a competitive advantage. We may become involved in litigations, interference proceedings, derivation proceedings, *inter partes* review proceedings, oppositions, reexaminations, protests or other potentially adverse intellectual property proceedings as a result of alleged infringement by us of the rights of others, or as a result of priority of invention disputes or ownership disputes with third parties, either in the United States or internationally. In those proceedings, Third parties may challenge the validity and enforceability of any of our issued patents, and whether we own those patents. Even if we believe such claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed by our product candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If we are found to infringe third-party patents, and we are unsuccessful in demonstrating that such patents are invalid or unenforceable, such third parties may be able to block our ability to commercialize the applicable product candidates or technology unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be held invalid or unenforceable. Such a license may not be available on commercially reasonable terms, or at all. Even if we are able to obtain a license, the license would likely obligate us to pay significant license fees and/or royalties, and the rights granted to us might be non-exclusive, which could result in our competitors gaining access to the same technology. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, we may be unable to commercialize our product candidates, or such commercialization efforts may be significantly delayed, which could in turn significantly harm our business.

Claims against us relating to the infringement of third-party proprietary rights or proprietary determinations, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, diversion of our management's attention and resources, or entrance into royalty or license agreements that are not advantageous to us. In any of these circumstances, we may need to spend significant amounts of money, time and effort defending our position. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations. Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material and adverse effect on us. If we are unable to avoid infringing the intellectual property rights of others, we may be required to seek a license, defend an infringement action, challenge the validity of intellectual property in court, redesign our product candidates, product candidates, or methods, or cease production of our product candidates altogether.

Competitors may also infringe our patents. If we file an infringement proceeding to enforce one or more of our patents, a court may decide that patents owned by us are invalid or unenforceable, or may refuse to enjoin the other party from using the technology at issue on the grounds that our patents do not cover such technology. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our management and other personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on our common stock price. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Any of the foregoing could have a material adverse effect on our business, financial condition or results of operations.

***If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.***

Our trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be violating or infringing other marks. We may not be able to protect our rights to these trademarks and trade names to build name recognition among potential partners and customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement or dilution claims brought by owners of other trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names or other intellectual property may be ineffective, could result in substantial costs and diversion of resources and could adversely affect our business, financial condition and results of operations.

***Intellectual property rights do not necessarily address all potential threats.***

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example, in addition to the factors discussed above:

● others may be able to make product candidates that are similar to our product candidates or utilize similar technology but that are not covered by the claims of our patents or that incorporate certain technology in our product candidates that is in the public domain;

● we, or our future licensors or collaborators, might not have been the first to make the inventions covered by the applicable issued patent or pending patent application that we own now or may own or license in the future;

● we, or our future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

● our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive product candidates for sale in our major commercial markets;

● we may not develop additional proprietary technologies that are patentable; and

● we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.

**Risks Related to Regulatory Approval and Other Governmental Regulations**

***Our business and product candidates are subject to extensive governmental regulation and oversight, and our failure to comply with applicable regulatory requirements could harm our business.***

Our product candidates and operations are subject to extensive regulation in the United States by the FDA and by regulatory agencies in other countries where we anticipate conducting business activities. The FDA in the U.S., and regulatory agencies in other jurisdictions regulate the development, testing, manufacturing, labeling, storage, record-keeping, promotion, marketing, sales, distribution and post-market support and reporting of medical devices. The regulations to which we are subject are complex and may become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales.

In order to conduct a clinical investigation involving human subjects to demonstrate the safety and effectiveness of a medical device, a company must first apply for and obtain FDA approval of an IDE application if the study involves a "significant risk" (as defined by the FDA) to human health. Our product candidates are considered significant risk devices, requiring an IDE prior to investigational use. With an IDE, which we received in November 2024 for the Revivent clinical trial, we can start the process of obtaining Institutional Review Board ("IRB") approvals at clinical sites before initiating studies at these sites. Despite securing an IDE, we may encounter challenges in obtaining IRB approvals or conducting studies that fully comply with the IDE and other regulations governing clinical investigations. Additionally, the data from any such trials may not support clearance or approval of the investigational device. Failure to obtain necessary approvals or comply with regulatory requirements could have a material adverse effect on our business, financial condition and results of operations. Furthermore, uncertainty remains as to whether clinical trials will meet desired endpoints, produce meaningful or useful data, be free of unexpected adverse effects, or whether the FDA will accept the validity of foreign clinical study data, if applicable. Such uncertainty could preclude or delay market clearance or authorizations, resulting in significant financial costs and reduced revenue.

In the case of the Revivent System, an IDE was initially approved in 2016 for the ALIVE study and a second IDE was approved in November 2024 for the RELIVE Study.

***Our product candidates may be subject to extensive governmental regulation in foreign jurisdictions, such as the European Economic Area (EEA), and our failure to comply with applicable requirements could cause our business, results of operations and financial condition to suffer.***

In the EEA, our product candidates will need to comply with the Essential Requirements set forth in Medical Device Directives (MDD) (Directive 93/42/EEC) and/or Medical Device Regulation (MDR). Compliance with these requirements is a prerequisite to be able to affix a CE mark to a product, without which a product cannot be marketed or sold in the EEA. To demonstrate compliance with the Essential Requirements and obtain the right to affix the CE mark to our product candidates, we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. The conformity assessment procedure requires the involvement of a Notified Body, which is an organization designated by a competent authority of an EEA country to conduct conformity assessments. The Notified Body would audit and examine the Technical File and the quality system for the manufacture, design and final inspection of our product candidates. The Notified Body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure and quality management system audit conducted in relation to the medical device and its manufacturer and their conformity with the Essential Requirements. This Certificate entitles the manufacturer to affix the CE mark to its medical product candidates after having prepared and signed a related EC Declaration of Conformity.

As a general rule, demonstration of conformity of medical product candidates and their manufacturers with the Essential Requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the product candidates during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device (e.g., product labeling and instructions for use) are supported by suitable evidence. This assessment must be based on clinical data, which can be obtained from (1) clinical studies conducted on the devices being assessed, (2) scientific literature from similar devices whose equivalence with the assessed device can be demonstrated or (3) both clinical studies and scientific literature. However, the pre-approval and post-market clinical requirements are much more rigorous. The conduct of clinical studies in the EEA is governed by detailed regulatory obligations. These may include the requirement of prior authorization by the competent authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee. This process can be expensive and time-consuming.

***The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable.***

In the United States, our product candidates are regulated as medical devices. Before our medical device product candidates may be marketed in the United States, we must submit, and the FDA must approve a PMA. For the PMA approval process, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical trial, manufacturing and labeling data. In addition, modifications to product candidates that are approved through a PMA generally require FDA approval. The time required to obtain approval, clearance or license by the FDA to market a new therapy is unpredictable but typically takes years and depends upon many factors, including the substantial discretion of the FDA. This timeline may be further extended as a result of the recent reduction in workforce that has taken place within the federal government, including at the FDA.

Our product candidates could fail to receive regulatory approval, clearance or license for many reasons, including the following:

● the FDA may disagree with the design or implementation of our clinical trials or study endpoints;

● we may be unable to demonstrate to the satisfaction of the FDA that our product candidates are safe and effective for their proposed indications or that our product candidates provide significant clinical benefits;

● the results of our clinical trials may not meet the level of statistical significance required by the FDA for approval, clearance or license or may not support approval of a label that could command a price sufficient for us to be profitable;

● the FDA may disagree with our interpretation of data from preclinical studies or clinical trials;

● the opportunity for bias in the clinical trials as a result of the open-label design may not be adequately handled and may cause our trial to fail;

● our product candidates may be subject to an FDA advisory committee review, which may be requested at the sole discretion of the FDA, and which may result in unexpected delays or hurdles to approval;

● the FDA may determine that the manufacturing processes at our facilities or facilities of third-party manufacturers with which we contract for clinical and commercial supplies are inadequate;

● the FDA may determine we cannot continue our clinical trials due to adverse patient reactions including patient deaths for reasons unrelated to our product candidates; and

● the approval, clearance or license policies or regulations of the FDA may significantly change in a manner rendering our clinical data insufficient for approval.

Even if we were to obtain approval, clearance or license, the FDA may grant approval, clearance or license contingent on the performance of costly post-marketing clinical trials or may approve our product candidates with a label that does not include the labeling claims necessary or desirable for successful commercialization of our product candidates. Any of the above could materially harm our product candidates' commercial prospects.

***Even if our product candidates are approved by regulatory authorities, if we fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our product candidates, our product candidates could be subject to restrictions or withdrawal from the market.***

The manufacturing processes, post-approval clinical data and promotional activities of any product candidate for which we obtain marketing approval are subject to continual review and periodic inspections by the FDA and other regulatory bodies. Even if regulatory approval of our product candidates is granted in the United States or elsewhere, the approval may be subject to limitations on the indicated uses for which the product candidates may be marketed or contain requirements for costly post-marketing testing and surveillance to monitor the safety or effectiveness of the product. Later discovery of previously unknown and unanticipated problems with our product candidates, including but not limited to unanticipated severity or frequency of adverse events, delays or problems with the manufacturer or manufacturing processes, or failure to comply with regulatory requirements, may result in restrictions on such product candidates or manufacturing processes, withdrawal of the product candidates from the market, voluntary or mandatory recall, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties.

***The RELIVE Trial may not demonstrate sufficient efficacy to support regulatory approval.***

Our RELIVE pivotal trial is designed to evaluate the safety and efficacy of the Revivent System for patients with ischemic heart failure, which would ultimately be determined by the FDA. While RELIVE incorporates what we believe to be appropriate refinements informed by prior clinical experience (which did not achieve in full the desired results due to certain trial design issues described in the "Business—Overview" section of this prospectus), there is no assurance the current trial design and related protocols will produce favorable efficacy results, including meeting its efficacy endpoints. If the RELIVE trial fails to meet its efficacy objectives or otherwise does not yield data sufficient to support premarket approval by the FDA or other regulators, our ability to commercialize the Revivent System will be significantly impaired, which would materially and adversely affect our business, financial condition, and prospects and could lead to the failure of our company.

***While Breakthrough Device Designation allows for increased interaction with FDA reviewers and prioritized submission review, it does not guarantee product approval, faster approval, or commercial success.***

In November 2019, the Revivent System received Breakthrough Device Designation from the FDA for the "treatment of heart failure symptoms in patients with left ventricular dilation due to a left ventricular aneurysm or scar." BDD is intended to expedite the development and regulatory review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. The designation allows for increased interaction with FDA reviewers and prioritized review of submissions. However, BDD does not guarantee product approval, faster approval, or commercial success. The Revivent System remains subject to extensive FDA regulatory requirements, including but not limited to, PMA, manufacturing quality systems, labeling and post-market surveillance. Medical devices may only be marketed for indications approved by the FDA, and we must comply with the FDA's Quality System Regulation, which governs manufacturing, testing, labeling, and documentation processes.

***We are required to report certain malfunctions, deaths and serious injuries associated with our product candidates once approved by regulatory bodies, which can result in voluntary corrective actions or agency enforcement actions.***

All manufacturers marketing medical devices in the EEA are legally bound to report incidents involving devices they produce or sell to the regulatory agency, or competent authority, in whose jurisdiction the incident occurred. Under the EU MDD, an incident is defined as any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health. In addition, under the EU MDR, the manufacturers are obligated to publish Periodic Safety Update Report (annually for high risk devices) which will be uploaded to European Database on Medical Devices (EUDAMED) and require conformity assessment by Notified Bodies.

Malfunction or misuse of our product candidates could result in future voluntary corrective actions, such as recalls, including corrections (e.g., customer notifications), or agency action, such as inspection or enforcement actions. If malfunctions or misuse do occur, we may be unable to correct the malfunctions adequately or prevent further malfunctions or misuse, in which case we may need to cease manufacture and distribution of the affected product candidates, initiate voluntary recalls, and redesign the product candidates or the instructions for use for those product candidates. Regulatory authorities may also take actions against us, such as ordering recalls, imposing fines, or seizing the affected product candidates. Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, may distract management from operating our business, and may harm our business, results of operations and financial condition.

***Legislative or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances or approvals for product candidates or to manufacture, market or distribute product candidates after clearance or approval is obtained.***

From time to time, legislation is drafted and introduced in the U.S. Congress that could significantly change the statutory provisions governing the regulation of medical devices or the reimbursement thereof. In addition, the FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our product candidates. Any new statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future product candidates or make it more difficult to manufacture, market or distribute our product candidates or future product candidates. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Such changes could, among other things, require:

● additional testing prior to obtaining clearance or approval;

● changes to manufacturing methods;

● recall, replacement or discontinuance of our systems or future product candidates; or

● additional record keeping.

Any of these changes could require substantial time and cost and could harm our business and our financial results.

The highly publicized PIP scandal (use of non-medical grade silicone in breast implants) in 2010 led to publishing the first version of EU Medical Device Regulation (MDR) by European Commission in 2012. After 347 amendments by European Parliament in 2014, followed by various versions, the final version of the new EU Medical Device Regulation (MDR 2017/745) was published on May 5, 2017. Notified Bodies are currently not accepting any new CE Mark applications under MDD (Medical Device Directives). All new medical devices, including ours, must undergo assessment under MDR.

The changes from EU Medical Device Directives (MDD) to Medical Device Regulation (MDR) are significant, with stricter clinical requirements and post-market surveillance, shift from pre-approval to Life-cycle approach, centralized EUDAMED database for public transparency (e.g. Periodic Safety Update Reports) and device registration, more device specific requirements (e.g. Common Specifications), legal liability for defective devices, etc. The QMS audit under MDR will be much more rigorous, including audits and assessment of suppliers and device testing.

Further, under either the FDA's Medical Device Reporting or MDR regulations, we are required to report to the FDA any incident in which our product candidates may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. Any adverse event involving our product candidates could result in future voluntary corrective actions, such as product actions or customer notifications, or regulatory authority actions, such as inspection, mandatory recall or other enforcement action. Repeated product malfunctions may result in a voluntary or involuntary product recall, which could divert managerial and financial resources, impair our ability to manufacture our product candidates in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results.

Moreover, depending on the corrective action we take to redress a product's deficiencies or defects, the FDA may require us, or we may decide that we will need, to obtain new approvals or clearances for the device before we may market or distribute the corrected device. Seeking such approvals or clearances may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our product candidates, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties, withdrawals or clearances or approvals or civil or criminal fines. We may also be required to bear other costs or take other actions that may have a negative impact on our sales as well as face significant adverse publicity or regulatory consequences, which could harm our business, including our ability to market our product candidates in the future.

***We are subject to federal, state and foreign healthcare laws and regulations, and a finding of failure to comply with such laws and regulations could have a material and adverse effect on our business.***

Our operations are, and will continue to be, directly and indirectly affected by various federal, state or foreign healthcare laws, including, but not limited to, those described below. These laws include:

● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Violations of the federal Anti-kickback Statute may result in substantial civil or criminal penalties, including criminal fines of up to $100,000, imprisonment of up to ten years, civil penalties under the Civil Monetary Penalties Law of up to $50,000 for each violation, plus three times the remuneration involved, civil penalties under the federal False Claims Act of up to $11,000 for each claim submitted, plus three times the amounts paid for such claims and exclusion from participation in the Medicare and Medicaid programs;

● the federal False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payors that are false or fraudulent. Suits filed under the False Claims Act, known as "qui tam" actions, can be brought by any individual on behalf of the government and such individuals, commonly known as "whistleblowers," may share in any amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the False Claims Act, the government may impose penalties of not less than $5,500 and not more than $11,000, plus three times the amount of the damages that the government sustains due to the submission of a false claim and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

● the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary's decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

● HIPAA, as amended by the HITECH Act, and their respective implementing regulations, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information. Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties up to $50,000 per violation, not to exceed $1.5 million per calendar year for non-compliance of an identical provision, and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment. State attorneys general can bring a civil action to enjoin a HIPAA violation or to obtain statutory damages up to $25,000 per violation on behalf of residents of his or her state. HIPAA also imposes criminal penalties for fraud against any healthcare benefit program and for obtaining money or property from a healthcare benefit program through false pretenses and provides for broad prosecutorial subpoena authority and authorizes certain property forfeiture upon conviction of a federal healthcare offense. Significantly, the HIPAA provisions apply not only to federal programs, but also to private health benefit programs. HIPAA also broadened the authority of the U.S. Office of Inspector General of the U.S. Department of Health and Human Services to exclude participants from federal healthcare programs;

● the federal physician sunshine requirements under the Patient Protection and Affordable Care Act, or PPACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the U.S. Department of Health and Human Services information related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers and teaching hospitals and ownership and investment interests held by physicians and their immediate family members. Manufacturers are required to submit reports by the 90<sup>th</sup> day of each calendar year. Failure to submit the required information may result in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for "knowing failures") for all payments, transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws or regulations; and

● analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third- party payor, including commercial insurers; state laws that require device companies to comply with the industry's voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Any failure by us to ensure that our employees and agents comply with applicable state and foreign laws and regulations could result in substantial penalties or restrictions on our ability to conduct business in those jurisdictions, and our results of operations and financial condition could be materially and adversely affected.

The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under such laws, it is possible that some of our business activities, including our relationships with heart failure specialists, surgeons, and other healthcare providers, some of whom recommend, purchase and/or prescribe our product candidates, and our distributors, could be subject to challenge under one or more of such laws.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us now or in the future, we may be subject to penalties, including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental health care programs and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management's attention from the operation of our business.

***Inadequate funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new product candidates and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.***

The ability of the FDA to review and approve new product candidates can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes, including changes to the FDA's priorities or processes. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for our product candidates or product candidates to be reviewed or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, the U.S. federal government has shut down several times and certain regulatory agencies, such as the FDA have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, or if the FDA is otherwise hindered by inadequate funding, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a newly public company, future government shutdowns or similar funding issues could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

***Our relationships with physician consultants, owners and investors could be subject to additional scrutiny from regulatory enforcement authorities and could subject us to possible administrative, civil or criminal sanctions.***

Federal and state laws and regulations impose restrictions on our relationships with physicians who are consultants, owners and investors. We may enter into consulting agreements, license agreements and other agreements with physicians in which we provide cash as compensation. We have or may have other written and oral arrangements with physicians, including for research and development grants and for other purposes.

We could be adversely affected if regulatory agencies were to interpret our financial relationships with these physicians, who may be in a position to influence the ordering of and use of our product candidates for which governmental reimbursement may be available, as being in violation of applicable laws. If our relationships with physicians are found to be in violation of the laws and regulations that apply to us, we may be required to restructure the arrangements and could be subject to administrative, civil and criminal penalties, including exclusion from participation in government healthcare programs, imprisonment, and the curtailment or restructuring of our operations, any of which could negatively impact our ability to operate our business and our results of operations.

***Our company and many of our collaborators and potential collaborators may be required to comply with the Federal Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act and implementing regulations affecting the transmission, security and privacy of health information, and failure to comply could result in significant penalties and reputational harm.***

Numerous federal and state laws and regulations, including HIPAA and the HITECH Act, govern the collection, dissemination, security, use and confidentiality of health information that identifies specific patients. HIPAA and the HITECH Act require our surgeon and hospital customers and potential customers to comply with certain standards for the use and disclosure of health information within their companies and with third parties. The Privacy Standards and Security Standards under HIPAA establish a set of standards for the protection of individually identifiable health information by health plans, health care clearinghouses and certain health care providers, referred to as Covered Entities, and the business associates with whom Covered Entities enter into service relationships pursuant to which individually identifiable health information may be exchanged. Notably, whereas HIPAA previously directly regulated only these Covered Entities, the HITECH Act makes certain of HIPAA's privacy and security standards also directly applicable to Covered Entities' business associates. As a result, both Covered Entities and business associates are subject to significant civil and criminal penalties for failure to comply with Privacy Standards and Security Standards.

HIPAA requires Covered Entities (like many of our customers and potential customers) and their business associates to develop and maintain policies and procedures with respect to protected health information that is used or disclosed, including the adoption of administrative, physical and technical safeguards to protect such information. The HITECH Act expands the notification requirement for breaches of patient-identifiable health information, restricts certain disclosures and sales of patient-identifiable health information and provides for civil monetary penalties for HIPAA violations. The HITECH Act also increased the civil and criminal penalties that may be imposed against Covered Entities and business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney fees and costs associated with pursuing federal civil actions. Additionally, certain states have adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA. While we are not directly subject to HIPAA as a Covered Entity or business associate, we may be required to comply with HIPAA requirements in connection with the conduct of our clinical trials.

Any new legislation or regulation in the area of privacy and security of personal information, including personal health information, could also adversely affect our business operations. If we do not comply with existing or new applicable federal or state laws and regulations related to patient health information, we could be subject to criminal or civil sanctions and any resulting liability could adversely affect our financial condition.

In addition, countries around the world have passed or are considering legislation that would impose data breach notification requirements and/or require that companies adopt specific data security requirements. If we experience a data breach that triggers one or more of these laws, we may be subject to breach notification obligations, civil liability and litigation, all of which could also generate negative publicity and have a negative impact on our business.

***We are currently, and in the future may be, subject to various governmental regulations related to the manufacturing of product candidates and their components, and we may incur significant expenses to comply with, experience delays in our product commercialization as a result of and be subject to material sanctions if we or our contract manufacturers violate these regulations.***

Our manufacturing processes and facility are required to comply with the FDA's QSR, which covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of product candidates. Although we believe we are compliant with the QSRs, the FDA enforces the QSR through periodic announced or unannounced inspections of manufacturing facilities. We anticipate in the future being subject to such inspections, as well as to inspections by other federal and state regulatory agencies. Once we receive FDA regulatory clearance or approval, we are required to register our manufacturing facility with the FDA and list all devices that are manufactured. We also operate our facility in Massachusetts as an International Organization for Standardization, or ISO, 13485 certified facility and annual audits are required to maintain that certification. The resuppliers of our components are also required to comply with the QSR and are subject to inspections. We have limited ability to ensure that any such third-party manufacturers will take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of our product candidates. Failure to comply with applicable FDA requirements, or later discovery of previously unknown problems with our product candidates or manufacturing processes, including our failure or the failure of one of our third-party manufacturers to take satisfactory corrective action in response to an adverse QSR inspection, can result in, among other things:

● administrative or judicially imposed sanctions;

● injunctions or the imposition of civil penalties;

● recall or seizure of our product candidates;

● total or partial suspension of production or distribution;

● the FDA's refusal to grant future clearance or pre-market approval for our product candidates;

● withdrawal or suspension of marketing clearances or approvals;

● clinical holds;

● warning letters;

● refusal to permit the import or export of our product candidates; and

● criminal prosecution of us or our employees.

Any of these actions, in combination or alone, could prevent us from marketing, distributing, or selling our product candidates and would likely harm our business. In addition, a product defect or regulatory violation could lead to a government-mandated or voluntary recall by us. Regulatory agencies in other countries have similar authority to recall devices because of material deficiencies or defects in design or manufacture that could endanger health. Any recall would divert management attention and financial resources, could expose us to product liability or other claims, including contractual claims from parties to whom we sold product candidates and harm our reputation with customers. A recall involving any of our product candidates would be particularly harmful to our business and financial results and, even if we remedied a particular problem, would have a lasting negative effect on our reputation and demand for our product candidates.

***While Breakthrough Device Designation allows for increased interaction with FDA reviewers and prioritized submission review, it does not guarantee product approval, faster approval, or commercial success.***

The FDA may grant BDD to medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. In July 2022, the Revivent TC System received BDD for the treatment of heart failure patients with left ventricular scar. This designation is intended to expedite development and regulatory review while maintaining the FDA's statutory standards for premarket approval, 510(k) clearance, or De Novo classification.

While BDD allows for increased interaction with FDA reviewers and prioritized submission review, it does not guarantee product approval, faster approval, or commercial success. The Revivent System remains subject to extensive regulatory requirements, including but not limited to premarket approval, manufacturing quality systems, labeling, and post-market surveillance. Medical devices may only be marketed for uses approved by the FDA, and we must comply with the FDA's QSR, covering manufacturing, testing, labeling, and documentation processes.

Our manufacturing facilities and those of our suppliers are subject to periodic FDA inspections, which may be unannounced. Any failure to comply with applicable regulations could delay approval, limit commercialization, or lead to enforcement actions that could materially impact our business.

**Risks Related to Our Securities and this Offering**

***No active trading market for our common stock currently exists, and an active trading market may not develop or be sustained following this offering.***

Prior to this offering, there has not been an active trading market for our common stock. If an active trading market for our common stock does not develop following this offering, you may not be able to sell your shares quickly or at the market price. Our ability to raise capital to continue to fund operations by selling shares of our common stock and our ability to acquire other companies or technologies by using shares of our common stock as consideration may also be impaired. The initial public offering price of our common stock will be determined by negotiations between us and the underwriters and may not be indicative of the market prices of our common stock that will prevail in the trading market.

***The trading price of our common stock may be volatile, and you could lose all or part of your investment.***

Prior to this offering, there has been no public market for shares of our common stock. The initial public offering price of our common stock will be determined through negotiations between us and the underwriters. This price does not necessarily reflect the price at which investors in the market will be willing to buy and sell shares of our common stock following this offering. In addition, the trading price of our common stock following this offering is likely to be volatile and could be subject to fluctuations in response to various factors, some of which are beyond our control. These fluctuations could cause you to lose all or part of your investment in our common stock as you might be unable to sell your shares at or above the price you paid in this offering. Factors that could cause fluctuations in the trading price of our common stock include the following:

● price and volume fluctuations in the overall stock market from time to time;

● volatility in the trading prices and trading volumes of transportation stocks;

● changes in operating performance and stock market valuations of other transportation companies generally, or those in our industry in particular;

● sales of shares of our common stock by us or our stockholders;

● failure of securities analysts to maintain coverage of us, changes in financial estimates by securities analysts who follow our company, or our failure to meet these estimates or the expectations of investors;

● the financial projections we may provide to the public, any changes in those projections, or our failure to meet those projections;

● announcements by us or our competitors of new product candidates, features, or services;

● the public's reaction to our press releases, other public announcements and filings with the SEC;

● rumors and market speculation involving us or other companies in our industry;

● actual or anticipated changes in our results of operations or fluctuations in our results of operations;

● actual or anticipated developments in our business, our competitors' businesses or the competitive landscape generally;

● litigation involving us, our industry, or both, or investigations by regulators into our operations or those of our competitors;

● developments or disputes concerning our intellectual property or other proprietary rights;

● announced or completed acquisitions of businesses, product candidates, services or technologies by us or our competitors;

● new laws or regulations or new interpretations of existing laws or regulations applicable to our business;

● changes in accounting standards, policies, guidelines, interpretations or principles;

● any significant change in our management; and

● general economic conditions and slow or negative growth of our markets.

In recent years, the stock markets generally have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of listed companies. Broad market and industry factors may significantly affect the market price of our common stock, regardless of our actual operating performance. These fluctuations may be even more pronounced in the trading market for our common stock shortly following this offering. If the market price of shares of our common stock after this offering does not ever exceed the initial public offering price, you may not realize any return on your investment in us and may lose some or all of your investment.

In addition, in the past, following periods of volatility in the overall market and in the market price of a particular company's securities, securities class action litigation has often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management's attention and resources.

***Certain recent initial public offerings of companies with public floats comparable to our anticipated public float have experienced extreme volatility that was seemingly unrelated to the underlying performance of the respective company. We may experience similar volatility, which may make it difficult for prospective investors to assess the value of our common stock.***

In addition to the risks addressed above in "*Risks Relating to Our Securities and this Offering — The trading price of our common stock may be volatile, and you could lose all or part of your investment*," our common stock may be subject to extreme volatility that is seemingly unrelated to the underlying performance of our business. Recently, companies with comparable public floats and initial public offering sizes have experienced instances of extreme stock price run-ups followed by rapid price declines, and such stock price volatility was seemingly unrelated to the respective company's underlying performance. Although the specific cause of such volatility is unclear, our anticipated public float may amplify the impact the actions taken by a few stockholders have on the price of our common stock, which may cause the price of our common stock to deviate, potentially significantly, from a price that better reflects the underlying performance of our business. Should our common stock experience run-ups and declines that are seemingly unrelated to our actual or expected operating performance and financial condition or prospects, prospective investors may have difficulty assessing the rapidly changing value of our common stock. In addition, investors of shares of our common stock may experience losses, which may be material, if the price of our common stock declines after this offering or if such investors purchase shares of our common stock prior to any price decline.

***If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.***

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. If no securities or industry analysts commence coverage of our company, the trading price for our stock would be negatively impacted. If we obtain securities or industry analyst coverage and if one or more of the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our stock could decrease, which could cause our stock price and trading volume to decline.

***Future sales of our common stock or securities convertible, exchangeable or exercisable into our common stock may depress our stock price.***

Sales of a substantial number of shares of our common stock or securities convertible, exchangeable or exercisable into our common stock in the public market after the completion of this offering, or the perception that these sales could occur, could adversely affect the market price of our common stock and could materially impair our ability to raise capital through equity offerings in the future.

The common stock sold in this offering will be freely tradable without restriction or further registration under the Securities Act of 1933, as amended (the "Securities Act"), and shares held by our existing stockholders may also be sold in the public market in the future subject to the restrictions in Rule 144 under the Securities Act and the applicable lock-up agreements. Following the consummation of this offering, assuming no exercise of outstanding options or the Underwriters' Warrants, there will be shares of common stock outstanding immediately after this offering assuming full exercise of the underwriters' over-allotment option, and shares of common stock assuming no exercise of the underwriters' over-allotment option, including 7,664,988 shares of common stock being issued upon the closing of this offering in connection with the conversion of: (i) 1,565,000 shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00) and (ii) $11,333,146 of our existing convertible notes into 6,099,988 shares of our common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00). In connection with this offering, we and each of our directors and officers named in the section "*Management,*" and our existing stockholders have agreed not to sell shares of common stock for a period of six (6) months from the date of the closing of this offering without the prior written consent of the representative of the underwriters, subject to customary exceptions. The representative of the underwriters may release these securities from lock-up restrictions at any time, subject to applicable regulations of the Financial Industry Regulatory Authority, Inc. ("FINRA"). We cannot predict what effect, if any, market sales of securities held by our significant stockholders or any other stockholder or the availability of these securities for future sale will have on the market price of our common stock. See "*Underwriting*" and "*Shares Eligible for Future Sale*" for a more detailed description of the restrictions on selling our securities after this offering.

***Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.***

There is a risk that our securities will not continue to be listed on Nasdaq even if our securities are listed on Nasdaq. Following this offering, in order to maintain our listing on Nasdaq, we will be required to comply with certain Nasdaq continuing listing rules, including those regarding minimum stockholders' equity, minimum share price, minimum market value of publicly held shares, corporate governance and various additional requirements. If we are unable to satisfy Nasdaq criteria for maintaining our listing, our securities could be subject to delisting. Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq's listing requirements.

***Our management will have broad discretion in how we use the net proceeds from this offering and might not use them effectively.***

Our management will have considerable discretion over the use of proceeds from this offering. We currently intend to use the net proceeds from this offering primarily to fund the RELIVE Trial and the associated manufacturing activities required to support such trial. The remaining portion of the net proceeds will be used to fund working capital and general administrative expenses. You will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used in a manner which you may consider most appropriate. Our management might spend a portion or all of the net proceeds from this offering in ways that our stockholders do not desire or that do not necessarily improve our operating results or enhance the value of our common stock. The failure of our management to apply these proceeds effectively could, among other things, result in unfavorable returns and uncertainty about our prospects, each of which could cause the price of our common stock to decline.

***You will experience immediate and substantial dilution as a result of this offering and may experience additional dilution in the future****.*

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the sale by us of shares in this offering at an assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus), and after deducting underwriting discounts and estimated offering expenses payable by us, investors in this offering can expect an immediate dilution of $ per share at the assumed initial public offering price. Additionally, to the extent that warrants (including the Underwriters' Warrants), or options we will grant to our officers, directors and employees, are ultimately exercised, you will sustain future dilution. We may also acquire new businesses or finance strategic alliances by issuing equity, which may result in additional dilution to our stockholders. Following the completion of this offering, our board of directors has the authority, within any limitations prescribed by relevant laws and our charter documents, to issue all or any part of our authorized but unissued shares of common stock, including shares issuable upon the exercise of options, or shares of our authorized but unissued preferred stock. Issuances of common stock or voting preferred stock would reduce your influence over matters on which our stockholders vote and, in the case of issuances of preferred stock, would likely result in your interest in us being subject to the prior rights of holders of that preferred stock. See the section titled "*Dilution*."

***We will incur significant costs as a result of operating as a public company and our management expects to devote substantial time to public company compliance programs.***

As a public company, we will incur significant legal, accounting and other expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley Act, as well as rules implemented by the SEC and Nasdaq. Shareholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact, in ways we cannot currently anticipate, the manner in which we operate our business. Our management and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly.

To comply with the requirements of being a public company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting or internal audit staff. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control over financial reporting. We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Exchange Act is accumulated and communicated to our principal executive and financial officers. Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial reporting may be discovered in the future. Any failure to develop or maintain effective controls when we become subject to this requirement could negatively impact the results of periodic management evaluations and annual independent registered public accounting firm attestation reports regarding the effectiveness of our internal control over financial reporting that we may be required to include in our periodic reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, harm our operating results, cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial statements. In the event that we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating results and the price of our common stock could decline. In addition, if we are unable to continue to meet these requirements, we may not be able to remain listed on Nasdaq.

***We restated certain of our previously issued consolidated financial statements, which resulted in unanticipated costs and may affect investor confidence and raise reputational issues.***

We reached a determination to restate our consolidated financial statements and related disclosures for the year ended December 31, 2024 included elsewhere in this prospectus. As a result, we have incurred unanticipated costs for accounting, professional and legal fees in connection with or related to the restatement, and could become subject to a number of additional risks and uncertainties, which may affect investor confidence in the accuracy of our financial disclosures and may raise reputational issues for our business.

***Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our financial condition and results of operations.***

We will be subject to income taxes in the United States, and our domestic tax liabilities will be subject to the allocation of expenses in differing jurisdictions. Our future effective tax rates could be subject to volatility or adversely affected by a number of factors, including:

● changes in the valuation of our deferred tax assets and liabilities;

● expected timing and amount of the release of any tax valuation allowances;

● tax effects of stock-based compensation;

● costs related to intercompany restructurings; or

● changes in tax laws, regulations or interpretations thereof.

In addition, we may be subject to audits of our income, sales and other transaction taxes by federal, state and local authorities. Outcomes from these audits could have an adverse effect on our financial condition and results of operations.

***Provisions in our charter documents and under Delaware law, including anti-takeover provisions, could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may limit attempts by our stockholders to replace or remove our current management.***

Our fourth amended and restated certificate of incorporation and amended and restated bylaws to be in effect following the consummation of this offering (the "Amended and Restated COI" and the "Amended and Restated Bylaws," respectively) include anti-takeover provisions, which may have the effect of delaying or preventing a merger, acquisition or other change of control of us that our stockholders may consider favorable. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, the charter and bylaws include provisions that:

● require super-majority voting to amend the bylaws and certain provisions in the charter;

● provide that only a majority of our board of directors, the chairman of our board of directors, our co-chief executive officers, our Vice Chairman (if any), our President or stockholders collectively holding more than 50% of our voting securities will be authorized to call a special meeting of stockholders;

● do not provide for cumulative voting;

● prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;

● provide that our board of directors is expressly authorized to make, alter, or repeal our bylaws, subject to DGCL requirements; and

● establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon by stockholders at annual stockholder meetings.

Public stockholders who might desire to participate in these types of transactions may not have an opportunity to do so, even if the transaction is considered favorable to stockholders. These anti-takeover provisions could substantially impede the ability of public stockholders to benefit from a change in control or a change in our management and board of directors and, as a result, may adversely affect the market price of our common stock and your ability to realize any potential change of control premium.

***We have never paid dividends on our capital stock, and we do not anticipate paying dividends for the foreseeable future.***

We have never declared or paid any cash dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends, if any, in the future is within the discretion of our board of directors and will depend on our earnings, capital requirements and financial condition and other relevant facts. We currently intend to retain all future earnings, if any, to finance the development and growth of our business. Accordingly, you must rely on the sale of your common stock after price appreciation, which may never occur, as the only way to realize any future gain on your investment.

***Our Amended and Restated COI designates certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.***

We recognize that the Delaware Forum Provision and the Federal Forum Provision in our bylaws may impose additional litigation costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware. Additionally, the Delaware Forum Provision and the Federal Forum Provision may limit our stockholders' ability to bring a claim in a forum that they find favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers and employees even though an action, if successful, might benefit our stockholders. If the Federal Forum Provision is found to be unenforceable, we may incur additional costs associated with resolving such matters. The Federal Forum Provision may also impose additional litigation costs on stockholders who assert that the provision is not enforceable or invalid. The competent courts of the State of Delaware and the United States District Court may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments may be more or less favorable to us than our stockholders.

***Our ability to use our U.S. net operating loss carryforwards to offset future taxable income may be subject to certain limitations.***

As of December 31, 2025, we had U.S. federal net operating loss ("NOL") carryforwards of approximately $183.8 million, which may be available to offset federal income tax liabilities in the future. In addition, we may generate additional NOLs in future years. In general, a corporation's ability to utilize its NOLs may be limited if it experiences an "ownership change" as defined in Section 382 of the U.S. Internal Revenue Code of 1986, as amended (the "Code"). An ownership change generally occurs if certain direct or indirect "5- percent shareholders," as defined in Section 382 of the Code, increase their aggregate percentage ownership of a corporation's stock by more than 50 percentage points over their lowest percentage ownership at any time during the testing period, which is generally the three-year period preceding any potential ownership change. If a corporation experiences an ownership change, the corporation will be subject to an annual limitation that applies to the amount of pre-ownership change NOLs that may be used to offset post-ownership change.

***We qualify as an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.***

We qualify as an "emerging growth company," as defined in the JOBS Act. For as long as we remain an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies, including, but not limited to, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We will remain an emerging growth company until the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues exceed $1.235 billion, (ii) the date on which we first qualify as a large accelerated filer under the rules of the SEC, (iii) the date on which we have, in any three-year period, issued more than $1.0 billion in non-convertible debt securities, and (iv) the last day of the fiscal year following the fifth anniversary of the completion of this offering.

We are a "smaller reporting company" as defined in Rule 12b-2 under the Exchange Act. We may continue to be a smaller reporting company until the fiscal year following the determination that our voting and non-voting common stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter.

If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our annual report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. Investors may find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and the market price of our common stock may be adversely affected and more volatile.

**CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS**

The information in this prospectus contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this prospectus other than statements of historical fact, including statements regarding our future operating results and financial position, our business strategy and plans, market growth, and our objectives for future operations, are forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

You can identify some of these forward-looking statements by words or phrases such as "may," "will," "could," "would," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "is/are likely to," "potential," "project," "target," "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this prospectus are only predictions and are based largely on our current expectations and projections about future events and financial trends that we reasonably believe may affect our business, financial condition, and results of operations. Although we believe the expectations reflected in any of our forward-looking statements are reasonable, actual results could differ materially from those projected or assumed in any of our forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to change and inherent risks and uncertainties.

These forward-looking statements present our estimates and assumptions only as of the date of this prospectus and are subject to several known and unknown risks, uncertainties, and assumptions. Accordingly, you are cautioned not to place undue reliance on forward-looking statements, which speak only as of the dates on which they are made. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, those summarized below:

● failure to obtain FDA approval to commercially sell our product candidates in a timely manner or at all;

● failure to carry out our trials on the timelines expected and with the expected efficacy or safety results;

● whether heart failure specialists, surgeons and patients in our target markets accept our product candidates, if approved;

● the expected growth of our business and our operations, and the capital resources needed to progress our business plan;

● failure to scale up of the manufacturing process of our product candidates in a timely manner, or at all;

● failure to manufacture our product candidates at a competitive price;

● our ability to retain and recruit key personnel, including the development of a sales and marketing infrastructure;

● reliance on third party suppliers for certain components of our product candidates;

● reliance on third parties to commercialize and distribute our product candidates in the United States and internationally;

● changes in external competitive market factors;

● uncertainties in generating sustained revenue or achieving profitability

● unanticipated working capital or other cash requirements;

● changes in FDA regulations, including testing procedures, of medical devices and related promotional and marketing activities;

● our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for, or ability to obtain, additional financing;

● estimates of our addressable market, market growth, future revenue, expenses, capital requirements and our needs for additional financing;

● our ability to obtain and maintain intellectual property protection for our product candidates; and

● changes in our business strategy or an inability to execute our strategy due to unanticipated changes in the medical device industry.

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with. Forward-looking statements necessarily involve risks and uncertainties, and our actual results could differ materially from those anticipated in the forward-looking statements due to a number of factors, including those set forth above under "*Risk Factors*" and elsewhere in this prospectus. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained above and throughout this prospectus. Prior to investing in our common stock, you should read this prospectus and the documents we have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we currently expect.

**USE OF PROCEEDS**

We estimate that we will receive net proceeds from this offering of approximately $ million (or approximately $ million if the underwriters exercise their over-allotment option in full), after deducting estimated offering expenses payable by us, and based upon an assumed initial public offering price of $ per share, the midpoint of the estimated price range set forth on the cover page of this prospectus.

We intend to use the net proceeds from this offering as follows:

● approximately $(or approximately $ million if the underwriters exercise their over-allotment option in full), or approximately 60% of the net proceeds from this offering, to fund the RELIVE Trial and the associated manufacturing activities required to support such trial; and

● approximately $(or approximately $ million if the underwriters exercise their over-allotment option in full), or approximately 40% of the net proceeds from this offering, for working capital and other general corporate purposes, including regulatory compliance, intellectual property protection, additional employee hires and additional contractor retainment.

Assuming the offering generates approximately $15.0 million in gross proceeds, we believe these funds will be sufficient to achieve full site engagement, enroll approximately 75% of patients, and complete patient enrollment within approximately three months thereafter.

A $1.00 increase (decrease) in the assumed initial public offering price would increase (decrease) the net proceeds to us from this offering by approximately $ million, after deducting the estimated underwriting discounts, non-accountable expense allowance and estimated aggregate offering expenses payable by us and assuming no change to the number of shares of common stock offered by us as set forth on the cover page of this prospectus.

We may change the amount of net proceeds to be used specifically for any of the foregoing purposes. The amounts and timing of our actual expenditures will depend upon numerous factors, including factors within our discretion and factors outside of our control. We may also use a portion of the net proceeds to acquire, license and invest in complementary product candidates, technologies, or additional businesses; however, we currently have no agreements or commitments with respect to any such transaction.

Moreover, the foregoing represents only our current intentions based upon our present plans and business conditions to allocate and use the net proceeds from this offering. You are cautioned that the nature, amounts and timing of our actual expenditures may vary significantly from what is described above or elsewhere in this prospectus depending on numerous factors. As a result, our management has and will retain broad discretion over the allocation of the net proceeds from this offering. We may find it necessary or advisable to in our business judgement to use the net proceeds from this offering for other purposes. Also, if an unforeseen event occurs or business conditions change, we may use the proceeds of this offering differently than as described above or elsewhere in this prospectus.

Pending our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments, and U.S. government securities.

In addition, as a general matter, given our limited operating history, early stage of business and a new and unproven technology model, it is difficult to evaluate our business prospects and actual expenditures in the future. Further, our business plan will be very costly, far more costly than the net proceeds we will receive from this offering. To develop and implement our business as currently planned, we will need to raise substantial amounts of additional capital and we intend to raise such additional capital through public or private offerings of equity or equity-linked securities, traditional loans, commercial collaborations such as licenses or joint ventures and, if available or desirable, government funding, including grants. No assurances can be given that we will be able to raise additional capital when needed, and our inability to raise additional capital could lead to the failure of our company.

**DIVIDEND POLICY**

We have never declared or paid any cash dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends, if any, in the future is within the discretion of our board of directors and will depend on our earnings, capital requirements and financial condition and other relevant facts. We currently intend to retain all future earnings, if any, to finance the development and growth of our business.

**CAPITALIZATION**

The following table sets forth our cash and equivalents and capitalization as of December 31, 2025:

● on an actual basis;

● on a pro forma basis to give effect to: the issuance of 7,277,645 shares of common stock upon the closing of this offering in connection with the conversion of: (i) 1,565,000 shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00) and (ii) $11,333,146 of our existing convertible notes into 6,099,988 shares of our common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00); and

● on a pro forma as adjusted basis to give effect to: (i) our issuance and sale of shares of our common stock in this offering at the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) and (ii) the deduction of $ of underwriting discounts and $ of estimated offering expenses payable by us, assuming the underwriters do not exercise any portion of their over-allotment option.

The information set forth in the table below is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering as determined at pricing. You should read this table together with "*Management's Discussion and Analysis of Financial Condition and Results of Operations*" and our audited financial statements and related notes and unaudited interim condensed financial statements and related notes thereto included elsewhere in this prospectus.

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| | | |
|:---|:---|:---|
|  | **As of December 31, 2025** | **As of December 31, 2025** |
|  | **Actual** | **Pro Forma**<br> **As Adjusted** |
| Cash and cash equivalents | $1838121 | $— |
| Total liabilities | 15134042 |  |
| Stockholders' Equity: |  |  |
| Preferred Stock: Par value of $0.0001 per share, 1,565,000 shares issued and outstanding, actual; par value of $0.0001 per share, no shares issued and outstanding, pro forma and pro forma as adjusted. | 157 |  |
| Common Stock: Par value of $0.0001 per share, 5,712,645 shares issued and outstanding, actual; par value of $0.0001 per share, shares issued and outstanding, pro forma; par value of $0.0001 per share shares issued and outstanding, pro forma as adjusted. | 571 |  |
| Additional paid-in capital | 218675435 |  |
| Accumulated deficit | (231241344) |  |
| Total stockholders' equity | (11965181) |  |
| Total capitalization | $2568861 | $— |

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The number of shares of our common stock to be outstanding upon completion of this offering will be shares assuming no exercise of the over-allotment by the underwriters, which is based on 5,712,645 shares of our common stock outstanding as of December 31, 2025, and includes 7,664,988 shares of common stock being issued upon the closing of this offering in connection with the conversion of: (i) 1,565,000 shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00) and (ii) $11,333,146 of our existing convertible notes into 6,099,988 shares of our common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00), and excludes, as of the date of this prospectus:

● shares of common stock issuable upon the exercise of the Underwriters' Warrants;

● 950,500 shares of our common stock reserved for issuance under stock option agreements issued pursuant to the 2024 Plan; and

● 549,500 shares of our common stock (which is equal to % of our issued and outstanding common stock immediately after the consummation this offering) reserved for future issuance under the 2026 Plan, which will become effective as of the closing of this offering.

Each $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the amount of cash, additional paid-in capital, total stockholders' equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $, assuming the number of shares, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and estimated offering expenses payable by us. Similarly, each increase (decrease) of shares offered by us would increase (decrease) cash, total stockholders' equity (deficit) and total capitalization on a pro forma as adjusted basis by approximately $, assuming the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

**DILUTION**

If you purchase shares of our common stock in this offering, your interest will be diluted immediately to the extent of the difference between the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) and the pro forma as adjusted net tangible book value per share of our common stock immediately upon the consummation of this offering. Net tangible book value per share of common stock is determined by dividing our total tangible assets less total liabilities by the number of outstanding shares of our common stock. As of December 31, 2025, we had a historical net tangible book value of $(12.0 million), or $(2.09) per share of common stock. Our historical net tangible book value per share represented total tangible assets less total liabilities, divided by 5,712,645 shares of our common stock outstanding as of December 31, 2025.

Our pro forma net tangible book value as of December 31, 2025 was $, or $ per share of our common stock based on shares of our common stock outstanding. Pro forma net tangible book value represents the amount of our historical total tangible assets less our total liabilities, after giving effect to the issuance of shares of common stock at a price of $ per share corresponding to a financing that ended subsequent to and the issuance of 7,664,988 shares of common stock being issued upon the closing of this offering in connection with the conversion of: (i) 1,565,000 shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00) and (ii) $11,333,146 of our existing convertible notes into 6,099,988 shares of our common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00).

After giving further effect to our sale of shares of common stock in this offering at an assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus), and after deducting underwriters' discounts and estimated offering expenses, upon the completion of this offering, our pro forma as adjusted net tangible book value as of December 31, 2025 would have been $, or $ per share of common stock. This represents an immediate increase in pro forma net tangible book value of $ per share of common stock to existing stockholders and an immediate dilution in net tangible book value of $ per share to new investors of shares in this offering. We determine dilution by subtracting the pro forma as adjusted net tangible book value per share after this offering from the public offering price that a new investor paid for a share of common stock in this offering.

If the underwriters exercise their over-allotment option in full to purchase additional shares of common stock in this offering at the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus), the pro forma as adjusted net tangible book value per share after this offering would be $ per share of common stock, the increase in the pro forma as adjusted net tangible book value per share would be $ per share of common stock and the dilution to new investors purchasing securities in this offering would be $ per share of common stock.

The following table illustrates this dilution on a per share of common stock basis assuming the underwriters do not exercise any portion of their over-allotment option and assuming the underwriters exercise their over-allotment option in full:

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| | | |
|:---|:---|:---|
|  | **Offering<br> Without<br> Over-Allotment** | **Offering<br> With<br> Over-Allotment** |
| Assumed public offering price per share | $— | $|
| Historical net tangible book value (deficit) per share as of December 31, 2025 | $(2.20) | $|
| Increase in net tangible book value (deficit) per share attributable to the pro forma adjustments described above | $— | $|
| Pro forma net tangible book value (deficit) per share, as of December 31, 2025, before giving effect to this offering | $— | $|
| Increase in pro forma net tangible book value (deficit) per share attributable to new investors in this offering | $— | $|
| Pro forma as adjusted net tangible book value per share after giving effect to this offering | $— | $|
| Dilution per share to new investors in this offering | $— | $|

---

The dilution information discussed above is illustrative only and may change based on the actual initial public offering price and other terms of this offering.

Assuming the underwriters' over-allotment option is not exercised, each $1.00 increase (decrease) in the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) our pro forma as adjusted net tangible book value after giving effect to this offering by $, or by approximately $ per share of common stock and the dilution to new investors purchasing our common stock in this offering by approximately $ per share, assuming the number of shares offered by us remains the same and after deducting the estimated underwriting discount and estimated offering expenses payable by us. In addition, to the extent any stock options that we granted to certain of our officers, directors, employees and permitted consultants, new investors would experience further dilution.

The following table illustrates our pro forma proportionate ownership, upon completion of this offering by present stockholders and investors in this offering, compared to the relative amounts paid by each. The table reflects payment by present stockholders as of the date the consideration was received and by investors in this offering at the public offering price. The table further assumes no changes in net tangible book value other than those resulting from this offering.

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
|  | **Shares Purchased** | **Shares Purchased** | **Total Consideration** | **Total Consideration** | **Average Price** |
|  | **Number** | **Percent<br> (%)** | **Amount ($)** | **Percent<br> (%)** | **Per Share<br> ($)** |
| Existing stockholders | [ ] | [ ]% | [ ] | [ ]% | $[ ] |
| New investors | [ ] | [ ]% | [ ] | [ ]% | $[ ] |
| Total | [ ] | 100% | [ ] | [ ]% | $[ ] |

---

The table above assumes no exercise of the underwriters' over-allotment option to purchase additional shares in this offering. If the underwriters' over-allotment option to purchase additional shares is exercised in full, the number of shares of our common stock held by existing stockholders would be reduced to % of the total number of shares of our common stock outstanding after this offering, and the number of shares of common stock held by new investors participating in this offering would be increased to % of the total number of shares outstanding after this offering.

The number of shares of our common stock to be outstanding upon completion of this offering will be shares assuming no exercise of the over-allotment by the underwriters, which is based on 13,377,633 shares of our common stock outstanding as of December 31, 2025, which includes 7,664,988 shares of common stock being issued upon the closing of this offering in connection with the conversion of: (i) 1,565,000 shares of our existing Series A Preferred Stock into 1,565,000 shares of common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00) and (ii) $11,333,146 of our existing convertible notes into 6,099,998 shares of our common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00), and excludes, as of the date of this prospectus:

● shares of common stock issuable upon the exercise of the Underwriters' Warrants;

● 950,500 shares of our common stock reserved for issuance under stock option agreements issued pursuant to the 2024 Plan; and

● 549,500 shares of our common stock (which is equal to % of our issued and outstanding common stock immediately after the consummation this offering) reserved for future issuance under the 2026 Equity Incentive Plan, which will become effective as of the closing of this offering.

**MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL<br> CONDITION AND RESULTS OF OPERATIONS**

*The following discussion and analysis summarize the significant factors affecting our operating results, financial condition, liquidity and cash flows of our company as of and for the periods presented below. The following discussion and analysis should be read in conjunction with our financial statements and the related notes thereto included elsewhere in this prospectus. The discussion contains forward-looking statements that are based on the beliefs of management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those discussed in or implied by forward-looking statements as a result of various factors, including those discussed below and elsewhere in this prospectus, particularly in the sections titled "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements".*

**Overview**

We are a medical device company focused on developing, manufacturing and commercializing proprietary devices to restore left ventricular function in heart failure patients with reduced ejection fraction ("HFrEF").

Our lead device program, the **Revivent System**, has a CE mark in Europe and is in its pivotal trial in the United States. In Europe (where we have obtained approval but are currently not commercially operating in order to preserve capital) or through an authorized U.S. clinical site (as we have not received FDA approval), heart failure specialists refer HFrEF patients with left ventricular dilation due to large anterior heart attack scars to cardiac surgeons who elect to utilize our product to restore left ventricular function by reducing the size of the left ventricle. The Revivent System accomplishes this reduction by folding the scar onto itself and fastening it together in a less invasive mini-thoracotomy procedure.

Based on our analysis of publicly available data and according to a 2016 New England Journal of Medicine article, patients with heart failure with HFrEF continue to face poor outcomes under the current standard of care, with multiple studies reporting an approximately 50–60% five-year mortality rate. Our goal is for the Revivent System to be the new standard of care for these patients.

We also have ownership rights to **Alginate**, a hydrogel-based device treatment for HFrEF patients without anterior scarring.

In November 2024, we received an investigational device exemption ("IDE") from the U.S. Food and Drug Administration (the "FDA") under a Breakthrough Device Designation ("BDD") to begin a pivotal trial of the Revivent System (called the "RELIVE Trial"). We began enrolling patients in the RELIVE Trial in September 2025. An IDE authorizes the use of a significant-risk investigational medical device in a clinical study in order to collect safety and effectiveness data but does not constitute FDA clearance or approval to market or commercialize the device. The FDA grants BDD if preliminary clinical evidence suggests the procedure may improve substantially upon at least one clinically significant endpoint for a serious or life-threatening condition compared to existing therapies.

Our company, under prior management, previously conducted a clinical trial of the Revivent System (called the "ALIVE Trial"), which ended in 2023. The ALIVE Trial achieved statistical significance upon secondary analysis on functional status and Quality-of-Life ("QoL") measures, three of the five measures in the trial's primary efficacy endpoint. The functional status and QoL endpoints included change in 6-minute walk test ("6MWT"), change in Minnesota Living with Heart Failure questionnaire score ("MLHF"), and change in New York Heart Association ("NYHA") functional classification assessed at 12 months. However, as reported in the Journal of the American College of Cardiology ("JACC") ALIVE Trial publication, the failure of the other two measures, cardiovascular mortality and heart failure hospitalization, were in part a result of the comparison of our trial results with a control group that was healthier than the treatment group. This was a result of prior management's decision to not randomize the ALIVE Trial. In the JACC ALIVE Trial publication, the authors noted that (i) the control group was healthier than the treated group as evidenced by heart failure treatments and hospitalizations in the twelve months prior to the trial and better baseline left-ventricle function; and (ii) the external anchor placement (surgical only approach) produced fewer major adverse events than the internal right ventricle-left ventricle (RV-LV) anchor placement (hybrid procedure). The composite primary safety endpoint through 30 days was met. Major adverse events occurred in 15 of 84 patients (17.9%) of which 12 out of 60 patients (20%) were in the hybrid procedure and 3 out of 23 (13.0%) were in the surgical only approach. In one patient, the device procedure was attempted but aborted before device anchor placement. While the ALIVE trial met its safety endpoints inclusive of the hybrid procedure and surgical only approach, we have decided to test the surgical only approach only in the RELIVE trial due to the fact that fewer major adverse events could indicate that it has a more favorable safety profile, which would ultimately be determined by the FDA.

Our current management team is following the JACC article authors' recommendations by designing a randomized control trial using the external anchor placement approach. We proposed and were approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition) to support our Revivent Therapy Pre-Market Approval ("PMA") application. We are actively engaged with 16 sites needed for the RELIVE Trial, providing confidence to management on their estimates on site initiation, recruitment rates, heart failure specialist referral rates, surgeon experience, and trial expense.

The Revivent System is classified by the FDA as a Class III medical device and requires PMA approval. In the event we receive FDA PMA approval for our Revivent System, which we believe could be by mid-2028, we intend to expand from the 20 or more cardiac surgery centers participating in the trial to the top 336 United States cardiac surgery centers which represent approximately 30% of hospitals performing cardiac surgeries and 51% of cardiac surgery volume according to data published in The American Journal of Accountable Care. Ultimately, through the approximately 1,545 U.S. heart failure specialist and 1,120 U.S. cardiac surgery centers, our goal is to deploy the Revivent System in the market to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. based on our estimations.

While our priority is conducting the RELIVE Trial, we intend to support post-market surveillance to maintain our Revivent System CE mark and may build a small European commercial organization if funding from this offering or otherwise becomes available in excess of our trial expenses. In addition, we expect to conduct post-approval studies to support marketing and to satisfy any ongoing regulatory requirements.

There is no guarantee that the RELIVE Trial will be sufficient for FDA approval, and in such case, we may be required to conduct additional trials for the Revivent System. *See* "*Risk Factors – If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.*" and "*Risk Factors – The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable."*

In the event we receive FDA PMA approval for our Revivent System, which we anticipate could be by mid-2028, we intend to expand from the 20 or more cardiac surgery centers participating in the trial to the top 336 United States cardiac surgery centers which represent 30% of hospitals performing cardiac surgeries and approximately 51% of cardiac surgery volume ("Inpatient and 90-Day Postdischarge Outcomes in Cardiac Surgery," The American Journal of Accountable Care). Ultimately, through the approximately 1,120 U.S. cardiac surgery centers, our goal is to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. Approximately 28,000 Revivent System-eligible patients are added each year to U.S. prevalence, respectively, and a similar number are lost each year to mortality. The Revivent System is classified by the FDA as a Class III medical device, which is subject to the most stringent regulatory requirements, including the requirement to demonstrate reasonable assurance of safety and effectiveness through well-controlled clinical investigations. While we currently anticipate submitting a PMA following completion of the RELIVE trial, FDA approval may not be obtained on this timeline or at all, and the FDA could require additional clinical trials or other data before granting any approval. See "Risks Related to Regulatory Approval and Other Governmental Regulations."

**Principal Factors Affecting Our Financial Performance**

Our operating results are primarily affected by the following factors:

● the ability to obtain regulatory approval to market our product candidates;

● the timing, costs and results of clinical trials and other development activities versus expectations;

● the ability to manufacture product candidates successfully;

● competition from product candidates sold or being developed by other companies;

● the price of, and demand for, our product candidates once approved;

● the ability to negotiate favorable licensing or other manufacturing and marketing agreements for our product candidates;

● patent reinforcement and prosecution; and

● changes in laws or the regulatory environment affecting our company.

**Our Status as an Emerging Growth Company and Smaller Reporting Company**

We qualify as an "emerging growth company" under the JOBS Act. As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements. For so long as we are an emerging growth company, we will not be required to:

● have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

● comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);

● submit certain executive compensation matters to shareholder advisory votes, such as "say-on-pay" and "say-on-frequency;" and

● disclose certain executive compensation related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer's compensation to median employee compensation.

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.

We will remain an emerging growth company for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our total annual gross revenues exceed $1.235 billion, (ii) the date that we become a "large accelerated filer" as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three year period.

Additionally, we are a "smaller reporting company" as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our ordinary shares held by non-affiliates is equal to or exceeds $250 million as of the prior June 30, or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our ordinary shares held by non-affiliates is equal to or exceeds $700 million as of the prior June 30. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies difficult or impossible.

**Results of Operations**

***Comparison of Years Ended December 31, 2025, and 2024***

The following table summarizes our results of operations for the years ended December 31, 2025, and 2024:

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Year Ended December 31,** | **Year Ended December 31,** | **Variance** | **Variance** |
|  | **2025** | **2024** | **Amount** | **%** |
| Gross (loss) profit: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Revenue | $- | $- | $- | -% |
| &nbsp;&nbsp;&nbsp;Cost of goods sold | - | - | - | -% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Gross profit |  |  |  | -% |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | 1173645 | 589951 | 583694 | 99% |
| &nbsp;&nbsp;&nbsp;General and administrative expenses | 5096785 | 2972565 | 2124220 | 71% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 6270430 | 3562516 | 2707914 | 76% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Operating loss | (6270430) | (3562516) | (2707914) | 76% |
| Other expense: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Interest | 1391294 | 309971 | 1081323 | 349% |
| &nbsp;&nbsp;&nbsp;Other | 5947 | (21813) | 27760 | (127)% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other expense | 1397241 | 288158 | 1109083 | 385% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net loss before taxes | (7667671) | (3850674) | (3816997) | 99% |
| Income Tax expense (benefit) | - | - | - | -% |
| Net loss and comprehensive loss | (7667671) | (3850674) | (3816997) | 99% |

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*<u>Revenues</u>*

We historically recorded product revenue primarily from the sale of our Revivent TC™ TransCatheter Ventricular Enhancement System. We sold our product candidates in Europe to hospitals through direct sales representatives, as well as through distributors in selected international markets. All such sales of product in Europe ceased at the end of 2023 when the decision to cease operations to preserve capital was made and although we have certain approvals to sell in Europe, such sales have not restarted as of the date of this prospectus.

*<u>Research and Development Expenses</u>*

Research and development program costs include employee compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions. Our product candidates are in various stages of development and significant additional expenditures will be required if we commence further clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new product candidates is lengthy, expensive and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.

Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase substantially and will comprise a large percentage of our total expenses for the foreseeable future.

Research and development expenses increased $583,694, or by 99%, to $1,173,645 for the year ended December 31, 2025, compared to $589,951 for the prior year. This increase was primarily due to the ramp up of activity in that began in the second quarter of 2025 in preparation for the RELIVE trial.

*<u>Selling, General and Administrative Expenses</u>*

Selling, general and administrative expenses include salaries, benefits, and stock-based compensation for employees not directly involved in production, as well as marketing and advertising costs, professional and legal fees, facilities expenses, and other administrative overhead.

Selling, general and administrative expenses increased $2,124,220, or by 71%, to $5,096,785 for the year ended December 31, 2025, compared to $2,972,565 for the prior year. This increase was primarily due to legal and professional fees incurred in preparation of this offering.

*<u>Other Expense</u>*

Other expenses increased by $1,109,083, or by 385%, to $1,397,241 for the year ended December 31, 2025, compared to $288,158 for the prior year. This increase was primarily due to interest expense related to the significantly higher balance of convertible notes outstanding in 2025 compared to 2024.

*<u>Net Earnings and Losses</u>*

Our net loss increased by $3,816,997, or by 99%, to $7,667,671 for the year ended December 31, 2025, compared to $3,850,674 for the prior year. This increase was due primarily to increased research and development expenses in preparation of the RELIVE trial, increased selling, general and administrative expenses in preparation of this offering and increased interest expense related to a significantly higher balance of convertible notes outstanding.

**Liquidity and Capital Resources**

As of December 31, 2025, we had cash of $1,838,121. To date, we have financed our operations primarily from proceeds from private equity offerings and various debt arrangements. See the section titled "*Description of Capital Stock — History of Securities Issuances*."

We are in the development stage and have incurred losses and negative cash flows from operations since inception. For the years ended December 31, 2025 and 2024, we had a net loss of $7,667,671 and $3,850,674, respectively, and negative cash flows from operations of $5,812,114 and $2,718,714, respectively. Further, we had an accumulated deficit of $231,241,344 as of December 31, 2025, and $223,573,673 as of December 31, 2024. For the three months ended December 31, 2025 and 2024, we had a net loss of $2,448,901 and $1,172,061, respectively, and negative cash flows from operations of $1,470,746 and $734,041, respectively. Based on the current development plans for our product candidates and other operating requirements, existing cash and equivalents are not sufficient to fund operations for the twelve months following the date of the registration statement of which this prospectus is a part. We expect to incur losses over the next several years as we continue the development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of product candidates. To date, we have been reliant on a small number of investors to finance our operations. From our inception through December 31, 2025, we received funding of $228,398,763.

Until we are successful in our efforts for capital infusion, which is not entirely within our control, a substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of our financial statements. In addition, the ability of our stockholders to continue to provide financial support is dependent on our ability to secure additional funding. Management continues to address our liquidity position and will adjust spending as needed in order to preserve liquidity. Our future liquidity needs will be determined primarily by the success of our operations with respect to the progression of our product candidates and key development and regulatory events in the future. Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) renegotiating third party agreements, (3) securing additional debt financing and/or (4) selling equity securities. There can be no assurances that we will be successful in these efforts.

We plan to raise additional capital from various potential sources, including equity and/or debt financings, grant funding, and strategic relationships. In addition, we have an engagement with the underwriters to sell up to $ million of our common stock in this initial public offering, which amount, if fully raised, would be sufficient to fund our operations for approximately months. However, there can be no guarantee that we will be able to successfully complete this initial public offering or otherwise raise the necessary capital on terms acceptable to us, if at all. Should such financings be unsuccessful, we would be required to delay, scale back or eliminate some or all of our research and development programs, which would likely have a material adverse effect on us and our consolidated and combined financial statements.

Due to the above factors, a substantial doubt exists as to our ability to continue as a going concern.

***Loans to the Company***

We borrowed $9,857,477 from accredited investors in the form of convertible notes with an interest rate of 15% as of December 31, 2025. As of December 31, 2025, we had accrued interest payable of $1,475,669.

***Summary of Cash Flow***

The following table provides detailed information about our net cash flow for all financial statement periods presented in this prospectus:

**Cash Flow**

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| | | |
|:---|:---|:---|
|  | **Years Ended December 31,** | **Years Ended December 31,** |
|  | **2025** | **2024** |
| Net cash flows used in operating activities | $(5812114) | $(2718714) |
| Net cash flows used in investing activities |  |  |
| Net cash flows provided by financing activities | 5012600 | 4710000 |
| Net change in cash | (799514) | 1991286 |
| Cash, beginning of year | 2637635 | 646349 |
| Cash, end of period | 1838121 | 2637635 |

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Net cash used in operating activities was $5,812,114 for the year ended December 31, 2025, as compared to net cash used in operating activities of $2,718,714 for the year ended December 31, 2024, which represents an increase of $3,093,400 in net cash used in operating activities. The increase in cash used in operating activities for the year ended December 31, 2025 was due to ramping up operations in advance on a new clinical trial and incurring expenses related to a potential initial public offering.

There was no cash used for investing activities for the years ended December 31, 2025 and 2024.

Net cash provided by financing activities was $5,012,600 and $4,710,000 for the years ended December 31, 2025 and 2024, respectively. Net cash provided by financing activities in both periods consisted of issuances of convertible notes to finance operations.

**Contractual Obligations**

*Lease Agreement*

We lease space at 120 Forbes Boulevard, Mansfield, MA 02048. The area of such lease is approximately 9,000 square feet and the lease expires in 2027. Payments under the lease range from $139,407 per year in the first year of the lease and increase to a high of $161,620 in the final year of the lease.

*Convertible Notes*

See the section titled "*Description of Capital Stock — History of Securities Issuances*."

**Off-Balance Sheet Arrangements**

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

**Critical Accounting Policies**

The following discussion relates to our critical accounting policies. The preparation of financial statements in conformity with GAAP requires our management to make assumptions, estimates and judgments that affect the amounts reported, including the notes thereto, and related disclosures of commitments and contingencies, if any. We have identified certain accounting policies that are significant to the preparation of our financial statements. These accounting policies are important for an understanding of our financial condition and results of operations. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require management's difficult, subjective, or complex judgment, often as a result of the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods. Certain accounting estimates are particularly sensitive because of their significance to financial statements and because of the possibility that future events affecting the estimate may differ significantly from management's current judgments. We believe the following critical accounting policies involve the most significant estimates and judgments used in the preparation of our financial statements:

***Use of Estimates***

The preparation of consolidated and combined financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and related disclosures of contingent assets and liabilities at the date of the consolidated and combined financial statements as well as the reported amounts of revenues and expenses during the reporting period. Estimates are based on several factors including the facts and circumstances available at the time the estimates are made, historical experience, risk of loss, general economic conditions and trends and the assessment of the probable future outcome. Subjective and significant estimates include, but are not limited to, the valuation of stock-based compensation, expense recognition and accruals associated with third party providers supporting pre-clinical studies and other research and development, and income tax asset realization. Actual results could differ from those estimates. Estimates and assumptions are reviewed periodically and the effects of changes, if any, are reflected in the consolidated and combined statements of operations in the period that they are determined.

***Collaborative Arrangements***

We analyze our collaborative arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards, and therefore are within the scope of FASB ASC Topic 808, *Collaborative Arrangements* ("ASC 808"). For collaborative arrangements that contain multiple elements, we determine which units of account are deemed to be within the scope of ASC 808 and which units of account are more reflective of a vendor-customer relationship, and therefore are within the scope of ASC 606. For units of account that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, either by analogy to appropriate accounting literature or by applying a reasonable accounting policy election. For collaborative arrangements that are within the scope of ASC 808, we evaluate the income statement classification for presentation of amounts due to or owed from other participants associated with multiple units of account in a collaborative arrangement based on the nature of each activity. Payments or reimbursements that are the result of a collaborative relationship instead of a customer relationship, such as co-development and co-commercialization activities, are recorded as increases or decreases to Research and Development Expense or General and Administrative Expense, as appropriate. Milestone payments are considered contingent liabilities and are recognized when we deem the milestone event to be probable.

***Fair Value Measurements***

FASB ASC Topic 820, *Fair Value Measurements and Disclosures*, defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. Fair value is to be determined based on the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants. In determining fair value, we used various valuation approaches. A fair value hierarchy has been established for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are those that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us.

Unobservable inputs reflect our assumption about the inputs that market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The fair value hierarchy is categorized into three levels, based on the inputs, as follows:

● Level 1 - Valuations based on quoted prices for identical instruments in active markets. Since valuations are based on quoted prices that are readily and regularly available in an active market, valuation of these instruments does not entail a significant degree of judgment.

● Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for either similar instruments in active markets, identical or similar instruments in markets that are not active, or model-derived valuations whose inputs or significant value drivers are observable or can be corroborated by observable market data.

● Level 3 - Valuations based on inputs that are unobservable. These valuations require significant judgment.

The availability of valuation techniques and observable inputs can vary and is affected by a wide variety of factors, including the type of asset or liability, whether the asset or liability is new and not yet established in the marketplace, and other characteristics particular to the transaction. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Those estimated values do not necessarily represent the amounts that may be ultimately realized due to the occurrence of future circumstances that cannot be reasonably determined. Because of the inherent uncertainty of valuations, those estimated values may be materially higher or lower than the values that would have been used had a ready market for the assets or liabilities existed.

***Research and Development***

Costs and expenses that can be clearly identified as research and development are charged to expense as incurred in accordance with FASB ASC 730-10. Research and development costs are charged to expense as incurred and include the cost of wages, equipment, materials, and laboratory fees paid in conducting scientific research on product candidates.

***Stock-Based Compensation***

We account for stock-based compensation to employees and non-employees in conformity with the provisions of FASB ASC Topic 718*, Compensation - Stock Based Compensation*. We expense stock-based compensation to employees and non-employees over the requisite service period based on the estimated grant-date fair value of the awards. We estimate the fair value of options granted using the Black Scholes Merton model. We estimate when and if performance-based awards will be earned. If an award is not considered probable of being earned, no amount of equity-based compensation expense is recognized. If the award is deemed probable of being earned, related equity-based compensation expense is recorded. The fair value of an award ultimately expected to vest is recognized as an expense, net of forfeitures, over the requisite service, which is generally the vesting period of the award. Options forfeitures are recorded as they occur.

The Black Scholes Merton model requires the input of certain subjective assumptions and the application of judgment in determining the fair value of the awards. The most significant assumptions and judgments include the following:

● Expected volatility - The expected price volatility is based on the historical volatilities of peer group companies as we do not have a sufficient trading history. Industry peers consist of several public companies in the bio-tech industry similar in size, stage of life cycle, and capital structure. We also blend in historical data on the volatility of its own equity, increasing in proportion as the period of historical data on our data becomes more representative.

● Risk-free interest rate - The risk-free rate was determined based on yields of U.S. Treasury Bonds of comparable terms.

● Expected dividend yield - We have not previously issued dividends and do not anticipate paying dividends in the foreseeable future. Therefore, we used a dividend rate of zero based on our expectation of additional dividends.

● Expected term -The expected term of the options was estimated using the simplified method.

Shares of common stock issued to third parties for services provided are valued at fair value of our common stock.

***Recently Adopted Accounting Pronouncements***

The Financial Accounting Standards Board (FASB) has issued several new accounting standards that are not yet effective for the Company, including ASU 2023-06 (Disclosure Improvements), ASU 2023-07 (Income Statement—Reporting Comprehensive Income), ASU 2023-09 (Income Taxes), ASU 2024-03 (Expense Disaggregation Disclosures), and ASU 2025-03 (VIE Business Combinations).

The Company has evaluated these new standards and does not expect them to have a material impact on its financial position, results of operations, or cash flows upon adoption.

**BUSINESS**

**Overview**

We are a medical device company focused on developing, manufacturing and commercializing proprietary devices to restore left ventricular function in heart failure patients with reduced ejection fraction ("HFrEF").

Our lead device program, the **Revivent System**, has a CE mark in Europe and is in its pivotal trial in the United States. In Europe (where we have obtained approval but are currently not commercially operating in order to preserve capital) or through an authorized U.S. clinical site (as we have not received FDA approval), heart failure specialists refer HFrEF patients with left ventricular dilation due to large anterior heart attack scars to cardiac surgeons who elect to utilize our product to restore left ventricular function by reducing the size of the left ventricle. The Revivent System accomplishes this reduction by folding the scar onto itself and fastening it together in a less invasive mini-thoracotomy procedure.

Based on our analysis of publicly available data and according to a 2016 New England Journal of Medicine article, patients with heart failure with HFrEF continue to face poor outcomes under the current standard of care, with multiple studies reporting an approximately 50–60% five-year mortality. Our goal is for the Revivent System to be the new standard of care for these patients.

We also have ownership rights to **Alginate**, a hydrogel-based device treatment for HFrEF patients without anterior scarring.

**Our Past and Current Clinical Trials in the United States**

In November 2024, we received an investigational device exemption ("IDE") from the U.S. Food and Drug Administration (the "FDA") under a Breakthrough Device Designation ("BDD") to begin a pivotal trial of the Revivent System (called the "RELIVE Trial"). We began enrolling patients in the RELIVE Trial in September 2025. An IDE authorizes the use of a significant-risk investigational medical device in a clinical study in order to collect safety and effectiveness data but does not constitute FDA clearance or approval to market or commercialize the device. The FDA grants BDD if preliminary clinical evidence suggests the procedure may improve substantially upon at least one clinically significant endpoint for a serious or life-threatening condition compared to existing therapies.

Our company, under prior management, previously conducted a clinical trial of the Revivent System (called the "ALIVE Trial"), which ended in 2023. The ALIVE Trial achieved statistical significance upon secondary analysis on functional status and Quality-of-Life ("QoL") measures, three of the five measures in the trial's primary efficacy endpoint. The functional status and QoL endpoints included change in 6-minute walk test ("6MWT"), change in Minnesota Living with Heart Failure questionnaire score ("MLHF"), and change in New York Heart Association ("NYHA") functional classification assessed at 12 months. However, as reported in the Journal of the American College of Cardiology ("JACC") ALIVE Trial publication, the failure of the other two measures, cardiovascular mortality and heart failure hospitalization, were in part a result of the comparison of our trial results with a control group that was healthier than the treatment group. This was a result of prior management's decision to not randomize the ALIVE Trial. In the JACC ALIVE Trial publication, the authors noted that (i) the control group was healthier than the treated group as evidenced by heart failure treatments and hospitalizations in the twelve months prior to the trial and better baseline left-ventricle function; and (ii) the external anchor placement (surgical only approach) produced fewer major adverse events than the internal right ventricle-left ventricle (RV-LV) anchor placement (hybrid procedure). The composite primary safety endpoint through 30 days was met. Major adverse events occurred in 15 of 84 patients (17.9%) of which 12 out of 60 patients (20%) were in the hybrid procedure and 3 out of 23 (13.0%) were in the surgical only approach. In one patient, the device procedure was attempted but aborted before device anchor placement. While the ALIVE trial met its safety endpoints inclusive of the hybrid procedure and surgical only approach, we have decided to test the surgical only approach only in the RELIVE trial due to the fact that fewer major adverse events could indicate that it has a more favorable safety profile, which would ultimately be determined by the FDA.

Our current management team is following the JACC article authors' recommendations by designing a randomized control trial using the external anchor placement approach. We proposed and were approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition) to support our Revivent Therapy Pre-Market Approval ("PMA") application. We are actively engaged with 16 sites needed for the RELIVE Trial, providing confidence to management on their estimates on site initiation, recruitment rates, heart failure specialist referral rates, surgeon experience, and trial expense.

The Revivent System is classified by the FDA as a Class III medical device and requires PMA approval. In the event we receive FDA PMA approval for our Revivent System, which we believe could be by mid-2028, we intend to expand from the 20 or more cardiac surgery centers participating in the trial to the top 336 United States cardiac surgery centers which represent approximately 30% of hospitals performing cardiac surgeries and 51% of cardiac surgery volume according to data published in The American Journal of Accountable Care. Ultimately, through the approximately 1,545 U.S. heart failure specialist and 1,120 U.S. cardiac surgery centers, our goal is to deploy the Revivent System in the market to serve the significant unmet medical needs of approximately 192,000 identifiable and eligible patients in the U.S. based on our estimations.

While our priority is conducting the RELIVE Trial, we intend to support post-market surveillance to maintain our Revivent System CE mark and may build a small European commercial organization if funding from this offering or otherwise becomes available in excess of our trial expenses. In addition, we expect to conduct post-approval studies to support marketing and to satisfy any ongoing regulatory requirements.

There is no guarantee that the RELIVE Trial will be sufficient for FDA approval, and in such case, we may be required to conduct additional trials for the Revivent System. *See* "*Risk Factors – If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.*" and "*Risk Factors – The FDA regulatory approval, clearance and license process is complex, time-consuming and unpredictable."*

**Background on ST Elevated Myocardial Infarction ("STEMI")**

Each year in the U.S., approximately 805,000 patients experience an acute myocardial infarction, according to the American Heart Association's 2025 Heart Disease and Stroke Statistics. Approximately 322,000 (or 40%) of these individuals experience a STEMI event according to 2010 data published in the Journal of the American College of Cardiology. About 35% of these patients who have experienced a STEMI event develop anterior wall scarring according to data published in the Journal of the American Heart Association in 2020, and 25% of that group (approximately 28,000 patients) have severe scarring affecting greater than 30% of the anterior wall according to data published in the Journal of the American College of Cardiology in 2016. These patients (who, as noted above, face the prognosis of 50-60% five-year mortality rates (or 40-50% survival rates) and the prospect of frequent hospitalization due to their HFrEF) represent our primary target market for the Revivent System.

Based on this information, and assuming a mid-point of 55% on five year mortality rates, we estimate that approximately 192,000 patients in the U.S. live with heart failure induced by a large anterior scar. While percutaneous coronary interventions ("PCIs"), such as stents, restore blood flow post-MI, they do not prevent scar formation in necrotic heart muscle damaged prior to blood flow restoration. As a result of the scarred tissue, the heart enlarges, the left ventricle remodels, pumping ability becomes impaired, and heart failure progresses – even with guideline directed medical therapy.

A heart attack, also known as a myocardial infarction, occurs when blood flow to the heart is blocked, preventing the heart muscle from getting enough oxygen. The amount of damage to the heart muscle due to lack of oxygen depends on the time between injury and treatment and the size of the area supplied by the blocked artery. The risk of recurrent myocardial infarction, heart failure, and death increases rapidly when the time between the heart attack and a PCI treatment exceeds one hour. According to an October 2024 research article from the International Journal of Cardiology, nearly half of U.S. patients receive their PCI treatment an hour or more after their heart attack. Many patients have undiagnosed heart attacks and, therefore, don't receive treatment directly related to a heart attack. Despite ongoing advancements in cardiovascular risk management and post-MI treatment, an estimated 20–60% of all MIs are undiagnosed in the acute phase, depending on the study population and diagnostic technique employed. We have not included undiagnosed STEMIs in our market sizing estimates. Whether diagnosed or not, heart muscle damaged by a heart attack heals by forming scar tissue. While PCI treatment in heart attack patients quickly restores heart blood flow to the coronary artery and heart, a PCI procedure does not repair the already damaged tissue caused by the heart attack. As a result of the scarred tissue, the heart enlarges and the left ventricle remodels. When the left ventricle remodels due to scar damage, it undergoes structural changes in size, shape, and thickness, which can lead to impaired pumping ability and potentially progress to heart failure if left untreated. Essentially, the left ventricle becomes enlarged and thinner (dilated), affecting its ability to efficiently pump blood throughout the body.

![](formdrs_003.jpg)

**Figure 1.** Cardiovascular Post-MI Remodeling Imaging

A remodeled heart pumps blood poorly, and as a result can cause heart failure, including associated symptoms, which include fatigue and shortness of breath, leg swelling, fluid buildup in the lungs, rapid and irregular heartbeat, coughing, weight gain, nausea and decreased alertness. According to a study published by the American College of Cardiology in August 2024, approximately 25% of New York Heart Association ("NYHA") Class II patients (patients who have suffered a previous heart attack and experience mild shortness of breath, angina, fatigue, or palpitations during ordinary physical activity) experience cardiovascular ("CV") death or Heart Failure ("HF") hospitalization within 27 months of follow-up, underscoring the severe nature of this condition.

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| | |
|:---|:---|
| **New York Heart Association (NYHA) Functional Classification** | **New York Heart Association (NYHA) Functional Classification** |
| **Class** | **Patient Symptoms** |
| I | No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. |
| II | Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. |
| III | Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. |
| IV | Symptoms of heart failure at rest. Any physical activity causes further discomfort. |

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Heart failure patients suffer worsening heart failure symptoms marked by occasional acute events, which often drive hospitalization and well-being deterioration rates as depicted in Figure 2 below and according to a research paper in the Journal of Pain and Symptom Management October 2007. Guideline directed medical therapy and cardiac resynchronization therapy (noted as Pharma and CRT, respectively, in Figure 2 below) slow progression of heart failure; however, heart failure progression nonetheless continues. STEMI patients with severe anterior scarring and heart failure have only advanced surgical options, such as ventricular assist devices ("VADs"), heart transplants, and artificial hearts, as alternatives. According to the Society of Thoracic Surgeons Intermacs 2025 Annual Report: Focus on Outcomes in Older Adults, 6,000 - 7,000 (<3%) out of the 250,000 prevalent US patients with advanced heart failure (<30% ejection fraction, NYHA class III or IV) have received an LVAD and/or a heart transplant each year in the 2018 – 2024 period. Heart transplants are not prevalent due to matching organ availability, the procedure complexity procedure expense, and the lifelong immunosuppressant medication required. Syncardia's Total Artificial Heart ("TAH"), the only FDA approved artificial heart, is used primarily as a bridge to transplant solution. Syncardia was approved in 2004 and has performed 2,000 implants over the last 20 years. The TAH extends life for patients to become eligible for heart transplants. VADs are not prevalent due to significant surgical risks, device site bleeding, site infection risks, sensitive device settings, monitoring requirements, lifelong anticoagulation therapy, stroke complications, and right heart failure complications. They are therefore reserved for patients with very advanced heart failure. The Revivent System is aimed at improving the prognosis of appropriate patients with heart failure so that their condition does not progress to require VADs and transplantation. The goal of the RELIVE Trial is to demonstrate that the Revivent System is safe (which will ultimately be determined by the FDA), beneficial to the patient, within the capabilities of most CT surgeons, and lower cost than the alternatives. Patients who receive the Revivent System procedure are expected, based on the trial endpoints, to have lower hospitalization rates, better quality-of-life, and extended survival outcomes. These factors position our Revivent System as a compelling option for patients, who currently face 50-60% mortality rates over five years.

![](formdrs_004.jpg)

**Figure 2.** Typical HF Patient Progression and Treatment Options

We believe that we are well-positioned to serve a substantial, underserved global addressable market of approximately $16 billion in eligible and appropriate patients (prevalence) and once served, $2.4 billion of annually recurring patients (incidence). Assuming we achieve similar reimbursement to Barostim and Impella devices, which we believe are similar treatment devices for HFrEF, the U.S. would represent an approximate $10 billion addressable market. This addressable market based on our assumptions for U.S. prevalence in 2024 is 192,000, U.S. incidence of 28,000. To obtain the global addressable market, we divide the U.S. market by 60% based on the average U.S. revenue share of Boston Scientific and Edwards Lifesciences, companies whose revenue is primarily cardiovascular medical devices, as the Revivent System is.

**The Revivent System**

The Revivent System is a novel and proprietary medical device engineered to exclude non-functional scar tissue in the left ventricular ("LV"), make the left ventricle smaller, restore shape, lower wall stress, increase ejection fraction, and restore efficient cardiac function. Cardiothoracic surgeons can perform the procedure on a beating heart in under ninety minutes through a mini-thoracotomy incision, making it significantly less invasive than open heart surgery. As a point of comparison, a similar procedure using open heart surgery requires a sternotomy (cutting through the breastbone to access the heart and lungs), cardiopulmonary bypass, cardioplegic arrest, frequent procedural complications, as well as long recovery times.

The Revivent System procedure places external left-ventricle to left-ventricle ("LV-LV") anchors with or without external right ventricle to left ventricle anchors ("RV-LV"). The anchoring system is composed of two polyester covered titanium anchors (5 x 25 mm) mounted on a polyethylene ether ether ketone (PEEK) tether. The anchors are drawn together to appose the LV free wall to the septum in the case of RV anchors as well as plicating the anterior wall onto itself in the case of LV-LV anchors, thereby excluding the nonviable anteroseptal scar.

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| | |
|:---|:---|
| **Plicated Non-Functional Scar** | **Revivent System Anchors** |
| ![](formdrs_005.jpg) | ![](formdrs_006.jpg) |

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**Figure 3.** Plicated Non-Functional Scar (Left) and Revivent System Anchors (Right).

![](formdrs_007.jpg)

**Figure 4.** Comparison of Healthy Heart, Dilated & Scarred Heart post-MI scarring, and Revivent Heart Post-Procedure.

By reducing LV volume and wall tension, the Revivent System is designed to hopefully enhance the performance of the remaining functional myocardium (or heart muscle), if successful, this may effectively address the core pathology of heart failure in patients with substantial LV scarring. The principles of Laplace's Law guide the remodeling process. Based on Laplace's Law, wall tension in the LV is proportional to the chamber's size and inversely proportional to wall thickness. The Revivent System will potentially exclude scarred tissue from the functional myocardium, and we anticipate this reduces LV size, decreasing wall tension and thereby improving cardiac function.

We believe the Revivent System's less invasive, controlled-access approach may make the procedure a suitable future candidate for robot-assisted surgical support, consistent with how robotics have been incorporated into robot-assisted coronary artery bypass graft procedures.

**Alginate**

In addition to the Revivent System, we also own an unapproved and investigatory alginate-based hydrogel product ("Alginate") to potentially treat heart failure patients with reduced ejection fraction ("HFrEF") who may not be appropriate for the Revivent System due to a non-anterior scar or non-ischemic cardiomyopathy. According to the Heart Failure Society of America HF Stats 2025: Heart Failure Epidemiology and Outcomes Statistics, approximately 6.7 million Americans over 20 years of age have heart failure, and the prevalence is expected to rise to 8.7 million in 2030, 10.3 million in 2040, and 11.4 million by 2050. We estimate that the U.S. prevalence of HRrEF is approximately 3.3 million adults, based on HFrEF being an estimated 50% of heart failure as found in the Journal of American Medicine Association publication "Heart Failure With Reduced Ejection Fraction: A Review". Presumed labeling would include an indication that therapeutic procedures would be limited to those with moderate symptoms (NYHA III; 25-35%) or severe symptoms (NYHA IV; 5-10%). 30-45% of 3.3 million HFrEF adults would suggest 1.0 to 1.5 million have moderate to severe HFrEF less the 322,000 appropriate for Revivent, suggesting 0.7 million to 1.2 million adults may be appropriate for Alginate

Further clinical work will provide greater precision in determining the target market size. Like the Revivent System, Alginate is theorized to reduce LV wall stress to enhance heart performance and we believe this does so by increasing wall thickness. Alginate was CE-marked in Europe and had an approved IDE for the U.S. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the FDA regarding a proposed plan). While we could resubmit and, subject to approval, start trials using a surgical approach to apply Alginate, we now believe the better procedure is to deliver Alginate via catheter.

The regulatory and clinical path forward for Alginate via catheter is not yet fully defined. The device previously held an approved IDE in the United States, which gives us confidence that a feasible path forward exists. To determine the most appropriate regulatory and clinical strategy, we will need to engage with the FDA to clarify whether we should resubmit under the existing IDE using prior testing data, or whether a new submission with updated testing will be required. Such a meeting would provide essential guidance on the regulatory pathway, additional testing or data needs (if any), and the impact on product development timelines. As of the date of this prospectus, no such meetings have been requested to date and it is not currently apparent when we will be ready to re-engage with the FDA regarding Alginate.

If and when the RELIVE trial is fully funded, we plan to use any excess capital to fund catheter development, a new or revised IDE submission (as the prior IDE for Alginate has lapsed), and a new Alginate trial. The earliest we expect to commence an Alginate trial is 2028 and the earliest possible commercialization year is estimated to be 2032. We estimate that reimbursement for Alginate will be similar to the Revivent System, since the prognosis and therapeutic alternatives are similar to those eligible for the Revivent System. The addition of Alginate aligns with and complements our strategic objective to address broader heart failure populations through targeted, innovative therapies.

The anticipated Alginate procedure, hydrogel beads are delivered percutaneously through a catheter to specific areas of the heart muscle to prevent further LV enlargement. The presumed action of the beads, which are inert and believed to be well tolerated by the local tissue, are designed to remain in the left ventricle muscle wall as a string of permanent implants that form a ring around the ventricle (hydrogel beads implants in figure 3 below). The implant ring acts as a permanent prosthetic scaffold, is thought to increase wall thickness, and changes the LV geometry to prevent further LV enlargement. If successful in our clinical trials, we believe that treated patients may benefit from improved LV systolic function without negatively impacting LV relaxation or filling.

![](formdrs_008.jpg)

<br>**Figure 5.** Illustration of Alginate Implant Mechanism. The image shows the placement of alginate implants on a heart model strategically positioned to support the ventricular walls and improve overall heart function.

**Historical and Planned Clinical Trials**

We have made considerable advancements in the clinical development of the Revivent System through a structured sequence of trials aimed at establishing the safety and efficacy of this minimally invasive intervention for heart failure patients with severe left ventricular scarring. We obtained our CE mark, the regulatory approval necessary for European commercial sales, in 2016 and followed up with a long term results study in 2019. We completed the ALIVE trial in 2023 and based on its findings and FDA granting the IDE in November 2024, launched the RELIVE trial in 2025.

*CE Mark in Europe*

To obtain our Revivent System CE mark, we conducted a CE-mark study evaluating the Revivent System, the results of which were published by Dr. Patrick Klein in 2019 (the publication was titled *Less invasive ventricular reconstruction for ischemic heart failure).* This study successfully met its primary safety endpoint of serious adverse events ("SAEs") during a 12-month follow-up period as compared to historical surgical ventricular reconstruction (SVR). The table below provides Major Adverse Events by treatment approach for the CE Mark Study. In the 86-patient study, major adverse events occurred in 7 patients (8.1%) within 30 days, with an in-hospital mortality rate of 4.5% (4 patients). Ventricular arrhythmias were the most frequently observed peri-procedural complication but were generally manageable with standard therapies. Emergent surgical conversion was required in a small number of patients, most often due to bleeding or perforation; importantly, no patient requiring emergent surgery died within 12 months of follow-up. The observed 12-month survival of 90.6% was also comparable to SVR outcomes. The study met the primary efficacy endpoint of a measurable decrease in LV volume by either an echocardiography or a cardiac magnetic resonance ("CMR") imaging at six months and one year. Specifically, the left ventricular end-systolic volume index ("LVESVi") was reduced by a statistically significant 27% reduction and left ventricular ejection fraction ("LVEF") was increased by 16% on a relative basis, underscoring the effectiveness of the Revivent System while maintaining a favorable safety profile. Based on these results, the study authors concluded that treatment with the Revivent System in the enrolled patients with symptomatic heart failure resulted in statistically significant and sustained reduction of LV volumes and improvement of LV function, symptoms, and quality-of-life. While a Single Center investigator initiated study and non-randomized, the study findings appear to suggest that the therapy could extend life and improve the quality-of-life that is extended.

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| *CE Mark Study*<br> *Major adverse events* | *Sternotomy approach (n = 51)* | *Sternotomy approach (n = 51)* | *Hybrid approach (n = 35)* | *Hybrid approach (n = 35)* | *All (n = 86)* | *All (n = 86)* | *P-value* |
| *Tricuspid valve insufficiency increase* | 1 | 2.0% | 4 | 11.4% | 5 | 5.8% | 0.0734 |
| *Mitral valve insufficiency increase* | 1 | 2.0% | 1 | 2.9% | 1 | 1.2% | 0.79 |
| *Pulmonary valve insufficiency increase* | 3 | 5.9% | 0 | 0.0% | 3 | 3.5% | 0.15 |
| *Ventricular septal defect* | 1 | 2.0% | 1 | 2.9% | 2 | 2.3% | 0.79 |
| *Bleeding* | 3 | 5.9% | 4 | 11.4% | 7 | 8.1% | 0.36 |
| *Renal dysfunction* | 3 | 5.9% | 1 | 2.9% | 4 | 4.7% | 0.52 |
| *Respiratory failure* | 1 | 2.0% | 1 | 2.9% | 2 | 2.3% | 0.79 |
| *Stroke* | 3 | 5.9% | 1 | 2.9% | 4 | 4.7% | 0.52 |
| *Late cardiac arrest* | 0 | 0.0% | 2 | 5.7% | 2 | 2.3% | 0.09 |

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*Post CE Mark Clinical Study Results in Europe*

Between October 2016 and September 2021 30 patients (5 females; mean age 62 ± 12 years) were operated on in a single Dutch center. Procedural success was 100%. On average 2.3 ± 0.8 anchor-pairs were used to reconstruct the LV. Comparing echocardiographic data pre- and directly postoperatively, LVEF increased from 33 ± 8% to 44 ± 10% (p < 0.0001). LV end-systolic volume index decreased from 58 ± 24 mL/m2 to 34 ± 19 mL/m2 (p < 0.0001) and LV end-diastolic volume index decreased from 84 ± 32 mL/m2 to 58 ± 25 mL/m2 (p < 0.0001). Hospital mortality was 0%. Median duration of ICU–stay was 2 days (IQR 1-48 days) and median length of hospital stay was 7 days (IQR 5-61 days). Survival at 8 years was 69.2%. At latest follow-up, 64.7% of surviving patients had improved to NYHA class I-II as compared to 70% in NYHA class III-IV preoperatively. Expected 8 year survival rates would be 32.8% based on an interpolation of 5 year mortality rates of 54.5% and 10 year mortality rates of 75.5% as found in the British Medical Journal 2019. Standard of care outcomes are improving, albeit slowly, as the 2002 Framingham Heart Study had expected 8 year survival rates of 24% based on an interpolation of 5 year mortality rates of 70% and 10 year mortality rates of 80%. Patients with large anterior scars have higher mortality rates based on a 2016 Journal of the American College of Cardiology publication which showed infarct size is strongly associated with all-cause mortality and hospitalization for heart failure within 1 year. We historically recorded product revenue primarily from the sale of our Revivent TC™ TransCatheter Ventricular Enhancement System. All such sales of product in Europe ceased at the end of 2023 when the decision to cease operations to preserve capital was made.

We currently have "NUB Status" in Germany, which is the German acronym for „Neue Untersuchungs-und Behandlungsmethode" which can be translated as "new examination and treatment method." It provides a mechanism for reimbursement for innovative devices and procedures. While our priority is the RELIVE Trial, we plan to build a small European commercial organization if funding from our initial public offering in excess of our trial expenses becomes available.

*ALIVE Trial*

We completed our ALIVE Trial in 2023, enrolling 126 patients (84 device; 42 control) at 28 sites in a prospective, multi-center, non-randomized study. The trial included heart failure patients with severe anterior scarring from a previous STEMI event. Patients showed NYHA Class III-IV symptoms, indicating advanced heart failure with significant activity limitations, and had LVEF of 45%, reflecting reduced pumping efficiency. Additionally, patients had LVESVI of at least 50 ml/m², indicating high residual blood volume post-contraction, and a transmural anterior LV scar, meaning full-thickness scarring in the left ventricular wall, which further limits heart function. Patients with inadequate scar or previous sternotomy served as the control group. The primary safety endpoint was the percent of patients with major adverse events in the device arm being less than an upper bound performance goal of 40.5%, as agreed with the FDA based on a database analysis of expected events in similar procedures. In other words, the FDA required a result of no more major adverse events than expected with similar procedures. The primary efficacy endpoint was the hierarchical composite of cardiovascular mortality, HF hospitalization, change in 6-minute walk test, change in Minnesota Living with Heart Failure questionnaire score, and change in NYHA classification assessed at 12 months as the win ratio in the device group compared with the control group.

The ALIVE Trial had two surgical approaches. The Internal Anchor ("Internal Anchor") approach required a hybrid surgical suite involving an interventional cardiologist ("IC") and a cardiothoracic ("CT") surgeon using a more complex technique and experienced more SAEs. The External Anchor ("External Anchor") approach required only a cardiac surgeon in a standard surgical suite using a simpler technique and experienced comparatively fewer SAEs. The main difference between the two approaches is that the External Anchor Approach places anchors on the outside of the heart (epicardial surface) through a standard and less invasive thoracotomy by a CT surgeon while the Internal Anchor Approach places anchors inside the left ventricular cavity directly in contact with the blood flow through a complex procedure needing IC and CT surgeons working in collaboration.

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| | |
|:---|:---|
| **External Anchor Approach**<br> CT / Standard Surgical Suite | **Internal Anchor Approach**<br> CT and IC / Hybrid Surgical Suite |
| ![](formdrs_009.jpg) | ![](formdrs_010.jpg) |

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**Figure 6.** Comparison of the External Anchor Approach versus Internal Anchor Approach.

At 30 days, the safety performance goal endpoint was met. 17.9% of subjects had major adverse events (15/84 subjects. (The performance goal was 40.5% (one-sided 97.5% upper confidence limit 27.7%; p<0.0001). A total of 30 major adverse events occurred in these 15 patients. The hybrid procedure had 23 major adverse events occur in 12 of 60 patients (20.0%), while the surgical only approach subgroup had 7 major adverse events occur in 3 of 23 patients (13.0%). There were 7 cardiac deaths in the Revivent arm (6 of which were caused by heart failure) occurring between days 5 and 357. A total of 4 patients required mechanical circulatory support (2 Impella and 2 intra-aortic balloon pumps), whereas 7 patients required emergent cardiac surgery: 1 for an incidental finding of LV thrombus, 5 for perforations, and 1 for bleeding. No patient requiring emergent cardiac surgery died within 1 year of follow-up. The table below provides Major Adverse Events by treatment approach for the ALIVE Trial.

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| | | | |
|:---|:---|:---|:---|
| ALIVE Trial Material Adverse Events at 30 Days | Revivent + GDMT Patients (%) (N = 84) | Revivent + GDMT Patients (%) (N = 84) | 1-Sided 97.5% Upper Confidence Bound, % (Pass if Upper Confidence Bound <40.5%) |
| Composite MAE at 30 d | 15 | 17.9% | 27.7 |
| All-cause death | 3 | 3.6% |  |
| Placement of mechanical support device intraoperatively or postoperatively | 4 | 4.8% |  |
| Emergent cardiac surgery | 7 | 8.3% |  |
| Prolonged mechanical ventilation | 8 | 9.5% |  |
| Renal failure | 3 | 3.6% |  |
| Clinically important stroke (Rankin score of ≥4) | 0 | 0.0% |  |

---

While the ALIVE trial met its safety endpoints inclusive of the hybrid procedure and surgical only approach, we have decided to test the surgical only approach only in the RELIVE trial due to what we believe is a more favorable safety profile, though any safety determination will ultimately be made by the FDA.

While the ALIVE Trial met its primary safety endpoints, it did not achieve its efficacy endpoints. The Journal of American College of Cardiology published article on the ALIVE trial noted that "in this nonrandomized study, there was an imbalance in the severity of illness between the device and control groups, with the Revivent TC group having more active HF at baseline (greater proportion of patients treated for HF in the prior year and more HF hospitalizations) and evidence of worse LV function, which complicates interpretation of the results of the study." Additionally, we noted that the Internal Anchor approach was more difficult to perform for the IC and CT, more expensive for the hospital and less safe for the patient than the External Anchor approach, based on number of serious adverse events (though any safety determination will ultimately be made by the FDA). Therefore, we have elected, and the FDA has agreed, to exclude the Internal Anchor approach in the RELIVE Trial. We believe that the External Anchor approach is also appropriate for all patients in which the Internal Anchor approach was previously used in the ALIVE Trial and thus will not disqualify such eligible patients for the RELIVE Trial.

In terms of Quality of Life and Functional Outcomes ("QoL"), the 23 subjects in the External Anchor group outperformed the control group on the six-minute walk test (6MWT), the Minnesota Living with Heart Failure Questionnaire (MLHF), and the NYHA Heart Failure Stage Classification. The QoL outcomes for the 23 treated External Anchor subjects showed a win ratio of 1.78 and achieved statistical significance (p-value=0.034). This win-ratio and statistical significance with 23 treated subjects suggest that the RELIVE trial may have a similar or greater win-ratio when compared to a control group that is equally sick (unlike the ALIVE trial, the RELIVE trial will be randomized, which may provide a balance so that the control group is as sick as the intervention group). We believe that the design of the RELIVE trial, with both randomization as well as use of what we believe is the safer External Anchors-only approach may improve the chance of a successful trial which could lead to FDA approval, thought any safety determination will ultimately be made by the FDA.

![](formdrs_011.jpg)

**Figure 7.** Composite Hierarchy Endpoint – Quality of Life (QoL) and Functional Outcomes. The QoL outcomes for the 23 treated External Anchor patients showed a win ratio of 1.78 and achieved statistical significance (p-value=0.034). This is the same efficacy endpoint that will be the basis for approval in the RELIVE trial. \*Internal Anchor = Internal RV-LV plus External Anchors (Hybrid Procedure)

*RELIVE Trial*

The RELIVE Trial aims to build on the insights and lessons from the ALIVE Trial by demonstrating efficacy and safety through randomization and sole use of the External Anchor approach (though any safety determination will ultimately be made by the FDA). While the inclusion and exclusion criteria largely mirrors those established in the ALIVE Trial, the RELIVE Trial allows the inclusion of patients with prior sternotomy and open-heart surgery. This adjustment reflects our evolving understanding of the patient population that could benefit from the Revivent System. Inclusion criteria is designed to ensure that only patients with significant LV aneurysm or scar, accompanied by viable myocardium in non-scar segments, are selected. Additionally, patients must have an LVEF of 40% or less and an LVESVI of 60 mL/m² or greater, among other specific conditions. In the RELIVE Trial, investigators will randomize the control group to ensure a balanced comparison with the treated group.

The RELIVE Trial is expected to capitalize on the infrastructure, sites and expertise established during the ALIVE Trial. We believe that we understand the required procedures, training, and documentation from the ALIVE Trial, with only minor modifications needed to align with RELIVE Trial protocol. The RELIVE Trial is designed to adhere to a well-defined treatment timeline, beginning with the pre-implantation phase, which includes baseline assessments (Computed Tomography (CT) and Magnetic Resonance Imaging ("MRI"), Transthoracic Echocardiogram ("TTE"), Kansas City Cardiomyopathy Questionnaire ("KCCQ"), 6-minute walk test ("6MWT"), and New York Heart Association Heart Failure Stage Classification ("NYHA"). It will then proceed through the procedure phase and culminate in follow-up assessments at 6 and 12 months, with annual evaluations extending up to five years (Proposed Timeline and Phases of the RELIVE Trial are shown in figure 8 below). Site enrollment and patient recruitment rates will be based on ALIVE Trial empirical experience. Three subjects have been enrolled as the date of this prospectus. Six-month data is expected by the first quarter of 2028 and FDA Premarket Approval ("PMA") approval is anticipated mid-year 2028. The FDA typically completes its review of a PMA submission within 180 days of the filing date, with BDD designed to accelerate this review process. We have budgeted six months for the RELIVE Trial PMA submission review.

Clinical leadership for the RELIVE Trial is anchored by national co-Principal Investigators Vinod H. Thourani, MD and Marat Fudim, MD, MHS, whose combined expertise in less invasive cardiac surgery and advanced heart-failure research underpins the study's oversight. We will maintain site principal investigators at www.clinicaltrials.gov and have already disclosed Andrew Kao, MD and Jessica Heimes, DO at Saint Luke's Mid America Heart Institute and John P. Boehmer, MD and Michael Pfeiffer, MD at Penn State College of Medicine.

![](formdrs_012.jpg)

**Figure 8.** Proposed Timeline and Phases of the RELIVE Trial: The procedural and follow-up phases include key assessment milestones and safety and efficacy evaluations.

**Our Industry and Market Opportunity**

Heart failure following STEMI events remains a significant cause of morbidity and mortality worldwide, particularly for patients who suffer from severe left ventricular remodeling due to scarring in the anterior wall. Approximately 322,000 (or 40%) of these individuals experience a STEMI event according to 2010 data published in the Journal of the American College of Cardiology, with over 28,000 of these cases developing into advanced heart failure due to anterior LV scarring. Our incidence and prevalence figures exclude undiagnosed STEMI events which are approximately 20-60% of all myocardial infarctions based on systematic review and meta-analysis published by Cardiovascular Research in October 2024. Whether diagnosed or not, scarred myocardium leads to heart failure which places a substantial economic burden on the healthcare system, with estimated costs exceeding $30 billion per year, driven by hospitalizations, readmissions and long-term cardiac management, as reported in a systematic literature review by the Journal of Managed Care + Specialty Pharmacy (JMCP) in a January 2022 article. Upon FDA approval, we can apply for a procedure-specific code and seek a new reimbursement rate. For the purposes of estimating our potential addressable market, we have assumed that the Revivent System could obtain a procedure-specific code in the United States with an average reimbursement of approximately $50,000 per procedure; however, there can be no assurance that such a code will be obtained, that the assumed rate will be achieved, or that any reimbursement will be secured at all. Due to the high cost of alternative treatments, the high cost to heart failure patients to payers, and the expected efficacy of the Revivent System therapeutic procedure, and based on our management team's experience, we expect over time that we can obtain similar reimbursement to the Impella and Barostim devices, which we believe are similar treatment devices for HFrEF. According to the 2020 Milliman Research Report, heart transplantation incurs average costs of approximately $1.6 million per patient and has 15–20% mortality within the first year post-transplant, followed by an estimated 4% annual mortality over the subsequent 18 years. Ventricular assist devices, such as Impella, which are small, catheter-based heart pumps that help the heart circulate blood when the heart is not functioning properly serve as a bridge to a heart transplant and cost $235,727 as documented in the preprint May 2025 article from Health Sciences. Based on a Center for Medicaid and Medicare Services 2024 data release., the national average hospital for reimbursement for an Impella device under MS-DRG-215 in 2024 was approximately $71,520. Based on publicly disclosed information from CVRx, Inc., the Barostim device (an implantable system designed to treat heart failure by stimulating baroreceptors, which are pressure sensors in the body) obtained average payment between $40,000 and $50,000 with a 1.26 win ratio in its pivotal trial on a healthier and less costly HFrEF patient population. Re-hospitalization is a major driver of the win ratio in HFrEF trials, of patient cost, and of reimbursement. CMS has a number of pathways to obtain written coverage, including "coverage with evidence development" and Transitional Coverage for Emerging Technologies. We will leverage the optimal pathway to seek coverage as we approach market launch. For Barostim and Impella, the approval for the permanent Category I CPT codes came 4 to 5 years after FDA approval.

The Revivent System procedure is performed by cardiothoracic surgeons. According to a December 2019 article from the International Journal of Academic Medicine, most cardiovascular device innovations in the last few decades have enabled many new procedures performed by interventional cardiologists ("IC") and electrophysiologists ("EP"). Despite significant innovation for procedures performed by ICs and EPs, cardiothoracic surgery departments and cardiothoracic surgeons ("CTs") still lead hospital metrics in revenue and profitability, according to a February 2025 study from Leonard Davis Institute of Health Economics ("Penn LDI"). Based on a February 2019 survey conducted by the physician and consulting firm Merritt Hawkins. CTs drive approximately $3.7 million in net revenue each year for a hospital system, the most among 18 physician specialties according to a February 2019 publication by Cardiovascular Business. CTs average charge per provider is $32,599; the highest among specialties, according to a April 2025 publication by Definitive Healthcare. While CTs have high surgical workloads, their work is increasingly concentrated (approximately 61%) on coronary arterial bypass grafts ("CABGs") and surgical aortic and mitral valve replacement (approximately 16%), according to The Society of Thoracic Surgeons Adult Cardiac Surgery Database. Additionally, over 60% of CABG procedures are urgent or non-elective procedures with median hospital stays of 5 to 7 days post procedure according to a January 2020 from the European Journal of Cardio-thoracic Surgery. Based on data from the Society of Thoracic Surgeons National Database, the American Heart Association, and publications in the Journal of Thoracic and Cardiovascular Surgery, high volume cardiac surgery programs comprise 30% of hospitals and represent 51% of procedures, according to data published in The American Journal of Accountable Care, though they are highly influential on the remaining 784 lower volume programs. We believe that CTs, hospitals, and industry need new cardiac surgical procedures, like the Revivent System procedure, that are surgical in nature, not complex, minimally invasive, address large unmet needs, extend patients' quality adjusted life years, and have the potential to generate high revenue/profit.

The RELIVE Trial is expected to be conducted in up to twenty five of the top 30% cardiac surgery hospitals. We believe that a relatively small salesforce can take the Revivent System to heart failure specialists and CTs from its trial sites into many of the remaining heart failure specialists and top cardiac surgery hospitals during its initial commercial launch and expand to the remaining approximately 838 cardiac surgery hospitals once the Revivent System procedure is accepted at the nation's leading cardiac surgery hospitals.

Given (1) the concentrated call point, (2) the statistically significant 1.78 win ratio achieved in the External Anchor treated population in the ALIVE Trial versus a healthy control, (3) the expected similar or better win ratio in the RELIVE Trial, (4) an expected attractive facility and physician fee similar to what is achieved with the CABG procedure, and (5) the opportunity for CTs to diversify their concentrated procedure mix, we believe that we are well-positioned for rapid adoption by CTs and a significant penetration into the prevalent patient population. As noted above, the Revivent System would serve a substantial, underserved addressable market of $16 billion in eligible and appropriate patients (prevalence) and once served, a $2.4 billion market of annually recurring patients (incidence).

**Competition**

We operate in the highly competitive medical device industry. While our product candidates are patent-protected and designed to serve the target patient population in a differentiated manner, there are other product candidates, treatments or devices that may now or in the future compete directly or indirectly with our product candidates. We expect to compete with various companies that operate in the medical device industry. Among these companies are Edwards Lifesciences, Johnson & Johnson, Boston Scientific, and Medtronic. Many of these competitors have substantially greater technological, financial, research and development, manufacturing, personnel and marketing resources than we do. We believe that we have competitive strengths that will position us favorably in our markets. However, our industry is evolving rapidly and is becoming increasingly competitive. Larger and more established companies may acquire or in-license devices and could directly compete with us. Additionally, certain of our competitors may be able to develop competing or superior technologies and processes and compete more aggressively and sustain that competition over a longer period of time than we are able. Our technologies and devices may be rendered obsolete or uneconomical by technological advances or entirely different approaches developed by one or more of our competitors, which could result in limited demand for our product candidates.

Several devices under development or in commercialization address related populations of patients with heart failure with reduced ejection fraction (HFrEF). For example, Barostim (CVRx) is a neuromodulation device approved for NYHA class II–III HFrEF patients. Unlike our Revivent System, Barostim does not address the underlying structural remodeling of the ventricle but instead modulates sympathetic and parasympathetic activity to improve symptoms and function. Impella (Abiomed, a Johnson & Johnson company) is a percutaneous ventricular assist device designed to provide temporary hemodynamic support in advanced decompensated heart failure or high-risk PCI. Impella serves a different segment of the market than Revivent, as it is not intended for durable ventricular remodeling or long-term heart failure stabilization, but we believe that Impella is relevant as a comparator in reimbursement and resource utilization discussions.

Other investigational heart therapy devices include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· AccuCinch
 (Ancora Heart), which reduces ventricular dilation in HFrEF patients but is not specific
 to scar-driven remodeling;

· V-Wave interatrial shunt and Alleviant
 interatrial decompression therapy, which target both HFrEF and HFpEF populations by reducing
 left atrial pressure rather than addressing ventricular mechanics; and

· CorWave LVAD, a novel left ventricular
 assist device designed for end-stage heart failure patients, competing in the advanced therapy
 space alongside durable LVADs and transplant, rather than the NYHA class II–III space
 where Revivent is positioned.

By contrast, we believe that the Revivent System is unique in requiring the presence of severe anterior or apical scar with associated left ventricular remodeling, which distinguishes it from devices that target non-ischemic or non-scar-related dilated cardiomyopathy. As of the date of this prospectus, we are not aware of any other medical device in clinical development that directly treats heart failure induced by scar-driven remodeling of the left ventricle. If there are companies with devices in development that we are unaware of, they would need to conduct feasibility studies and pivotal clinical trials, typically a 6 to 9 year process, and demonstrate safety and efficacy equivalent to or superior to the Revivent System in the appropriate population. In this case, we would retain a substantial timeline advantage, and given the size of the market, we believe we would continue to have significant revenue opportunities.

We do not believe that biopharmaceutical solutions can be an effective therapy for heart remodeling. Scarred tissue has less vascularization than healthy issue, reduced vascularization impedes biopharmaceutical delivery to scarred areas, and biological and mechanical properties of mature scar tissue are typically resistant to change – even by antifibrotic agents.

**Our Strategy**

Our business strategy focuses on heart failure surgical device research & development, manufacturing, and clinical trial management. Since inception, we have focused on advancing clinical and regulatory milestones to demonstrate the safety, effectiveness, and novel benefits of the Revivent System for treating heart failure in patients with severe LV scarring post-myocardial infarction. Our clinical studies have shown positive outcomes in LV remodeling and patient survival, underscoring the potential of our technology to provide a valuable alternative to traditional heart failure treatments.

To support our regulatory pathway, we are in the process of developing and executing a series of clinical trials, including the recently completed ALIVE Trial, which informed protocol improvements for our pivotal RELIVE Trial. Our RELIVE Trial began in 2025 and is designed to meet FDA requirements for full market approval. By adhering to rigorous trial designs and collaborating with experienced clinical sites, we aim to accelerate regulatory approvals and establish a robust evidence base for the Revivent System.

We receive reimbursement from our hospital customers as payment for our Revivent System for patients treated during the trial. We expect this reimbursement level to remain relatively constant during earlier commercialization, which we believe will provide an opportunity for gross margins to be accretive to our business. In parallel with FDA PMA review or based upon FDA approval, we intend to work with CMS to obtain a new procedure code and seek to increase reimbursement consistent with the approach taken by the Impella and Barostim devices, which we believe are similar treatment devices for HFrEF. For therapies with BDD, CMS offers parallel review and coverage with evidence development to support faster access to promising therapies. BDD does not automatically qualify a therapy for these programs, but it can increase the likelihood that CMS will prioritize its review.

Our development pipeline also includes expanding the capabilities of our product portfolio with the development of Alginate, a complementary device that addresses heart failure patients that have not experienced significant scarring. Alginate was CE-marked in Europe and had an approved IDE for the U.S. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the FDA regarding a proposed plan). As we advance the RELIVE Trial, we are also planning further research and development for Alginate, including a catheter-based delivery system to improve accessibility for additional heart failure patient segments.

Becoming a public company is an important step in advancing our long-term strategy. We believe access to the public capital markets will provide us with an opportunity to enhance our ability to fund ongoing clinical development, support potential commercialization of the Revivent System, and expand our operating infrastructure. In addition, public company status may increase our visibility among physicians, partners, and patients, helping to accelerate adoption of our therapy if approved.

Through these focused development initiatives, we are strategically positioned to deliver high-impact therapies for heart failure, capture significant market share, and drive long-term growth in the cardiovascular device market. Our ongoing investments in clinical validation, product refinement, and commercial readiness are designed to meet the needs of healthcare providers and improve outcomes for patients worldwide.

**Our Competitive Strengths**

We believe that we possess several competitive strengths that position us favorably in the medical device industry for heart failure treatments:

●  ***Serving Large Unmet Medical Need*:** The Revivent System targets an identifiable U.S. patient population of approximately 192,000 monitored individuals suffering from STEMI-induced heart failure, with an additional 28,000 patients added and 28,000 patients lost each year, creating relatively stable patient base. Currently, we believe that no alternative therapies specifically address the needs of this patient population, which faces deteriorating well-being and a five-year mortality rate of approximately 50-60%.

●  ***Providing Hospitals and CTs a High-Volume and High Value Procedure within Their Capabilities*:** Most cardiac surgery device innovation over the last two to three decades supports catheter-based procedures performed by interventional cardiologists, not surgeries performed by CTs. CTs are, nonetheless, among the highest earners among physicians and for hospitals. Hospitals typically seek to increase high-revenue elective surgeries, like ours, and reduce bed utilization by deteriorating heart failure patients, like our eligible patients.

●  ***Utilizing Breakthrough Device Designation to Obtain Accelerated FDA Review :*** Based on certain positive signals from the ALIVE trial (where quality of life and functional status improved in the Revivent group despite lack of randomization and a healthier control group at baseline), as well as the exclusive use of external anchors in the ongoing RELIVE trial (the external only approach has shown better safety compared with the hybrid approach, as measured by number of SAEs), we expect the RELIVE trial to demonstrate both adequate safety and efficacy and hopes to receive accelerated FDA review under BDD of its RELIVE trial safety and efficacy data. However, the process of medical device development is inherently uncertain and there is no guarantee that this designation will accelerate the timeline for approval or make it more likely that the Revivent System will be approved.

●  ***An Efficacious and Patent Protected Less Invasive Therapy*:** We believe our Revivent System procedure offers a novel, less invasive procedure for left ventricular reconstruction in patients with severe anterior wall scarring following myocardial infarction. If the RELIVE Trial meets its endpoints and the Revivent System is approved by the FDA, we believe that it will demonstrate that the Revivent System procedure is safer, easier to perform, faster to recover from, and more beneficial to patient quality-of-life than current advanced therapy alternatives, such as heart transplant and left ventricular assist devices.

●  ***Prospect for***  ***Achieving the Same or Better Safety and Efficacy Outcomes in Our RELIVE Trial that we Demonstrated with Statistical Significance in the ALIVE trial*:** The ALIVE Trial demonstrated statistically significant safety and efficacy outcomes with 23 External Anchor patients and provided valuable data to inform the pivotal RELIVE Trial. While the FDA requires an additional trial with at least 84 treated patients and 42 control patients, we expect to achieve the safety and efficacy endpoints based on the ALIVE Trial evidence and potentially achieve better results than the non-randomized ALIVE Trial given that the treated and control patient populations in the RELIVE Trial should have equal health characteristics due to randomization. In the ALIVE Trial the control patients were demonstrably healthier than the treated patients.

●  ***Access to a Large Market Driven by Potential Healthcare Savings and Quality of Life Improvements*:** If the RELIVE trial indeed demonstrates a significant improvement in the hierarchical composite endpoints which include death, heart failure hospitalization, quality of life, and functional measures and meets its safety endpoint (as it did in the ALIVE trial), we expect the FDA to approve the Revivent System thus allowing us to provide a significant new treatment for patients. However, the results of the ALIVE trial may not be replicated or ultimately accepted by the FDA as part of our PMA submission. We believe, based on our completed and current studies, that we will have sufficient evidence to show significant savings for payors, largely driven by reduced hospitalizations, and improved quality adjusted life years. Given recent experience with heart failure devices, such as Impella (Abiomed/J&J) and Barostim (CVRx), it is reasonable to expect that CMS will assign appropriate MS_DRG groups to the Revivent procedure. Based on similar reimbursement to the Impella and Barostim devices and an estimated $2-3 billion global total addressable market, we believe that the Revivent System offers attractive revenue potential.

●  ***Demonstrated Trial Progress*:** We are engaged with 16 potential sites needed for our RELIVE Trial of which eight are activated and actively screening subjects.

●  ***Expanding Product Portfolio and Product Synergies*:** In addition to the Revivent System, we hold ownership rights to Alginate, a therapeutic device designed to treat heart failure patients without myocardial scarring. This device was CE-marked in Europe, had received an IDE in the U.S. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the FDA regarding a proposed plan), and represents a significant opportunity for expanding our addressable market and diversifying our product offerings.

●  ***Experienced Clinical Trial and Manufacturing Management across Cardiovascular Devices and Specifically Running the Needed Trial*:** Our Chief Medical Officer has played a major role in running many cardiovascular trials, including Gilead Sciences (TERISA, RIVER-PCI), Abbott (COAPT), Edwards (TAVR-UNLOAD), Cardiovalve (TARGET), Medinol (Bionics, BLADE-PCI), Heartflow (PRECISE), and Microport (Target IV-NA). Our Co-CEO has played a significant role in running many clinical trials, including BioVentrix (ALIVE, RELIVE), PROSPECT 2, PROSPECT Absorb, Sirtex (DOORwaY90), Anika Therapeutics (Cingal 16-02, Cingal 17-02). Complemented by a team of industry consultants, our leadership team brings deep medical affairs, clinical trial management, regulatory, and manufacturing expertise and established relationships with leading clinical investigators and trial sites. Complemented by a team of industry consultants, our leadership team brings deep medical affairs, clinical trial management, regulatory, and manufacturing expertise and established relationships with leading clinical investigators and trial sites.

●  ***Robust IP Portfolio*:** Multiple U.S. and international patents, some of which extend through 2041.

**Intellectual Property**

We maintain a robust intellectual property portfolio that protects its proprietary technology underlying the Revivent System, a minimally invasive device for ventricular remodeling in patients with ischemic heart failure. Our intellectual property strategy is designed to secure its competitive advantage within the cardiac therapeutic market by safeguarding its innovative approach to ventricular remodeling.

The Revivent System's proprietary designs are protected through a series of U.S. and international patents and pending applications owned by BioVentrix. These patents cover surgical deployment techniques and anchors for systems developed by BioVentrix, including the Revivent System.

The following table lists U.S. patents and patent applications are owned by BioVentrix and material to the Revivent System used in the RELIVE clinical trial. The table identifies other jurisdictions in which related patent applications were filed:

---

| | | | |
|:---|:---|:---|:---|
| **U.S. Utility Patents and Applications** | **Other Jurisdictions** | **Expiration Date (if maintenance fees are paid)** | **Title** |
| 11540822 | Europe and Israel | Aug. 28, 2034 | Cardiac tissue anchoring devices, methods, and systems for treatment of congestive heart failure and other conditions |
| Ap. 2024/0245513<br>| Europe and Israel | Aug. 29, 2034 | Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions |
| Ap. 2025/0005759 | Europe | Oct. 14, 2042 | Device and methods for monitoring heart function for treatment of congestive heart failure and other conditions |

---

We believe that all other patents owned by us are not material to the Revivent System or have lapsed. In our view, we hold no patent licenses that are material to the Revivent System. The following table lists some of the other U.S. patents owned by us that are directed to a hybrid procedure or other technologies that may or may not be used by the Revivent System:

---

| | | | |
|:---|:---|:---|:---|
| **U.S. Utility Patent** | **Other Jurisdictions** | **Expiration Date (if maintenance fees are paid)** | **Title** |
| Pat. 12,533,235 | Europe, Australia, and Israel. | Jul. 25, 2035 | Heart anchor positioning systems for treatment of congestive heart |
| 10575953 | Europe and Israel | June 9, 2037 | Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions |
| 11559212 | Israel | May 20, 2034 | Cardiac tissue penetrating devices, methods, and systems for treatment of congestive heart failure and other conditions |
| 11331190 | Europe | Aug. 21, 2026 | Steerable lesion excluding heart implants for congestive heart failure |
| 11903834 | Europe and Israel | Aug. 29, 2034 | Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions |
| 11744615 | None yet. | Oct. 21, 2041 | Pericardial inflation catheter and systems and methods employing same |
| 11185414 | Europe and Israel | Jan. 31, 2037 | Systems and methods for deploying a cardiac anchor |
| 11051942 | Europe, Israel, and Australia | Dec. 12, 2032 | Trans-catheter ventricular reconstruction structures, methods, and systems for treatment of congestive heart failure and other conditions |

---

We have filed patents in key markets, including the United States, the European Union, Hong Kong and Israel, to protect essential features of the Revivent System. This includes its novel anchoring mechanism, which allows for precise exclusion of non-functional myocardial tissue without the need for open-heart surgery and indicators of tension on the tether when seating an anchor against a heart wall. This novel approach to scar tissue targeting is central to enhancing procedural efficiency and improving patient outcomes.

The inventors named on the BioVentrix patents and applications include founder Lon S. Annest and BioVentrix former biomedical engineers Ernest Heflin, Kevin Van Bladel, Gilbert Mata, Jr., William Butler and Michael Dana. The inventors assigned their patent rights to BioVentrix.

In addition, we have developed specialized manufacturing processes for the Revivent System to ensure consistent quality and regulatory compliance. These proprietary processes encompass the use of advanced materials, precise fabrication techniques, and stringent sterilization protocols, all of which align with FDA and ISO standards. We employ rigorous quality control and assurance programs within our production strategy to maintain the high standards required for life-sustaining medical devices. The specialized manufacturing processes are protected as trade secrets through applicable confidentiality provisions. We have also worked with third-party manufacturing to develop proprietary equipment to ensure accurate and consistent deployment of the Revivent anchors with every implantation.

We also remain committed to continuous innovation within its intellectual property framework, seeking to further enhance the Revivent System's capabilities and expand its potential applications. This includes refining procedural techniques and exploring new features to identify suitable patients for ventricular remodeling. As we advance these innovations, it actively pursues intellectual property protection to expand and reinforce its existing portfolio.

We were previously party to a license agreement with CLPH, LLC relating to catheter development for our Alginate product, which we terminated in October 2025. As of December 31, 2025, milestone payments in an aggregate amount of approximately $196,500 remain outstanding under this agreement.

We hold a patent license from the Henry Ford Health System for techniques and instruments to deliver hydrogels to walls in a heart. The delivery of hydrogel is a therapeutic technique for ventricular remodeling in patients with ischemic heart failure. We are not currently developing this technique and thus the patents licensed from the Henry Ford Health System are not material to the BioVentrix business. The license includes licenses to patents held by the Henry Ford Health System related to techniques and instruments to deliver hydrogels to walls in a heart. Under the license, BioVentrix is obligated to pay license maintenance fees of $35,000 after execution of the agreement, $36,000 within 300 days of the effective date of the agreement, patent prosecution costs and $16,250 annually. The license also requires BioVentrix to pay 1% of net sales of the licensed product or licensed method, which is defined as products and methods covered by valid claims of the licensed patents. BioVentrix is also required to pay due diligence and milestone payments that include $200,000 upon approval of the first IND or IDE from the U.S. FDA; $500,000 upon U.S. regulatory market approval; $125,000 upon a second IND or IDE, and $250,000 upon second U.S. regulatory market approval. The term of the license is until the expiration or abandonment of the last of the licensed patents.

Representative U.S. patents licensed by us from the Henry Ford Health System are:

---

| | | |
|:---|:---|:---|
| **U.S. Utility Patent** | **Expiration Date (if maintenance fees are paid)** | **Title** |
| 9375313 | Sept. 7, 2027 | Intramyocardial Patterning For Global Cardiac Resizing And Reshaping. |
| 8801665 | April 9, 2029 | Apparatus And Method For Controlled Depth Of Injection Into Myocardial Tissue |
| 7875017 | April 10, 2028 | Cardiac Repair, Resizing And Reshaping Using The Venous System Of The Heart |

---

The patents licensed from the Henry Ford Health System do not cover the Revivent System. The representative Henry Ford Health System patents listed above do not include lapsed patents or non-U.S. patents licensed from the Henry Ford System.

The term of individual patents depends upon the legal term for patents in the countries in which they are granted. In most countries, including the United States, the patent term is 20 years from the earliest claimed filing date of a non-provisional patent application in the applicable country. In the United States, a patent's term may, in certain cases, be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the United States Patent and Trademark Office in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date. We cannot be sure that our pending patent applications that we have filed or may file in the future will result in issued patents, and we can give no assurance that any patents that have issued or might issue in the future will protect our current or future product candidates, will provide us with any competitive advantage, and will not be challenged, invalidated, or circumvented. Maintenance or annuity fees must be paid to government patent offices to keep a patent enforceable for its entire term.

**Research and Development**

We are dedicated to advancing minimally invasive cardiac therapies through rigorous research and development efforts focused on innovation, clinical efficacy, and continuous improvement of its proprietary Revivent System. Our research and development strategy centers on refining our core technology to optimize patient outcomes, expand therapeutic applications, and enhance the overall usability and procedural efficiency of its device for healthcare providers.

Over the past four years, we have accelerated our research initiatives to support the ALIVE and RELIVE Trials, gathering additional data to strengthen the clinical foundation for PMA. These efforts include extensive device testing, protocol development, and patient selection criteria, all tailored to meet regulatory standards and improve clinical results. To advance the Revivent System's therapeutic capabilities, our research team has conducted iterative design enhancements and prototyping to address both clinician feedback and patient-specific needs. Each iteration of the device undergoes comprehensive bench testing, mechanical evaluations, and clinical simulations to validate functionality, durability, and ease of use.

In addition, we have historically maintained collaborative relationships with leading academic institutions, cardiac specialists, and contract research organizations to enhance our research and development capabilities. These relationships have facilitated access to specialized expertise and clinical insights, supporting the development of new procedural techniques and therapeutic approaches. BioVentrix regularly conducts educational webinars, hands-on training sessions, and physician workshops to gather insights that drive targeted improvements in product design and support broader adoption of the Revivent System. There were no collaborative agreements in place during the periods presented in this prospectus that we consider to be material to our business.

**Production/Manufacturing**

We currently utilize a combination of in-house manufacturing and outsource manufacturing to assemble our Revivent System. In-house manufacturing occurs at a 1,200 square foot ISO 13485 certified facility in Mansfield, Massachusetts within our 9,000 square foot lease. We have the ability to inspect, assemble, test, package, store and ship finished product candidates from this facility. The components are assembled and pouch sealed in a certified Class 8 controlled environment located at the BioVentrix Mansfield facility. We outsource production of the Force Gauge component of the finished system. We receive the Force Gauges, inspect the lot and then ships the units to the approved sterilization supplier. our have intentionally pursued primarily a vertically integrated manufacturing strategy, as it believes this offers important advantages, including rapid product iteration and control over product quality. We believe that its current manufacturing capacity is sufficient to meet its current expected demand for at least the next 12 months.

We are required to manufacture its product candidates in compliance with the FDA's QSR. We moved to our current Mansfield, Massachusetts facility in January 2023, and manufacturing and distribution from that facility is being undertaken under the IDE which was received by FDE in September 2024 relating to the RELIVE Trial.

We have received International Organization for Standardization, or ISO, 13485:2016 certification for our quality management system. ISO certification generally includes recertification audits every third year, scheduled annual surveillance audits and periodic unannounced audits. We recently received our recertification audit in October 2024. The most recent surveillance audit was conducted on the new Mansfield facility in August 2024 and no major non-conformities were identified. To date, our surveillance and unannounced audits have not identified any major non-conformities. The BioVentrix notified body, BSI, is a well-established notified body, also extended the CE certificate during the most recent audit and stated the BioVentrix QMS is compliant to the European Union ("EU") under the current Medical Device Directive.

We use a combination of internally manufactured and externally-sourced components to produce the Revivent System. Externally-sourced components include off-the-shelf materials, sub-assemblies and custom parts that are provided by approved suppliers. Almost all of these components are provided by single-source suppliers. While there are other suppliers that could make or provide any one of our externally-sourced components, we seek to manage single-source supplier risk by regularly assessing the quality and capacity of its suppliers, implementing supply and quality agreements where appropriate and actively managing lead times and inventory levels of sourced components. We generally seek to maintain sufficient supply levels to help mitigate any supply interruptions and enable it to find and qualify another source of supply. For certain components, we estimate that it would take up to six months to find and qualify a second source. Order quantities and lead times for externally sourced components are based on our forecasts, which are derived from historical demand and anticipated future demand. Lead times for components may vary depending on the size of the order, time required to fabricate and test the components, specific supplier requirements and current market demand for the materials, sub-assemblies and parts.

Suppliers are evaluated, qualified and approved as part of our supplier quality program, which includes verification and monitoring procedures to ensure that our suppliers comply with FDA and ISO standards, as well as our own specifications and requirements. We inspect and verify externally-sourced components under strict processes supported by internal policies and procedures. We maintain a rigorous change control policy to assure that no product or process changes are implemented without prior review and approval. Our finished product candidates are sterilized via gamma radiation by an approved supplier.

**Regulatory Pathway**

Our regulatory pathway for the Revivent System is strategically structured to facilitate clinical validation and eventual market approval, following the FDA's guidelines for Class III medical devices. The Revivent System, designed to treat ischemic heart failure through minimally invasive ventricular remodeling, has been granted BDD status that underscores its potential to meet a critical unmet medical need. This designation provides us with FDA priority review and enhanced guidance on regulatory submissions, with the goal of expediting patient access to the device.

The regulatory process for the Revivent System began with the completion of the ALIVE Trial, a PMA study that served as the basis for an IDE. An IDE was granted by the FDA to initiate the pivotal RELIVE Trial, which is structured as the definitive study supporting PMA submission. The RELIVE Trial, which began in 2025, evaluates the Revivent System's safety and efficacy through a comprehensive clinical protocol, including patient-specific endpoints such as left ventricular volume reduction, quality-of-life metrics, and device-related adverse events. We anticipate completing the study and submitting the results to the FDA as part of its PMA application by 2028.

To support regulatory compliance, we have conducted extensive preclinical studies, including biocompatibility testing, device fatigue assessments, and animal model evaluations in alignment with FDA guidelines and ISO 13485 standards. These preclinical studies seek to validate the durability and safety of the device's External Anchor configuration (any such determinations would be made by the FDA), designed to improve procedural outcomes and reduce adverse events compared to traditional cardiac surgery. We continue to engage with the FDA through formal meetings and ongoing data submissions to streamline the regulatory process and align trial protocols with FDA expectations.

In addition to U.S. regulatory progress, we have initiated regulatory applications for the Revivent System in the European Union, where it has achieved CE Mark approval for clinical use. This approval serves as a basis for the system's potential expansion to additional global markets and provides supportive evidence for its efficacy and safety in treating heart failure patients with severe left ventricular scarring.

Through its coordinated regulatory strategy, we aim to meet all FDA requirements for PMA submission while concurrently expanding its global market presence. The Breakthrough Device Designation, combined with an IDE for the pivotal RELIVE Trial, along with the already obtained CE Mark, positions us to bring the Revivent System to market as an innovative solution for ischemic heart failure, with the potential to transform therapeutic standards in cardiac care.

If and when the RELIVE trial is fully funded, we plan to use excess capital to fund Alginate's clinical and regulatory development through catheter development, a new or revised IDE submission, and a new trial. The earliest we expect to commence an Alginate trial is 2028 and the earliest possible commercialization year for Alginate is estimated to be 2032.

**Government Regulation**

Our operations are governed by comprehensive regulatory requirements enforced by the FDA, state authorities, and comparable regulatory bodies worldwide. The Revivent System is classified as a Class III medical device under the Federal Food, Drug, and Cosmetic Act ("FDCA"), subjecting it to rigorous oversight to ensure safety and effectiveness. These regulations impact every stage of the product lifecycle, from development, non-clinical and clinical research, manufacturing, quality assurance, and labeling to post-market surveillance. We are committed to strict compliance with all applicable regulatory frameworks to ensure its product candidates meet FDA and international standards for safety and efficacy.

*FDA Pre-market Approval ("PMA") Application*

As a Class III medical device, the Revivent System requires Pre-market Approval from the FDA before it can be legally marketed in the United States. The PMA process is highly rigorous, requiring the sponsor to present comprehensive data establishing the device's safety and effectiveness for its intended use. Our PMA application for the Revivent System is structured to include extensive non-clinical and clinical data, as well as information on manufacturing, quality control systems, device labeling, and intended use.

The PMA process involves multiple stages of review, beginning with the submission of detailed device design, testing protocols, and clinical trial results. The FDA initially reviews the application for completeness before entering a substantive review phase, where the device's safety and efficacy data are evaluated. The FDA is statutorily required to complete this review within 180 days; however, the review process may extend beyond this timeframe based on factors such as the complexity of data or additional information requests. If the FDA deems the data to demonstrate a reasonable assurance of safety and effectiveness, the device may be approved for commercial distribution. As part of PMA approval, the FDA may impose post-approval requirements, including patient follow-up, additional clinical studies, or surveillance to gather long-term safety and efficacy data. Any significant modification to the Revivent System following PMA approval requires a PMA supplement or, if the modification substantially changes the device's intended use or design, an entirely new PMA application.

*Quality System Regulation and Current Good Manufacturing Practices ("cGMP")*

Our manufacturing activities for the Revivent System comply with FDA's QSR, a comprehensive set of requirements governing the design, production, and distribution of medical devices. Contract manufacturers used by us must adhere to QSR, including cGMP, to maintain high standards of product quality, consistency, and regulatory compliance. QSR encompasses detailed standards for quality assurance, including device design, raw material selection, production testing, labeling, and packaging, as well as stringent recordkeeping requirements to ensure traceability.

Compliance with QSR and cGMP is enforced by the FDA through periodic inspections of our contract manufacturing facilities. These inspections assess adherence to FDA standards and identify any deficiencies, which could result in warning letters, civil penalties, or other enforcement actions if not addressed promptly. Non-compliance may lead to more severe regulatory actions, including restrictions on device production or distribution. We maintain a continuous monitoring program with its manufacturing partners to ensure that all production and quality control processes meet QSR and cGMP standards, safeguarding the integrity and safety of the Revivent System.

*Post-market Surveillance and Reporting Obligations*

Having obtained CE Mark and after obtaining clearance or approval in other geographical areas including the U.S., we must fulfill extensive post-market requirements to ensure the Revivent System continues to meet safety and performance standards. These obligations include, but are not limited to, compliance with Medical Device Directive ("MDD") and Medical Device Reporting ("MDR") regulations, which require us to report incidents in which the device may have contributed to or caused a death, serious injury, or significant malfunction. In addition, we must remain in compliance with FDA post-market requirements to be determined at time of approval. Proper agreed upon compliance and reporting is crucial for ongoing FDA oversight and enables proactive risk management for both us and the FDA.

Additionally, we are subject to FDA requirements for field actions, including recalls or corrective actions. If we identify or are informed of any issues posing potential health risks, it must report these to the FDA and undertake corrective actions, which may include product recalls, notifications to healthcare providers, or technical adjustments to the device. The FDA retains authority to initiate or mandate additional post-market surveillance, such as long-term clinical studies or patient registries, to gather data on the device's safety and effectiveness in larger, real-world populations. We proactively monitor all post-market data and incident reports, using this information to improve product performance and align with FDA post-market expectations.

*Foreign Regulatory Compliance and CE Mark Approval*

In addition to meeting U.S. regulatory standards, we have achieved CE Mark approval for the Revivent System in the European Union, a significant milestone that enables commercialization across all EU member states. The CE Mark certifies that the Revivent System meets stringent EU safety, performance, and quality standards under the EU Medical Device Directives. This approval is critical to our global expansion strategy, allowing access to EU markets while serving as a recognized certification in additional international markets that accept or require CE certification.

To maintain the CE Mark, we must comply with EU-specific post-market requirements, including adverse event reporting and regular assessments by notified bodies in the EU, which are authorized to review the device's ongoing safety and performance. This includes periodic audits and compliance with EU requirements on labeling, packaging, and clinical data reporting. CE Mark approval also facilitates entry into other international markets that recognize EU regulatory standards, significantly expanding our potential market reach for the Revivent System.

*Federal, State, and International Fraud, Abuse, and Privacy Regulations*

We operate within a complex regulatory landscape that includes federal and state laws designed to prevent healthcare fraud and abuse. In the U.S., the federal Anti-Kickback Statute prohibits the exchange of any form of remuneration to induce the referral of business reimbursable by government healthcare programs, while the False Claims Act restricts the submission of false claims for federal reimbursement. Additionally, under the Physician Payment Sunshine Act, we must report payments and other transfers of value made to healthcare providers. Compliance with these laws is critical, as violations can result in substantial civil and criminal penalties, exclusion from federal healthcare programs, and significant reputational damage.

Data privacy regulations also govern our handling of sensitive information. HIPAA in the U.S. mandates strict protocols for the collection, storage, and disclosure of patient health information. In the European Union, we are subject to the General Data Protection Regulation ("GDPR"), which imposes stringent rules on the use, transfer, and protection of personal data. Both HIPAA and GDPR carry significant penalties for non-compliance, and we have implemented policies and safeguards to ensure adherence to these data protection laws. Compliance with international privacy regulations is essential for protecting patient confidentiality, maintaining trust, and avoiding severe financial and operational penalties.

**Employees**

As of December 31, 2025, we had five full-time employees and one consultant. None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage. We believe we have good relations with our employees.

**Properties and Facilities**

Our corporate headquarters and sole manufacturing facility is located in Mansfield, Massachusetts. We occupy approximately 9,000 square feet of leased space at this location pursuant to a lease agreement that expires in September 2028, with an option to renew for an additional five years. This facility houses our manufacturing operations, quality control laboratory, research and development activities, limited administrative functions, and serves as our corporate headquarters.

Our Mansfield facility is designed and operated to comply with current cGMP as required by the FDA and the applicable requirements of the European Union, including ISO 13485 certification. We manufacture product at this facility primarily to support our clinical studies, commercial activities outside of the United States, and anticipated future commercial sales in the United States, subject to regulatory approval.

While this facility serves as our corporate headquarters, only one of our co-Chief Executive Officers is based at this location on a regular basis. The majority of our other executive and administrative functions operate in a remote-first environment.

We believe that our existing facility is adequate to meet our current needs for manufacturing, development, and limited corporate functions. However, as we expand our operations and prepare for potential commercial-scale production, we may evaluate the need for additional manufacturing capacity or expansion of our current facility. We believe that suitable additional or alternative space would be available in the Mansfield area or other locations on commercially reasonable terms if required.

**Legal Proceedings**

On August 31, 2023, we received a complaint (the "Complaint") by former stockholder Gary Moline (the "Plaintiff") that was filed in the Court of Chancery of the State of Delaware (the "Court"), in which the Plaintiff asserted various causes of action, including breach of our charter, breach of fiduciary duties claims, and assertion of a class action designation plus attorney's fees, against BioVentrix, its officers and directors, and certain other parties in connection with a recapitalization of BioVentrix that was consummated in February 2023. We believe that we have substantial defenses to these claims and intend to vigorously dispute these allegations and defend against the assertions in the Complaint and filed a Motion to Dismiss the Complaint on October 5, 2023 and an Opening Brief in support of our Motion to Dismiss on November 7, 2023. The Plaintiff responded to the Motion to Dismiss on December 15, 2023 in which the Plaintiff conceded that he no longer intends to pursue a breach of charter claim but otherwise opposed the remainder of Defendants' Motion to Dismiss. On January 5, 2024, the Defendants filed their Reply to Plaintiff's Opposition to Defendants' Motion to Dismiss. The Court dismissed Count I and Count III of the Plaintiff's Complaint on May 1, 2024 and the Defendants filed an Answer to Plaintiff's Complaint with the Court on June 12, 2024. We are currently in the discovery process regarding this Complaint.

Although the outcome of this matter is uncertain, we recorded an accrual of $600,000 as of December 31, 2025 related to a settlement proposal. The settlement proposal was not accepted, and there can be no assurance that the matter will be resolved on similar terms or at all. We may incur additional losses in excess of the amount accrued, however such additional losses cannot be reasonably estimated at this time.

**Changes in and Disagreements with Accountants**

None.

**Corporate Information and History**

Our predecessor, CHF Technologies, Inc. ("CHF"), was incorporated under the laws of the State of California on October 15, 2003. On June 8, 2012, we incorporated BioVentrix, Inc., under the laws of the State of Delaware, and subsequently merged CHF Technologies, Inc. with and into BioVentrix, Inc. on June 18, 2012 with BioVentrix, Inc. being the surviving corporation in the merger. Our principal executive office is located at 120 Forbes Blvd., Suite 125, Mansfield, MA 02048, and our telephone number is (925) 290-1000. Our website is *www.bioventrix.com*. Information contained on, or available through, our website does not constitute part of, and is not deemed incorporated by reference into, this prospectus, and investors should not consider any such information as part of this prospectus.

On December 23, 2021, we incorporated BVX Acquisition Inc, a wholly owned subsidiary of BioVentrix, Inc., under the laws of the State of Delaware. On January 6, 2022, BVX Acquisition, Inc. was merged with and into MateraCor, Inc., a Delaware corporation ("MateraCor"), through a reverse triangular merger, with MateraCor being the surviving corporation in the merger and in which the stockholders of MateraCor received cash and shares of common stock of BioVentrix with the potential to receive additional shares of our common stock upon our achievement of certain milestones.

BioVentrix GmbH, our wholly-owned subsidiary, is a German limited liability company (Gesellschaft mit beschränkter Haftung) that was organized under the laws of Germany in 2020 with a business address at Muehlenhof 7-9, 40721 Hilden, registered with the commercial register of the local court (Amtsgericht) in Duesseldorf under HRB 90756.

Our lead device program, the **Revivent System**, has a CE mark in Europe (where we have obtained approval but are currently not commercially operating in order to preserve capital) and is in its pivotal trial in the United States.

We also have ownership rights to **Alginate**, a hydrogel-based device treatment for HFrEF patients without anterior scarring. This device was CE-marked in Europe and had received an IDE in the U.S. (though the CE-mark has lapsed and utilizing the IDE would require a meeting with the FDA regarding a proposed plan).

**MANAGEMENT**

**Executive Officers and Directors**

The following table sets forth information regarding our executive officers and directors as of the date of this prospectus.

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| | | |
|:---|:---|:---|
| **Name** | **Age** | **Position** |
| David Richmond | 54 | Chairman, Co-Chief Executive Officer, and Chief Financial Officer |
| Steven Chartier | 57 | President, Co-Chief Executive Officer, and Director |
| Dr. Ori Ben-Yehuda | 66 | Chief Medical Officer |
| Mark Ravich | 73 | Independent Director |
| Dr. Rishi Puri | 48 | Independent Director |
| Dr. William Abraham | 66 | Independent Director |

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*Executive Officers*

***David Richmond*** has been our Chairman, President, Co-Chief Executive Officer, and Chief Financial Officer since January 2024. Prior to that, from July 2019, Mr. Richmond was a board observer of our Board before being asked to become a full board member in August 2021. Since 1994, Mr. Richmond has also been the founding partner and Chairman of Richmond Brothers, Inc. ("RBI"), an SEC registered investment advisor. Mr. Richmond has been responsible for the strategic planning of RBI and its affiliates, led the creation of RBI private funds, and sits as committee chairman for overall client asset allocation. RBI private funds specialize in (but are not limited to) biotech, pharma, specialty pharma, and medical device companies. RBI private funds prefer to focus on disruptive companies developing their first drug or device changing the paradigm in the area in which they operate.

Mr. Richmond earned his BA in Marketing from Michigan State University in 1994. He earned his Master of Science in Financial Services (MSFS) as well as his CLU, ChFC, CAP designations from the American College. Mr. Richmond is a Certified Public Company Director through the UCLA Anderson School of Management (2021).

***Steven Chartier*** has been our President, Co-Chief Executive Officer, and Director since Jan 15, 2025. With over 30 years of experience in the medical device and biotechnology industries, Mr. Chartier has demonstrated leadership in both large organizations and startup environments. Prior to his current role, from January 2024 to January 2025, he served as Vice President of Regulatory and Quality at Conformal Medical, Inc., a company specializing in cardiovascular left atrial appendage devices. His previous tenure at BioVentrix, spanning from December 2021 to December 2023, included serving as Chief Operating Officer. Mr. Chartier was Vice President of Clinical Operations at Sirtex Medical from September 2020 to December 2021. Mr. Chartier has also held key positions at Cardiovascular Clinical Sciences (2019-2020), Anika Therapeutics (2017-2019), and InfraReDx (2007-2015), where he developed expertise in clinical operations, regulatory affairs, quality assurance, and manufacturing. Notably, at Anika Therapeutics, he was Vice President of Regulatory and Clinical Affairs, overseeing global regulatory strategies and clinical development for the company's orthobiologics and regenerative medicine pipeline. Mr. Chartier began his career in clinical research and trial coordination at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. Mr. Chartier earned a Bachelor of Arts in Psychology from Saint Anselm College in 1990 and obtained Regulatory Affairs Certification from the Regulatory Affairs Professional Society in 2003.

***Dr. Ori Ben-Yehuda*** has been our Chief Medical Officer since January 2024 and is a distinguished clinical cardiologist and clinical trialist with over 25 years of experience in treating patients with coronary disease, myocardial infarction, and heart failure. In addition to his role at BioVentrix, Dr. Ben-Yehuda is a Professor of Medicine at the University of California, San Diego (UCSD), where he leads the Cardiovascular Outcomes Group at the Sulpizio Cardiovascular Institute. Dr. Ben-Yehuda also holds editorial positions as Editor-in-Chief of Coronary Artery Disease and Deputy Editor of Structural Heart: The Journal of the Heart Team. Dr. Ben-Yehuda's previous roles include Executive Director of the Clinical Trials Center at the Cardiovascular Research Foundation and Vice President of Cardiovascular Clinical Trials at Gilead Sciences. Dr. Ben-Yehuda has authored and co-authored over 200 peer-reviewed publications and has been recognized with multiple awards, including Top Abstract at the TCT Conference in 2017 and the Sackler Faculty Prize for Excellence for his MD thesis. Dr. Ben-Yehuda earned his medical degree from the Sackler School of Medicine at Tel Aviv University in Israel and completed a cardiovascular medicine fellowship at UCSD.

*Independent Directors*

***Mark H. Ravich*** has served as a director since July 2025. Since June 2017, Mr. Ravich has been a director of Rockwell Medical (Nasdaq: RMTI), a pharmaceutical company, and is currently a member of its audit committee. Mr. Ravich also currently serves as president of Tri-Star Management, Inc., a commercial real estate management and syndication company that he co-founded in 1998. From October 2010 through December 2022, Mr. Ravich served as a director of Dilon Technologies, Inc., a designer and manufacturer of medical imaging solutions. In addition, from February 2019 to March 2023, Mr. Ravich previously served as a director of BioVentrix. Previously, from February 2013 to 2018, Mr. Ravich served as a director of Orchids Paper Products Company, a national supplier of high-quality consumer tissue products, as well as chairman of its governance committee and as a member of its audit committee. Orchids Paper Products Company filed for Chapter 11 bankruptcy on April 1, 2019, in the U.S. Bankruptcy Court for the District of Delaware. From June 2004 to 2018, Mr. Ravich served as a director of MR Instruments, Inc., an independent designer and manufacturer of advanced MRI Radiofrequency coils. From 1990 until its sale in 1998, Mr. Ravich served as the chief executive officer and a director of Universal International, Inc., a wholesale retail company, where he also led its initial public offering. From 1978 to 1990, Mr. Ravich was a developer of commercial real estate where he was involved with all aspects of development, finance, construction, marketing, leasing and management of various commercial, industrial, office and multi-family real estate projects. Mr. Ravich began his career in 1975 as an account officer at Citibank N.A., where he made real estate construction loans to national real estate developers. Mr. Ravich also is the chief manager of various real estate entities. Mr. Ravich graduated Magna Cum Laude from the Wharton School of the University of Pennsylvania with a B.S. and an M.B.A. degree with a major in finance. We believe that Mr. Ravich's extensive board experience across the pharmaceutical, medical device, and real estate sectors, combined with his financial expertise and leadership in both public and private companies qualifies him to be a member of our board of directors.

***Rishi Puri****,* M.D., Ph.D., FRACP, FACC has served as a director since July 2025.

Dr. Puri has been a coronary and structural interventional cardiologist at the Cleveland Clinic since 2018. With his appointment he was also named an Associate Professor of Medicine and Medical Director of the Angiography & IVUS Core Laboratory and has also served in such capacity since 2018. Since July 2025, he has served as Chief Medical Director of T45 Labs, a Bay Area medical device incubator, and since July 2018, he has served as Medical Director of the Atherosclerosis Imaging Core Laboratory. He has held the post of Adjunct Professor at Swinburne University of Technology since 2024. Dr. Puri was Associate Professor (adjunct) at the Institute for Intelligent Systems Research and Innovation at Deakin University from 2017 through April 2025.

He has published over 450 original manuscripts in high-impact journals across a broad topic base including transcatheter structural heart interventions for valvular heart disease and heart failure, atherosclerosis progression-regression and plaque imaging, and coronary physiology/pharmacology. He is actively involved in developing novel device-based technologies in coronary, structural heart disease, and interventional heart failure, and has co-founded and advises a range of medical start-up companies and larger strategics.

Dr. Puri currently serves as global co-principal investigator ("PI") for the TRICAV-1 and TRICAV-2 FDA pivotal trials, a position he has held since April 2022, and the ADVANCE-DCB first-in-man trial, which he has served as since September 2022. Since early 2025, Dr. Puri has been national principal investigator for the ALLAY-HFrEF trial. He also serves on the global steering committees of multiple other pivotal trials in the aortic, mitral and tricuspid valve therapy space.

Dr. Puri completed his medical degree (MBBS) and a Ph.D. in medicine/cardiology at the University of Adelaide in 2001 and 2014, respectively, during which time he also held an internship, residency, and a fellowship in internal medicine and cardiology at the Royal Adelaide Hospital.Dr. Puri then completed subspecialty training in interventional and structural heart disease at the Québec Heart and Lung Institute in Quebec City from 2014 to 2017, at the Rennes University Hospital during 2017, and was appointed visiting Senior Staff Cardiologist at Royal Adelaide Hospital in 2017 and 2018, and at the Universitätsspital Zürich in 2018.He received his FRACP degree from the Royal Australasian College of Physicians in 2008.

***William T. Abraham***, M.D., FACP, FACC, FAHA, FESC, FRCPE has served as a director since July 2025.

Dr. Abraham, age 66, has served as a member of our board of directors since August 2025. He has also served as a member of the board of directors of scPharmaceuticals Inc. (Nasdaq: SCPH) since February 2021.

Dr. Abraham joined Cardiac Dimensions as Chief Medical Officer in September 2025 having served as Chief Medical Officer of V-Wave Ltd. (now a subsidiary of Johnson & Johnson) since March 2019. Over his career, he has participated as a site principal investigator, national or international principal investigator, and/or on the executive or steering committees in numerous multicenter clinical drug and device trials. He was the lead author of the MIRACLE cardiac resynchronization therapy trial (2002), a principal investigator of the CHAMPION implantable hemodynamic monitoring trial (2011), and a co-principal investigator of the COAPT percutaneous mitral valve repair trial (2018).

Dr. Abraham has authored or co-authored more than 1,000 manuscripts, book chapters, and scientific papers published in peer-reviewed journals, including The New England Journal of Medicine, The Lancet, and The Journal of the American Medical Association. His research interests include the role of the kidney in heart failure, neurohormonal mechanisms in heart failure, sleep-disordered breathing, and clinical drug and device trials in heart failure and cardiac transplantation.

Dr. Abraham received his B.A. in Honors Philosophy from the University of Pittsburgh in 1982 and his M.D. from Harvard Medical School in 1986. He completed his internal medicine residency (1986–1990) at the University of Colorado Health Sciences Center where he also completed fellowships in cardiovascular disease and advanced heart failure/cardiac transplantation (1990–1993) and served on the faculty (1993-1997). He then joined the faculty at the University of Cincinnati as Associate Professor of Medicine and Director, Section of Heart Failure and Cardiac Transplantation from 1997–2000 and subsequently the University of Kentucky faculty as Chief of Cardiovascular Medicine from 2000 to 2002. Dr. Abraham is Professor of Medicine, Physiology and Cell Biology at The Ohio State University Wexner Medical Center having served as the Chief of Cardiovascular Medicine at The Ohio State University from 2002 to 2019. He is board-certified in internal medicine and advanced heart failure and transplant cardiology. We believe that Dr. Abraham's clinical-trial leadership, academic expertise, regulatory experience, and board service at other life sciences companies qualify him to serve as a member of our board of directors.

**Family Relationships**

There are no family relationships between or among any of the current directors, executive officers or persons nominated or charged to become directors or executive officers.

**Number and Terms of Office of Officers and Directors**

Our business and affairs are organized under the direction of our board of directors. Upon the consummation of this offering, our board of directors will consist of five directors, including two executive directors and three independent directors.

Our Amended and Restated Bylaws provide that the number of directors will be fixed by the board of directors within a range of between 1 and 9 directors. The directors need not be stockholders unless so required by our certificate of incorporation. The minimum or maximum number may be increased or decreased from time to time only by an amendment to the bylaws, which power belongs exclusively to our board of directors.

Our officers are appointed by the board of directors and shall hold office at the discretion of the board of directors until their successors are duly elected and qualified, unless sooner removed. Our board of directors is authorized to appoint officers to the offices set forth in our bylaws.

**Director Independence**

The Nasdaq listing standards require that a majority of our board of directors be independent. An "independent director" is defined generally as a person who has no material relationship with the listed company (either directly or as a partner, shareholder or officer of an organization that has a relationship with our company). We have three "independent directors" as defined in the Nasdaq listing standards and applicable SEC rules prior to completion of this offering.

Our board has determined that Mark Ravich, Rishi Puri and William Abraham are independent directors under applicable SEC and Nasdaq rules. Our independent directors will have regularly scheduled meetings at which only independent directors are present.

**Board Committees**

Our board of directors has established an Audit Committee, a Nominating and Corporate Governance Committee and a Compensation Committee. Our board of directors has adopted a charter for each of these three committees. Prior to the completion of this offering, copies of each committee's charter will be posted on the Investor Relations section of our website, which will be located at *www.bioventrix.com*. Each of the committees of our board of directors shall have the composition and responsibilities described below. Our board of directors may from time to time establish other committees as it deems appropriate.

*Audit Committee*

Mr. Ravich, Dr. Abraham and Dr. Puri will serve as members of our Audit Committee with Mr. Ravich serving as the chairman of the Audit Committee. Each of our Audit Committee members will satisfy the "independence" requirements of the Nasdaq listing rules and meet the independence standards under Rule 10A-3 under the Exchange Act. Our board of directors has determined that Mark Ravich possesses accounting or related financial management experience that qualifies her as an "audit committee financial expert" as defined by the rules and regulations of the SEC. Our Audit Committee oversees our accounting and financial reporting processes and the audits of our financial statements. Our Audit Committee will perform several functions, including:

● evaluating the performance, independence and qualifications of our independent registered public accounting firm and determining whether to retain our existing independent registered public accounting firm or engage new independent registered public accounting firm;

● reviewing and approving the engagement of our independent registered public accounting firm to perform audit services and any permissible non-audit services;

● reviewing our annual and quarterly financial statements and reports, including the disclosures contained under the caption "*Management's Discussion and Analysis of Financial Condition and Results of Operations*," and discussing the statements and reports with our independent registered public accounting firm and management;

● reviewing with our independent registered public accounting firm and management significant issues that arise regarding accounting principles and financial statement presentation and matters concerning the scope, adequacy and effectiveness of our financial controls;

● reviewing our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented; and

● reviewing and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter.

*Compensation Committee*

Mr. Ravich, Dr. Abraham and Dr. Puri will serve as members of our Compensation Committee with Mr. Ravich serving as the chairman of the Compensation Committee. All of our Compensation Committee members satisfy the "independence" requirements of the Nasdaq listing rules and meet the independence standards under Rule 10A-3 under the Exchange Act. The functions of this committee include, among other things:

● reviewing, modifying and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall compensation strategy and policies;

● reviewing and approving the compensation, the performance goals and objectives relevant to the compensation, and other terms of employment of our executive officers;

● reviewing and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and programs;

● reviewing and approving the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory arrangements for our executive officers;

● reviewing with management and approving our disclosures under the caption "*Compensation Discussion and Analysis*" in our periodic reports or proxy statements to be filed with the SEC; and

● preparing the report that the SEC requires in our annual proxy statement.

*Nominating and Corporate Governance Committee*

Mr. Ravich, Dr. Abraham, and Dr. Puri will serve as members of our Nominating and Corporate Governance Committee with Dr. Abraham serving as the chairman of the Nominating and Corporate Governance Committee. All of our Nominating and Corporate Governance Committee members will satisfy the "independence" requirements of the Nasdaq listing rules and meet the independence standards under Rule 10A-3 under the Exchange Act. The functions of this committee include, among other things:

● identifying, reviewing and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors;

● evaluating director performance on the board and applicable committees of the board and determining whether continued service on our board is appropriate;

● evaluating, nominating and recommending individuals for membership on our board of directors; and

● evaluating nominations by stockholders of candidates for election to our board of directors.

The nominating and corporate governance committee will take into account many factors in determining recommendations for persons to serve on the board of directors, including the following:

● personal and professional integrity, ethics and values;

● experience in corporate management, such as serving as an officer or former officer of a publicly-held company;

● experience as a board member or executive officer of another publicly-held company;

● strong finance experience;

● diversity of expertise and experience in substantive matters pertaining to our business relative to other board members;

● diversity of background and perspective including, without limitation, with respect to age, gender, race, place of residence and specialized experience;

● experience relevant to our business industry and with relevant social policy concerns; and

● relevant academic expertise or other proficiency in an area of our business operations.

**Role of Board in Risk Oversight Process**

Periodically, our board of directors assesses these roles and the board of directors leadership structure to ensure the interests of our company and our stockholders are best served. Our board of directors has determined that its current leadership structure is appropriate.

While management is responsible for assessing and managing risks to our company, our board of directors is responsible for overseeing management's efforts to assess and manage risk. This oversight is conducted primarily by our full board of directors, which has responsibility for general oversight of risks, and standing committees of our board of directors. Our board of directors satisfies this responsibility through full reports by each committee chair regarding the committee's considerations and actions, as well as through regular reports directly from officers responsible for oversight of particular risks within our company. Our board of directors believes that full and open communications between management and the board of directors are essential for effective risk management and oversight.

**Compensation Committee Interlocks and Insider Participation**

None of our executive officers serves, or in the past has served, as a member of the board of directors or compensation committee, or other committee serving an equivalent function, of any entity that has one or more executive officers who serve as members of our board of directors or our compensation committee. None of the members of our compensation committee is, or has ever been, an officer or employee of our company.

**Clawback Policy**

We will adopt a compensation recovery policy that is compliant with Nasdaq listing rules as required by the Dodd-Frank Act.

**Code of Business Conduct and Ethics**

On or prior to the completion of this offering, we will adopt a written code of business conduct and ethics that applies to our employees, officers and directors. A current copy of the code will be posted on the Corporate Governance section of our website, which will be located at *www.bioventrix.com*. We intend to disclose future amendments to certain provisions of our code of business conduct and ethics, or waivers of such provisions applicable to any principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, and our directors, on our website identified above or in filings with the SEC.

**Involvement in Certain Legal Proceedings**

Except as otherwise disclosed below, to the best of our knowledge, none of our directors or executive officers has, during the past ten years:

● been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);

● had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time. Mr. Ravich served as a director of Orchids Paper Products Company from February 2013 to 2018, as well as chairman of the governance committee and as a member of the audit committee. Orchids Paper Products Company filed for Chapter 11 bankruptcy on April 1, 2019, in the U.S. Bankruptcy Court for the District of Delaware;

● been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, by any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;

● been found by a court of competent jurisdiction in a civil action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;

● been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

● been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

From time to time, we may be subject to various legal or administrative claims and proceedings arising in the ordinary course of business. Litigation or any other legal or administrative proceeding, regardless of the outcome, is likely to result in substantial cost and diversion of our company's resources, including our company's management's time and attention.

**EXECUTIVE AND DIRECTOR COMPENSATION**

The following table sets forth the aggregate compensation paid to our named executive officers for the fiscal years ended December 31, 2025 and 2024. Individuals we refer to as our "named executive officers" include our Chief Executive Officer and our two other most highly compensated executive officers who were serving as executive officers at the end of the fiscal year ended December 31, 2025 and whose total compensation for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2025.

**Summary Compensation Table**

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| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| Name and Principal Position | Year | Salary<br> ($) | Bonus<br> ($) | Stock Awards ($)(2) | Option Awards<br> ($)(2) | Non-Equity Incentive Plan Compensation<br> ($) | Nonqualified Deferred Compensation Earnings<br> ($) | All Other Compensation<br> ($) | Total<br> ($) |
| David Richmond, <br>Chairman, Co-Chief Executive Officer and Chief Financial Officer | 2025 | $300000 |  | $- | $8900 | – |  | $36176&nbsp;&nbsp;&nbsp;&nbsp;<sup>(3)</sup> | $345076 |
|  | 2024 |  |  | $155200 |  | – |  |  | $155200 |
| Steve Chartier, <br>President, Co-Chief Executive Officer and Director | 2025 | $375000 | $50000 | $- | $9881 | – |  | $97059&nbsp;&nbsp;&nbsp;&nbsp;<sup>(4)</sup> | $531940 |
|  | 2024 | $10384&nbsp;&nbsp;&nbsp;&nbsp;<sup>(1)</sup> |  | $88000 |  | – |  |  | $98384 |
| Ori Ben-Yehuda, <br>Chief Medical Officer | 2025 |  |  | $- | $563 | – |  | $120000&nbsp;&nbsp;&nbsp;&nbsp;<sup>(5)</sup> | $120563 |
|  | 2024 |  |  | $88000 |  | – |  |  | $88000 |

---

(1) This
 amount reflects the pay out of unused vacation time for 2024.

(2) Amounts
 reflect the full grant-date fair value of restricted stock and stock option awards granted during the applicable fiscal year computed
 in accordance with ASC Topic 718, rather than the amounts paid to or realized by the named executive officer. We provide information
 regarding the assumptions used to calculate the value of all awards made to our named executive officers in Note 9 of the Consolidated
 Financial Statements.

(3) This
 amount includes medical insurance of $32,552.

(4) This
 amount includes medical insurance of $63,569 and matching contributions in our 401(k) plan of $29,625.

(5) Consulting
 fees as our CMO is a consultant, paid monthly in arrears.

**Employment Arrangements with our Executive Officers and Directors**

Current Arrangements

Mr. Richmond is currently employed pursuant to an offer letter agreement with the Company that became effective January 15, 2025 (the "Richmond Offer Letter"). Pursuant to the Richmond Offer Letter, Mr. Richmond serves as the Co-Chief Executive Officer of the Company, reporting to the board of directors. The Richmond Offer Letter contains the following compensatory terms: (i) an annual base salary of $300,000, (ii) eligibility to receive a discretionary bonus of up to 30% of his base salary, contingent upon the achievement of objectives mutually agreed upon with the board of directors, and (iii) an option to purchase 191,000 shares of the Company's common stock, which vests as to 25% of the underlying shares on the first anniversary of the effective date of the award agreement, with the remaining 75% vesting in equal monthly installments over the following 36 months, subject to Mr. Richmond's continued employment. The options fully vest upon a change in control of the Company. In the event the Company terminates Mr. Richmond's employment without "cause" or Mr. Richmond terminates his employment for "good reason" (each, as defined in the Richmond Offer Letter), Mr. Richmond is entitled to receive severance equal to twelve months of his then-current base salary.

Mr. Chartier is currently employed pursuant to an offer letter agreement with the Company that became effective December 3, 2024 (the "Chartier Offer Letter"). Pursuant to the Chartier Offer Letter, Mr. Chartier serves as the Co-Chief Executive Officer and President of the Company, reporting to the board of directors. The Chartier Offer Letter contains the following compensatory terms: (i) an annual base salary of $375,000, (ii) eligibility to receive a discretionary bonus of up to 30% of his base salary, contingent upon the achievement of objectives mutually agreed upon with the board of directors, (iii) a sign-on bonus of $50,000, and (iv) an option to purchase 220,000 shares of the Company's common stock, which vests as to 25% of the underlying shares on the first anniversary of the effective date of the award agreement, with the remaining 75% vesting in equal monthly installments over the following 36 months, subject to Mr. Chartier's continued employment. The options fully vest upon a change in control of the Company. In the event the Company terminates Mr. Chartier's employment without "cause" or Mr. Chartier terminates his employment for "good reason" (each, as defined in the Chartier Offer Letter), Mr. Chartier is entitled to receive severance equal to twelve months of his then-current base salary.

Dr. Ben-Yehuda is engaged as a consultant pursuant to a consulting agreement that became effective September 20, 2022 (the "Ben-Yehuda Consulting Agreement"). The Ben-Yehuda Consulting Agreement has an open term and entitles Dr. Ben-Yehuda to $500 per hour of work plus all reasonable pre-approved out-of-pocket expenses. The Ben-Yehuda Consulting Agreement may be terminated by either party upon ten days' written notice. Additionally, the Ben-Yehuda Consulting Agreement contains standard confidentiality and indemnification provisions and a six-month post-engagement non-solicitation clause.

New Arrangements

Our Co-Chief Executive Officers will be engaged with the Company pursuant to employment agreements that will become effective prior to or in connection with the closing of this offering. Under the agreements, Messrs. Chartier and Richmond report to our Board.

Each agreement will continue until terminated in accordance with its terms, and provides for (A) an annual base salary paid in accordance with our normal payroll practices and which may be increased in the discretion of our board of directors, but not reduced, (B) a target annual bonus equal to 30% for Messrs. Chartier and Richmond, with the actual amount of such bonus determined in the discretion of our board of directors, based on the achievement of individual and/or company performance goals determined by our board of directors and payable on the date annual bonuses are paid to our other senior executives, but in no event later than March 15th of the calendar year following the calendar year in which such annual bonus was earned, provided the applicable executive is employed in active working status with the company at the time the bonus is paid, (C) eligibility to receive equity-based compensation awards, as determined by our board for each calendar year during the employment period, (D) eligibility to participate in customary health, welfare and retirement benefit plans we provide our employees, (E) prompt reimbursement for all reasonable business expenses, and (F) fifteen vacation days annually.

Under the employment agreements for Messrs. Chartier and Richmond, if the executive's employment is terminated by the company without "cause," or by the executive for "good reason" (each, as defined in the applicable employment agreement, and referred to herein as a qualifying termination) then the executive will be entitled to receive (i) severance in an amount equal to one times the executive's base salary, as in effect on the termination date, payable over twelve months following the termination date, and (ii) 12 months' of employer-provided COBRA, each subject to the executive executing and not revoking a release of claims in favor of the company.

The employment agreements also include standard confidentiality and invention assignment provisions and a "best pay" provision under Section 280G of the Code, pursuant to which any "parachute payments" that become payable to the executive will either be paid in full or reduced so that such payments are not subject to the excise tax under Section 4999 of the Code, whichever results in the better after-tax treatment to the executive.

The following table sets forth each executive's title and annual base salary under his employment agreement.

---

| | | |
|:---|:---|:---|
| Name | Title | Base Salary |
| Steve Chartier | President and Co-CEO | $386250 |
| David Richmond | Co-CEO | $309000 |

---

**Outstanding Equity Awards at Fiscal 2025 Year-End** 

---

| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| | | | **Option Awards** | **Option Awards** | **Option Awards** | | **Stock Awards** | **Stock Awards** |
| <br> **Name** | <br> **Vesting<br> Commencement<br> Date** | <br> **Grant<br> Date** | **Number of<br> Securities<br> Underlying<br> Unexercised<br> Options (#)<br> Exercisable** | **Number of<br> Securities<br> Underlying<br> Unexercised<br> Options (#)<br> Unexercisable** | **Option<br> Exercise<br> Price ($)** | <br> **Option<br> Expiration<br> Date** | **Number of<br> Shares or Units<br> of Stock That<br> Have Not<br> Vested (#)** | **Market Value<br> of Shares or<br> Units of Stock<br> That Have Not<br> Vested ($)** |
| David Richmond, | 1/1/25 | 1/1/25 |  | 191000&nbsp;&nbsp;&nbsp;&nbsp;<sup>(1)</sup> | $1.00 | 12/31/34 |  | $- |
| *Chairman, Co-Chief Executive Officer and Chief Financial Officer* | 10/1/25 | 10/1/25 |  | 80000&nbsp;&nbsp;&nbsp;&nbsp;<sup>(2)</sup> | $1.14 | 9/30/35 |  | $- |
| Steve Chartier, | 1/15/25 | 1/15/25 |  | 222000&nbsp;&nbsp;&nbsp;&nbsp;<sup>(3)</sup> | $1.00 | 1/14/35 |  | $- |
| President, *Co-Chief Executive Officer and Director* | 10/1/25 | 10/1/25 |  | 70000&nbsp;&nbsp;&nbsp;&nbsp;<sup>(4)</sup> | $1.14 | 9/30/35 |  | $- |
| Ori Ben-Yehuda, | 10/1/25 | 10/1/25 |  | 25000&nbsp;&nbsp;&nbsp;&nbsp;<sup>(5)</sup> | $1.14 | 9/30/35 |  | $- |
| *Chief Medical Officer* |  |  |  |  |  |  |  | $- |

---

(1) 47,750
 of the shares underlying the option vest on the first anniversary of the vesting commencement date and then 3,979 shares underlying
 the option will vest in each of the subsequent 36 months, subject to continued employment.

(2) 20,000
 of the shares underlying the option vest on the first anniversary of the vesting commencement date and then 1,666 shares underlying
 the option will vest in each of the subsequent 36 months, subject to continued employment.

(3) 55,000
 of the shares underlying the option vest on the first anniversary of the vesting commencement date and then 4,625 shares underlying
 the option will vest in each of the subsequent 36 months, subject to continued employment.

(4) 17,500
 of the shares underlying the option vest on the first anniversary of the vesting commencement date and then 1,458 shares underlying
 the option will vest in each of the subsequent 36 months, subject to continued employment.

(5) 6,250
 of the shares underlying the option vest on the first anniversary of the vesting commencement date and then 521 shares underlying
 the option will vest in each of the subsequent 36 months, subject to continued employment.

Retirement Benefits

We currently provide a 401(k) retirement savings plan for our employee who satisfy certain eligibility requirements, including one or more of our named executive officers. Our named executive officers are eligible to participate in the 401(k) plan on the same terms as other full-time employees. The Internal Revenue Code allows eligible employees to defer a portion of their compensation, within prescribed limits, on a pre-tax basis through contributions to the 401(k) plan. Currently, we match participants' contributions to the 401(k) plan up to 4% of compensation.

Potential Payments Upon Termination or Change in Control

Our named executive officers are entitled to payments upon certain termination events, as described in the employment agreement summary above.

**Director Compensation**

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| Name | Fees earned or paid in cash<br> ($) | Stock awards<br> ($) | Option awards<br> ($) | Non-equity incentive plan<br> compensation<br> ($) | Nonqualified deferred<br> compensation earnings<br> ($) | All other compensation<br> ($) | Total<br> ($) |
| Mark Ravich |  |  | $18012&nbsp;&nbsp;&nbsp;&nbsp;<sup>(2)</sup> |  |  |  | $18012 |
| William Abraham |  |  | $18012&nbsp;&nbsp;&nbsp;&nbsp;<sup>(2)</sup> |  |  |  | $18012 |
| Rishi Puri |  |  | $18012&nbsp;&nbsp;&nbsp;&nbsp;<sup>(2)</sup> |  |  |  | $18012 |

---

(1) As
 of December 31, 2025, each non-employee director held 18,012 option awards and no restricted stock awards.

(2) Amounts
 reflect the full grant-date fair value of stock option awards granted during the applicable fiscal year computed in accordance with
 ASC Topic 718, rather than the amounts paid to or realized by the non-employee director. We provide information regarding the assumptions
 used to calculate the value of all awards made to our directors in Note 9 of the Consolidated Financial Statements.

**Director Compensation**

Other than as set forth in the table above relating to their capacity as officers, our board members did not pay any compensation, reimburse any expense of, make any equity awards or non-equity awards to, or pay any other compensation to, any of the other non-employee members of the Board in the fiscal year ended December 31, 2025. In connection with the closing of this offering, we plan to establish a non-employee director compensation program, the terms of which have yet to be determined. On January 2, 2026, each non-employee director was granted 30,000 restricted stock awards.

**Summary of Material Terms of the 2024 Plan**

The following is a summary of the material features of the BioVentrix, Inc. 2024 Equity Incentive Plan (the "2024 Plan").

*Eligibility*

The Administrator may grant awards to any director, employee or consultant of the Company or its affiliates. Only employees are eligible to receive incentive stock options.

*Administration*

The 2024 Plan is administered by the Board of Directors (the "Board") or one more committees or subcommittees of the Board, (collectively, the "Administrator"). The Administrator has the authority to construe and interpret the 2024 Plan and the awards granted under it, and to establish, amend, and revoke rules and regulations for its administration. The Administrator may correct any defect, omission, or inconsistency in the 2024 Plan or in any award in a manner and to the extent it deems necessary or expedient to make the 2024 Plan fully effective.

*Share Reserve*

The maximum aggregate number of shares of our common stock (the "Shares") that may be issued under the 2024 Plan is 1,500,000.

1,500,000 Shares may be issued upon the exercise of incentive stock options.

The share reserve described herein may be subject to certain adjustments in the event of certain changes in our capitalization (see *Equitable Adjustments* below).

*Types of Awards*

The 2024 Plan provides for the grant of stock options (both incentive stock options and nonqualified stock options) and restricted stock (collectively, "awards").

Stock Options. The 2024 Plan permits the granting of both options intended to qualify as incentive stock options under Section 422 of the Internal Revenue Code of 1986, as amended (the "Code") and options that do not so qualify. Options granted under the 2024 Plan will be nonqualified options if they fail to qualify as incentive stock options or exceed the annual limit on incentive stock options. Incentive stock options may only be granted to our employees. Nonqualified options may be granted to any persons eligible to receive awards under the 2024 Plan.

The exercise price of each option will be determined by the Administrator, but such exercise price may not be less than 100% of the fair market value of one Share on the date of grant or, in the case of an incentive stock option granted to a 10% or greater stockholder, 110% of such Share's fair market value. The term of each option will be set by the Administrator and may not exceed ten (10) years from the date of grant (or five (5) years for an incentive stock option granted to a 10% or greater stockholder). The Administrator will determine at what time or times each option may be exercised, including the ability to accelerate the vesting of such options.

Restricted Stock. A restricted stock award is an award of Shares that vests in accordance with the terms and conditions established by the Administrator. The Administrator will determine the persons to whom grants of restricted stock awards are made, the number of restricted shares to be awarded, the price (if any) to be paid for the restricted shares, the time or times within which awards of restricted stock may be subject to forfeiture, the vesting schedule and rights to acceleration thereof, and all other terms and conditions of restricted stock awards. Unless otherwise provided in the applicable award agreement, a participant generally will have the rights and privileges of a stockholder as to such restricted shares, including, without limitation, the right to vote such restricted shares and the right to receive cash dividends, if applicable.

*Equitable Adjustments*

If any change is made in the Shares subject to the 2024 Plan, or subject to any stock award, without the receipt of consideration (through merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, stock split, liquidating dividend, combination of shares, exchange of shares, change in corporate structure or other transaction not involving the receipt of consideration by us), the 2024 Plan will be appropriately adjusted in the class(es) and maximum number of securities subject to the 2024 Plan and the outstanding awards will be appropriately adjusted in the class(es) and number of securities and price per Share subject to such outstanding awards.

*Change in Control*

In the event of (x) a sale, lease or other disposition of all or substantially all of our assets, (y) a merger or consolidation in which we are not the surviving corporation or (z) a reverse merger in which we are the surviving corporation but the Shares outstanding immediately preceding the merger are converted by virtue of the merger into other property, whether in the form of securities, cash or otherwise, all options outstanding under the 2024 Plan will be treated in the manner described in the definitive transaction agreement approved by the Board, which agreement need not treat all options outstanding in an identical manner. Such treatment may include, without limitation, one or more of the following with respect to each outstanding option outstanding under the 2024 Plan: (i) continuation of the option by the us (if we are the surviving entity in the transaction), (ii) assumption of the option by the surviving corporation or its parent in a manner that complies with applicable law and tax provisions, (iii) substitution by the surviving corporation or its parent of a new option or stock purchase right for the option in a manner than complies with applicable law and tax provisions, (iv) cancellation of the option and a payment of the spread (unless such option is underwater, in which case it may be cancelled for no payment), (v) cancellation of the option without the payment of any consideration; provided that the optionholder will be notified of such treatment and given an opportunity to exercise the option to the extent vested, (vi) suspension of the optionholder's right to exercise the option during a limited period of time preceding the closing if such suspension is administratively necessary to permit the closing of the transaction, and/or (vii) termination of any right of an optionholder has to exercise the option prior to vesting in the shares subject to the option, such that at or following the closing of the transaction, the option may only be exercised to the extent it is vested, in each case, as determined by the Board.

*Term*

The 2024 Plan became effective upon approval by the Board on August 7, 2024, but was terminated in connection with our adoption of the 2026 Plan, as discussed below. Awards made under the 2024 Plan will remain subject to the terms and conditions of such plan until they vest, expire, or are forfeited. Following the termination of the 2024 Plan, no further awards may be made under the 2024 Plan.

**Summary of Material Terms of the 2026 Plan**

The following is a summary of the material features of the BioVentrix, Inc. 2026 Equity Incentive Plan (the "2026 Plan"), which was adopted by the Board and our stockholders on [________].

*Eligibility*

The Administrator may grant awards to any director, employee or consultant of the Company or its subsidiaries. Only employees are eligible to receive incentive stock options.

*Administration*

The 2026 Plan will be administered by the Board of Directors (the "Board") or one more committees or subcommittees of the Board, which will be comprised, unless otherwise determined by the Board, solely of not less than two members who will be non-employee directors (a "Committee"), or any officer that has been delegated administrative authority pursuant to the 2026 Plan for the duration such delegation is in effect (collectively, the "Administrator"). The Administrator, which initially will be the Board with respect to awards to non-employee directors and the Compensation Committee of our Board with respect to other participants. The Administrator will have the authority to make all determinations and interpretations under, prescribe all forms for use with, and adopt rules for the administration of the 2026 Plan, subject to the 2026 Plan's express terms and conditions. The Administrator will also set the terms and conditions of all awards under the 2026 Plan, including any vesting and vesting acceleration conditions.

*Share Reserve*

The maximum aggregate number of Shares that may be issued under the 2026 Plan is the sum of (A) 10% of the issued and outstanding shares of the Company as of the closing of this offering, plus (B) an increase commencing on January 1, 2027, and continuing annually on each anniversary thereof through and including January 1, 2035, equal to the lesser of (i) 3% of the Shares issued and outstanding on the last day of the immediately preceding calendar year and (ii) such smaller number of Shares as determined by the Board or the Committee.

Also, 20% of the issued and outstanding shares of the Company as of the closing of this offering may be issued upon the exercise of incentive stock options.

Shares issuable under the 2026 Plan may be authorized, but unissued, or reacquired shares. Shares underlying any awards under the 2026 Plan that are settled in cash, forfeited, canceled, repurchased, held back upon exercise of an option or settlement of an award to cover the exercise price or tax withholding satisfied without the issuance of stock or otherwise terminated (other than by exercise) will be added back to the Shares available for issuance under the 2026 Plan, although Shares shall not again become available for issuance as incentive stock options. Additionally, Shares issued as "substitute awards" (as defined in the 2026 Plan) will not count against the 2026 Plan's share limit, except substitute awards that are incentive stock options will count against the incentive stock option limit.

The share reserve described herein may be subject to certain adjustments in the event of certain changes in our capitalization (see *Equitable Adjustments* below).

*Annual Limitation on Awards to Non-Employee Directors*

The 2026 Plan contains a limitation whereby the value of all awards under the 2026 Plan and all other cash compensation paid by us to any non-employee director may not exceed $950,000 for the first calendar year a non-employee director is initially appointed to the Board, and $700,000 in any other calendar year.

*Types of Awards*

The 2026 Plan provides for the grant of stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalent awards, and other stock- or cash-based awards (collectively, "awards").

<u>Stock Options</u>. The 2026 Plan permits the granting of both options intended to qualify as incentive stock options under Section 422 of the Internal Revenue Code of 1986, as amended (the "Code") and options that do not so qualify. Options granted under the 2026 Plan will be nonqualified options if they fail to qualify as incentive stock options or exceed the annual limit on incentive stock options. Incentive stock options may only be granted to employees of the Company and its subsidiaries. Nonqualified options may be granted to any persons eligible to receive awards under the 2026 Plan.

The exercise price of each option will be determined by the Administrator, but such exercise price may not be less than 100% of the fair market value of one Share on the date of grant or, in the case of an incentive stock option granted to a 10% or greater stockholder, 110% of such Share's fair market value. The term of each option will be set by the Administrator and may not exceed ten (10) years from the date of grant (or five (5) years for an incentive stock option granted to a 10% or greater stockholder). The Administrator will determine at what time or times each option may be exercised, including the ability to accelerate the vesting of such options.

<u>Stock Appreciation Rights</u>. The Administrator may award stock appreciation rights subject to such conditions and restrictions as it may determine. Stock appreciation rights entitle the recipient to Shares or cash, equal to the value of the appreciation in our stock price over the exercise price, as set by the Administrator and which will be at least equal to the fair market value of a Share on the grant date. The term of each stock appreciation right will be set by the Administrator and may not exceed ten years from the date of grant. The Administrator will determine at what time or times each stock appreciation right may be exercised, including the ability to accelerate the vesting of such stock appreciation rights.

<u>Restricted Stock</u>. A restricted stock award is an award of Shares that vests in accordance with the terms and conditions established by the Administrator. The Administrator will determine the persons to whom grants of restricted stock awards are made, the number of restricted shares to be awarded, the price (if any) to be paid for the restricted shares, the time or times within which awards of restricted stock may be subject to forfeiture, the vesting schedule and rights to acceleration thereof, and all other terms and conditions of restricted stock awards. Unless otherwise provided in the applicable award agreement, a participant generally will have the rights and privileges of a stockholder as to such restricted shares, including without limitation the right to vote such restricted shares and the right to receive cash dividends, if applicable.

<u>Restricted Stock Units</u>. Restricted stock units are the right to receive Shares at a future date in accordance with the terms of such grant upon the attainment of certain conditions specified by the Administrator. Restrictions or conditions could include, but are not limited to, the attainment of performance goals, continuous service with the Company or its subsidiaries, the passage of time or other restrictions or conditions. The Administrator determines the persons to whom grants of restricted stock units are made, the number of restricted stock units to be awarded, the time or times within which awards of restricted stock units may be subject to forfeiture, the vesting schedule, and rights to acceleration thereof, and all other terms and conditions of the restricted stock unit awards. The value of the restricted stock units may be paid in Shares, cash, other securities, other property, or a combination of the foregoing, as determined by the Administrator.

The holders of restricted stock units will have no voting rights. Prior to settlement or forfeiture, restricted stock units awarded under the 2026 Plan may, at the Administrator's discretion, provide for a right to dividend equivalents.

<u>Performance Awards</u>. The Administrator has the authority to grant stock options, stock appreciation rights, restricted stock, or restricted stock units as a performance award, which means that such awards vest at least in part upon the attainment of one or more specified performance criteria. For each performance period, the Administrator will have the sole authority to select the length of such performance period, the types of performance awards to be granted, the performance criteria that will be used to establish the performance goals, and the level(s) of performance which shall result in a performance award being earned. At any time, the Administrator may adjust or modify the calculation of a performance goal for a performance period to appropriately reflect any circumstance or event that occurs during a performance period and that, in the Administrator's sole discretion, warrants adjustment or modification. Depending on the type of performance award granted, the previously discussed terms and conditions will also apply to a performance award.

Performance criteria for a performance award may be based on the attainment of specific levels of our performance (and/or one or more subsidiaries, divisions, business segments or operational units, or any combination of the foregoing) and may include, without limitation, any of the following: (i) net earnings or net income (before or after taxes); (ii) basic or diluted earnings per share (before or after taxes); (iii) revenue or revenue growth (measured on a net or gross basis); (iv) gross profit or gross profit growth; (v) operating profit (before or after taxes); (vi) return measures (including, but not limited to, return on assets, capital, invested capital, equity, or sales); (vii) cash flow (including, but not limited to, operating cash flow, free cash flow, net cash provided by operations and cash flow return on capital); (viii) financing and other capital raising transactions (including, but not limited to, sales of our equity or debt securities); (ix) earnings before or after taxes, interest, depreciation and/or amortization; (x) gross or operating margins; (xi) productivity ratios; (xii) share price (including, but not limited to, growth measures and total shareholder return); (xiii) expense targets; (xiv) margins; (xv) productivity and operating efficiencies; (xvi) customer satisfaction; (xvii) customer growth; (xviii) working capital targets; (xix) measures of economic value added; (xx) inventory control; (xxi) enterprise value; (xxii) sales; (xxiii) debt levels and net debt; (xxiv) combined ratio; (xxv) timely launch of new facilities; (xxvi) client retention; (xxvii) employee retention; (xxviii) timely completion of new product rollouts; (xxix) cost targets; (xxx) reductions and savings; (xxxi) productivity and efficiencies; (xxxii) strategic partnerships or transactions; and (xxxiii) personal targets, goals or completion of projects. Any one or more of the performance criteria may be used on an absolute or relative basis to measure our performance and/or one or more subsidiaries as a whole or any business unit(s) of the Company and/or one or more subsidiaries or any combination thereof, or any of the above performance criteria may be compared to the performance of a selected group of comparison or peer companies, or a published or special index that the Administrator deems appropriate, or as compared to various stock market indices.

<u>Dividend Equivalents</u>. An award of dividend equivalents entitles the holder to be credited with an amount equal to all dividends paid on one Share while the holder's tandem award is outstanding. Dividend equivalents may be paid currently or credited to an account for the participant, settled in cash or Shares, and subject to the same restriction on transferability and forfeitability as the award with respect to which the dividend equivalents are granted.

<u>Other Stock- or Cash-Based Awards</u>. Other stock-based awards may be granted either alone, in addition to, or in tandem with, other awards granted under the 2026 Plan and/or cash awards made outside of the 2026 Plan. The Administrator shall have authority to determine the service providers to whom and the time or times at which other stock-based awards shall be made, the amount of such other stock-based awards, and all other conditions of the other stock-based awards including any dividend and/or voting rights. The Administrator may grant cash awards in such amounts and subject to such performance or other vesting criteria and terms and conditions as the Administrator may determine.

*Repricing*

Notwithstanding anything to the contrary in the 2026 Plan, unless a repricing is approved by shareholders, in no case may the Administrator (i) amend an outstanding option or stock appreciation right to reduce the exercise price of the award, (ii) cancel, exchange, or surrender an outstanding option or stock appreciation right in exchange for cash or other awards for the purpose of repricing the award, or (iii) cancel, exchange, or surrender an outstanding option or stock appreciation right in exchange for an option or stock appreciation right with an exercise price that is less than the exercise price of the original award.

*Equitable Adjustments*

In the event of a merger, consolidation, recapitalization, stock split, reverse stock split, reorganization, split-up, spin-off, combination, repurchase or other change in corporate structure affecting the Shares, the Administrator will adjust (i) the number and class of shares which may be delivered under the 2026 Plan (or number and kind of other securities or other property); (ii) the number, class and price (including the exercise or strike price of options and stock appreciation rights) of shares subject to outstanding awards, (iii) any applicable performance criteria, performance period, and other terms and conditions of outstanding performance awards, and (iv) the 2026 Plan's numerical limits.

*Change in Control*

In the event of any proposed change in control (as defined in the 2026 Plan), the Administrator will take any action as it deems appropriate, which action may include, without limitation, the following: (i) the continuation of any award, if we are the surviving corporation; (ii) the assumption of any award by the surviving corporation or its parent or subsidiary; (iii) the substitution by the surviving corporation or its parent or subsidiary of equivalent awards; (iv) accelerated vesting of the award, with all performance objectives and other vesting criteria deemed achieved at targeted levels, and a limited period during which to exercise the award prior to closing of the change in control, or (v) settlement of any award for the change in control price (less, to the extent applicable, the per share exercise price). Unless determined otherwise by the Administrator, in the event that the successor corporation refuses to assume or substitute for the award, a participant shall fully vest in and have the right to exercise the award as to all the underlying Shares, including those that would not otherwise be vested or exercisable, all applicable restrictions will lapse, and all performance objectives and other vesting criteria will be deemed achieved at targeted levels.

*Term*

The 2026 Plan will become effective when approved by our stockholders, and, unless terminated earlier, the 2026 Plan will continue in effect for a term of ten (10) years.

*Amendment and Termination*

Our Board may amend, alter, suspend, or terminate the 2026 Plan at any time. No amendment or termination of the 2026 Plan will materially impair the rights of any participant, unless mutually agreed otherwise between the participant and us. Approval of the stockholders shall be required for any amendment, where required by applicable law, as well as (i) to increase the number of Shares available for issuance under the 2026 Plan and (ii) to change the persons or class of persons eligible to receive awards under the 2026 Plan.

*Recoupment Policy*

All awards granted under the 2026 Plan, all amounts paid under the 2026 Plan, and all Shares issued under the 2026 Plan shall be subject to reduction, recoupment, clawback, or recovery by us in accordance with applicable laws and with our policy.

*Form S-8*

We intend to file with the SEC a registration statement on Form S-8 covering the Shares issuable under the 2026 Plan.

*Material United States Federal Income Tax Considerations*

The following is a general summary under current law of the material U.S. federal income tax considerations related to awards and certain transactions under the 2024 Plan and the 2026 Plan, based upon the current provisions of the Code and regulations promulgated thereunder. This summary deals with the general federal income tax principles that apply and is provided only for general information. It does not describe all federal tax consequences under the 2024 Plan and the 2026 Plan, nor does it describe state, local, or foreign income tax consequences or federal employment tax consequences. The rules governing the tax treatment of such awards are quite technical, so the following discussion of tax consequences is necessarily general in nature and is not complete. In addition, statutory provisions are subject to change, as are their interpretations, and their application may vary in individual circumstances. This summary is not intended as tax advice to participants, who should consult their own tax advisors.

Neither the 2024 Plan nor the 2026 Plan is qualified under the provisions of Section 401(a) of the Code, and neither is subject to any of the provisions of the Employee Retirement Income Security Act of 1974, as amended. Our ability to realize the benefit of any tax deductions described below depends on our generation of taxable income as well as the requirement of reasonableness and the satisfaction of our tax reporting obligations.

<u>Incentive Stock Options</u>. No taxable income is generally realized by the optionee upon the grant or exercise of an incentive stock option. If Shares issued to an optionee pursuant to the exercise of an incentive stock option are sold or transferred after two years from the date of grant and after one year from the date of exercise, then generally (i) upon sale of such Shares, any amount realized in excess of the option exercise price (the amount paid for the shares) will be taxed to the optionee as a long-term capital gain, and any loss sustained will be a long-term capital loss, and (ii) neither we nor our subsidiaries will be entitled to any deduction for federal income tax purposes; provided that such incentive stock option otherwise meets all of the technical requirements of an incentive stock option. The exercise of an incentive stock option will give rise to an item of tax preference that may result in alternative minimum tax liability for the optionee.

If the Shares acquired upon the exercise of an incentive stock option are disposed of prior to the expiration of the two-year and one-year holding periods described above (a "disqualifying disposition"), generally (i) the optionee will realize ordinary income in the year of disposition in an amount equal to the excess (if any) of the fair market value of the Shares at exercise (or, if less, the amount realized on a sale of such Shares) over the option exercise price thereof, and (ii) the Company or its subsidiaries will be entitled to deduct such amount. Special rules will apply where all or a portion of the exercise price of the incentive stock option is paid by tendering Shares.

If an incentive stock option is exercised at a time when it no longer qualifies for the tax treatment described above, the option is treated as a nonqualified option. Generally, an incentive stock option will not be eligible for the tax treatment described above if it is exercised more than three months following termination of employment (or one year in the case of termination of employment by reason of disability). In the case of termination of employment by reason of death, the three-month rule does not apply.

<u>Nonqualified Options</u>. No income is generally realized by the optionee at the time a nonqualified option is granted. Generally, (i) at exercise, ordinary income is realized by the optionee in an amount equal to the difference between the option exercise price and the fair market value of the Shares issued on the date of exercise, and the Company or its subsidiaries receive a tax deduction for the same amount, and (ii) at disposition, appreciation or depreciation after the date of exercise is treated as either short-term or long-term capital gain or loss depending on how long the Shares have been held. Special rules will apply where all or a portion of the exercise price of the nonqualified option is paid by tendering Shares. Upon exercise, the optionee will also be subject to Social Security taxes on the excess of the fair market value of the Shares over the exercise price of the option.

<u>Stock Appreciation Rights, Restricted Stock, Restricted Stock Units, Dividend Equivalent Awards and Other Stock- and Cash-Based Awards</u>. The current federal income tax consequences of other awards generally follow certain basic patterns: (i) stock appreciation rights are taxed and deductible in substantially the same manner as nonqualified options; (ii) nontransferable restricted stock subject to a substantial risk of forfeiture results in income recognition equal to the excess of the fair market value of the Shares over the price paid, if any, only at the time the restrictions lapse (unless the recipient elects to accelerate recognition as of the date of grant through a Section 83(b) election); and (iii) restricted stock units, dividend equivalents, and other stock- or cash-based awards are generally subject to tax at the time of payment. The Company or its subsidiaries generally should be entitled to a federal income tax deduction in an amount equal to the ordinary income recognized by the participant at the time the participant recognizes such income.

The participant's basis for the determination of gain or loss upon the subsequent disposition of Shares acquired from a stock appreciation right, restricted stock, restricted stock unit, dividend equivalent award, or other stock-based award will be the amount paid for such Shares plus any ordinary income recognized when the Shares were originally delivered, and the participant's capital gain holding period for those shares will begin on the day after they are transferred to the participant.

<u>Performance Awards</u>. The tax consequences of performance awards will generally mirror those of the underlying award type, each of which is discussed above.

<u>Parachute Payments</u>. The vesting of any portion of an award that is accelerated due to the occurrence of a change in control (such as a sale event) may cause all or a portion of the payments with respect to such accelerated awards to be treated as "parachute payments" as defined in the Code. Any such parachute payments may be non-deductible to either the Company or its subsidiaries, in whole or in part, and may subject the recipient to a non-deductible 20% federal excise tax on all or a portion of such payment (in addition to other taxes ordinarily payable).

<u>Section 409A</u>. The foregoing description assumes that Section 409A of the Code does not apply to an award under the 2024 Plan or the 2026 Plan. In general, stock options and stock appreciation rights are exempt from Section 409A if the exercise price per share is at least equal to the fair market value per share of the underlying stock at the time the option or stock appreciation right was granted. Restricted stock awards are not generally subject to Section 409A. Restricted stock units are subject to Section 409A unless they are settled within two and one-half months after the end of the later of (1) the end of our fiscal year in which vesting occurs or (2) the end of the calendar year in which vesting occurs. If an award is subject to Section 409A and the provisions for the exercise or settlement of that award do not comply with Section 409A, then the participant would be required to recognize ordinary income whenever a portion of the award vested (regardless of whether it had been exercised or settled). This amount would also be subject to a 20% federal tax and premium interest in addition to the federal income tax at the participant's usual marginal rate for ordinary income.

**Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information**

We currently grant equity awards to our employees at the discretion of the board of directors. We do not have a written policy regarding the timing of the grant of equity awards, but we do not grant equity awards in anticipation of the release of material nonpublic information, nor do we time the release of material nonpublic information based on equity award grant dates.

**Director Compensation**

Other than as set forth in the table above relating to their capacity as officers, our board members did not pay any compensation, reimburse any expense of, make any equity awards or non-equity awards to, or pay any other compensation to, any of the other non-employee members of the Board in the fiscal year ended December 31, 2025.

**PRINCIPAL STOCKHOLDERS**

The following table sets forth certain information concerning the ownership of our common stock as of the date of this prospectus, with respect to: (i) each person, or group of affiliated persons, known to us to be the beneficial owner of 5% or more of our common stock; (ii) each of our directors; (iii) each of our named executive officers; and (iv) all of our current directors and executive officers as a group.

Applicable percentage ownership is based on 13,516,632 shares of our common stock outstanding as of the date of this prospectus, which includes 7,803,987 shares of common stock being issued upon the closing of this offering in connection with the conversion of: (i) 1,302,950 shares of our existing Series A Preferred Stock into 1,302,950 shares of common stock (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00), and (ii) $12,499,157, of our existing Series A Secured Convertible Notes and A-1 Secured Convertible Notes into 6,501,037 shares of our common stock as of the date of this prospectus (assuming an initial public offering price of at least $10.00 and an assumed conversion price of $10.00). In addition, the number of shares and percentage of beneficial ownership after the offering assumes the sale and gives effect to the issuance by us of shares of common stock in this offering and assuming an initial public offering price of $ per share (the mid-point of the price range set forth on the cover page of this prospectus). The percentage ownership information assumes no exercise of the underwriters of their' over-allotment option to purchase additional shares of common stock.

We have determined beneficial ownership in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting or investment power with respect to such securities. In addition, pursuant to such rules, we deemed outstanding shares of common stock subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days of the date of this prospectus. We did not deem such shares outstanding, however, for the purpose of computing the percentage ownership of any other person. Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the beneficial owners named in the table below have sole voting and investment power with respect to all shares of our common stock that they beneficially own, subject to applicable community property laws.

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| | | | | |
|:---|:---|:---|:---|:---|
| | **Shares of common stock<br> Beneficially Owned Prior to<br> Offering** | **Shares of common stock<br> Beneficially Owned Prior to<br> Offering** | **Shares of common stock<br> Beneficially Owned After<br> Offering** | **Shares of common stock<br> Beneficially Owned After<br> Offering** |
| <br>**Name and Address of Beneficial Owner <sup>(1)</sup>** | **Number<sup>(7) (8)</sup>** | **Percentage <sup>(2)</sup>** | **Number** | **Percentage <sup>(3)</sup>** |
| **Executive Officers and Directors** |  |  |  |  |
| Steve Chartier | 110530 | 0.82% |  | \* |
| Ori Ben-Yehuda | 110000 | 0.81% |  | \* |
| David Richmond | 4119644<sup>(4)</sup> | 30.48% |  | [●]% |
| Mark Ravich | 1015018<sup>(6)</sup> | 7.51% |  | [●]% |
| Rishi Puri |  |  |  |  |
| William T. Abraham |  |  |  |  |
| **All directors and executive officers as a group (6 individuals)** | 5355191 | 39.62% |  |  |
| **5% or Greater Stockholders** |  |  |  |  |
| Michael Taglich | 1128499<sup>(5)</sup> | 8.35% |  | [●]% |

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\* Less than 1%.

(1) Except
 as otherwise indicated, the business address of our directors and executive officers is 120 Forbes Blvd., Suite 125, Mansfield, MA
 02048.

(2) Based
 on 13,516,632 shares of common stock outstanding as of the date of this prospectus.

(3) Based
 on [●] shares of common stock outstanding immediately after this offering assuming no exercise of the underwriters'
 over-allotment option.

(4) Includes
 (a) 194,000 shares of common stock directly held by Mr. Richmond (including 25,665 shares of common stock from Second RSA Grant 2024
 and 18,335 shares of common stock from Second RSA Grant 2025), (b) 2,524,268 shares of common stock, comprised of 148,400 Series
 A shares convertible into common stock and $2,396,926 Secured Convertible Notes held by RBI BioVentrix LLC convertible into
 2,396,926 shares of common stock, (c) 461,223 shares of common stock comprised of 385,832 shares of common stock and 75,391
 Series A shares convertible into common stock held by RBI Opportunities Fund LLC, (d) 355,595 shares of common stock comprised of
 311,668 shares of common stock and 43,927 Series A shares convertible into common stock held by RBI BV Private Investment, (e) 277,590
 common shares comprised of 226,025 shares of common stock and 51,565 Series A shares convertible into common stock held by RBI Private
 Investment III LLC, (f) 255,740 shares, comprised of 215,077 shares of common stock and 40,663 Series A shares convertible into common
 stock held by RBI Opportunities Fund II LLC, (g) 11,199 shares comprised of 8,300 shares of common stock and 2,899 Series A shares
 convertible into common stock held by David Richmond & Stephanie Richmond, (h) 9,486 shares comprised of 8,123 shares of common
 stock and 1,363 Series A shares convertible into common stock held by RBI Private Investment I LLC, and (i) 9,485 shares, comprised
 of 8,123 shares of common stock and 1,362 Series A shares convertible into common stock held by Richmond Brothers Inc. Mr. Richmond
 is the Manager and has voting and investment control of RBI BioVentrix LLC, RBI Opportunities Fund LLC, RBI BioVentrix, LLC, RBI
 BV Private Investment, RBI Private Investment III LLC, RBI Opportunities Fund II LLC, David Richmond & Stephanie Richmond, RBI
 Private Investment I LLC, and Richmond Brothers Inc, (collectively, the "Richmond Entities"). Mr. Richmond disclaims
 any beneficial ownership of the securities held by the Richmond Entities, other than to the extent of any pecuniary interest he may
 have therein, directly or indirectly.

(5) Includes
 (a) 119,902 shares of common stock directly held by Mr. Taglich, (b) 103,654 shares of common stock held by Taglich
 Brothers Inc., (c) 84,408 shares of common stock held by Michael N. Taglich & Claudia Taglich, (d) 177 shares of common stock
 held by Claudia Ruggiero Taglich, (e) 3,179 shares of common stock held by Michael Taglich C/F Amanda Taglich UTMA NY, (f) 3,179
 shares of common stock held by Michael Taglich C/F Lucy Taglich UTMA NY, (g) 3,179 shares of common stock held by Michael Taglich
 C/F Stella Taglich UTMA NY, (h) 130,142 shares of common stock held by Michael N. Taglich Keogh Account, (i) 3,179 shares of common
 stock held by Michael Taglich TTEE Hope A Taglich Supplemental Needs Trust UAD 8/23/17, and (j) 677,500 Series A shares convertible
 into common stock held by Bioventrix investors LLC. Mr. Taglich is the President of Taglich Brothers Inc., Michael N. Taglich Keogh
 Account, Michael Taglich TTEE Hope A Taglich Supplemental Needs Trust UAD 8/23/17, and Bioventrix investors LLC and has voting and
 investment control over the shares held by Michael N. Taglich & Claudia Taglich, Claudia Ruggiero Taglich, Michael Taglich C/F
 Amanda Taglich UTMA NY, Michael Taglich C/F Lucy Taglich UTMA NY, and Michael Taglich C/F Stella Taglich UTMA NY (collectively, the
 "Taglich Entities"). Mr. Taglich disclaims any beneficial ownership of the securities held by the Taglich Entities, other
 than to the extent of any pecuniary interest he may have therein, directly or indirectly.

(6) Includes
 (a) 165,000 common shares directly held by Mr. Ravich (including 57,750 common shares from Second RSA Grant 2024 and 41,250 common
 shares from Second RSA Grant 2025), (b) 10,000 common shares comprised of 10,000 Series A shares held by Mark Ravich Irrevocable
 Trust, (c) 228,954 common shares comprised of 79,880 Series A shares, $133,042 Secured Convertible Notes, and $16,032
 Series A-1 Secured Convertible Notes held by Mark Ravich Revocable Trust, (d) 372,406 common shares comprised of 93,590 common
 shares, 10,000 Series A shares, and $268,816 Secured Convertible Notes held by Mark Ravich TTEE Mark Ravich Irrevocable Trust
 UAD 11/05/18, (e) 87,938 common shares held by Mark H. Ravich TTEE Revocable Trust of Mark H. Ravich UAD 10/08/19, (f) 71,255
 common shares comprised of 5,000 Series A shares and $66,255 Secured Convertible Notes held by Norman and Sally Ravich Family
 Trust, (g) 40,261 common shares held by Mark Ravich TTEE Cindy Libman Irrevocable Trust UAD 11/05/18, (h) 17,482 common shares held
 by Mark H. Ravich TTEE Norman & Sally Ravich Family Trust UAD 12/24/92, (i) 8,123 common shares held by Alexander Coleman Ravich
 1991 Irrevocable Trust, (j) 8,123 common shares held by Alyssa Danielle Ravich 1991 Irrevocable Trust, and (k) 5,475 common shares
 held by Ilyne Ravich. Mr. Ravich is the Trustee and has voting and investment control of Mark Ravich Irrevocable Trust, Revocable
 Trust of Mark Ravich, Mark Ravich TTEE Mark Ravich Irrevocable Trust UAD 11/05/18, Mark H. Ravich TTEE Revocable Trust of Mark H.
 Ravich UAD 10/08/19, Norman and Sally Ravich Family Trust, Mark Ravich TTEE Cindy Libman Irrevocable Trust UAD 11/05/18, Mark H.
 Ravich TTEE Norman & Sally Ravich Family Trust UAD 12/24/92, Alexander Coleman Ravich 1991 Irrevocable Trust, and Alyssa Danielle
 Ravich 1991 Irrevocable Trust (collectively, the "Ravich Entities"). Mr. Ravich disclaims any beneficial ownership of
 the securities held by the Ravich Entities, other than to the extent of any pecuniary interest he may have therein, directly or indirectly.

(7) For
 note conversions into shares assumes that interest accrues through November 30, 2025 on the
 March 2024 Through August 2024 Series A Secured Convertible Note Financing and the October
 2024 Through September 2025 Series A-1 Secured Convertible Note Financing.

(8) The
 Secured Convertible Notes convert into our common stock subject to an initial public offering
 generating $7.5 million of gross proceeds. We have assumed the initial public offering price
 is at least $10.00 per share, generating gross proceeds of $[ ]. Each
 $1.00 decrease in the assumed initial public offering price of $ per share (the midpoint of the estimated price range set forth on the cover page of this
 prospectus) below $10.00 per share would increase the number of shares issued upon
 the conversion by approximately $, assuming the
 number of shares, as set forth on the cover page of this prospectus, remains the same and
 after deducting underwriting discounts and estimated offering expenses payable by us.

**CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS**

During the period from January 1, 2023 to the date of this prospectus, we have entered into or participated in the following transactions with related persons:

On January 2, 2026, the Company granted 90,000 restricted stock awards to the three independent members of the Company's board of directors, valued at $1.14 per share, of which 3,750 will vest each month through December 2027.

On October 1, 2025, the Company granted 422,500 stock options at an exercise price of $1.14 per share. The options vest 105,625 after one year and, thereafter, 8,802 of the option shares shall vest at the end of each full month over thirty-six (36) consecutive months. Certain of the Company's executive officers and members of the board were granted 265,000 of the 422,500 stock options granted.

On January 15, 2025, Mr. Chartier, our Co-Chief Executive Officer and President, was granted 220,000 stock options at an exercise price of $1.00 per share. The option shares vest 55,000 after one year and, thereafter, 4,583 of the option shares shall vest at the end of each full month over thirty-six (36) consecutive months.

On January 1, 2025, Mr. Richmond, our Co-Chief Executive Officer and Chief Financial Officer was granted 191,000 stock options at an exercise price of $1.00 per share. The option shares vest 47,750 after one year and, thereafter, 3,979 of the option shares shall vest at the end of each full month over thirty-six (36) consecutive months.

In March 2024, officers and directors received 348,000 shares of restricted stock awards, 232,000 shares valued at $0.80 per share vested immediately.

In March 2024, Mr. Richmond, our Co-Chief Executive Officer and Chief Financial Officer and entities controlled by him purchased $1,830,000 Series A Secured Convertible Notes from us.

In February 2024, Mr. Taglich and Mr. Richmond and entities controlled by them purchased 650,000 Preferred Series A shares from other investors Mr. Taglich and Mr. Richmond subsequently sold 195,780 of these shares to us at cost to be used as incentive for certain purchasers of Series A Secured Convertible Notes (the "Sweetener Shares"). We acquired an additional 30,120 Preferred Series A shares from Mr. Mark Ravich for a total of 225,900 Sweetener Shares.

On March 20, 2023, we entered into a Voting Agreement with holders of the Series A Preferred Stock. According to its terms, the Voting Agreement will terminate upon the closing of this offering.

In March 2022, we entered into a placement agent agreement with Taglich Brothers, Inc. ("Taglich Brothers"), when Michael Taglich was a director at BioVentrix. Under the agreement, Taglich Brothers, where Michael Taglich is an owner, acted as the exclusive placement agent on a best-efforts basis for our Series B Preferred Stock financing, and was contracted to receive a 7% cash fee on new cash investments and warrants equal to 10% of the underlying shares of common stock issuable upon conversion. Pursuant to this placement agent agreement, Taglich Brothers received $1,320,053 in Series B Preferred Stock in 2023 which subsequently converted to 587 shares of common in the February 2023 recapitalization. See "*Description of Capital Stock — History of Securities Issuances — February 2023 Recapitalization*."

**Policies and Procedures with Respect to Related Party Transactions**

Pursuant to the audit committee charter to be adopted upon closing of this offering, our audit committee will be responsible for reviewing and approving transactions with related persons. A related person includes directors, executive officers, beneficial owners of 5% or more of any class of our voting securities, immediate family members of any of the foregoing persons, and any entities in which any of the foregoing is an executive officer or is an owner of 5% or more ownership interest.

If a transaction involving an amount in excess of $120,000 has been identified as a related person transaction, including any transaction that was not a related person transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to consummation, information regarding the related person transaction will be reviewed by our audit committee, which will determine whether to approve the transaction.

In considering related person transactions, our audit committee will take into account the relevant available facts and circumstances including, but not limited to:

● the related person's interest in the related person transaction;

● the approximate dollar value of the amount involved in the related person transaction;

● the approximate dollar value of the amount of the related person's interest in the transaction without regard to the amount of any profit or loss;

● whether the transaction was undertaken in our ordinary course of business;

● whether the transaction with the related person is proposed to be, or was, entered into on terms no less favorable to us than terms that could have been reached with an unrelated third party;

● the purpose of, and the potential benefits to us of, the transaction; and

● any other information regarding the related person transaction or the related person in the context of the proposed transaction that would be material to investors in light of the circumstances of the particular transaction.

In determining whether to approve, ratify or reject a related person transaction, the audit committee will review all relevant information available to it about such transaction, and it will approve or ratify the related person transaction only if it determines that, under all of the circumstances, the transaction is in, or is not inconsistent with, our best interests.

**Indemnification of Officers and Directors**

Our Amended and Restated COI contains provisions to indemnify the directors, officers, employees or other agents to the fullest extent permitted by the Delaware General Corporation Law. These provisions may have the practical effect in certain cases of eliminating the ability of stockholders to collect monetary damages from directors. We are also a party to indemnification agreements with each of our directors and executive officers. We believe that these provisions will assist us in attracting or retaining qualified individuals to serve as our directors and executive officers.

**DESCRIPTION OF CAPITAL STOCK**

The following summary of the capital stock and our Amended and Restated COI and Amended and Restated Bylaws (each to be in effect as of the effectiveness of the registration statement of which this prospectus forms a part) does not purport to be complete and is qualified in its entirety by reference to the provisions of applicable law and such documents, which are filed as exhibits to the registration statement of which this prospectus is a part.

**Common Stock**

*Voting Rights.* Holders of shares of common stock are entitled to one vote per share held of record on all matters to be voted upon by the stockholders. Holders of shares of common stock have no cumulative voting rights.

*Quorum*. Our Amended and Restated Bylaws provide that the holders of not less than one third (33 1/3 percent) of the outstanding shares of common stock entitled to vote constitutes a quorum. In the absence of a quorum, any meeting of stockholders may be adjourned, from time to time, either by the chairman of the meeting or by vote of the holders of a majority of the shares represented thereat, but no other business shall be transacted at such meeting. Where a separate vote by a class or classes or series is required, except where otherwise provided by the statute or by our Amended and Restated COI or our Amended and Restated Bylaws, one-third (33 1/3 percent) of the outstanding shares of such class or classes or series, present in person or represented by proxy, shall constitute a quorum entitled to take action with respect to that vote on that matter and, except where otherwise provided by the statute or by our Amended and Restated COI or our Amended and Restated Bylaws, the affirmative vote of the majority (plurality, in the case of the election of directors) of the votes cast, including abstentions, by the holders of shares of such class or classes or series shall be the act of such class or classes or series.

*Dividend Rights.* Holders of shares of common stock are entitled to ratably receive dividends when and if declared by the board of directors out of funds legally available for that purpose, subject to the provisions of our Amended and Restated COI or our Amended and Restated Bylaws, any statutory or contractual restrictions on the payment of dividends, and any prior rights and preferences that may be applicable to any outstanding preferred stock.

*Liquidation Rights.* Upon liquidation, dissolution, distribution of assets or other winding up, the holders of common stock are entitled to receive ratably the assets available for distribution to the stockholders after payment of liabilities and the liquidation preference of any of our outstanding shares of preferred stock.

*Other Matters.* The shares of common stock have no preemptive or preferential right to acquire any of our shares or securities, including shares or securities held in our treasury. All outstanding shares of our common stock are fully paid and non-assessable.

**Preferred Stock**

Our Amended and Restated COI gives the board of directors the power to issue shares of preferred stock in one or more series without stockholder approval. The board of directors has the discretion to determine the designations, rights, qualifications, preferences, privileges, and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. The purpose of authorizing the board of directors to issue preferred stock and determine its rights and preferences is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from acquiring, a majority of our outstanding voting stock.

**Stock Options**

As of the date of this prospectus, we had reserved the following shares of common stock for issuance pursuant to stock options under the 2024 Equity Incentive Plan:

● 950,500 shares of our common stock reserved for issuance under stock option agreements issued pursuant to the 2024 Equity Incentive Plan with a weighted average exercise price of $1.00 per share; and

● 549,500 shares of our common stock reserved for future issuance under the 2026 Equity Incentive Plan (which is equal to % of our issued and outstanding common stock immediately after the consummation of this offering, less the number of outstanding option grants).

**Transfer Agent and Registrar**

The transfer agent and registrar of our common stock is Issuer Direct Corporation.

**Underwriters' Warrants**

We have agreed to issue the Underwriters' Warrants to the underwriters of this offering as a portion of the underwriting compensation payable in connection with this offering. The Underwriters' Warrant shall be exercisable for shares of our common stock (or 5% of the shares of common stock sold in this offering, including any shares of common stock sold pursuant to the exercise of the underwriters' over-allotment option). The Underwriters' Warrants shall contain customary "cashless exercise" provisions and shall be exercisable at any time, and from time to time, in whole or in part, from the first day of the seventh month after the closing of this offering to the date that is five years from the date of commencement of sales in this offering at an exercise price equal to the initial public offering price of the shares of common stock. Please see "*Underwriting — Underwriters' Warrants*" for further information.

**Lock-Up Agreements**

Pursuant to certain "lock-up" agreements, our executive officers, directors and our existing stockholders have agreed, subject to certain exceptions, not to offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of or announce the intention to otherwise dispose of, or enter into any swap, hedge or similar agreement or arrangement that transfers, in whole or in part, the economic risk of ownership of, directly or indirectly, engage in any short selling of any common stock or securities convertible into or exchangeable or exercisable for any common stock, whether currently owned or subsequently acquired, without the prior written consent of the representative of the underwriters, for a period of six (6) months following the closing of this offering.

In addition, we have agreed, subject to certain exceptions, not to offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of or announce the intention to otherwise dispose of, or enter into any swap, hedge or similar agreement or arrangement that transfers, in whole or in part, the economic risk of ownership of, directly or indirectly, engage in any short selling of any common stock or securities convertible into or exchangeable or exercisable for any common stock, whether currently owned or subsequently acquired, without the prior written consent of the representative of the underwriters, for a period of six (6) months following the closing of this offering.

**Delaware Law and Certain Charter and Bylaw Provisions**

Our Charter and Bylaws and the DGCL contain provisions, which are summarized in the following paragraphs, that are intended to enhance the likelihood of continuity and stability in the composition of our board of directors. These provisions are intended to avoid costly takeover battles, reduce our vulnerability to a hostile or abusive change of control and enhance the ability of our board of directors to maximize stockholder value in connection with any unsolicited offer to acquire us. However, these provisions may have an anti-takeover effect and may delay, deter or prevent a merger or acquisition of the Company by means of a tender offer, a proxy contest or other takeover attempt that a stockholder might consider in its best interest, including those attempts that might result in a premium over the prevailing market price for the shares of Common Stock held by stockholders.

*Authorized but Unissued Capital Stock* 

Delaware law does not require stockholder approval for any issuance of shares that are authorized and available for issuance. However, the listing requirements of the Nasdaq, which would apply so long as our Common Stock remains listed on the Nasdaq, require stockholder approval of certain issuances equal to or exceeding 20% of the then outstanding voting power of our capital stock or then outstanding number of shares of Common Stock. These additional shares may be used for a variety of corporate purposes, including future public offerings, to raise additional capital or to facilitate acquisitions.

Our board of directors may generally issue shares of one or more series of preferred stock on terms calculated to discourage, delay or prevent a change of control of the Company or the removal of our management. Moreover, our authorized but unissued shares of preferred stock will be available for future issuances in one or more series without stockholder approval and could be utilized for a variety of corporate purposes, including future offerings to raise additional capital, to facilitate acquisitions and employee benefit plans.

One of the effects of the existence of authorized and unissued and unreserved Common Stock or preferred stock may be to enable our board of directors to issue shares to persons friendly to current management, which issuance could render more difficult or discourage an attempt to obtain control of our company by means of a merger, tender offer, proxy contest or otherwise, and thereby protect the continuity of our management and possibly deprive our stockholders of opportunities to sell their shares of Common Stock at prices higher than prevailing market prices.

*Delaware Law* 

We will not be subject to the provisions of Section 203 of the DGCL, regulating corporate takeovers. In general, those provisions prohibit a Delaware corporation, including those whose securities are listed for trading on the Nasdaq, from engaging in any business combination with any interested stockholder for a period of three years following the date that the stockholder became an interested stockholder, unless:

● the transaction is approved by the board of directors before the date the interested stockholder attained that status;

● upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced; or

● on or after such time the business combination is approved by the board of directors and authorized at a meeting of stockholders by at least two-thirds of the outstanding voting stock that is not owned by the interested stockholder.

*Removal of Directors; Vacancies and Newly Created Directorships* 

Under the DGCL, directors may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors. In addition, under the DGCL, subject to the rights granted to one or more series of preferred stock then outstanding, any vacancies on our board of directors, and any newly created directorships, will be filled only by the affirmative vote of a majority of the directors then in office, even if less than a quorum, by a sole remaining director or by the stockholders.

*No Cumulative Voting* 

Under Delaware law, the right to vote cumulatively does not exist unless the certificate of incorporation specifically authorizes cumulative voting. Our Charter does not authorize cumulative voting. Therefore, stockholders holding a majority in voting power of the shares of our stock entitled to vote generally in the election of directors will be able to elect all our directors.

*Special Stockholder Meetings* 

Our Bylaws provide that special meetings of our stockholders may be called at any time only by or at the direction of the board of directors. Our Bylaws prohibit the conduct of any business at a special meeting other than as specified in the notice for such meeting. These provisions may have the effect of deterring, delaying or discouraging hostile takeovers, or changes in control or management of the Company.

*Director Nominations and Stockholder Proposals* 

Our Bylaws establish advance notice procedures with respect to stockholder proposals. In order for any matter to be "properly brought" before a meeting, a stockholder will have to comply with advance notice requirements and provide us with certain information. For a stockholder's proposal to be timely, a stockholder's notice , must be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the 90th day nor earlier than the opening of business on the 120th day before the anniversary date of the immediately preceding annual meeting of stockholders; provided, however, that in the event that the annual meeting is more than 30 days before or more than 60 days after such anniversary date (or if there has been no prior annual meeting), notice by the stockholder to be timely must be so delivered not earlier than the close of business on the 120th day before the meeting and not later than the later of (x) the close of business on the 90th day before the meeting or (y) the close of business on the 10th day following the day on which public announcement of the date of the annual meeting is first made by the Corporation. Our Bylaws also specify requirements as to the form and content of a stockholder's notice.

Our Bylaws also establish advance notice procedures with respect to the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of the board of directors. To be timely, a stockholder's notice to the Secretary must be received by the Secretary at the principal executive offices of the Corporation (i) in the case of an annual meeting, not later than the close of business on the 90th day nor earlier than the close of business on the 120th day before the anniversary date of the immediately preceding annual meeting of stockholders; provided, however, that in the event that the annual meeting is more than 30 days before or more than 60 days after such anniversary date (or if there has been no prior annual meeting), notice by the stockholder to be timely must be so received not earlier than the close of business on the 120th day before the meeting and not later than the later of (x) the close of business on the 90th day before the meeting or (y) the close of business on the 10th day following the day on which public announcement of the date of the annual meeting was first made by the Corporation; and (ii) in the case of a special meeting of stockholders called for the purpose of electing directors, not later than the close of business on the 10th day following the day on which public announcement of the date of the special meeting is first made by the Corporation. In no event shall the public announcement of an adjournment or postponement of an annual meeting or special meeting commence a new time period (or extend any time period) for the giving of a stockholder's notice. Our Bylaws also specify requirements as to the form and content of a stockholder's notice.

*Stockholder Action by Written Consent* 

Pursuant to Section 228 of the DGCL, any action required to be taken at any annual or special meeting of the stockholders may be taken without a meeting, without prior notice and without a vote if a consent or consents in writing, setting forth the action so taken, is or are signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares of our stock entitled to vote thereon were present and voted. Pursuant to our Bylaws, any action required to be taken at any annual or special meeting of stockholders, or any action which may be taken at any annual or special meeting of such stockholders, may be taken without a meeting, without prior notice and without a vote, if a consent in writing, setting forth the action so taken, shall be signed by the holders of outstanding stock entitled to vote thereon having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted, and shall be delivered to the Corporation by delivery to its registered office in the State of Delaware, its principal place of business, or an officer or agent of the Corporation having custody of the book in which proceedings of meetings of stockholders are recorded.

**Elimination of Monetary Liability for Officers and Directors**

Our Amended and Restated COI incorporates certain provisions permitted under the Delaware General Corporation Law relating to the liability of directors. The provisions eliminate a director's liability for monetary damages for a breach of fiduciary duty, including gross negligence, except in circumstances involving certain wrongful acts, such as the breach of director's duty of loyalty or acts or omissions, which involve intentional misconduct or a knowing violation of law. These provisions do not eliminate a director's duty of care. Moreover, these provisions do not apply to claims against a director for certain violations of law, including knowing violations of federal securities law. Our Amended and Restated COI also contains provisions to indemnify the directors, officers, employees or other agents to the fullest extent permitted by the Delaware General Corporation Law. We believe that these provisions will assist us in attracting and retaining qualified individual to serve as directors.

**Indemnification of Officers and Directors**

Our Amended and Restated COI contains provisions to indemnify the directors, officers, employees or other agents to the fullest extent permitted by the Delaware General Corporation Law. These provisions may have the practical effect in certain cases of eliminating the ability of stockholders to collect monetary damages from directors. We are also a party to indemnification agreements with each of our directors and officers. We believe that these provisions will assist us in attracting or retaining qualified individuals to serve as our directors and officers.

**Disclosure of Commission Position on Indemnification for Securities Act Liabilities**

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

**Listing**

We have applied to have our common stock listed on Nasdaq under the symbol "BVXX".

**History of Securities Issuances**

During the past three years, we issued securities that were not registered under the Securities Act as set forth below. The following is a summary of transactions from our inception until the date of this prospectus involving issuance of our securities that were not registered under the Securities Act. The offers, sales and issuances of the securities described below were exempt from registration either (i) under Section 4(a)(2) of the Securities Act and the rules and regulations promulgated thereunder in that the transactions were between an issuer and sophisticated investors, initial purchasers or members of the issuer's senior executive management and did not involve any public offering within the meaning of Section 4(a)(2), (ii) under Regulation S promulgated under the Securities Act in that offers, sales and issuances were not made to persons in the United States and no directed selling efforts were made in the United States, (iii) under Rule 144A under the Securities Act in that the securities were offered and sold by the initial purchasers to persons reasonably believed to be qualified institutional buyers, and/or (iv) under Rule 701 promulgated under the Securities Act in that the transactions were under compensatory benefit plans and contracts relating to compensation.

*April 2022 Through August 2022 Series B Preferred Stock Financing*

From April 2022 through August 2022, we issued $10,000,000 of Series B Preferred Stock to accredited investors. As noted below, such Series B Preferred Stock were later converted into common stock pursuant to the February 2023 recapitalization.

*January 2023 Unsecured Convertible Note Financing*

In January 2023, we issued $3,000,000 in principal amount of its unsecured convertible promissory notes (the "Unsecured Convertible Notes") to accredited investors which $3,000,000 principal amount included the exchange of $1,000,000 in principal amount of its then outstanding unsecured short-term promissory notes for $1,000,000 in principal amount of Unsecured Convertible Notes. The Unsecured Convertible Notes accrue interest at an annual rate of 10%, had a maturity date of June 30, 2023, and the principal amount automatically converts into the type of securities issued by us in a subsequent equity financing of at least $10,000,000 in gross proceeds at the price per share paid by investors in the equity financing. A cash fee of 1.5% of the principal amount of the Unsecured Convertible Note is also due on the earlier of the conversion of the Unsecured Convertible Note or the maturity date of the Unsecured Convertible Note. On March 21, 2023, we issued an additional Unsecured Convertible Note in the principal amount of $2,650,000. The aggregate outstanding amount of $5,650,000 was later converted into 565,000 shares of Series A Preferred Stock in the March 2023 Series A Preferred Stock Financing.

*February 2023 Recapitalization*

In February 2023, we completed a recapitalization pursuant to which all of the Company's then outstanding Common Stock, Series A Preferred Stock, Series A-1 Preferred Stock, Series B Preferred Stock were exchanged for new shares of Common Stock of the Company, and all of the Company's outstanding Common Stock then underwent a reverse Common Stock split of 1 share of Common Stock share for each 65,500 shares of Common Stock with any fractional shares of Common Stock existing immediately after the reverse Common Stock split being purchased in cash by the Company at fair value. Additionally, substantially all of the Company's then outstanding stock options and warrants were exchanged for Common Stock.

*March 2023 Series A Preferred Stock Financing*

On March 30, 2023, we consummated a Series A Preferred Stock financing (the "March 2023 Series A Preferred Stock Financing") pursuant to which we issued $15,650,000 of newly authorized Series A Preferred Stock (which amount included the conversion of the $5,650,000 in principal amount of our then outstanding Unsecured Convertible Notes) to accredited investors at the initial closing with the potential for issuance of up to $32,850,000 in additional Series A Preferred Stock in subsequent closings if certain milestones were achieved by us on or before September 30, 2023. Such milestones were not achieved by us. In connection with the March 2023 Series A Preferred Stock Financing, we amended and restated our then existing Second Amended and Restated Certificate of Incorporation to read as set forth in its Third Amended and Restated Certificate of Incorporation which amended and restated certificate provided for an immediate forward Common Stock split of 176.582 shares of Common Stock for each 1 share of outstanding Common Stock and set forth the rights, preferences, and privileges of the newly authorized Series A Preferred Stock. Additionally, as part of the March 2023 Series A Preferred Stock Financing, we entered into an Investors' Rights Agreement, a Right of First Refusal and Co-Sale Agreement, and a Voting Agreement with the holders of our Series A Preferred Stock and certain holders of our Common Stock. The Right of First Refusal and Co-Sale Agreement and the Voting Agreement automatically terminate immediately prior to the closing of this offering. Subsequent to the closing of the March 2023 Series A Preferred Stock Financing, we filed two amendments to its Third Amended and Restated Certificate of Incorporation which amendments amended, reduced or eliminated several rights of the Series A Preferred Stock, increased the authorized amount of Common Stock and Preferred Stock, and designated some of the authorized Preferred Stock as Blank Check Preferred Stock. Upon the closing of this offering (assuming gross proceeds of $7,500,000 to us in this offering), the Series A Preferred Stock is subject to mandatory conversion such that each outstanding share of Series A Preferred Stock will automatically convert into shares of Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate as calculated pursuant to <u>Section 5</u> of the Third Amended and Restated Certificate of Incorporation, as amended or (B) the original issue price of the Series A Preferred Stock divided by the price per share of the Common Stock issued in this offering.

*March 2024 Through August 2024 Series A Secured Convertible Note Financing*

From March 2024 through August 2024, we issued $3,000,000 in principal amount of secured convertible promissory notes (the "Series A Secured Convertible Notes") to accredited investors the repayment of which is secured by a grant of security interest in all of our assets. We also issued shares of our Series A Preferred Stock to those purchasers that had purchased at least $50,000 in principal amount of the Secured Convertible Notes on or before March 21, 2024 (the "Series A Sweetener Shares"). As part of the Series A Secured Convertible Note financing, we repurchased from certain holders of Series A Preferred Stock the same amount of Series A Preferred Stock shares as the amount of Series A Sweetener Shares that were issued to certain purchasers of the Series A Secured Convertible Notes. The Series A Secured Convertible Notes accrue interest at the annual rate of 15% compounded quarterly and have a maturity date of December 31, 2027. The Series A Secured Convertible Notes will automatically convert into shares of our Series A Preferred Stock immediately prior to the closing of this offering (assuming gross proceeds of $7,500,000 to us in this offering), which Series A Preferred Stock is then subject to immediate mandatory conversion into Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate as calculated pursuant to <u>Section 5</u> of the Third Amended and Restated Certificate of Incorporation, as amended or (B) the original issue price of the Series A Preferred Stock divided by the price per share of the Common Stock issued in this offering. Therefore, if the offering price is $10.00/share or greater, each share of Series A Preferred Stock will convert into one share of Common Stock. If the offering price is less than $10.00/share, then each share of Series A Preferred Stock will convert into the number of shares of Common Stock as calculated by dividing $10.00 by the offering price. For example, if the offering price is $8.00, then each share of Series A Preferred Stock will get $10.00 divided by $8.00 (1.25000) shares of Common Stock.

*October 2024 Through January 2026 Series A-1 Secured Convertible Note Financing*

From October 2024 through January 2026, we issued $7,575,000 in principal amount of secured convertible promissory notes (the "Series A-1 Secured Convertible Notes") to accredited investors the repayment of which is secured by a grant of security interest in all of our assets which security interest is pari passu to the security interest granted to the Secured Convertible Note holders. The Series A-1 Secured Convertible Notes accrue interest at the annual rate of 15% compounded quarterly and have a maturity date of December 31, 2027. As part of the Series A-1 Secured Convertible Note financing, we filed a Certificate of Designations of the Rights, Preferences and Privileges of Series A-1 Preferred Stock which designated a new Series A-1 Preferred Stock from its authorized Blank Check Preferred Stock. The Series A-1 Secured Convertible Notes automatically convert into shares of Series A-1 Preferred Stock at the conversion price of $3.33 per share immediately prior to the closing of this Offering (assuming gross proceeds of $7,500,000 to us in this offering), which shares of Series A-1 Preferred Stock are then subject to immediate mandatory conversion into Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate as calculated pursuant to Section 4.1.1 of the Certificate of Designations of Rights, Preferences and Privileges of Series A-1 Preferred Stock or (B) three times (3x) the original issue price of the Series A-1 Preferred Stock divided by the price per share of the Common Stock issued in this offering. Therefore, if the offering price is $10.00/share or greater, each share of Series A-1 Preferred Stock will convert into one share of Common Stock. If the offering price is less than $10.00/share, then each share of Series A-1 Preferred Stock will convert into the number of shares of Common Stock as calculated by dividing $9.99 by the offering price. For example, if the offering price is $8.00, then each share of Series A-1 Preferred Stock will get $9.99 divided by $8.00 (1.24875) shares of Common Stock.

**Investors' Rights Agreement** 

We are party to an Investors' Rights Agreement (the "Investors' Rights Agreement"), dated March 30, 2023, with certain holders of our capital stock. Under our Investors' Rights Agreement, certain holders of our capital stock have the right to demand that we file a registration statement or request that their shares of our capital stock be covered by a registration statement that we are otherwise filing. Pursuant to the Investors' Rights Agreement, after the completion of this offering, certain holders of our common stock will be entitled to rights with respect to the registration of their shares under the Securities Act.

**Demand Registration Rights** 

After the completion of this offering, the holders of up to [ ] shares of our common stock will be entitled to certain demand registration rights. At the earlier of (i) March 30, 2026 and (ii) 180 days from the effective date of this Registration Statement and upon the request of the holders of at least 50% of Series A Preferred Stock and common stock issuable upon the conversion of the Series A Preferred Stock, and common stock acquired by such holders after the date of the Investors' Rights Agreement (the "Registrable Securities"), we will be required register the offer and sale of at least 40% of the Registrable Securities then outstanding (or a lesser percent if the anticipated aggregate public offering price (net of selling expenses) would exceed $10 million, subject to certain expenses

**Piggyback Registration Rights** 

After the completion of this offering, if we propose to register the offer and sale of shares of our common stock under the Securities Act, in connection with the public offering of such common stock, certain holders will be entitled to certain "piggyback" registration rights under the Investors' Rights Agreement, allowing such holders to include their shares in such registration, subject to certain marketing and other limitations.

**SHARES ELIGIBLE FOR FUTURE SALE**

Immediately prior to this offering, there has been no market for our common stock, and a liquid trading market for our common stock may not develop or be sustained after this offering. Future sales of substantial amounts of our common stock in the public market, or the perception that such sales could occur, could adversely affect market prices prevailing from time to time and could impair our ability to raise capital through the sale of our equity securities. Furthermore, because only a limited number of shares will be available for sale shortly after this offering due to existing contractual and legal restrictions on resale as described below, there may be sales of substantial amounts of our common stock in the public market after the restrictions lapse. This may adversely affect the prevailing market prices for the shares of our common stock, and our ability to raise equity capital in the future.

Based on the number of shares outstanding as of the date of this prospectus, upon the closing of this offering, approximately shares of common stock will be outstanding, assuming an initial public offering price of per share (the mid-point of the price range set forth on the cover page of this prospectus), offered hereby and further assuming no exercise of the underwriters' over-allotment option. Of the shares to be outstanding immediately after completion of this offering, all shares sold in this offering will be freely tradable except that any shares purchased in this offering by our affiliates, as that term is defined in Rule 144 under the Securities Act, would only be able to be sold in compliance with the Rule 144 limitations described below.

All of our existing stockholders prior to this offering, our officers and directors have entered into lock-up agreements under which they have agreed, subject to specific exceptions, not to sell any of our stock for at least 180 days following the date of this prospectus, as described below. As a result of these agreements, subject to the provisions of Rule 144 or Rule 701, shares will be available for sale in the public market as follows:

● beginning on the date of this prospectus, all of the shares sold in this offering will be immediately available for sale in the public market (except as described above); and

● beginning 181 days after the date of this prospectus, additional shares will become eligible for sale in the public market, of which shares will be held by affiliates and subject to the volume and other restrictions of Rule 144, as described below.

**Rule 144**

In general, under Rule 144 as currently in effect, beginning 90 days after the effective date of the registration statement of which this prospectus is a part, any person who is not an affiliate of ours and has held their shares for at least six months, as measured by SEC rule, including the holding period of any prior owner other than one of our affiliates, may sell shares without restriction, provided current public information about us is available. In addition, under Rule 144, any person who is not an affiliate of ours and has held their shares for at least one year, as measured by SEC rule, including the holding period of any prior owner other than one of our affiliates, would be entitled to sell an unlimited number of shares immediately upon the closing of this offering without regard to whether current public information about us is available. Beginning 90 days after the effective date of the registration statement of which this prospectus is a part, a person who is an affiliate of ours and who has beneficially owned restricted securities for at least six months, as measured by SEC rule, including the holding period of any prior owner other than one of our affiliates, is entitled to sell a number of restricted shares within any three-month period that does not exceed the greater of:

● 1% of the number of shares of our common stock then outstanding, which will equal approximately [ ] shares immediately after this offering; and

● the average weekly trading volume of our common stock on Nasdaq during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

Sales of restricted shares under Rule 144 held by our affiliates are also subject to requirements regarding the manner of sale, notice and the availability of current public information about us. Rule 144 also provides that affiliates relying on Rule 144 to sell shares of our common stock that are not restricted shares must nonetheless comply with the same restrictions applicable to restricted shares, other than the holding period requirement. Notwithstanding the availability of Rule 144, our existing stockholders have entered into lock-up agreements as described below and their restricted shares will become eligible for sale at the expiration of the restrictions set forth in those agreements.

**Rule 701**

Under Rule 701 under the Securities Act, shares of our common stock acquired upon the exercise of currently outstanding options or pursuant to other rights granted under our stock plans may be resold, by:

● persons other than affiliates, beginning 90 days after the effective date of the registration statement of which this prospectus is a part, subject only to the manner-of-sale provisions of Rule 144; and

● our affiliates, beginning 90 days after the effective date of the registration statement of which this prospectus is a part, subject to the manner-of-sale and volume limitations, current public information and filing requirements of Rule 144, in each case, without compliance with the six-month holding period requirement of Rule 144.

Notwithstanding the foregoing, all our Rule 701 shares are subject to lock-up agreements as described above and in the section titled "*Underwriting*" and will become eligible for sale upon the expiration of the restrictions set forth in those agreements.

**Registration Statements on Form S-8**

Following the completion of this offering, we may file one or more registration statements on Form S-8 under the Securities Act, which would become effective immediately upon filing, to register all of the shares of common stock reserved for issuance under our equity incentive plans that may be in effect from time to time. Shares covered by these registration statements will then be eligible for sale in the public markets, subject to vesting restrictions, any applicable lock-up agreements described below and Rule 144 limitations applicable to affiliates.

**MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS**

The following is a summary of the material U.S. federal income tax consequences of the ownership and disposition of our common stock acquired in this offering by a "non-U.S. holder" (as defined below), but does not purport to be a complete analysis of all the potential tax considerations relating thereto. This summary is based upon the provisions of the United States Internal Revenue Code of 1986, as amended, or the Code, Treasury Regulations promulgated thereunder, administrative rulings and judicial decisions, all as of the date hereof. These authorities may be changed, possibly retroactively, so as to result in U.S. federal income tax consequences different from those set forth below. We have not sought, and do not intend to seek, any ruling from the Internal Revenue Service, or IRS, with respect to the statements made and the conclusions reached in the following summary, and there can be no assurance that the IRS or a court will agree with such statements and conclusions.

This summary also does not address the tax considerations arising under the laws of any state or local or non-U.S. jurisdiction or under U.S. federal gift and estate tax rules, or rising out of other non-income tax rules, except to the limited extent set forth below. In addition, this discussion does not address tax considerations applicable to an investor's particular circumstances or to investors that may be subject to special tax rules, including, without limitation:

● banks, insurance companies, regulated investment companies, real estate investment trusts or other financial institutions;

● persons subject to the alternative minimum tax or the tax on net investment income;

● persons subject to special tax accounting rules as a result of any item of gross income with respect to our common stock being taken into account in an applicable financial statement;

● tax-exempt organizations or governmental organizations;

● pension plans and tax-qualified retirement plans;

● controlled foreign corporations, passive foreign investment companies and corporations that accumulate earnings to avoid U.S. federal income tax;

● partnerships or other entities or arrangements treated as partnership for U.S. federal income tax purposes (and investors therein);

● brokers or dealers in securities or currencies;

● traders in securities that elect to use a mark-to-market method of accounting for their securities holdings;

● persons that own, or are deemed to own, more than five percent of our capital stock (except to the extent specifically set forth below);

● certain former citizens or long-term residents of the United States;

● persons who hold our common stock as a position in a hedging transaction, "straddle," "conversion transaction" or other risk reduction transaction or integrated investment;

● persons who hold or receive our common stock pursuant to the exercise of any option or otherwise as compensation;

● persons who do not hold our common stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment); and

● persons deemed to sell our common stock under the constructive sale provisions of the Code.

In addition, if a partnership, entity or arrangement classified as a partnership or flow-through entity for U.S. federal income tax purposes holds our common stock, the tax treatment of a partner generally will depend on the status of the partner and upon the activities of the partnership or other entity. A partner in a partnership or other such entity that will hold our common stock should consult his, her or its own tax advisor regarding the tax consequences of the ownership and disposition of our common stock through a partnership or other such entity, as applicable.

**This summary is for informational purposes only and is not tax advice. Each non-U.S. holder is urged to consult its own tax advisor with respect to the application of the U.S. federal income tax laws to its particular situation, as well as any tax consequences of the purchase, ownership and disposition of our common stock arising under the U.S. federal gift or estate tax rules or under the laws of any state, local, non-U.S. or other taxing jurisdiction or under any applicable tax treaty.**

**Non-U.S. Holder Defined**

For purposes of this discussion, a "non-U.S. holder" is a beneficial owner of our common stock that, for U.S. federal income tax purposes, is neither a "U.S. person" nor an entity (or arrangement) treated as a partnership. A "U.S. person" is any person that, for U.S. federal income tax purposes, is or is treated as any of the following:

● an individual who is a citizen or resident of the United States;

● a corporation or other entity taxable as a corporation created or organized in the United States or under the laws of the United States or any political subdivision thereof, or otherwise treated as such for U.S. federal income tax purposes;

● an estate whose income is subject to U.S. federal income tax regardless of its source; or

● a trust (x) whose administration is subject to the primary supervision of a U.S. court and that has one or more U.S. persons who have the authority to control all substantial decisions of the trust or (y) that has made a valid election under applicable Treasury Regulations to be treated as a U.S. person.

**Distributions**

As described in the section titled "*Dividend Policy*," we have never declared or paid cash dividends on our common stock. However, following the completion of this offering, if we do make distributions of cash or property on our common stock to non-U.S. holders, such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. To the extent those distributions exceed both our current and our accumulated earnings and profits, the excess will first constitute a return of capital and will reduce each non-U.S. holder's adjusted tax basis in our common stock, but not below zero. Any additional excess will then be treated as capital gain from the sale of stock, as discussed under "*Gain on Disposition of common stock*."

Subject to the discussions below on effectively connected income, backup withholding and the Foreign Account Tax Compliance Act, or FATCA, any dividend paid to a non-U.S. holder generally will be subject to U.S. federal withholding tax either at a rate of 30% of the gross amount of the dividend or such lower rate as may be specified by an applicable income tax treaty between the United States and such non-U.S. holder's country of residence. In order to receive a reduced treaty rate, such non-U.S. holder must provide the applicable withholding agent with an IRS Form W-8BEN or W-8BEN-E or other appropriate version of IRS Form W-8 certifying qualification for the reduced treaty rate. A non-U.S. holder of shares of our common stock eligible for a reduced rate of U.S. federal withholding tax pursuant to an income tax treaty may obtain a refund of any excess amounts withheld by filing an appropriate claim for refund with the IRS. If such non-U.S. holder holds our common stock through a financial institution or other agent acting on the non-U.S. holder's behalf, the non-U.S. holder will be required to provide appropriate documentation to such agent, which then will be required to provide certification to the applicable withholding agent, either directly or through other intermediaries. Each non-U.S. holder should consult its own tax advisors regarding their entitlement to benefits under any applicable income tax treaty.

Dividends received by a non-U.S. holder that are treated as effectively connected with such non-U.S. holder's conduct of a trade or business within the United States (and, if an applicable income tax treaty so provides, such non-U.S. holder maintains a permanent establishment or fixed base in the United States to which such dividends are attributable) are generally exempt from the 30% U.S. federal withholding tax, subject to the discussion below on backup withholding and FATCA withholding. To claim this exemption, a non-U.S. holder must provide the applicable withholding agent with a properly executed IRS Form W-8ECI or other applicable IRS Form W-8 properly certifying such exemption. Such effectively connected dividends, although not subject to U.S. federal withholding tax, are taxed at the same graduated rates applicable to U.S. persons, net of certain deductions and credits, subject to an applicable income tax treaty providing otherwise. In addition, if a non-U.S. holder is a corporation, dividends such non-U.S. holder receives that are effectively connected with its conduct of a U.S. trade or business may also be subject to a branch profits tax at a rate of 30% or such lower rate as may be specified by an applicable income tax treaty between the United States and such non-U.S. holder's country of residence. Each non-U.S. holder should consult its own tax advisor regarding the tax consequences of the ownership and disposition of our common stock, including any applicable tax treaties that may provide for different rules.

**Gain on Disposition of common stock**

Subject to the discussion below regarding backup withholding and FATCA withholding, a non-U.S. holder generally will not be required to pay U.S. federal income tax on any gain realized upon the sale or other disposition of our common stock unless:

● the gain is effectively connected with such non-U.S. holder's conduct of a U.S. trade or business (and, if an applicable income tax treaty so provides, such non-U.S. holder maintains a permanent establishment or fixed base in the United States to which such gain is attributable);

● such non-U.S. holder is an individual who is present in the United States for an aggregate 183 days or more during the taxable year in which the sale or disposition occurs and certain other conditions are met; or

● our common stock constitutes a United States real property interest, or USRPI, by reason of our status as a "United States real property holding corporation," or USRPHC, for U.S. federal income tax purposes.

We believe that we are not currently and will not become a USRPHC for U.S. federal income tax purposes, and the remainder of this discussion so assumes. However, because the determination of whether we are a USRPHC depends on the fair market value of our U.S. real property interests relative to the fair market value of our U.S. and worldwide real property interests plus our other business assets, there can be no assurance that we will not become a USRPHC in the future. Even if we become a USRPHC, however, as long as our common stock is regularly traded on an established securities market, your common stock will be treated as U.S. real property interests only if you actually (directly or indirectly) or constructively hold more than 5% of such regularly traded common stock at any time during the shorter of the five-year period preceding your disposition of, or your holding period for, our common stock.

A non-U.S. holder described in the first bullet above will be required to pay U.S. federal income tax on the gain derived from the sale (net of certain deductions and credits) under regular graduated U.S. federal income tax rates. In addition, a non-U.S. holder that is a corporation may be subject to the branch profits tax at a 30% rate on a portion of its effectively connected earnings and profits for the taxable year that are attributable to such gain, as adjusted for certain items. A lower rate may be specified by an applicable income tax treaty.

A non-U.S. holder described in the second bullet above will be subject to tax at 30% (or such lower rate specified by an applicable income tax treaty) on the gain derived from the sale, which gain may be offset by U.S. source capital losses of such non-U.S. holder for the taxable year, provided such non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses.

Each non-U.S. holder should consult its own tax advisor regarding any applicable income tax or other treaties that may provide for different rules.

**Information Reporting and Backup Withholding**

Generally, we or an applicable withholding agent must report annually to the IRS the amount of dividends paid to a non-U.S. holder, such non-U.S. holder's name and address, and the amount of tax withheld, if any. A similar report is sent to such non-U.S. holder. Pursuant to any applicable income tax treaty or other agreement, the IRS may make such report available to the tax authority in such non-U.S. holder's country of residence.

Dividends paid by us (or our paying agent) to a non-U.S. holder may also be subject to backup withholding at a current rate of 24%.

Such information reporting and backup withholding requirements may be avoided, however, if such non-U.S. holder establishes an exemption by providing a properly executed, and applicable, IRS Form W-8, or otherwise establishes an exemption. Generally, such information reporting and backup withholding requirements will not apply to a non-U.S. holder where the transaction is effected outside the United States, through a non-U.S. office of a non-U.S. broker. Notwithstanding the foregoing, backup withholding and information reporting may apply, however, if the applicable withholding agent has actual knowledge, or reason to know, that such non-U.S. holder is a U.S. person.

Backup withholding is not an additional tax; rather, the U.S. federal income tax liability of persons subject to backup withholding will be reduced by the amount of tax withheld. If withholding results in an overpayment of taxes, a refund or credit may generally be obtained from the IRS, provided that the required information is furnished to the IRS in a timely manner.

**Foreign Account Tax Compliance Act (FATCA)**

Sections 1471 to 1474 of the Code, Treasury Regulations issued thereunder and related official IRS guidance, commonly referred to as FATCA, generally impose a U.S. federal withholding tax of 30% on dividends on our common stock paid to a "foreign financial institution" (as defined under FATCA, and which may include banks, traditional financial institutions, investment funds, and certain holding companies), unless such institution enters into an agreement with the U.S. Department of the Treasury to, among other things, identify accounts held by certain "specified United States persons" or "United States-owned foreign entities" (each as defined under FATCA), report annually substantial information about such accounts, and withhold on certain payments to non-compliant foreign financial institutions and certain other account holders. FATCA also generally imposes a U.S. federal withholding tax of 30% on dividends on our common stock paid to a "non-financial foreign entity" (as specially defined under FATCA), unless such entity provides identifying information regarding each of its direct or indirect "substantial United States owners" (as defined under FATCA), certifies that it does not have any substantial United States owners, or otherwise establishes an exemption. Accordingly, the institution or entity through which our common stock is held will affect the determination of whether such withholding is required.

The withholding obligations under FATCA generally apply to dividends on our common stock. Such withholding will apply regardless of whether the beneficial owner of the payment otherwise would be exempt from withholding pursuant to an applicable tax treaty with the United States, the Code, or other exemptions described above. Under certain circumstances, a non-U.S. holder might be eligible for refunds or credits of such taxes.

Under proposed regulations, FATCA withholding on payments of gross proceeds has been eliminated. These proposed regulations are subject to change.

An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements described in this section. Prospective investors are encouraged to consult with their own tax advisors regarding the application of FATCA withholding to their investment in, and ownership and disposition of, our common stock.

**The preceding discussion of U.S. federal tax considerations is for general information only. It is not tax advice to investors in their particular circumstances. Each prospective investor should consult its own tax advisor regarding the particular U.S. federal, state and local and non-U.S. tax consequences of purchasing, holding and disposing of our common stock, including the consequences of any proposed change in applicable laws.**

**UNDERWRITING**

We have entered into an underwriting agreement with The Benchmark Company, LLC, acting as the representative of the underwriters in this offering (the "Representative"). Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to the underwriters named below, and the underwriters have agreed, severally and not jointly, to purchase from us the number of shares of common stock set forth opposite each underwriter's name in the following table at the initial public offering price less the underwriting discounts set forth on the cover page of this prospectus:

---

| | |
|:---|:---|
| **Underwriter** | **Number of<br> Shares** |
| **The Benchmark Company, LLC** | |
| **TOTAL** | |

---

The underwriters have committed to purchase all of the shares offered by us other than those shares covered by the over-allotment option described below, if they purchase any shares. The obligations of the underwriters may be terminated upon the occurrence of certain events specified in the underwriting agreement.

We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, or to contribute to payments the underwriters may be required to make in respect of those liabilities.

The underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions contained in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

**Over-Allotment Option** 

We have granted the underwriters an option to purchase from us, at the initial public offering price less the underwriting discounts and commissions, up to an additional shares of our common stock, solely to cover over-allotments, if any. The underwriters may exercise this option, one or more times in whole or in part, for our common stock, any time during the 30-day period from the date of the closing of this offering.

**Underwriting Discount, Commissions and Expenses** 

The following table shows the per share and total underwriting discounts and commissions to be paid to the underwriters. These amounts are shown assuming both no exercise and full exercise of the underwriters' option to purchase additional shares of our common stock, assuming an initial public offering price of $ per share, the midpoint of the estimated price range set forth on the cover page of this prospectus.

---

| | | | |
|:---|:---|:---|:---|
|  | **Per Share** | **Total Without Exercise of Over-Allotment Option** | **Total With Exercise of Over Allotment Option** |
| **Initial public offering price** | $| $| $|
| **Underwriting discounts and commissions<sup>(1)</sup>** | $| $| $|
| **Proceeds to us, before expenses** | $| $| $|

---

&nbsp;&nbsp;&nbsp;&nbsp;(1) Represents
 underwriting discounts equal to seven percent (7%) of the gross proceeds from sales of shares
 of common stock in this offering.

The Representative has advised us that the underwriters propose initially to offer the shares to the public at the initial public offering price set forth on the cover page of this prospectus and to dealers at that price less a concession not in excess of $ per share. After the initial public offering, the public offering price, concession and discount may be changed.

We have agreed to pay the Representative a non-accountable expense allowance equal to one percent (1%) of the aggregate gross proceeds from sales of shares of common stock in this offering (including any shares of common stock sold pursuant to the exercise of the underwriters' over-allotment option).

We have also agreed to reimburse the Representative for its out-of-pocket and accountable expenses in an amount not to exceed $150,000 and background checks on our senior management and directors in an amount not to exceed $7,500.

Pursuant to the engagement letter between us and the Representative, dated August 5, 2024 (the "Engagement Letter"), we have paid the Representative a retainer of $10,000 upon signing of the Engagement Letter and subsequent payments of $10,000 on each month thereafter for a period of five months from the date of the Engagement Letter, in each case to be applied against actual out-of-pocket expenses. If the Engagement Letter is terminated or the proposed initial public offering does not occur, any retainer balance will be refunded to the extent expenses were not actually incurred in accordance with FINRA Rule 5110(g)(4)(A).

We estimate that the total expenses of this offering payable by us, excluding the total underwriting discount, will be approximately $.

**Discretionary Accounts** 

The underwriters do not intend to confirm sales of the shares offered hereby to any accounts over which they have discretionary authority.

**Electronic Distribution** 

A prospectus in electronic format may be made available on the websites maintained by one or more of the underwriters or selling group members, if any, participating in this offering. The Representative may allocate a number of shares to the underwriters and selling group members, if any, for sale to their online brokerage account holders. Any such allocations for online distributions will be made by the Representative on the same basis as other allocations.

 **Underwriters' Warrants**

Upon the closing of this offering, we have agreed to issue to the underwriters or their designees five-year warrants to purchase an aggregate of up to five percent (5%) of the shares of common stock sold by us in this offering (including any shares of common stock sold pursuant to the exercise of the underwriters' over-allotment option) (the "Underwriters' Warrants"). The Underwriters' Warrants will be exercisable at a per share exercise price equal to the public offering price per share. The Underwriters' Warrants will be exercisable at any time, and from time to time, in whole or in part, from the first day of the seventh month after the closing of this offering to the date that is five years from the date of commencement of sales in this offering, in compliance with FINRA Rule 5110. The Underwriters' Warrants are also exercisable on a cashless basis. The registration statement of which this prospectus is a part also registers the offer and sale of the Underwriters' Warrants and the shares of our common stock issuable upon exercise thereof.

The Underwriters' Warrants has been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to FINRA Rule 5110. Except as permitted by Rule 5110, the underwriters (or permitted assignees under such rule) will not sell, transfer, assign, pledge, or hypothecate the Underwriters' Warrants or the securities underlying the Underwriters' Warrants, nor will any of them engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the Underwriters' Warrants or the underlying securities for a period of 180 days from the commencement of sales under this prospectus.

The exercise price and number of shares of common stock issuable upon exercise of the Underwriters' Warrants may be adjusted in certain circumstances including in the event of a stock dividend, extraordinary cash dividend or recapitalization, reorganization, merger or consolidation.

**Lock-Up Agreements** 

Our officers and directors and our existing stockholders prior to this offering have agreed not to, without the prior written consent of the underwriters, directly or indirectly, offer to sell, sell or otherwise transfer or dispose of any shares of our common stock (or enter into any transaction or device that is designed to, or could be expected to, result in the transfer or disposition by any person at any time in the future of shares of our common stock), enter into any swap or other derivatives transaction that transfers to another, in whole or in part, any of the economic benefits or risks of ownership of shares of common stock, make any demand for or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the registration of any of the shares of common stock or securities convertible into or exercisable or exchangeable for shares of common stock or any other of our securities or publicly disclose the intention to do any of the foregoing, subject to customary exceptions, for a period of six (6) months from the date of closing of this offering.

**Securities Issuance Standstill**

We have agreed that for a period of 180 days from the closing of this offering, we will not, without the prior written consent of the Representative, (a) offer, sell or otherwise transfer or dispose of, directly or indirectly, any shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of our capital stock; or (b) file or cause to be filed any registration statement with the SEC relating to this offering of any shares of our capital stock or any securities convertible into or exercisable or exchangeable for shares of our capital stock.

**Tail Financing** 

The Representative will also be entitled to an aggregate additional fee of seven percent (7%) of the gross proceeds of future financings and warrants to purchase up to five percent (5%) of the number of securities sold in future financings consummated solely with investors with whom we have had a conference call or a meeting arranged by the Representative prior to the expiration or termination of the Engagement Letter; provided that the future financing is consummated at any time within the twelve (12) month period following the earlier to occur of (i) the expiration or termination of the Engagement Letter or (ii) the closing of this offering.

**Right of First Refusal** 

We have granted the Representative the right to act as lead or joint-lead investment banker, lead or joint book-runner, lead or joint placement agent and/or investment banker/advisor, for any of our future public and private equity and debt offerings, including all equity linked financings, during the twelve (12) month period following the completion of this offering in compliance with FINRA Rule 5110(g)(6).

**Determination of Offering Price** 

Prior to this offering, there has been no public market for our common stock. The public offering price was negotiated between the Representative and us. In determining the public offering price of our common stock, the Representative considered:

● the history and prospects for the industry in which we compete;

● our financial information;

● the ability of our management and our business potential and earning prospects;

● the prevailing securities markets at the time of this offering; and

● the recent market prices of, and the demand for, publicly traded shares of generally comparable companies, as well as the recent market price of our common stock.

**Listing**

We have applied to have our common stock listed on Nasdaq under the symbol "BVXX". In order to meet one of the requirements for listing our common stock on Nasdaq, the underwriters have undertaken to sell lots of 100 or more shares to a minimum of 300 beneficial holders.

**Stabilization** 

● Stabilizing transactions permit bids to purchase securities so long as the stabilizing bids do not exceed a specified maximum and are engaged in for the purpose of preventing or retarding a decline in the market price of the securities while this offering is in progress.

● Over-allotment transactions involve sales by the underwriters of securities in excess of the number of securities the underwriters are obligated to purchase. This creates a syndicate short position which may be either a covered short position or a naked short position. In a covered short position, the number of securities over-allotted by the underwriters is not greater than the number of securities that they may purchase in the over-allotment option. In a naked short position, the number of securities involved is greater than the number of securities in the over-allotment option. The underwriters may close out any short position by exercising their over-allotment option and/or purchasing securities in the open market.

● Syndicate covering transactions involves purchases of securities in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of securities to close out the short position, the underwriters will consider, among other things, the price of securities available for purchase in the open market as compared with the price at which they may purchase securities through exercise of the over-allotment option. If the underwriters sell more securities than could be covered by exercise of the over-allotment option and, therefore, have a naked short position, the position can be closed out only by buying securities in the open market. A naked short position is more likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the securities in the open market that could adversely affect investors who purchase in this offering.

● Penalty bids permit the underwriters to reclaim a selling concession from a syndicate member when the securities originally sold by that syndicate member are purchased in stabilizing or syndicate covering transactions to cover syndicate short positions.

These stabilizing transactions, over-allotment transactions, syndicate covering transactions, and penalty bids may have the effect of raising or maintaining the market price of our securities or preventing or retarding a decline in the market price of our securities. As a result, the price of our securities in the open market may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriters make any representation or prediction as to the effect that the transactions described above may have on the price of our securities. These transactions may be affected on the Nasdaq Stock Market, in the over-the-counter market or otherwise and, if commenced, may be discontinued at any time.

**Passive Market Making** 

In connection with this offering, underwriters, and selling group members may engage in passive market making transactions in our securities on the Nasdaq Stock Market in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the shares and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker's bid, then that bid must then be lowered when specified purchase limits are exceeded**.**

**Other Relationships**

The underwriters and their respective affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. Certain of the underwriters and their respective affiliates have provided, and may in the future provide, a variety of these services to us and to persons and entities with relationships with us, for which they received or will receive customary fees and expenses.

**Offer Restrictions Outside the United States**

Other than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons who come into possession of this prospectus are advised to inform themselves about and to observe any restrictions relating to this offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.

**Selling Restrictions** 

***Australia***

This prospectus:

● does not constitute a disclosure document or a prospectus under Chapter 6D.2 of the Corporations Act 2001 (Cth), or the Corporations Act;

● has not been, and will not be, lodged with the Australian Securities and Investments Commission, or ASIC, as a disclosure document for the purposes of the Corporations Act and does not purport to include the information required of a disclosure document for the purposes of the Corporations Act; and

● may only be provided in Australia to select investors who are able to demonstrate that they fall within one or more of the categories of investors, available under section 708 of the Corporations Act, or Exempt Investors.

The securities may not be directly or indirectly offered for subscription or purchased or sold, and no invitations to subscribe for or buy the securities may be issued, and no draft or definitive offering memorandum, advertisement or other offering material relating to any securities may be distributed in Australia, except where disclosure to investors is not required under Chapter 6D of the Corporations Act or is otherwise in compliance with all applicable Australian laws and regulations. By submitting an application for the securities, you represent and warrant to us that you are an Exempt Investor.

As any offer of securities under this prospectus will be made without disclosure in Australia under Chapter 6D.2 of the Corporations Act, the offer of those securities for resale in Australia within 12 months may, under section 707 of the Corporations Act, require disclosure to investors under Chapter 6D.2 if none of the exemptions in section 708 applies to that resale. By applying for the securities you undertake to us that you will not, for a period of 12 months from the date of issue of the securities, offer, transfer, assign or otherwise alienate those securities to investors in Australia except in circumstances where disclosure to investors is not required under Chapter 6D.2 of the Corporations Act or where a compliant disclosure document is prepared and lodged with ASIC.

***Canada***

The securities may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser's province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser's province or territory for particulars of these rights or consult with a legal advisor.

Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriters conflicts of interest in connection with this offering.

***European Economic Area***

In relation to each Member State of the European Economic Area and the United Kingdom, or each a Relevant State, no securities have been offered or will be offered pursuant to this offering to the public in that Relevant State prior to the publication of a prospectus in relation to the securities which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that offers of securities may be made to the public in that Relevant State at any time under the following exemptions under the Prospectus Regulation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) to
 any legal entity which is a qualified investor as defined under the Prospectus Regulation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) to
 fewer than 150 natural or legal persons (other than qualified investors as defined under
 the Prospectus Regulation), subject to obtaining the prior consent of the underwriters; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) in
 any other circumstances falling within Article 1(4) of the Prospectus Regulation,

*provided* that no such offer of securities shall require us or any underwriter to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation and each person who initially acquires any securities or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the underwriters and us that it is a "qualified investor" within the meaning of Article 2(e) of the Prospectus Regulation. In the case of any securities being offered to a financial intermediary as that term is used Prospectus Regulation, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the securities acquired by it in the offer have not been acquired on a non-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any securities to the public other than their offer or resale in a Relevant State to qualified investors as so defined or in circumstances in which the prior consent of the Representative has been obtained to each such proposed offer or resale.

For the purposes of this provision, the expression an "offer to the public" in relation to securities in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase or subscribe for any securities, and the expression "Prospectus Regulation" means Regulation (EU) 2017/1129.

***Hong Kong***

The securities have not been offered or sold and will not be offered or sold in Hong Kong, by means of any document, other than (a) to "professional investors" as defined in the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong), or the SFO, of Hong Kong and any rules made thereunder; or (b) in other circumstances which do not result in the document being a "prospectus" as defined in the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32) of Hong Kong), or the CO, or which do not constitute an offer to the public within the meaning of the CO. No advertisement, invitation or document relating to the securities has been or may be issued or has been or may be in the possession of any person for the purposes of issue, whether in Hong Kong or elsewhere, which is directed at, or the contents of which are likely to be accessed or read by, the public of Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to securities which are or are intended to be disposed of only to persons outside Hong Kong or only to "professional investors" as defined in the SFO and any rules made thereunder.

***Israel***

This prospectus does not constitute a prospectus under the Israeli Securities Law, 5728-1968, and has not been filed with or approved by the Israel Securities Authority. In Israel, this prospectus may be distributed only to, and is directed only at, investors listed in the first addendum, or the Addendum, to the Israeli Securities Law, consisting primarily of joint investment in trust funds; provident funds; insurance companies; banks, portfolio managers, investment advisors, members of the Tel Aviv Stock Exchange Ltd., underwriters, each purchasing for their own account; venture capital funds; entities with equity in excess of NIS 50 million and "qualified individuals," each as defined in the Addendum (as it may be amended from time to time), collectively referred to as qualified investors. Qualified investors shall be required to submit written confirmation that they fall within the scope of the Addendum.

***Japan***

The securities have not been and will not be registered pursuant to Article 4, Paragraph 1 of the Financial Instruments and Exchange Act. Accordingly, none of the securities nor any interest therein may be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any "resident" of Japan (which term as used herein means any person resident in Japan, including any corporation or other entity organized under the laws of Japan), or to others for re-offering or resale, directly or indirectly, in Japan or to or for the benefit of a resident of Japan, except pursuant to an exemption from the registration requirements of, and otherwise in compliance with, the Financial Instruments and Exchange Act and any other applicable laws, regulations and ministerial guidelines of Japan in effect at the relevant time.

***Singapore***

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, the underwriters have not offered or sold any securities or caused the securities to be made the subject of an invitation for subscription or purchase and will not offer or sell any securities or cause the securities to be made the subject of an invitation for subscription or purchase, and has not circulated or distributed, nor will it circulate or distribute, this prospectus or any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of the securities, whether directly or indirectly, to any person in Singapore other than:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) to
 an institutional investor (as defined in Section 4A of the Securities and Futures Act (Chapter
 289) of Singapore, as modified or amended from time to time, or the SFA) pursuant to Section
 274 of the SFA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) to
 a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of
 the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the
 conditions specified in Section 275 of the SFA; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) otherwise
 pursuant to, and in accordance with the conditions of, any other applicable provision of
 the SFA.

Where the securities are subscribed or purchased under Section 275 of the SFA by a relevant person which is:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) a
 corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the
 sole business of which is to hold investments and the entire share capital of which is owned
 by one or more individuals, each of whom is an accredited investor; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) a
 trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments
 and each beneficiary of the trust is an individual who is an accredited investor, securities
 or securities-based derivatives contracts (each term as defined in Section 2(1) of the SFA)
 of that corporation or the beneficiaries' rights and interest (howsoever described)
 in that trust shall not be transferred within six months after that corporation or that trust
 has acquired the securities pursuant to an offer made under Section 275 of the SFA except:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. to
 an institutional investor or to a relevant person, or to any person arising from an offer
 referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. where
 no consideration is or will be given for the transfer;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. where
 the transfer is by operation of law;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. as
 specified in Section 276(7) of the SFA; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;v. as
 specified in Regulation 37A of the Securities and Futures (Offers of Investments) (Securities
 and Securities-based Derivatives Contracts) Regulations 2018.

***Switzerland***

The securities may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange, or SIX, or on any other stock exchange or regulated trading facility in Switzerland. This prospectus does not constitute a prospectus within the meaning of, and has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this prospectus nor any other offering or marketing material relating to the securities or this offering may be publicly distributed or otherwise made publicly available in Switzerland.

Neither this prospectus nor any other offering or marketing material relating to this offering, the Company, the securities have been or will be filed with or approved by any Swiss regulatory authority. In particular, this prospectus will not be filed with, and the offer of securities will not be supervised by, the Swiss Financial Market Supervisory Authority FINMA (FINMA), and the offer of securities has not been and will not be authorized under the Swiss Federal Act on Collective Investment Schemes, or CISA. The investor protection afforded to acquirers of interests in collective investment schemes under the CISA does not extend to acquirers of securities.

***United Kingdom***

The securities may not be made in the United Kingdom, except that an offer to the public of any securities may be made in the United Kingdom at any time:

&nbsp;&nbsp;&nbsp;&nbsp;(a) to
 any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus
 Regulation;

&nbsp;&nbsp;&nbsp;&nbsp;(b) to
 fewer than 150 natural or legal persons (other than qualified investors as defined under
 Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the
 Representative for any such offer; or

&nbsp;&nbsp;&nbsp;&nbsp;(c) in
 any other circumstances falling within Section 86 of the Financial Services and Markets Act
 2000 (as amended, the "FSMA");

*provided* that no such offer of securities shall result in the requirement for the publication by us of a prospectus pursuant to Section 85 of the FSMA or supplement a prospectus pursuant to Article 23 of the UK Prospectus Regulation.

For the purposes of this provision, the expression an "offer to the public" in relation to the any securities in the United Kingdom means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe for the securities, and the expression "UK Prospectus Regulation" means Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018.

This prospectus is only being distributed to and is only directed at: (1) persons who are outside the United Kingdom; (2) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (3) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (ed) of the Order (all such persons falling within (1)-(3) together being referred to as "relevant persons"). The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire the securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this prospectus or any of its contents.

**LEGAL MATTERS**

The validity of the issuance of the securities offered by us in this offering will be passed upon for us by Ellenoff Grossman & Schole LLP, New York, New York. The underwriters are being represented by McGuireWoods LLP, New York, New York.

**EXPERTS**

M&K CPAS, PLLC, our independent registered public accounting firm, has audited our consolidated balance sheets as of December 31, 2025 and 2024, and the related consolidated statements of operations, changes in stockholders' equity and cash flows for the years ended December 31, 2025 and 2024, as set forth in their report dated February 9, 2026. We have included our consolidated financial statements in this prospectus and in this registration statement in reliance on M&K CPA PLLC's report given on their authority as experts in accounting and auditing.

**WHERE YOU CAN FIND MORE INFORMATION**

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the shares of common stock offered hereby. This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement or the exhibits filed therewith. For further information about us and the common stock offered hereby, reference is made to the registration statement and the exhibits filed therewith. Statements contained in this prospectus concerning the contents of any contract or any other document are not necessarily complete, please see the copy of the contract or document that has been filed for the complete contents of that contract or document. Each statement in this prospectus relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. The exhibits to the registration statement should be reviewed for the complete contents of these contracts and documents.

We currently do not file periodic reports with the SEC. Upon the completion of this offering, we will be required to file periodic reports, proxy statements and other information with the SEC pursuant to the Exchange Act. The SEC maintains a website that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC. The address of the website is *www.sec.gov*.

We also maintain a website at *www.bioventrix.com*. Upon completion of this offering, you may access these materials at our website free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained in, or that can be accessed through, our website is not a part of, and is not incorporated into, this prospectus.

**INDEX TO CONSOLIDATED FINANCIAL STATEMENTS**

**BIOVENTRIX, INC.**

**CONSOLIDATED FINANCIAL STATEMENTS**

**Years Ended December 31, 2025 and 2024**

**and Report of Independent Registered Accounting Firm**

**BIOVENTRIX, INC.**

**CONSOLIDATED FINANCIAL STATEMENTS**

**Years Ended December 31, 2025 and 2024**

**Table of Contents**

---

| | |
|:---|:---|
| [Report of Independent Registered Accounting Firm](#a_001) | F-2 |
| &nbsp;&nbsp;&nbsp;Consolidated Financial Statements: |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[Consolidated Balance Sheets](#a_002) | F-3 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[Consolidated Statements of Operations](#a_003) | F-4 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[Consolidated Statements of Changes in Stockholders' Deficit](#a_004) | F-5 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[Consolidated Statements of Cash Flows](#a_005) | F-6 |
| &nbsp;&nbsp;&nbsp;[Notes to Consolidated Financial Statements](#a_006) | F-7 |

---

![](fin_001.jpg)

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and

Stockholders of Bioventrix, Inc.

**Opinion on the Consolidated Financial Statements**

We have audited the accompanying consolidated balance sheets of Bioventrix, Inc. (the Company) as of December 31, 2025 and 2024, and the related consolidated statements of operations, changes in stockholders' deficit, and cash flows for the years ended December 31, 2025, and the related notes (collectively referred to as the financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its consolidated operations and its cash flows for the two-year period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

**Going Concern**

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in the Note 1 to the financial statements, the Company has suffered net losses from operations in current and prior periods and the Company has incurred and expects to continue to incur significant costs in pursuit of its expansion and development plans, which raises substantial doubt about its ability to continue as a going concern. Management's plans regarding those matters are discussed in the notes to the financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

**Basis for Opinion**

These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, audits of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

**Critical Audit Matter**

The critical audit matter communicated below is matter arising from the current period audits of the consolidated financial statements that was communicated or required to be communicated to the audits committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinion on the critical audit matter or on the accounts or disclosures.

*Going Concern*

As discussed in Note 1, the Company has not yet generated any significant revenue, has incurred recurring losses from operations, generated negative cash flows from operating activities and had an accumulated deficit that raises substantial doubt about the Company's ability to continue as a going concern. Auditing management's evaluation of a going concern can be a significant judgment given the fact that the Company uses management estimates on future revenues and expenses, which are difficult to substantiate. We evaluated the appropriateness of the going concern, we examined and evaluated the financial information along with management's plans to mitigate the going concern and management's disclosure on going concern.

/s/ M&K CPAS, PLLC

www.mkacpas.com

We have served as the Company's auditor since 2025.

The Woodlands, Texas

February 9, 2026

**BIOVENTRIX, INC.**

**<u>Consolidated Balance Sheets</u>**

---

| | | |
|:---|:---|:---|
|  | As of December 31, | As of December 31, |
|  | 2025 | 2024 |
| **<u>ASSETS</u>** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $1838121 | $2637635 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 251734 | 104711 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 2089855 | 2742346 |
| Long-term assets: |  |  |
| &nbsp;&nbsp;&nbsp;Property and equipment, net | 101689 | 146884 |
| &nbsp;&nbsp;&nbsp;Lease right of use asset | 231785 | 344487 |
| &nbsp;&nbsp;&nbsp;Deposits | 145532 | 45532 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total long-term assets | 479006 | 536903 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $2568861 | $3279249 |
| **<u>LIABILITIES AND STOCKHOLDERS' DEFICIT</u>** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $2088060 | $2470535 |
| &nbsp;&nbsp;&nbsp;Accrued liabilities | 2779397 | 784350 |
| &nbsp;&nbsp;&nbsp;Lease liability, current | 146323 | 142061 |
| &nbsp;&nbsp;&nbsp;Convertible notes | 9857477 | 4710000 |
| &nbsp;&nbsp;&nbsp;Discount on convertible notes | (1188905) | (375.292) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 13682352 | 7731654 |
| Long-term liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Derivative liability | 1349735 | 364398 |
| &nbsp;&nbsp;&nbsp;Lease liability, non-current | 101955 | 222332 |
| &nbsp;&nbsp;&nbsp;Total long-term liabilities | 1451690 | 586730 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 15134042 | 8318384 |
| Stockholders' deficit: |  |  |
| &nbsp;&nbsp;&nbsp;Common stock, $0.0001 par value, 25,000,000 shares authorized; 5,712,615 and 5,616,390 shares issued and outstanding at December 31, 2025, and December 31, 2024, respectively | 571 | 561 |
| &nbsp;&nbsp;&nbsp;Convertible preferred stock, $0.0001 par value, 12,500,000 shares authorized; 1,565,000 shares issued and outstanding at December 31, 2025, and December 31, 2024, respectively | 157 | 157 |
| &nbsp;&nbsp;&nbsp;Additional paid-in capital | 218675435 | 218533820 |
| &nbsp;&nbsp;&nbsp;Accumulated deficit | (231241344) | (223573673) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' deficit | (11965181) | (5039135) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' deficit | $2568861 | $3279249 |

---

See accompanying notes which are an integral part of these financial statements.

**BIOVENTRIX, INC.**

**<u>Consolidated Statements of Operations</u>**

---

| | | |
|:---|:---|:---|
|  | For the Year Ended <br> December 31, | For the Year Ended <br> December 31, |
|  | 2025 | 2024 |
| Operating income: |  |  |
| &nbsp;&nbsp;&nbsp;Sales | $- | $- |
| &nbsp;&nbsp;&nbsp;Cost of goods sold | - | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Gross profit |  |  |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | 1173645 | 589951 |
| &nbsp;&nbsp;&nbsp;Selling, general and administrative | 5096785 | 2972565 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 6270.430 | 3562516 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Loss from operations | (6270430) | (3562516) |
| Other expense: |  |  |
| &nbsp;&nbsp;&nbsp;Interest, net | 1391294 | 309971 |
| &nbsp;&nbsp;&nbsp;Other | 5947 | (21813) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other expense | 1397241 | 288158 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Loss from operations before provision for income taxes | (7667671) | (3850674) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Provision for Income taxes | - | - |
| Net loss | $(7667671) | $(3850674) |
| Net loss per share – basic and diluted | $(1.35) | $(0.72) |
| Weighted average common shares outstanding – basic and diluted | 5696603 | 5355663 |

---

See accompanying notes which are an integral part of these financial statements.

**BIOVENTRIX, INC.**

**<u>Statements of Changes in Stockholders' Deficit</u>**

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
|  | Preferred Stock | Preferred Stock | Common Stock | Common Stock | | | |
|  | Shares | Amount | Shares | Amount | Additional Paid<br>In Capital | Accumulated<br>Deficit | Total Stockholders'<br>Deficit |
| Balances, January 1, 2024 | 1565000 | $157 | 5000971 | $500 | $218147685 | $(219722999) | $(1574657) |
| &nbsp;&nbsp;&nbsp;Stock-based compensation expense |  |  | 482745 | $48 | $386148 |  | $386196 |
| &nbsp;&nbsp;&nbsp;Issuance of common shares to former Preferred A-1 shareholders |  |  | 132674 | $13 | $(13) |  | $- |
| &nbsp;&nbsp;&nbsp;Net Loss |  |  |  |  |  | $(3850674) | $(3850674) |
| Balances, December 31, 2024 | 1565000 | $157 | 5616390 | $561 | $218533820 | $(223573673) | $(5039135) |
| &nbsp;&nbsp;&nbsp;Stock-based compensation expense |  |  | 96255 | $10 | $141615 |  | $141625 |
| &nbsp;&nbsp;&nbsp;Net loss |  |  |  |  | $— | $(7667671) | $(7667671) |
| Balances, December 31, 2025 | 1565000 | $157 | 5712645 | $571 | $218675435 | $(231241344) | $(12565181) |

---

See accompanying notes which are an integral part of these financial statements.

**BIOVENTRIX, INC.**

**<u>Consolidated Statements of Cash Flows</u>**

---

| | | |
|:---|:---|:---|
|  | For the Year Ended <br> December 31, | For the Year Ended <br> December 31, |
|  | 2025 | 2024 |
| Cash flows from operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Net loss | $(7667671) | $(3850674) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Depreciation | 45195 | 45195 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Stock based compensation | 141625 | 386196 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Change in fair value of derivative liabilities | 932 | (28731) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Discount on convertible notes | 305669 | 17837 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Changes in operating assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | (382475) | 289984 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accrued liabilities | 1995047 | 351862 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Lease liability | (116115) | (99706) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Lease asset | 112702 | 100646 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Deposits | (100000) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaid expense | (147023) | 68677 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash used in operating activities | (5812114) | (2718714) |
| Cash flows from investing activities: |  |  |
| &nbsp;&nbsp;&nbsp;Purchases of property and equipment | - | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash used in investing activities |  |  |
| Cash flows from financing activities: |  |  |
| &nbsp;&nbsp;&nbsp;Proceeds from convertible notes payable | 5012600 | 4710000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net cash provided by financing activities | 5012600 | 4710000 |
| Increase (Decrease) in cash and cash equivalents | $(799514) | $1991286 |
| Cash and cash equivalents, start of year | 2637635 | 646349 |
| Cash and cash equivalents, end of year | $1838121 | $2637635 |
| <u>Supplemental disclosure of cash flow information</u> |  |  |
| Non-cash operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Derivative liability | $984405 | $393129 |
| Non-cash financing activities: |  |  |
| &nbsp;&nbsp;&nbsp;Issuance of common shares to former A-1 shareholders | $- | $13 |
| Cash paid during the year for: |  |  |
| &nbsp;&nbsp;&nbsp;Income taxes | $- | $- |

---

See accompanying notes which are an integral part of these financial statements.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

**<u>Note 1 – Organization and operations and basis of presentation:</u>**

BioVentrix, Inc. (the "Company") is a private medical device company that was incorporated in the state of California on October 15, 2003, as CHF Technologies, Inc. During 2012, the Company created BioVentrix, Inc., a Delaware corporation, which it then merged into CHF Technologies, Inc. From 2004 through 2007, the Company marketed products and services to treat various heart related issues. In 2007, the Company ceased sales and marketing of these product lines and began developing a new product to treat heart failure. In June 2016 the Company received CE Mark Certification for its product Revivent TC™ TransCatheter Ventricular Enhancement System ("Revivent"). In 2016 the Company tested and marketed the system in Europe. In May 2016 the Company received Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") approval for its clinical trial and began to test and market the system in the United States in 2017. The Company's trial, which was completed in 2023 (the "ALIVE Trial"), achieved statistical significance with a subpopulation on functional status and Quality-of-Life ("QoL") measures, three of the measures in our efficacy endpoint composite. Leveraging this subpopulation finding, the Company proposed and was approved by the FDA via an IDE for the RELIVE Trial for 84 treated patients and 42 control patients, for a total of 126 trial patients (135 randomized patients starting the trial to account for trial patient attrition). In November 2024, the Company received an IDE from the FDA under Breakthrough Device Designation ("BDD") to begin the RELIVE Trial. The FDA grants BDD if preliminary clinical evidence suggests the procedure may improve substantially upon at least one clinically significant endpoint for a serious or life-threatening condition compared to existing therapies.

Going Concern – The accompanying financial statements are prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

The Company has experienced net operating losses and negative cash flows from operations since inception, which raise substantial doubt about its ability to continue as a going concern. Since inception, the Company has accumulated a deficit of approximately $231 million as of December 31, 2025, and management expects to incur additional losses in the foreseeable future. Management believes that successful marketing and sales of its products will result in lower losses. To date, the Company has financed its operations primarily with proceeds from private equity offerings and various debt arrangements (see Note 14, Subsequent events). Management believes that it will be able to obtain additional capital from private equity, corporate partners, or from other sources, however there can be no assurance that it will be successful in securing additional capital. These conditions raise substantial doubt about the Company's ability to continue as a going concern for at least one year from the date of this report. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

<u>**Note 2 – Summary of significant accounting policies:**</u>

<u>Use of estimates</u> – The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America ("GAAP") requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reported period. Management bases its estimates on historical experience and market specific or other relevant assumptions that it believes are reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, including those related to accruals for research and development costs, fair value of equity instruments and accounting for stock-based compensation. Actual results could differ from those estimates

<u>Concentration of credit risk</u> – Substantially all the Company's cash and cash equivalents are held by one financial institution that management believes is of high credit quality. Such deposits may, at times, exceed federally insured limits. Management believes the Company is not exposed to significant credit risk due to the financial strength of the depository institution in which the cash and cash equivalents are held. The Company has not experienced any losses on its deposits of cash and cash equivalents.

<u>Risks and Uncertainties</u> – The Company is subject to certain risks and uncertainties, including, but not limited to changes in any of the following areas that the Company believes could have a material adverse effect on future financial position or results of operations: ability to obtain future financing; regulatory clearance and market acceptance of the Company's products; development of sales channels; protection of the intellectual property; litigation or claims against the Company based on intellectual property, or other factors; and the Company's ability to attract and retain employees necessary to support its growth.

<u>Cash and cash equivalents</u> – Cash and cash equivalents include investments in money market funds with a maturity of generally three months or less, and are carried at cost which approximates market value.

<u>Inventories</u> – In accordance with Accounting Standards Codification ("ASC") 730 Research and Development, all costs associated with Revivent devices during the RELIVE Trial are recorded as research and development expense.

<u>Property and equipment</u> – Property and equipment are recorded at cost, subject to adjustments for impairments, and depreciated over their estimated useful lives of approximately two to five years on a straight-line basis. Leasehold improvements are depreciated over the shorter of either the useful life or the remaining term of the lease. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to other income or expense. Repairs and maintenance costs are expensed as incurred.

<u>Impairment of Long-Lived Assets</u> – Long-lived assets consist of property and equipment. The Company assesses potential impairment losses on long-lived assets used in operations when events and circumstances indicate that assets might be impaired. The Company has not recognized any impairment losses in the years ended December 31, 2025, and 2024.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

<u>Advertising costs</u> – Advertising costs are expensed as incurred. Advertising expenses were insignificant for the years ended December 31, 2025, and 2024.

<u>Fair value of financial instruments</u> – The Company calculates the fair value of its assets and liabilities which qualify as financial instruments and includes this information in the notes to the financial statements when the fair value is different than the carrying value of those financial instruments. The estimated fair value of accounts receivable, other receivables, prepaid expenses, accounts payable and accrued liabilities approximate the carrying amounts due to the relatively short maturity of these instruments. None of these instruments are held for trading purposes.

<u>Revenue Recognition</u> – the Company adopted ASU No. 2014-09 Revenue from Contracts with Customers ("ASC 606") as of January 1, 2018. The standard establishes a single revenue recognition model for all contracts with customers, eliminates industry specific requirements, and expands disclosure requirements.

Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company is focused on the RELIVE Trial in the United States and therefore has not focused on commercialization of Revivent although the Company has obtained approval to sell the System in Europe.

Under ASC 730, any revenue realized from Revivent during the RELIVE Trial is recorded as an offset to research and development expense.

<u>Research and development</u> – Costs to develop the Company's products are expensed as incurred. These costs include salaries and other personnel related expenses, contractor fees, facility costs, supplies, depreciation of equipment, and other outside services associated with the design and development of new products prior to the establishment of their technological feasibility.

<u>Income taxes</u> – The Company accounts for income taxes under the asset and liability method, which requires that deferred income taxes be provided for temporary differences between the tax basis of the Company's assets and liabilities and their financial statements, reported amounts. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. A valuation allowance is provided against deferred tax assets unless it is more likely than not that they will be realized.

In evaluating the ability to recover its deferred income tax assets, the Company considers all available positive and negative evidence, including its operating results, ongoing tax planning and forecasts of future taxable income on a jurisdiction-by-jurisdiction basis. In the event the Company determines that it would be able to realize its deferred income tax assets in the future in excess of their net recorded amount, it would make an adjustment to the valuation allowance that would reduce the provision for income taxes. Conversely, in the event that all or part of the net deferred tax assets are determined not to be realizable in the future, an adjustment to the valuation allowance would be charged to earnings in the period when such determination is made. As of December 31, 2025 and 2024, the Company has recorded a full valuation allowance on its net deferred tax assets.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

Accounting for uncertain tax positions requires the Company to use a two-step approach to recognize and measure uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. The Company classifies the liability for unrecognized tax benefits as current to the extent that the Company anticipates payment (or receipt) of cash within one year. Interest and penalties related to uncertain tax positions are recognized in the provision for income taxes.

<u>Stock-based compensation</u> – The Company measures and recognizes stock-based compensation expense in the financial statements for all share-based payment awards made to employees, directors, and non-employees based on estimated fair values on the date of grant based on using the Black-Scholes option pricing model. Common stock issued for services are recorded based on the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable.

The Company's determination of fair value of share-based payment awards on the date of grant using the Black-Scholes option-pricing model is affected by the Company's estimated fair value of common stock as well as assumptions regarding a number of highly complex and subjective variables. These variables include, but are not limited to:

*Expected Term* – Expected term represents the period that the Company's stock-based awards are expected to be outstanding and is determined using the simplified method.

*Expected Volatility* – Expected volatility is estimated by studying the volatility of comparable public companies for similar terms.

*Expected Dividend* – The Black-Scholes valuation model calls for a single expected dividend yield as an input.

*Risk-Free Interest Rate* – The risk-free interest rate is based on the U.S. Treasury zero-coupon issued in effect at the time of grant for periods corresponding with the expected term of the option.

Stock-based compensation expense for all share-based payment awards is based on the grant date calculated fair value. The Company recognizes these compensation costs, net of an estimated forfeiture rate, and recognizes the compensation costs for only those shares expected to vest on a straight-line basis over the requisite service period of the award, which is generally the option vesting term of four years. The Company estimated the forfeiture rate based on its historical experience for annual grant years where the majority of the vesting terms have been satisfied.

The Financial Accounting Standards Board ("FASB") has issued accounting standards updates ("ASUs") that are not yet effective for the Company. The Company is currently evaluating the impact of these ASUs on its consolidated financial statements.

**BIOVENTRIX, INC**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

<u>Expense Disaggregation (ASU 2023-07, Income Statement—Reporting Comprehensive Income).</u> This ASU requires enhanced disclosures about significant expense categories, including the nature and amounts of expenses included in each relevant income statement line item. The Company expects this guidance to result in expanded disclosures, particularly related to research and development expenses, including clinical trial costs. The Company does not expect the adoption of this ASU to have a material impact on its consolidated financial position, results of operations, or cash flows.

<u>Income Taxes (ASU 2023-09, Improvements to Income Tax Disclosures).</u> This ASU enhances income tax disclosure requirements, including additional disaggregation of income taxes paid and expanded information regarding the effective tax rate reconciliation. The Company expects this ASU to impact disclosures only and does not expect a material impact on its consolidated financial statements.

The Company does not expect the adoption of any other recently issued accounting standards to have a material impact on its consolidated financial statements.

**<u>Note 3 – Fair value of derivative liability:</u>**

The Company has identified an embedded derivative related to the maturity conversion feature of its secured convertible notes that is required to be bifurcated and accounted for separately in accordance with ASC 815, Derivatives and Hedging. The derivative liability is measured at fair value at each reporting date, with changes in fair value recognized in the consolidated statement of operations.

At December 31, 2025, the fair value of the derivative liability was $1,349,735. The fair value was estimated using a probability-weighted expected return model, which incorporates significant unobservable inputs, including probability of different events, timing of each event, discount rate and value of the Company's common stock. Accordingly, the derivative liability is classified within Level 3 of the fair value hierarchy under ASC 820.

The primary valuation assumptions used were:

---

| | |
|:---|:---|
| Maturity date | 12/31/2027 |
| Bond rate (CCC) | 12.49% |
| Volatility | 94.0% |
| Probability of Qualified Financing | 25% |

---

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

---

| | |
|:---|:---|
| Timing of Qualified Financing | 6/30/26 |
| Probability of Qualified IPO | 50% |
| Timing of Qualified IPO | 6/30/26 |
| Value of common stock, per 409A valuation | $0.80 |

---

The following table presents the change in the fair value of the derivative liability during the years ended December 31:

---

| | | |
|:---|:---|:---|
|  | 2025 | 2024 |
| Fair value at January 1 | $364398 | $- |
| Initial recognition upon issuance | 984405 | 393129 |
| Loss (Gain) recognized in earnings | 932 | (28731) |
| Transfers in / out of Level 3 | - | - |
| **Fair value at December 31,** | $1349735 | $364398 |

---

Changes in the fair value of the derivative liability resulted in an unrealized gain of $4,794 and $28,731 for the years ended December 31, 2025 and 2024, respectively, which was recognized in *other expense* in the consolidated statement of operations.

**<u>Note 4 – Balance sheet components:</u>**

**Prepaid expenses and other current assets consist of the following:**

---

| | | |
|:---|:---|:---|
|  | December 31,<br> 2025 | December 31,<br> 2024 |
| Insurance | $101357 | $102657 |
| Rent | 18287 |  |
| Licenses | 19883 |  |
| Research and development | 60153 |  |
| Undeposited funds | 50000 |  |
| Other | 2054 | 2054 |
|  | $251734 | $104711 |

---

Property and equipment, net consists of the following:

---

| | | |
|:---|:---|:---|
| Leasehold improvements | $229742 | $229742 |
| Accumulated depreciation | (128053) | (82858) |
| &nbsp;&nbsp;&nbsp;Property and equipment, net | $101689 | $146884 |

---

Depreciation expense was $45,195 for the years ended December 31, 2025 and 2024.

Accrued expenses and other current liabilities consist of the following:

---

| | | |
|:---|:---|:---|
| Accrued payroll liabilities | $303890 | $225087 |
| Accrued interest | 1475669 | 352105 |
| Royalties | 190213 | 190213 |
| Legal | 750429 |  |
| Other accrued expenses | 59196 | 16945 |
|  | $2779397 | $784350 |

---

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

**<u>Note 5 – Convertible notes payable:</u>**

**Series A Secured Convertible Notes**

From March 2024 through August 2024, the Company issued $3,000,000 in principal amount of its secured convertible promissory notes (the "Series A Secured Convertible Notes") to accredited investors the repayment of which is secured by a grant of security interest in all of the Company's assets. The Series A Secured Convertible Notes accrue interest at the annual rate of 15% compounded quarterly and have a maturity date of December 31, 2027. The aggregate limit of the Series A Convertible Notes that can be issued is $3,000,000.

The conversion features of the Series A Secured Convertible Notes are as follows:

*Automatic Conversion* – The outstanding principal and unpaid accrued interest of each note shall be automatically converted into either (i) such equity securities sold in the Qualified Financing (equity financing of at least $20,000,000) a conversion price equal to the price paid per share for the equity securities paid by the investors in the Qualified Financing multiplied by 0.75, or (ii) Series A Preferred Stock of the Company at the price of $1.00 per share.

*Non-Qualified Financing Conversion* – The outstanding principal and unpaid accrued interest of each note may, at the sole election of the noteholder, be converted into either (i) such equity securities sold in the Non-Qualified Financing (equity financing of at least $10,000,000) at a conversion price equal to the price paid per share for the equity securities paid by the investors in the Non-Qualified Financing multiplied by 0.75, or (ii) Series A Preferred Stock of the Company at the price of $1.0 per share.

*Maturity Conversion* – If the closing of a Qualified Financing or a Non-Qualified has not occurred on or before the Maturity Date, then the holder of each note shall elect either: (i) the Company pay the holder an amount equal to the sum of all accrued and unpaid interest due plus (2) two times (2x) the outstanding principal balance; or (ii) the outstanding principal and unpaid accrued interest be converted into Series A Preferred Stock at the price of $1.00 per share.

*Corporate Transaction Conversion* – In the event of a Corporate Transaction the holder of each note may elect either: (i) the sum of all accrued and unpaid interest due plus (2) two times (2x) the outstanding principal balance; or (ii) the outstanding principal and unpaid accrued interest will convert, effective immediately prior to, but contingent upon, the consummation of such Corporate Transaction, into Series A Preferred Stock at the price of $1.00 per share.

*Qualified IPO Conversion* – In the event of a sale of shares of Common Stock of the Company in a Qualified IPO (at least $7,500,000 of gross proceeds), each note shall automatically convert into shares of Series A Preferred Stock of the Company.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

**Series A-1 Secured Convertible Notes**

From October 2024 through December 31, 2025, the Company issued $6,857,477 in principal amount of its secured convertible promissory notes (the "Series A-1 Secured Convertible Notes") to accredited investors the repayment of which is secured by a grant of security interest in all of the Company's assets which security interest is pari passu to the security interest granted to the Secured Convertible Note holders. The Series A-1 Secured Convertible Notes accrue interest at the annual rate of 15% compounded quarterly and have a maturity date of December 31, 2027. The aggregate limit of the Series A-1 Secured Convertible Notes that can be issued is $12,000,000.

The conversion features of the Series A-1 Secured Convertible Notes are as follows:

 

*Automatic Conversion* – The outstanding principal and unpaid accrued interest of each note shall be automatically converted into either (i) such equity securities sold in the Qualified Financing (equity financing of at least $20 million) a conversion price equal to the price paid per share for the equity securities paid by the investors in the Qualified Financing multiplied by 0.75, or (ii) Series A-1 Preferred Stock of the Company at the price of $3.33 per share.

*Non-Qualified Financing Conversion* – The outstanding principal and unpaid accrued interest of each note may, at the sole election of the noteholder, be converted into either (i) such equity securities sold in the Non-Qualified Financing (equity financing of at least $10 million) at a conversion price equal to the price paid per share for the equity securities paid by the investors in the Non-Qualified Financing multiplied by 0.75, or (ii) Series A-1 Preferred Stock of the Company at the price of $3.33 per share.

*Maturity Conversion* – If the closing of a Qualified Financing or a Non-Qualified has not occurred on or before the Maturity Date, then the holder of each note shall elect either: (i) the Company pay the holder an amount equal to the sum of all accrued and unpaid interest due plus two times the outstanding principal balance; or (ii) the outstanding principal and unpaid accrued interest be converted into Series A-1 Preferred Stock at the price of $3.33 per share. *Corporate Transaction Conversion* – In the event of a Corporate Transaction the holder of each note may elect either: (i) the sum of all accrued and unpaid interest due plus (2) two times (2x) the outstanding principal balance; or (ii) the outstanding principal and unpaid accrued interest will convert, effective immediately prior to, but contingent upon, the consummation of such Corporate Transaction, into Series A-1 Preferred Stock at the price of $3.33 per share.

*Qualified IPO Conversion* – In the event of a Qualified IPO the outstanding principal and unpaid accrued interest of each note will automatically convert into shares of Series A-1 Preferred Stock of the Company at the price of $3.33 per share.

While the Company anticipates an automatic conversion of the convertible notes due to achieving a Qualified Financing or Qualified IPO prior to maturity, a derivative liability of $1,349,735 has been recorded as the fair value of the possibility the notes will fully mature. See Note 3.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

**<u>Note 6 – Obligation for intellectual property:</u>**

The Company has licensed certain patents to be used in the development of future products. Certain licensing agreements provide for minimum payments as well as royalties on future net sales. An agreement entered into by the Company requires a payment of $50,000 within 60 days of the first commercial sale by the Company of any product capable of treating a heart by drawing heart walls together. In addition to the minimum payment above, the licensing agreement also provides for the payment of a royalty due on the sale of products at 3% of net sales, as defined in the agreement. The Company terminated the licensing agreement in October 2025 and has liability a balance of $140,213 and at December 31, 2024, and 2023. No royalty expense for this agreement was recorded during the years ended December 31, 2025 and 2024.

**<u>Note 7 – Related party transactions:</u>**

In February 2024, two members of the Board of Directors and entities controlled by them purchased 650,000 Preferred Series A shares from other investors. The directors subsequently sold 195,780 of these shares to the Company at cost to be used as incentive for certain purchasers of Series A Secured Convertible Notes (the "Sweetener Shares"). The Company acquired an additional 30,120 Preferred Series A shares from an investor for a total of 225,900 Sweetener Shares. See Note 9.

In March 2024, a member of the Board of Directors and entities controlled by him purchased $1,830,000 Series A Secured Convertible Notes from the Company. See Note 5.

In April 2024, the Company issued 225,900 Sweetener Shares to certain purchasers of Series A Secured Convertible Notes. An entity controlled by a member of the Board of Directors received 148,400 of the Sweetener Shares related to his $1,830,000 purchase of notes in March 2024. See Note 9.

In April 2024, the Company issued 216,000 restricted stock awards to two officers of the Company. These awards fully vested, resulting in $172,800 of stock-based compensation expense recorded in 2024. See Note 9.

In September 2024, the Company issued 88,000 restricted stock awards to two officers of the Company of which 51,300 vested, resulting in $41,064 of stock-based compensation expense recorded in 2024. The remaining 36,670 restricted stock awards vested in May 2025. See Note 9.

In January 2025, the Company issued 413,000 incentive stock options to two officers of the Company of which 103,250 vested, resulting in $39,952 of stock-based compensation expense recorded in 2025. The remaining 309,750 stock options will vest monthly through December 2028. See Note 9.

In October 2025, the Company issued 150,000 incentive stock options to two officers of the Company of which 9,375 vested, resulting in $5,581 of stock-based compensation expense recorded in 2025. The remaining 140,625 stock options will vest monthly through September 2029. See Note 9.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

In October 2025, the Company issued 25,000 non-qualified stock options to one officer of the Company of which 1,563 vested, resulting in $930 of stock-based compensation expense recorded in 2025. The remaining 23,437 stock options will vest monthly through September 2029. See Note 9.

In October 2025, the Company issued 90,000 non-qualified stock options to three members of the Company's board of directors of which 5,625 vested, resulting in $3,348 of stock-based compensation expense recorded in 2025. The remaining 84,375 stock options will vest monthly through September 2029. See Note 9.

**<u>Note 8 – Income taxes:</u>**

There is no provision for federal income taxes because the Company has incurred cumulative operating losses from the date of inception. The Company has made tax payments consisting of the state minimum tax. A reconciliation between the expected income tax provision at the federal statutory tax rate and the reported income tax provision is as follows:

---

| | | |
|:---|:---|:---|
|  | 2025 | 2024 |
| Federal income tax at statutory rate | (21.0)% | (21.0)% |
| State income tax net of federal benefit | (7.5)% | (6.3)% |
| Change in valuation allowance | 22.6% | 22.0% |
| Permanent differences | 0.1% | 0.0% |
| Research and development incentive | (0.7)% | 0.0% |
| Net operating loss expiration | 6.5% | 5.3% |
| Stock compensation conversion | 0.0% | 0.0% |
| &nbsp;&nbsp;&nbsp;Effective income tax rate | 0.0% | 0.0% |

---

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

The tax effects of temporary differences that give rise to significant portions of the Company's deferred tax assets and liabilities as of December 31, 2025, and 2024, are related to the following:

---

| | | |
|:---|:---|:---|
| Deferred tax assets: | 2025 | 2024 |
| Net operating loss carryforwards | $40823025 | $38505661 |
| &nbsp;&nbsp;&nbsp;Capitalized research and development | 4181056 | 4967980 |
| &nbsp;&nbsp;&nbsp;Research and development credits | 1221154 | 1174548 |
| &nbsp;&nbsp;&nbsp;Stock compensation | 144201 | 105509 |
| &nbsp;&nbsp;&nbsp;Lease liability | 67830 | 99552 |
| &nbsp;&nbsp;&nbsp;Inventory |  | 80600 |
| &nbsp;&nbsp;&nbsp;Fixed assets | 2173 | - |
|  | 46439439 | 44933850 |
| &nbsp;&nbsp;&nbsp;Less valuation allowance | (46366955) | (44836353) |
|  | $72484 | $97497 |
| Deferred tax liabilities |  |  |
| &nbsp;&nbsp;&nbsp;Fixed assets | $- | $(3385) |
| &nbsp;&nbsp;&nbsp;Other | (9159) |  |
| &nbsp;&nbsp;&nbsp;Right-of-use assets | (63325) | (94112) |
|  | $(72484) | $(97497) |
| Net deferred tax asset | - | $- |

---

The Company has incurred significant tax losses since inception. Based on the available objective evidence, management cannot conclude it is more likely than not that the net deferred tax assets will be fully realized. Accordingly, the Company has provided a full valuation allowance against its net deferred tax assets.

As of December 31, 2025, the Company had net operating loss carryforwards of $183,803,545 for federal tax purposes available to reduce future taxable income, if any. These carryforwards will expire as follows:

---

| | |
|:---|:---|
| 2026 | $2536405 |
| 2027 | 4692198 |
| 2028 | 3912543 |
| 2029 | 1707675 |
| 2030 | 3728577 |
| Thereafter | 59850050 |
| Indefinite | 107376097 |
|  | $183803545 |

---

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

As of December 31, 2025, the Company had net operating loss carryforwards of $35,194,306 for state tax purposes available to reduce future taxable income, if any. These carryforwards will expire as follows:

---

| | |
|:---|:---|
| 2043 | $16768931 |
| 2044.0 | 7379871 |
| 2045.0 | 11045504 |
|  | $35194306 |

---

Benefits from net operating loss carryforwards may be impaired or limited in certain circumstances. Events which may cause, or may have caused, limitation in the amount of net operating losses that the Company may utilize in any one year include but are not limited to a cumulative ownership change of more than 50% over a three-year period. The impact of any limitations that may be imposed due to current or future issuances of equity securities, including issuances with respect to acquisitions, has not been determined.

As of December 31, 2025, and 2024 the Company has research development credit carryforwards of $1,221,154 for federal and state tax purposes. If not utilized, the federal carryforward will expire in beginning in 2039.

The Company does not have any unrecognized tax benefits as of December 31, 2025. The Company did not recognize any expense for interest and penalties related to uncertain tax positions during 2025, and the Company does not have any amounts related to interest and penalties accrued at December 31, 2025.

The Company's income tax returns for the years ending December 31, 2022, and later, remain open for examination. Carryforward attributes from prior years may be adjusted upon examination by tax authorities if they are used in an open period.

**<u>Note 9 – Capital stock:</u>**

The Company's Third Amendment to the Amended and Restated Certificate of Incorporation, was filed on March 29, 2023, stating the total number of shares of all classes of stock which the corporation shall have authority to issue is 12,000,000 shares of common stock, $0.0001 par value per share and 4,850,000 shares of preferred stock, $0.0001 par value per share.

Total shares as of January 1, 2024, were as follows:

---

| | | | |
|:---|:---|:---|:---|
| **Class of Security** | **Shares<br> Authorized** | **Shares<br> Outstanding** | **Shares <br> Available** |
| Common | 10500000 | 5000971 | 5499029 |
| Common Stock Options | 1500000 |  | 1500000 |
| Series A Preferred | 4850000 | 1565000 | 3285000 |
| &nbsp;&nbsp;&nbsp;**January 1, 2024** | 16850000 | 6565971 | 10284029 |

---

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

In April 2024, the Company repurchased 225,900 Series A Preferred shares from three investors. The Company issued these 225,900 Sweetener Shares to certain purchasers of Series A Secured Convertible Notes. See Note 7.

Also, in April 2024, the Company issued 348,000 shares of restricted common stock to certain officers, directors and consultants of the Company. The restricted stock was valued at $0.80 per share based on an independent 409A valuation received from a global financial advisory firm specializing in corporate finance and business enterprise valuations. As the restricted shares fully vested by December 31, 2024, the Company recorded $278,400 in selling, general administration expenses in 2024. See Note 7.

In June 2024, the Company issued 132,674 shares of common stock to former Series A-1 preferred stock shareholders that were owed shares due to a miscalculation of shares issued as part of the re-capitalization of the Company on February 2, 2023. There was no additional cash received by the Company for the issuance of these shares.

In August 2024, the Company amended its Certificate of Incorporation to increase the number of authorized shares of common stock to 25,000,000 and preferred stock to 12,500,000 shares of which 6,000,000 were designated Series A and 6,500,000 were designated blank check preferred stock.

In August 2024, the Company adopted the 2024 Equity Incentive Plan (the "2024 Plan"), which provides for the granting of incentive stock options, nonstatutory stock options and restricted stock awards to employees, directors and consultants of the Company and its affiliates. See Note 10.

In September 2024, the Company issued 231,000 shares of restricted common stock to certain officers, directors and consultants of the Company. The restricted stock was valued at $0.80 per share based on an independent 409A valuation received from a global financial advisory firm specializing in corporate finance and business enterprise valuations. As 134,745 shares vested by December 31, 2024, the Company recorded $107,796 in selling, general administration expenses in 2024. The remaining 96,255 shares vested in 2025. See Note 7.

In October 2024, the Company filed Certificate of Designations of Series A-1 Preferred Stock providing for the authorization of 1,200,000 shares of Series A-1 Preferred Stock from the authorized but undesignated Blank Check Preferred Stock.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

As a result of the above transactions, total shares as of December 31, 2024, were as follows:

---

| | | | |
|:---|:---|:---|:---|
| **Class of Security** | **Shares<br> Authorized** | **Shares<br> Outstanding** | **Shares<br> Available** |
| Common | 23500000 | 5616390 | 17883610 |
| Common Stock Options | 1500000 |  | 1500000 |
| Series A Preferred | 6000000 | 1565000 | 4435000 |
| Series A-1 Preferred | 1200000 |  | 1200000 |
| Blank Check Preferred | 5300000 | - | 5300000 |
| **December 31, 2024** | 37500000 | 7181390 | 30318610 |

---

In January 2025, the Company granted 413,000 incentive stock options to officers under the Company's equity incentive plan. The options have an exercise price equal to the fair value of the Company's common stock on the grant date. Of the total options granted, 103,250 vested in 2025 and the remaining 309,750 vest in equal monthly installments through December 2028, subject to continued service. The options are equity-classified awards.

The weighted-average grant-date fair value of the options was $0.39 per share, resulting in an aggregate grant-date fair value of $159,808. The fair value was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: expected volatility of 50%, expected term of 6 years, risk-free interest rate of 4.62%, and an expected dividend yield of 0%.

The Company recognized $39,952 of stock-based compensation expense related to these options during the year ended December 31, 2025, which was recorded in selling, general and administrative expenses. As of December 31, 2025, total unrecognized compensation cost related to unvested stock options was **$**119,856, which is expected to be recognized over a weighted-average remaining vesting period of 3.0 years. See Note 7.

In February 2025, the Company granted 85,000 incentive stock options to employees under the Company's equity incentive plan. The options have an exercise price equal to the fair value of the Company's common stock on the grant date. Of the total options granted, 19,479 vested in 2025 and the remaining 65,521 vest in equal monthly installments through January 2029, subject to continued service. The options are equity-classified awards.

The weighted-average grant-date fair value of the options was $0.39 per share, resulting in an aggregate grant-date fair value of $32,776. The fair value was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: expected volatility of 50%, expected term of 6 years, risk-free interest rate of 4.52%, and an expected dividend yield of 0%.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

The Company recognized $7,511 of stock-based compensation expense related to these options during the year ended December 31, 2025, which was recorded in selling, general and administrative expenses. As of December 31, 2025, total unrecognized compensation cost related to unvested stock options was **$**25,265, which is expected to be recognized over a weighted-average remaining vesting period of 3.1 years.

In April 2025, the Company filed Certificate of First Amendment of Certificate of Designations of Series A-1 Preferred Stock increasing the amount of authorized shares designated as Series A-1 Preferred Stock from 1,200,000 shares to 3,000,000 shares from the Company's authorized Blank Check Preferred Stock.

In May 2025, the remaining 96,225 of restricted common stock awards issued in September 2024 became fully vested.

In June 2025, the Company granted 30,000 incentive stock options to employees under the Company's equity incentive plan. The options have an exercise price equal to the fair value of the Company's common stock on the grant date. Of the total options granted, 3,750 vested in 2025 and the remaining 26,250 vest in equal monthly installments through May 2029, subject to continued service. The options are equity-classified awards.

The weighted-average grant-date fair value of the options was $0.38 per share, resulting in an aggregate grant-date fair value of $11,496. The fair value was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: expected volatility of 50%, expected term of 6 years, risk-free interest rate of 4.34%, and an expected dividend yield of 0%.

The Company recognized $1,437 of stock-based compensation expense related to these options during the year ended December 31, 2025, which was recorded in selling, general and administrative expenses. As of December 31, 2025, total unrecognized compensation cost related to unvested stock options was **$**10,059, which is expected to be recognized over a weighted-average remaining vesting period of 3.5 years.

In August 2025, the Company filed Certificate of Second Amendment of Certificate of Designations of Series A-1 Preferred Stock increasing the amount of authorized shares designated as Series A-1 Preferred Stock from 3,500,000 shares to 5,500,000 shares the Company's authorized Blank Check Preferred Stock.

In October 2025, the Company granted 177,500 incentive stock options to officers and employees under the Company's equity incentive plan. The options have an exercise price equal to the fair value of the Company's common stock on the grant date. Of the total options granted, 11,094 vested in 2025 and the remaining 166,406 vest in equal monthly installments through September 2029, subject to continued service. The options are equity-classified awards. See Note 7.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

The weighted-average grant-date fair value of the options was $0.60 per share, resulting in an aggregate grant-date fair value of $105,561. The fair value was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: expected volatility of 50%, expected term of 6 years, risk-free interest rate of 4.12%, and an expected dividend yield of 0%.

The Company recognized $6,604 of stock-based compensation expense related to these options during the year ended December 31, 2025, which was recorded in selling, general and administrative expenses. As of December 31, 2025, total unrecognized compensation cost related to unvested stock options was **$**99,057, which is expected to be recognized over a weighted-average remaining vesting period of 3.8 years.

In October 2025, the Company granted 245,000 non-qualified stock options to members of the board of directors, consultants and an officer under the Company's equity incentive plan. The options have an exercise price equal to the fair value of the Company's common stock on the grant date. Of the total options granted, 15,313 vested in 2025 and the remaining 229,687 vest in equal monthly installments through September 2029, subject to continued service. The options are equity-classified awards. See Note 7.

The weighted-average grant-date fair value of the options was $0.60 per share, resulting in an aggregate grant-date fair value of $145,842. The fair value was estimated using the Black-Scholes option-pricing model with the following weighted-average assumptions: expected volatility of 50%, expected term of 6 years, risk-free interest rate of 4.12%, and an expected dividend yield of 0%.

The Company recognized $9,115 of stock-based compensation expense related to these options during the year ended December 31, 2025, which was recorded in selling, general and administrative expenses. As of December 31, 2025, total unrecognized compensation cost related to unvested stock options was **$**136,727, which is expected to be recognized over a weighted-average remaining vesting period of 3.8 years.

As a result of the above transactions, total shares as of December 31, 2025, were as follows:

---

| | | | |
|:---|:---|:---|:---|
| **Class of Security** | **Shares<br> Authorized** | **Shares<br> Outstanding** | **Shares<br> Available** |
| Common | 23500000 | 5712615 | 17787385 |
| Common Stock Options | 1500000 | 950500 | 549500 |
| Series A Preferred | 6000000 | 1565000 | 4435000 |
| Series A-1 Preferred | 5500000 |  | 5500000 |
| Blank Check Preferred | 1000000 | - | 1000000 |
| &nbsp;&nbsp;&nbsp;**December 31, 2025** | 37500000 | 8228115 | 29271885 |

---

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

**Rights and Preferences of Preferred Shareholders**

*Dividend*s – Holders of preferred stock are entitled to receive dividends whenever funds are legally available and when declared by the Board of Directors, subject to the prior rights of holders of all classes of stock outstanding. The holders of the Series A preferred stock are not entitled to cumulative dividends. No dividends have been declared by the board of directors as of December 31, 2025.

*Liquidation Rights* – In the event of any liquidation, dissolution, or winding-up of the Company, each holder of Series A preferred stock is entitled to receive a liquidation preference amount equal to one times the original issue price plus any dividends declared but unpaid. After payment of the full liquidation preference to holders of preferred stock the remaining assets of the Company legally available for distribution shall be distributed ratably to the holders of the common stock.

*Conversion* – Each share of preferred stock is convertible at the option of the holder into shares of common stock (subject to adjustment for certain events, including dilutive issuances, stock splits, and reclassifications) at a conversion price originally equal to the original issue price subject to certain adjustments.

*Mandatory Conversion, Series A Preferred Stock* – Upon an IPO with gross proceeds of $7,500,000 or more, the Series A Preferred Stock is subject to immediate mandatory conversion into Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate (defined as the Series A Original Issue Price divided by the Series A Conversion Price) or (B) one times (1x) the Original Issue Price of the Series A Preferred Stock divided by the price per share of the Common Stock issued in this offering. For Series A preferred shares, the original issue price is $10.00 per share and the current conversion price is $10.00 per share subject to adjustment for stock splits and other forms of recapitalization.

*Mandatory Conversion, Series A-1 Preferred Stock* – Upon the closing of an offering with gross proceeds of $7,500,000 or more, Series A-1 Preferred Stock is subject to immediate mandatory conversion into Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate (defined as the Series A-1 Original Issue Price divided by the Series A-1 Conversion Price) or (B) three times (3x) the Original Issue Price of the Series A-1 Preferred Stock divided by the price per share of the Common Stock issued in this offering. For Series A-1, the original issue price is $3.33 per share and the current conversion price is $3.33 per share subject to adjustment for stock splits and other forms of recapitalization.

*Voting Rights* – Each share of Series A preferred stock shall entitle the holder thereof to the number of votes per share equal to the number of shares of common stock into which such share is convertible.

**Rights and Preferences of Common Shareholders**

*Dividend*s – Holders of common stock are entitled to receive dividends whenever funds are legally available and when declared by the Board of Directors, subject to the prior rights of holders of all classes of stock outstanding.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

*Liquidation Rights* – after payment of the full liquidation preference to holders of preferred stock in the event of any liquidation, dissolution, or winding-up of the Company the remaining assets of the Company legally available for distribution shall be distributed ratably to the holders of the common stock.

*Voting Rights* – Each share of common stock is entitled to one vote.

*Reserved shares of common stock* – As of December 31, 2025, the Company had reserved shares of common stock for future issuance as follows:

---

| | |
|:---|:---|
| Series A Preferred Stock | 1565000 |
| Convertible Notes | 6099989 |
| Stock options available for grant | 549500 |
| Stock options outstanding | 950500 |
| Total common shares reserved | 9164989 |

---

**<u>Note 10 – Stock compensation plan:</u>**

In August 2024, the Company adopted the 2024 Equity Incentive Plan (the "2024 Plan"), which provides for the granting of incentive stock options, nonstatutory stock options and restricted stock awards to employees, directors and consultants of the Company and its affiliates.

The 2024 Plan is administered by the Board of Directors and permits the issuance of options for the purchase of shares of the Company's common stock. Options to purchase its common stock are granted at an exercise price not less than the fair value of the Company's common stock as of the date of grant. Nonstatutory stock options are granted at an exercise price not less than the fair value of the Company's common stock at the date of grant unless granted pursuant to a merger or other corporate transaction.

Options vest as determined by the Board of Directors and are exercisable for a maximum period of ten years after the date of grant. Under the terms of the 2024 Plan, certain options are immediately exercisable and subject to repurchase by the Company.

The 2024 Plan reserves a total of 1,500,000 shares that may be used. As of December 31, 2025, there were 950,500 shares granted under the 2024 Plan. See Note 9.

**<u>Note 11 – Commitments and contingencies:</u>**

The Company leases its facility under a non-cancelable lease agreement accounted for in accordance with ASC 842, Leases. The Company determines if an arrangement is a lease at inception. Right-of-use (ROU) assets represent the Company's right to use an underlying asset for the lease term, and lease liabilities represent the Company's obligation to make lease payments over the term. Lease ROU assets and liabilities are recognized at commencement based on the present value of lease payments over the lease term, using the Company's incremental borrowing rate unless the rate implicit in the lease is readily determinable.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

Lease-related assets and liabilities at December 31, consist of the following:

---

| | | |
|:---|:---|:---|
|  | 2025 | 2024 |
| Lease right of use asset | $231785 | $344487 |
| Lease liability, current | 146323 | 142061 |
| Lease liability, non-current | 101955 | 222332 |
| &nbsp;&nbsp;&nbsp;Total lease liability | $248278 | $364393 |

---

Lease payments remaining at December 31, 2025, consist of the following :

---

| | |
|:---|:---|
| 2026 | 153857 |
| 2027 | 118070 |
| Total lease payments | 271927 |
| Less: imputed interest at 11.67% | (23649) |
| Present value of lease payments | $248278 |
| Weighted-average remaining lease term | 1.75 years |

---

Lease expense of $145,962 was recorded in 2025 and 2024.

In the normal course of business, the Company is subject to various legal matters from which contingent liabilities may arise. The Company assesses, in conjunction with its legal counsel, the need to record a liability for litigation and contingencies. Reserve estimates are recorded when and if it is determined that a loss-related matter is both probable and reasonably estimable. As of December 31, 2025, and 2024, the Company did not have any material reserve estimates recorded.

On August 31, 2023, the Company received a complaint filed by former stockholder Gary Moline in the Court of Chancery of the State of Delaware against the Company, its officers and directors, and certain other parties. The complaint alleges, among other things, breaches of fiduciary duty in connection with the Company's recapitalization consummated in February 2023 and seeks class certification and an award of attorneys' fees. The complaint does not assert an amount of liquidated damages.

The Company believes it has meritorious defenses and intends to vigorously defend against the claims. On October 5, 2023, the Company filed a motion to dismiss. On May 1, 2024, the Court dismissed certain counts of the complaint. The Company filed its answer on June 12, 2024. The matter is currently in discovery.

Although the outcome of this matter is uncertain, the Company recorded an accrual of $600,000 as of December 31, 2025 related to a settlement proposal. The settlement proposal was not accepted, and there can be no assurance that the matter will be resolved on similar terms. The Company may incur additional losses in excess of the amount accrued, however such additional losses cannot be reasonably estimated at this time.

**BIOVENTRIX, INC.**

**Notes to Consolidated Financial Statements**

December 31, 2025 and 2024

**<u>Note 12 – Employee benefit plans:</u>**

The Company has a 401(k) Plan in which employees who have met certain eligibility requirements may participate. Each eligible employee may elect to contribute to the 401(k) Plan, and the Company may make discretionary contributions. For the years ended December 31, 2025, and 2024 the Company recorded contributions of $98,600 and $10,549, respectively.

**<u>Note 13 – Segments:</u>**

The Company operates in one reportable segment, which is the development of a new product to treat heart failure. The Company's chief operating decision maker ("CODM") is the chief executive officer. The CODM regularly reviews and uses consolidated net loss, as reported on our Consolidated Statements of Operations in evaluating the overall performance of our single reporting segment. As a result, the Company has determined that it has only one reportable segment.

Although the Company has generated minimal revenue during the reporting period, it continues to incur expenses related to research and development, general and administrative activities, and other operational costs. The CODM uses these expense categories to assess the Company's performance and allocate resources.

The accounting policies of the single segment are the same as those described in the summary of significant accounting policies. There have been no significant changes in measurement methods during the reporting period.

Geographically, we have no assets in a foreign country requiring separate disclosure.

The following table provides the significant expenses that management used to manage our one reportable segment:

---

| | | |
|:---|:---|:---|
|  | 2025 | 2024 |
| Research and development | $1173645 | $589951 |
| Selling, general and administrative | 5096785 | 2972565 |
| &nbsp;&nbsp;&nbsp;Total operating expenses | $6270430 | $3562516 |

---

**<u>Note 14 – Subsequent events:</u>**

In preparing the financial statements, the Company has evaluated all subsequent events and transactions for potential recognition or disclosure through the date of the of the Report of Independent Registered Accounting Firm, the date the financial statements were available for issuance.

In January 2026, the Company issued 90,000 restricted stock awards to the three independent members of the Company's board of directors, which will vest monthly through December 2027.

In January 2026, the Company sold $717,523 of Series A-1 Secured Convertible Notes.

**Through and including , 2026 (the 25<sup>th</sup> day after the date of this prospectus) all dealers that effect transactions in these securities, whether or not participating in the listing, may be required to deliver a prospectus. This is in addition to a dealer's obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Shares**

**Common Stock**

![](formdrs_002.jpg)

**BIOVENTRIX, INC.**

**PROSPECTUS**

**BENCHMARK, A STONEX** **COMPANY**

**, 2026**

**PART II — INFORMATION NOT REQUIRED IN PROSPECTUS**

**Item 13. Other Expenses of Issuance and Distribution**

The following table sets forth an itemized statement of the amounts of all our expenses (excluding underwriting discounts and non-accountable expense allowance) in connection with the registration of the common stock offered hereby. With the exception of the SEC registration fee, the FINRA filing fee and the Nasdaq initial listing fee, the amounts set forth below are estimates.

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| | |
|:---|:---|
| SEC registration fee | $2502 |
| FINRA filing fee | 2750 |
| Nasdaq initial listing fee | 50000 |
| Transfer agent fees | 5000 |
| Accounting fees and expenses | **[●]** |
| Legal fees and expenses | **[●]** |
| Printing and engraving expenses | 30000 |
| Other expenses | **[●]** |
| Total | $**[●]** |

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**Item 14. Indemnification of Directors and Officers**

Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys' fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with any threatened, pending or completed actions, suits or proceedings in which such person is made a party by reason of such person being or having been a director, officer, employee or agent of the corporation. Section 145 of the Delaware General Corporation Law also provides that expenses (including attorneys' fees) incurred by a director or officer in defending an action may be paid by a corporation in advance of the final disposition of an action if the director or officer undertakes to repay the advanced amounts if it is determined such person is not entitled to be indemnified by the corporation. The Delaware General Corporation Law provides that Section 145 is not exclusive of other rights to which those seeking indemnification may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise. Our amended and restated bylaws, which will be in effect upon the consummation of this offering, provide that, to the fullest extent permitted by law, we shall indemnify and hold harmless any person who was or is made or is threatened to be made a party or is otherwise involved in any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative by reason of the fact that such person, or the person for whom he is the legally representative, is or was a director or officer of ours, against all liabilities, losses, expenses (including attorney's fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such proceeding.

The Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director or officer of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability of (i) a director or officer for any breach of his or her duty of loyalty to the corporation or its stockholders, (ii) a director or officer for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) a director for unlawful payments of dividends or unlawful stock repurchases, redemptions or other distributions, (iv) a director or officer for any transaction from which he or she derived an improper personal benefit, or (v) an officer in any action by or in the right of the corporation. Our amended and restated certificate of incorporation includes this provision.

Additionally, our fourth amended and restated certificate of incorporation provides that we shall, to the maximum extent permitted from time to time under the law of the State of Delaware, indemnify and upon request shall advance expenses to any person who is or was a party or is threatened to be made a party to any threatened, pending or completed action, suit, proceeding or claim, whether civil, criminal, administrative or investigative, by reason of the fact that such person is or was or has agreed to be a director or officer of ours or while a director or officer is or was serving at our request as a director, officer, partner, trustee, employee or agent of any corporation, partnership, joint venture, trust or other enterprise, including service with respect to employee benefit plans, against expenses (including attorneys' fees and expenses), judgments, fines, penalties and amounts paid in settlement incurred in connection with the investigation, preparation to defend or defense of such action, suit, proceeding or claim; provided, however, that the foregoing shall not require us to indemnify or advance expenses to any person in connection with any action, suit, proceeding or claim initiated by or on behalf of such person or any counterclaim against us initiated by or on behalf of such person. Such indemnification shall not be exclusive of other indemnification rights arising under any by-law, agreement, vote of directors or stockholders or otherwise and shall inure to the benefit of the heirs and legal representatives of such person. Any person seeking indemnification shall be deemed to have met the standard of conduct required for such indemnification unless the contrary shall be established. Any repeal or modification of our amended and restated certificate of incorporation shall not adversely affect any right or protection of a director or officer of ours with respect to any acts or omissions of such director or officer occurring prior to such repeal or modification.

Expenses incurred by such a person in defending a civil or criminal action, suit or proceeding by reason of the fact that such person is or was, or has agreed to become, a director or officer of ours, or is or was serving, or has agreed to serve, at our request, as a director, officer or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, including any employee benefit plan, or by reason of any action alleged to have been taken or omitted in such capacity shall be paid by us in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such person to repay such amount if it shall ultimately be determined that he is not entitled to be indemnified by us as authorized by relevant sections of the Delaware General Corporation Law. Notwithstanding the foregoing, we shall not be required to advance such expenses to a person who is a party to an action, suit or proceeding brought by us and approved by a majority of our Board of Directors that alleges willful misappropriation of corporate assets by such person, disclosure of confidential information in violation of such person's fiduciary or contractual obligations to us or any other willful and deliberate breach in bad faith of such person's duty to us or our stockholders.

We shall not indemnify any such person seeking indemnification in connection with a proceeding (or part thereof) initiated by such person unless the initiation thereof was approved by our Board of Directors.

The indemnification rights provided in our amended and restated bylaws, which will be in effect upon the consummation of this offering, shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any by-law, agreement or vote of stockholders or disinterested directors or otherwise, both as to action in their official capacities and as to action in another capacity while holding such office, continue as to such person who has ceased to be a director or officer, and inure to the benefit of the heirs, executors and administrators of such a person.

If the Delaware General Corporation Law is amended to expand further the indemnification permitted to indemnitees, then we shall indemnify such persons to the fullest extent permitted by the Delaware General Corporation Law, as so amended.

We may, to the extent authorized from time to time by our Board of Directors, grant indemnification rights to other employees or agents of ours or other persons serving us and such rights may be equivalent to, or greater or less than, those set forth in our amended and restated bylaws, which will be in effect upon the consummation of this offering.

Our obligation to provide indemnification under our amended and restated bylaws, which will be in effect upon the consummation of this offering, shall be offset to the extent of any other source of indemnification or any otherwise applicable insurance coverage under a policy maintained by us or any other person.

To assure indemnification under our amended and restated bylaws, which will be in effect upon the consummation of this offering, of all directors, officers, employees or agents who are determined by us or otherwise to be or to have been "fiduciaries" of any employee benefit plan of ours that may exist from time to time, Section 145 of the Delaware General Corporation Law shall, for the purposes of our amended and restated bylaws, which will be in effect upon the consummation of this offering, be interpreted as follows: an "other enterprise" shall be deemed to include such an employee benefit plan, including without limitation, any plan of ours that is governed by the Act of Congress entitled "Employee Retirement Income Security Act of 1974," as amended from time to time; we shall be deemed to have requested a person to serve an employee benefit plan where the performance by such person of his duties to us also imposes duties on, or otherwise involves services by, such person to the plan or participants or beneficiaries of the plan; and excise taxes assessed on a person with respect to an employee benefit plan pursuant to such Act of Congress shall be deemed "fines."

Our amended and restated bylaws, which will be in effect upon the consummation of this offering, shall be deemed to be a contract between us and each person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that person is or was, or has agreed to become, a director or officer of ours, or is or was serving, or has agreed to serve, at our request, as a director, officer or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, including any employee benefit plan, or by reason of any action alleged to have been taken or omitted in such capacity, at any time while this by-law is in effect, and any repeal or modification thereof shall not affect any rights or obligations then existing with respect to any state of facts then or theretofore existing or any action, suit or proceeding theretofore or thereafter brought based in whole or in part upon any such state of facts.

The indemnification provision of our amended and restated bylaws, which will be in effect upon the consummation of this offering, does not affect directors' responsibilities under any other laws, such as the federal securities laws or state or federal environmental laws.

We may purchase and maintain insurance on behalf of any person who is or was a director, officer or employee of ours, or is or was serving at our request as a director, officer, employee or agent of another company, partnership, joint venture, trust or other enterprise against liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or not we would have the power to indemnify him against liability under the provisions of this section. We currently maintain such insurance.

The right of any person to be indemnified is subject to our right, in lieu of such indemnity, to settle any such claim, action, suit or proceeding at our expense of by the payment of the amount of such settlement and the costs and expenses incurred in connection therewith.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling our company pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

In the event that a claim for indemnification against such liabilities (other than the payment of expenses incurred or paid by a director, officer or controlling person in a successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered herewith, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to the court of appropriate jurisdiction the question whether such indemnification by us is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

We have entered or will enter into, and intend to continue to enter into, separate indemnification agreements with our directors and officers that may be broader than the specific indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things, to indemnify our officers and directors against certain liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct. These indemnification agreements also generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act.

**Item 15. Recent Sales of Unregistered Securities**

During the last three years, the Company has not issued unregistered securities to any person, except as described below. None of these transactions involved any underwriters, underwriting discounts or commissions, except as specified below, or any public offering, and, unless otherwise indicated below, the Company believes that each transaction was exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof and/or Rule 506 of Regulation D promulgated thereunder, and/or Regulation S promulgated thereunder regarding offshore offers and sales. All recipients had adequate access, though their relationships with the Company, to information about the Company.

*April 2022 Through August 2022 Series B Preferred Stock Financing*

From April 2022 through August 2022, the Company issued $10,000,000 of Series B Preferred Stock to accredited investors. As noted below, such Series B Preferred Stock were later exchanged for Common Stock pursuant to the February 2023 recapitalization.

*January 2023 Unsecured Convertible Note Financing*

In January 2023, the Company issued $3,000,000 in principal amount of its unsecured convertible promissory notes (the "Unsecured Convertible Notes") to accredited investors which $3,000,000 principal amount included the exchange of $1,000,000 in principal amount of its then outstanding unsecured short-term promissory notes for $1,000,000 in principal amount of Unsecured Convertible Notes. The Unsecured Convertible Notes accrue interest at an annual rate of 10%, had a maturity date of June 30, 2023, and the principal amount automatically converts into the type of securities issued by the Company in a subsequent equity financing of at least $10,000,000 in gross proceeds at the price per share paid by investors in the equity financing. A cash fee of 1.5% of the principal amount of the Unsecured Convertible Note is also due on the earlier of the conversion of the Unsecured Convertible Note or the maturity date of the Unsecured Convertible Note. On March 21, 2023, the Company issued an additional Unsecured Convertible Note in the principal amount of $2,650,000. The aggregate outstanding amount of $5,650,000 was later converted into preferred stock in the March 2023 Series A Preferred Stock Financing.

*February 2023 Recapitalization*

In February 2023, the Company completed a recapitalization pursuant to which all of the Company's then outstanding Common Stock, Series A Preferred Stock, Series A-1 Preferred Stock, Series B Preferred Stock were exchanged for new shares of Common Stock of the Company, and all of the Company's outstanding Common Stock then underwent a reverse Common Stock split of 1 share of Common Stock share for each 65,500 shares of Common Stock with any fractional shares of Common Stock existing immediately after the reverse Common Stock split being purchased in cash by the Company at fair value. Additionally, substantially all of the Company's then outstanding stock options and warrants were exchanged for Common Stock.

*March 2023 Series A Preferred Stock Financing*

On March 30, 2023, the Company consummated a Series A Preferred Stock financing (the "March 2023 Series A Preferred Stock Financing") pursuant to which the Company issued $15,650,000 of newly authorized Series A Preferred Stock (which amount included the conversion of the $5,650,000 in principal amount of the Company's then outstanding Unsecured Convertible Notes) to accredited investors at the initial closing with the potential for issuance of up to $32,850,000 in additional Series A Preferred Stock in subsequent closings if certain milestones were achieved by the Company on or before September 30, 2023. Such milestones were not achieved by the Company. In connection with the March 2023 Series A Preferred Stock Financing, the Company amended and restated its then existing Second Amended and Restated Certificate of Incorporation to read as set forth in its Third Amended and Restated Certificate of Incorporation which amended and restated certificate provided for an immediate forward Common Stock split of 176.582 shares of Common Stock for each 1 share of outstanding Common Stock and set forth the rights, preferences, and privileges of the newly authorized Series A Preferred Stock. Additionally, as part of the March 2023 Series A Preferred Stock Financing, the Company entered into an Investors' Rights Agreement, a Right of First Refusal and Co-Sale Agreement, and a Voting Agreement with the holders of the Company's Series A Preferred Stock and certain holders of the Company's Common Stock. The Right of First Refusal and Co-Sale Agreement and the Voting Agreement automatically terminate immediately prior to the closing of this offering. Subsequent to the closing of the March 2023 Series A Preferred Stock Financing, the Company filed two amendments to its Third Amended and Restated Certificate of Incorporation which amendments amended, reduced or eliminated several rights of the Series A Preferred Stock, increased the authorized amount of Common Stock and Preferred Stock, and designated some of the authorized Preferred Stock as Blank Check Preferred Stock. Upon the closing of this offering (assuming gross proceeds of $7,500,000 to the Company in this offering), the Series A Preferred Stock is subject to mandatory conversion such that each outstanding share of Series A Preferred Stock will automatically convert into shares of Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate as calculated pursuant to <u>Section 5</u> of the Third Amended and Restated Certificate of Incorporation, as amended or (B) the original issue price of the Series A Preferred Stock divided by the price per share of the Common Stock issued in this offering.

*March 2024 Through August 2024 Series A Secured Convertible Note Financing*

From March 2024 through August 2024, we issued $3,000,000 in principal amount of secured convertible promissory notes (the "Series A Secured Convertible Notes") to accredited investors the repayment of which is secured by a grant of security interest in all of our assets. We also issued shares of our Series A Preferred Stock to those purchasers that had purchased at least $50,000 in principal amount of the Secured Convertible Notes on or before March 21, 2024 (the "Series A Sweetener Shares"). As part of the Series A Secured Convertible Note financing, we repurchased from certain holders of Series A Preferred Stock the same amount of Series A Preferred Stock shares as the amount of Series A Sweetener Shares that were issued to certain purchasers of the Series A Secured Convertible Notes. The Series A Secured Convertible Notes accrue interest at the annual rate of 15% compounded quarterly and have a maturity date of December 31, 2027. The Series A Secured Convertible Notes will automatically convert into shares of our Series A Preferred Stock immediately prior to the closing of this offering (assuming gross proceeds of $7,500,000 to us in this offering), which Series A Preferred Stock is then subject to immediate mandatory conversion into Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate as calculated pursuant to <u>Section 5</u>of the Third Amended and Restated Certificate of Incorporation, as amended or (B) the original issue price of the Series A Preferred Stock divided by the price per share of the Common Stock issued in this offering.

*October 2024 Through January 2026 Series A-1 Secured Convertible Note Financing*

From October 2024 through January 2026, we issued $7,575,000 in principal amount of its secured convertible promissory notes (the "Series A-1 Secured Convertible Notes") to accredited investors the repayment of which is secured by a grant of security interest in all of our assets which security interest is pari passu to the security interest granted to the Secured Convertible Note holders. The Series A-1 Secured Convertible Notes accrue interest at the annual rate of 15% compounded quarterly and have a maturity date of December 31, 2027. As part of the Series A-1 Secured Convertible Note financing, we filed a Certificate of Designations of the Rights, Preferences and Privileges of Series A-1 Preferred Stock which designated a new Series A-1 Preferred Stock from its authorized Blank Check Preferred Stock. The Series A-1 Secured Convertible Notes automatically convert into shares of Series A-1 Preferred Stock at the conversion price of $3.33 per share immediately prior to the closing of this Offering (assuming gross proceeds of $7,500,000 to us in this offering), which shares of Series A-1 Preferred Stock are then subject to immediate mandatory conversion into Common Stock at a conversion rate equal to the greater of (A) the then effective conversion rate as calculated pursuant to Section 5 of the Certificate of Designations of Rights, Preferences and Privileges of Series A-1 Preferred Stock or (B) three times (3x) the original issue price of the Series A Preferred Stock divided by the price per share of the Common Stock issued in this offering.

**Item 16. Exhibits**

The following is a list of exhibits filed as a part of this registration statement:

---

| | |
|:---|:---|
| **Exhibit Number** | **Description of Document** |
| 1.1\*\* | [Form of Underwriting Agreement](ex1-1.htm) |
| 3.1\* | [Third Amended and Restated Certificate of Incorporation of BioVentrix, Inc.](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-1.htm) |
| 3.2\* | [Amendment No. 1 to Third Amended and Restated Certificate of Incorporation of BioVentrix, Inc.](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-2.htm) |
| 3.3\* | [Amendment No. 2 to Third Amended and Restated Certificate of Incorporation of BioVentrix, Inc.](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-3.htm) |
| 3.4\* | [Amendment No. 3 to Third Amended and Restated Certificate of Incorporation of BioVentrix, Inc.](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-4.htm) |
| 3.5\* | [Fourth Amended and Restated Certificate of Incorporation of BioVentrix, Inc., to be in effect upon the consummation of the initial public offering](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-5.htm) |
| 3.6\*\* | [Bylaws of BioVentrix, Inc.](ex3-6.htm) |
| 3.7\* | [Certificate of Designations of the Series A-1 Preferred Stock](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-7.htm) |
| 3.8\* | [Certificate of First Amendment of Certificate of Designations of the Rights, Preferences and Privileges of the Series A-1 Preferred Stock](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-8.htm) |
| 3.9\* | [Certificate of Second Amendment of Certificate of Designations of the Rights, Preferences and Privileges of the Series A-1 Preferred Stock](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex3-9.htm) |
| 4.1\* | [Form of Underwriters' Warrant](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex4-1.htm) |
| 5.1\* | [Opinion of Ellenoff Grossman & Schole LLP](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex5-1.htm) |
| 10.1\* | [Form of Indemnification Agreement](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex10-1.htm) |
| 10.2\* | [2024 Equity Incentive Plan](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex10-2.htm) |
| 10.3\*\* | [2026 Equity Incentive Plan](ex10-3.htm) |
| 10.4\*\* | [Form of David Richmond Employment Agreement](ex10-4.htm) |
| 10.5\*\* | [Form of Steve Chartier Employment Agreement](ex10-5.htm) |
| 10.6\* | [Lease between BioVentrix, Inc. and Brickman Forbes Boulevard LLC](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex10-5.htm) |
| 10.7\*\* | [Exclusive License Agreement, dated as of December 28, 2021, by and between BioVentrix Inc. and Henry Ford Health System](ex10-7.htm) |
| 10.8\*\* | [Amendment to Exclusive License Agreement, dated as of February 12, 2025](ex10-8.htm) |
| 10.9\* | [Investors' Rights Agreement, dated March 30, 2023, by and among BioVentrix and the other parties thereto](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex10-8.htm) |
| 10.10\* | [Form of Lockup Agreement](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex10-9.htm) |
| 14.1\* | [Form of Code of Ethics of BioVentrix, Inc.](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex14-1.htm) |
| 21.1\* | [List of Subsidiaries](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex21-1.htm) |
| 23.1\*\* | [Consent of M&K CPAS PLLC, Independent Registered Public Accounting Firm](ex23-1.htm) |
| 23.2\* | [Consent of Ellenoff Grossman & Schole LLP (contained in Exhibit 5.1)](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex5-1.htm) |
| 24.1\* | [Powers of Attorney (included on signature page to this registration statement)](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/forms-1.htm#D_012) |
| 99.1\* | [Form of Audit Committee Charter](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex99-1.htm) |
| 99.2\* | [Form of Compensation Committee Charter](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex99-2.htm) |
| 99.3\* | [Form of Nominating and Corporate Governance Committee Charter](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex99-3.htm) |
| 107\* | [Filing Fee Table](https://www.sec.gov/Archives/edgar/data/1283259/000149315226006407/ex107.htm) |

---

\* Previously filed. <br>\*\* Filed herewith.

**Item 17. Undertakings** 

The undersigned registrant hereby undertakes:

&nbsp;&nbsp;&nbsp;&nbsp;1. To
 file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. To
 include any prospectus required by section 10(a)(3) of the Securities Act of 1933;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. To
 reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent
 post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set
 forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if
 the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end
 of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b)
 if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set
 forth in the "Calculation of Filing Fee Tables" or "Calculation of Registration Fee" table, as applicable,
 in the effective registration statement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. To
 include any material information with respect to the plan of distribution not previously disclosed in the registration statement
 or any material change to such information in the registration statement.

&nbsp;&nbsp;&nbsp;&nbsp;2. That,
 for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed
 to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall
 be deemed to be the initial bona fide offering thereof.

&nbsp;&nbsp;&nbsp;&nbsp;3. To
 remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the
 termination of the offering.

&nbsp;&nbsp;&nbsp;&nbsp;4. That,
 for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. If
 the registrant is relying on Rule 430B, each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part
 of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for
 the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and
 included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or
 the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability
 purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of
 the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering
 of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement
 made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed
 incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a
 purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration
 statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective
 date.

&nbsp;&nbsp;&nbsp;&nbsp;5. That,
 for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution
 of the securities:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. The
 undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration
 statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold
 to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and
 will be considered to offer or sell such securities to such purchaser:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. Any
 preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule
 424;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. Any
 free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by
 the undersigned registrant;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. The
 portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant
 or its securities provided by or on behalf of the undersigned registrant; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. Any
 other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

&nbsp;&nbsp;&nbsp;&nbsp;6. Insofar
 as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
 persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion
 of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore,
 unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of
 expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action,
 suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered,
 the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court
 of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and
 will be governed by the final adjudication of such issue.

&nbsp;&nbsp;&nbsp;&nbsp;7. The
 undersigned registrant hereby undertakes that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. For
 purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed
 as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant
 to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the
 time it was declared effective.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. For
 the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of
 prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such
 securities at that time shall be deemed to be the initial bona fide offering thereof.

**SIGNATURES**

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the Town of Mansfield, Commonwealth of Massachusetts, on March 17, 2026.

---

| | |
|:---|:---|
| **BioVentrix, Inc.** | **BioVentrix, Inc.** |
| By: | */s/ David Richmond* |
| Name: | David Richmond |
| Title: | Co-Chief Executive Officer |

---

---

| | | |
|:---|:---|:---|
| **Signature** | **Title** | **Date** |
| */s/ David Richmond* | Chairman of the Board, Co-Chief Executive Officer and Chief Financial Officer | March 17, 2026 |
| David Richmond | *(Principal Executive Officer, Principal Accounting Officer and Principal Financial Officer)* |  |
| */s/ Steven Chartier* | Co-Chief Executive Officer, President and Director | March 17, 2026 |
| Steven Chartier |  |  |
| */s/ Mark Ravich* | Director | March 17, 2026 |
| Mark Ravich |  |  |
| */s/ Rishi Puri* | Director | March 17, 2026 |
| Rishi Puri |  |  |
| */s/ William Abraham* | Director | March 17, 2026 |
| William Abraham |  |  |

---

## Exhibit 1.1

**Exhibit 1.1**

**BIOVENTRIX, INC.**

**UNDERWRITING AGREEMENT**

New York, New York

[—] [—], 2026

The Benchmark Company, LLC

As Representative of the several underwriters named on Schedule 1 attached hereto

150 E. 58<sup>th</sup> Street, 17<sup>th</sup> Floor

New York, NY 10155

Ladies and Gentlemen:

The undersigned, BioVentrix, Inc., a Delaware corporation (collectively with its subsidiaries and affiliates, the "<u>Company</u>"), hereby confirms its agreement (this "<u>Agreement</u>") with The Benchmark Company, LLC (hereinafter referred to as "<u>you</u>" (including its correlatives) or the "<u>Representative</u>"), and with the other underwriters named on <u>Schedule 1</u> hereto for which the Representative is acting as representative (the Representative and such other underwriters being collectively called the "<u>Underwriters</u>" or, individually, an "<u>Underwriter</u>" and if there are no Underwriters other than the Representative, references to multiple Underwriters shall be disregarded and the term Representative shall have the same meaning as Underwriter and all corresponding changes from plural to singular shall be deemed to have been made) as follows:

1 <u>Purchase and Sale of Shares</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1 *Firm Shares*.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.1 <u>Nature and Purchase of Firm Shares</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) On the basis of the representations and warranties herein contained, but subject to the terms and conditions herein set forth, the Company agrees to issue and sell to the several Underwriters, an aggregate of [—] shares ("<u>Firm Shares</u>") of the Company's common stock, $0.0001 par value per share (the "<u>Common Stock</u>").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) The Underwriters, severally and not jointly, agree to purchase from the Company the number of Firm Shares set forth opposite their respective names on <u>Schedule 1</u> attached hereto and made a part hereof at a purchase price of $[—] per share (93% of the per Firm Share offering price). The Firm Shares are to be offered initially to the public at the offering price set forth on the cover page of the Prospectus (as defined in Section 2.1.1 hereof).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.2 <u>Firm Shares Payment and Delivery</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) Delivery and payment for the Firm Shares shall be made at 10:00 a.m., Eastern time, on [—] [—], 2026, or at such other time as shall be agreed upon by the Representative and the Company, at the offices of Ellenoff Grossman & Schole LLP, 1345 Avenue of the Americas, New York, NY 10105 ("<u>Company Counsel</u>"), or McGuireWoods LLP, 1251 Avenue of the Americas, 20<sup>th</sup> Floor, New York, NY 10020 ("<u>Representative Counsel</u>") or at such other place (or remotely by facsimile or other electronic transmission) as shall be agreed upon by the Representative and the Company. The hour and date of delivery and payment for the Firm Shares is hereinafter called the "<u>Closing Date</u>."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) Payment for the Firm Shares shall be made on the Closing Date by wire transfer in Federal (same day) funds, payable to the order of the Company upon delivery of the certificates (in form and substance satisfactory to the Underwriters) representing the Firm Shares or through the facilities of the Depository Trust Company ("<u>DTC</u>") for the account of the Underwriters. The Firm Shares shall be registered in such name or names and in such authorized denominations as the Representative may request in writing at least two (2) full Business Days prior to the Closing Date. The Company shall not be obligated to sell or deliver the Firm Shares except upon tender of payment by the Representative for all of the Firm Shares. The term "<u>Business Day</u>" means any day other than a Saturday, a Sunday or a legal holiday or a day on which banking institutions are authorized or obligated by law to close in New York, New York.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2 *Over-Allotment Option*.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2.1 Solely for the purposes of covering any over-allotments in connection with the distribution and sale of the Firm Shares, the Representative is hereby granted an option (the "<u>Over-Allotment Option</u>") to purchase, in the aggregate, up to [—] shares of Common Stock, representing 15% of the Firm Shares (the "<u>Option Shares</u>" and, collectively with the Firm Shares, the "<u>Public Shares</u>" and the offering of the Public Shares, the Representative's Warrants and the Representative Warrant Shares (each as defined below) the "<u>Offering</u>"). If the Over-Allotment Option is exercised in whole or in part, the Option Shares shall be purchased by the Underwriters in the amounts set forth opposite their respective names on <u>Schedule 1</u> attached hereto (or a pro rata portion thereof if less than the full Over-Allotment Option is exercised).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2.2 In connection with an exercise of the Over-Allotment Option, the aggregate purchase price to be paid for the Option Shares is equal to the product of the number of Option Shares to be purchased multiplied by the same price per share paid by the Underwriters for the Firm Shares as provided for in Section 1.1.1(ii).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2.3 The Over-Allotment Option granted pursuant to this Section 1.2 may be exercised by the Representative as to all (at any time) or any part (from time to time) of the Option Shares within thirty (30) days after the Closing Date. An Underwriter will not be under any obligation to purchase any Option Shares prior to the exercise of the Over-Allotment Option. The Over-Allotment Option granted hereby may be exercised by the giving of written notice to the Company from the Representative, setting forth the number of Option Shares to be purchased and the date and time for delivery of and payment for the Option Shares (each, an "<u>Option Closing Date</u>"), which will not be later than two (2) full Business Days after the date of the notice or such other time as shall be agreed upon by the Company and the Representative, at the offices of Company Counsel or at such other place (including remotely by facsimile or other electronic transmission) as shall be agreed upon by the Company and the Representative. If such delivery and payment for the Option Shares does not occur on the Closing Date, each Option Closing Date will be as set forth in the notice. Upon exercise of the Over-Allotment Option, the Company will become obligated to convey to the Underwriters, and, subject to the terms and conditions set forth herein, the Underwriters will become obligated to purchase, the number of Option Shares specified in such notice, provided that the Company's obligation to sell and deliver the Option Shares shall be conditioned upon the Representative's tender of payment for the applicable Option Shares. The Representative shall deliver the aggregate Option Closing Purchase Price to the Company on the Closing Date or any Option Closing Date. The Representative may cancel the Over-Allotment Option at any time prior to the expiration of the Over-Allotment Option by written notice to the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3 *Representative's Warrants*.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3.1 The Company hereby agrees to issue to the Representative (and/or its designees) on the Closing Date warrants for the purchase of the number of shares of Common Stock equal to five percent (5%) of the total number of Firm Shares, and upon any Option Closing Date, five percent (5%) of the total number of Option Shares sold on such Option Closing Date, in each case pursuant to a warrant substantially in the form hereto as <u>Exhibit C</u> (the "<u>Representative's Warrants</u>"). The Representative's Warrants shall be exercisable, in whole or in part, commencing on the date that is the first day of the seventh month after the Closing Date and expiring on the five (5) year anniversary of the date of this Agreement, and shall be exercisable at an initial exercise price equal to the public offering price per share, and may be exercised on a cashless basis. The shares of Common Stock issuable upon exercise of the Representative's Warrants are hereinafter referred to together as the "<u>Representative Warrant Shares</u>." The Representative understands and agrees that there are significant restrictions pursuant to FINRA Rule 5110 against transferring the Representative's Warrants and the Representative Warrant Shares during the 180 days after the commencement date of sales in the Offering and by its acceptance thereof shall agree that it will not sell, transfer, assign, pledge or hypothecate the Representative's Warrants, or any portion thereof, or be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of such securities for a period of 180 days after the commencement date of sales in the Offering, except as expressly permitted by FINRA Rule 5110(e), and only if any such transferee agrees to the foregoing lock-up restrictions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3.2 Delivery of the Representative's Warrants shall be made on the Closing Date and any Option Closing Date, as applicable, and shall be issued in the name or names and in such authorized denominations as the Representative may reasonably request.

2 <u>Representations and Warranties of the Company</u>. The Company hereby represents and warrants to the Underwriters as of the Applicable Time (as defined below), the Closing Date and any Option Closing Date, as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1 <u>Filing of Registration Statement</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.1 <u>Pursuant to the Securities Act</u>. The Company has filed with the U.S. Securities and Exchange Commission (the "<u>Commission</u>") a registration statement, and an amendment or amendments thereto, on Form S-1 (File No. 333-293418), including any related prospectus or prospectuses, for the registration of the Public Shares under the Securities Act of 1933, as amended (the "<u>Securities Act</u>"), which registration statement and amendment or amendments have been prepared by the Company in all material respects in conformity with the requirements of the Securities Act and the rules and regulations of the Commission under the Securities Act (the "<u>Securities Act Regulations</u>") and will contain all material statements that are required to be stated therein in accordance with the Securities Act and the Securities Act Regulations. Except as the context may otherwise require, such registration statement, as amended, on file with the Commission at the time the registration statement became effective (including the Preliminary Prospectus included in the registration statement, financial statements, schedules, exhibits and all other documents filed as a part thereof or incorporated therein and all information deemed to be a part thereof as of its effective date (the "<u>Effective Date</u>") pursuant to paragraph (b) of Rule 430A of the Securities Act Regulations (the "<u>Rule 430A Information</u>")), is referred to herein as the "<u>Registration Statement</u>." If the Company files any registration statement pursuant to Rule 462(b) of the Securities Act Regulations, then after such filing, the term "<u>Registration Statement</u>" shall include such registration statement filed pursuant to Rule 462(b). The Registration Statement has been declared effective by the Commission on the date hereof.

Each prospectus used prior to the effectiveness of the Registration Statement, and each prospectus that omitted the Rule 430A Information that was used after such effectiveness and prior to the execution and delivery of this Agreement, is herein called a "<u>Preliminary Prospectus</u>." The Preliminary Prospectus, subject to completion, dated [—] [—], 2026, that was included in the Registration Statement immediately prior to the Applicable Time is hereinafter called the "<u>Pricing Prospectus</u>." The final prospectus in the form first furnished to the Underwriters for use in the Offering is hereinafter called the "<u>Prospectus</u>."

"<u>Applicable Time</u>" means [—] p.m., Eastern Time, on the date of this Agreement.

"<u>Issuer Free Writing Prospectus</u>" means any "issuer free writing prospectus," as defined in Rule 433 of the Securities Act Regulations ("<u>Rule 433</u>"), including, without limitation, any "free writing prospectus" (as defined in Rule 405 of the Securities Act Regulations) relating to the Public Shares, the Representative's Warrants and/or the Representative Warrant Shares that is (i) required to be filed with the Commission by the Company, (ii) a "road show that is a written communication" within the meaning of Rule 433(d)(8)(i), whether or not required to be filed with the Commission, or (iii) exempt from filing with the Commission pursuant to Rule 433(d)(5)(i) because it contains a description of the Public Shares, the Representative's Warrants, the Representative Warrant Shares or of the Offering that does not reflect the final terms, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company's records pursuant to Rule 433(g).

"<u>Issuer General Use Free Writing Prospectus</u>" means any Issuer Free Writing Prospectus that is intended for general distribution to prospective investors (other than a "*bona fide* electronic road show," as defined in Rule 433 (the "<u>Bona Fide Electronic Road Show</u>")), as evidenced by its being specified in <u>Schedule 2-B</u> hereto.

"<u>Issuer Limited Use Free Writing Prospectus</u>" means any Issuer Free Writing Prospectus that is not an Issuer General Use Free Writing Prospectus.

"<u>Pricing Disclosure Package</u>" means any Issuer General Use Free Writing Prospectus issued at or prior to the Applicable Time, the Pricing Prospectus and the information included on <u>Schedule 2-A</u> hereto, all considered together.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.2 <u>Pursuant to the Exchange Act</u>. The Company has filed with the Commission a Form 8-A (File Number 001-[—]) providing for the registration pursuant to Section 12(b) under the Securities Exchange Act of 1934, as amended (the "<u>Exchange Act</u>"), of the Common Stock. The Company has taken no action designed to, or likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act, nor has the Company received any notification that the Commission is contemplating terminating such registration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2 <u>Listing</u>. The Nasdaq Capital Market (the "<u>Exchange</u>") has duly approved the Common Stock for listing, subject only to official notice of issuance, and the Company has taken no action designed to, or likely to have the effect of, delisting the Common Stock from the Exchange, nor has the Company received any notification that the Exchange is contemplating terminating such listing except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus. The Company has taken all actions it deems reasonably necessary or advisable to take on or prior to the date of this Agreement to ensure that it will be in compliance in all material respects with all applicable corporate governance requirements set forth in the rules of the Exchange that are then in effect and applicable to the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3 <u>No Stop Orders, etc</u>. Neither the Commission nor, to the Company's knowledge, any state regulatory authority has issued any order preventing or suspending the use of the Registration Statement, any Preliminary Prospectus or the Prospectus or has instituted or, to the Company's knowledge, threatened to institute, any proceedings with respect to such an order. The Company has complied with each request (if any) from the Commission for additional information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4 <u>Disclosures in Registration Statement</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.1 <u>Compliance with Securities Act and 10b-5 Representation</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) Each of the Registration Statement and any post-effective amendment thereto, at the time it became effective, complied in all material respects with the requirements of the Securities Act and the Securities Act Regulations. Each Preliminary Prospectus, including the prospectus filed as part of the Registration Statement as originally filed or as part of any amendment or supplement thereto, and the Prospectus, at the time each was filed with the Commission, complied in all material respects with the requirements of the Securities Act and the Securities Act Regulations. Each Preliminary Prospectus delivered to the Underwriters for use in connection with the Offering and the Prospectus was or will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) Neither the Registration Statement nor any amendment thereto, at its effective time, as of the Applicable Time, at the Closing Date or at any Option Closing Date, contained, contains or will contain an untrue statement of a material fact or omitted, omits or will omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) The Pricing Disclosure Package, as of the Applicable Time, at the Closing Date or at any Option Closing Date, did not, does not and will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading; and each Issuer Limited Use Free Writing Prospectus hereto does not conflict in any material respect with the information contained in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, and each such Issuer Limited Use Free Writing Prospectus, as supplemented by and taken together with the Pricing Prospectus as of the Applicable Time, did not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to statements made or statements omitted in reliance upon and in conformity with written information furnished to the Company with respect to the Underwriters by the Representative expressly for use in the Registration Statement, the Preliminary Prospectus, the Pricing Prospectus or the Prospectus or any amendment thereof or supplement thereto. The parties acknowledge and agree that such information provided by or on behalf of any Underwriter consists solely of the following disclosure contained in the "Underwriting" section of the Prospectus: the table showing the number of securities to be purchased by each Underwriter and the corresponding share amounts set forth in the table of Underwriters, the concession amount set forth in the sub-section titled "Underwriting Discount, Commissions and Expenses" and the information under the subsections "Discretionary Accounts," "Electronic Distribution," "Stabilization" and "Passive Market Making" (the "<u>Underwriters' Information</u>"); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) Neither the Prospectus nor any amendment or supplement thereto (including any prospectus wrapper), as of its issue date, at the time of any filing with the Commission pursuant to Rule 424(b), at the Closing Date or at any Option Closing Date, included, includes or will include an untrue statement of a material fact or omitted, omits or will omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to the Underwriters' Information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.2 <u>Disclosure of Agreements</u>. The agreements and documents described in the Registration Statement, the Pricing Disclosure Package and the Prospectus conform in all material respects to the descriptions thereof contained therein and there are no agreements or other documents required by the Securities Act and the Securities Act Regulations to be described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or to be filed with the Commission as exhibits to the Registration Statement, that have not been so described or filed. Each agreement or other instrument (however characterized or described) to which the Company is a party or by which it is or may be bound or affected and (i) that is filed as an exhibit to the Registration Statement, the Pricing Disclosure Package and the Prospectus, or (ii) is material to the Company's business, has been duly authorized and validly executed by the Company, is in full force and effect in all material respects and is enforceable against the Company and, to the Company's knowledge, the other parties thereto, in accordance with its terms, except (x) as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors' rights generally, (y) as enforceability of any indemnification or contribution provision may be limited under the federal and state securities laws, and (z) that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. None of such agreements or instruments has been assigned by the Company, and neither the Company nor, to the Company's knowledge, any other party is in default thereunder and, to the Company's knowledge, no event has occurred that, with the lapse of time or the giving of notice, or both, would constitute a default thereunder except for such defaults that would not reasonably be expected to result in a Material Adverse Change (as defined in Section 2.5.1 below). To the best of the Company's knowledge, performance by the Company of the provisions of such agreements or instruments will not result in a violation of any existing applicable law, rule, regulation, judgment, order or decree of any governmental agency or court, domestic or foreign, having jurisdiction over the Company or any of its assets or businesses (each, a "<u>Governmental Entity</u>"), including, without limitation, those relating to environmental laws and regulations, except for any violation that, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.3 <u>Prior Securities Transactions</u>. During the period starting two (2) years prior to the date of this Agreement, no securities of the Company have been sold by the Company or by or on behalf of, or for the benefit of, any person or persons controlling, controlled by or under common control with the Company, except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Preliminary Prospectus.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.4 <u>Regulations</u>. The disclosures in the Registration Statement, the Pricing Disclosure Package and the Prospectus concerning the effects of federal, state, local and all foreign regulation on the Offering and the Company's business as currently conducted are correct in all material respects and no other such regulations are required to be disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus which are not so disclosed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5 <u>Changes After Dates in Registration Statement</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5.1 <u>No Material Adverse Change</u>. Since the respective dates as of which information is given in the Registration Statement, the Pricing Disclosure Package and the Prospectus, except as otherwise specifically stated therein: (i) there has been no material adverse change in the financial position or results of operations of the Company and its Subsidiaries (as defined below) taken as a whole, nor, to the Company's knowledge, any change or development that, singularly or in the aggregate, would involve a material adverse change, in or affecting the condition (financial or otherwise), results of operations, business, assets or prospects of the Company and its Subsidiaries taken as a whole (a "<u>Material Adverse Change</u>"); (ii) other than in the ordinary course of business, there have been no material transactions entered into by the Company, other than as contemplated pursuant to this Agreement; and (iii) no executive officer or director of the Company has resigned from any position with the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5.2 <u>Recent Securities Transactions, etc</u>. Subsequent to the respective dates as of which information is given in the Registration Statement, the Pricing Disclosure Package and the Prospectus, and except as may otherwise be indicated or contemplated herein or disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not: (i) issued any securities or incurred any liability or obligation, direct or contingent, for borrowed money; or (ii) declared or paid any dividend or made any other distribution on or in respect to its capital stock.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6 <u>Independent Accountants</u>. M&K CPAS PLLC (the "<u>Auditor</u>"), whose report is filed with the Commission as part of the Registration Statement, the Pricing Disclosure Package and the Prospectus, is an independent registered public accounting firm as required by the Securities Act and the Securities Act Regulations and the Public Company Accounting Oversight Board. The Auditor has not, during the periods covered by the financial statements included in the Registration Statement, the Pricing Disclosure Package and the Prospectus, provided to the Company any non-audit services, as such term is used in Section 10A(g) of the Exchange Act.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.7 <u>Financial Statements, etc</u>. The financial statements, including the notes thereto and supporting schedules, included in the Registration Statement, the Pricing Disclosure Package and the Prospectus, fairly present, in all material respects, the financial position and the results of operations of the Company at the dates and for the periods stated therein; and such financial statements have been prepared in conformity with U.S. generally accepted accounting principles ("<u>GAAP</u>"), consistently applied throughout the periods involved (provided that unaudited interim financial statements are subject to year-end audit adjustments that are not expected to be material in the aggregate and do not contain all footnotes required by GAAP); and the supporting schedules, if any, included in the Registration Statement present fairly the information required to be stated therein. Except as included therein, no historical or pro forma financial statements are required to be included in the Registration Statement, the Pricing Disclosure Package or the Prospectus under the Securities Act or the Securities Act Regulations. All disclosures contained in the Registration Statement, the Pricing Disclosure Package or the Prospectus regarding "non-GAAP financial measures" (as such term is defined by the rules and regulations of the Commission), if any, comply in all material respects with Regulation G of the Exchange Act and Item 10 of Regulation S-K of the Securities Act, to the extent applicable. Each of the Registration Statement, the Pricing Disclosure Package and the Prospectus discloses all material off-balance sheet transactions, arrangements, obligations (including contingent obligations), and other relationships of the Company with unconsolidated entities or other persons that may have a material current or future effect on the Company's financial condition, changes in financial condition, results of operations, liquidity, capital expenditures, capital resources, or significant components of revenues or expenses. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (a) neither the Company nor any of its direct and indirect subsidiaries, including each entity disclosed or described in the Registration Statement, the Pricing Disclosure Package and the Prospectus as being a subsidiary of the Company (each, a "<u>Subsidiary</u>" and, collectively, "<u>Subsidiaries</u>"), has incurred any material liabilities or obligations, direct or contingent, or entered into any material transactions other than in the ordinary course of business, (b) the Company has not declared or paid any dividends or made any distribution of any kind with respect to its capital stock, (c) there has not been any change in the capital stock of the Company or any of its Subsidiaries, or, other than in the ordinary course of business, any grants under any stock compensation plan, and (d) there has not been any Material Adverse Change in the Company's long-term or short-term debt.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8 <u>Authorized Capital; Options, etc</u>. The Company had, at the date or dates indicated in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the duly authorized, issued and outstanding capitalization as set forth therein. Based on the assumptions stated in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company will have on the Closing Date the adjusted stock capitalization set forth therein. Except as set forth in, or contemplated by, the Registration Statement, the Pricing Disclosure Package and the Prospectus, on the Effective Date, as of the Applicable Time and on the Closing Date, there will be no stock options, warrants, or other rights to purchase or otherwise acquire any authorized, but unissued shares of Common Stock or any security convertible or exercisable into shares of Common Stock, or any contracts or commitments to issue or sell shares of Common Stock or any such options, warrants, rights or convertible securities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.9 <u>Valid Issuance of Securities, etc</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.9.1 <u>Outstanding Securities</u>. All issued and outstanding securities of the Company issued prior to the transactions contemplated by this Agreement have been duly authorized and validly issued and are fully paid and non-assessable; the holders thereof have no rights of rescission with respect thereto, and are not subject to personal liability by reason of being such holders; and none of such securities were issued in violation of the preemptive rights of any holders of any security of the Company or similar contractual rights granted by the Company. The authorized shares of Common Stock conform in all material respects to all statements relating thereto contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus. The offers and sales of the outstanding shares of Common Stock were at all relevant times either registered under the Securities Act and the applicable state securities or "blue sky" laws or, based in part on the representations and warranties of the purchasers of such shares, exempt from such registration requirements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.9.2 <u>Securities Sold Pursuant to this Agreement</u>. The Public Shares have been duly and validly authorized for issuance and sale and, when issued and paid for, will be validly issued, fully paid and non-assessable; the holders thereof are not and will not be subject to personal liability by reason of being such holders; and the Public Shares are not and will not be subject to the preemptive rights of any holders of any security of the Company or similar contractual rights granted by the Company. The Representative's Warrants have been duly and validly authorized for issuance and sale and, when executed and delivered by the Company will be valid and binding agreements of the Company, enforceable against the Company in accordance with their terms, except as the enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting the rights and remedies of creditors or by general equitable principles. When issued and delivered upon exercise of the Representative's Warrants in accordance therewith, the Representative Warrant Shares will be validly issued, fully paid and non-assessable; the holders thereof will not be subject to personal liability by reason of being such holders; and the Representative Warrant Shares will not be subject to the preemptive rights of any holders of any security of the Company or similar contractual rights granted by the Company. The Public Shares, Representative's Warrants and Representative Warrant Shares, when issued, will each conform in all material respects to all statements with respect thereto contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.10 <u>Registration Rights of Third Parties</u>. Except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus, no holders of any securities of the Company or any rights exercisable for or convertible or exchangeable into securities of the Company have the right to require the Company to register any such securities of the Company under the Securities Act or to include any such securities in a registration statement to be filed by the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.11 <u>Validity and Binding Effect of Agreement</u>. This Agreement has been duly and validly authorized by the Company, and, when executed and delivered, will constitute, the valid and binding agreements of the Company, enforceable against the Company in accordance with their respective terms, except: (i) as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors' rights generally; (ii) as enforceability of any indemnification or contribution provision may be limited under the federal and state securities laws; and (iii) that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion of the court before which any proceeding therefor may be brought.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.12 <u>No Conflicts, etc</u>. The execution, delivery and performance by the Company of this Agreement, the Representative's Warrants and all ancillary documents, the consummation by the Company of the transactions herein and therein contemplated and the compliance by the Company with the terms hereof and thereof do not and will not, with or without the giving of notice or the lapse of time or both: (i) result in a breach of, or conflict with any of the terms and provisions of, or constitute a material default under, or result in the creation, modification, termination or imposition of any lien, charge or encumbrance upon any property or assets of the Company pursuant to the terms of any agreement or instrument to which the Company is a party; (ii) result in any violation of the provisions of the organizational or governing documents of the Company; or (iii) violate any existing applicable law, rule, regulation, judgment, order or decree of any Governmental Entity as of the date hereof (including, without limitation, those enforced by the U.S. Food and Drug Administration (the "<u>FDA</u>") or by any foreign, federal, state or local regulatory authority performing functions similar to those performed by the FDA) except in the case of clauses (i) and (iii) for any such breach, conflict, violation, default, lien, charge or encumbrance that would not reasonably be expected to result in, individually or in the aggregate, a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.13 <u>No Defaults; Violations</u>. No material default exists in the due performance and observance of any term, covenant or condition of any material license, contract, indenture, mortgage, deed of trust, note, loan or credit agreement, or any other agreement or instrument evidencing an obligation for borrowed money, or any other material agreement or instrument to which the Company or and of its Subsidiaries is a party or by which the Company or any of its Subsidiaries may be bound or to which any of the properties or assets of the Company or any of its Subsidiaries is subject. The Company and each of its Subsidiaries is not (i) in violation of any term or provision of its organizational or governing documents, (ii) in violation of any franchise, license or permit, or (iii) in violation of applicable law, rule, regulation, judgment or decree of any Governmental Entity (including, without limitations, those administered by the FDA or by any foreign, federal, state or local regulatory authority performing functions similar to those performed by the FDA) except in the case of clause (ii) and (iii) for any such violation that would not reasonably be expected to result in, individually or in the aggregate, a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.14 <u>Corporate Power; Licenses; Consents</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.14.1 <u>Conduct of Business</u>. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has all requisite corporate power and authority, and has all necessary material authorizations, approvals, orders, licenses, registrations, certificates and permits of and from all governmental regulatory officials and bodies (including, without limitation, the FDA and any foreign, federal, state or local regulatory authority performing functions similar to those performed by the FDA) (collectively, the "<u>Approvals</u>"), that it needs as of the date hereof to conduct its business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, except for any such Approvals the absence of which would not be reasonably expected to have a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.14.2 <u>Transactions Contemplated Herein</u>. The Company has all corporate power and authority to enter into this Agreement and to issue the Representative's Warrants and to carry out the provisions and conditions hereof and thereof, and all consents, authorizations, approvals and orders required in connection therewith have been obtained. No consent, authorization or order of, and no filing with, any court, government agency or other body is required for the valid issuance, sale and delivery of the Public Shares, the Representative's Warrants and the Representative Warrant Shares and the consummation of the transactions and agreements contemplated by this Agreement and the Representative's Warrants as contemplated by the Registration Statement, the Pricing Disclosure Package and the Prospectus, except (i) such consents, approvals, authorizations, orders, filings, registrations or qualifications that have already been obtained or made and (ii) with respect to applicable federal and state securities laws and the rules and regulations of the Financial Industry Regulatory Authority, Inc. ("<u>FINRA</u>").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.15 <u>D&O Questionnaires</u>. To the Company's knowledge, all information contained in the questionnaires (the "<u>Questionnaires</u>") completed by each of the Company's directors and executive officers immediately prior to the Offering (the "<u>Insiders</u>") as supplemented by all information concerning the Company's directors, executive officers and principal stockholders as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as well as in the Lock-Up Agreement (as defined in Section 2.24 below), provided to the Underwriters, is true and correct in all material respects and the Company has not become aware of any information which would cause the information disclosed in the Questionnaires to become materially inaccurate and incorrect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.16 <u>Litigation; Governmental Proceedings</u>. There is no action, suit, proceeding, inquiry, arbitration, investigation, litigation or governmental proceeding pending or, to the Company's knowledge, threatened against, or involving the Company or any of its Subsidiaries or, to the Company's knowledge, any executive officer or director which has not been disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or in connection with the Company's listing application for the listing of the Public Shares and the Representative Warrant Shares on the Exchange, except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.17 <u>Good Standing</u>. The Company and each of its Subsidiaries have been duly incorporated and are validly existing as corporations or other legal entities in good standing (or such equivalent concept in a given jurisdiction, as applicable) as of the date hereof under the laws of the respective jurisdiction where the entity is organized, and are in good standing in each other jurisdiction in which its ownership or lease of property or the conduct of business requires such qualification, except where the failure to be so qualified, singularly or in the aggregate, would not reasonably be expected to result in a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.18 <u>Insurance</u>. On the Closing Date, the Company and its Subsidiaries will carry or will be entitled to the benefits of insurance with, to the Company's knowledge, reputable insurers, in such amounts and covering such risks which the Company believes are adequate, including, but not limited to, directors and officers insurance coverage and all such insurance is in full force and effect. The Company has no reason to believe that the Company or its Subsidiaries will not be able (i) to renew the existing insurance coverage as and when such policies expire or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that would not reasonably be expected to result in a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.19 <u>Transactions Affecting Disclosure to FINRA</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.19.1 <u>Finder's Fees</u>. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there are no claims, payments, arrangements, agreements or understandings relating to the payment of a finder's, consulting or origination fee by the Company or any Insider with respect to the sale of the Public Shares, the Representative's Warrants or the Representative Warrant Shares hereunder or any other arrangements, agreements or understandings of the Company or, to the Company's knowledge, any of its stockholders that may affect the Underwriters' compensation, as determined by FINRA.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.19.2 <u>Payments Within Twelve (12) Months</u>. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not made any direct or indirect payments (in cash, securities or otherwise) to: (i) any person, as a finder's fee, consulting fee or otherwise, in consideration of such person raising capital for the Company or introducing to the Company persons who raised or provided capital to the Company; (ii) any FINRA member; or (iii) any person or entity that has any direct or indirect affiliation or association with any FINRA member, within the twelve (12) months prior to the Effective Date, other than the payment to the Underwriters as provided hereunder in connection with the Offering.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.19.3 <u>Use of Proceeds</u>. None of the net proceeds of the Offering will be paid by the Company to any participating FINRA member or its affiliates, except as specifically authorized herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.19.4 <u>FINRA Affiliation</u>. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, to the Company's knowledge, there is no (i) officer or director of the Company, (ii) beneficial owner of 10% or more of any class of the Company's securities or (iii) beneficial owner of the Company's unregistered equity securities which were acquired during the 180-day period immediately preceding the filing of the Registration Statement, that is an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.19.5 <u>Information</u>. To the Company's knowledge, all information provided by the Company in its FINRA questionnaire to Representative Counsel specifically for use by Representative Counsel in connection with its Public Offering System filings (and related disclosure) with FINRA is true, correct and complete in all material respects.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.20 <u>Foreign Corrupt Practices Act</u>. None of the Company or its Subsidiaries, or to the Company's knowledge, any director, officer, agent, employee or affiliate of the Company and its Subsidiaries or any other person acting on behalf of the Company and its Subsidiaries, has, directly or indirectly, given or agreed to give any money, gift or similar benefit (other than legal price concessions to customers in the ordinary course of business) to any customer, supplier, employee or agent of a customer or supplier, or official or employee of any governmental agency or instrumentality of any government (domestic or foreign) or any political party or candidate for office (domestic or foreign) or other person who was, is, or may be in a position to help or hinder the business of the Company (or assist it in connection with any actual or proposed transaction) that (i) might subject the Company to any damage or penalty in any civil, criminal or governmental litigation or proceeding, (ii) if not given in the past, might have had a Material Adverse Change or (iii) if not continued in the future, might adversely affect the assets, business, operations or prospects of the Company. The Company has taken reasonable steps to ensure that its accounting controls and procedures are sufficient to cause the Company to comply in all material respects with the Foreign Corrupt Practices Act of 1977, as amended.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.21 <u>Compliance with Sanctions</u>. Neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, affiliate or other person associated with or acting on behalf of the Company or any of its Subsidiaries is currently the subject or the target of any sanctions administered or enforced by the U.S. government (including, without limitation, the Office of Foreign Assets Control of the U.S. Department of the Treasury ("<u>OFAC</u>") or the U.S. Department of State and including, without limitation, the designation as a "specially designated national" or "blocked person"), the United Nations Security Council ("<u>UNSC</u>"), the European Union, HM Treasury ("<u>HMT</u>"), or other relevant sanctions authority (collectively, "<u>Sanctions</u>"), nor is the Company, any of its Subsidiaries located, organized or resident in a country or territory that is the subject or target of Sanctions, including, without limitation, the Crimea Region and the non-government controlled areas of the Zaporizhzhia and Kherson Regions of Ukraine, the so-called Luhansk People's Republic or any other Covered Region of Ukraine identified pursuant to Executive Order 14065, Cuba, Iran, North Korea, and Syria (each, a "<u>Sanctioned Country</u>"); and the Company will not directly or indirectly use the proceeds of the Offering hereunder, or lend, contribute or otherwise make available such proceeds to any Subsidiary, joint venture partner or other person or entity (A) to fund or facilitate any activities of or business with any person that, at the time of such funding or facilitation, is the subject or target of Sanctions, (B) to fund or facilitate any activities of or business in any Sanctioned Country or (C) in any other manner that will result in a violation by any person (including any person participating in the transaction, whether as underwriter, initial purchaser, advisor, investor or otherwise) of Sanctions. For the past ten years, the Company and its Subsidiaries have not knowingly engaged in, and are not now knowingly engaged in any dealings or transactions with any person that at the time of the dealing or transaction is or was the subject or the target of Sanctions or with any Sanctioned Country.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.22 <u>Money Laundering Laws</u>. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any Governmental Entity (collectively, the "<u>Money Laundering Laws</u>"); and no action, suit or proceeding by or before any Governmental Entity involving the Company with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.23 <u>Officers' Certificate</u>. Any certificate signed by any duly authorized officer of the Company and delivered to you or to Representative Counsel shall be deemed a representation and warranty by the Company to the Underwriters as to the matters covered thereby.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.24 <u>Lock-Up Agreements</u>. <u>Schedule 3</u> hereto contains a complete and accurate list of the Company's officers, directors and holders of record of the Company's outstanding shares of Common Stock (collectively, the "<u>Lock-Up Parties</u>"). The Company has caused each of the Lock-Up Parties to deliver to the Representative an executed Lock-Up Agreement, in the form attached hereto as <u>Exhibit A</u> (the "<u>Lock-Up Agreement</u>"), prior to the execution of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.25 <u>Related Party Transactions</u>. There are no business relationships or related party transactions involving the Company or any other person required to be described in the Registration Statement, the Pricing Disclosure Package and the Prospectus that have not been described as required by the Securities Act.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.26 <u>Board of Directors</u>. The Board of Directors of the Company is comprised of the persons set forth under the heading of the Pricing Prospectus and the Prospectus captioned "Management." The qualifications of the persons serving as board members and the overall composition of the board comply with the Exchange Act, the Exchange Act Regulations, the Sarbanes-Oxley Act of 2002 and the rules promulgated thereunder (the "<u>Sarbanes-Oxley Act</u>") applicable to the Company and the listing rules of the Exchange. At least one member of the Audit Committee of the Board of Directors of the Company qualifies as an "audit committee financial expert," as such term is defined under Regulation S-K and the listing rules of the Exchange. In addition, at least a majority of the persons serving on the Board of Directors qualify as "independent," as defined under the listing rules of the Exchange.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.27 <u>Sarbanes-Oxley Compliance</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.27.1 <u>Disclosure Controls</u>. The Company has taken all necessary actions to ensure that, in the time periods required, the Company will comply with Rule 13a-15 or 15d-15, as applicable, under the Exchange Act Regulations, and such controls and procedures are effective to ensure that all material information concerning the Company will be made known on a timely basis to the individuals responsible for the preparation of the Company's Exchange Act filings and other public disclosure documents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.27.2 <u>Compliance</u>. The Company is, or at the Applicable Time and on the Closing Date and on any Option Closing Date will be, in material compliance with the provisions of the Sarbanes-Oxley Act applicable to it, and has implemented or will implement such programs and taken reasonable steps to ensure the Company's future compliance (not later than the relevant statutory and regulatory deadlines therefor) with all of the material provisions of the Sarbanes-Oxley Act then applicable to it.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.28 <u>Accounting Controls</u>. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company and its Subsidiaries maintain systems of "internal control over financial reporting" (as defined under Rules 13a-15 and 15d-15 under the Exchange Act Regulations) that comply in all material respects with the requirements of the Exchange Act and have been designed by, or under the supervision of, their respective principal executive and principal financial officers, or persons performing similar functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP, including, but not limited to, internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management's general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management's general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any material weaknesses in its internal controls. To the Company's knowledge, the Auditor and the Audit Committee of the Board of Directors of the Company have been advised of: (i) all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are known to the Company's management and that have adversely affected or are reasonably likely to adversely affect the Company's ability to record, process, summarize and report financial information; and (ii) any fraud known to the Company's management, whether or not material, that involves management or other employees who have a significant role in the Company's internal controls over financial reporting. Notwithstanding any provision above, nothing in this Agreement requires the Company to comply with Section 404 of the Sarbanes-Oxley Act and the rules and regulations promulgated in connection therewith as of an earlier date than it would otherwise be required to do so under applicable law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.29 <u>No Investment Company Status</u>. The Company and each of its Subsidiaries is not and, after giving effect to the Offering and the application of the proceeds thereof, as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, will not be, required to register as an "investment company," as defined in the Investment Company Act of 1940, as amended.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.30 <u>No Labor Disputes</u>. No labor dispute with the employees of the Company or any of its Subsidiaries exists or, to the knowledge of the Company, is imminent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.31 <u>Intellectual Property Rights</u>. The Company and each of its Subsidiaries owns or possesses or has valid rights to use the domain names ("<u>Intellectual Property Rights</u>") necessary for the conduct of the business of the Company and its Subsidiaries as now conducted or, otherwise, as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus. To the knowledge of the Company, no action or use by the Company or any of its Subsidiaries necessary for the conduct of its business as currently carried on and as described in the Registration Statement and the Prospectus will involve or give rise to any infringement of, or license or similar fees for, any Intellectual Property Rights of others, except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Neither the Company nor any of its Subsidiaries has received any notice alleging any such infringement, fee or conflict with asserted Intellectual Property Rights of others. Except as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change (A) to the knowledge of the Company, there is no infringement, misappropriation or violation by third parties of any of the Intellectual Property Rights owned by the Company; (B) there is no pending or, to the knowledge of the Company, threatened action, suit, proceeding or claim by others challenging the rights of the Company in or to any such Intellectual Property Rights, and the Company is unaware of any facts which would form a reasonable basis for any such claim; (C) to the knowledge of the Company, the Intellectual Property Rights owned by the Company and, to the knowledge of the Company, the Intellectual Property Rights licensed to the Company have not been adjudged by a court of competent jurisdiction invalid or unenforceable, in whole or in part, and there is no pending, to the knowledge of the Company, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intellectual Property Rights, and the Company is unaware of any facts which would form a reasonable basis for any such claim; (D) there is no pending or, to the Company's knowledge, threatened action, suit, proceeding or claim by others that the Company infringes, misappropriates or otherwise violates any Intellectual Property Rights or other proprietary rights of others, the Company has not received any written notice of such claim and the Company is unaware of any other facts which would form a reasonable basis for any such claim; and (E) to the Company's knowledge, no employee of the Company is in or has ever been in violation of any term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement or any restrictive covenant to or with a former employer where the basis of such violation relates to such employee's employment with the Company, or actions undertaken by the employee while employed with the Company. To the Company's knowledge, all material technical information developed by and belonging to the Company which has not been patented has been kept confidential. The Company is not a party to or bound by any options, licenses or agreements with respect to the Intellectual Property Rights of any other person or entity that are required to be set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus and are not described therein. The Registration Statement, the Pricing Disclosure Package and the Prospectus contain in all material respects the same description of the matters set forth in the preceding sentence. None of the technology employed by the Company has been obtained or is knowingly being used by the Company in violation of any contractual obligation binding on the Company or, to the Company's knowledge, any of its officers, directors or employees, or otherwise in violation of the rights of any persons.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.32 <u>Taxes</u>. Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Change, each of the Company and its Subsidiaries has (i) filed all returns (as hereinafter defined) required to be filed with taxing authorities prior to the date hereof or has duly obtained extensions of time for the filing thereof and (ii) has paid all taxes (as hereinafter defined) shown as due on such returns that were filed and has paid all taxes imposed on or assessed against the Company or such respective Subsidiary except as currently being contested in good faith and for which reserves required by GAAP have been created in the financial statements of the Company. The provisions for taxes payable, if any, shown on the financial statements filed with or as part of the Registration Statement are sufficient for all accrued and unpaid taxes, whether or not disputed, and for all periods to and including the dates of such consolidated financial statements. Except as disclosed in writing to the Underwriters, (i) no issues have been raised (and are currently pending) by any taxing authority in connection with any of the returns or taxes asserted as due from the Company or its Subsidiaries, and (ii) no waivers of statutes of limitation with respect to the returns or collection of taxes have been given by or requested from the Company or its Subsidiaries. The term "taxes" means all federal, state, local, foreign and other net income, gross income, gross receipts, sales, use, ad valorem, transfer, franchise, profits, license, lease, service, service use, withholding, payroll, employment, excise, severance, stamp, occupation, premium, property, windfall profits, customs, duties or other taxes, fees, assessments or charges of any kind whatever, together with any interest and any penalties, additions to tax or additional amounts with respect thereto. The term "returns" means all returns, declarations, reports, statements and other documents required to be filed in respect to taxes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.33 <u>ERISA Compliance</u>. The Company and any "employee benefit plan" (as defined under the Employee Retirement Income Security Act of 1974, as amended, and the regulations and published interpretations thereunder (collectively, "<u>ERISA</u>")) established or maintained by the Company or its "ERISA Affiliates" (as defined below) are in compliance in all material respects with ERISA. "<u>ERISA Affiliate</u>" means, with respect to the Company, any member of any group of organizations described in Sections 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986, as amended, and the regulations and published interpretations thereunder (the "<u>Code</u>") of which the Company is a member. No "reportable event" (as defined under ERISA) has occurred or is reasonably expected to occur with respect to any "employee benefit plan" established or maintained by the Company or any of its ERISA Affiliates. No "employee benefit plan" established or maintained by the Company or any of its ERISA Affiliates, if such "employee benefit plan" were terminated, would have any "amount of unfunded benefit liabilities" (as defined under ERISA). Neither the Company nor any of its ERISA Affiliates has incurred or reasonably expects to incur any material liability under (i) Title IV of ERISA with respect to termination of, or withdrawal from, any "employee benefit plan" or (ii) Sections 412, 4971, 4975 or 4980B of the Code. Each "employee benefit plan" established or maintained by the Company or any of its ERISA Affiliates that is intended to be qualified under Section 401(a) of the Code is so qualified and, to the knowledge of the Company, nothing has occurred, whether by action or failure to act, which would cause the loss of such qualification.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.34 <u>Compliance with Laws</u>. The Company and each of its Subsidiaries: (A) is and at all times has been in compliance with all statutes, rules, or regulations, applicable to the business of the Company and its Subsidiaries (including, but not limited to any applicable health care laws such as the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), including without limitation, the FDA current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, facility registration, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company's products, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the civil False Claims Act (31 U.S.C. §3729 et seq.), the criminal False Claims Law (42 U.S.C. §1320a-7b(a), 18 U.S.C. §§286 and 287, the Physician Payments Sunshine Act (42 U.S.C. §1320a-7h), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. § 17921 et seq.), the exclusions law (42 U.S.C. §1320a-7),) Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, and the regulations promulgated pursuant to such laws, and comparable state laws, and all other local, state, federal, national, supranational, and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, "<u>Applicable Laws</u>"), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, registrations, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws ("<u>Authorizations</u>"); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (D) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and has no knowledge that any such governmental authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding that if brought, would result in a Material Adverse Change; (E) has not received written notice that any governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such governmental authority is considering such action; and (F) has filed, obtained, maintained or submitted or taken reasonably practicable steps to file, obtain, maintain or submit all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.35 <u>Ineligible Issuer</u>. At the time of filing the Registration Statement and any post-effective amendment thereto, at the time of effectiveness of the Registration Statement and any amendment thereto, at the earliest time thereafter that the Company or another offering participant made a bona fide offer (within the meaning of Rule 164(h)(2) of the Securities Act Regulations) of the Public Shares, the Representative's Warrants or the Representative Warrant Shares and at the date hereof, the Company was not and is not an "ineligible issuer," as defined in Rule 405.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.36 <u>Leased Property</u>. Except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company and its Subsidiaries have valid rights to lease, all items of real or personal property which are material to the business of the Company and its Subsidiaries taken as a whole. All of the leases and subleases material to the business of the Company and its Subsidiaries, considered as one enterprise, and under which the Company or any of its Subsidiaries holds properties described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, are in full force and effect, and neither the Company nor any Subsidiary has received any notice of any material claim of any sort that has been asserted by anyone adverse to the rights of the Company or any Subsidiary under any of the leases or subleases mentioned above, or affecting or questioning the rights of the Company or such Subsidiary to the continued possession of the leased or subleased premises under any such lease or sublease.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.37 <u>Contracts Affecting Capital</u>. There are no transactions, arrangements or other relationships between and/or among the Company, any of its affiliates (as such term is defined in Rule 405 of the Securities Act Regulations) and any unconsolidated entity, including, but not limited to, any structured finance, special purpose or limited purpose entity that could reasonably be expected to materially affect the Company's or its Subsidiaries' liquidity or the availability of or requirements for their capital resources required to be described in the Registration Statement, the Pricing Disclosure Package and the Prospectus which have not been described as required.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.38 <u>Loans to Directors or Officers</u>. There are no outstanding loans, advances (except normal advances for business expenses in the ordinary course of business) or guarantees or indebtedness by the Company or its Subsidiaries to or for the benefit of any of the officers or directors of the Company, its Subsidiaries or any of their respective family members, except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.39 <u>Smaller Reporting Company</u>. As of the time of filing of the Registration Statement, the Company was a "smaller reporting company," as defined in Rule 12b-2 of the Exchange Act Regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.40 <u>Third-party Data</u>. Any statistical, industry-related and market-related data included in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus are based on or derived from sources that the Company reasonably and in good faith believes to be reliable and accurate or represent the Company's good faith estimates that are made on the basis of data derived from such sources, and the Company has obtained the written consent for the use of such data from such sources to the extent required.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.41 <u>Testing-the-Waters Communications</u>. The Company has not (i) alone engaged in any Testing-the-Waters Communications, other than Testing-the-Waters Communications with the written consent of the Representative and with entities that are qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act and (ii) authorized anyone other than the Representative to engage in Testing-the-Waters Communications. The Company confirms that the Representative has been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written Testing-the-Waters Communications other than those listed on <u>Schedule 2-C</u> hereto. "<u>Written Testing-the-Waters Communication</u>" means any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Securities Act. "<u>Testing-the-Waters Communication</u>" means any oral or written communication with potential investors undertaken in reliance on Rule 163B of the Securities Act.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.42 <u>Electronic Road Show</u>. The Company has made available a Bona Fide Electronic Road Show in compliance with Rule 433(d)(8)(ii) of the Securities Act Regulations such that no filing of any "road show" (as defined in Rule 433(h) of the Securities Act Regulations) is required in connection with the Offering.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.43 <u>Margin Securities</u>. The Company owns no "margin securities" as that term is defined in Regulation U of the Board of Governors of the Federal Reserve System (the "<u>Federal Reserve Board</u>"), and none of the proceeds of the Offering to be received by the Company will be used, directly or indirectly, for the purpose of purchasing or carrying any margin security, for the purpose of reducing or retiring any indebtedness which was originally incurred to purchase or carry any margin security or for any other purpose which might cause any shares of the Common Stock to be considered a "purpose credit" within the meanings of Regulation T, U or X of the Federal Reserve Board.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.44 <u>Regulatory Filings</u>. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (i) neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authority any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Change; and (ii) all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not result in a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.45 <u>Environmental Laws</u>. Except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company and its Subsidiaries (i) are in compliance with any and all applicable federal, state, local and foreign laws, rules, regulations, decisions and orders relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (collectively, "<u>Environmental Laws</u>"); (ii) have received and are in compliance with all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct its business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iii) have not received notice of any actual or potential liability for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, except, in the case of any of clauses (i), (ii) or (iii) above, for any such failure to comply or failure to receive required permits, licenses, other approvals or liability as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.46 <u>IT Systems, Data Security and Cybersecurity</u>. The Company and its Subsidiaries' information technology assets and equipment, computers, systems, networks, hardware, software, websites, applications, and databases (collectively, "<u>IT Systems</u>") are adequate for, and operate and perform in all material respects as required in connection with the operation of the business of the Company and its Subsidiaries as currently conducted, and, to the knowledge of the Company, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. The Company and its Subsidiaries have implemented commercially reasonable physical, technical and administrative controls, policies, procedures, and safeguards to maintain and protect their material confidential information and the integrity, continuous operation, redundancy and security of all IT Systems and data, including "Personal Data," used in connection with their businesses. "<u>Personal Data</u>" means (i) a natural person's name, street address, telephone number, e-mail address, photograph, social security number or tax identification number, driver's license number, passport number, credit card number, bank information, or customer or account number; (ii) any information which would qualify as "personally identifying information" under the Federal Trade Commission Act, as amended; (iii) "personal data" as defined by the European Union General Data Protection Regulation ("<u>GDPR</u>") (EU 2016/679) and by the UK GDPR (as defined below), as applicable; (iv) any information which would qualify as "protected health information" under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, "<u>HIPAA</u>"); and (v) any other piece of information that allows the identification of such natural person, or his or her family, or permits the collection or analysis of any data related to an identified person's health or sexual orientation. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (a) there has been no material security breach or incident, material unauthorized access or disclosure, or other material compromise relating to the Company's and its Subsidiaries' IT Systems and Personal Data and (b) neither the Company nor any of its Subsidiaries has been notified of, and has no knowledge of any event or condition that would result in, any material security breach or incident, material unauthorized access or disclosure or other material compromise to its IT Systems and Personal Data. The Company and its Subsidiaries are presently in material compliance with all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations relating to the privacy and security of IT Systems and Personal Data and to the protection of such IT Systems and Personal Data from unauthorized use, access, misappropriation or modification.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.47 <u>Compliance with Data Privacy Laws</u>. The Company and its Subsidiaries are, and at all prior times were, in material compliance with any and all applicable data privacy and security laws and regulations, including, without limitation, HIPAA and the GDPR (including as it continues to form part of law in the United Kingdom by virtue of section 3 of the European Union (Withdrawal) Act 2018 (the "<u>UK GDPR</u>")), as applicable (collectively, the "<u>Privacy Laws</u>"). To ensure compliance with the Privacy Laws, the Company and its Subsidiaries have in place, comply with, and take appropriate steps reasonably designed to ensure compliance in all material respects with their policies and procedures relating to data privacy and security and the collection, storage, use, disclosure, handling, and analysis of Personal Data (the "<u>Policies</u>"). The Company and its Subsidiaries have, to the knowledge of the Company, at all times made all disclosures to users or customers required by applicable laws and regulatory rules or requirements, and none of such disclosures made or contained in any Policy have, to the knowledge of the Company, been inaccurate or in violation of any applicable laws and regulatory rules or requirements in any material respect. The Company further certifies that neither it nor any Subsidiary: (i) has received notice of any actual or potential liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is a party to any order, decree, or agreement that imposes any obligation or liability under any Privacy Law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.48 <u>Healthcare Regulatory Matters</u>. The research, preclinical tests and studies, or clinical trials or studies conducted by or on behalf of the Company that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus (the "<u>Company Studies and Trials</u>") were and, if still pending, are being, conducted in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations, including without limitation the current Good Clinical Practices ("<u>cGCP</u>") as well as in accordance with experimental protocols that were submitted to the relevant Regulatory Authority (defined below) in the relevant jurisdiction; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and not misleading in all material respects; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and, except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not received any written notices or correspondence with the FDA or with or from any foreign, federal, state or local regulatory authority performing functions similar to those performed by the FDA (collectively "<u>Regulatory Authorities</u>**"**), requiring or threatening the termination, suspension or material modification of any Company Studies or Trials that are described in, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, that would reasonably be expected to result in a Material Adverse Change and, to the Company's knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. Neither the Company, nor its Subsidiaries or any of their respective directors, officers, employees or, to the Company's knowledge, agents is or has been debarred, suspended or excluded, or has been convicted of any crime or, to the knowledge of the Company or its Subsidiaries, engaged in any conduct that would result in a debarment, suspension or exclusion from any U.S. federal or state government health care program or human clinical research. To the Company's knowledge, none of the Company Studies and Trials involved any investigator, as such term is defined in Title 21, Section 50.3 of the U.S. Code of Federal Regulations, who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company's knowledge, the manufacturing facilities and operations of it and its suppliers, as applicable, are operated in compliance in all material respects with all applicable statutes, rules and regulations of the FDA and any foreign, federal, state or local regulatory authority performing functions similar to those performed by the FDA to which the Company is subject. The Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued, any recall of any clinical trial materials related to any of the Company Studies and Trials. Further, the Company and its Subsidiaries have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any of the Company Studies and Trials is in violation of any Applicable Laws nor, to the Company's knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except as would not, singularly or in the aggregate, reasonably be expected to result in a Material Adverse Change.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.49 <u>Health Care Products Manufacturing</u>. The manufacture of the Company's products by or on behalf of the Company is being conducted in material compliance with all Applicable Laws, including, without limitation, the FDA's current good manufacturing practice regulations at 21 CFR Part 820 and in compliance with all facility registration regulations, and, to the extent applicable, the respective counterparts thereof promulgated by any other Regulatory Authorities. The Company has had no manufacturing site (whether Company-owned or to the Company's knowledge, that of a third party manufacturer for the Company's products) subject to an FDA or other Regulatory Authority shutdown or import or export prohibition, nor received any unresolved written notice of adverse finding, warning letter, untitled letter, requests to make material changes to the Company's products, processes or operations, or similar written correspondence or notice from the FDA or any other Regulatory Authority alleging or asserting material noncompliance with any Applicable Laws or any governmental licenses required by any such Applicable Laws. To the Company's knowledge, neither the FDA nor any other Regulatory Authority is considering such action.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.50 <u>No Safety Notices</u>. Except as would not, singularly or in the aggregate, result in a Material Adverse Change: (i) there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, "dear doctor" letters, investigator notices, import alert, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company's products (collectively, "<u>Safety Notices</u>") and (ii) there are no facts that would be reasonably likely to result in (x) a Safety Notice with respect to the Company's products or services, or (y) a material change in labeling of any of the Company's products or (z) a termination or suspension of marketing, testing or distribution of any of the Company's products or services.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.51 <u>Forward-Looking Statements</u>. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) included in any of the Registration Statement, the Pricing Disclosure Package or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith, based on the information available to the Company as of the Effective Date.

3 <u>Covenants of the Company</u>. The Company covenants and agrees as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1 <u>Amendments to Registration Statement</u>. The Company shall deliver to the Representative, prior to filing, any amendment or supplement to the Registration Statement or Prospectus proposed to be filed after the Effective Date and not file any such amendment or supplement to which the Representative shall reasonably object in writing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2 <u>Federal Securities Laws</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.1 <u>Compliance</u>. The Company, subject to Section 3.2.2, shall comply with the requirements of Rule 430A of the Securities Act Regulations, and will, during the period required to permit the completion of the distribution of the Public Shares, the Representative's Warrants and the Representative Warrant Shares as contemplated in this Agreement and in the Registration Statement, the Pricing Disclosure Package and the Prospectus, notify the Representative promptly, and confirm the notice in writing, (i) when any post-effective amendment to the Registration Statement shall become effective or any amendment or supplement to the Prospectus shall have been filed; (ii) of the receipt of any comments from the Commission; (iii) of any request by the Commission for any amendment to the Registration Statement or any amendment or supplement to the Prospectus or for additional information; (iv) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment or of any order preventing or suspending the use of any Preliminary Prospectus or the Prospectus, or of the suspension of the qualification of the Public Shares, the Representative's Warrants or the Representative Warrant Shares for offering or sale in any jurisdiction, or of the initiation or threatening of any proceedings for any of such purposes or of any examination pursuant to Section 8(d) or 8(e) of the Securities Act concerning the Registration Statement; and (v) if the Company becomes the subject of a proceeding under Section 8A of the Securities Act in connection with the Offering of the Public Shares, the Representative's Warrants or the Representative Warrant Shares. The Company shall effect all filings required under Rule 424(b) of the Securities Act Regulations, in the manner and within the time period required by Rule 424(b) (without reliance on Rule 424(b)(8)), and shall take such steps as it deems necessary to ascertain promptly whether the form of prospectus transmitted for filing under Rule 424(b) was received for filing by the Commission and, in the event that it was not, it will promptly file such prospectus. The Company shall use its commercially reasonable efforts to prevent the issuance of any stop order, prevention or suspension and, if any such order is issued, to obtain the lifting thereof at the earliest possible moment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.2 <u>Continued Compliance</u>. The Company shall comply with the Securities Act, the Securities Act Regulations, the Exchange Act and the Exchange Act Regulations so as to permit the completion of the distribution of the Public Shares, the Representative's Warrants and the Representative Warrant Shares as contemplated in this Agreement and in the Registration Statement, the Pricing Disclosure Package and the Prospectus. If at any time when a prospectus relating to the Public Shares, the Representative's Warrants and/or the Representative Warrant Shares is (or, but for the exception afforded by Rule 172 of the Securities Act Regulations ("<u>Rule 172</u>"), would be) required by the Securities Act to be delivered in connection with sales of such securities, any event shall occur or condition shall exist as a result of which it is necessary, in the opinion of counsel for the Underwriters or for the Company, to (i) amend the Registration Statement in order that the Registration Statement will not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; (ii) amend or supplement the Pricing Disclosure Package or the Prospectus in order that the Pricing Disclosure Package or the Prospectus, as the case may be, will not include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in light of the circumstances existing at the time it is delivered to a purchaser or (iii) amend the Registration Statement or amend or supplement the Pricing Disclosure Package or the Prospectus, as the case may be, in order to comply with the requirements of the Securities Act or the Securities Act Regulations, the Company will promptly (A) give the Representative notice of such event; (B) prepare any amendment or supplement as may be necessary to correct such statement or omission or to make the Registration Statement, the Pricing Disclosure Package or the Prospectus comply with such requirements and, a reasonable amount of time prior to any proposed filing or use, furnish the Representative with copies of any such amendment or supplement and (C) file with the Commission any such amendment or supplement; provided that the Company shall not file or use any such amendment or supplement to which the Representative or counsel for the Underwriters shall reasonably object. The Company will furnish to the Underwriters such number of copies of such amendment or supplement as the Underwriters may reasonably request. The Company has given the Representative notice of any filings made pursuant to the Exchange Act or the Exchange Act Regulations within 48 hours prior to the Applicable Time. The Company shall give the Representative notice of its intention to make any such filing from the Applicable Time until the later of the Closing Date and any Option Closing Date and will furnish the Representative with copies of the related document(s) a reasonable amount of time prior to such proposed filing, as the case may be, and will not file or use any such document to which the Representative or counsel for the Underwriters shall reasonably object.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.3 <u>Exchange Act Registration</u>. For a period of two (2) years after the date of this Agreement, the Company shall use its commercially reasonable efforts to maintain the registration of the Common Stock under the Exchange Act, unless the Company is taken private in a bona fide acquisition transaction. During such two (2) year period, the Company shall not deregister the Common Stock under the Exchange Act without the prior written consent of the Representative, which consent shall not be unreasonably withheld.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.4 <u>Free Writing Prospectuses</u>. The Company agrees that, unless it obtains the prior written consent of the Representative, it shall not make any offer relating to the Public Shares, the Representative's Warrants or the Representative Warrant Shares that would constitute an Issuer Free Writing Prospectus or that would otherwise constitute a "free writing prospectus," or a portion thereof, required to be filed by the Company with the Commission or retained by the Company under Rule 433; provided that the Representative shall be deemed to have consented to each Issuer General Use Free Writing Prospectus hereto and any "road show that is a written communication" within the meaning of Rule 433(d)(8)(i) that has been reviewed by the Representative. The Company represents that it has treated or agrees that it will treat each such free writing prospectus consented to, or deemed consented to, by the Underwriters as an "issuer free writing prospectus," as defined in Rule 433, and that it has complied and will comply with the applicable requirements of Rule 433 with respect thereto, including timely filing with the Commission where required, legending and record keeping. If at any time following issuance of an Issuer Free Writing Prospectus there occurred or occurs an event or development as a result of which such Issuer Free Writing Prospectus conflicted or would conflict with the information contained in the Registration Statement or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify the Underwriters and will promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to eliminate or correct such conflict, untrue statement or omission.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.5 <u>Testing-the-Waters Communications</u>. If at any time following the distribution of any Written Testing-the-Waters Communication there occurred or occurs an event or development as a result of which such Written Testing-the-Waters Communication included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in light of the circumstances existing at that subsequent time, not misleading, the Company shall promptly notify the Representative and shall promptly amend or supplement, at its own expense, such Written Testing-the-Waters Communication to eliminate or correct such untrue statement or omission.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3 <u>Delivery to the Underwriters of Registration Statements</u>. The Company has delivered or made available or shall deliver or make available to the Representative and counsel for the Representative, upon request and without charge, signed copies of the Registration Statement as originally filed and each amendment thereto (including exhibits filed therewith) and signed copies of all consents and certificates of experts, and will also deliver to the Underwriters, without charge, a conformed copy of the Registration Statement as originally filed and each amendment thereto (without exhibits) for each of the Underwriters, upon receipt of a written request therefor. The copies of the Registration Statement and each amendment thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4 <u>Delivery to the Underwriters of Prospectuses</u>. The Company has delivered or made available or will deliver or make available to each Underwriter, without charge, as many copies of each Preliminary Prospectus as such Underwriter reasonably requested, and the Company hereby consents to the use of such copies for purposes permitted by the Securities Act. The Company will furnish to each Underwriter, without charge, during the period when a prospectus relating to the Public Shares, the Representative's Warrants and/or the Representative Warrant Shares is (or, but for the exception afforded by Rule 172, would be) required to be delivered under the Securities Act, such number of copies of the Prospectus (as amended or supplemented) as such Underwriter may reasonably request. The Prospectus and any amendments or supplements thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5 [<u>Reserved</u>].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6 <u>Review of Financial Statements.</u> For a period of two (2) years after the date of this Agreement, the Company, at its expense, shall use its commercially reasonable efforts to cause its regularly engaged independent registered public accounting firm to review (but not audit) the Company's interim financial statements immediately preceding the announcement of any interim financial information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7 <u>Listing</u>. The Company shall use its commercially reasonable efforts to list for trading, subject only to official notice of issuance, the Public Shares and the Representative Warrant Shares on the Exchange and to maintain the listing of the Common Stock on the Exchange for at least two (2) years from the date of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8 <u>Reports to the Representative</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8.1 <u>Periodic Reports, etc</u>. For a period of two (2) years after the date of this Agreement, the Company shall furnish or make available to the Representative copies of such financial statements and other periodic and special reports as the Company from time to time furnishes generally to holders of any class of its securities and also promptly furnish to the Representative: (i) a copy of each periodic report the Company shall be required to file with the Commission under the Exchange Act and the Exchange Act Regulations; (ii) a copy of every press release and every news item and article with respect to the Company or its affairs which was released by the Company; (iii) a copy of each Form 8-K prepared and filed or furnished by the Company; and (iv) a copy of each registration statement filed by the Company under the Securities Act; provided the Representative shall sign, if requested by the Company, a Regulation FD compliant confidentiality agreement which is reasonably acceptable to the Representative and Representative Counsel in connection with the Representative's receipt of such information. Documents filed with the Commission pursuant to its EDGAR system (or with respect to articles and press releases, posted on the Company's website) shall be deemed to have been delivered to the Representative pursuant to this Section 3.8.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8.2 <u>Transfer Agent; Transfer Sheets</u>. For a period of one (1) year after the date of this Agreement, the Company shall retain a transfer agent and registrar acceptable to the Representative (the "<u>Transfer Agent</u>") and shall furnish to the Representative at the Company's sole cost and expense such transfer sheets of the Company's securities as the Representative may reasonably request, including the daily and monthly consolidated transfer sheets of the Transfer Agent and DTC. Equniti Trust Company, LLC is acceptable to the Representative to act as Transfer Agent for the Common Stock.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.9 <u>Payment of Expenses</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.9.1 <u>General Expenses Related to the Offering</u>. The Company hereby agrees to pay on the Closing Date and on any Option Closing Date to the extent not paid on the Closing Date, all expenses incident to the performance of the obligations of the Company under this Agreement, including, but not limited to: (a) all filing fees and communication expenses relating to the registration of the Public Shares, the Representative's Warrants and the Representative Warrant Shares with the Commission; (b) all public filing system filing fees associated with the review of the Offering by FINRA; (c) all fees and expenses relating to the listing of the Public Shares and the Representative Warrant Shares on the Exchange and such other stock exchanges as the Company and the Representative together determine; (d) all fees, expenses and disbursements relating to the registration or qualification of the Public Shares, the Representative's Warrants and the Representative Warrant Shares under the "blue sky" securities laws of such states and other jurisdictions as the Representative may reasonably designate (including, without limitation, all filing and registration fees); (e) all fees, expenses and disbursements relating to the registration, qualification or exemption of the Public Shares, the Representative's Warrants and the Representative Warrant Shares under the securities laws of such foreign jurisdictions as the Representative may reasonably designate; (f) the costs of all mailing and printing of the Registration Statements, Prospectuses and all amendments, supplements and exhibits thereto and as many preliminary and final Prospectuses as the Representative may reasonably deem necessary; (g) the costs and expenses of the Company's investor relations firm; (h) fees and expenses of the Transfer Agent; (i) the fees and expenses of the Company's accountants; (j) the fees and expenses of the Company's legal counsel and other agents and representatives; (k) fees and expenses of the Representative's legal counsel; (l) the costs associated with the Underwriter's use of Ipreo's book-building, prospectus tracking and compliance software for the Offering; (m) the Underwriters' actual accountable "road show" expenses; and (n) the costs associated with receiving commemorative mementos and lucite tombstones. The Underwriters shall be entitled to reimbursement by the Company for all reasonable and documented expenses under <u>Section 3.9.1</u> – (n), which reimbursement shall not exceed $150,000. In addition, the Company shall be responsible for all fees, expenses and disbursements relating to background checks of the Company's officers and directors in an amount not to exceed $7,500 in the aggregate. It is acknowledged that the Company has heretofore paid a retainer to the Representative of an aggregate of $[60,000] (the "<u>Retainer</u>"), which shall be applied against the accountable expenses under this Section 3.9.1. The Representative may deduct from the net proceeds of the Offering payable to the Company on the Closing Date and on any Option Closing Date, the expenses set forth herein to be paid by the Company to the Underwriters. Any portion of the Retainer in excess of expenses actually incurred shall be returned to the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.9.2 <u>Non-accountable Expenses</u>. The Company further agrees that, in addition to the expenses payable pursuant to Section 3.9.1, on the Closing Date and on any Option Closing Date it shall pay to the Representative, by deduction from the net proceeds of the Offering contemplated herein, a non-accountable expense allowance equal to one percent (1%) of the gross proceeds received by the Company from the sale of the Firm Shares and the Option Shares, provided, however, that in the event that the Offering is terminated, the Company agrees to reimburse the Underwriters pursuant to Section 8.3 hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.10 <u>Application of Net Proceeds</u>. The Company shall apply the net proceeds from the Offering received by it in a manner consistent with the application thereof described under the caption "Use of Proceeds" in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11 <u>Delivery of Earnings Statement to Security Holders</u>. The Company shall make generally available to its security holders as soon as practicable, but not later than the first day of the fifteenth (15th) full calendar month following the date of this Agreement, an earnings statement (which need not be certified by an independent registered public accounting firm unless required by the Securities Act or the Securities Act Regulations, but which shall satisfy the provisions of Rule 158(a) under Section 11(a) of the Securities Act) covering a period of at least twelve (12) consecutive months beginning after the date of this Agreement; provided that such earnings statement shall be deemed to be made available to the extent it is included in a filing with the Commission on EDGAR.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.12 <u>Stabilization</u>. Neither the Company nor any of its Subsidiaries nor, to its knowledge, any of their respective employees, directors or stockholders (without the consent of the Representative) has taken or shall take, directly or indirectly, any action designed to or that has constituted or that might reasonably be expected to cause or result in, under Regulation M of the Exchange Act, or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Public Shares, the Representative's Warrants or the Representative Warrant Shares.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.13 <u>Internal Controls</u>. Except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company shall maintain a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with management's general or specific authorization; (ii) transactions are recorded as necessary in order to permit preparation of financial statements in accordance with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management's general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.14 <u>Accountants</u>. As of the date of this Agreement, the Company has retained an independent registered public accounting firm reasonably acceptable to the Representative, and the Company shall continue to retain a nationally recognized independent registered public accounting firm for a period of at least two (2) years after the date of this Agreement. The Representative acknowledges that the Auditor is acceptable to the Representative.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.15 <u>FINRA</u>. For a period of 60 days from the later of the Closing Date and any Option Closing Date, except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company shall advise the Representative (who shall make an appropriate filing with FINRA) if it is or becomes aware that (i) any officer or director of the Company, (ii) any beneficial owner of 10% or more of any class of the Company's securities or (iii) any beneficial owner of the Company's unregistered equity securities which were acquired during the 180 days immediately preceding the filing of the Registration Statement is or becomes an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.16 <u>No Fiduciary Duties</u>. The Company acknowledges and agrees that the Underwriters' responsibility to the Company is solely contractual in nature and that none of the Underwriters or their affiliates or any selling agent shall be deemed to be acting in a fiduciary capacity, or otherwise owes any fiduciary duty to the Company or any of its affiliates in connection with the Offering and the other transactions contemplated by this Agreement, except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.17 <u>Company Lock-Up Agreements</u>. The Company, on behalf of itself and any successor entity, agrees that, without the prior written consent of the Representative, it will not, nor will it publicly disclose an intention to, for a period commencing on the date hereof and ending 180 days after the Closing Date (the "<u>Lock-Up Period</u>"), (i) offer, issue, pledge, sell (including, without limitation, any short sale), contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend, establish an open "put equivalent position" within the meaning of Rule 16a-1(h) under the Exchange Act or otherwise transfer or dispose of, or any shares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock of the Company; (ii) file or caused to be filed any registration statement with the Commission relating to the offering of any shares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for shares of capital stock of the Company, other than a registration statement on Form S-8; (iii) complete any offering of debt securities of the Company, other than entering into a line of credit or similar financing agreements; or (iv) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of capital stock of the Company, whether any such transaction described in clause (i), (ii), (iii) or (iv) above is to be settled by delivery of shares of capital stock of the Company or such other securities, in cash or otherwise. The restrictions contained in this Section 3.17 shall not apply to (a) the Public Shares, Representative's Warrants and Representative Warrant Shares to be issued pursuant to the terms hereunder; (b) the issuance by the Company of shares of Common Stock upon the exercise of a stock option or warrant or the conversion of a security outstanding on the date hereof, or other issuances of additional shares in accordance with the terms of securities, in each case, as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, provided that such options, warrants, and securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities or to extend the term of such securities; (c) the issuance by the Company of stock options or other stock-based awards or the issuance by the Company of shares of capital stock of the Company under any equity compensation or incentive plan of the Company described in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and (d) any warrants issued by the Company pursuant to Section 7.4 hereunder as a Future Financing Fee (or any securities underlying any such warrants); provided that in the case of (b) and (c) above, each recipient of such shares of Common Stock shall be contractually prohibited from selling, offering, disposing of or otherwise transferring any such shares during the remainder of the Lock-Up Period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.18 <u>Release of D&O Lock-Up Period</u>. If the Representative, in its sole discretion, agrees to release or waive the restrictions set forth in the Lock-Up Agreements described in Section 2.24 hereof for an officer or director of the Company and provides the Company with notice of the impending release or waiver at least three (3) Business Days before the effective date of the release or waiver, the Company agrees to announce the impending release or waiver by a press release substantially in the form of <u>Exhibit B</u> hereto through a major news service at least two (2) Business Days before the effective date of the release or waiver.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.19 <u>Blue Sky Qualifications</u>. The Company shall use its commercially reasonable efforts, in cooperation with the Underwriters, if necessary, to qualify the Public Shares, the Representative's Warrants and the Representative Warrant Shares for offering and sale under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Representative may designate and to maintain such qualifications in effect so long as required to complete the distribution of the applicable securities; provided, however, that the Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.20 <u>Reporting Requirements</u>. The Company, during the period when a prospectus relating to the Public Shares, the Representative's Warrants and/or the Representative Warrant Shares is (or, but for the exception afforded by Rule 172, would be) required to be delivered under the Securities Act, will file all documents required to be filed with the Commission pursuant to the Exchange Act within the time periods required by the Exchange Act and Exchange Act Regulations. Additionally, the Company shall report the use of proceeds from the issuance of the Public Shares, the Representative's Warrants and the Representative Warrant Shares as may be required under Rule 463 under the Securities Act Regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.21 <u>Representative Warrant Shares Reserved</u>. The Company shall, at all times while any Representative's Warrants are outstanding, reserve and keep available out of the aggregate of its authorized but unissued and otherwise unreserved shares of Common Stock, solely for the purpose of enabling it to issue Representative Warrant Shares upon exercise of the Representative's Warrants, the number of Representative Warrant Shares that are initially issuable and deliverable upon the exercise of the then-outstanding Representative's Warrants.

4 <u>Conditions of Underwriters' Obligations</u>. The obligations of the Underwriters to purchase and pay for the Public Shares, as provided herein, shall be subject to (i) the continuing accuracy of the representations and warranties of the Company as of the date hereof and as of the Closing Date and any Option Closing Date; (ii) the accuracy of the statements of officers of the Company made pursuant to the provisions hereof; (iii) the performance by the Company of its obligations hereunder; and (iv) the following conditions:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1 <u>Regulatory Matters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1.1 <u>Effectiveness of Registration Statement; Rule 430A Information</u>. The Registration Statement has become effective not later than 5:30 p.m., Eastern time, on the date of this Agreement or such later date and time as shall be consented to in writing by you, and, at the Closing Date and at any Option Closing Date, no stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto has been issued under the Securities Act, no order preventing or suspending the use of any Preliminary Prospectus or the Prospectus has been issued and no proceedings for any of those purposes have been instituted or are pending or, to the Company's knowledge, contemplated by the Commission. The Company has complied with each request (if any) from the Commission for additional information. The Prospectus containing the Rule 430A Information shall have been filed with the Commission in the manner and within the time frame required by Rule 424(b) (without reliance on Rule 424(b)(8)) or a post-effective amendment providing such information shall have been filed with, and declared effective by, the Commission in accordance with the requirements of Rule 430A.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1.2 <u>FINRA Clearance</u>. On or before the date of this Agreement, the Representative shall have received clearance from FINRA as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1.3 <u>Exchange Stock Market Clearance</u>. On the Closing Date and on any Option Closing Date, the Firm Shares or the Option Shares, as the case may be, shall have been duly approved for listing on the Exchange, subject only to official notice of issuance.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2 <u>Company Counsel Matters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2.1 <u>Opinion of Counsel</u>. On the Closing Date and on any Option Closing Date, the Representative shall have received the favorable opinions of (i) Company Counsel and (ii) Nixon & Vanderhye PC, special intellectual property counsel to the Company, each dated the Closing Date or the applicable Option Closing Date and addressed to the Representative, in form and substance reasonably satisfactory to the Representative.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2.2 <u>Reliance</u>. In rendering such opinions, such counsel may rely: (i) as to matters involving the application of laws other than the laws of the United States and jurisdictions in which they are admitted, to the extent such counsel deems proper and to the extent specified in such opinion, if at all, upon an opinion or opinions (in form and substance reasonably satisfactory to the Representative) of other counsel reasonably acceptable to the Representative, familiar with the applicable laws; and (ii) as to matters of fact, to the extent they deem proper, on certificates or other written statements of officers of the Company and officers of departments of various jurisdictions having custody of documents respecting the corporate existence or good standing of the Company, provided that copies of any such statements or certificates shall be delivered to Representative Counsel if requested.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3 <u>Comfort Letters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3.1 <u>Comfort Letter</u>. At the time this Agreement is executed you shall have received a comfort letter from the Auditor containing statements and information of the type customarily included in accountants' comfort letters with respect to the financial statements and certain financial information contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus, addressed to the Representative and in form and substance satisfactory in all respects to you and to the Auditor, dated as of the date of this Agreement and with a specified date therein not more than two (2) Business Days prior to the date of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3.2 <u>Bring-down Comfort Letter</u>. At the Closing Date and at any Option Closing Date, the Representative shall have received from the Auditor a letter, dated as of the Closing Date or the applicable Option Closing Date, to the effect that the Auditor reaffirms the statements made in the letter furnished pursuant to Section 4.3.1, except that the specified date referred to shall be a date no earlier than the later of (i) the date of this Agreement and (ii) the date that is two (2) Business Days prior to the Closing Date or the applicable Option Closing Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4 <u>Officers' Certificates</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4.1 <u>Officers' Certificate</u>. The Company shall have furnished to the Representative a certificate, dated the Closing Date and any Option Closing Date, of its Chief Executive Officer and its Chief Financial Officer on behalf of the Company and not in an individual capacity stating that (i) such officers have carefully examined the Registration Statement, the Pricing Disclosure Package and the Prospectus and, in their opinion, the Registration Statement and each amendment thereto, as of the Applicable Time and as of the Closing Date and any Option Closing Date did not include any untrue statement of a material fact and did not omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, and the Pricing Disclosure Package, as of the Applicable Time and as of the Closing Date and any Option Closing Date, the Prospectus and each amendment or supplement thereto, as of the respective date thereof and as of the Closing Date and any Option Closing Date, did not include any untrue statement of a material fact and did not omit to state a material fact necessary in order to make the statements therein, in light of the circumstances in which they were made, not misleading, (ii) since the effective date of the Registration Statement, no event has occurred which should have been set forth in a supplement or amendment to the Registration Statement, the Pricing Disclosure Package or the Prospectus, (iii) to the best of their knowledge after reasonable investigation, as of the Closing Date and any Option Closing Date, the representations and warranties of the Company in this Agreement are true and correct and the Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied hereunder at or prior to the Closing Date and any Option Closing Date, and (iv) there has not been, subsequent to the date of the most recent audited financial statements included or incorporated by reference in the Pricing Disclosure Package, any Material Adverse Change, except as set forth in the Prospectus.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4.2 <u>Secretary's Certificate</u>. At the Closing Date and at any Option Closing Date, the Representative shall have received a certificate of the Company signed by the Secretary (or the Chief Financial Officer in lieu of the Secretary) of the Company, dated the Closing Date and the applicable Option Closing Date, certifying: (i) that the Company's certificate of incorporation and bylaws are true and complete, have not been modified and are in full force and effect; (ii) that the resolutions of the Company's Board of Directors relating to the Offering are in full force and effect and have not been modified; (iii) as to the accuracy and completeness of all correspondence between the Company or its counsel and the Commission; and (iv) as to the incumbency of the officers of the Company. The documents referred to in such certificate shall be attached to such certificate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5 <u>No Material Changes</u>. Prior to and on the Closing Date and any Option Closing Date: (i) there shall have been no Material Adverse Change in the condition or the business activities, financial or otherwise, of the Company from the latest dates as of which such condition is set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (ii) no action, suit or proceeding, at law or in equity, shall have been pending or threatened against the Company or any Insider before or by any court or federal or state commission, board or other administrative agency wherein an unfavorable decision, ruling or finding may reasonably be expected to cause a Material Adverse Change, except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iii) no stop order shall have been issued under the Securities Act and no proceedings therefor shall have been initiated or threatened by the Commission; and (iv) the Registration Statement, the Pricing Disclosure Package and the Prospectus and any amendments or supplements thereto shall contain all material statements which are required to be stated therein in accordance with the Securities Act and the Securities Act Regulations and shall conform in all material respects to the requirements of the Securities Act and the Securities Act Regulations, and neither the Registration Statement, the Pricing Disclosure Package nor the Prospectus nor any amendment or supplement thereto shall contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6 <u>Delivery of Agreements and Representative's Warrants</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6.1 <u>Lock-Up Agreements</u>. On or before the date of this Agreement, the Company shall have delivered to the Representative executed copies of the Lock-Up Agreements from each of the persons listed in <u>Schedule 3</u> hereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6.2 <u>Representative's Warrants</u>. On the Closing Date and on any Option Closing Date, the Company shall have delivered to the Representative an executed copy of the Representative's Warrants.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.7 <u>Additional Documents</u>. At the Closing Date and at any Option Closing Date, Representative Counsel shall have been furnished with such documents and opinions as they may reasonably require for the purpose of enabling Representative Counsel to deliver an opinion to the Underwriters, or in order to evidence the accuracy of any of the representations or warranties, or the fulfillment of any of the conditions, herein contained; and all proceedings taken by the Company in connection with the issuance and sale of the Public Shares, the Representative's Warrants and the Representative Warrant Shares as herein contemplated shall be reasonably satisfactory in form and substance to the Representative and Representative Counsel.

5 Indemnification.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1 <u>Indemnification of the Underwriters</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.1 <u>General</u>. Subject to the conditions set forth below, the Company agrees to indemnify and hold harmless each Underwriter, its affiliates (as defined in Rule 405 under the Securities Act, as amended) and each of its and their respective directors, officers, members, employees, representatives, partners, shareholders, affiliates, counsel, and agents and each person, if any, who controls any such Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (collectively the "<u>Underwriter Indemnified Parties</u>," and each an "<u>Underwriter Indemnified Party</u>"), against any and all loss, liability, claim, damage and expense whatsoever (including, but not limited to, any and all legal or other expenses reasonably incurred in investigating, preparing or defending against any litigation, commenced or threatened, or any claim whatsoever, whether arising out of any action between any of the Underwriter Indemnified Parties and the Company or between any of the Underwriter Indemnified Parties and any third party, or otherwise) to which they or any of them may become subject under the Securities Act, the Exchange Act or any other statute or at common law or otherwise or under the laws of foreign countries (a "<u>Claim</u>"), arising out of or based upon any untrue statement or alleged untrue statement of a material fact contained in (A) the Registration Statement, the Pricing Disclosure Package, any Preliminary Prospectus, the Prospectus, or in any Written Testing-the-Waters Communication (as from time to time each may be amended and supplemented); (B) any materials or information provided to investors by, or with the approval of, the Company in connection with the marketing of the Offering, including any "road show" or investor presentations made to investors by the Company (whether in person or electronically); or (C) any application or other document or written communication (in this Section 5, collectively called "<u>application</u>") executed by the Company or based upon written information furnished by the Company in any jurisdiction in order to qualify the Public Shares, the Representative's Warrants and the Representative Warrant Shares under the securities laws thereof or filed with the Commission, any state securities commission or agency, the Exchange or any other national securities exchange; or the omission or alleged omission therefrom of a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, unless such statement or omission was made in reliance upon, and in conformity with, the Underwriters' Information. The Company also agrees that it will reimburse each Underwriter Indemnified Party for all fees and expenses (including, but not limited to, any and all legal or other expenses reasonably incurred in investigating, preparing or defending against any litigation, commenced or threatened, or any claim whatsoever, whether arising out of any action between any of the Underwriter Indemnified Parties and the Company or between any of the Underwriter Indemnified Parties and any third party, or otherwise) (collectively, the "<u>Expenses</u>"), and further agrees wherever and whenever possible to advance payment of Expenses as they are incurred by an Underwriter Indemnified Party in investigating, preparing, pursuing or defending any Claim. The Company shall not be liable under this Section 5 to the extent that a final judgment by a court of competent jurisdiction determines that such loss, claim, damage, or liability resulted from an Underwriter Indemnified Party's fraud or knowing violation of law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.2 <u>Procedure</u>. If any action is brought against an Underwriter Indemnified Party in respect of which indemnity may be sought against the Company pursuant to Section 5.1.1, such Underwriter Indemnified Party shall promptly notify the Company in writing of the institution of such action and the Company shall assume the defense of such action, including the employment and fees of counsel (subject to the reasonable approval of such Underwriter Indemnified Party) and payment of actual expenses if an Underwriter Indemnified Party requests that the Company do so. Such Underwriter Indemnified Party shall have the right to employ its or their own counsel in any such case, but the fees and expenses of such counsel shall be at the expense of such Underwriter Indemnified Party unless (i) the employment of such counsel at the expense of the Company shall have been authorized in writing by the Company in connection with the defense of such action, or (ii) the Company shall not have employed counsel to have charge of the defense of such action, or (iii) such indemnified party or parties shall have reasonably concluded that there may be defenses available to it or them which are different from or additional to those available to the Company (in which case the Company shall not have the right to direct the defense of such action on behalf of the indemnified party or parties), in any of which events the reasonable fees and expenses of not more than one additional firm of attorneys selected by the Underwriter Indemnified Party (in addition to local counsel) shall be borne by the Company. Notwithstanding anything to the contrary contained herein, if any Underwriter Indemnified Party shall assume the defense of such action as provided above, the Company shall have the right to approve the terms of any settlement of such action, which approval shall not be unreasonably withheld. The Company shall not be liable for any settlement of any action effected without its consent (which shall not be unreasonably withheld). In addition, the Company shall not, without the prior written consent of the Underwriters, settle, compromise or consent to the entry of any judgment in or otherwise seek to terminate any pending or threatened action in respect of which advancement, reimbursement, indemnification or contribution may be sought hereunder (whether or not such Underwriter Indemnified Party is a party thereto) unless such settlement, compromise, consent or termination (i) includes an unconditional release of each Underwriter Indemnified Party, acceptable to such Underwriter Indemnified Party, from all liabilities, expenses and claims arising out of such action for which indemnification or contribution may be sought and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act, by or on behalf of any Underwriter Indemnified Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2 <u>Indemnification of the Company</u>. Each Underwriter, severally and not jointly, shall indemnify and hold harmless the Company, its directors, its officers who signed the Registration Statement and persons who control the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act against any and all loss, liability, claim, damage and expense described in the foregoing indemnity from the Company to the several Underwriters, as incurred, but only with respect to such losses, liabilities, claims, damages and expenses (or actions in respect thereof) which arise out of or are based upon untrue statements or omissions, or alleged untrue statements or omissions made in the Registration Statement, any Preliminary Prospectus, the Pricing Disclosure Package or Prospectus or any amendment or supplement thereto or in any application, in reliance upon, and in strict conformity with, the Underwriters' Information. In case any action shall be brought against the Company or any other person so indemnified based on any Preliminary Prospectus, the Registration Statement, the Pricing Disclosure Package or Prospectus or any amendment or supplement thereto or any application, and in respect of which indemnity may be sought against any Underwriter, such Underwriter shall have the rights and duties given to the Company, and the Company and each other person so indemnified shall have the rights and duties given to the several Underwriters by the provisions of Section 5.1.2. The Company agrees promptly to notify the Representative of the commencement of any litigation or proceedings against the Company or any of its officers, directors or any person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, in connection with the issuance and sale of the Public Shares, the Representative's Warrants or the Representative Warrant Shares or in connection with the Registration Statement, the Pricing Disclosure Package, the Prospectus, or any Written Testing-the-Waters Communication.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3 <u>Contribution</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3.1 <u>Contribution Rights</u>. If the indemnification provided for in this Section 5 shall for any reason be unavailable to or insufficient to hold harmless an indemnified party under Section 5.1 or 5.2 in respect of any loss, claim, damage or liability, or any action in respect thereof, referred to therein, then each indemnifying party shall, in lieu of indemnifying such indemnified party, contribute to the amount paid or payable by such indemnified party as a result of such loss, claim, damage or liability, or action in respect thereof, (i) in such proportion as shall be appropriate to reflect the relative benefits received by the Company, on the one hand, and each of Underwriters, on the other, from the Offering of the Public Shares, or (ii) if, but only if, the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company, on the one hand, and each of the Underwriters, on the other, with respect to the statements or omissions that resulted in such loss, claim, damage or liability, or action in respect thereof, as well as any other relevant equitable considerations. The relative benefits received by the Company, on the one hand, and the Underwriters, on the other, with respect to such Offering shall be deemed to be in the same proportion as the total net proceeds from the Offering of the Public Shares purchased under this Agreement (before deducting expenses) received by the Company, as set forth in the table on the cover page of the Prospectus, on the one hand, and the total underwriting discounts and commissions received by the Underwriters with respect to the Public Shares purchased under this Agreement, as set forth in the table on the cover page of the Prospectus, on the other hand. The relative fault shall be determined by reference to whether the untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company or the Underwriters, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Underwriters agree that it would not be just and equitable if contributions pursuant to this Section 5.3.1 were to be determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation that does not take into account the equitable considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, damage or liability, or action in respect thereof, referred to above in this Section 5.3.1 shall be deemed to include, for purposes of this Section 5.3.1, any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this Section 5.3.1 in no event shall an Underwriter be required to contribute any amount in excess of the amount by which the total underwriting discounts and commissions received by such Underwriter with respect to the Offering of the Public Shares exceeds the amount of any damages that such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3.2 <u>Contribution Procedure</u>. Within fifteen (15) days after receipt by any party to this Agreement (or its representative) of notice of the commencement of any action, suit or proceeding, such party will, if a claim for contribution in respect thereof is to be made against another party ("<u>contributing party</u>"), notify the contributing party of the commencement thereof, but the failure to so notify the contributing party will not relieve it from any liability which it may have to any other party other than for contribution hereunder. In case any such action, suit or proceeding is brought against any party, and such party notifies a contributing party or its representative of the commencement thereof within the aforesaid fifteen (15) days, the contributing party will be entitled to participate therein with the notifying party and any other contributing party similarly notified. Any such contributing party shall not be liable to any party seeking contribution on account of any settlement of any claim, action or proceeding affected by such party seeking contribution on account of any settlement of any claim, action or proceeding affected by such party seeking contribution without the written consent of such contributing party. The contribution provisions contained in this Section 5.3.2 are intended to supersede, to the extent permitted by law, any right to contribution under the Securities Act, the Exchange Act or otherwise available. Each Underwriter's obligations to contribute pursuant to this Section 5.3.2 are several and in proportion to their respective underwriting obligation and not joint.

6 <u>Default by an Underwriter</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1 <u>Default Not Exceeding 10% of Firm Shares or Option Shares</u>. If any Underwriter or Underwriters shall default in its or their obligations to purchase the Firm Shares (or, as the case may be, the Option Shares), and if the number of the Firm Shares or Option Shares with respect to which such default relates does not exceed in the aggregate ten percent (10%) of the number of Firm Shares or Option Shares that all Underwriters have agreed to purchase hereunder, then such Firm Shares or Option Shares to which the default relates shall be purchased by the non-defaulting Underwriters in proportion to their respective commitments hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2 <u>Default Exceeding 10% of Firm Shares or Option Shares</u>. In the event that the default addressed in Section 6.1 relates to more than ten percent (10%) of the Firm Shares or applicable Option Shares, you may in your discretion arrange for yourself or for another party or parties to purchase such Firm Shares or Option Shares to which such default relates on the terms contained herein. If, within one (1) Business Day after such default relating to more than ten percent (10%) of the Firm Shares or Option Shares, you do not arrange for the purchase of such Firm Shares, then the Company shall be entitled to a further period of one (1) Business Day within which to procure another party or parties satisfactory to you to purchase said Firm Shares or Option Shares on such terms. In the event that neither you nor the Company arrange for the purchase of the Firm Shares or Option Shares to which a default relates as provided in this Section 6, this Agreement will automatically be terminated by you or the Company without liability on the part of the Company (except as provided in Sections 3.10 and 5 hereof) or the several Underwriters (except as provided in Section 5 hereof); provided, however, that if such default occurs with respect to the Option Shares, this Agreement will not terminate as to the Firm Shares; and provided, further, that nothing herein shall relieve a defaulting Underwriter of its liability, if any, to the other Underwriters and to the Company for damages occasioned by its default hereunder. For the avoidance of doubt, nothing contained in this Section 6.2 shall excuse a default by the Representative (in its capacity as an Underwriter) in its obligations to purchase the Firm Shares or the Option Shares, if the Over-Allotment Option is exercised hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3 <u>Postponement of Closing Date</u>. In the event that the Firm Shares or Option Shares to which the default relates are to be purchased by the non-defaulting Underwriters, or are to be purchased by another party or parties as aforesaid, you or the Company shall have the right to postpone the Closing Date for a reasonable period, but not in any event exceeding five (5) Business Days, in order to effect whatever changes may thereby be made necessary in the Registration Statement, the Pricing Disclosure Package or the Prospectus or in any other documents and arrangements, and the Company agrees to file promptly any amendment to the Registration Statement, the Pricing Disclosure Package or the Prospectus that in the opinion of Company Counsel and counsel to the Representative may thereby be made necessary. The term "Underwriter" as used in this Agreement shall include any party substituted under this Section 6 with like effect as if it had originally been a party to this Agreement with respect to such Public Shares.

7 Additional Covenants.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1 <u>Board Composition and Board Designations</u>. The Company shall ensure as of the Closing Date that: (i) the qualifications of the persons serving as members of the Board of Directors and the overall composition of the Board of Directors comply with the Sarbanes-Oxley Act, with the Exchange Act and with the listing rules of the Exchange or any other national securities exchange, as the case may be, in the event the Company seeks to have its Public Shares or Representative Warrant Shares listed on another exchange or quoted on an automated quotation system, and (ii) if applicable, at least one (1) member of the Audit Committee of the Board of Directors qualifies as an "audit committee financial expert," as such term is defined under Regulation S-K and the listing rules of the Exchange.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2 <u>Prohibition on Press Releases and Public Announcements</u>. Except as required by law or rule of the Exchange, the Company shall not issue press releases or engage in any other publicity, without the Representative's prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed, for a period ending at 5:00 p.m., Eastern time, on the first (1<sup>st</sup>) Business Day following the twenty-fifth (25<sup>th</sup>) day after the Closing Date or expiration or termination of this Agreement, other than normal and customary releases issued in the ordinary course of the Company's business.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3 <u>Right of First Refusal</u>. Provided that the Firm Shares are sold in accordance with the terms of this Agreement, the Representative shall have an irrevocable right of first refusal (the "<u>Right of First Refusal</u>"), for a period of twelve (12) months after the Closing Date, to act as lead or joint-lead investment banker, lead or joint book-runner, lead or joint placement agent and/or investment banker/advisor, at the Representative's sole and exclusive discretion, for each and every future public and private equity and debt offering, including all equity linked financings (each, a "<u>Subject Transaction</u>"), during such twelve (12) month period, of the Company, or any successor to or Subsidiary of the Company, on terms and conditions customary to the Representative for such Subject Transactions. For the avoidance of any doubt, the Company shall not retain, engage or solicit any additional investment banker, book-runner and/or placement agent in a Subject Transaction without the express written consent of the Representative, which consent shall not be unreasonably withheld, conditioned or delayed.

The Company shall notify the Representative of its intention to pursue a Subject Transaction, including the material terms thereof, by providing written notice thereof by email. If the Representative fails to exercise its Right of First Refusal with respect to any Subject Transaction within ten (10) calendar days after receipt of such written notice, then the Representative shall have no further claim or right with respect to the Subject Transaction. The Representative may elect, in its sole and absolute discretion, not to exercise its Right of First Refusal with respect to any Subject Transaction; provided that any such election by the Representative shall not adversely affect the Representative's Right of First Refusal with respect to any other Subject Transaction during the twelve (12) month period agreed to above.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4 <u>Tail Financing</u>. The Representative shall be entitled to receive from the Company (i) an aggregate additional fee of seven percent (7%) of the gross proceeds from any public offering or other financing or capital raising transaction of any kind consummated by the Company ("<u>Future Financings</u>") and (ii) warrants, in a form to be reasonably satisfactory to the Representative, to purchase up to five percent (5%) of the number of any securities sold by the Company in Future Financings (such additional fee and warrants, the "<u>Future Financing Fees</u>"), in each case to the extent that such financing or capital is consummated with investors (or any entity under common management or having a common investment advisor) with whom the Company has had a conference call or a meeting arranged by the Representative so long as such Future Financing is consummated at any time within twelve (12) months after the earlier to occur of (i) the Closing Date or (ii) the expiration or termination of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5 <u>Covenant of the Underwriters</u>. The Underwriters covenant with the Company not to take any action that would result in the Company being required to file with the Commission under Rule 433(d) a free writing prospectus prepared by or on behalf of such Underwriters that otherwise would not be required to be filed by the Company thereunder but for the action of the Underwriters.

8 Effective Date of this Agreement and Termination Thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1 <u>Effective Date</u>. This Agreement shall become effective when both the Company and the Representative have executed the same and delivered counterparts of such signatures to the other party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2 <u>Termination</u>. The Representative shall have the right to terminate this Agreement at any time prior to any Closing Date, (i) if any domestic or international event or act or occurrence has materially disrupted, or in your reasonable opinion will in the immediate future materially disrupt, general securities markets in the United States; (ii) if trading on the New York Stock Exchange or the Nasdaq Stock Market LLC shall have been suspended or materially limited, or minimum or maximum prices for trading shall have been fixed, or maximum ranges for prices for securities shall have been required by FINRA or by order of the Commission or any other government authority having jurisdiction; (iii) if the United States shall have become involved in a new war or an increase in major hostilities; (iv) if a banking moratorium has been declared by a New York State or federal authority; (v) if a moratorium on foreign exchange trading has been declared which materially adversely impacts the United States securities markets; (vi) if the Company shall have sustained a material loss by fire, flood, accident, hurricane, earthquake, theft, sabotage or other calamity or malicious act which, whether or not such loss shall have been insured, will, in your reasonable judgment, make it inadvisable to proceed with the delivery of the Firm Shares (or Option Shares, as the case may be); (vii) if the Company is in material breach of any of its representations, warranties or covenants hereunder; or (viii) if the Representative shall have become aware after the date hereof of a Material Adverse Change or an adverse material change in general market conditions as in the Representative's reasonable judgment would make it impracticable to proceed with the offering, sale and/or delivery of the Public Shares or to enforce contracts made by the Underwriters for the sale of the Public Shares.

The Company may terminate this Agreement for cause at any time. For purposes of this Agreement, "termination for cause" means a termination of this Agreement with respect to the Representative, after reasonable notice by the Company, as a result of (i) the material failure of the Representative to provide the services in connection with the Offering contemplated in this Agreement, provided that such failure to provide such services is not a result of market, economic or political conditions, the Company's condition (financial or otherwise), any failure by the Company to perform its obligations hereunder or under the securities laws, or any other circumstances outside the Representative's control, or (ii) fraud, gross negligence or willful misconduct by the Representative.

Notwithstanding anything to the contrary herein, if the Company determines in its reasonable good faith judgment to terminate for cause with respect to the Representative (which shall include the material failure of the Underwriters to provide underwriting services, as provided in FINRA Rule 5110(g)(5)(B)), the Company shall have no obligation to pay any Future Financing Fees under Section 7.4 of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3 <u>Expenses</u>. Notwithstanding anything to the contrary in this Agreement, except in the case of a default by the Underwriters, pursuant to Section 6 above, in the event that this Agreement shall expire or be terminated for any reason whatsoever, within the time specified herein or any extensions thereof pursuant to the terms herein, the Company shall be obligated to pay to the Representative, within fifteen (15) calendar days of receipt by the Company, their actual and accountable out-of-pocket and documented expenses related to the transactions contemplated herein then due and payable (including the fees and disbursements of Representative Counsel), subject to the maximum amount set forth in Section 3.10. Notwithstanding the foregoing, any portion of the Retainer received by the Representative will be reimbursed to the Company to the extent not actually incurred in compliance with FINRA Rule 5110(g)(4)(A).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4 <u>Survival of Indemnification</u>. Notwithstanding any contrary provision contained in this Agreement, any election hereunder or any termination of this Agreement, and whether or not this Agreement is otherwise carried out, the provisions of Section 5 shall remain in full force and effect and shall not be in any way affected by, such election or termination or failure to carry out the terms of this Agreement or any part hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.5 <u>Representations, Warranties, Agreements to Survive</u>. All representations, warranties and agreements contained in this Agreement or in certificates of officers of the Company submitted pursuant hereto, shall remain operative and in full force and effect regardless of (i) any investigation made by or on behalf of any Underwriter or its Affiliates or selling agents, any person controlling any Underwriter, its officers or directors or any person controlling the Company or (ii) delivery of and payment for the Public Shares, the Representative's Warrants and/or the Representative Warrant Shares.

9 <u>Miscellaneous</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1 <u>Notices</u>. All communications hereunder, except as herein otherwise specifically provided, shall be in writing and shall be mailed (registered or certified mail, return receipt requested), personally delivered or sent by electronic transmission and confirmed and shall be deemed given when so delivered or emailed and confirmed (which may be by email) or if mailed, two (2) days after such mailing.

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| | |
|:---|:---|
| If to the Representative: | If to the Representative: |
| The Benchmark Company, LLC | The Benchmark Company, LLC |
| 150 East 58th Street, 17th Floor | 150 East 58th Street, 17th Floor |
| New York, NY 10155 | New York, NY 10155 |
| Attention: | Michael Jacobs |
| Email: | mjacobs@benchmarkcompany.com |
| with a copy (which shall not constitute notice) to: | with a copy (which shall not constitute notice) to: |
| McGuireWoods LLP | McGuireWoods LLP |
| 1251 Avenue of the Americas, 20<sup>th</sup> Floor | 1251 Avenue of the Americas, 20<sup>th</sup> Floor |
| New York, NY 10020 | New York, NY 10020 |
| Attention: | Stephen Older, Esq. |
| Email: | SOlder@mcguirewoods.com |

---

---

| | |
|:---|:---|
| If to the Company: | If to the Company: |
| BioVentrix, Inc. | BioVentrix, Inc. |
| 120 Forbes Blvd., Suite 125 | 120 Forbes Blvd., Suite 125 |
| Mansfield, MA 02048 | Mansfield, MA 02048 |
| Attention: | David Richmond |
| Email: | dave@Richmondbrothers.com |
| with a copy (which shall not constitute notice) to: | with a copy (which shall not constitute notice) to: |
| Ellenoff Grossman & Schole LLP | Ellenoff Grossman & Schole LLP |
| 1345 Avenue of the Americas | 1345 Avenue of the Americas |
| New York, NY 10105 | New York, NY 10105 |
| Attention: | Lawrence A. Rosenbloom, Esq. |
|  | Steven Mermelstein, Esq. |
| Email: | lrosenbloom@egsllp.com |
|  | smermelstein@egsllp.com |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2 <u>Headings</u>. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3 <u>Amendment</u>. This Agreement may only be amended by a written instrument executed by each of the parties hereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4 <u>Entire Agreement</u>. This Agreement (together with the other agreements and documents being delivered pursuant to or in connection with this Agreement) constitutes the entire agreement of the parties hereto with respect to the subject matter hereof and thereof, and supersedes all prior agreements and understandings of the parties, oral and written, with respect to the subject matter hereof. Notwithstanding anything to the contrary set forth herein, it is understood and agreed by the parties hereto that the terms and conditions of that certain engagement letter between the Company and The Benchmark Company, LLC dated August 5, 2024, as amended, are superseded by this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.5 <u>Binding Effect</u>. This Agreement shall inure solely to the benefit of and shall be binding upon the Representative, the Underwriters, the Company and the controlling persons, directors and officers referred to in Section 5 hereof, and their respective successors, legal representatives, heirs and assigns, and no other person shall have or be construed to have any legal or equitable right, remedy or claim under or in respect of or by virtue of this Agreement or any provisions herein contained. The term "successors and assigns" shall not include a purchaser, in its capacity as such, of securities from any of the Underwriters.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.6 <u>Governing Law; Consent to Jurisdiction; Trial by Jury</u>. This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of New York, without giving effect to conflict of laws principles thereof. The Company hereby agrees that any action, proceeding or claim against it arising out of, or relating in any way to this Agreement shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum. Any such process or summons to be served upon the Company may be served by transmitting a copy thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in Section 9.1 hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any action, proceeding or claim. The Company agrees that the prevailing party(ies) in any such action shall be entitled to recover from the other party(ies) all of its reasonable attorneys' fees and expenses relating to such action or proceeding and/or incurred in connection with the preparation therefor. The Company (on its behalf and, to the extent permitted by applicable law, on behalf of its stockholders and affiliates) and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7 <u>Execution in Counterparts</u>. This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which shall be deemed to be an original, but all of which taken together shall constitute one and the same agreement, and shall become effective when one or more counterparts has been signed by each of the parties hereto and delivered to each of the other parties hereto. Electronic signatures complying with the New York Electronic Signatures and Records Act (N.Y. State Tech. §§ 301-309), as amended from time to time, or other applicable law will be deemed original signatures for purposes of this Agreement. Delivery of a signed counterpart of this Agreement by facsimile or email/pdf transmission shall constitute valid and sufficient delivery thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.8 <u>Waiver, etc</u>. The failure of any of the parties hereto to at any time enforce any of the provisions of this Agreement shall not be deemed or construed to be a waiver of any such provision, nor to in any way affect the validity of this Agreement or any provision hereof or the right of any of the parties hereto to thereafter enforce each and every provision of this Agreement. No waiver of any breach, non-compliance or non-fulfillment of any of the provisions of this Agreement shall be effective unless set forth in a written instrument executed by the party or parties against whom or which enforcement of such waiver is sought; and no waiver of any such breach, non-compliance or non-fulfillment shall be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.

[Signature Page Follows]

If the foregoing correctly sets forth the understanding between the Underwriters and the Company, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement between us.

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| | |
|:---|:---|
| Very truly yours, | Very truly yours, |
| BIOVENTRIX, INC. | BIOVENTRIX, INC. |
| By: |  |
| Name: | David Richmond |
| Title: | Co-Chief Executive Officer |

---

Confirmed as of the date first written above mentioned, on behalf of itself and as Representative of the underwriters named on <u>Schedule 1</u> hereto:

---

| | |
|:---|:---|
| THE BENCHMARK COMPANY, LLC | THE BENCHMARK COMPANY, LLC |
| By: |  |
| Name: | John J. Borer III |
| Title: | Senior Managing Director |

---

[SIGNATURE PAGE]

BIOVENTRIX, INC. – UNDERWRITING AGREEMENT

**<u>SCHEDULE 1</u>**

---

| | | |
|:---|:---|:---|
| **Underwriter** | **Total Number of Firm Shares to be Purchased** | **Total Number of Option Shares Subject to Over-Allotment Option** |
| The Benchmark Company, LLC | [—] | [—] |
| **TOTAL** | [—] | [—] |

---

**<u>SCHEDULE 2-A</u>**

**Pricing Information**

Number of Firm Shares: [—]

Public Offering Price per Share: $[—]

Underwriting Discount per Share: 7%

Proceeds to Company per Share (before expenses): $[—]

**<u>SCHEDULE 2-B</u>**

**Issuer General Use Free Writing Prospectuses**

None.

**<u>SCHEDULE 2-C</u>**

**Written Testing-the-Waters Communications**

None.

**<u>SCHEDULE 3</u>**

**List of Lock-Up Parties**

1. David
 Richmond

2. Steven
 Chartier

3. Dr.
 Ori Ben-Yehuda

4. Mark
 Ravich

5. Dr.
 Rishi Puri

6. Dr.
 William Abraham

7. Michael
 Taglich

8. RBI
 BioVentrix LLC

9. RBI
 Opportunities Fund LLC

10. RBI
 BV Private Investment

11. RBI
 Private Investment III LLC

12. RBI
 Opportunities Fund II

13. David
 Richmond & Stephanie Richmond

14. RBI
 Private Investment I LLC

15. Richmond
 Brothers Inc.

16. Taglich
 Brothers Inc.

17. Michael
 N. Taglich & Claudia Taglich

18. Claudia
 Ruggiero Taglich

19. Michael
 Taglich C/F Amanda Taglich UTMA NY

20. Michael
 Taglich C/F Lucy Taglich UTMA NY

21. Michael
 Taglich C/F Stella Taglich UTMA NY

22. Michael
 N. Taglich Keogh Account

23. Michael
 Taglich TTEE Hope A Taglich Supplemental Needs Trust UAD 8/23/17

24. Bioventrix
 investors LLC

25. Mark
 Ravich Irrevocable Trust

26. Mark
 Ravich Revocable Trust

27. Mark
 Ravich TTEE Mark Ravich Irrevocable Trust UAD 11/05/18

28. Mark
 H. Ravich TTEE Revocable Trust of Mark H. Ravich UAD 10/08/19

29. Norman
 and Sally Ravich Family Trust

30. Mark
 Ravich TTEE Cindy Libman Irrevocable Trust UAD 11/05/18

31. Mark
 H. Ravich TTEE Norman & Sally Ravich Family Trust UAD 12/24/92

32. Alexander
 Coleman Ravich 1991 Irrevocable Trust

33. Alyssa
 Danielle Ravich 1991 Irrevocable Trust

34. Ilyne
 Ravich

35. [—]

**Exhibit A**

[Form of lock up]

**Exhibit B**

Form of Press Release

**BIOVENTRIX, INC.**

**[Date]**

BioVentrix, Inc. (the "<u>Company</u>") announced today that The Benchmark Company, LLC, acting as representative for the underwriters in the Company's recent public offering of _______ shares of the Company's common stock, is [waiving] [releasing] a lock-up restriction with respect to _________ shares of the Company's common stock held by [certain officers or directors] [an officer or director] of the Company. The [waiver] [release] will take effect on _________, 20___, and the shares may be sold on or after such date.

**This press release is not an offer or sale of the securities in the United States or in any other jurisdiction where such offer or sale is prohibited, and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act of 1933, as amended.**

**Exhibit C**

[Form of warrant]

## Exhibit 3.6

**Exhibit 3.6**

**AMENDED AND RESTATED BYLAWS**

**OF**

**BIOVENTRIX, INC.**

**(THE "CORPORATION")**

**ARTICLE I**

**OFFICES**

**Section 1.1. Registered Office**. The registered office of the Corporation within the State of Delaware shall be located at either (a) the principal place of business of the Corporation in the State of Delaware or (b) the office of the corporation or individual acting as the Corporation's registered agent in Delaware.

**Section 1.2. Additional Offices**. The Corporation may, in addition to its registered office in the State of Delaware, have such other offices and places of business, both within and outside the State of Delaware, as the Board of Directors of the Corporation (the "***Board***") may from time to time determine or as the business and affairs of the Corporation may require.

**ARTICLE II**

**STOCKHOLDERS MEETINGS**

**Section 2.1. Annual Meetings**. The annual meeting of stockholders shall be held at such place, either within or without the State of Delaware, and at such time and on such date as shall be determined by the Board and stated in the notice of the meeting, provided that the Board may in its sole discretion determine that the meeting shall not be held at any place, but may instead be held solely by means of remote communication pursuant to <u>Section 10.5(a)</u>. At each annual meeting, the stockholders entitled to vote on such matters shall elect those directors of the Corporation to fill any term of a directorship that expires on the date of such annual meeting and may transact any other business as may properly be brought before the meeting.

**Section 2.2. Special Meetings**. Subject to the rights of the holders of any outstanding series of the preferred stock of the Corporation ("***Preferred Stock***"), and to the requirements of applicable law, special meetings of stockholders, for any purpose or purposes, shall be called only by the Board and may not be called by any other person or persons. Special meetings of stockholders shall be held at such place, either within or without the State of Delaware, and at such time and on such date as shall be determined by the Board and stated in the Corporation's notice of the meeting, provided that the Board may in its sole discretion determine that the meeting shall not be held at any place, but may instead be held solely by means of remote communication pursuant to <u>Section 9.5(a)</u>.

**Section 2.3. Notices.** Written notice of each stockholders meeting stating the place, if any, date, and time of the meeting, and the means of remote communication, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such meeting and the record date for determining the stockholders entitled to vote at the meeting, if such date is different from the record date for determining stockholders entitled to notice of the meeting, shall be given in the manner permitted by <u>Section 9.3</u> to each stockholder entitled to vote thereat as of the record date for determining the stockholders entitled to notice of the meeting, by the Corporation not less than 10 nor more than 60 days before the date of the meeting unless otherwise required by the General Corporation Law of the State of Delaware (the "***DGCL***"). If said notice is for a stockholders meeting other than an annual meeting, it shall in addition state the purpose or purposes for which the meeting is called, and the business transacted at such meeting shall be limited to the matters so stated in the Corporation's notice of meeting (or any supplement thereto). Any meeting of stockholders as to which notice has been given may be postponed, and any meeting of stockholders as to which notice has been given may be cancelled, by the Board upon public announcement (as defined in <u>Section 2.7(c)</u>) given before the date previously scheduled for such meeting.

**Section 2.4. Quorum**. Except as otherwise provided by applicable law, the Corporation's Certificate of Incorporation, as the same may be amended or restated from time to time (the "***Certificate of Incorporation***") or these Bylaws, the presence, in person or by proxy, at a stockholders meeting of the holders of shares of outstanding capital stock of the Corporation representing one-third (1/3) of the voting power of all outstanding shares of capital stock of the Corporation entitled to vote at such meeting shall constitute a quorum for the transaction of business at such meeting, except that when specified business is to be voted on by a class or series of stock voting as a class, the holders of shares representing a majority of the voting power of the outstanding shares of such class or series shall constitute a quorum of such class or series for the transaction of such business. If a quorum shall not be present or represented by proxy at any meeting of the stockholders of the Corporation, the chairman of the meeting may adjourn the meeting from time to time in the manner provided in <u>Section 2.6</u> until a quorum shall attend. The stockholders present at a duly convened meeting may continue to transact business until adjournment, notwithstanding the withdrawal of enough stockholders to leave less than a quorum. Shares of its own stock belonging to the Corporation or to another corporation, if a majority of the voting power of the shares entitled to vote in the election of directors of such other corporation is held, directly or indirectly, by the Corporation, shall neither be entitled to vote nor be counted for quorum purposes; provided, however, that the foregoing shall not limit the right of the Corporation or any such other corporation to vote shares held by it in a fiduciary capacity.

**Section 2.5. Voting of Shares**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Voting Lists</u>. The Secretary of the Corporation (the "***Secretary***") shall prepare, or shall cause the officer or agent who has charge of the stock ledger of the Corporation to prepare and make, at least 10 days before every meeting of stockholders, a complete list of the stockholders of record entitled to vote at such meeting; provided, however, that if the record date for determining the stockholders entitled to vote is less than 10 days before the meeting date, the list shall reflect the stockholders entitled to vote as of the tenth day before the meeting date, arranged in alphabetical order and showing the address and the number and class of shares registered in the name of each stockholder. Nothing contained in this Section 2.5(a) shall require the Corporation to include electronic mail addresses or other electronic contact information on such list. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours for a period of at least 10 days prior to the meeting: (i) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (ii) during ordinary business hours, at the principal place of business of the Corporation. In the event that the Corporation determines to make the list available on an electronic network, the Corporation may take reasonable steps to ensure that such information is available only to stockholders of the Corporation. If the meeting is to be held at a place, then the list shall be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any stockholder who is present. If a meeting of stockholders is to be held solely by means of remote communication as permitted by Section 9.5(a), the list shall be open to the examination of any stockholder during the whole time of the meeting on a reasonably accessible electronic network, and the information required to access such list shall be provided with the notice of meeting. The stock ledger shall be the only evidence as to who are the stockholders entitled to examine the list required by this Section 2.5(a) or to vote in person or by proxy at any meeting of stockholders.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Manner of Voting</u>. At any stockholders meeting, every stockholder entitled to vote may vote in person or by proxy. If authorized by the Board, the voting by stockholders or proxy holders at any meeting conducted by remote communication may be effected by a ballot submitted by electronic transmission (as defined in <u>Section 9.3</u>), provided that any such electronic transmission must either set forth or be submitted with information from which the Corporation can determine that the electronic transmission was authorized by the stockholder or proxy holder. The Board, in its discretion, or the chairman of the meeting of stockholders, in such person's discretion, may require that any votes cast at such meeting shall be cast by written ballot.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Proxies</u>. Each stockholder entitled to vote at a meeting of stockholders or to express consent or dissent to corporate action in writing without a meeting may authorize another person or persons to act for such stockholder by proxy, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period. Proxies need not be filed with the Secretary until the meeting is called to order, but shall be filed with the Secretary before being voted. Without limiting the manner in which a stockholder may authorize another person or persons to act for such stockholder as proxy, either of the following shall constitute a valid means by which a stockholder may grant such authority. No stockholder shall have cumulative voting rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) A stockholder may execute a writing authorizing another person or persons to act for such stockholder as proxy. Execution may be accomplished by the stockholder or such stockholder's authorized officer, director, employee or agent signing such writing or causing such person's signature to be affixed to such writing by any reasonable means, including, but not limited to, by facsimile signature.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) A stockholder may authorize another person or persons to act for such stockholder as proxy by transmitting or authorizing the transmission of an electronic transmission to the person who will be the holder of the proxy or to a proxy solicitation firm, proxy support service organization or like agent duly authorized by the person who will be the holder of the proxy to receive such transmission, provided that any such electronic transmission must either set forth or be submitted with information from which it can be determined that the electronic transmission was authorized by the stockholder. Any copy, facsimile telecommunication or other reliable reproduction of the writing or transmission authorizing another person or persons to act as proxy for a stockholder may be substituted or used in lieu of the original writing or transmission for any and all purposes for which the original writing or transmission could be used; provided that such copy, facsimile telecommunication or other reproduction shall be a complete reproduction of the entire original writing or transmission.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Required Vote</u>. Subject to the rights of the holders of one or more series of Preferred Stock, voting separately by class or series, to elect directors pursuant to the terms of one or more series of Preferred Stock, at all meetings of stockholders at which a quorum is present, the election of directors shall be determined by a plurality of the votes cast by the stockholders present in person or represented by proxy at the meeting and entitled to vote thereon. All other matters presented to the stockholders at a meeting at which a quorum is present shall be determined by the vote of a majority of the votes cast by the stockholders present in person or represented by proxy at the meeting and entitled to vote thereon, unless the matter is one upon which, by applicable law, the Certificate of Incorporation, these Bylaws or applicable stock exchange rules, a different vote is required, in which case such provision shall govern and control the decision of such matter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Inspectors of Election</u>. The Board may, and shall if required by law, in advance of any meeting of stockholders, appoint one or more persons as inspectors of election, who may be employees of the Corporation or otherwise serve the Corporation in other capacities, to act at such meeting of stockholders or any adjournment thereof and to make a written report thereof. The Board may appoint one or more persons as alternate inspectors to replace any inspector who fails to act. If no inspectors of election or alternates are appointed by the Board, the chairman of the meeting shall appoint one or more inspectors to act at the meeting. Each inspector, before discharging his or her duties, shall take and sign an oath faithfully to execute the duties of inspector with strict impartiality and according to the best of his or her ability. The inspectors shall ascertain and report the number of outstanding shares and the voting power of each; determine the number of shares present in person or represented by proxy at the meeting and the validity of proxies and ballots; count all votes and ballots and report the results; determine and retain for a reasonable period a record of the disposition of any challenges made to any determination by the inspectors; and certify their determination of the number of shares represented at the meeting and their count of all votes and ballots. No person who is a candidate for an office at an election may serve as an inspector at such election. Each report of an inspector shall be in writing and signed by the inspector or by a majority of them if there is more than one inspector acting at such meeting. If there is more than one inspector, the report of a majority shall be the report of the inspectors.

**Section 2.6. Adjournments**. Any meeting of stockholders, annual or special, may be adjourned by the chairman of the meeting, from time to time, whether or not there is a quorum, to reconvene at the same or some other place. Notice need not be given of any such adjourned meeting if the date, time, and place, if any, thereof, and the means of remote communication, if any, by which stockholders and proxy holders may be deemed to be present in person and vote at such adjourned meeting are announced at the meeting at which the adjournment is taken. At the adjourned meeting the stockholders, or the holders of any class or series of stock entitled to vote separately as a class, as the case may be, may transact any business that might have been transacted at the original meeting. If the adjournment is for more than 30 days, notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting. If after the adjournment a new record date for stockholders entitled to vote is fixed for the adjourned meeting, the Board shall fix a new record date for notice of such adjourned meeting in accordance with <u>Section 9.2</u>, and shall give notice of the adjourned meeting to each stockholder of record entitled to vote at such adjourned meeting as of the record date fixed for notice of such adjourned meeting.

**Section 2.7. Advance Notice for Business**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Annual Meetings of Stockholders</u>. No business may be transacted at an annual meeting of stockholders, other than business that is either (i) specified in the Corporation's notice of meeting (or any supplement thereto) given by or at the direction of the Board, (ii) otherwise properly brought before the annual meeting by or at the direction of the Board or (iii) otherwise properly brought before the annual meeting by any stockholder of the Corporation (x) who is a stockholder of record entitled to vote at such annual meeting on the date of the giving of the notice provided for in this <u>Section 2.7(a)</u> and on the record date for the determination of stockholders entitled to vote at such annual meeting and (y) who complies with the notice procedures set forth in this <u>Section 2.7(a)</u>. Notwithstanding anything in this <u>Section 2.7(a)</u> to the contrary, only persons nominated for election as a director to fill any term of a directorship that expires on the date of the annual meeting pursuant to <u>Section 3.2</u> will be considered for election at such meeting.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) In addition to any other applicable requirements, for business (other than nominations) to be properly brought before an annual meeting by a stockholder, such stockholder must have given timely notice thereof in proper written form to the Secretary and such business must otherwise be a proper matter for stockholder action. Subject to <u>Section 2.7(a)(iii)</u>, a stockholder's notice to the Secretary with respect to such business, to be timely, must be received by the Secretary at the principal executive offices of the Corporation not later than the close of business on the 90th day nor earlier than the opening of business on the 120th day before the anniversary date of the immediately preceding annual meeting of stockholders; provided, however, that in the event that the annual meeting is more than 30 days before or more than 60 days after such anniversary date (or if there has been no prior annual meeting), notice by the stockholder to be timely must be so delivered not earlier than the close of business on the 120th day before the meeting and not later than the later of (x) the close of business on the 90th day before the meeting or (y) the close of business on the 10th day following the day on which public announcement of the date of the annual meeting is first made by the Corporation. The public announcement of an adjournment or postponement of an annual meeting shall not commence a new time period (or extend any time period) for the giving of a stockholder's notice as described in this Section 2.7(a).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) To be in proper written form, a stockholder's notice to the Secretary with respect to any business (other than nominations) must set forth as to each such matter such stockholder proposes to bring before the annual meeting (A) a brief description of the business desired to be brought before the annual meeting, the text of the proposal or business (including the text of any resolutions proposed for consideration and in the event such business includes a proposal to amend these Bylaws, the language of the proposed amendment) and the reasons for conducting such business at the annual meeting, (B) the name and record address of such stockholder and the name and address of the beneficial owner, if any, on whose behalf the proposal is made, (C) the class or series and number of shares of capital stock of the Corporation that are owned beneficially and of record by such stockholder and by the beneficial owner, if any, on whose behalf the proposal is made, (D) a description of all arrangements or understandings between such stockholder and the beneficial owner, if any, on whose behalf the proposal is made and any other person or persons (including their names) in connection with the proposal of such business by such stockholder, (E) any material interest of such stockholder and the beneficial owner, if any, on whose behalf the proposal is made in such business and (F) a representation that such stockholder (or a qualified representative of such stockholder) intends to appear in person or by proxy at the annual meeting to bring such business before the meeting.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) The foregoing notice requirements of this <u>Section 2.7(a)</u> shall be deemed satisfied by a stockholder as to any proposal (other than nominations) if the stockholder has notified the Corporation of such stockholder's intention to present such proposal at an annual meeting in compliance with Rule 14a-8 (or any successor thereof) of the Securities Exchange Act of 1934, as amended (the "***Exchange Act***"), and such stockholder has complied with the requirements of such Rule for inclusion of such proposal in a proxy statement prepared by the Corporation to solicit proxies for such annual meeting. No business shall be conducted at the annual meeting of stockholders except business brought before the annual meeting in accordance with the procedures set forth in this <u>Section 2.7(a)</u>, provided, however, that once business has been properly brought before the annual meeting in accordance with such procedures, nothing in this <u>Section 2.7(a)</u> shall be deemed to preclude discussion by any stockholder of any such business. If the Board or the chairman of the annual meeting determines that any stockholder proposal was not made in accordance with the provisions of this <u>Section 2.7(a)</u> or that the information provided in a stockholder's notice does not satisfy the information requirements of this <u>Section 2.7(a)</u>, such proposal shall not be presented for action at the annual meeting. Notwithstanding the foregoing provisions of this <u>Section 2.7(a)</u>, if the stockholder (or a qualified representative of the stockholder) does not appear at the annual meeting of stockholders of the Corporation to present the proposed business, such proposed business shall not be transacted, notwithstanding that proxies in respect of such matter may have been received by the Corporation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) In addition to the provisions of this <u>Section 2.7(a)</u>, a stockholder shall also comply with all applicable requirements of the Exchange Act and the rules and regulations thereunder with respect to the matters set forth herein. Nothing in this <u>Section 2.7(a)</u> shall be deemed to affect any rights of stockholders to request inclusion of proposals in the Corporation's proxy statement pursuant to Rule 14a-8 under the Exchange Act.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Special Meetings of Stockholders</u>. Only such business shall be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the Corporation's notice of meeting. Nominations of persons for election to the Board may be made at a special meeting of stockholders at which directors are to be elected pursuant to the Corporation's notice of meeting only pursuant to <u>Section 3.2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Public Announcement</u>. For purposes of these Bylaws, "***public announcement***" shall mean disclosure in a press release reported by the Dow Jones News Service, Associated Press or comparable national news service or in a document publicly filed or furnished by the Corporation with the Securities and Exchange Commission pursuant to Sections 13, 14 or 15(d) of the Exchange Act (or any successor thereto).

**Section 2.8. Conduct of Meetings**. The chairman of each annual and special meeting of stockholders shall be the Chairman of the Board or, in the absence (or inability or refusal to act) of the Chairman of the Board, the Chief Executive Officer (if he or she shall be a director) or, in the absence (or inability or refusal to act of the Chief Executive Officer or if the Chief Executive Officer is not a director) of the Chief Executive Officer, the President (if he or she shall be a director) or, in the absence (or inability or refusal to act) of the President or if the President is not a director, a Vice President (if he or she shall be a director) or, in the absence (or inability or refusal to act of the Vice President or if the Vice President is not a director) of the Vice President, such other person as shall be appointed by the Board. The date and time of the opening and the closing of the polls for each matter upon which the stockholders will vote at a meeting shall be announced at the meeting by the chairman of the meeting. The Board may adopt such rules and regulations for the conduct of the meeting of stockholders as it shall deem appropriate. Except to the extent inconsistent with these Bylaws or such rules and regulations as adopted by the Board, the chairman of any meeting of stockholders shall have the right and authority to convene and to adjourn the meeting, to prescribe such rules, regulations and procedures and to do all such acts as, in the judgment of such chairman, are appropriate for the proper conduct of the meeting. Such rules, regulations or procedures, whether adopted by the Board or prescribed by the chairman of the meeting, may include, without limitation, the following: (a) the establishment of an agenda or order of business for the meeting; (b) rules and procedures for maintaining order at the meeting and the safety of those present; (c) limitations on attendance at or participation in the meeting to stockholders of record of the Corporation, their duly authorized and constituted proxies or such other persons as the chairman of the meeting shall determine; (d) restrictions on entry to the meeting after the time fixed for the commencement thereof; and (e) limitations on the time allotted to questions or comments by participants. Unless and to the extent determined by the Board or the chairman of the meeting, meetings of stockholders shall not be required to be held in accordance with the rules of parliamentary procedure. The secretary of each annual and special meeting of stockholders shall be the Secretary or, in the absence (or inability or refusal to act) of the Secretary, an Assistant Secretary so appointed to act by the chairman of the meeting. In the absence (or inability or refusal to act) of the Secretary and all Assistant Secretaries, the chairman of the meeting may appoint any person to act as secretary of the meeting.

**Section 2.9. Consents in Lieu of Meeting**. Unless otherwise provided by the Certificate of Incorporation, any action required to be taken at any annual or special meeting of stockholders, or any action which may be taken at any annual or special meeting of such stockholders, may be taken without a meeting, without prior notice and without a vote, if a consent in writing, setting forth the action so taken, shall be signed by the holders of outstanding stock entitled to vote thereon having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted, and shall be delivered to the Corporation by delivery to its registered office in the State of Delaware, its principal place of business, or an officer or agent of the Corporation having custody of the book in which proceedings of meetings of stockholders are recorded. Delivery made to the Corporation's registered office shall be by hand or by certified or registered mail, return receipt requested.

Every written consent shall bear the date of signature of each stockholder who signs the consent, and no written consent shall be effective to take the corporate action referred to therein unless, within 60 days of the earliest dated consent delivered in the manner required by this section and the DGCL to the Corporation, written consents signed by a sufficient number of holders entitled to vote to take action are delivered to the Corporation by delivery to its registered office in Delaware, its principal place of business or an officer or agent of the Corporation having custody of the book in which proceedings of meetings of stockholders are recorded. Delivery made to the Corporation's registered office shall be by hand or by certified or registered mail, return receipt requested.

**ARTICLE III**

**DIRECTORS**

**Section 3.1. Powers; Number**. The business and affairs of the Corporation shall be managed by or under the direction of the Board, which may exercise all such powers of the Corporation and do all such lawful acts and things as are not by statute or by the Certificate of Incorporation or by these Bylaws required to be exercised or done by the stockholders. The Board shall consist of not less than one (1) nor more than nine (9) directors. Subject to the foregoing, the exact number of directors shall be established from time to time by resolution of the Board, and subject to the Certificate of Incorporation, the number of directors shall be fixed exclusively by resolution of the Board.. If the terms of the directors are staggered or classified under Section 3.4 of these Bylaws, any increase or decrease in the number of directors shall be allocated proportionately among the classes. Directors must be natural persons who are eighteen (18) years of age or older, but need not be stockholders or residents of the State of Delaware.

**Section 3.2. Advance Notice for Nomination of Directors**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Only persons who are nominated in accordance with the following procedures shall be eligible for election as directors of the Corporation, except as may be otherwise provided by the terms of one or more series of Preferred Stock with respect to the rights of holders of one or more series of Preferred Stock to elect directors. Nominations of persons for election to the Board at any annual meeting of stockholders, or at any special meeting of stockholders called for the purpose of electing directors as set forth in the Corporation's notice of such special meeting, may be made (i) by or at the direction of the Board or (ii) by any stockholder of the Corporation (x) who is a stockholder of record entitled to vote in the election of directors on the date of the giving of the notice provided for in this <u>Section 3.2</u> and on the record date for the determination of stockholders entitled to vote at such meeting and (y) who complies with the notice procedures set forth in this <u>Section 3.2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) In addition to any other applicable requirements, for a nomination to be made by a stockholder, such stockholder must have given timely notice thereof in proper written form to the Secretary. To be timely, a stockholder's notice to the Secretary must be received by the Secretary at the principal executive offices of the Corporation (i) in the case of an annual meeting, not later than the close of business on the 90th day nor earlier than the close of business on the 120th day before the anniversary date of the immediately preceding annual meeting of stockholders; provided, however, that in the event that the annual meeting is more than 30 days before or more than 60 days after such anniversary date (or if there has been no prior annual meeting), notice by the stockholder to be timely must be so received not earlier than the close of business on the 120th day before the meeting and not later than the later of (x) the close of business on the 90th day before the meeting or (y) the close of business on the 10th day following the day on which public announcement of the date of the annual meeting was first made by the Corporation; and (ii) in the case of a special meeting of stockholders called for the purpose of electing directors, not later than the close of business on the 10th day following the day on which public announcement of the date of the special meeting is first made by the Corporation. In no event shall the public announcement of an adjournment or postponement of an annual meeting or special meeting commence a new time period (or extend any time period) for the giving of a stockholder's notice as described in this <u>Section 3.2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) To be in proper written form, a stockholder's notice to the Secretary must set forth (i) as to each person whom the stockholder proposes to nominate for election as a director (A) the name, age, business address and residence address of the person, (B) the principal occupation or employment of the person, (C) the class or series and number of shares of capital stock of the Corporation that are owned beneficially or of record by the person and (D) any other information relating to the person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for election of directors pursuant to Section 14 of the Exchange Act and the rules and regulations promulgated thereunder; and (ii) as to the stockholder giving the notice (A) the name and record address of such stockholder as they appear on the Corporation's books and the name and address of the beneficial owner, if any, on whose behalf the nomination is made, (B) the class or series and number of shares of capital stock of the Corporation that are owned beneficially and of record by such stockholder and the beneficial owner, if any, on whose behalf the nomination is made, (C) a description of all arrangements or understandings relating to the nomination to be made by such stockholder among such stockholder, the beneficial owner, if any, on whose behalf the nomination is made, each proposed nominee and any other person or persons (including their names), (D) a representation that such stockholder (or a qualified representative of such stockholder) intends to appear in person or by proxy at the meeting to nominate the persons named in its notice and (E) any other information relating to such stockholder and the beneficial owner, if any, on whose behalf the nomination is made that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for election of directors pursuant to Section 14 of the Exchange Act and the rules and regulations promulgated thereunder. Such notice must be accompanied by a written consent of each proposed nominee to being named as a nominee and to serve as a director if elected.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) If the Board or the chairman of the meeting of stockholders determines that any nomination was not made in accordance with the provisions of this <u>Section 3.2</u>, or that the information provided in a stockholder's notice does not satisfy the information requirements of this <u>Section 3.2</u>, then such nomination shall not be considered at the meeting in question. Notwithstanding the foregoing provisions of this <u>Section 3.2</u>, if the stockholder (or a qualified representative of the stockholder) does not appear at the meeting of stockholders of the Corporation to present the nomination, such nomination shall be disregarded, notwithstanding that proxies in respect of such nomination may have been received by the Corporation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) In addition to the provisions of this <u>Section 3.2</u>, a stockholder shall also comply with all of the applicable requirements of the Exchange Act and the rules and regulations thereunder with respect to the matters set forth herein. Nothing in this <u>Section 3.2</u> shall be deemed to affect any rights of the holders of Preferred Stock to elect directors pursuant to the Certificate of Incorporation.

**Section 3.3. Compensation**. Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, the Board shall have the authority to fix the compensation of directors, including for service on a committee of the Board, and may be paid either a fixed sum for attendance at each meeting of the Board or other compensation as director. The directors may be reimbursed their expenses, if any, of attendance at each meeting of the Board. No such payment shall preclude any director from serving the Corporation in any other capacity and receiving compensation therefor. Members of committees of the Board may be allowed like compensation and reimbursement of expenses for service on the committee.

**Section 3.4. Staggered Terms for Directors/Classification of the Board of Directors.** The Board of Directors may, by the Certificate of Incorporation, or by amendment to these Bylaws adopted by a vote of the stockholders, be divided into one, two or three classes with the number of directors in each class being as nearly equal as possible; the term of office of those of the first class to expire at the annual meeting next ensuing; of the second class one year thereafter; at the third class two years thereafter; and at each annual election held after such classification and election, directors shall be chosen for a full term, as the case may be, to succeed those whose terms expire. If the directors have staggered terms, then any increase or decrease in the number of directors shall be so apportioned among the classes as to make all classes as nearly equal in number as possible.

**ARTICLE IV**

**BOARD MEETINGS**

**Section 4.1. Annual Meetings**. The Board shall meet as soon as practicable after the adjournment of each annual stockholders meeting at the place of the annual stockholders meeting unless the Board shall fix another time and place and give notice thereof in the manner required herein for special meetings of the Board. No notice to the directors shall be necessary to legally convene this meeting, except as provided in this <u>Section 4.1</u>.

**Section 4.2. Regular Meetings**. Regularly scheduled, periodic meetings of the Board may be held without notice at such times, dates and places (within or without the State of Delaware) as shall from time to time be determined by the Board.

**Section 4.3. Special Meetings**. Special meetings of the Board (a) may be called by the Chairman of the Board, the Vice Chairman (if any), the Chief Executive Officer or the President and (b) shall be called on the written request of at least a majority of directors then in office, or the sole director, as the case may be, and shall be held at such time, date and place (within or without the State of Delaware) as may be determined by the person calling the meeting or through telephonic communications or videoconferencing in accordance with <u>Section 10.5(b)</u> or, if called upon the request of directors or the sole director, as specified in such written request. Notice of each special meeting of the Board shall be given, as provided in <u>Section 9.3</u>, to each director (i) at least 24 hours before the meeting if such notice is oral notice given personally or by telephone or written notice given by hand delivery or by means of a form of electronic transmission and delivery; (ii) at least two days before the meeting if such notice is sent by a nationally recognized overnight delivery service; and (iii) at least five days before the meeting if such notice is sent through the United States mail. If the Secretary shall fail or refuse to give such notice, then the notice may be given by the officer who called the meeting or the directors who requested the meeting. Any and all business that may be transacted at a regular meeting of the Board may be transacted at a special meeting. Except as may be otherwise expressly provided by applicable law, the Certificate of Incorporation, or these Bylaws, neither the business to be transacted at, nor the purpose of, any special meeting need be specified in the notice or waiver of notice of such meeting. A special meeting may be held at any time without notice if all the directors are present or if those not present waive notice of the meeting in accordance with <u>Section 9.4</u>.

**Section 4.4. Quorum; Required Vote**. A majority of the total number of directors shall constitute a quorum for the transaction of business at any meeting of the Board, and the act of a majority of the directors present at any meeting at which there is a quorum shall be the act of the Board, except as may be otherwise specifically provided by applicable law, the Certificate of Incorporation or these Bylaws. If a quorum shall not be present at any meeting, a majority of the directors present may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum is present.

**Section 4.5. Consent In Lieu of Meeting**. Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, any action required or permitted to be taken at any meeting of the Board or any committee thereof may be taken without a meeting if all members of the Board or committee, as the case may be, consent thereto in writing or by electronic transmission, and the writing or writings or electronic transmission or transmissions (or paper reproductions thereof) are filed with the minutes of proceedings of the Board or committee. Such filing shall be in paper form if the minutes are maintained in paper form and shall be in electronic form if the minutes are maintained in electronic form.

**Section 4.6. Organization**. The chairman of each meeting of the Board shall be the Chairman of the Board or, in the absence (or inability or refusal to act) of the Chairman of the Board, the Chief Executive Officer (if he or she shall be a director) or, in the absence (or inability or refusal to act) of the Chief Executive Officer or if the Chief Executive Officer is not a director, the President (if he or she shall be a director) or in the absence (or inability or refusal to act) of the President or if the President is not a director, a Vice President (if he or she shall be a director) or, in the absence (or inability or refusal to act) of the Vice President, a chairman elected by a majority of the directors present. The Secretary shall act as secretary of all meetings of the Board. In the absence (or inability or refusal to act) of the Secretary, an Assistant Secretary shall perform the duties of the Secretary at such meeting. In the absence (or inability or refusal to act) of the Secretary and all Assistant Secretaries, the chairman of the meeting may appoint any person to act as secretary of the meeting.

****

**ARTICLE V**

**COMMITTEES OF DIRECTORS**

**Section 5.1. Establishment**. The Board may by resolution adopted by a majority of all of the directors then in office designate one or more committees, each committee to consist of one or more of the directors of the Corporation. Each committee shall keep regular minutes of its meetings and report the same to the Board when required by the resolution designating such committee. The Board shall have the power at any time to fill vacancies in, to change the membership of, or to dissolve any such committee.

**Section 5.2. Available Powers**. Any committee established pursuant to <u>Section 5.1</u> hereof, to the extent permitted by applicable law and by resolution of the Board, shall have and may exercise all of the powers and authority of the Board in the management of the business and affairs of the Corporation, and may authorize the seal of the Corporation to be affixed to all papers that may require it. However, no committee shall have the authority to (a) approve, recommend to stockholders or propose to stockholders actions required by the DGCL to be approved by stockholders, (b) fill vacancies on the Board of Directors or any committee thereof, (c) adopt, amend, or repeal these Bylaws, or (d) authorize or approve the reacquisition of shares unless pursuant to a general formula or method, within limits, prescribed by the Board.

**Section 5.3. Alternate Members**. The Board may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of such committee. In the absence or disqualification of a member of the committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not he, she or they constitute a quorum, may unanimously appoint another member of the Board to act at the meeting in place of any such absent or disqualified member.

**Section 5.4. Procedures**. Unless the Board otherwise provides, the time, date, place, if any, and notice of meetings of a committee shall be determined by such committee. At meetings of a committee, a majority of the number of members of the committee (but not including any alternate member, unless such alternate member has replaced any absent or disqualified member at the time of, or in connection with, such meeting) shall constitute a quorum for the transaction of business. The act of a majority of the members present at any meeting at which a quorum is present shall be the act of the committee, except as otherwise specifically provided by applicable law, the Certificate of Incorporation, these Bylaws or the Board. If a quorum is not present at a meeting of a committee, the members present may adjourn the meeting from time to time, without notice other than an announcement at the meeting, until a quorum is present. Unless the Board otherwise provides and except as provided in these Bylaws, each committee designated by the Board may make, alter, amend and repeal rules for the conduct of its business. In the absence of such rules each committee shall conduct its business in the same manner as the Board is authorized to conduct its business pursuant to <u>Article III</u> and <u>Article IV</u> of these Bylaws.

**ARTICLE VI**

**OFFICERS**

**Section 6.1. Officers**. The officers of the Corporation elected by the Board shall include a Chief Executive Officer, a Treasurer, and a Secretary. The officers of the Corporation may include such other officers and agents (including interim officers) with such titles as the Board may prescribe, including, without limitation, a President (who may also be the Chief Executive Officer), a Chief Financial Officer, one or more Vice Presidents (any one or more of which may be designated Senior Executive Vice President, Executive Vice President, or Senior Vice President), Assistant Vice Presidents, Assistant Secretaries and Assistant Treasurers. Officers elected by the Board shall each have such powers and duties as generally pertain to their respective offices, subject to the specific provisions of this <u>Article VI</u>. Such officers shall also have such powers and duties as from time to time may be conferred by the Board. Subject to the requirements of applicable law, rule or regulation, the Chief Executive Officer or President may also appoint such other officers (including without limitation one or more Vice Presidents and Controllers) as may be necessary or desirable for the conduct of the business of the Corporation. Such other officers shall have such powers and duties and shall hold their offices for such terms as may be provided in these Bylaws or as may be prescribed by the Board or, if such officer has been appointed by the Chief Executive Officer or President, as may be prescribed by the appointing officer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Chairman of the Board</u>. The Chairman of the Board shall preside when present at all meetings of the stockholders and the Board. The Chairman of the Board shall generally supervise the activities of the Corporation's officers subject to the ultimate authority of the Board, and shall be responsible for the execution of the policies of the Board with respect to such matters. In the absence (or inability or refusal to act) of the Chairman of the Board, the Chief Executive Officer (if he or she shall be a director) shall preside when present at all meetings of the stockholders and the Board. The powers and duties of the Chairman of the Board shall not include supervision or control of the preparation of the financial statements of the Corporation (other than through participation as a member of the Board). The position of Chairman of the Board and Chief Executive Officer may be held by the same person. The Board may also designate the Chairman of the Board as the "Executive Chairman" and designate the roles and responsibilities of the Executive Chairman.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Chief Executive Officer.</u> The Chief Executive Officer shall be the principal executive officer of the Corporation, shall have general supervision of the affairs of the Corporation and general control of all of its business subject to the ultimate authority of the Board, and shall be responsible for the execution of the policies of the Board with respect to such matters, except to the extent any such powers and duties have been prescribed to the Chairman of the Board pursuant to <u>Section 6.1(a)</u> above. In the absence (or inability or refusal to act) of the Chairman of the Board, the Chief Executive Officer (if he or she shall be a director) shall preside when present at all meetings of the stockholders and the Board. The position of Chief Executive Officer and President may be held by the same person. If there shall be Co-Chief Executive Officers of the Corporation as designated by the Board, then such individuals shall exercise such rights and powers attendant to the office of Chief Executive Officer as may be designated by the Board.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>President</u>. The President, if such office shall be filled, shall make recommendations to the Chief Executive Officer on all operational matters that would normally be reserved for the final executive responsibility of the Chief Executive Officer. In the absence (or inability or refusal to act) of the Chairman of the Board and a Chief Executive Officer, the President (if he or she shall be a director) shall preside when present at all meetings of the stockholders and the Board. The President shall also perform such duties and have such powers as shall be designated by the Board. The position of President and Chief Executive Officer may be held by the same person. If the office of Chief Executive Officer shall be vacant and the office of President filled, the President shall be the principal executive officer of the Corporation with the authority provided for in these Bylaws.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Vice Presidents</u>. In the absence (or inability or refusal to act) of the President, the Vice President (or in the event there be more than one Vice President, the Vice Presidents in the order designated by the Board) shall perform the duties and have the powers of the President. Any one or more of the Vice Presidents may be given an additional designation of rank or function.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Secretary</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) The Secretary shall attend all meetings of the stockholders, the Board and (as required) committees of the Board and shall record the proceedings of such meetings in books to be kept for that purpose. The Secretary shall give, or cause to be given, notice of all meetings of the stockholders and special meetings of the Board and shall perform such other duties as may be prescribed by the Board, the Chairman of the Board, any Chief Executive Officer or President. The Secretary shall have custody of the corporate seal of the Corporation and the Secretary, or any Assistant Secretary, shall have authority to affix the same to any instrument requiring it, and when so affixed, it may be attested by his or her signature or by the signature of such Assistant Secretary. The Board may give general authority to any other officer to affix the seal of the Corporation and to attest the affixing thereof by his or her signature.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) The Secretary shall keep, or cause to be kept, at the principal executive office of the Corporation or at the office of the Corporation's transfer agent or registrar, if one has been appointed, a stock ledger, or duplicate stock ledger, showing the names of the stockholders and their addresses, the number and classes of shares held by each and, with respect to certificated shares, the number and date of certificates issued for the same and the number and date of certificates cancelled.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) <u>Assistant Secretaries</u>. The Assistant Secretary or, if there be more than one, the Assistant Secretaries in the order determined by the Board shall, in the absence (or inability or refusal to act) of the Secretary, perform the duties and have the powers of the Secretary.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) <u>Chief Financial Officer</u>. The Chief Financial Officer shall perform all duties commonly incident to that office (including, without limitation, the care and custody of the funds and securities of the Corporation, which from time to time may come into the Chief Financial Officer's hands and the deposit of the funds of the Corporation in such banks or trust companies as the Board, the Chief Executive Officer or the President may authorize).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h) <u>Treasurer</u>. The Treasurer shall, in the absence (or inability or refusal to act) of the Chief Financial Officer, perform the duties and exercise the powers of the Chief Financial Officer.

**Section 6.2. Term of Office; Removal; Vacancies**. The elected officers of the Corporation shall hold office until their successors are duly elected and qualified by the Board or until their earlier death, resignation, retirement, disqualification, or removal from office. Any officer may be removed, with or without cause, at any time by the Board. Any officer may be removed, with or without cause, by the Board and, unless restricted by the Board, an officer may remove any officer or assistant officer appointed by that officer, at any time, with or without cause and notwithstanding the contract rights, if any, of the officer removed. Any vacancy occurring in any elected office of the Corporation may be filled by the Board. Any vacancy occurring in any office appointed by the Chief Executive Officer or President may be filled by the Chief Executive Officer, or President, as the case may be, unless the Board then determines that such office shall thereupon be elected by the Board, in which case the Board shall elect such officer.

**Section 6.3. Other Officers**. The Board may delegate the power to appoint such other officers and agents, and may also remove such officers and agents or delegate the power to remove same, as it shall from time to time deem necessary or desirable.

**Section 6.4. Multiple Officeholders; Stockholder and Director Officers**. Any number of offices may be held by the same person unless the Certificate of Incorporation or these Bylaws otherwise provide. Officers need not be stockholders or residents of the State of Delaware.

**ARTICLE VII**

**SHARES**

**Section 7.1. Certificated and Uncertificated Shares**. The shares of the Corporation may be certificated or uncertificated, subject to the sole discretion of the Board and the requirements of the DGCL.

**Section 7.2. Multiple Classes of Stock**. If the Corporation shall be authorized to issue more than one class of stock or more than one series of any class, the Corporation shall (a) cause the powers, designations, preferences and relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights to be set forth in full or summarized on the face or back of any certificate that the Corporation issues to represent shares of such class or series of stock or (b) in the case of uncertificated shares, within a reasonable time after the issuance or transfer of such shares, send to the registered owner thereof a written notice containing the information required to be set forth on certificates as specified in clause (a) above; provided, however, that, except as otherwise provided by applicable law, in lieu of the foregoing requirements, there may be set forth on the face or back of such certificate or, in the case of uncertificated shares, on such written notice a statement that the Corporation will furnish without charge to each stockholder who so requests the powers, designations, preferences and relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences or rights.

**Section 7.3. Signatures**. Each certificate representing capital stock of the Corporation (if utilized) shall be signed by or in the name of the Corporation by (a) the Chairman of the Board, the Chief Executive Officer, the President or a Vice President and (b) the Treasurer, an Assistant Treasurer, the Secretary or an Assistant Secretary of the Corporation. Any or all the signatures on the certificate may be a facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, such certificate may be issued by the Corporation with the same effect as if such person were such officer, transfer agent or registrar on the date of issue.

**Section 7.4. Consideration and Payment for Shares**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Subject to applicable law and the Certificate of Incorporation, shares of stock may be issued for such consideration, having in the case of shares with par value a value not less than the par value thereof, and to such persons, as determined from time to time by the Board. The consideration may consist of any tangible or intangible property or any benefit to the Corporation including cash, promissory notes, services performed, contracts for services to be performed or other securities, or any combination thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Subject to applicable law and the Certificate of Incorporation, shares may not be issued until the full amount of the consideration has been paid, unless upon the face or back of each certificate issued to represent any partly paid shares of capital stock or upon the books and records of the Corporation in the case of partly paid uncertificated shares, there shall have been set forth the total amount of the consideration to be paid therefor and the amount paid thereon up to and including the time said certificate representing certificated shares or said uncertificated shares are issued.

**Section 7.5. Lost, Destroyed or Wrongfully Taken Certificates**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) If an owner of a certificate representing shares claims that such certificate has been lost, destroyed or wrongfully taken, the Corporation shall issue a new certificate representing such shares or such shares in uncertificated form if the owner: (i) requests such a new certificate before the Corporation has notice that the certificate representing such shares has been acquired by a protected purchaser; (ii) if requested by the Corporation, delivers to the Corporation a bond sufficient to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, wrongful taking or destruction of such certificate or the issuance of such new certificate or uncertificated shares; and (iii) satisfies other reasonable requirements imposed by the Corporation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) If a certificate representing shares has been lost, apparently destroyed or wrongfully taken, and the owner fails to notify the Corporation of that fact within a reasonable time after the owner has notice of such loss, apparent destruction or wrongful taking and the Corporation registers a transfer of such shares before receiving notification, the owner shall be precluded from asserting against the Corporation any claim for registering such transfer or a claim to a new certificate representing such shares or such shares in uncertificated form.

**Section 7.6. Transfer of Stock**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) If a certificate representing shares of the Corporation is presented to the Corporation with an endorsement requesting the registration of transfer of such shares or an instruction is presented to the Corporation requesting the registration of transfer of uncertificated shares, the Corporation shall register the transfer as requested if:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) in the case of certificated shares, the certificate representing such shares has been surrendered;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) (A) with respect to certificated shares, the endorsement is made by the person specified by the certificate as entitled to such shares; (B) with respect to uncertificated shares, an instruction is made by the registered owner of such uncertificated shares; or (C) with respect to certificated shares or uncertificated shares, the endorsement or instruction is made by any other appropriate person or by an agent who has actual authority to act on behalf of the appropriate person;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii) the Corporation has received a guarantee of signature of the person signing such endorsement or instruction or such other reasonable assurance that the endorsement or instruction is genuine and authorized as the Corporation may request;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv) the transfer does not violate any restriction on transfer imposed by the Corporation that is enforceable in accordance with <u>Section 7.8(a)</u>; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v) such other conditions for such transfer as shall be provided for under applicable law have been satisfied.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Whenever any transfer of shares shall be made for collateral security and not absolutely, the Corporation shall so record such fact in the entry of transfer if, when the certificate for such shares is presented to the Corporation for transfer or, if such shares are uncertificated, when the instruction for registration of transfer thereof is presented to the Corporation, both the transferor and transferee request the Corporation to do so.

**Section 7.7. Registered Stockholders**. Before due presentment for registration of transfer of a certificate representing shares of the Corporation or of an instruction requesting registration of transfer of uncertificated shares, the Corporation may treat the registered owner as the person exclusively entitled to inspect for any proper purpose the stock ledger and the other books and records of the Corporation, vote such shares, receive dividends or notifications with respect to such shares and otherwise exercise all the rights and powers of the owner of such shares, except that a person who is the beneficial owner of such shares (if held in a voting trust or by a nominee on behalf of such person) may, upon providing documentary evidence of beneficial ownership of such shares and satisfying such other conditions as are provided under applicable law, may also so inspect the books and records of the Corporation.

**Section 7.8. Effect of the Corporation's Restriction on Transfer**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) A written restriction on the transfer or registration of transfer of shares of the Corporation or on the amount of shares of the Corporation that may be owned by any person or group of persons, if permitted by the DGCL and noted conspicuously on the certificate representing such shares or, in the case of uncertificated shares, contained in a notice, offering circular or prospectus sent by the Corporation to the registered owner of such shares within a reasonable time prior to or after the issuance or transfer of such shares, may be enforced against the holder of such shares or any successor or transferee of the holder including an executor, administrator, trustee, guardian or other fiduciary entrusted with like responsibility for the person or estate of the holder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) A restriction imposed by the Corporation on the transfer or the registration of shares of the Corporation or on the amount of shares of the Corporation that may be owned by any person or group of persons, even if otherwise lawful, is ineffective against a person without actual knowledge of such restriction unless: (i) the shares are certificated and such restriction is noted conspicuously on the certificate; or (ii) the shares are uncertificated and such restriction was contained in a notice, offering circular or prospectus sent by the Corporation to the registered owner of such shares within a reasonable time prior to or after the issuance or transfer of such shares.

**Section 7.9. Regulations**. The Board shall have power and authority to make such additional rules and regulations, subject to any applicable requirement of law, as the Board may deem necessary and appropriate with respect to the issue, transfer or registration of transfer of shares of stock or certificates representing shares. The Board may appoint one or more transfer agents or registrars and may require for the validity thereof that certificates representing shares bear the signature of any transfer agent or registrar so appointed.

**ARTICLE VIII**

**INDEMNIFICATION**

**Section 8.1. Right to Indemnification**. To the fullest extent permitted by applicable law, as the same exists or may hereafter be amended, the Corporation shall indemnify and hold harmless each person who was or is made a party or is threatened to be made a party to or is otherwise involved in any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (hereinafter a "***proceeding***"), by reason of the fact that he or she is or was a director or officer of the Corporation or, while a director or officer of the Corporation, is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust, other enterprise or nonprofit entity, including service with respect to an employee benefit plan (hereinafter an "***Indemnitee***"), whether the basis of such proceeding is alleged action in an official capacity as a director, officer, employee or agent, or in any other capacity while serving as a director, officer, employee or agent, against all liability and loss suffered and expenses (including, without limitation, attorneys' fees, judgments, fines, ERISA excise taxes and penalties and amounts paid in settlement) reasonably incurred by such Indemnitee in connection with such proceeding; provided, however, that, except as provided in <u>Section 8.3</u> with respect to proceedings to enforce rights to indemnification, the Corporation shall indemnify an Indemnitee in connection with a proceeding (or part thereof) initiated by such Indemnitee only if such proceeding (or part thereof) was authorized by the Board.

**Section 8.2. Right to Advancement of Expenses**. In addition to the right to indemnification conferred in <u>Section 8.1</u>, an Indemnitee shall also have the right to be paid by the Corporation to the fullest extent not prohibited by applicable law the expenses (including, without limitation, attorneys' fees) incurred in defending or otherwise participating in any such proceeding in advance of its final disposition (hereinafter an "***advancement of expenses***"); provided, however, that, if the DGCL requires, an advancement of expenses incurred by an Indemnitee in his or her capacity as a director or officer of the Corporation (and not in any other capacity in which service was or is rendered by such Indemnitee, including, without limitation, service to an employee benefit plan) shall be made only upon the Corporation's receipt of an undertaking (hereinafter an "***undertaking***"), by or on behalf of such Indemnitee, to repay all amounts so advanced if it shall ultimately be determined that such Indemnitee is not entitled to be indemnified under this <u>Article VIII</u> or otherwise.

**Section 8.3. Right of Indemnitee to Bring Suit**. If a claim under <u>Section 8.1</u> or <u>Section 8.2</u> is not paid in full by the Corporation within 60 days after a written claim therefor has been received by the Corporation, except in the case of a claim for an advancement of expenses, in which case the applicable period shall be 20 days, the Indemnitee may at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim. If successful in whole or in part in any such suit, or in a suit brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Indemnitee shall also be entitled to be paid the expense of prosecuting or defending such suit. In (a) any suit brought by the Indemnitee to enforce a right to indemnification hereunder (but not in a suit brought by an Indemnitee to enforce a right to an advancement of expenses) it shall be a defense that, and (b) in any suit brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Corporation shall be entitled to recover such expenses upon a final judicial decision from which there is no further right to appeal (hereinafter a "***final adjudication***") that, the Indemnitee has not met any applicable standard for indemnification set forth in the DGCL. Neither the failure of the Corporation (including its directors who are not parties to such action, a committee of such directors, independent legal counsel, or its stockholders) to have made a determination prior to the commencement of such suit that indemnification of the Indemnitee is proper in the circumstances because the Indemnitee has met the applicable standard of conduct set forth in the DGCL, nor an actual determination by the Corporation (including a determination by its directors who are not parties to such action, a committee of such directors, independent legal counsel, or its stockholders) that the Indemnitee has not met such applicable standard of conduct, shall create a presumption that the Indemnitee has not met the applicable standard of conduct or, in the case of such a suit brought by the Indemnitee, shall be a defense to such suit. In any suit brought by the Indemnitee to enforce a right to indemnification or to an advancement of expenses hereunder, or by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the burden of proving that the Indemnitee is not entitled to be indemnified, or to such advancement of expenses, under this <u>Article VIII</u> or otherwise shall be on the Corporation.

**Section 8.4. Non-Exclusivity of Rights**. The rights provided to any Indemnitee pursuant to this <u>Article VIII</u> shall not be exclusive of any other right, which such Indemnitee may have or hereafter acquire under applicable law, the Certificate of Incorporation, these Bylaws, an agreement, a vote of stockholders or disinterested directors, or otherwise.

**Section 8.5. Insurance**. The Corporation may maintain insurance, at its expense, to protect itself and/or any director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise against any expense, liability or loss, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the DGCL.

**Section 8.6. Indemnification of Other Persons**. This <u>Article VIII</u> shall not limit the right of the Corporation to the extent and in the manner authorized or permitted by law to indemnify and to advance expenses to persons other than Indemnitees. Without limiting the foregoing, the Corporation may, to the extent authorized from time to time by the Board, grant rights to indemnification and to the advancement of expenses to any employee or agent of the Corporation and to any other person who is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan, to the fullest extent of the provisions of this <u>Article VIII</u> with respect to the indemnification and advancement of expenses of Indemnitees under this <u>Article VIII</u>.

**Section 8.7. Amendments**. Any repeal or amendment of this <u>Article VIII</u> by the Board or the stockholders of the Corporation or by changes in applicable law, or the adoption of any other provision of these Bylaws inconsistent with this <u>Article VIII</u>, will, to the extent permitted by applicable law, be prospective only (except to the extent such amendment or change in applicable law permits the Corporation to provide broader indemnification rights to Indemnitees on a retroactive basis than permitted prior thereto), and will not in any way diminish or adversely affect any right or protection existing hereunder in respect of any act or omission occurring prior to such repeal or amendment or adoption of such inconsistent provision; provided however, that amendments or repeals of this <u>Article VIII</u> shall require the affirmative vote of the stockholders holding at least 66.7% of the voting power of all outstanding shares of capital stock of the Corporation.

**Section 8.8. Certain Definitions**. For purposes of this <u>Article VIII</u>, (a) references to "***other enterprise***" shall include any employee benefit plan; (b) references to "***fines***" shall include any excise taxes assessed on a person with respect to an employee benefit plan; (c) references to "***serving at the request of the Corporation***" shall include any service that imposes duties on, or involves services by, a person with respect to any employee benefit plan, its participants, or beneficiaries; and (d) a person who acted in good faith and in a manner such person reasonably believed to be in the interest of the participants and beneficiaries of an employee benefit plan shall be deemed to have acted in a manner "not opposed to the best interest of the Corporation" for purposes of Section 145 of the DGCL.

**Section 8.9. Contract Rights**. The rights provided to Indemnitees pursuant to this <u>Article VIII</u> shall be contract rights and such rights shall continue as to an Indemnitee who has ceased to be a director, officer, agent or employee and shall inure to the benefit of the Indemnitee's heirs, executors and administrators.

**Section 8.10. Severability**. If any provision or provisions of this <u>Article VIII</u> shall be held to be invalid, illegal or unenforceable for any reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of this <u>Article VIII</u> shall not in any way be affected or impaired thereby; and (b) to the fullest extent possible, the provisions of this <u>Article VIII</u> (including, without limitation, each such portion of this <u>Article VIII</u> containing any such provision held to be invalid, illegal or unenforceable) shall be construed so as to give effect to the intent manifested by the provision held invalid, illegal or unenforceable.

**ARTICLE IX**

**EXCLUSIVE JURISDICTION**

**Section 9.2. U.S. Federal Courts.** Unless the Corporation consents in writing to the selection of an alternative forum, the U.S. federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action against the Corporation or any director, officer, other employee or agent of the Corporation arising under the Securities Act of 1933, as amended.

**Section 9.3. Deemed Notice and Consent.** Any person or entity purchasing or otherwise acquiring any interest in any security of the Corporation shall be deemed to have notice of and consented to the provisions of this Article 9. This Article 9 shall be enforceable by any party to a complaint covered by the provisions of this Article 9.

**ARTICLE X**

**MISCELLANEOUS**

**Section 10.1. Place of Meetings**. If the place of any meeting of stockholders, the Board or committee of the Board for which notice is required under these Bylaws is not designated in the notice of such meeting, such meeting shall be held at the principal business office of the Corporation; provided, however, if the Board has, in its sole discretion, determined that a meeting shall not be held at any place, but instead shall be held by means of remote communication pursuant to <u>Section 10.5(a)</u> hereof, then such meeting shall not be held at any place.

**Section 10.2. Fixing Record Dates**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) In order that the Corporation may determine the stockholders entitled to notice of any meeting of stockholders or any adjournment thereof, the Board may fix a record date, which shall not precede the date upon which the resolution fixing the record date is adopted by the Board, and which record date shall not be more than 60 nor less than 10 days before the date of such meeting. If the Board so fixes a date, such date shall also be the record date for determining the stockholders entitled to vote at such meeting unless the Board determines, at the time it fixes such record date, that a later date on or before the date of the meeting shall be the date for making such determination. If no record date is fixed by the Board, the record date for determining stockholders entitled to notice of and to vote at a meeting of stockholders shall be at the close of business on the business day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the business day next preceding the day on which the meeting is held. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board may fix a new record date for the adjourned meeting, and in such case shall also fix as the record date for stockholders entitled to notice of such adjourned meeting the same or an earlier date as that fixed for determination of stockholders entitled to vote in accordance with the foregoing provisions of this <u>Section 9.2(a)</u> at the adjourned meeting.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) In order that the Corporation may determine the stockholders entitled to receive payment of any dividend or other distribution or allotment of any rights or the stockholders entitled to exercise any rights in respect of any change, conversion or exchange of stock, or for the purpose of any other lawful action, the Board may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted, and which record date shall be not more than 60 days prior to such action. If no record date is fixed, the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the Board adopts the resolution relating thereto.

**Section 10.3. Means of Giving Notice**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Notice to Directors</u>. Whenever under applicable law, the Certificate of Incorporation or these Bylaws notice is required to be given to any director, such notice shall be given either (i) in writing and sent by mail, or by a nationally recognized delivery service, (ii) by means of facsimile telecommunication or other form of electronic transmission (including electronic mail), or (iii) by oral notice given personally or by telephone. A notice to a director will be deemed given as follows: (i) if given by hand delivery, orally, or by telephone, when actually received by the director, (ii) if sent through the United States mail, when deposited in the United States mail, with postage and fees thereon prepaid, addressed to the director at the director's address appearing on the records of the Corporation, (iii) if sent for next day delivery by a nationally recognized overnight delivery service, when deposited with such service, with fees thereon prepaid, addressed to the director at the director's address appearing on the records of the Corporation, (iv) if sent by facsimile telecommunication, when sent to the facsimile transmission number for such director appearing on the records of the Corporation, (v) if sent by electronic mail, when sent to the electronic mail address for such director appearing on the records of the Corporation, or (vi) if sent by any other form of electronic transmission, when sent to the address, location or number (as applicable) for such director appearing on the records of the Corporation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Notice to Stockholders</u>. Whenever under applicable law, the Certificate of Incorporation or these Bylaws notice is required to be given to any stockholder, such notice may be given (i) in writing and sent either by hand delivery, through the United States mail, or by a nationally recognized overnight delivery service for next day delivery, or (ii) by means of a form of electronic transmission consented to by the stockholder, to the extent permitted by, and subject to the conditions set forth in Section 232 of the DGCL. A notice to a stockholder shall be deemed given as follows: (i) if given by hand delivery, when actually received by the stockholder, (ii) if sent through the United States mail, when deposited in the United States mail, with postage and fees thereon prepaid, addressed to the stockholder at the stockholder's address appearing on the stock ledger of the Corporation, (iii) if sent for next day delivery by a nationally recognized overnight delivery service, when deposited with such service, with fees thereon prepaid, addressed to the stockholder at the stockholder's address appearing on the stock ledger of the Corporation, and (iv) if given by a form of electronic transmission consented to by the stockholder to whom the notice is given and otherwise meeting the requirements set forth above, (A) if by facsimile transmission, when directed to a number at which the stockholder has consented to receive notice, (B) if by electronic mail, when directed to an electronic mail address at which the stockholder has consented to receive notice, (C) if by a posting on an electronic network together with separate notice to the stockholder of such specified posting, upon the later of (1) such posting and (2) the giving of such separate notice, and (D) if by any other form of electronic transmission, when directed to the stockholder. A stockholder may revoke such stockholder's consent to receiving notice by means of electronic communication by giving written notice of such revocation to the Corporation. Any such consent shall be deemed revoked if (1) the Corporation is unable to deliver by electronic transmission two consecutive notices given by the Corporation in accordance with such consent and (2) such inability becomes known to the Secretary or an Assistant Secretary or to the Corporation's transfer agent, or other person responsible for the giving of notice; provided, however, the inadvertent failure to treat such inability as a revocation shall not invalidate any meeting or other action.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) <u>Electronic Transmission</u>. "***Electronic transmission***" means any form of communication, not directly involving the physical transmission of paper, that creates a record that may be retained, retrieved and reviewed by a recipient thereof, and that may be directly reproduced in paper form by such a recipient through an automated process, including but not limited to transmission by telex, facsimile telecommunication, electronic mail, telegram and cablegram.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) <u>Notice to Stockholders Sharing Same Address</u>. Without limiting the manner by which notice otherwise may be given effectively by the Corporation to stockholders, any notice to stockholders given by the Corporation under any provision of the DGCL, the Certificate of Incorporation or these Bylaws shall be effective if given by a single written notice to stockholders who share an address if consented to by the stockholders at that address to whom such notice is given. A stockholder may revoke such stockholder's consent by delivering written notice of such revocation to the Corporation. Any stockholder who fails to object in writing to the Corporation within 60 days of having been given written notice by the Corporation of its intention to send such a single written notice shall be deemed to have consented to receiving such single written notice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e) <u>Exceptions to Notice Requirements</u>. Whenever notice is required to be given, under the DGCL, the Certificate of Incorporation or these Bylaws, to any person with whom communication is unlawful, the giving of such notice to such person shall not be required and there shall be no duty to apply to any governmental authority or agency for a license or permit to give such notice to such person. Any action or meeting that shall be taken or held without notice to any such person with whom communication is unlawful shall have the same force and effect as if such notice had been duly given. In the event that the action taken by the Corporation is such as to require the filing of a certificate with the Secretary of State of Delaware, the certificate shall state, if such is the fact and if notice is required, that notice was given to all persons entitled to receive notice except such persons with whom communication is unlawful.

Whenever notice is required to be given by the Corporation, under any provision of the DGCL, the Certificate of Incorporation or these Bylaws, to any stockholder to whom (1) notice of two consecutive annual meetings of stockholders and all notices of stockholder meetings or of the taking of action by written consent of stockholders without a meeting to such stockholder during the period between such two consecutive annual meetings, or (2) all, and at least two payments (if sent by first-class mail) of dividends or interest on securities during a 12-month period, have been mailed addressed to such stockholder at such stockholder's address as shown on the records of the Corporation and have been returned undeliverable, the giving of such notice to such stockholder shall not be required. Any action or meeting that shall be taken or held without notice to such stockholder shall have the same force and effect as if such notice had been duly given. If any such stockholder shall deliver to the Corporation a written notice setting forth such stockholder's then current address, the requirement that notice be given to such stockholder shall be reinstated. In the event that the action taken by the Corporation is such as to require the filing of a certificate with the Secretary of State of Delaware, the certificate need not state that notice was not given to persons to whom notice was not required to be given pursuant to Section 230(b) of the DGCL. The exception in subsection (1) of the first sentence of this paragraph to the requirement that notice be given shall not be applicable to any notice returned as undeliverable if the notice was given by electronic transmission.

**Section 10.4. Waiver of Notice**. Whenever any notice is required to be given under applicable law, the Certificate of Incorporation, or these Bylaws, a written waiver of such notice, signed by the person or persons entitled to said notice, or a waiver by electronic transmission by the person entitled to said notice, whether before or after the time stated therein, shall be deemed equivalent to such required notice. All such waivers shall be kept with the books of the Corporation. Attendance at a meeting shall constitute a waiver of notice of such meeting, except where a person attends for the express purpose of objecting to the transaction of any business on the ground that the meeting was not lawfully called or convened.

**Section 10.5. Meeting Attendance via Remote Communication Equipment.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) <u>Stockholder Meetings</u>. If authorized by the Board in its sole discretion, and subject to such guidelines and procedures as the Board may adopt, stockholders entitled to vote at such meeting and proxy holders not physically present at a meeting of stockholders may, by means of remote communication:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i) participate in a meeting of stockholders; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii) be deemed present in person and vote at a meeting of stockholders, whether such meeting is to be held at a designated place or solely by means of remote communication, provided that (A) the Corporation shall implement reasonable measures to verify that each person deemed present and permitted to vote at the meeting by means of remote communication is a stockholder or proxy holder, (B) the Corporation shall implement reasonable measures to provide such stockholders and proxy holders a reasonable opportunity to participate in the meeting and, if entitled to vote, to vote on matters submitted to the applicable stockholders, including an opportunity to read or hear the proceedings of the meeting substantially concurrently with such proceedings, and (C) if any stockholder or proxy holder votes or takes other action at the meeting by means of remote communication, a record of such votes or other action shall be maintained by the Corporation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) <u>Board Meetings</u>. Unless otherwise restricted by applicable law, the Certificate of Incorporation or these Bylaws, members of the Board or any committee thereof may participate in a meeting of the Board or any committee thereof by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other. Such participation in a meeting shall constitute presence in person at the meeting, except where a person participates in the meeting for the express purpose of objecting to the transaction of any business on the ground that the meeting was not lawfully called or convened.

**Section 10.6. Dividends**. The Board may from time to time declare, and the Corporation may pay, dividends (payable in cash, property or shares of the Corporation's capital stock) on the Corporation's outstanding shares of capital stock, subject to applicable law and the Certificate of Incorporation.

**Section 10.7. Reserves**. The Board may set apart out of the funds of the Corporation available for dividends a reserve or reserves for any proper purpose and may abolish any such reserve.

**Section 10.8. Contracts and Negotiable Instruments**. Except as otherwise provided by applicable law, the Certificate of Incorporation or these Bylaws, any contract, bond, deed, lease, mortgage or other instrument may be executed and delivered in the name and on behalf of the Corporation by such officer or officers or other employee or employees of the Corporation as the Board may from time to time authorize. Such authority may be general or confined to specific instances as the Board may determine. The Chairman of the Board, the Chief Executive Officer, the President, the Chief Financial Officer, the Treasurer or any Vice President may execute and deliver any contract, bond, deed, lease, mortgage or other instrument in the name and on behalf of the Corporation. Subject to any restrictions imposed by the Board, the Chairman of the Board , Chief Executive Officer, President, the Chief Financial Officer, the Treasurer or any Vice President may delegate powers to execute and deliver any contract, bond, deed, lease, mortgage or other instrument in the name and on behalf of the Corporation to other officers or employees of the Corporation under such person's supervision and authority, it being understood, however, that any such delegation of power shall not relieve such officer of responsibility with respect to the exercise of such delegated power.

**Section 10.9. Fiscal Year**. The fiscal year of the Corporation shall be fixed by the Board.

**Section 10.10. Seal**. The Board may adopt a corporate seal, which shall be in such form as the Board determines. The seal may be used by causing it or a facsimile thereof to be impressed, affixed or otherwise reproduced.

**Section 10.11. Books and Records**. The books and records of the Corporation may be kept within or outside the State of Delaware at such place or places as may from time to time be designated by the Board.

**Section 10.12. Resignation**. Any director, committee member or officer may resign by giving notice thereof in writing or by electronic transmission to the Chairman of the Board, the Chief Executive Officer, the President or the Secretary. The resignation shall take effect at the time it is delivered unless the resignation specifies a later effective date or an effective date determined upon the happening of an event or events. Unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective.

**Section 10.13. Surety Bonds**. Such officers, employees and agents of the Corporation (if any) as the Chairman of the Board, any Chief Executive Officer, President or the Board may direct, from time to time, shall be bonded for the faithful performance of their duties and for the restoration to the Corporation, in case of their death, resignation, retirement, disqualification or removal from office, of all books, papers, vouchers, money and other property of whatever kind in their possession or under their control belonging to the Corporation, in such amounts and by such surety companies as the Chairman of the Board, Chief Executive Officer, President or the Board may determine. The premiums on such bonds shall be paid by the Corporation and the bonds so furnished shall be in the custody of the Secretary.

**Section 10.14. Securities of Other Corporations**. Powers of attorney, proxies, waivers of notice of meeting, consents in writing and other instruments relating to securities owned by the Corporation may be executed in the name of and on behalf of the Corporation by the Chairman of the Board, any Chief Executive Officer, President, any Vice President or any officers authorized by the Board. Any such officer, may, in the name of and on behalf of the Corporation, take all such action as any such officer may deem advisable to vote in person or by proxy at any meeting of security holders of any corporation in which the Corporation may own securities, or to consent in writing, in the name of the Corporation as such holder, to any action by such corporation, and at any such meeting or with respect to any such consent shall possess and may exercise any and all rights and power incident to the ownership of such securities and which, as the owner thereof, the Corporation might have exercised and possessed. The Board may from time to time confer like powers upon any other person or persons.

**Section 10.15. Amendments**. The Board shall have the power to adopt, amend, alter or repeal the Bylaws are any part hereof. The affirmative vote of a majority of the Board shall be required to adopt, amend, alter or repeal the Bylaws. The Bylaws also may be adopted, amended, altered or repealed by the stockholders; provided, however, that in addition to any vote of the holders of any class or series of capital stock of the Corporation required by applicable law or the Certificate of Incorporation, the affirmative vote of the holders of at least two-thirds (2/3) of the voting power (except as otherwise provided in Section 8.7) of all outstanding shares of capital stock of the Corporation entitled to vote generally in the election of directors, voting together as a single class, shall be required for the stockholders to adopt, amend, alter or repeal the Bylaws.

**Section 10.16. <u>Application of Delaware Law</u>**. Whenever any provision of these Bylaws is inconsistent with any provision of the DGCL, as they may be amended from time to time, then in such instance, Delaware law shall prevail.

**Section 10.17. <u>Conflicts with the Certificate of Incorporation</u>.** In the event that any provision contained in these Bylaws conflicts with any provision of the Certificate of Incorporation, as amended from time to time, the provisions of the Certificate of Incorporation shall prevail and be given full force and effect, to the full extent permissible under the DGCL.

## Exhibit 10.3

**Exhibit 10.3**

**BIOVENTRIX, INC.**

**2026 EQUITY INCENTIVE PLAN**

**1.**  **<u>Purpose</u>** 

The Plan's purpose is to attract, retain, and motivate persons who make important contributions to the Company by providing these individuals with the opportunity to acquire Shares. Additionally, the Plan is intended to align the interests of these individuals to those of the Company's other shareholders.

**2.**  **<u>Definitions</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;2.1.  ***Administrator*** means the Board or a Committee to the extent the Board's powers and authorities under
 the Plan have been delegated to a Committee. "Administrator" also includes any
 officer that has been delegated authority pursuant to Section 4.2 for such time as such delegation
 is in effect.

&nbsp;&nbsp;&nbsp;&nbsp;2.2.  ***Affiliate*** means (i) any person or entity that directly or indirectly controls, is controlled by or
 is under common control with the Company and/or (ii) to the extent provided by the Board
 or a Committee, any person or entity in which the Company has a significant interest as determined
 by the Board or a Committee in its discretion. The term "control" (including,
 with correlative meaning, the terms "controlled by" and "under common control
 with"), as applied to any person or entity, means the possession, directly or indirectly,
 of the power to direct or cause the direction of the management and policies of such person
 or entity, whether through the ownership of voting or other securities, by contract or otherwise.

&nbsp;&nbsp;&nbsp;&nbsp;2.3.  ***Applicable Law*** means any applicable law, including without limitation: (i) provisions of the
 Code, the Securities Act, the Exchange Act and any rules or regulations thereunder, (ii)
 corporate, securities, tax or other laws, statutes, rules, requirements, or regulations,
 whether federal, state, local, or foreign, and (iii) rules of any securities exchange or
 automated quotation system on which the Shares are listed, quoted, or traded.

&nbsp;&nbsp;&nbsp;&nbsp;2.4.  ***Award*** means an Option award, Stock Appreciation Right award, Restricted Stock award, Restricted
 Stock Unit award, Performance Award, Dividend Equivalents award, or Other Stock or Cash Based
 Award granted to a Participant under the Plan.

&nbsp;&nbsp;&nbsp;&nbsp;2.5.  ***Award Agreement*** means an agreement (written or electronic) made and delivered in accordance
 with Section 12.3 of this Plan, evidencing the grant of an Award hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;2.6.  ***Board*** means the Board of Directors of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;2.7.  ***Cause*** means, in the case of a particular Award, unless the applicable Award Agreement states otherwise,
 (i) the Company or an Affiliate having "cause" to terminate a Participant's
 employment or service, as defined in any employment or consulting agreement or similar document
 or policy between the Participant and the Company or an Affiliate in effect at the time of
 such termination or (ii) in the absence of any such employment or consulting agreement, document
 or policy (or the absence of any definition of "Cause" contained therein), (A)
 a continuing material breach or material default (including, without limitation, any material
 dereliction of duty) by Participant of any agreement between the Participant and the Company,
 except for any such breach or default which is caused by the Participant's Disability,
 or a continuing failure by the Participant to follow the direction of a duly authorized representative
 of the Company; (B) gross negligence, willful misfeasance or breach of fiduciary duty to
 the Company or Affiliate by the Participant; (C) the commission by the Participant of an
 act of fraud, embezzlement or any felony or other crime of dishonesty in connection with
 the Participant's duties to the Company or Affiliate; or (D) the Participant's
 conviction of, or plea of *nolo contendere* to, a felony or any other crime that would
 materially and adversely affect: (i) the business reputation of the Company or Affiliate
 or (ii) the performance of the Participant's duties to the Company or an Affiliate.
 Any determination of whether Cause exists shall be made by the Administrator in its sole
 discretion.

&nbsp;&nbsp;&nbsp;&nbsp;2.8.  ***Change in Control*** shall, in the case of a particular Award, unless the applicable Award
 Agreement provides otherwise or contains a different definition of "Change in Control"
 be deemed to occur upon:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8.1. A
 tender offer (or series of related offers) which is made and consummated for the ownership
 of 50% or more of the outstanding voting securities of the Company, unless as a result of
 such tender offer more than 50% of the outstanding voting securities of the surviving or
 resulting corporation or entity are owned in the aggregate by (A) the shareholders of the
 Company (as of the time immediately prior to the commencement of such offer), or (B) any
 employee benefit plan of the Company or its Subsidiaries, and their Affiliates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8.2. The
 consummation of the Company's merger or consolidation with another corporation, unless
 as a result of such merger or consolidation, more than 50% of the outstanding voting securities
 of the surviving or resulting corporation or entity shall be owned in the aggregate by (A)
 the shareholders of the Company (as of the time immediately prior to such transaction); provided,
 that a merger or consolidation of the Company with another company which is controlled by
 persons owning more than 50% of the outstanding voting securities of the Company shall constitute
 a Change in Control unless the Administrator, in its discretion, determine otherwise, or
 (B) any employee benefit plan of the Company or its Subsidiaries, and their Affiliates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8.3. The
 consummation of the Company's sale of substantially all of its assets to another entity
 that is not wholly owned by the Company, unless as a result of such sale more than 50% of
 such assets shall be owned in the aggregate by (A) the shareholders of the Company (as of
 the time immediately prior to such transaction), or (B) any employee benefit plan of the
 Company or its Subsidiaries, and their Affiliates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8.4. The
 consummation of a transaction, or series of transactions, in which a Person acquires 50%
 or more of the outstanding voting securities of the Company (whether directly, indirectly,
 beneficially or of record), unless as a result of such acquisition more than 50% of the outstanding
 voting securities of the surviving or resulting corporation or entity shall be owned in the
 aggregate by (A) the shareholders of the Company (as of the time immediately prior to the
 first acquisition of such securities by such Person), or (B) any employee benefit plan of
 the Company or its Subsidiaries, and their Affiliates; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8.5. The
 Incumbent Directors cease to constitute a majority of the Board for any reason.

For purposes of this Section 2.8, ownership of voting securities shall take into account and shall include ownership as determined by applying the provisions of Rule 13d-3(d)(1)(i) (as in effect on the date hereof) under the Exchange Act.

Notwithstanding the foregoing, if a Change in Control constitutes a payment event with respect to any Award or portion thereof that provides for the deferral of compensation that is subject to Section 409A, then to the extent required to avoid the imposition of additional taxes under Section 409A, the transaction or event described above in this Section 2.8 with respect to such Award or portion thereof shall only constitute a Change in Control for purposes of the payment timing of such Award if such transaction also constitutes a "change in control event," as defined in Treasury Regulation Section 1.409A-3(i)(5).

The Administrator shall have the authority, in its sole discretion, to determine whether a Change in Control has occurred, the effective date of such Change in Control, and any incidental matters relating thereto; provided that any exercise of authority in conjunction with a determination of whether a Change in Control is a "change in control event" as defined in Treasury Regulation Section 1.409A-3(i)(5) shall be consistent with such regulation.

&nbsp;&nbsp;&nbsp;&nbsp;2.9.  ***Clawback Policies*** means any policy of the Company regarding the reduction, recoupment, clawback
 or recovery of compensation, as such policies may be amended from time to time. "Clawback
 Policies" includes the Company's policies to comply with the Dodd-Frank Wall
 Street Reform and Consumer Protection Act, the Sarbanes-Oxley Act, or other Applicable Law,
 as well as any implementing regulations and/or listing standards.

&nbsp;&nbsp;&nbsp;&nbsp;2.10.  ***Closing*** means the closing of the Company's IPO.

 ****

&nbsp;&nbsp;&nbsp;&nbsp;2.11.  ***Code*** means the Internal Revenue Code of 1986, as amended, and any successor thereto. References
 in this Plan to any section of the Code shall be deemed to include any regulations or other
 interpretative guidance issued by any governmental authority under such section, and any
 amendments or successor provisions to such section, regulations or guidance.

&nbsp;&nbsp;&nbsp;&nbsp;2.12.  ***Committee*** means one or more committees or subcommittees of the Board, which shall be comprised, unless
 otherwise determined by the Board, solely of not less than two members who shall be (i) Non-Employee
 Directors, and (ii) "Non-Employee Directors" within the meaning of Rule 16b-3.

&nbsp;&nbsp;&nbsp;&nbsp;2.13.  ***Company*** means BioVentrix, Inc., a Delaware corporation.

&nbsp;&nbsp;&nbsp;&nbsp;2.14.  ***Consultant*** means any person, including any adviser, engaged by the Company or a Subsidiary to
 render services to such entity if the consultant or adviser: (i) renders bona fide services
 to the Company or a Subsidiary, (ii) renders services not in connection with the offer or
 sale of securities in a capital-raising transaction and does not directly or indirectly promote
 or maintain a market for the Company's securities, and (iii) who qualifies as a consultant
 or advisor under Instruction A.1.(a)(1) of Form S-8 under the Securities Act.

&nbsp;&nbsp;&nbsp;&nbsp;2.15.  ***Designated Beneficiary*** means, if permitted by the Company, the beneficiary or beneficiaries
 the Participant designates, in a manner the Company determines, to receive amounts due or
 exercise the Participant's rights if the Participant dies. If a Participant does not
 make an effective designation, then the "Designated Beneficiary" will mean the
 Participant's estate or legal heirs.

&nbsp;&nbsp;&nbsp;&nbsp;2.16.  ***Director*** means a Board member.

&nbsp;&nbsp;&nbsp;&nbsp;2.17.  ***Disability*** means a permanent and total disability under Code Section 22(e)(3).

&nbsp;&nbsp;&nbsp;&nbsp;2.18.  ***Dividend Equivalents*** means a right granted to a Participant to receive the equivalent value
 (in cash or Shares) of dividends paid on a specified number of Shares. Such Dividend Equivalents
 shall be converted to cash or additional Shares, or a combination of cash and Shares, by
 such formula and at such time and subject to such limitations as may be determined by the
 Administrator.

&nbsp;&nbsp;&nbsp;&nbsp;2.19.  ***Effective Date*** has the meaning ascribed to such term in Section 21.

&nbsp;&nbsp;&nbsp;&nbsp;2.20.  ***Employee*** means any employee of the Company or any of its Subsidiaries.

&nbsp;&nbsp;&nbsp;&nbsp;2.21.  ***Exchange Act*** means the United States Securities Exchange Act of 1934, as amended, and all
 regulations, guidance, and other interpretive authority issued thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;2.22.  ***Fair Market Value*** means unless otherwise provided by the Administrator in accordance with
 Applicable Law, on a given date, (i) if the Shares are listed on a national securities exchange,
 the closing sales price on the principal exchange of the Shares on such date, as reported
 in *The Wall Street Journal* or another source the Administrator deems reliable, or,
 in the absence of reported sales on such date, the closing sales price on the immediately
 preceding date on which sales were reported, or (ii) if the Shares are not listed on a national
 securities exchange, the mean between the bid and offered prices as quoted by any nationally
 recognized interdealer quotation system for such date, as reported in *The Wall Street Journal* or another source the Administrator deems reliable, provided that if the Shares
 are not quoted on an interdealer quotation system or it is determined that the fair market
 value is not properly reflected by such quotations, Fair Market Value will be determined
 by such other method as the Administrator determines in good faith to be reasonable and in
 compliance with Section 409A.

&nbsp;&nbsp;&nbsp;&nbsp;2.23.  ***GAAP*** means United States Generally Accepted Accounting Principles.

&nbsp;&nbsp;&nbsp;&nbsp;2.24.  ***Greater Than 10% Shareholder*** means an individual then owning (within the meaning of Code
 Section 424(d)) more than 10% of the total combined voting power of all classes of stock
 of the Company or any Parent or Subsidiary.

&nbsp;&nbsp;&nbsp;&nbsp;2.25.  ***Incentive Stock Option*** means an Option that meets the requirements to qualify as an "incentive
 stock option" as defined in Code Section 422.

&nbsp;&nbsp;&nbsp;&nbsp;2.26.  ***Incumbent Directors*** means, for any period of 12 consecutive months, individuals who, at the
 beginning of such period, constitute the Board together with any new Director(s) (other than
 a Director designated by a person who shall have entered into an agreement with the Company
 to effect a transaction described in clause 2.8.1 or 2.8.3 of the Change in Control definition)
 whose election or nomination for election to the Board was approved by a vote of at least
 a majority (either by a specific vote or by approval of the proxy statement of the Company
 in which such person is named as a nominee for Director without objection to such nomination)
 of the Directors then still in office who either were Directors at the beginning of the 12-month
 period or whose election or nomination for election was previously so approved. No individual
 initially elected or nominated as a director of the Company as a result of an actual or threatened
 election contest with respect to Directors or as a result of any other actual or threatened
 solicitation of proxies by or on behalf of any person other than the Board shall be an Incumbent
 Director.

&nbsp;&nbsp;&nbsp;&nbsp;2.27.  ***IPO*** means the first underwritten public offering of the Shares registered under the Securities
 Act on Form S-1 filed with the Securities and Exchange Commission, and upon the closing of
 which such Shares are listed for trading on a national securities exchange.

 ****

&nbsp;&nbsp;&nbsp;&nbsp;2.28.  ***Non-Employee Director*** means a Director who is not an Employee.

&nbsp;&nbsp;&nbsp;&nbsp;2.29.  ***Nonqualified Option*** means an Option that by its terms, or in operation, does not qualify or is
 not intended to qualify as an Incentive Stock Option.

&nbsp;&nbsp;&nbsp;&nbsp;2.30.  ***Option*** means an Award granted pursuant to Section 6 hereof (excepting Stock Appreciation Rights)
 to purchase a specified number of Shares at a specified price per Share during a specified
 time period, each as specified in an Award Agreement. An Option may be either an Incentive
 Stock Option or a Nonqualified Option.

&nbsp;&nbsp;&nbsp;&nbsp;2.31.  ***Other Stock or Cash Based Awards*** means cash awards, awards of Shares, and other awards
 valued by reference to or based on, Shares or other property.

&nbsp;&nbsp;&nbsp;&nbsp;2.32.  ***Parent*** means a "parent corporation," whether now or hereafter existing, as defined by
 Code Section 424(e).

 ****

&nbsp;&nbsp;&nbsp;&nbsp;2.33.  ***Participant*** means a Service Provider who has been granted an Award.

&nbsp;&nbsp;&nbsp;&nbsp;2.34.  ***Performance Award*** means an Award granted hereunder that vests or is earned based at least in
 part upon the attainment of performance criteria established by the Administrator.

&nbsp;&nbsp;&nbsp;&nbsp;2.35.  ***Period of Restriction*** means the period during which the transfer of Restricted Stock is
 subject to restrictions and a substantial risk of forfeiture. Such restrictions may be based
 on the passage of time, the achievement of certain performance criteria, or the occurrence
 of other events as determined by the Administrator.

 ****

&nbsp;&nbsp;&nbsp;&nbsp;2.36.  ***Person*** means as defined in Section 3(a)(9) of the Exchange Act, as modified and used in
 Sections 13(d) and 14(d) thereof; however, a Person shall not include (A) the Company or
 any of its Subsidiaries; (B) a trustee or other fiduciary holding securities under an employee
 benefit plan of the Company or any of its Subsidiaries; (C) an underwriter temporarily holding
 securities pursuant to an offering of such securities; or (D) a corporation owned, directly
 or indirectly, by the shareholders of the Company in substantially the same proportion as
 their ownership of stock of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;2.37.  ***Plan*** means this BioVentrix, Inc. 2026 Equity Incentive Plan.

&nbsp;&nbsp;&nbsp;&nbsp;2.38.  ***Restricted Stock*** means Shares, subject to a Period of Restriction or certain other specified
 restrictions (including, without limitation, a requirement that the Participant remain continuously
 employed or provide continuous service for a specified period of time), granted under Section
 7 or issued pursuant to the early exercise of an Option.

&nbsp;&nbsp;&nbsp;&nbsp;2.39.  ***Restricted Stock Unit*** or  ***RSU*** means an unfunded and unsecured promise to deliver
 Shares, cash, other securities, or other property, subject to certain restrictions (including,
 without limitation, a requirement that the Participant remain continuously employed or provide
 continuous service for a specified period of time), granted under Section 8.

&nbsp;&nbsp;&nbsp;&nbsp;2.40.  ***Restrictive Covenant*** means any non-competition, non-solicitation, confidentiality, non-disparagement,
 non-disclosure, or similar agreement between a Participant and the Company or an Affiliate.

&nbsp;&nbsp;&nbsp;&nbsp;2.41.  ***Rule 16b-3*** means Rule 16b-3 promulgated under the Exchange Act, as amended.

&nbsp;&nbsp;&nbsp;&nbsp;2.42.  ***Securities Act*** means the United States Securities Act of 1933, as amended, and all regulations,
 guidance, and other interpretive authority issued thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;2.43.  ***Section 409A*** means Code Section 409A and the regulations and other guidance promulgated thereunder
 by the United States Treasury Department, as amended.

&nbsp;&nbsp;&nbsp;&nbsp;2.44.  ***Service Provider*** means an Employee, Consultant, or a Director.

&nbsp;&nbsp;&nbsp;&nbsp;2.45.  ***Share Limit*** has the meaning ascribed to such term in Section 5.1.

 ****

&nbsp;&nbsp;&nbsp;&nbsp;2.46.  ***Shares*** means shares of the Company's common stock, par value $0.0001 per share.

&nbsp;&nbsp;&nbsp;&nbsp;2.47.  ***Stock Appreciation Right*** or  ***SAR*** means a right granted under Section 6 hereof
 to receive a payment equal to the excess of the Fair Market Value of a specified number of
 Shares on the date the right is exercised over the exercise price set forth in the applicable
 Award Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;2.48.  ***Subsidiary*** means a "subsidiary corporation," whether now or hereafter existing, as defined
 by Code Section 424(f).

&nbsp;&nbsp;&nbsp;&nbsp;2.49.  ***Substitute Awards*** means Awards granted or Shares issued by the Company in assumption of, or
 in substitution or exchange for, awards previously granted, or the right or obligation to
 make future awards, in each case by a company or other entity acquired by the Company or
 any Subsidiary or with which the Company or any Subsidiary combines.

&nbsp;&nbsp;&nbsp;&nbsp;2.50.  ***Tax Obligations*** means any United States and non-United States federal, state, and/or
 local taxes, including income tax, social insurance contributions, fringe benefit tax, employment
 tax, stamp tax, and any employer tax liability which has been transferred to a Participant,
 for which a Participant is liable in connection with Awards and/or Shares.

&nbsp;&nbsp;&nbsp;&nbsp;2.51.  ***Termination of Service*** means the time at which a Participant has terminated from all service
 with the Company and its Affiliates, for any reason. A Termination of Service shall occur
 when a Participant is no longer a Consultant, Employee, or Non-Employee Director. The Company,
 in its sole discretion, shall make all determinations regarding whether a Termination of
 Service has occurred.

**3.**  **<u>Eligibility</u>** 

Service Providers are eligible to receive Awards pursuant to the Plan, subject to the Plan's conditions and limitations. No Service Provider shall have any right to be granted an Award pursuant to the Plan, and neither the Company nor the Administrator is obligated to treat Service Providers, Participants, or other persons uniformly.

**4.**  **<u>Administration</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;4.1. <u>Generally</u>.
 The Plan will be administered by the Administrator. The Administrator is authorized, subject
 to the provisions of the Plan, to establish such rules and regulations as it deems necessary
 for the proper administration of the Plan and to make such determinations and interpretations,
 and to take such action in connection with the Plan and any benefits granted hereunder as
 it deems necessary or advisable. Without limiting the foregoing, the Administrator shall
 have the sole discretion to (i) designate Participants; (ii) determine the type or types
 of Awards to be granted to a Participant; (iii) determine the number of Shares to be covered
 by, or with respect to which payments, rights, or other matters are to be calculated in connection
 with, Awards; (iv) determine the terms and conditions of any Award; (v) determine whether,
 to what extent, and under what circumstances Awards may be settled or exercised in cash,
 Shares, other securities, other Awards or other property, or canceled, forfeited, or suspended,
 and the method or methods by which Awards may be settled, exercised, canceled, forfeited,
 or suspended; (vi) determine whether, to what extent, and under what circumstances the delivery
 of cash, Shares, other securities, other Awards or other property and other amounts payable
 with respect to an Award shall be made; (vii) interpret, administer, reconcile any inconsistency
 in, settle any controversy regarding, correct any defect in and/or complete any omission
 in this Plan and any instrument or agreement relating to, or Award granted under, this Plan;
 (viii) establish, amend, suspend, or waive any rules and regulations and appoint such agents
 as the Administrator shall deem appropriate for the proper administration of this Plan; (ix)
 accelerate the vesting or exercisability of, payment for or lapse of restrictions on, Awards;
 (x) to reprice existing Awards or to grant Awards in connection with or in consideration
 of the cancellation of an outstanding Award with a higher price; and (xi) make any other
 determination and take any other action that the Administrator deems necessary or desirable
 for the administration of the Plan. All determinations and interpretations made by the Administrator
 shall be binding and conclusive on all Participants and their legal representatives.

&nbsp;&nbsp;&nbsp;&nbsp;4.2. <u>Delegation</u>.
 The Board or a Committee may delegate its powers and authorities to one or more Committees
 or officers of the Company, provided, however, that no officer of the Company or any Subsidiary
 may be delegated authority to grant, amend, modify, make any administrative determination
 to, or cancel any Awards held by either (A) any person subject to Section 16 of the Exchange
 Act or (B) an officer who has been delegated any authority under the Plan. All delegations
 shall be subject to terms and conditions determined by the Board or a Committee. Any delegation
 of authority under the Plan may be revoked at any time. Regardless of any delegation, the
 Board or a Committee may act as the Administrator at any time in accordance with Applicable
 Law.

&nbsp;&nbsp;&nbsp;&nbsp;4.3. <u>Liability</u>.
 Neither the Administrator nor any employee of the Company shall be liable for any act or
 failure to act hereunder, except in circumstances involving his or her bad faith, gross negligence,
 or willful misconduct, or for any act or failure to act hereunder by any other member or
 employee or by any agent to whom duties in connection with the administration of this Plan
 have been delegated. The Company shall indemnify members of the Administrator and any agent
 of the Administrator who is an employee of the Company, a Subsidiary, or an Affiliate against
 any and all liabilities or expenses to which they may be subjected by reason of any act or
 failure to act with respect to their duties on behalf of the Plan, except in circumstances
 involving such person's bad faith, gross negligence or willful misconduct.

&nbsp;&nbsp;&nbsp;&nbsp;4.4. <u>Administrative Delegation and Reliance</u>. The Administrator may delegate to one or more of its members,
 or to one or more agents, such administrative duties as it may deem advisable, and the Administrator,
 or any person to whom it has delegated duties as aforesaid, may employ one or more persons
 to render advice with respect to any responsibility the Administrator or such person may
 have under the Plan. The Administrator may employ such legal or other counsel, consultants,
 and agents as it may deem desirable for the administration of the Plan and may rely upon
 any opinion or computation received from any such counsel, consultant, or agent.

**5.**  **<u>Plan Limits</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;5.1. <u>Number of Shares Available for Issuance</u>. Subject to the provisions of Section 11, the maximum
 aggregate number of Shares that may be issued under the Plan shall be the sum of (A) 10%
 of the issued and outstanding Shares as of the Closing, plus (B) an increase commencing on
 January 1, 2027 and continuing annually on each anniversary thereof through and including
 January 1, 2036, equal to the lesser of (i) 3% of the Shares issued and outstanding on the
 last day of the immediately preceding calendar year and (ii) such smaller number of Shares
 as determined by the Board or the Committee (the "  ***Share Limit*** ").
 The Shares subject to the Plan may be authorized, but unissued, or reacquired shares.

&nbsp;&nbsp;&nbsp;&nbsp;5.2. <u>Share Recycling</u>. Upon payment in Shares pursuant to the exercise or settlement of an Award,
 the number of Shares available for issuance under the Plan shall be reduced only by the number
 of Shares actually issued in such payment. If a Participant pays the exercise price (or purchase
 price, if applicable) of an Award through the tender of Shares, or if the Shares are tendered
 or withheld to satisfy any tax withholding obligations, the number of Shares so tendered
 or withheld shall again be available for issuance pursuant to future Awards under the Plan,
 although such Shares shall not again become available for issuance as Incentive Stock Options.
 Shares shall not be deemed to have been issued pursuant to the Plan with respect to any portion
 of an Award that is settled in cash. If any outstanding Award expires or is terminated or
 canceled without having been exercised or settled in full, or if the Shares acquired pursuant
 to an Award subject to forfeiture or repurchase are forfeited or repurchased by the Company,
 the Shares allocable to the terminated portion of such Award or such forfeited or repurchased
 Shares shall again be available for grant under the Plan.

&nbsp;&nbsp;&nbsp;&nbsp;5.3. <u>Incentive Stock Option Limit</u>. No more than 20% of the issued and outstanding Shares as of the Closing
 (subject to adjustment pursuant to Section 11) may be issued under the Plan upon the exercise
 of Incentive Stock Options.

&nbsp;&nbsp;&nbsp;&nbsp;5.4. <u>Substitute Awards</u>. Substitute Awards shall not be counted against the Share Limit; provided, however,
 that Substitute Awards issued in connection with the assumption of, or in substitution for,
 outstanding Options intended to qualify as Incentive Stock Options shall be counted against
 the Incentive Stock Option limit in Section 5.3. Additionally, Shares subject to Substitute
 Awards shall not be added to the Shares available for Awards under the Plan pursuant to Section
 5.2. If the Company or any Subsidiary acquires or combines with a company that has shares
 available under an equity plan approved by shareholders and in place prior to such acquisition
 or combination (and not adopted in contemplation of such acquisition or combination), the
 available shares under the acquired or combined entity's plan (as appropriately adjusted
 to reflect the transaction) may be used for Awards under the Plan and shall not count against
 the Share Limit (and Shares subject to such Awards may again become available for Awards
 under the Plan as provided in Section 5.2). Awards made from the available shares of an acquired
 or combined entity's plan shall not be made after the date awards or grants could not
 be under the terms of the acquired or combined entity's plan prior to the acquisition
 or combination, and shall only be made to individuals who were not Service Providers prior
 to such acquisition or combination. Substitute Awards may be granted on such terms and conditions
 as the Administrator deems appropriate.

&nbsp;&nbsp;&nbsp;&nbsp;5.5. <u>Non-Employee Director Award Limit</u>. Notwithstanding any provision to the contrary in the Plan or in
 any policy of the Company regarding Non-Employee Director compensation, the sum of the grant
 date fair value (determined as of the grant date in accordance with Financial Accounting
 Standards Board Accounting Standards Codification Topic 718, or any successor thereto) of
 all equity-based Awards and the maximum amount that may become payable pursuant to all cash-based
 Awards that may be granted to a Service Provider as compensation for services as a Non-Employee
 Director during any calendar year shall not exceed $950,000 for such Service Provider's
 first year of service as a Non-Employee Director and $700,000 for each year thereafter.

**6.**  **<u>Options and Stock Appreciation Rights</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;6.1. <u>General</u>.
 The Administrator, at any time and from time to time, may grant Options or Stock Appreciation
 Rights under the Plan to Service Providers. Each Option or Stock Appreciation Right shall
 be subject to such terms and conditions consistent with the Plan as the Administrator may
 impose from time to time, subject to the limitations in this Section 6. Any Option or Stock
 Appreciation Rights granted hereunder will be exercisable according to the terms of the Plan
 and at such times and under such conditions as determined by the Administrator and set forth
 in the Award Agreement. Exercising an Option or Stock Appreciation Right in any manner will
 decrease the number of Shares thereafter available for purchase under the Option or Stock
 Appreciation Right, by the number of Shares as to which the Option or Stock Appreciation
 Right is exercised.

&nbsp;&nbsp;&nbsp;&nbsp;6.2. <u>Exercise Price</u>. The per share exercise price for Shares to be issued pursuant to exercise of an
 Option or Stock Appreciation Right will be determined by the Administrator; provided, however,
 that to avoid the imposition of taxes under Section 409A, the exercise price per Share shall
 be no less than one hundred percent (100%) of the Fair Market Value per Share on the date
 of grant, subject to Section 5.4. In the case of an Option or Stock Appreciation Right that
 is a Substitute Award, the exercise price for Shares subject to such Option or Stock Appreciation
 Right may be less than the Fair Market Value per Share on the date of grant; provided that
 the exercise price of any Substitute Award shall be determined in accordance with the applicable
 requirements of Code Sections 424 and 409A.

&nbsp;&nbsp;&nbsp;&nbsp;6.3. <u>Exercise Period</u>. Options and Stock Appreciation Rights shall be exercisable at such time or times
 and subject to such terms and conditions as shall be determined by the Administrator; provided,
 however, that no Option or Stock Appreciation Right shall be exercisable later than ten (10)
 years after the date it is granted. No portion of an Option or Stock Appreciation Right which
 is unexercisable at a Participant's Termination of Service shall thereafter become
 exercisable and the portion of an Option or Stock Appreciation Right which is unexercisable
 at a Participant's Termination of Service shall automatically expire on the date of
 such Termination of Service. Options and Stock Appreciation Rights granted to an Employee
 who is a non-exempt employee for purposes of overtime pay under the United States Fair Labor
 Standards Act of 1938 shall not become exercisable earlier than six months after its date
 of grant. Options and Stock Appreciation Rights shall terminate at such earlier times and
 upon such conditions or circumstances as the Administrator shall in its discretion set forth
 in such Award Agreement at the date of grant; provided, however, the Administrator may, in
 its sole discretion, later waive any such condition. If, prior an Option's or Stock
 Appreciation Right's exercise and prior to its termination, a Participant commits an
 act of Cause (to be determined by the Administrator), or violates a Restrictive Covenant,
 the Administrator may terminate the Participant's right to exercise the Option or Stock
 Appreciation Right when it reasonably believes that the Participant may have participated
 in such act or violation.

&nbsp;&nbsp;&nbsp;&nbsp;6.4. <u>Exercise</u>.
 Options and Stock Appreciation Rights may be exercised by delivering to the Company (or such
 other person or entity designated by the Administrator) a notice of exercise, in a form and
 manner the Company approves, which may be written or electronic, signed or authenticated
 by the person authorized to exercise the Option or Stock Appreciation Right, together with,
 as applicable, (a) payment in full of the exercise price for the number of Shares for which
 the Option is exercised in a manner consistent with Section 6.5 and (b) satisfaction in full
 of any withholding obligations for Tax Obligations in a manner specified in Section 12.5.
 The Administrator may, in its discretion, require that any partial exercise of an Option
 or Stock Appreciation Right be with respect to a minimum number of Shares.

&nbsp;&nbsp;&nbsp;&nbsp;6.5. <u>Payment Upon Exercise</u>. To the extent permitted by Applicable Law, the Participant may pay the
 Option exercise price by cash, wire transfer, or check and, if approved by the Administrator,
 as determined in its sole discretion, by the following methods:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5.1. surrender
 of other Shares that meet the conditions established by the Administrator to avoid adverse
 accounting consequences to the Company (as determined by the Administrator);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5.2. by
 a broker-assisted cashless exercise in accordance with procedures approved by the Administrator,
 whereby payment of the exercise price may be satisfied, in whole or in part, with Shares
 subject to the Option by delivery of an irrevocable direction to a securities broker (on
 a form prescribed by the Administrator) to sell Shares and to deliver all or part of the
 sale proceeds to the Company in payment of the aggregate exercise price;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5.3. for
 a Nonqualified Option, by delivery of a notice of "net exercise" to the Company,
 pursuant to which the Participant shall surrender Shares then issuable upon the Nonqualified
 Option's exercise valued at their Fair Market Value on the exercise date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5.4. such
 other consideration and method of payment for the issuance of Shares to the extent permitted
 by Applicable Law;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5.5. any
 combination of the foregoing methods of payment.

&nbsp;&nbsp;&nbsp;&nbsp;6.6. <u>Incentive Stock Options</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6.1. Each
 Option will be designated in the Award Agreement as either an Incentive Stock Option or a
 Nonqualified Option. However, notwithstanding such designation, to the extent that the aggregate
 Fair Market Value of the Shares with respect to which Incentive Stock Options are exercisable
 for the first time by the Participant during any calendar year (under all plans of the Company,
 its Parent, or any Subsidiary) exceeds $100,000 (or such other limit established in the Code),
 such Options will be treated as Nonqualified Options. For purposes of this Section 6.6.1,
 Incentive Stock Options will be taken into account in the order in which they were granted.
 The Fair Market Value of the Shares will be determined as of the time the Option is granted.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6.2. In
 the case of an Incentive Stock Option, the exercise price will be determined by the Administrator,
 but shall be no less than one hundred percent (100%) of the Fair Market Value per Share on
 the date of grant. The term of any Incentive Stock Option will be ten (10) years from the
 date of grant or such shorter term as may be provided in the Award Agreement. Moreover, in
 the case of an Incentive Stock Option granted to a Greater Than 10% Shareholder, the term
 of the Incentive Stock Option will be five (5) years from the date of grant or such shorter
 term as may be provided in the Award Agreement and the exercise price shall not be less than
 one hundred ten percent (110%) of the Fair Market Value per Share on the date of grant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6.3. No
 Option shall be treated as an Incentive Stock Option unless this Plan has been approved by
 the shareholders of the Company in a manner intended to comply with the shareholder approval
 requirements of Code Section 422(b)(1), provided that any Option intended to be an Incentive
 Stock Option shall not fail to be effective solely on account of a failure to obtain such
 approval, but rather such Option shall be treated as a Nonqualified Option unless and until
 such approval is obtained.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6.4. In
 the case of an Incentive Stock Option, the terms and conditions of such grant shall be subject
 to and comply with such rules as may be prescribed by Code Section 422. If for any reason
 an Option intended to be an Incentive Stock Option (or any portion thereof) shall not qualify
 as an Incentive Stock Option, then, to the extent of such nonqualification, such Option or
 portion thereof shall be regarded as a Nonqualified Option appropriately granted under this
 Plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6.5. By
 accepting an Incentive Stock Option, the Participant agrees to give prompt notice to the
 Company of dispositions or other transfers (other than in connection with a Change in Control)
 of Shares acquired under the Option made within the later of (a) two years from the grant
 date of the Option or (b) one year after the transfer of such Shares to the Participant,
 specifying the date of the disposition or other transfer and the amount the Participant realized,
 in cash, other property, or other consideration, in such disposition or transfer. Neither
 the Company nor the Administrator will be liable to a Participant, or any other party, if
 an Incentive Stock Option fails or ceases to qualify as an "incentive stock option"
 under Code Section 422. Any Incentive Stock Option or portion thereof that fails to qualify
 as an "incentive stock option" under Code Section 422 for any reason, will be
 a Nonqualified Option.

**7.**  **<u>Restricted Stock</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;7.1. <u>Generally</u>.
 The Administrator, at any time and from time to time, may grant Restricted Stock to Service
 Providers in such amounts as the Administrator, in its sole discretion, will determine, subject
 to the limitations of this Section 7. Each Award of Restricted Stock will be evidenced by
 an Award Agreement that will specify the Period of Restriction and the applicable restrictions,
 the number of Shares granted, and such other terms and conditions as the Administrator, in
 its sole discretion, will determine. Restricted Stock may be awarded in consideration for
 (i) cash, check, bank draft or money order payable to the Company, (ii) past service, or
 (iii) any other form of legal consideration (including future Service) that may be acceptable
 to the Administrator, in its sole discretion, and permissible under Applicable Laws.

&nbsp;&nbsp;&nbsp;&nbsp;7.2. <u>Restrictions; Voting Rights; Transferability</u>. Unless the Administrator determines otherwise, Restricted
 Stock will be held by the Company as escrow agent until the restrictions on such Restricted
 Stock have lapsed. The Administrator, in its discretion, may accelerate the time at which
 any restrictions will lapse or be removed. During the Period of Restriction, a Participant
 holding Restricted Stock may exercise the voting rights applicable to those restricted Shares,
 unless the Administrator determines otherwise. Restricted Stock may not be sold, transferred,
 pledged, assigned, or otherwise alienated or hypothecated until the end of the applicable
 Period of Restriction.

&nbsp;&nbsp;&nbsp;&nbsp;7.3. <u>Dividends and Other Distributions</u>. Except as provided in the Award Agreement, during the Period
 of Restriction, a Participant holding Restricted Stock will be entitled to receive all dividends
 and other distributions paid with respect to such Restricted Stock. If any such dividends
 or distributions are paid in Shares, such Shares will be subject to the same restrictions
 on transferability and forfeitability as the Restricted Stock with respect to which they
 were paid.

&nbsp;&nbsp;&nbsp;&nbsp;7.4. <u>Return of Restricted Stock to the Company</u>. On the date set forth in the Award Agreement, the
 Restricted Stock for which restrictions have not lapsed will be forfeited and will revert
 to the Company and again will become available for grant under the Plan.

&nbsp;&nbsp;&nbsp;&nbsp;7.5. <u>Section 83(b) Election</u>. If a Participant makes an election under Code Section 83(b) to be taxed
 with respect to the Restricted Stock as of the date of transfer of the Restricted Stock rather
 than as of the date or dates upon which such Participant would otherwise be taxable under
 Code Section 83(a), such Participant shall be required to deliver a copy of such election
 to the Company promptly after filing such election with the Internal Revenue Service along
 with proof of the timely filing thereof.

**8.**  **<u>Restricted Stock Units (RSUs)</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;8.1. <u>Generally</u>.
 The Administrator, at any time and from time to time, may grant RSUs under the Plan to Service
 Providers. Each RSU shall be subject to such terms and conditions as are consistent with
 the Plan and as the Administrator may impose from time to time, subject to this Section 8.
 Each Award of RSUs will be evidenced by an Award Agreement that will specify the terms, conditions,
 and restrictions related to the grant, including the number of RSUs and such other terms
 and conditions as the Administrator, in its sole discretion, will determine. A Participant
 holding RSUs will have only the rights of a general unsecured creditor of the Company until
 delivery of Shares, cash, other securities, other property, or a combination of the foregoing.

&nbsp;&nbsp;&nbsp;&nbsp;8.2. <u>Vesting and Other Terms</u>. The Administrator will set vesting criteria in its discretion, which,
 depending on the extent to which the criteria are met, will determine the number of RSUs
 that will be paid out to the Participant. Upon meeting the applicable vesting criteria, the
 Participant will be entitled to receive a payout as determined by the Administrator. Notwithstanding
 the foregoing, at any time after the grant of RSUs, the Administrator, in its sole discretion,
 may reduce or waive any vesting criteria that must be met to receive a payout.

&nbsp;&nbsp;&nbsp;&nbsp;8.3. <u>Form and Timing of Payment</u>. Payment of earned RSUs will be made as soon as practicable after
 the date(s) determined by the Administrator and set forth in the Award Agreement. The Administrator,
 in its sole discretion, may settle earned RSUs in Shares, cash, other securities, other property,
 or a combination of the foregoing. If a cash payment is made in lieu of delivering Shares,
 the amount of such payment shall be equal to the fair market value of the Shares as of the
 date on which the restricted period lapsed with respect to such RSUs, less an amount equal
 to any taxes required to be withheld or paid. The Administrator may provide that RSUs will
 be deferred, on a mandatory basis or at the Participant's election, subject to compliance
 with Applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;8.4. <u>Voting</u>.
 The holders of RSUs shall have no voting rights as the Company's shareholders.

**9.**  **<u>Performance Awards</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;9.1. <u>Generally</u>.
 The Administrator shall have the authority to designate any Award described in Sections 6
 through 8 of the Plan as a Performance Award. Additionally, the Administrator shall have
 the authority to make an award of a cash bonus to any Participant and designate such Award
 as a Performance Award.

&nbsp;&nbsp;&nbsp;&nbsp;9.2. <u>Discretion of Administrator</u>. The Administrator shall have the discretion to establish the terms,
 conditions, and restrictions of any Performance Award. For each performance period, the Administrator
 shall have the sole authority to select the length of such performance period, the types
 of Performance Awards to be granted, the performance criteria that will be used to establish
 the performance goals, and the level(s) of performance which shall result in a Performance
 Award being earned.

&nbsp;&nbsp;&nbsp;&nbsp;9.3. <u>Performance Criteria</u>. The Administrator may establish performance-based conditions for an Award as
 specified in the Award Agreement, which may be based on the attainment of specific levels
 of performance of the Company (and/or one or more Subsidiaries, divisions, business segments
 or operational units, or any combination of the foregoing) and may include, without limitation,
 any of the following: (i) net earnings or net income (before or after taxes); (ii) basic
 or diluted earnings per share (before or after taxes); (iii) revenue or revenue growth (measured
 on a net or gross basis); (iv) gross profit or gross profit growth; (v) operating profit
 (before or after taxes); (vi) return measures (including, but not limited to, return on assets,
 capital, invested capital, equity, or sales); (vii) cash flow (including, but not limited
 to, operating cash flow, free cash flow, net cash provided by operations and cash flow return
 on capital); (viii) financing and other capital raising transactions (including, but not
 limited to, sales of the Company's equity or debt securities); (ix) earnings before
 or after taxes, interest, depreciation and/or amortization; (x) gross or operating margins;
 (xi) productivity ratios; (xii) share price (including, but not limited to, growth measures
 and total shareholder return); (xiii) expense targets; (xiv) margins; (xv) productivity and
 operating efficiencies; (xvi) customer satisfaction; (xvii) customer growth; (xviii) working
 capital targets; (xix) measures of economic value added; (xx) inventory control; (xxi) enterprise
 value; (xxii) sales; (xxiii) debt levels and net debt; (xxiv) combined ratio; (xxv) timely
 launch of new facilities; (xxvi) client retention; (xxvii) employee retention; (xxviii) timely
 completion of new product rollouts; (xxix) cost targets; (xxx) reductions and savings; (xxxi)
 productivity and efficiencies; (xxxii) strategic partnerships or transactions; and (xxxiii)
 personal targets, goals or completion of projects. Any one or more of the performance criteria
 may be used on an absolute or relative basis to measure the performance of the Company and/or
 one or more Subsidiaries as a whole or any business unit(s) of the Company and/or one or
 more Subsidiaries or any combination thereof, as the Administrator may deem appropriate,
 or any of the above performance criteria may be compared to the performance of a selected
 group of comparison or peer companies, or a published or special index that the Administrator,
 in its sole discretion, deems appropriate, or as compared to various stock market indices.
 The Administrator also has the authority to provide for accelerated vesting of any Award
 based on the achievement of performance criteria specified in this paragraph. Any performance
 criteria that are financial metrics, may be determined in accordance with GAAP or may be
 adjusted when established to include or exclude any items otherwise includable or excludable
 under GAAP.

&nbsp;&nbsp;&nbsp;&nbsp;9.4. <u>Modification of Performance Goals</u>. At any time, the Administrator may adjust or modify the calculation
 of a performance goal for a performance period, to appropriately reflect any circumstance
 or event that occurs during a performance period and that in the Administrator's sole
 discretion, warrants adjustment or modification. Adjustments the Administrator may make include
 but are not limited to the following: (i) asset write-downs; (ii) litigation or claim judgments
 or settlements; (iii) the effect of changes in tax laws, accounting principles, or other
 laws or regulatory rules affecting reported results; (iv) any reorganization and restructuring
 programs; (v) unusual and/or infrequently occurring items; (vi) acquisitions or divestitures;
 (vii) discontinued operations; (viii) any other specific unusual or infrequently occurring
 or non-recurring events, or objectively determinable category thereof; (ix) foreign exchange
 gains and losses; and (x) a change in the Company's fiscal year.

&nbsp;&nbsp;&nbsp;&nbsp;9.5. <u>Terms and Conditions to Payment</u>. Except as otherwise provided in an Award Agreement, a Participant
 must be employed by the Company on the last day of a performance period to be eligible to
 vest and receive Shares, cash, or other consideration in respect of a Performance Award for
 such performance period. A Participant shall be eligible to receive payment in respect of
 a Performance Award only to the extent that the performance goals for such period are achieved
 and any other vesting conditions specified in the Participant's Award Agreement are
 satisfied. Following the completion of a performance period, the Administrator shall determine
 whether, and to what extent, the performance goals for the performance period have been achieved
 and determine the number of Shares, cash or other consideration that will be settled pursuant
 to Performance Awards.

&nbsp;&nbsp;&nbsp;&nbsp;9.6. <u>Timing of Award Payments</u>. Except as provided in an Award agreement, Performance Awards granted
 for a performance period shall be paid to Participants as soon as administratively practicable
 following the Administrator's determination in accordance with Section 9.5.

**10.**  **<u>Other Awards</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;10.1. <u>General</u>.
 The Administrator may grant Dividend Equivalents or Other Stock or Cash Based Awards, to
 one or more Service Providers, in such amounts and subject to such terms and conditions as
 are consistent with the Plan.

&nbsp;&nbsp;&nbsp;&nbsp;10.2. <u>Dividend Equivalents</u>. The Administrator may provide that any Award, other than an Option or Stock
 Appreciation Right, may provide a Participant with the right to receive Dividend Equivalents.
 Dividend Equivalents may be paid currently or credited to an account for the Participant,
 settled in cash or Shares and subject to the same restrictions on transferability and forfeitability
 as the Award with respect to which the Dividend Equivalents are granted. The payment of Dividend
 Equivalents shall be specified in the applicable Award Agreement and shall in all cases be
 subject to Applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;10.3. <u>Other Stock or Cash Based Awards</u>. Other Stock-Based Awards may be granted either alone, in
 addition to, or in tandem with, other Awards granted under the Plan and/or cash awards made
 outside of the Plan. The Administrator shall have authority to determine the Service Providers
 to whom and the time or times at which Other Stock-Based Awards shall be made, the amount
 of such Other Stock-Based Awards, and all other conditions of the Other Stock-Based Awards
 including any dividend and/or voting rights. The Administrator may grant Cash Awards in such
 amounts and subject to such performance or other vesting criteria and terms and conditions
 as the Administrator may determine. Cash Awards shall be evidenced in such form as the Administrator
 may determine.

**11.**  **<u>Adjustments; Change in Control</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;11.1. <u>Adjustments</u>.
 In the event that any dividend or other distribution (whether in the form of cash, Shares,
 other securities, or other property), recapitalization, share split, reverse share split,
 reorganization, merger, consolidation, split-up, spin-off, combination, repurchase, or exchange
 of Shares or other securities of the Company, or other change in the corporate structure
 of the Company affecting the Shares occurs such that an adjustment is determined by the Administrator
 (in its sole discretion) to be appropriate in order to prevent dilution or enlargement of
 the benefits or potential benefits intended to be made available under the Plan, then the
 Administrator shall, in such manner as it may deem equitable, adjust (i) the number and class
 of Shares which may be delivered under the Plan (or number and kind of other securities or
 other property); (ii) the number, class and price (including the exercise or strike price
 of Options and SARs) of Shares subject to outstanding Awards, (iii) any applicable performance
 criteria, performance period, and other terms and conditions of outstanding Performance Awards,
 and (iv) the numerical limits in Section 5. Notwithstanding the preceding, the number of
 Shares subject to any Award always shall be a whole number.

&nbsp;&nbsp;&nbsp;&nbsp;11.2. <u>Dissolution or Liquidation</u>. In the event of the proposed dissolution or liquidation of the Company,
 the Administrator will notify each Participant as soon as practicable prior to the effective
 date of such proposed transaction. The Administrator in its discretion may provide for a
 Participant to have the right to exercise an Award, to the extent applicable, until ten (10)
 days prior to such transaction as to all of the Shares covered thereby, including Shares
 as to which the Award would not be vested or otherwise be exercisable. In addition, the Administrator
 may provide that any Company repurchase option or forfeiture rights applicable to any Award
 shall lapse one hundred percent (100%), and that any Award vesting shall accelerate one hundred
 percent (100%), provided the proposed dissolution or liquidation takes place at the time
 and in the manner contemplated. To the extent it has not been previously vested and, if applicable,
 exercised, an Award will terminate immediately prior to the consummation of such proposed
 action.

&nbsp;&nbsp;&nbsp;&nbsp;11.3. <u>Change in Control</u>. In the event of a Change in Control, each outstanding Award shall be assumed
 or an equivalent award substituted by the acquiring or successor corporation or a parent
 of the acquiring or successor corporation. Unless determined otherwise by the Administrator,
 in the event that the successor corporation refuses to assume or substitute an Award, (A)
 the Participant shall fully vest in and have the right to exercise the Award as to all of
 the Shares, including those as to which it would not otherwise be vested or exercisable;
 (B) all applicable restrictions will lapse; and (C) all performance objectives and other
 vesting criteria will be deemed achieved at targeted levels. If an Option or SAR is not assumed
 or substituted in the event of a Change in Control, the Administrator shall notify the Participant
 in writing or electronically that the Option or SAR shall be exercisable, to the extent vested,
 for a period of up to fifteen (15) days from the date of such notice, and the Option or SAR
 shall terminate upon the expiration of such period. For the purposes of this Section 11.3,
 the Award shall be considered assumed if, following the Change in Control, the Award confers
 the right to purchase or receive, for each Share subject to the Award immediately prior to
 the Change in Control, the consideration (whether shares, cash, or other securities or property)
 received in the Change in Control by holders of Shares for each Share held on the effective
 date of the transaction (and if holders were offered a choice of consideration, the type
 of consideration chosen by the holders of a majority of the outstanding Shares); <u>provided</u>, <u>however</u>, that if such consideration received in the Change in Control is not solely
 common shares of the acquiring or successor corporation or its parent, the Administrator
 may, with the consent of the acquiring or successor corporation, provide for the consideration
 to be received, for each Share subject to the Award, to be solely common shares of the acquiring
 or successor corporation or its parent equal in fair market value to the per share consideration
 received by holders of Shares in the Change in Control. Notwithstanding anything herein to
 the contrary, an Award that vests, is earned, or is paid out upon the satisfaction of one
 or more performance goals will not be considered assumed if the Company or the acquiring
 or successor corporation modifies any of such performance goals without the Participant's
 consent; <u>provided</u>, <u>however</u>, that a modification to such performance goals only
 to reflect the acquiring or successor corporation's post-Change in Control corporate
 structure will not be deemed to invalidate an otherwise valid Award assumption. Payments
 under this Section 11.3 may be delayed to the same extent that payment of consideration to
 the holders of Shares in connection with the Change in Control is delayed as a result of
 escrows, earnouts, holdbacks, or any other contingencies.

**12.**  **<u>Provisions Applicable to Awards</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;12.1. <u>Conditions Upon Issuance of Shares</u>. Shares will not be issued pursuant to an Award unless the exercise
 of such Award and the issuance and delivery of such Shares will comply with Applicable Law
 and will be further subject to the approval of counsel for the Company with respect to such
 compliance. As a condition to the exercise or receipt of an Award, the Company may require
 the person exercising or receiving such Award to represent and warrant at the time of any
 such exercise or receipt that the Shares are being purchased only for investment and without
 any present intention to sell or distribute such Shares if, in the opinion of counsel for
 the Company, such a representation is required or desirable.

&nbsp;&nbsp;&nbsp;&nbsp;12.2. <u>Transferability</u>.
 No Award may be sold, assigned, transferred, pledged or otherwise encumbered, either voluntarily
 or by operation of law, except by will or the laws of descent and distribution. Each Participant
 may file with the Administrator a written designation of one or more persons as the beneficiary(ies)
 who shall be entitled to receive the amounts payable with respect to an Award, if any, due
 under this Plan upon his or her death. A Participant may, from time to time, revoke or change
 his or her beneficiary designation without the consent of any prior beneficiary by filing
 a new designation with the Administrator. The last such designation filed with the Administrator
 shall be controlling; provided, however, that no designation, or change or revocation thereof,
 shall be effective unless received by the Administrator prior to the Participant's
 death, and in no event shall it be effective as of a date prior to such receipt. If no beneficiary
 designation is filed by a Participant, the beneficiary shall be deemed to be his or her spouse
 or, if the Participant is unmarried at the time of death, his or her estate. Upon the occurrence
 of a Participant's divorce (as evidenced by a final order or decree of divorce), any
 spousal designation previously given by such Participant shall automatically terminate.

&nbsp;&nbsp;&nbsp;&nbsp;12.3. <u>Documentation</u>.
 All Awards made under the Plan shall be made pursuant to an Award Agreement. The Administrator
 may, in its sole discretion, determine the terms and conditions set forth in each Award Agreement,
 provided that all such terms and conditions are consistent with the Plan.

&nbsp;&nbsp;&nbsp;&nbsp;12.4. <u>Discretion</u>.
 All Awards made pursuant to the Plan may be made alone or in addition to or in conjunction
 with any other Award. The terms of each Award are not required to be identical, and the Administrator
 does not have to treat Participants or Awards uniformly.

&nbsp;&nbsp;&nbsp;&nbsp;12.5. <u>Withholding</u>.
 A Participant shall be required to pay to the Company or any Affiliate, or the Company or
 any Affiliate shall have the right and is hereby authorized to withhold, from any cash, Shares,
 other securities or other property deliverable under any Award or from any compensation or
 other amounts owing to a Participant, the amount (in cash, Shares, other securities or other
 property) of any required withholding taxes, including any Tax Obligations, in respect of
 an Award, its exercise, or any payment or transfer under an Award or under this Plan and
 to take such other action as may be necessary in the opinion of the Administrator or the
 Company to satisfy all obligations for the payment of such withholding and taxes. In addition,
 the Administrator, in its discretion, may make arrangements mutually agreeable with a Participant
 who is not an employee of the Company or an Affiliate to facilitate the payment of applicable
 income and self-employment taxes. Without limitation, the Administrator may, in its sole
 discretion, permit a Participant to satisfy, in whole or in part, the foregoing withholding
 liability by (A) the delivery of Shares (which are not subject to any pledge or other security
 interest) owned by the Participant having a fair market value equal to such withholding liability,
 (B) having the Company withhold from the number of Shares otherwise issuable or deliverable
 pursuant to the exercise or settlement of the Award a number of shares with a fair market
 value equal to such withholding liability, (C) deducting an amount sufficient to satisfy
 such withholding obligation from any payment of any kind otherwise due to a Participant,
 (D) accepting a payment from the Participant in cash, by wire transfer of immediately available
 funds, or by check made payable to the order of the Company, or (E) if there is a public
 market for Shares at the time the withholding obligation for Tax Obligations is to be satisfied,
 selling Shares issued pursuant to the Award creating the withholding obligation. The amount
 withheld pursuant to any of the foregoing payment forms shall be determined by the Company
 and may be up to (but not in excess of) the aggregate amount of such obligations based on
 the maximum statutory withholding rates in the Participant's jurisdiction for all Tax
 Obligations that are applicable to such taxable income.

&nbsp;&nbsp;&nbsp;&nbsp;12.6. <u>Award Modification; Repricing</u>. The Administrator may at any time, and from time to time, amend
 the terms of any one or more Awards without the consent of any Participant; provided, however,
 that the Administrator may not make any amendment which would otherwise constitute an impairment
 of the material rights under any Award unless the Participant consents to such impairment
 in writing. Notwithstanding anything to the contrary in Section 4 and except for an adjustment
 pursuant to Section 11 or a repricing approved by shareholders, in no case may the Administrator
 (i) amend an outstanding Option or Stock Appreciation Right to reduce the exercise price
 of the Award, (ii) cancel, exchange, or surrender an outstanding Option or Stock Appreciation
 Right in exchange for cash or other awards for the purpose of repricing the Award, or (iii)
 cancel, exchange, or surrender an outstanding Option or Stock Appreciation Right in exchange
 for an Option or Stock Appreciation Right with an exercise price that is less than the exercise
 price of the original Award.

&nbsp;&nbsp;&nbsp;&nbsp;12.7. <u>Acceleration</u>.
 The Administrator may at any time provide that any Award will become immediately vested and
 fully or partially exercisable, free of some or all restrictions or conditions, or otherwise
 fully or partially realizable, in each case, subject to Applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;12.8. <u>Fractional Shares</u>. No fractional Shares shall be issued or delivered pursuant to the Plan. The Administrator
 shall determine whether cash, additional Awards, or other property shall be issued or paid
 in lieu of fractional Shares or whether any fractional Shares should be rounded, forfeited,
 or otherwise eliminated.

**13.**  **<u>Section 409A</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;13.1. <u>General</u>.
 The Plan is intended to comply with Section 409A to the extent subject thereto, and shall
 be interpreted and administered to be in compliance therewith. Any payments described in
 the Plan that are due within the "short-term deferral period" (as defined in
 Section 409A) shall not be treated as deferred compensation unless Applicable Law requires
 otherwise. Notwithstanding anything in the Plan or any Award Agreement to the contrary, the
 Administrator may, without a Participant's consent, amend this Plan or any Award, adopt
 policies and procedures, make corrective filings, or take any other actions (including amendments
 and retroactive actions) as are necessary or appropriate to preserve the intended tax treatment
 of Awards, including exempting the Plan and Awards from Section 409A or complying with 409A.

&nbsp;&nbsp;&nbsp;&nbsp;13.2. <u>Payments to Specified Employees</u>. Notwithstanding anything in the Plan or an Award Agreement to
 the contrary, any payment or settlement made pursuant to an Award to a "specified employee"
 (as defined by Section 409A and as determined by the Administrator) due to such Participant's
 "separation from service" (as defined by Section 409A) will, to the extent necessary
 to avoid adverse tax consequences to the Participant, be delayed for the six-month period
 immediately following such "separation from service (or, if earlier, on the "specified
 employee's" death) and will instead be paid on the day immediately following
 such six-month period or as soon as practicable thereafter. Any delayed payment under this
 Section 13.2 shall not accrue interest during the delay. All payments of "nonqualified
 deferred compensation" (as defined by Section 409A) that are scheduled to be paid more
 than six months following a "specified employee's" termination, shall be
 made on their regular schedule.

&nbsp;&nbsp;&nbsp;&nbsp;13.3. <u>Change in Control</u>. If any Award is or becomes subject to Code Section 409A and if payment of
 such Award would be accelerated or otherwise triggered under a Change in Control, then the
 definition of Change in Control shall be deemed modified, only to the extent necessary to
 avoid the imposition of an excise tax under Code Section 409A, to mean a "change in
 control event" as such term is defined for purposes of Code Section 409A.

**14.**  **<u>Amendment of the Plan</u>** 

The Board may at any time amend, alter, suspend, or terminate the Plan. The Company may obtain shareholder approval of any Plan amendment to the extent necessary or, as determined by the Administrator in its sole discretion, desirable to comply with Applicable Law, including any amendment that (i) increases the number of Shares available for issuance under the Plan or (ii) changes the persons or class of persons eligible to receive Awards. No amendment, alteration, suspension, or termination of the Plan will materially impair the rights of any Participant with respect to outstanding Awards, unless mutually agreed otherwise between the Participant and the Administrator, which agreement must be in writing and signed by the Participant and the Company. Termination of the Plan will not affect the Administrator's ability to exercise the powers granted to it hereunder with respect to Awards granted under the Plan prior to the date of such termination.

**15.**  **<u>Foreign Participants</u>** 

The Administrator may from time to time establish sub-plans under the Plan for purposes of satisfying securities, tax, or other laws of various jurisdictions in which the Company intends to grant Awards. Any sub-plans shall contain such limitations and other terms and conditions as the Administrator determines are necessary or desirable. All sub-plans shall be deemed a part of the Plan, but each sub-plan shall apply only to the Participants in the jurisdiction for which the sub-plan was designed.

**16.**  **<u>Clawbacks</u>** 

Notwithstanding any other provisions in the Plan, the Administrator may cancel any Award, require reimbursement of any Award, and effect any other right of recoupment of equity or other compensation provided under the Plan in accordance with Company policies, including the Company's Clawback Policies. A Participant may be required to repay to the Company previously paid compensation, whether provided pursuant to the Plan or an Award Agreement, in accordance with the Clawback Policies. By accepting an Award, the Participant agrees to be bound by the Clawback Policies and to adhere to the Clawback Policies to the extent required by Applicable Law.

**17.**  **<u>No Right to Continued Service</u>** 

Nothing in the Plan or any instrument executed or Award granted pursuant thereto shall confer upon any Participant any right to continue to serve the Company or an Affiliate in the capacity in effect at the time the Award was granted or shall affect the right of the Company or an Affiliate to terminate (i) a Participant's employment with or without notice and with or without Cause, or (ii) a Participant's service as a Consultant or Director.

**18.**  **<u>No Rights as a Shareholder</u>** 

Except as provided in the Plan or an Award Agreement, no Participant shall be deemed to be the holder of, or to have any of the rights of a holder with respect to, any Shares subject to such Award unless and until such Participant has satisfied all requirements for exercise of the Award pursuant to its terms and no adjustment shall be made for dividends (ordinary or extraordinary, whether in cash, securities, or other property) or distributions of other rights for which the record date is prior to the date such Share certificates are issued, except as provided in Section 11.

**19.**  **<u>Miscellaneous</u>** 

&nbsp;&nbsp;&nbsp;&nbsp;19.1. <u>Limitations on Liability</u>. Neither the Company, nor its Parent, nor any Subsidiary, nor any person
 serving as Administrator shall have any liability to a Participant in the event an Award
 held by the Participant fails to achieve its intended characterization under the tax, securities,
 or other applicable laws and regulations.

&nbsp;&nbsp;&nbsp;&nbsp;19.2. <u>Inability to Obtain Authority</u>. The inability of the Company to obtain authority from any regulatory
 body having jurisdiction, which authority is deemed by the Company's counsel to be
 necessary to the lawful issuance and sale of any Shares hereunder, will relieve the Company
 of any liability in respect of the failure to issue or sell such Shares as to which such
 requisite authority will not have been obtained.

&nbsp;&nbsp;&nbsp;&nbsp;19.3. <u>Severability</u>.
 Notwithstanding any contrary provision of the Plan or an Award Agreement, if any one or more
 of the provisions (or any part thereof) of this Plan or an Award Agreement shall be held
 invalid, illegal, or unenforceable in any respect, such provision shall be modified so as
 to make it valid, legal, and enforceable, and the validity, legality, and enforceability
 of the remaining provisions (or any part thereof) of the Plan or Award Agreement, as applicable,
 shall not in any way be affected or impaired thereby.

&nbsp;&nbsp;&nbsp;&nbsp;19.4. <u>Governing Documents</u>. The Plan and each Award Agreement evidencing an Award are intended to be read
 together, and together, set forth the complete terms and conditions of each Award. To the
 extent of any contradiction between the Plan and any Award Agreement or other written agreement
 between a Participant and the Company, the Plan will govern unless the Award Agreement or
 other written agreement was approved by the Administrator and expressly provides that a specific
 provision of the Plan will not apply.

&nbsp;&nbsp;&nbsp;&nbsp;19.5. <u>Governing Law</u>. The Plan will be governed by and construed in accordance with the internal laws
 of the State of Delaware, without reference to any choice of law principles.

&nbsp;&nbsp;&nbsp;&nbsp;19.6. <u>Titles and Headings</u>. The titles and headings in the Plan are for purposes of convenience only
 and are not intended to define or limit the construction of the provisions hereof.

&nbsp;&nbsp;&nbsp;&nbsp;19.7. <u>Intended to Comply with Applicable Law</u>. The Plan and all Awards granted hereunder are intended
 to fully comply with Applicable Law. All administrative actions, determinations, and exercises
 of discretion by the Administrator shall comply with Applicable Law.

**20.**  **<u>Shareholder Approval</u>** 

The Plan will be subject to approval by the shareholders of the Company within twelve (12) months after the date the Plan is adopted. Such shareholder approval will be obtained in the manner and to the degree required under Applicable Law. All Awards hereunder are contingent on approval of the Plan by the Company's shareholders. Notwithstanding any other provision of this Plan, if the Plan is not approved by the Company's shareholders within twelve (12) months after the date the Plan is adopted, the Plan and any Awards hereunder shall be automatically terminated.

**21.**  **<u>Effective Date</u>** 

The Plan shall be effective as of ________________ ___, 2026, the date on which the Plan was adopted by the Board (the "***Effective Date***").

Unless terminated earlier under Section 14, this Plan shall terminate on ________ ___, 2036, ten (10) years after the Effective Date.

## Exhibit 10.4

**Exhibit 10.4**

**<u>EMPLOYMENT AGREEMENT</u>**

THIS EMPLOYMENT AGREEMENT (this "***Agreement***"), dated March [__], 2026 (the "***Effective Date***"), is entered into by and between BioVentrix, Inc. (the "***Company***") and David Richmond (the "***Executive***").

WHEREAS, the Company currently employs the Executive pursuant to an offer of employment letter, dated January 15, 2025 (the "***Offer Letter***").

WHEREAS, the Company and the Executive desire to enter into an agreement that embodies the terms of such employment and that supersedes and replaces the Offer Letter, subject to the terms and conditions of this Agreement.

NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. <u>Employment Period</u>. The Company shall employ the Executive pursuant to this Agreement for a term (the "***Employment Period***") commencing on the Effective Date and continuing indefinitely until terminated by either party in accordance with the provisions of Section 3 hereof. As of the Effective Date, the Offer Letter is superseded and replaced in its entirety.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. <u>Terms of Employment</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Position and Duties</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. <u>Role and Responsibilities</u>. During the Employment Period, the Executive shall serve as the Company's Co-CEO, and shall perform such employment duties as are usual and customary for such position. The Executive shall report directly to the Board. At the Company's request, the Executive shall serve the Company and/or its subsidiaries and Affiliates in other capacities in addition to the foregoing, consistent with the Executive's position hereunder. In the event that the Executive, during the Employment Period, serves in any one or more of such additional capacities, the Executive's compensation shall not be increased beyond that specified in Section 2(b) hereof. In addition, in the event the Executive's service in one or more of such additional capacities is terminated, the Executive's compensation, as specified in Section 2(b) hereof, shall not be diminished or reduced in any manner as a result of such termination provided that the Executive otherwise remains employed under the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. <u>Exclusivity</u>. During the Employment Period, the Executive agrees to devote the Executive's full business time and attention to the business and affairs of the Company. Notwithstanding the foregoing, during the Employment Period, it shall not be a violation of the Agreement for the Executive to: (A) serve on boards, committees or similar bodies of charitable or nonprofit organizations, (B) fulfill limited teaching, speaking and writing engagements, and (C) manage the Executive's personal investments, in each case, so long as such activities do not individually or in the aggregate materially interfere or conflict with the performance of the Executive's duties and responsibilities under the Agreement; provided, that with respect to the activities in subclauses (A) and/or (B), the Executive receives prior written approval from the Board.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Compensation, Benefits, Etc</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. <u>Base Salary</u>. Effective as of the Effective Date and during the Employment Period, the Executive shall receive a base salary (the "***Base Salary***") of $309,000 per annum. The Base Salary shall be paid in accordance with the Company's normal payroll practices for executive salaries generally, but no less often than monthly and shall be pro-rated for partial years of employment. The Base Salary may be increased in the discretion of the Board or a subcommittee thereof, but not reduced, and the term "Base Salary" as utilized in this Agreement shall refer to the Base Salary as so increased.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. <u>Annual Cash Bonus</u>. For each calendar year ending during the Employment Period beginning with calendar year 2026, the Executive shall be eligible to earn a cash performance bonus (an "***Annual Bonus***") under the Company's bonus plan or program applicable to senior executives targeted at thirty percent (30%) of Base Salary (the "***Annual Bonus***"). The actual amount of any Annual Bonus shall be determined by the Board (or a subcommittee thereof) in its discretion, based on the achievement of individual and/or Company performance goals as determined by the Board (or a subcommittee thereof), and shall be pro-rated for any partial year of employment or service. The payment of any Annual Bonus, to the extent any Annual Bonus becomes payable, will be made on the date on which annual bonuses are paid generally to the Company's senior executives, but in no event later than March 15th of the calendar year following the calendar year in which such Annual Bonus was earned. In order to be eligible for the Annual Bonus, the Executive must be in Active Working Status at the time the Annual Bonus is paid.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. <u>Annual Equity Grant</u>. The Executive shall be eligible to receive equity-based compensation award(s), as determined by the Board (or a subcommittee thereof), for each calendar year during the Employment Period. The Board or such subcommittee shall determine in its sole discretion the grant timing, vesting requirements, mix, and such other terms and conditions (including exercise and settlement) applicable to any annual equity-based compensation award, taking into account the Executive's and the Company's performance. Any such award shall be evidenced by a separate award agreement in a form prescribed by the Company, to be entered into by the Company and the Executive.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. <u>Benefits</u>. During the Employment Period, the Executive (and the Executive's spouse and/or eligible dependents to the extent provided in the applicable plans and programs) shall be eligible to participate in and be covered under the health and welfare benefit plans and programs maintained by the Company for the benefit of its employees from time to time, pursuant to the terms of such plans and programs including any medical, life, hospitalization, dental, disability, accidental death and dismemberment and travel accident insurance plans and programs on the same terms and conditions as those applicable to similarly situated senior executives. In addition, during the Employment Period, the Executive shall be eligible to participate in any retirement, savings and other employee benefit plans and programs maintained from time to time by the Company for the benefit of its senior executive officers. Nothing contained in this Section 2(b)(v) shall create or be deemed to create any obligation on the part of the Company to adopt or maintain any health, welfare, retirement or other benefit plan or program at any time or to create any limitation on the Company's ability to modify or terminate any such plan or program.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;v. <u>Expenses</u>. During the Employment Period, the Executive shall be entitled to receive prompt reimbursement for all reasonable business expenses incurred by the Executive in connection with the performance of the Executive's duties under this Agreement in accordance with the policies, practices and procedures of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;vi. <u>Fringe Benefits</u>. During the Employment Period, the Executive shall be eligible to receive such fringe benefits and perquisites as are provided by the Company to its employees from time to time, in accordance with the policies, practices and procedures of the Company, and shall receive such additional fringe benefits and perquisites as the Company may, in its discretion, from time-to-time provide to its senior executive officers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;vii. <u>Vacation</u>. During the Employment Period, the Executive shall be eligible for a maximum of fifteen (15) vacation days per calendar year, to be taken at such times as approved by the Company, and shall accrue at the rate of 1.25 days per month that the Executive is employed in a calendar year. Accrued but unused vacation days in excess of ten (10) may not be carried over into the following year, and the Executive will not receive pay in lieu of taking vacation. All vacations shall be taken in accordance with the plans, policies, programs, and practices of the Company applicable to its employees, as in effect from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. <u>Termination of Employment</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Death or Disability</u>. The Executive's employment shall terminate automatically upon the Executive's death during the Employment Period. Either the Company or the Executive may terminate the Executive's employment in the event of the Executive's Disability during the Employment Period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Termination by the Company</u>. The Company may terminate the Executive's employment during the Employment Period for Cause or without Cause.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. <u>Termination by the Executive</u>. The Executive's employment may be terminated by the Executive for any or no reason, including with Good Reason or by the Executive without Good Reason.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. <u>Notice of Termination</u>. Any termination of employment other than due to the Executive's death, shall be communicated by a Notice of Termination to the other party hereto given in accordance with Section 12(b) hereof. The failure by the Executive or the Company to set forth in the Notice of Termination any fact or circumstance which contributes to a showing of Good Reason or Cause shall not waive any right of the Executive or the Company, respectively, hereunder or preclude the Executive or the Company respectively, from asserting such fact or circumstance in enforcing the Executive's or the Company's rights hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. <u>Termination of Offices and Directorships; Return of Property</u>. Upon termination of the Executive's employment for any reason, unless otherwise specified in a written agreement between the Executive and the Company, the Executive shall be deemed to have resigned from all offices, directorships, and other employment positions if any, then held with the Company, and shall take all actions reasonably requested by the Company to effectuate the foregoing. In addition, upon the termination of the Executive's employment for any reason, the Executive agrees to return to the Company all documents of the Company and its Affiliates (and all copies thereof) and all other Company or Company Affiliate property that the Executive has in Executive's possession, custody or control. Such property includes, without limitation: (i) any materials of any kind that the Executive knows contain or embody any proprietary or confidential information of the Company or an Affiliate of the Company (and all reproductions thereof), (ii) computers (including, but not limited to, laptop computers, desktop computers and similar devices) and other portable electronic devices (including, but not limited to, tablet computers), cellular phones/smartphones, credit cards, phone cards, entry cards, identification badges and keys, and (iii) any correspondence, drawings, manuals, letters, notes, notebooks, reports, programs, plans, proposals, financial documents, or any other documents concerning the customers, business plans, marketing strategies, products and/or processes of the Company or any of its Affiliates and any information received from the Company or any of its Affiliates regarding third parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. <u>Obligations of the Company Upon Termination</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Accrued Obligations</u>. In the event that the Executive's employment under this Agreement terminates during the Employment Period for any reason, the Company will pay or provide to the Executive: (i) any earned but unpaid Base Salary, (ii) reimbursement of any business expenses incurred by the Executive prior to the Date of Termination that are reimbursable in accordance with Section 2(b)(v) hereof, and (iii) any vested amounts due to the Executive under any plan, program or policy of the Company (together, the "***Accrued Obligations***"). The Accrued Obligations described in clauses (i) – (ii) of the preceding sentence shall be paid within 30 days after the Date of Termination (or such earlier date as may be required by applicable law), and the Accrued Obligations described in clause (iii) of the preceding sentence shall be paid in accordance with the terms of the governing plan or program.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Qualifying Termination</u>. Subject to Sections 4(c), 12(c) and 12(e), and the Executive's continued compliance with the provisions of Section 7 hereof, if the Executive's employment with the Company is terminated during the Employment Period due to a Qualifying Termination, then in addition to the Accrued Obligations, the Company shall pay the Executive:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. *Cash Severance*. The Company shall pay the Executive an amount equal to one (1.0) times the Executive's Base Salary, as in effect on the Date of Termination (the "***Severance***"). The Severance shall be paid in substantially equal installments in accordance with the Company's normal payroll practices over the twelve- (12-) month period following the Date of Termination, but shall commence on the first normal payroll date following the Release Effective Date, and amounts otherwise payable prior to such first payroll date shall be paid on such date without interest thereon.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. *COBRA*. Subject to the Executive's valid election to continue healthcare coverage under Section 4980B of the Code, the Company shall continue to provide, during the COBRA Period, the Executive and the Executive's eligible dependents with coverage under its group health plans at the same levels as would have applied if the Executive's employment had not been terminated based on the Executive's elections in effect on the Date of Termination at no cost to the Executive, provided, however, that (A) if any plan pursuant to which such benefits are provided is not, or ceases prior to the expiration of the period of continuation coverage to be, exempt from the application of Section 409A under Treasury Regulation Section 1.409A-1(a)(5), or (B) the Company is otherwise unable to continue to cover the Executive under its group health plans without incurring penalties (including without limitation, pursuant to Section 2716 of the Public Health Service Act or the Patient Protection and Affordable Care Act), then, in either case, an amount equal to each remaining Company contribution shall thereafter be paid to the Executive in substantially equal monthly installments over the continuation coverage period (or the remaining portion thereof). For purposes of this Agreement, "***COBRA Period***" shall mean the period beginning on the Date of Termination and ending on the first anniversary thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. <u>Release</u>. Notwithstanding the foregoing, it shall be a condition to the Executive's right to receive the amounts provided for in Sections 4(b) hereof that the Executive execute and deliver to the Company an effective release of claims in substantially the form attached hereto as Exhibit A (the "***Release***") and the Release becomes irrevocable within 30 days (or, to the extent required by law, 52 days) following the Date of Termination (the date such Release becomes irrevocable herein referred to as the "***Release Effective Date***").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. <u>Other Terminations</u>. If the Executive's employment is terminated for any reason not described in Sections 4(b) hereof, the Company will pay the Executive only the Accrued Obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. <u>Exclusive Benefits</u>. Except as expressly provided in this Section 4 and subject to Section 5 hereof, the Executive shall not be entitled to any additional payments or benefits upon or in connection with the Executive's termination of employment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. <u>Non-Exclusivity of Rights</u>. Amounts which are vested benefits or which the Executive is otherwise entitled to receive under any plan, policy, practice or program of or any contract or agreement with the Company at or subsequent to the Date of Termination shall be payable in accordance with such plan, policy, practice or program or contract or agreement except as explicitly modified by this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. <u>Excess Parachute Payments; Limitation on Payments</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Best Pay Cap</u>. Notwithstanding any other provision of this Agreement, in the event that any payment or benefit received or to be received by the Executive (including any payment or benefit received in connection with a termination of the Executive's employment, whether pursuant to the terms of this Agreement or any other plan, arrangement or agreement) (all such payments and benefits, including the payments and benefits under Section 4 hereof, being hereinafter referred to as the "***Total Payments***") would be subject (in whole or part), to the excise tax imposed under Section 4999 of the Code (the "***Excise Tax***"), then, the Total Payments shall be reduced, to the extent necessary so that no portion of the Total Payments is subject to the Excise Tax but only if (i) the net amount of such Total Payments, as so reduced (and after subtracting the net amount of federal, state and local income taxes on such reduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such reduced Total Payments) is greater than or equal to (ii) the net amount of such Total Payments without such reduction (but after subtracting the net amount of federal, state and local income taxes on such Total Payments and the amount of Excise Tax to which the Executive would be subject in respect of such unreduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such unreduced Total Payments). If the Total Payments are so reduced, the Company shall reduce or eliminate the Total Payments (A) by first reducing or eliminating the portion of the Total Payments which are not payable in cash (other than that portion of the Total Payments subject to clause (C) hereof), (B) then by reducing or eliminating cash payments (other than that portion of the Total Payments subject to clause (C) hereof) and (C) then by reducing or eliminating the portion of the Total Payments (whether payable in cash or not payable in cash) to which Treasury Regulation § 1.280G-1 Q/A 24(c) (or successor thereto) applies, in each case in reverse order beginning with payments or benefits which are to be paid the farthest in time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Certain Exclusions</u>. For purposes of determining whether and the extent to which the Total Payments will be subject to the Excise Tax, (i) no portion of the Total Payments the receipt or enjoyment of which the Executive shall have waived at such time and in such manner as not to constitute a "payment" within the meaning of Section 280G(b) of the Code shall be taken into account; (ii) no portion of the Total Payments shall be taken into account which, in the written opinion of an independent, nationally recognized accounting firm (the "***Independent Advisors***") selected by the Company, does not constitute a "parachute payment" within the meaning of Section 280G(b)(2) of the Code (including by reason of Section 280G(b)(4)(A) of the Code) and, in calculating the Excise Tax, no portion of such Total Payments shall be taken into account which, in the opinion of Independent Advisors, constitutes reasonable compensation for services actually rendered, within the meaning of Section 280G(b)(4)(B) of the Code, in excess of the "base amount" (as defined in Section 280G(b)(3) of the Code) allocable to such reasonable compensation; and (iii) the value of any non-cash benefit or any deferred payment or benefit included in the Total Payments shall be determined by the Independent Advisors in accordance with the principles of Sections 280G(d)(3) and (4) of the Code.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. <u>Restrictive Covenants</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Confidential and Proprietary Information</u>. The Executive agrees that all materials and items produced or developed by the Executive for the Company or any of its Affiliates, or obtained by the Executive from the Company or any of its Affiliates either directly or indirectly pursuant to this Agreement, shall be and remain the property of the Company and its Affiliates. The Executive acknowledges that the Executive will, during the Executive's association with the Company, acquire, or be exposed to, or have access to, materials, data and information that constitute valuable, confidential and proprietary information of the Company and its Affiliates, including, without limitation, any or all of the following: business plans, practices and procedures, pricing information, sales figures, profit or loss figures, this Agreement and its terms, information relating to customers, clients, intellectual property, suppliers, technology, sources of supply and customer lists, research, technical data, trade secrets or know-how, software, developments, inventions, processes, formulas, technology, designs, drawings, engineering, hardware configuration information, marketing, finances, policies, training manuals and similar materials used by the Company in conducting its business operations, personnel information of any Person employed by the Company, potential business combinations, and such other information or material as the Company may designate as confidential and/or proprietary from time to time (collectively hereinafter, the "***Confidential and Proprietary Information***"). Notwithstanding the foregoing, "Confidential and Proprietary Information" does not include information that is or becomes publicly available, other than information made publicly available by the Executive or another person in violation of the Executive's obligations in this Section 7(a). During the Executive's employment with the Company and at all times thereafter, the Executive shall not, directly or indirectly, use, misuse, misappropriate, disclose or make known, without the prior written approval of the Board, to any party, firm, corporation, association or other entity any such Confidential and Proprietary Information for any reason or purpose whatsoever, except as may be required in the course of the Executive's performance of the Executive's duties hereunder. In consideration of the unique nature of the Confidential and Proprietary Information, all obligations pertaining to the confidentiality and nondisclosure thereof shall remain in effect until the Company and its Affiliates have released such information; provided that the provisions of this Section 7(a) shall not apply to the disclosure of Confidential and Proprietary Information to the Company's Affiliates together with each of their respective shareholders, directors, officers, accountants, lawyers and other representatives or agents in furtherance of the Executive's duties hereunder, nor to a Permitted Disclosure. In addition, it shall not be a breach of the confidentiality obligations hereof if the Executive is required by applicable law to disclose any Confidential and Proprietary Information; provided that in such case, the Executive shall (x) give the Company the earliest notice possible that such disclosure is or may be required and (y) cooperate with the Company, at the Company's expense, in protecting to the maximum extent legally permitted, the confidential or proprietary nature of the Confidential and Proprietary Information which must be so disclosed. Upon the termination of the Executive's employment, the Executive agrees that all Confidential and Proprietary Information, directly or indirectly, in the Executive's possession that is in writing or other tangible form (together with all duplicates thereof) will promptly (and in any event within 10 days following such termination) be returned to the Company and will not be retained by the Executive or furnished to any person, either by sample, facsimile, film, audio or video cassette, electronic data, verbal communication or any other means of communication.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Inventions</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. The Executive acknowledges and agrees that all ideas, methods, inventions, discoveries, improvements, work products, and developments, whether patentable or unpatentable, (x) that relate to the Executive's work with the Company, made or conceived by the Executive, solely or jointly with others, prior to or during the Employment Period, or (y) suggested by any work that the Executive performs in connection with the Company, either while performing the Executive's duties with the Company or on the Executive's own time, but only insofar as such ideas, methods, inventions, discoveries, improvements, work products, and developments are related to the Executive's work as an employee or other service provider to the Company (the "***Inventions***"), shall belong exclusively to the Company (or its designee), whether or not patent applications are filed thereon. The Executive will keep full and complete written records (the "***Records***"), in the manner prescribed by the Company of all Inventions and will promptly disclose all Inventions completely and in writing to the Company. The Records shall be the sole and exclusive property of the Company and the Executive will surrender them upon the termination of the Employment Period, or upon the Company's request. The Executive hereby assigns to the Company the Inventions and all patents that may be issued thereon in any and all countries, whether prior to, during or subsequent to the Employment Period, together with the right to file, in the Executive's name or in the name of the Company (or its designee), applications for patents and equivalent rights (the "***Applications***"). The Executive will, at any time during and subsequent to the Employment Period, make such applications, sign such papers, take all rightful oaths, and perform all acts as may be requested from time to time by the Company with respect to the Inventions. The Executive will also execute assignments to the Company (or its designee), of the Applications, and give the Company and its attorneys all reasonable assistance (including the giving of testimony) to obtain the Inventions for its benefit, all without additional compensation to the Executive from the Company but entirely at the Company's expense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. In addition, the Inventions will be deemed Work for Hire, as such term is defined under the copyright law of the United States, on behalf of the Company and the Executive agrees that the Company will be the sole owner of the Inventions, and all underlying rights therein, in all media now known or hereinafter devised, throughout the universe and in perpetuity, without any further obligations to the Executive. If the Inventions, or any portion thereof, are deemed not to be Work for Hire, the Executive hereby irrevocably conveys, transfers and assigns to the Company all rights, in all media now known or hereinafter devised, throughout the universe and in perpetuity, in and to the Inventions, including, without limitation, all of the Executive's right, title and interest in the copyrights (and all renewals, revivals and extensions thereof) to the Inventions, including, without limitation, all rights of any kind or any nature now or hereafter recognized, including, without limitation, the unrestricted right to make modifications, adaptations and revisions to the Inventions, to exploit and allow others to exploit the Inventions and all rights to sue at law or in equity for any infringement or other unauthorized use or conduct in derogation of the Inventions, known or unknown, prior to the date hereof, including, without limitation, the right to receive all proceeds and damages therefrom. In addition, the Executive hereby waives any so-called "moral rights" with respect to the Inventions. The Executive hereby waives any and all currently existing and future monetary rights in and to the Inventions and all patents that may be issued thereon, including, without limitation, any rights that would otherwise accrue to the Executive's benefit by virtue of the Executive being an employee of or other service provider to the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. Subject to Sections 7(a), nothing in this Section 7(b) will restrict the Executive from the use of concepts, ideas or methods that are generally known by others in the industry, nor shall the Executive be restricted from using the general know-how or experience obtained during employment with the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. Notwithstanding anything in this Agreement to the contrary, nothing contained in this Agreement shall prohibit either party (or either party's attorney(s)) from (i) filing a charge with, reporting possible violations of federal law or regulation to, participating in any investigation by, or cooperating with the U.S. Securities and Exchange Commission, the Financial Industry Regulatory Authority, the Equal Employment Opportunity Commission, the National Labor Relations Board, the Occupational Safety and Health Administration, the U.S. Commodity Futures Trading Commission, the U.S. Department of Justice or any other securities regulatory agency, self-regulatory authority or federal, state or local regulatory authority (collectively, "***Government Agencies***"), or making other disclosures that are protected under the whistleblower provisions of applicable law or regulation, (ii) communicating directly with, cooperating with, or providing information (including trade secrets) in confidence to any Government Agencies for the purpose of reporting or investigating a suspected violation of law, or from providing such information to such party's attorney(s) or in a sealed complaint or other document filed in a lawsuit or other governmental proceeding, and/or (iii) receiving an award for information provided to any Government Agency. Pursuant to 18 USC Section 1833(b), (1) the Executive will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made: (x) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and solely for the purpose of reporting or investigating a suspected violation of law; or (y) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal and (2) the Executive acknowledges that an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual files any document containing the trade secret under seal and does not disclose the trade secret, except pursuant to court order. All disclosures permitted under this Section 7(c) are herein referred to as "***Permitted Disclosures***." Further, nothing in this Agreement is intended to or shall preclude either party from providing truthful testimony in response to a valid subpoena, court order, regulatory request or other judicial, administrative or legal process or otherwise as required by law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. <u>Representations</u>. The Executive hereby represents and warrants to the Company that (a) the Executive is entering into this Agreement voluntarily and that the performance of the Executive's obligations hereunder will not violate any agreement between the Executive and any other person, firm, organization or other entity, or any policy, program or code of such other person, firm, organization or other entity person, and (b) the Executive is not bound by the terms of any agreement with any previous employer or other party to refrain from competing, directly or indirectly, with the business of such previous employer or other party that would be violated by the Executive's entering into this Agreement and/or providing services to the Company pursuant to the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. <u>Successors</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. This Agreement is personal to the Executive and, without the prior written consent of the Company, shall not be assignable by the Executive other than by will or the laws of descent and distribution. This Agreement shall inure to the benefit of and be enforceable by the Executive's legal representatives.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. This Agreement shall inure to the benefit of and be binding upon the Company and its respective successors and assigns.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10. <u>Certain Definitions</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. "***Active Working Status***" means the Executive is actively performing work for the Company and has not resigned (or given notice of the Executive's intent to resign) and has not been terminated (or been given notice of the Executive's termination).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. "***Affiliate***" means any entity that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. "***Board***" means the Board of Directors of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. "***Cause***" means the occurrence of any one or more of the following events:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. The Executive's conviction of an act constituting a misdemeanor involving moral turpitude or a felony under federal, state, or local law;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. The Executive's commitment of an act constituting a breach of fiduciary duty, gross negligence or willful misconduct with respect to the Company;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. The Executive's commitment of an act of fraud, self-dealing, or dishonesty with respect to the Company; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. The Executive's engagement in conduct that is materially detrimental to the business, reputation, character, or standing of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. "***Code***" means the Internal Revenue Code of 1986, as amended and the regulations thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;f. "***Date of Termination***" means the date on which the Executive's employment with the Company terminates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;g. "***Disability***" means that the Executive has become entitled to receive benefits under an applicable Company long-term disability plan or, if no such plan covers the Executive, the Executive's inability, due to physical or mental illness, to perform the essential functions of the Executive's job, with or without a reasonable accommodation for 180 consecutive days.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;h. "***Good Reason***" means a decrease in the Executive's Base Salary (unless such decrease is applied to all senior management base salaries on a pro rata basis) without the Executive's prior written consent, unless the Company fully corrects the circumstances constituting Good Reason.

Notwithstanding the foregoing, the Executive will not be deemed to have resigned for Good Reason unless (1) the Executive provides the Company with written notice setting forth in reasonable detail the facts and circumstances claimed by the Executive to constitute Good Reason within 45 days after the date of the occurrence of any event that the Executive knows or should reasonably have known to constitute Good Reason, (2) the Company fails to cure such acts or omissions within 30 days following its receipt of such notice, and (3) the Date of Termination for Good Reason occurs no later than 60 days after the expiration of the Company's cure period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. "***Notice of Termination***" means a written notice which (i) indicates the specific termination provision in this Agreement relied upon, (ii) sets forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive's employment under the provision so indicated and (iii) if the Date of Termination is other than the date of receipt of such notice, specifies the termination date (which date shall be not more than 30 days after the giving of such notice unless as otherwise provided upon a termination for Good Reason).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;j. "***Person***" means an individual, a partnership, a corporation, an association, a limited liability company, a joint stock company, a trust, a joint venture, an unincorporated organization or a governmental entity or any department, agency or political subdivision thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;k. "***Qualifying Termination***" means a termination of the Executive's employment (i) by the Company without Cause (other than by reason of the Executive's death or Disability) or (ii) by the Executive for Good Reason.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;l. ***Section 409A***" means Section 409A of the Code and Department of Treasury regulations and other interpretive guidance issued thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;m. "***Separation from Service***" means a "separation from service" within the meaning of Section 409A.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11. <u>Indemnification</u>. The Company shall indemnify the Executive to the fullest extent permitted by applicable law in the event that the Executive was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, by reason of the fact that the Executive is or was a director, officer, employee or agent of the Company or any of its Affiliates, whether or not the claim is asserted during the Employment Period. The Executive shall be covered under any directors' and officers' insurance that the Company maintains for its directors and other officers in the same manner and on the same basis as the Company's directors and other officers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12. <u>Miscellaneous</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Governing Law</u>. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without reference to principles of conflict of laws. The captions of this Agreement are not part of the provisions hereof and shall have no force or effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Notices</u>. All notices and other communications hereunder shall be in writing and shall be given by hand delivery to the other party or by registered or certified mail, return receipt requested, postage prepaid, addressed as follows:

<u>If to the Executive</u>: at the Executive's most recent address on the records of the Company.

<u>If to the Company</u>:

BioVentrix, Inc.

120 Forbes Blvd., Suite 125

Mansfield, MA 02048 USA

Attn: General Counsel

or to such other address as either party shall have furnished to the other in writing in accordance herewith. Notice and communications shall be effective when actually received by the addressee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. <u>Section 409A of the Code</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. To the extent applicable, this Agreement shall be interpreted in accordance with Section 409A. Notwithstanding any provision of this Agreement to the contrary, if the Company determines that any compensation or benefits payable under this Agreement may be subject to Section 409A, the Company shall work in good faith with the Executive to adopt such amendments to this Agreement or adopt other policies and procedures (including amendments, policies and procedures with retroactive effect), or take any other actions, that the Company determines are necessary or appropriate to avoid the imposition of taxes under Section 409A, including without limitation, actions intended to (i) exempt the compensation and benefits payable under this Agreement from Section 409A, and/or (ii) comply with the requirements of Section 409A; provided*,* <u>however</u>*,* that this Section 12(c) shall not create an obligation on the part of the Company to adopt any such amendment, policy or procedure or take any such other action, nor shall the Company have any liability for failing to do so.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. Any right to a series of installment payments pursuant to this Agreement is to be treated as a right to a series of separate payments. To the extent permitted under Section 409A, any separate payment or benefit under this Agreement or otherwise shall not be deemed "nonqualified deferred compensation" subject to Section 409A to the extent provided in the exceptions in Treasury Regulation Section 1.409A-1(b)(4), Section 1.409A-1(b)(9) or any other applicable exception or provision of Section 409A. Any payments subject to Section 409A that are subject to execution of a waiver and release which may be executed and/or revoked in a calendar year following the calendar year in which the payment event (such as termination of employment) occurs shall commence payment only in the calendar year in which the consideration period or, if applicable, release revocation period ends, as necessary to comply with Section 409A. All payments of nonqualified deferred compensation subject to Section 409A to be made upon a termination of employment under this Agreement shall only be made upon the Executive's Separation from Service.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. To the extent that any payments or reimbursements provided to the Executive under this Agreement are deemed to constitute compensation to the Executive to which Treasury Regulation Section 1.409A-3(i)(1)(iv) would apply, such amounts shall be paid or reimbursed reasonably promptly, but not later than December 31 of the year following the year in which the expense was incurred. The amount of any such payments eligible for reimbursement in one year shall not affect the payments or expenses that are eligible for payment or reimbursement in any other taxable year, and the Executive's right to such payments or reimbursement of any such expenses shall not be subject to liquidation or exchange for any other benefit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. <u>Severability</u>. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. <u>Withholding</u>. The Company may withhold from any amounts payable under this Agreement such federal, state, local or foreign taxes as the Company determines in its good faith discretion to be required to be withheld pursuant to any applicable law or regulation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;f. <u>No Waiver</u>. The Executive's or the Company's failure to insist upon strict compliance with any provision of this Agreement or the failure to assert any right the Executive or the Company may have hereunder, including, without limitation, the right of the Executive to terminate employment for Good Reason pursuant to Section 3(c) hereof, shall not be deemed to be a waiver of such provision or right or any other provision or right of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;g. <u>Entire Agreement</u>. As of the Effective Date, this Agreement constitutes the final, complete and exclusive agreement between the Executive and the Company with respect to the subject matter hereof and replaces and supersedes any and all other agreements, offers or promises, whether oral or written, by any member of the Company and its subsidiaries or Affiliates, or representative thereof, including the Offer Letter. Notwithstanding anything herein to the contrary, this Agreement and the obligations and commitments hereunder shall neither commence nor be of any force or effect prior to the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;h. <u>Arbitration</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. Any controversy or dispute that establishes a legal or equitable cause of action ("***Arbitration Claim***") between any two or more Persons Subject to Arbitration (as defined below), including any controversy or dispute, whether based on contract, common law, or federal, state or local statute or regulation, arising out of, or relating to the Executive's service or the termination thereof, shall be submitted to final and binding arbitration as the sole and exclusive remedy for such controversy or dispute in accordance with the rules of JAMS pursuant to its Employment Arbitration Rules and Procedures, which are available at http://www.jamsadr.com/rules-employment-arbitration/, and the Company will provide a copy upon the Executive's request. Notwithstanding the foregoing, this Agreement shall not require any Person Subject to Arbitration to arbitrate pursuant to this Agreement any claims: (A) under a Company benefit plan subject to the Employee Retirement Income Security Act, as amended; or (B) as to which applicable law not preempted by the Federal Arbitration Act prohibits resolution by binding arbitration. Either party may seek provisional non-monetary remedies in a court of competent jurisdiction to the extent that such remedies are not available or not available in a timely fashion through arbitration. It is the parties' intent that issues of arbitrability of any dispute shall be decided by the arbitrator.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. "***Persons Subject to Arbitration***" means, individually and collectively, (A) the Executive, (B) any person in privity with or claiming through, on behalf of or in the right of the Executive, (C) the Company, (D) any past, present or future Affiliate, employee, officer, director or agent of the Company, and/or (E) any person or entity alleged to be acting in concert with or to be jointly liable with any of the foregoing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. The arbitration shall take place before a single neutral arbitrator at the JAMS office in Boston, MA. Such arbitrator shall be provided through JAMS by mutual agreement of the parties to the arbitration; provided that, absent such agreement, the arbitrator shall be selected in accordance with the rules of JAMS then in effect. The arbitrator shall permit reasonable discovery. The award or decision of the arbitrator shall be rendered in writing; shall be final and binding on the parties; and may be enforced by judgment or order of a court of competent jurisdiction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. THE EXECUTIVE AND THE COMPANY UNDERSTAND THAT BY AGREEING TO ARBITRATE ANY ARBITRATION CLAIM, THEY WILL NOT HAVE THE RIGHT TO HAVE ANY ARBITRATION CLAIM DECIDED BY A JURY OR A COURT, BUT SHALL INSTEAD HAVE ANY ARBITRATION CLAIM DECIDED THROUGH ARBITRATION.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;v. THE EXECUTIVE AND THE COMPANY WAIVE ANY CONSTITUTIONAL OR OTHER RIGHT TO BRING CLAIMS COVERED BY THIS AGREEMENT OTHER THAN IN THEIR INDIVIDUAL CAPACITIES. EXCEPT AS MAY BE PROHIBITED BY LAW, THIS WAIVER INCLUDES THE ABILITY TO ASSERT CLAIMS AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE PROCEEDING.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;vi. This Section 12(h) shall be interpreted to conform to any applicable law concerning the terms and enforcement of agreements to arbitrate service disputes. To the extent any terms or conditions of this Section 12(h) would preclude its enforcement, such terms shall be severed or interpreted in a manner to allow for the enforcement of this Section 12(h). To the extent applicable law imposes additional requirements to allow enforcement of this Section 12(h), this Agreement shall be interpreted to include such terms or conditions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. <u>Cooperation</u>. From and after the Executive's termination of employment, the Executive shall provide the Executive's reasonable cooperation in connection with any action or proceeding (or any appeal from any action or proceeding) which relates to events occurring during the Executive's employment hereunder, and assist and advise the Company in any investigation which may be performed by the Company, provided that the Company shall reimburse the Executive for the Executive's reasonable costs and expenses and such cooperation shall not unreasonably burden the Executive or unreasonably interfere with any subsequent employment that the Executive may undertake. In the event the Executive is subpoenaed by any person or entity (including, but not limited to, any Government Agency) to give testimony or provide documents (in a deposition, court proceeding, or otherwise), that in any way relates to the Executive's employment by the Company, the Executive will give prompt notice of such subpoena to the Company and will make no disclosure until the Company has had a reasonable opportunity to contest the right of the requesting person or entity to such disclosure. Nothing in this Section 12(i) shall limit the Executive's right to make Permitted Disclosures.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;j. <u>Amendment; Survival</u>. No amendment or other modification of this Agreement shall be effective unless made in writing and signed by the parties hereto. The respective rights and obligations of the parties under this Agreement shall survive the Executive's termination of employment and the termination of this Agreement to the extent necessary for the intended preservation of such rights and obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;k. <u>Clawback</u>. The compensation payable hereunder shall be subject to (i) any Company clawback or recoupment policy required in order to comply with applicable law, including the Dodd-Frank Wall Street Reform and Consumer Protection Act and any rules or regulations promulgated thereunder and (ii) any Company clawback or recoupment policy approved by the Board which applies to the senior executives of the Company. The Company and the Executive acknowledge that this Section 12(k) is not intended to limit any clawback and/or disgorgement of such compensation pursuant to Section 304 of the Sarbanes-Oxley Act of 2002.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;l. <u>Counterparts</u>. This Agreement and any agreement referenced herein may be executed in two or more counterparts, each of which shall be deemed an original but which together shall constitute one and the same instrument.

**[*SIGNATURES APPEAR ON THE FOLLOWING PAGE*]**

IN WITNESS WHEREOF, the Executive has hereunto set the Executive's hand and, pursuant to the authorization from the Board, the Company has caused this Agreement to be executed in its name and on its behalf, all as of the day and year first written above.

---

| |
|:---|
| BIOVENTRIX, INC. |
| By: |
| Name: |
| Title: |
| "EXECUTIVE" |
| David Richmond |
| **Attachments:** |
| Exhibit A – General Release |

---

**<u>EXHIBIT A</u>**

**GENERAL RELEASE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. <u>Release</u>. For valuable consideration, the receipt and adequacy of which are hereby acknowledged, the undersigned does hereby release and forever discharge the "***Releasees***" hereunder, consisting of BioVentrix, Inc. (the "***Company***") and the Company's partners, subsidiaries, associates, affiliates, successors, heirs, assigns, agents, directors, officers, employees, representatives, lawyers, insurers, and all persons acting by, through, under or in concert with them, or any of them, of and from any and all manner of action or actions, cause or causes of action, in law or in equity, suits, debts, liens, contracts, agreements, promises, liability, claims, demands, damages, losses, costs, attorneys' fees or expenses, of any nature whatsoever, known or unknown, fixed or contingent (hereinafter called "***Claims***"), which the undersigned now has or may hereafter have against the Releasees, or any of them, by reason of any matter, cause, or thing whatsoever from the beginning of time to the date hereof. The Claims released herein include, without limiting the generality of the foregoing, any Claims in any way arising out of, based upon, or related to the employment or termination of employment of the undersigned by the Releasees, or any of them; any alleged breach of any express or implied contract of employment; any alleged torts or other alleged legal restrictions on Releasees' right to terminate the employment of the undersigned; and any alleged violation of any federal, state or local statute or ordinance including, without limitation, Title VII of the Civil Rights Act of 1964, the Age Discrimination In Employment Act ("***ADEA***"), the Americans With Disabilities Act.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. <u>Claims Not Released</u>. Notwithstanding the foregoing, this general release (the "***Release***") shall not operate to release any rights or claims of the undersigned (i) to payments or benefits under Sections 4(b) of that certain Employment Agreement, dated as of [March [_], 2026], between the Company and the undersigned (the "***Employment Agreement***"), with respect to the payments and benefits provided in exchange for this Release, (ii) to payments or benefits under any equity award agreement between the undersigned and the Company or as a holder of any securities of the Company, (iii) with respect to Sections 2(b)(v) or 4(a) of the Employment Agreement, (iv) to accrued or vested benefits the undersigned may have, if any, as of the date hereof under any applicable plan, policy, practice, program, contract or agreement with the Company, (v) to any Claims, including claims for indemnification and/or advancement of expenses arising under any indemnification agreement between the undersigned and the Company or under the bylaws, certificate of incorporation or other similar governing document of the Company, (vi) to any Claims which cannot be waived by an employee under applicable law or (vii) with respect to the undersigned's right to communicate directly with, cooperate with, or provide information to, any federal, state or local government regulator.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. <u>Exceptions</u>. Notwithstanding anything in this Release to the contrary, nothing contained in this Release shall prohibit the undersigned from (i) filing a charge with, reporting possible violations of federal law or regulation to, participating in any investigation by, or cooperating with any governmental agency or entity or making other disclosures that are protected under the whistleblower provisions of applicable law or regulation and/or (ii) communicating directly with, cooperating with, or providing information (including trade secrets) in confidence to, any federal, state or local government regulator (including, but not limited to, the U.S. Securities and Exchange Commission, the U.S. Commodity Futures Trading Commission, or the U.S. Department of Justice) for the purpose of reporting or investigating a suspected violation of law, or from providing such information to the undersigned's attorney or in a sealed complaint or other document filed in a lawsuit or other governmental proceeding. Pursuant to 18 USC Section 1833(b), (1) the undersigned will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made: (x) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and solely for the purpose of reporting or investigating a suspected violation of law; or (y) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal and (2) the undersigned acknowledges that an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual files any document containing the trade secret under seal and does not disclose the trade secret, except pursuant to court order.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. <u>Representations</u>. The undersigned represents and warrants that there has been no assignment or other transfer of any interest in any Claim which the undersigned may have against Releasees, or any of them, and the undersigned agrees to indemnify and hold Releasees, and each of them, harmless from any liability, Claims, demands, damages, costs, expenses and attorneys' fees incurred by Releasees, or any of them, as the result of any such assignment or transfer or any rights or Claims under any such assignment or transfer. It is the intention of the parties that this indemnity does not require payment as a condition precedent to recovery by the Releasees against the undersigned under this indemnity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. <u>No Action</u>. The undersigned agrees that if the undersigned hereafter commences any suit arising out of, based upon, or relating to any of the Claims released hereunder or in any manner asserts against Releasees, or any of them, any of the Claims released hereunder, then the undersigned agrees to pay to Releasees, and each of them, in addition to any other damages caused to Releasees thereby, all attorneys' fees incurred by Releasees in defending or otherwise responding to said suit or Claim. Notwithstanding the foregoing, this provision shall not apply to any suit or Claim to the extent it challenges the effectiveness of this release with respect to a claim under the ADEA.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. <u>No Admission</u>. The undersigned further understands and agrees that neither the payment of any sum of money nor the execution of this Release shall constitute or be construed as an admission of any liability whatsoever by the Releasees, or any of them, who have consistently taken the position that they have no liability whatsoever to the undersigned.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. <u>OWBPA</u>. The undersigned agrees and acknowledges that this Release constitutes a knowing and voluntary waiver and release of all Claims the undersigned has or may have against the Company and/or any of the Releasees as set forth herein, including, but not limited to, all Claims arising under the Older Worker's Benefit Protection Act and the ADEA. In accordance with the Older Worker's Benefit Protection Act, the undersigned is hereby advised as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. the undersigned has read
 the terms of this Release, and understands its terms and effects, including the fact that the undersigned agreed to release and forever
 discharge the Company and each of the Releasees, from any Claims released in this Release;

b. the undersigned understands
 that, by entering into this Release, the undersigned does not waive any Claims that may arise after the date of the undersigned's
 execution of this Release, including without limitation any rights or claims that the undersigned may have to secure enforcement of
 the terms and conditions of this Release;

c. the undersigned has signed
 this Release voluntarily and knowingly in exchange for the consideration described in this Release, which the undersigned acknowledges
 is adequate and satisfactory to the undersigned and which the undersigned acknowledges is in addition to any other benefits to which
 the undersigned is otherwise entitled;

d. the Company advises the undersigned
 to consult with an attorney prior to executing this Release;

e. the undersigned has been
 given at least [21]-days in which to review and consider this Release. To the extent that the undersigned chooses to sign this Release
 prior to the expiration of such period, the undersigned acknowledges that the undersigned has done so voluntarily, had sufficient time
 to consider the Release, to consult with counsel and that the undersigned does not desire additional time and hereby waives the remainder
 of the [21]-day period; and

f. the undersigned may revoke
 this Release within seven days from the date the undersigned signs this Release and this Release will become effective upon the expiration
 of that revocation period if the undersigned has not revoked this Release during such seven-day period. If the undersigned revokes
 this Release during such seven-day period, this Release will be null and void and of no force or effect on either the Company or the
 undersigned and the undersigned will not be entitled to any of the payments or benefits which are expressly conditioned upon the execution
 and non-revocation of this Release. Any revocation must be in writing and sent to [ *name* ], via electronic mail at [ *email address* ],
 on or before [5:00 p.m. Eastern time] on the seventh day after this Release is executed by the undersigned.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. <u>Acknowledgement</u>. The undersigned acknowledges that different or additional facts may be discovered in addition to what is now known or believed to be true by the undersigned with respect to the matters released in this Release, and the undersigned agrees that this Release shall be and remain in effect in all respects as a complete and final release of the matters released, notwithstanding any different or additional facts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. <u>Governing Law</u>. This Release is deemed made and entered into in the State of Delaware, and in all respects shall be interpreted, enforced and governed under the internal laws of the State of Delaware, to the extent not preempted by federal law.

IN WITNESS WHEREOF, the undersigned has executed this Release this ____ day of ____________________.

  <br> David Richmond

## Exhibit 10.5

**Exhibit 10.5**

**<u>EMPLOYMENT AGREEMENT</u>**

THIS EMPLOYMENT AGREEMENT (this "***Agreement***"), dated March [__], 2026 (the "***Effective Date***"), is entered into by and between BioVentrix, Inc. (the "***Company***") and Steve Chartier (the "***Executive***").

WHEREAS, the Company currently employs the Executive pursuant to an offer of employment letter, dated December 3, 2024 (the "***Offer Letter***").

WHEREAS, the Company and the Executive desire to enter into an agreement that embodies the terms of such employment and that supersedes and replaces the Offer Letter, subject to the terms and conditions of this Agreement.

NOW, THEREFORE, IT IS HEREBY AGREED AS FOLLOWS:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. <u>Employment Period</u>. The Company shall employ the Executive pursuant to this Agreement for a term (the "***Employment Period***") commencing on the Effective Date and continuing indefinitely until terminated by either party in accordance with the provisions of Section 3 hereof. As of the Effective Date, the Offer Letter is superseded and replaced in its entirety.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. <u>Terms of Employment</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Position and Duties</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. <u>Role and Responsibilities</u>. During the Employment Period, the Executive shall serve as the Company's President and Co-CEO, and shall perform such employment duties as are usual and customary for such position. The Executive shall report directly to the Board. At the Company's request, the Executive shall serve the Company and/or its subsidiaries and Affiliates in other capacities in addition to the foregoing, consistent with the Executive's position hereunder. In the event that the Executive, during the Employment Period, serves in any one or more of such additional capacities, the Executive's compensation shall not be increased beyond that specified in Section 2(b) hereof. In addition, in the event the Executive's service in one or more of such additional capacities is terminated, the Executive's compensation, as specified in Section 2(b) hereof, shall not be diminished or reduced in any manner as a result of such termination provided that the Executive otherwise remains employed under the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. <u>Exclusivity</u>. During the Employment Period, the Executive agrees to devote the Executive's full business time and attention to the business and affairs of the Company. Notwithstanding the foregoing, during the Employment Period, it shall not be a violation of the Agreement for the Executive to: (A) serve on boards, committees or similar bodies of charitable or nonprofit organizations, (B) fulfill limited teaching, speaking and writing engagements, and (C) manage the Executive's personal investments, in each case, so long as such activities do not individually or in the aggregate materially interfere or conflict with the performance of the Executive's duties and responsibilities under the Agreement; provided, that with respect to the activities in subclauses (A) and/or (B), the Executive receives prior written approval from the Board.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Compensation, Benefits, Etc</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. <u>Base Salary</u>. Effective as of the Effective Date and during the Employment Period, the Executive shall receive a base salary (the "***Base Salary***") of $386,250 per annum. The Base Salary shall be paid in accordance with the Company's normal payroll practices for executive salaries generally, but no less often than monthly and shall be pro-rated for partial years of employment. The Base Salary may be increased in the discretion of the Board or a subcommittee thereof, but not reduced, and the term "Base Salary" as utilized in this Agreement shall refer to the Base Salary as so increased.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. <u>Annual Cash Bonus</u>. For each calendar year ending during the Employment Period beginning with calendar year 2026, the Executive shall be eligible to earn a cash performance bonus (an "***Annual Bonus***") under the Company's bonus plan or program applicable to senior executives targeted at thirty percent (30%) of Base Salary (the "***Annual Bonus***"). The actual amount of any Annual Bonus shall be determined by the Board (or a subcommittee thereof) in its discretion, based on the achievement of individual and/or Company performance goals as determined by the Board (or a subcommittee thereof), and shall be pro-rated for any partial year of employment or service. The payment of any Annual Bonus, to the extent any Annual Bonus becomes payable, will be made on the date on which annual bonuses are paid generally to the Company's senior executives, but in no event later than March 15th of the calendar year following the calendar year in which such Annual Bonus was earned. In order to be eligible for the Annual Bonus, the Executive must be in Active Working Status at the time the Annual Bonus is paid.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. <u>Annual Equity Grant</u>. The Executive shall be eligible to receive equity-based compensation award(s), as determined by the Board (or a subcommittee thereof), for each calendar year during the Employment Period. The Board or such subcommittee shall determine in its sole discretion the grant timing, vesting requirements, mix, and such other terms and conditions (including exercise and settlement) applicable to any annual equity-based compensation award, taking into account the Executive's and the Company's performance. Any such award shall be evidenced by a separate award agreement in a form prescribed by the Company, to be entered into by the Company and the Executive.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. <u>Benefits</u>. During the Employment Period, the Executive (and the Executive's spouse and/or eligible dependents to the extent provided in the applicable plans and programs) shall be eligible to participate in and be covered under the health and welfare benefit plans and programs maintained by the Company for the benefit of its employees from time to time, pursuant to the terms of such plans and programs including any medical, life, hospitalization, dental, disability, accidental death and dismemberment and travel accident insurance plans and programs on the same terms and conditions as those applicable to similarly situated senior executives. In addition, during the Employment Period, the Executive shall be eligible to participate in any retirement, savings and other employee benefit plans and programs maintained from time to time by the Company for the benefit of its senior executive officers. Nothing contained in this Section 2(b)(v) shall create or be deemed to create any obligation on the part of the Company to adopt or maintain any health, welfare, retirement or other benefit plan or program at any time or to create any limitation on the Company's ability to modify or terminate any such plan or program.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;v. <u>Expenses</u>. During the Employment Period, the Executive shall be entitled to receive prompt reimbursement for all reasonable business expenses incurred by the Executive in connection with the performance of the Executive's duties under this Agreement in accordance with the policies, practices and procedures of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;vi. <u>Fringe Benefits</u>. During the Employment Period, the Executive shall be eligible to receive such fringe benefits and perquisites as are provided by the Company to its employees from time to time, in accordance with the policies, practices and procedures of the Company, and shall receive such additional fringe benefits and perquisites as the Company may, in its discretion, from time-to-time provide to its senior executive officers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;vii. <u>Vacation</u>. During the Employment Period, the Executive shall be eligible for a maximum of fifteen (15) vacation days per calendar year, to be taken at such times as approved by the Company, and shall accrue at the rate of 1.25 days per month that the Executive is employed in a calendar year. Accrued but unused vacation days in excess of ten (10) may not be carried over into the following year, and the Executive will not receive pay in lieu of taking vacation. All vacations shall be taken in accordance with the plans, policies, programs, and practices of the Company applicable to its employees, as in effect from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. <u>Termination of Employment</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Death or Disability</u>. The Executive's employment shall terminate automatically upon the Executive's death during the Employment Period. Either the Company or the Executive may terminate the Executive's employment in the event of the Executive's Disability during the Employment Period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Termination by the Company</u>. The Company may terminate the Executive's employment during the Employment Period for Cause or without Cause.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. <u>Termination by the Executive</u>. The Executive's employment may be terminated by the Executive for any or no reason, including with Good Reason or by the Executive without Good Reason.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. <u>Notice of Termination</u>. Any termination of employment other than due to the Executive's death, shall be communicated by a Notice of Termination to the other party hereto given in accordance with Section 12(b) hereof. The failure by the Executive or the Company to set forth in the Notice of Termination any fact or circumstance which contributes to a showing of Good Reason or Cause shall not waive any right of the Executive or the Company, respectively, hereunder or preclude the Executive or the Company respectively, from asserting such fact or circumstance in enforcing the Executive's or the Company's rights hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. <u>Termination of Offices and Directorships; Return of Property</u>. Upon termination of the Executive's employment for any reason, unless otherwise specified in a written agreement between the Executive and the Company, the Executive shall be deemed to have resigned from all offices, directorships, and other employment positions if any, then held with the Company, and shall take all actions reasonably requested by the Company to effectuate the foregoing. In addition, upon the termination of the Executive's employment for any reason, the Executive agrees to return to the Company all documents of the Company and its Affiliates (and all copies thereof) and all other Company or Company Affiliate property that the Executive has in Executive's possession, custody or control. Such property includes, without limitation: (i) any materials of any kind that the Executive knows contain or embody any proprietary or confidential information of the Company or an Affiliate of the Company (and all reproductions thereof), (ii) computers (including, but not limited to, laptop computers, desktop computers and similar devices) and other portable electronic devices (including, but not limited to, tablet computers), cellular phones/smartphones, credit cards, phone cards, entry cards, identification badges and keys, and (iii) any correspondence, drawings, manuals, letters, notes, notebooks, reports, programs, plans, proposals, financial documents, or any other documents concerning the customers, business plans, marketing strategies, products and/or processes of the Company or any of its Affiliates and any information received from the Company or any of its Affiliates regarding third parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. <u>Obligations of the Company Upon Termination</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Accrued Obligations</u>. In the event that the Executive's employment under this Agreement terminates during the Employment Period for any reason, the Company will pay or provide to the Executive: (i) any earned but unpaid Base Salary, (ii) reimbursement of any business expenses incurred by the Executive prior to the Date of Termination that are reimbursable in accordance with Section 2(b)(v) hereof, and (iii) any vested amounts due to the Executive under any plan, program or policy of the Company (together, the "***Accrued Obligations***"). The Accrued Obligations described in clauses (i) – (ii) of the preceding sentence shall be paid within 30 days after the Date of Termination (or such earlier date as may be required by applicable law), and the Accrued Obligations described in clause (iii) of the preceding sentence shall be paid in accordance with the terms of the governing plan or program.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Qualifying Termination</u>. Subject to Sections 4(c), 12(c) and 12(e), and the Executive's continued compliance with the provisions of Section 7 hereof, if the Executive's employment with the Company is terminated during the Employment Period due to a Qualifying Termination, then in addition to the Accrued Obligations, the Company shall pay the Executive:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. *Cash Severance*. The Company shall pay the Executive an amount equal to one (1.0) times the Executive's Base Salary, as in effect on the Date of Termination (the "***Severance***"). The Severance shall be paid in substantially equal installments in accordance with the Company's normal payroll practices over the twelve- (12-) month period following the Date of Termination, but shall commence on the first normal payroll date following the Release Effective Date, and amounts otherwise payable prior to such first payroll date shall be paid on such date without interest thereon.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. *COBRA*. Subject to the Executive's valid election to continue healthcare coverage under Section 4980B of the Code, the Company shall continue to provide, during the COBRA Period, the Executive and the Executive's eligible dependents with coverage under its group health plans at the same levels as would have applied if the Executive's employment had not been terminated based on the Executive's elections in effect on the Date of Termination at no cost to the Executive, provided, however, that (A) if any plan pursuant to which such benefits are provided is not, or ceases prior to the expiration of the period of continuation coverage to be, exempt from the application of Section 409A under Treasury Regulation Section 1.409A-1(a)(5), or (B) the Company is otherwise unable to continue to cover the Executive under its group health plans without incurring penalties (including without limitation, pursuant to Section 2716 of the Public Health Service Act or the Patient Protection and Affordable Care Act), then, in either case, an amount equal to each remaining Company contribution shall thereafter be paid to the Executive in substantially equal monthly installments over the continuation coverage period (or the remaining portion thereof). For purposes of this Agreement, "***COBRA Period***" shall mean the period beginning on the Date of Termination and ending on the first anniversary thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. <u>Release</u>. Notwithstanding the foregoing, it shall be a condition to the Executive's right to receive the amounts provided for in Sections 4(b) hereof that the Executive execute and deliver to the Company an effective release of claims in substantially the form attached hereto as Exhibit A (the "***Release***") and the Release becomes irrevocable within 30 days (or, to the extent required by law, 52 days) following the Date of Termination (the date such Release becomes irrevocable herein referred to as the "***Release Effective Date***").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. <u>Other Terminations</u>. If the Executive's employment is terminated for any reason not described in Sections 4(b) hereof, the Company will pay the Executive only the Accrued Obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. <u>Exclusive Benefits</u>. Except as expressly provided in this Section 4 and subject to Section 5 hereof, the Executive shall not be entitled to any additional payments or benefits upon or in connection with the Executive's termination of employment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. <u>Non-Exclusivity of Rights</u>. Amounts which are vested benefits or which the Executive is otherwise entitled to receive under any plan, policy, practice or program of or any contract or agreement with the Company at or subsequent to the Date of Termination shall be payable in accordance with such plan, policy, practice or program or contract or agreement except as explicitly modified by this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. <u>Excess Parachute Payments; Limitation on Payments</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Best Pay Cap</u>. Notwithstanding any other provision of this Agreement, in the event that any payment or benefit received or to be received by the Executive (including any payment or benefit received in connection with a termination of the Executive's employment, whether pursuant to the terms of this Agreement or any other plan, arrangement or agreement) (all such payments and benefits, including the payments and benefits under Section 4 hereof, being hereinafter referred to as the "***Total Payments***") would be subject (in whole or part), to the excise tax imposed under Section 4999 of the Code (the "***Excise Tax***"), then, the Total Payments shall be reduced, to the extent necessary so that no portion of the Total Payments is subject to the Excise Tax but only if (i) the net amount of such Total Payments, as so reduced (and after subtracting the net amount of federal, state and local income taxes on such reduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such reduced Total Payments) is greater than or equal to (ii) the net amount of such Total Payments without such reduction (but after subtracting the net amount of federal, state and local income taxes on such Total Payments and the amount of Excise Tax to which the Executive would be subject in respect of such unreduced Total Payments and after taking into account the phase out of itemized deductions and personal exemptions attributable to such unreduced Total Payments). If the Total Payments are so reduced, the Company shall reduce or eliminate the Total Payments (A) by first reducing or eliminating the portion of the Total Payments which are not payable in cash (other than that portion of the Total Payments subject to clause (C) hereof), (B) then by reducing or eliminating cash payments (other than that portion of the Total Payments subject to clause (C) hereof) and (C) then by reducing or eliminating the portion of the Total Payments (whether payable in cash or not payable in cash) to which Treasury Regulation § 1.280G-1 Q/A 24(c) (or successor thereto) applies, in each case in reverse order beginning with payments or benefits which are to be paid the farthest in time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Certain Exclusions</u>. For purposes of determining whether and the extent to which the Total Payments will be subject to the Excise Tax, (i) no portion of the Total Payments the receipt or enjoyment of which the Executive shall have waived at such time and in such manner as not to constitute a "payment" within the meaning of Section 280G(b) of the Code shall be taken into account; (ii) no portion of the Total Payments shall be taken into account which, in the written opinion of an independent, nationally recognized accounting firm (the "***Independent Advisors***") selected by the Company, does not constitute a "parachute payment" within the meaning of Section 280G(b)(2) of the Code (including by reason of Section 280G(b)(4)(A) of the Code) and, in calculating the Excise Tax, no portion of such Total Payments shall be taken into account which, in the opinion of Independent Advisors, constitutes reasonable compensation for services actually rendered, within the meaning of Section 280G(b)(4)(B) of the Code, in excess of the "base amount" (as defined in Section 280G(b)(3) of the Code) allocable to such reasonable compensation; and (iii) the value of any non-cash benefit or any deferred payment or benefit included in the Total Payments shall be determined by the Independent Advisors in accordance with the principles of Sections 280G(d)(3) and (4) of the Code.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. <u>Restrictive Covenants</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Confidential and Proprietary Information</u>. The Executive agrees that all materials and items produced or developed by the Executive for the Company or any of its Affiliates, or obtained by the Executive from the Company or any of its Affiliates either directly or indirectly pursuant to this Agreement, shall be and remain the property of the Company and its Affiliates. The Executive acknowledges that the Executive will, during the Executive's association with the Company, acquire, or be exposed to, or have access to, materials, data and information that constitute valuable, confidential and proprietary information of the Company and its Affiliates, including, without limitation, any or all of the following: business plans, practices and procedures, pricing information, sales figures, profit or loss figures, this Agreement and its terms, information relating to customers, clients, intellectual property, suppliers, technology, sources of supply and customer lists, research, technical data, trade secrets or know-how, software, developments, inventions, processes, formulas, technology, designs, drawings, engineering, hardware configuration information, marketing, finances, policies, training manuals and similar materials used by the Company in conducting its business operations, personnel information of any Person employed by the Company, potential business combinations, and such other information or material as the Company may designate as confidential and/or proprietary from time to time (collectively hereinafter, the "***Confidential and Proprietary Information***"). Notwithstanding the foregoing, "Confidential and Proprietary Information" does not include information that is or becomes publicly available, other than information made publicly available by the Executive or another person in violation of the Executive's obligations in this Section 7(a). During the Executive's employment with the Company and at all times thereafter, the Executive shall not, directly or indirectly, use, misuse, misappropriate, disclose or make known, without the prior written approval of the Board, to any party, firm, corporation, association or other entity any such Confidential and Proprietary Information for any reason or purpose whatsoever, except as may be required in the course of the Executive's performance of the Executive's duties hereunder. In consideration of the unique nature of the Confidential and Proprietary Information, all obligations pertaining to the confidentiality and nondisclosure thereof shall remain in effect until the Company and its Affiliates have released such information; provided that the provisions of this Section 7(a) shall not apply to the disclosure of Confidential and Proprietary Information to the Company's Affiliates together with each of their respective shareholders, directors, officers, accountants, lawyers and other representatives or agents in furtherance of the Executive's duties hereunder, nor to a Permitted Disclosure. In addition, it shall not be a breach of the confidentiality obligations hereof if the Executive is required by applicable law to disclose any Confidential and Proprietary Information; provided that in such case, the Executive shall (x) give the Company the earliest notice possible that such disclosure is or may be required and (y) cooperate with the Company, at the Company's expense, in protecting to the maximum extent legally permitted, the confidential or proprietary nature of the Confidential and Proprietary Information which must be so disclosed. Upon the termination of the Executive's employment, the Executive agrees that all Confidential and Proprietary Information, directly or indirectly, in the Executive's possession that is in writing or other tangible form (together with all duplicates thereof) will promptly (and in any event within 10 days following such termination) be returned to the Company and will not be retained by the Executive or furnished to any person, either by sample, facsimile, film, audio or video cassette, electronic data, verbal communication or any other means of communication.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Inventions</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. The Executive acknowledges and agrees that all ideas, methods, inventions, discoveries, improvements, work products, and developments, whether patentable or unpatentable, (x) that relate to the Executive's work with the Company, made or conceived by the Executive, solely or jointly with others, prior to or during the Employment Period, or (y) suggested by any work that the Executive performs in connection with the Company, either while performing the Executive's duties with the Company or on the Executive's own time, but only insofar as such ideas, methods, inventions, discoveries, improvements, work products, and developments are related to the Executive's work as an employee or other service provider to the Company (the "***Inventions***"), shall belong exclusively to the Company (or its designee), whether or not patent applications are filed thereon. The Executive will keep full and complete written records (the "***Records***"), in the manner prescribed by the Company of all Inventions and will promptly disclose all Inventions completely and in writing to the Company. The Records shall be the sole and exclusive property of the Company and the Executive will surrender them upon the termination of the Employment Period, or upon the Company's request. The Executive hereby assigns to the Company the Inventions and all patents that may be issued thereon in any and all countries, whether prior to, during or subsequent to the Employment Period, together with the right to file, in the Executive's name or in the name of the Company (or its designee), applications for patents and equivalent rights (the "***Applications***"). The Executive will, at any time during and subsequent to the Employment Period, make such applications, sign such papers, take all rightful oaths, and perform all acts as may be requested from time to time by the Company with respect to the Inventions. The Executive will also execute assignments to the Company (or its designee), of the Applications, and give the Company and its attorneys all reasonable assistance (including the giving of testimony) to obtain the Inventions for its benefit, all without additional compensation to the Executive from the Company but entirely at the Company's expense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. In addition, the Inventions will be deemed Work for Hire, as such term is defined under the copyright law of the United States, on behalf of the Company and the Executive agrees that the Company will be the sole owner of the Inventions, and all underlying rights therein, in all media now known or hereinafter devised, throughout the universe and in perpetuity, without any further obligations to the Executive. If the Inventions, or any portion thereof, are deemed not to be Work for Hire, the Executive hereby irrevocably conveys, transfers and assigns to the Company all rights, in all media now known or hereinafter devised, throughout the universe and in perpetuity, in and to the Inventions, including, without limitation, all of the Executive's right, title and interest in the copyrights (and all renewals, revivals and extensions thereof) to the Inventions, including, without limitation, all rights of any kind or any nature now or hereafter recognized, including, without limitation, the unrestricted right to make modifications, adaptations and revisions to the Inventions, to exploit and allow others to exploit the Inventions and all rights to sue at law or in equity for any infringement or other unauthorized use or conduct in derogation of the Inventions, known or unknown, prior to the date hereof, including, without limitation, the right to receive all proceeds and damages therefrom. In addition, the Executive hereby waives any so-called "moral rights" with respect to the Inventions. The Executive hereby waives any and all currently existing and future monetary rights in and to the Inventions and all patents that may be issued thereon, including, without limitation, any rights that would otherwise accrue to the Executive's benefit by virtue of the Executive being an employee of or other service provider to the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. Subject to Sections 7(a), nothing in this Section 7(b) will restrict the Executive from the use of concepts, ideas or methods that are generally known by others in the industry, nor shall the Executive be restricted from using the general know-how or experience obtained during employment with the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. Notwithstanding anything in this Agreement to the contrary, nothing contained in this Agreement shall prohibit either party (or either party's attorney(s)) from (i) filing a charge with, reporting possible violations of federal law or regulation to, participating in any investigation by, or cooperating with the U.S. Securities and Exchange Commission, the Financial Industry Regulatory Authority, the Equal Employment Opportunity Commission, the National Labor Relations Board, the Occupational Safety and Health Administration, the U.S. Commodity Futures Trading Commission, the U.S. Department of Justice or any other securities regulatory agency, self-regulatory authority or federal, state or local regulatory authority (collectively, "***Government Agencies***"), or making other disclosures that are protected under the whistleblower provisions of applicable law or regulation, (ii) communicating directly with, cooperating with, or providing information (including trade secrets) in confidence to any Government Agencies for the purpose of reporting or investigating a suspected violation of law, or from providing such information to such party's attorney(s) or in a sealed complaint or other document filed in a lawsuit or other governmental proceeding, and/or (iii) receiving an award for information provided to any Government Agency. Pursuant to 18 USC Section 1833(b), (1) the Executive will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made: (x) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and solely for the purpose of reporting or investigating a suspected violation of law; or (y) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal and (2) the Executive acknowledges that an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual files any document containing the trade secret under seal and does not disclose the trade secret, except pursuant to court order. All disclosures permitted under this Section 7(c) are herein referred to as "***Permitted Disclosures***." Further, nothing in this Agreement is intended to or shall preclude either party from providing truthful testimony in response to a valid subpoena, court order, regulatory request or other judicial, administrative or legal process or otherwise as required by law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. <u>Representations</u>. The Executive hereby represents and warrants to the Company that (a) the Executive is entering into this Agreement voluntarily and that the performance of the Executive's obligations hereunder will not violate any agreement between the Executive and any other person, firm, organization or other entity, or any policy, program or code of such other person, firm, organization or other entity person, and (b) the Executive is not bound by the terms of any agreement with any previous employer or other party to refrain from competing, directly or indirectly, with the business of such previous employer or other party that would be violated by the Executive's entering into this Agreement and/or providing services to the Company pursuant to the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. <u>Successors</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. This Agreement is personal to the Executive and, without the prior written consent of the Company, shall not be assignable by the Executive other than by will or the laws of descent and distribution. This Agreement shall inure to the benefit of and be enforceable by the Executive's legal representatives.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. This Agreement shall inure to the benefit of and be binding upon the Company and its respective successors and assigns.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10. <u>Certain Definitions</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. "***Active Working Status***" means the Executive is actively performing work for the Company and has not resigned (or given notice of the Executive's intent to resign) and has not been terminated (or been given notice of the Executive's termination).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. "***Affiliate***" means any entity that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. "***Board***" means the Board of Directors of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. "***Cause***" means the occurrence of any one or more of the following events:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. The Executive's conviction of an act constituting a misdemeanor involving moral turpitude or a felony under federal, state, or local law;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. The Executive's commitment of an act constituting a breach of fiduciary duty, gross negligence or willful misconduct with respect to the Company;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. The Executive's commitment of an act of fraud, self-dealing, or dishonesty with respect to the Company; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. The Executive's engagement in conduct that is materially detrimental to the business, reputation, character, or standing of the Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. "***Code***" means the Internal Revenue Code of 1986, as amended and the regulations thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;f. "***Date of Termination***" means the date on which the Executive's employment with the Company terminates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;g. "***Disability***" means that the Executive has become entitled to receive benefits under an applicable Company long-term disability plan or, if no such plan covers the Executive, the Executive's inability, due to physical or mental illness, to perform the essential functions of the Executive's job, with or without a reasonable accommodation for 180 consecutive days.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;h. "***Good Reason***" means the occurrence of any one or more of the following events without the Executive's prior written consent, unless the Company fully corrects the circumstances constituting Good Reason, as provided below:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. A decrease in the Executive's Base Salary (unless such decrease is applied to all senior management base salaries on a pro rata basis); or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. The Company requires the Executive to relocate to an office that is more than 150 miles from 120 Forbes Blvd., Suite 125, Mansfield, MA.

Notwithstanding the foregoing, the Executive will not be deemed to have resigned for Good Reason unless (1) the Executive provides the Company with written notice setting forth in reasonable detail the facts and circumstances claimed by the Executive to constitute Good Reason within 45 days after the date of the occurrence of any event that the Executive knows or should reasonably have known to constitute Good Reason, (2) the Company fails to cure such acts or omissions within 30 days following its receipt of such notice, and (3) the Date of Termination for Good Reason occurs no later than 60 days after the expiration of the Company's cure period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. "***Notice of Termination***" means a written notice which (i) indicates the specific termination provision in this Agreement relied upon, (ii) sets forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive's employment under the provision so indicated and (iii) if the Date of Termination is other than the date of receipt of such notice, specifies the termination date (which date shall be not more than 30 days after the giving of such notice unless as otherwise provided upon a termination for Good Reason).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;j. "***Person***" means an individual, a partnership, a corporation, an association, a limited liability company, a joint stock company, a trust, a joint venture, an unincorporated organization or a governmental entity or any department, agency or political subdivision thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;k. "***Qualifying Termination***" means a termination of the Executive's employment (i) by the Company without Cause (other than by reason of the Executive's death or Disability) or (ii) by the Executive for Good Reason.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;l. ***Section 409A***" means Section 409A of the Code and Department of Treasury regulations and other interpretive guidance issued thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;m. "***Separation from Service***" means a "separation from service" within the meaning of Section 409A.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11. <u>Indemnification</u>. The Company shall indemnify the Executive to the fullest extent permitted by applicable law in the event that the Executive was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, by reason of the fact that the Executive is or was a director, officer, employee or agent of the Company or any of its Affiliates, whether or not the claim is asserted during the Employment Period. The Executive shall be covered under any directors' and officers' insurance that the Company maintains for its directors and other officers in the same manner and on the same basis as the Company's directors and other officers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12. <u>Miscellaneous</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. <u>Governing Law</u>. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without reference to principles of conflict of laws. The captions of this Agreement are not part of the provisions hereof and shall have no force or effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. <u>Notices</u>. All notices and other communications hereunder shall be in writing and shall be given by hand delivery to the other party or by registered or certified mail, return receipt requested, postage prepaid, addressed as follows:

<u>If to the Executive</u>: at the Executive's most recent address on the records of the Company.

<u>If to the Company</u>:

BioVentrix, Inc.

120 Forbes Blvd., Suite 125

Mansfield, MA 02048 USA

Attn: General Counsel

or to such other address as either party shall have furnished to the other in writing in accordance herewith. Notice and communications shall be effective when actually received by the addressee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. <u>Section 409A of the Code</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. To the extent applicable, this Agreement shall be interpreted in accordance with Section 409A. Notwithstanding any provision of this Agreement to the contrary, if the Company determines that any compensation or benefits payable under this Agreement may be subject to Section 409A, the Company shall work in good faith with the Executive to adopt such amendments to this Agreement or adopt other policies and procedures (including amendments, policies and procedures with retroactive effect), or take any other actions, that the Company determines are necessary or appropriate to avoid the imposition of taxes under Section 409A, including without limitation, actions intended to (i) exempt the compensation and benefits payable under this Agreement from Section 409A, and/or (ii) comply with the requirements of Section 409A; provided*,* <u>however</u>*,* that this Section 12(c) shall not create an obligation on the part of the Company to adopt any such amendment, policy or procedure or take any such other action, nor shall the Company have any liability for failing to do so.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. Any right to a series of installment payments pursuant to this Agreement is to be treated as a right to a series of separate payments. To the extent permitted under Section 409A, any separate payment or benefit under this Agreement or otherwise shall not be deemed "nonqualified deferred compensation" subject to Section 409A to the extent provided in the exceptions in Treasury Regulation Section 1.409A-1(b)(4), Section 1.409A-1(b)(9) or any other applicable exception or provision of Section 409A. Any payments subject to Section 409A that are subject to execution of a waiver and release which may be executed and/or revoked in a calendar year following the calendar year in which the payment event (such as termination of employment) occurs shall commence payment only in the calendar year in which the consideration period or, if applicable, release revocation period ends, as necessary to comply with Section 409A. All payments of nonqualified deferred compensation subject to Section 409A to be made upon a termination of employment under this Agreement shall only be made upon the Executive's Separation from Service.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. To the extent that any payments or reimbursements provided to the Executive under this Agreement are deemed to constitute compensation to the Executive to which Treasury Regulation Section 1.409A-3(i)(1)(iv) would apply, such amounts shall be paid or reimbursed reasonably promptly, but not later than December 31 of the year following the year in which the expense was incurred. The amount of any such payments eligible for reimbursement in one year shall not affect the payments or expenses that are eligible for payment or reimbursement in any other taxable year, and the Executive's right to such payments or reimbursement of any such expenses shall not be subject to liquidation or exchange for any other benefit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. <u>Severability</u>. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. <u>Withholding</u>. The Company may withhold from any amounts payable under this Agreement such federal, state, local or foreign taxes as the Company determines in its good faith discretion to be required to be withheld pursuant to any applicable law or regulation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;f. <u>No Waiver</u>. The Executive's or the Company's failure to insist upon strict compliance with any provision of this Agreement or the failure to assert any right the Executive or the Company may have hereunder, including, without limitation, the right of the Executive to terminate employment for Good Reason pursuant to Section 3(c) hereof, shall not be deemed to be a waiver of such provision or right or any other provision or right of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;g. <u>Entire Agreement</u>. As of the Effective Date, this Agreement constitutes the final, complete and exclusive agreement between the Executive and the Company with respect to the subject matter hereof and replaces and supersedes any and all other agreements, offers or promises, whether oral or written, by any member of the Company and its subsidiaries or Affiliates, or representative thereof, including the Offer Letter. Notwithstanding anything herein to the contrary, this Agreement and the obligations and commitments hereunder shall neither commence nor be of any force or effect prior to the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;h. <u>Arbitration</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. Any controversy or dispute that establishes a legal or equitable cause of action ("***Arbitration Claim***") between any two or more Persons Subject to Arbitration (as defined below), including any controversy or dispute, whether based on contract, common law, or federal, state or local statute or regulation, arising out of, or relating to the Executive's service or the termination thereof, shall be submitted to final and binding arbitration as the sole and exclusive remedy for such controversy or dispute in accordance with the rules of JAMS pursuant to its Employment Arbitration Rules and Procedures, which are available at http://www.jamsadr.com/rules-employment-arbitration/, and the Company will provide a copy upon the Executive's request. Notwithstanding the foregoing, this Agreement shall not require any Person Subject to Arbitration to arbitrate pursuant to this Agreement any claims: (A) under a Company benefit plan subject to the Employee Retirement Income Security Act, as amended; or (B) as to which applicable law not preempted by the Federal Arbitration Act prohibits resolution by binding arbitration. Either party may seek provisional non-monetary remedies in a court of competent jurisdiction to the extent that such remedies are not available or not available in a timely fashion through arbitration. It is the parties' intent that issues of arbitrability of any dispute shall be decided by the arbitrator.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii. "***Persons Subject to Arbitration***" means, individually and collectively, (A) the Executive, (B) any person in privity with or claiming through, on behalf of or in the right of the Executive, (C) the Company, (D) any past, present or future Affiliate, employee, officer, director or agent of the Company, and/or (E) any person or entity alleged to be acting in concert with or to be jointly liable with any of the foregoing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iii. The arbitration shall take place before a single neutral arbitrator at the JAMS office in Boston, MA. Such arbitrator shall be provided through JAMS by mutual agreement of the parties to the arbitration; provided that, absent such agreement, the arbitrator shall be selected in accordance with the rules of JAMS then in effect. The arbitrator shall permit reasonable discovery. The award or decision of the arbitrator shall be rendered in writing; shall be final and binding on the parties; and may be enforced by judgment or order of a court of competent jurisdiction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;iv. THE EXECUTIVE AND THE COMPANY UNDERSTAND THAT BY AGREEING TO ARBITRATE ANY ARBITRATION CLAIM, THEY WILL NOT HAVE THE RIGHT TO HAVE ANY ARBITRATION CLAIM DECIDED BY A JURY OR A COURT, BUT SHALL INSTEAD HAVE ANY ARBITRATION CLAIM DECIDED THROUGH ARBITRATION.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;v. THE EXECUTIVE AND THE COMPANY WAIVE ANY CONSTITUTIONAL OR OTHER RIGHT TO BRING CLAIMS COVERED BY THIS AGREEMENT OTHER THAN IN THEIR INDIVIDUAL CAPACITIES. EXCEPT AS MAY BE PROHIBITED BY LAW, THIS WAIVER INCLUDES THE ABILITY TO ASSERT CLAIMS AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE PROCEEDING.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;vi. This Section 12(h) shall be interpreted to conform to any applicable law concerning the terms and enforcement of agreements to arbitrate service disputes. To the extent any terms or conditions of this Section 12(h) would preclude its enforcement, such terms shall be severed or interpreted in a manner to allow for the enforcement of this Section 12(h). To the extent applicable law imposes additional requirements to allow enforcement of this Section 12(h), this Agreement shall be interpreted to include such terms or conditions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i. <u>Cooperation</u>. From and after the Executive's termination of employment, the Executive shall provide the Executive's reasonable cooperation in connection with any action or proceeding (or any appeal from any action or proceeding) which relates to events occurring during the Executive's employment hereunder, and assist and advise the Company in any investigation which may be performed by the Company, provided that the Company shall reimburse the Executive for the Executive's reasonable costs and expenses and such cooperation shall not unreasonably burden the Executive or unreasonably interfere with any subsequent employment that the Executive may undertake. In the event the Executive is subpoenaed by any person or entity (including, but not limited to, any Government Agency) to give testimony or provide documents (in a deposition, court proceeding, or otherwise), that in any way relates to the Executive's employment by the Company, the Executive will give prompt notice of such subpoena to the Company and will make no disclosure until the Company has had a reasonable opportunity to contest the right of the requesting person or entity to such disclosure. Nothing in this Section 12(i) shall limit the Executive's right to make Permitted Disclosures.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;j. <u>Amendment; Survival</u>. No amendment or other modification of this Agreement shall be effective unless made in writing and signed by the parties hereto. The respective rights and obligations of the parties under this Agreement shall survive the Executive's termination of employment and the termination of this Agreement to the extent necessary for the intended preservation of such rights and obligations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;k. <u>Clawback</u>. The compensation payable hereunder shall be subject to (i) any Company clawback or recoupment policy required in order to comply with applicable law, including the Dodd-Frank Wall Street Reform and Consumer Protection Act and any rules or regulations promulgated thereunder and (ii) any Company clawback or recoupment policy approved by the Board which applies to the senior executives of the Company. The Company and the Executive acknowledge that this Section 12(k) is not intended to limit any clawback and/or disgorgement of such compensation pursuant to Section 304 of the Sarbanes-Oxley Act of 2002.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;l. <u>Counterparts</u>. This Agreement and any agreement referenced herein may be executed in two or more counterparts, each of which shall be deemed an original but which together shall constitute one and the same instrument.

**[*SIGNATURES APPEAR ON THE FOLLOWING PAGE*]**

IN WITNESS WHEREOF, the Executive has hereunto set the Executive's hand and, pursuant to the authorization from the Board, the Company has caused this Agreement to be executed in its name and on its behalf, all as of the day and year first written above.

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| |
|:---|
| BIOVENTRIX, INC. |
| By: |
| Name: |
| Title: |
| "EXECUTIVE" |
| Steve Chartier |
| **Attachments:** |
| Exhibit A – General Release |

---

**<u>EXHIBIT A</u>**

**GENERAL RELEASE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. <u>Release</u>. For valuable consideration, the receipt and adequacy of which are hereby acknowledged, the undersigned does hereby release and forever discharge the "***Releasees***" hereunder, consisting of BioVentrix, Inc. (the "***Company***") and the Company's partners, subsidiaries, associates, affiliates, successors, heirs, assigns, agents, directors, officers, employees, representatives, lawyers, insurers, and all persons acting by, through, under or in concert with them, or any of them, of and from any and all manner of action or actions, cause or causes of action, in law or in equity, suits, debts, liens, contracts, agreements, promises, liability, claims, demands, damages, losses, costs, attorneys' fees or expenses, of any nature whatsoever, known or unknown, fixed or contingent (hereinafter called "***Claims***"), which the undersigned now has or may hereafter have against the Releasees, or any of them, by reason of any matter, cause, or thing whatsoever from the beginning of time to the date hereof. The Claims released herein include, without limiting the generality of the foregoing, any Claims in any way arising out of, based upon, or related to the employment or termination of employment of the undersigned by the Releasees, or any of them; any alleged breach of any express or implied contract of employment; any alleged torts or other alleged legal restrictions on Releasees' right to terminate the employment of the undersigned; and any alleged violation of any federal, state or local statute or ordinance including, without limitation, Title VII of the Civil Rights Act of 1964, the Age Discrimination In Employment Act ("***ADEA***"), the Americans With Disabilities Act.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. <u>Claims Not Released</u>. Notwithstanding the foregoing, this general release (the "***Release***") shall not operate to release any rights or claims of the undersigned (i) to payments or benefits under Sections 4(b) of that certain Employment Agreement, dated as of [March [_], 2026], between the Company and the undersigned (the "***Employment Agreement***"), with respect to the payments and benefits provided in exchange for this Release, (ii) to payments or benefits under any equity award agreement between the undersigned and the Company or as a holder of any securities of the Company, (iii) with respect to Sections 2(b)(v) or 4(a) of the Employment Agreement, (iv) to accrued or vested benefits the undersigned may have, if any, as of the date hereof under any applicable plan, policy, practice, program, contract or agreement with the Company, (v) to any Claims, including claims for indemnification and/or advancement of expenses arising under any indemnification agreement between the undersigned and the Company or under the bylaws, certificate of incorporation or other similar governing document of the Company, (vi) to any Claims which cannot be waived by an employee under applicable law or (vii) with respect to the undersigned's right to communicate directly with, cooperate with, or provide information to, any federal, state or local government regulator.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. <u>Exceptions</u>. Notwithstanding anything in this Release to the contrary, nothing contained in this Release shall prohibit the undersigned from (i) filing a charge with, reporting possible violations of federal law or regulation to, participating in any investigation by, or cooperating with any governmental agency or entity or making other disclosures that are protected under the whistleblower provisions of applicable law or regulation and/or (ii) communicating directly with, cooperating with, or providing information (including trade secrets) in confidence to, any federal, state or local government regulator (including, but not limited to, the U.S. Securities and Exchange Commission, the U.S. Commodity Futures Trading Commission, or the U.S. Department of Justice) for the purpose of reporting or investigating a suspected violation of law, or from providing such information to the undersigned's attorney or in a sealed complaint or other document filed in a lawsuit or other governmental proceeding. Pursuant to 18 USC Section 1833(b), (1) the undersigned will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made: (x) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and solely for the purpose of reporting or investigating a suspected violation of law; or (y) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal and (2) the undersigned acknowledges that an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the individual files any document containing the trade secret under seal and does not disclose the trade secret, except pursuant to court order.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. <u>Representations</u>. The undersigned represents and warrants that there has been no assignment or other transfer of any interest in any Claim which the undersigned may have against Releasees, or any of them, and the undersigned agrees to indemnify and hold Releasees, and each of them, harmless from any liability, Claims, demands, damages, costs, expenses and attorneys' fees incurred by Releasees, or any of them, as the result of any such assignment or transfer or any rights or Claims under any such assignment or transfer. It is the intention of the parties that this indemnity does not require payment as a condition precedent to recovery by the Releasees against the undersigned under this indemnity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. <u>No Action</u>. The undersigned agrees that if the undersigned hereafter commences any suit arising out of, based upon, or relating to any of the Claims released hereunder or in any manner asserts against Releasees, or any of them, any of the Claims released hereunder, then the undersigned agrees to pay to Releasees, and each of them, in addition to any other damages caused to Releasees thereby, all attorneys' fees incurred by Releasees in defending or otherwise responding to said suit or Claim. Notwithstanding the foregoing, this provision shall not apply to any suit or Claim to the extent it challenges the effectiveness of this release with respect to a claim under the ADEA.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. <u>No Admission</u>. The undersigned further understands and agrees that neither the payment of any sum of money nor the execution of this Release shall constitute or be construed as an admission of any liability whatsoever by the Releasees, or any of them, who have consistently taken the position that they have no liability whatsoever to the undersigned.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. <u>OWBPA</u>. The undersigned agrees and acknowledges that this Release constitutes a knowing and voluntary waiver and release of all Claims the undersigned has or may have against the Company and/or any of the Releasees as set forth herein, including, but not limited to, all Claims arising under the Older Worker's Benefit Protection Act and the ADEA. In accordance with the Older Worker's Benefit Protection Act, the undersigned is hereby advised as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. the undersigned has read
 the terms of this Release, and understands its terms and effects, including the fact that the undersigned agreed to release and forever
 discharge the Company and each of the Releasees, from any Claims released in this Release;

b. the undersigned understands
 that, by entering into this Release, the undersigned does not waive any Claims that may arise after the date of the undersigned's
 execution of this Release, including without limitation any rights or claims that the undersigned may have to secure enforcement of
 the terms and conditions of this Release;

c. the undersigned has signed
 this Release voluntarily and knowingly in exchange for the consideration described in this Release, which the undersigned acknowledges
 is adequate and satisfactory to the undersigned and which the undersigned acknowledges is in addition to any other benefits to which
 the undersigned is otherwise entitled;

d. the Company advises the undersigned
 to consult with an attorney prior to executing this Release;

e. the undersigned has been
 given at least [21]-days in which to review and consider this Release. To the extent that the undersigned chooses to sign this Release
 prior to the expiration of such period, the undersigned acknowledges that the undersigned has done so voluntarily, had sufficient time
 to consider the Release, to consult with counsel and that the undersigned does not desire additional time and hereby waives the remainder
 of the [21]-day period; and

f. the undersigned may revoke
 this Release within seven days from the date the undersigned signs this Release and this Release will become effective upon the expiration
 of that revocation period if the undersigned has not revoked this Release during such seven-day period. If the undersigned revokes
 this Release during such seven-day period, this Release will be null and void and of no force or effect on either the Company or the
 undersigned and the undersigned will not be entitled to any of the payments or benefits which are expressly conditioned upon the execution
 and non-revocation of this Release. Any revocation must be in writing and sent to [ *name* ], via electronic mail at [ *email address* ],
 on or before [5:00 p.m. Eastern time] on the seventh day after this Release is executed by the undersigned.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. <u>Acknowledgement</u>. The undersigned acknowledges that different or additional facts may be discovered in addition to what is now known or believed to be true by the undersigned with respect to the matters released in this Release, and the undersigned agrees that this Release shall be and remain in effect in all respects as a complete and final release of the matters released, notwithstanding any different or additional facts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. <u>Governing Law</u>. This Release is deemed made and entered into in the State of Delaware, and in all respects shall be interpreted, enforced and governed under the internal laws of the State of Delaware, to the extent not preempted by federal law.

IN WITNESS WHEREOF, the undersigned has executed this Release this ____ day of ____________________.

  <br> Steve Chartier

## Exhibit 10.7

**Exhibit 10.7**

**HENRY FORD HEALTH SYSTEM**

**Exclusive License Agreement**

This license agreement ("Agreement") is made effective as of the 28th day of December ("Effective Date"), by and between Henry Ford Health System, a Michigan nonprofit corporation, having its statewide administrative offices at One Ford Place, 4B, Detroit, Michigan 48202-3450, ("HFHS"), and MateraCor, Inc., a Delaware corporation, having a principal place of business at 30965 La Brise, Laguna Niguel, CA 92677 ("Licensee").

BACKGROUND

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A. A portfolio of inventions for the treatment of heart failure invented by Dr. Hani Sabbah, et al ("Invention") and claimed in Patent Rights as defined below.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B. The Licensee wishes to obtain rights from HFHS for the commercial development of the Invention, in accordance with the terms and conditions set forth herein and HFHS is willing to grant those rights so that the Invention may be developed and the benefits enjoyed by the general public.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C. The scope of such rights granted by HFHS is intended to extend to the scope of the patents and patent applications in Patent Rights, but only to the extent that HFHS has proprietary rights in and to the Valid Claims of such Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D. Both parties recognize and agree that Earned Royalties are due under this Agreement with respect to products, services and methods and that such royalties will be paid. with respect to both pending patent applications and issued patents, in accordance with the terms and conditions set forth herein.

The parties agree as follows:

1. DEFINITIONS — As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1 "Affiliate" of the Licensee means any entity which, directly or indirectly, Controls the Licensee, is Controlled by the Licensee or is under common Control with the Licensee. "Control" means (i) having the actual, present capacity to elect a majority of the directors of such affiliate; (ii) having the power to direct at least forty percent (40%) of the voting rights entitled to elect directors; or (iii) in any country where the local law will not permit foreign equity participation of a majority, ownership or control, directly or indirectly, of the maximum percentage of such outstanding stock or voting rights permitted by local law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2 "Combination Product" means a combined Product that contains or uses a Licensed Product or Licensed Method and at least one other Product that is not a Licensed Product or Licensed Method, where the market price of such combined Product is higher than the market price for the Licensed Product or Licensed Method.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1.3 "Earned Royalty" shall have the meaning given in Paragraph 5.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1.4 "Field of Use" means all cardiac applications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.5 "First Commercial Sale" shall mean the first Sale for which payment has been invoiced in any particular country after receipt of any necessary regulatory approval in that country.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.6 "Joint Venture" means any separate entity established pursuant to an agreement between a third party and the Licensee and/or Sublicensee to constitute a vehicle for a joint venture, in which the separate entity manufactures, uses, purchases, Sells or acquires Licensed Products or Licensed Methods from the Licensee or Sublicensee.

I.7 "Licensed Method" means any process, art or method the use or practice of which, but for the license granted in this Agreement, would infringe, or contribute to, or induce the infringement of, any Patent Rights. Such infringement, contributory infringement or inducement to infringement will be determined on a country-by-country basis. With respect to patent applications in a country, such infringement, contributory infringement or inducement to infringement will be determined as if a patent based on such patent application were issued at the time of the infringing activity in that country.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.8 "Licensed Product" means any Product, including, without limitation, a Product for use or used in practicing a Licensed Method and any Product made by practicing a Licensed Method, the manufacture, use, Sale, offer for Sale or import of which, but for the license granted in this Agreement, would infringe, or contribute to, or induce the infringement of, any Patent Rights. Such infringement, contributory infringement or inducement to infringement will be determined on a country-by- country basis. With respect to patent applications in a country, such infringement, contributory infringement or inducement to infringement will be determined as if a patent based on such patent application were issued at the time of the infringing activity in that country. Any practice of the Licensed Method is included within Licensed Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.9 "Net Invoice Price" means the gross invoice price charged for a Licensed Product or Licensed Method, less (i) an allowance for those accounts deemed uncollectible (in accordance with industry standards and U.S. GAAP), and (ii) the following items:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.9.1 Allowances
 actually granted to customers for rejections, returns and prompt payment and volume discounts;
 Freight, transport packing and insurance charges associated with transportation; Taxes, including
 Deductible Value Added Tax, tariffs or import/export duties based on Sales when included
 in the gross invoice price. "Deductible Value Added Tax" means value added tax
 only to the extent that such value added tax is actually incurred and is not reimbursable,
 refundable or creditable under the tax authority of any country; Discounts and rebates that
 are part of a formulary program and are paid or credited to customers, third-party payers,
 healthcare systems, or administrators for a Licensed Product or Licensed Method when included
 in such formulary program; and Rebates and discounts paid or credited pursuant to applicable
 law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1.10 "Net Sales" means:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.10.1 The
 Net Invoice Price, except for any Relationship- Influenced Sale of a Licensed Product or
 Licensed Method in which case Net Sales shall be based on the Net Invoice Price at which
 the Relationship-Influenced Sale Purchaser resells such Licensed Product or Licensed Method.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.10.2 In
 the event that a Licensed Product or Licensed Method is Sold as part of a Combination Product,
 the Net Sales from the Combination Product, for the purposes of determining Earned Royalties,
 shall be determined by multiplying the Net Sales of the Combination Product by the fraction,
 A/(A+B) where A is the average sale price of Licensed Product or Licensed Method when Sold
 separately and B is the average sale price of the other Product(s) Sold separately. In the
 event that such average sale price cannot be determined for both the Licensed Product or
 Licensed Method and other Product(s) in the Combination Product, Net Sales for purposes of
 determining Earned Royalties shall be calculated by multiplying the Net Sales of the Combination
 Products by the fraction C/(C+D) where C is Licensee's cost of goods for the Licensed
 Product or Licensed Method and D is Licensee's cost of goods of the other Product(s),
 determined in accordance with U.S. GAAP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.11 "New Developments" means new inventions made by HFHS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.12 "Patent Rights" means the Valid Claims of, to the extent assigned to or otherwise obtained by HFHS, the United States patents and patent applications and their foreign equivalents listed in Appendix A.

Patent Rights shall further include advancements, improvements and expanded claims to this Invention and the Valid Claims of, to the extent assigned to or otherwise obtained by HFHS, any reissues, extensions, substitutions, continuations, divisions, continuation-in-part applications and the corresponding foreign patents and patent applications. This definition of Patent Rights excludes any rights in and to New Developments.

Prior to filing a patent application in any country that names as an inventor Dr. Hani Sabbah or other employee of HFHS, Licensee shall provide HFHS with written notice of the intention to file and a review copy of the proposed patent application. HFHS shall have no less than fifteen (15) days to review any such application and provide comments to Licensee, which Licensee shall review and consider in good faith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.13 "Product" means any kit, article of manufacture, composition of matter, material, compound, component or product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.14 "Related Party" means a corporation, firm or other entity with which, or individual with whom, the Licensee and/or any Sublicensee (or any of their respective stockholders, subsidiaries, Joint Ventures or Affiliates) have any agreement, understanding or arrangement (for example, but not by way of limitation, an option to purchase stock or other equity interest, or an arrangement involving a division of revenue, profits, discounts, rebates or allowances) unrelated to the Sale of the Licensed Products and/or Licensed Methods without which such other agreement, understanding or arrangement, the amounts, if any, charged by the Licensee or any Sublicensee to such entity or individual for the Licensed Product and/or Licensed Method, would be higher than the Net Invoice Price actually received, or if such agreement, understanding or arrangement results in the Licensee or any Sublicensee extending to such entity or individual lower prices for such Licensed Product and/or Licensed Method than those charged to others without such agreement, understanding or arrangement buying similar Products, methods or services in similar quantities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.15 "Relationship-Influenced Sale" means a Sale of a Licensed Product or Licensed Method between the Licensee and/or any Sublicensee and (i) an Affiliate; (ii) a Joint Venture; (iii) a Related Party or (iv) the Licensee and/or a Sublicensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.16 "Relationship-Influenced Sale Purchaser" means the purchaser of Licensed Product or Licensed Method in a Relationship-Influenced Sale.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.17 "Sale" means the act of selling, leasing or otherwise transferring, providing, or furnishing for use for any consideration. Correspondingly, "Sell" means to make or cause to be made a Sale and "Sold" means to have made or caused to be made a Sale.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.18 "Sublicensee" means any person or entity (including any Affiliate or Joint Venture) to which any of the license rights granted to the Licensee hereunder are sublicensed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.19 "Valid Claim" means a claim of a patent or patent application in any country that (i) has not expired or been abandoned; (ii) has not been disclaimed; (iii) has not been cancelled or superseded, or if cancelled or superseded, has been reinstated; and (iv) has not been revoked, held invalid, or otherwise declared unenforceable or not allowable by a tribunal or patent authority of competent jurisdiction over such claim in such country from which no further appeal has or may be taken; provided that if a claim of a pending patent application is continuously pending in the U.S. for more than seven (7) years, then such pending claim shall only be a Valid Claim for the purposes of this Agreement from and after such time as such claim issues. A valid claim in a pending application includes any and all amendments made to the claim.

2. GRANT

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1 Subject to the limitations and other terms and conditions set forth in this Agreement, HFHS grants to the Licensee an exclusive license under its rights in and to Patent Rights to make, have made, use, Sell, offer for Sale and import Licensed Products and to practice or have practiced Licensed Methods, in the United States and in other countries where HFHS may lawfully grant such licenses in the Field of Use.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2 HFHS also grants to the Licensee the right to sublicense to third parties (including to Affiliates and Joint Ventures) the rights granted to the Licensee under this Agreement through multiple tiers of sublicensees, provided that the economic return to HFHS from Sales by such sublicensees is equivalent to what it would have been had the Sales been by Licensee. Licensee will notify HFHS of each sublicense granted hereunder and will provide HFHS with a complete copy of each written sublicense agreement and each amendment to such sublicense within thirty (30) days of issuance of such sublicense or such amendment. The Licensee will collect from Sublicensees and pay to HFHS all fees, payments, royalties and the cash equivalent of any consideration due HFHS.

3. PAYMENT TERMS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1 Earned Royalties are payable on Licensed Products and Licensed Methods covered by pending patent applications and/or issued patents. Earned Royalties will accrue in each country for the duration of Patent Rights in that country when Licensed Products and/or Licensed Methods are invoiced, or if not invoiced, when delivered by the Licensee or Sublicensee in a manner constituting a Net Sale.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2 The Licensee will pay all Earned Royalties to HFHS quarterly on or before February 28 (for the calendar quarter ending December 31), May 31 (for the calendar quarter ending March 31), August 31 (for the calendar quarter ending June 30) and November 30 (for the calendar quarter ending September 30) of each calendar year. Each payment will be for Earned Royalties and other consideration which has accrued within the Licensee's most recently completed calendar quarter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3 Consideration due HFHS will be payable and will be made in United States dollars by check payable to HFHS or by wire transfer to an account designated by HFHS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4 Notwithstanding the provisions of Article 24 (Force Majeure) if at any time legal restrictions prevent the prompt remittance of Earned Royalties or other consideration owed to HFHS by the Licensee with respect to any country where a sublicense is issued or a Licensed Product or Licensed Method is Sold, then the Licensee shall convert the amount owed to HFHS into United States dollars and will pay HFHS directly from another source of funds in order to remit the entire amount owed to HFHS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5 In the event that any patent or claim thereof included within the Patent Rights is held invalid in a final decision by a court of competent jurisdiction and last resort and from which no appeal has or can be taken, then all obligation in that country to pay royalties based on that patent or claim or any claim indistinct therefrom will cease as of the date of final decision. The Licensee will not, however, be relieved from paying any royalties that accrued before such final decision, unless said court of competent jurisdiction makes a legally binding decision otherwise.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6 No Earned Royalties will be collected or paid hereunder to HFHS on Licensed Products or Licensed Methods Sold to the United States Government as provided for in any license to or agreement with the United States Government. The Licensee and its Sublicensees will reduce the amount charged for Licensed Products or Licensed Methods Sold to the United States Government by an amount equal to the Earned Royalty for such Licensed Products or Licensed Methods otherwise due HFHS . Such reduction in Earned Royalties will be in addition to any other reductions in price required by the United States Government.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7 In the event that royalties, fees, reimbursements for Patent Prosecution Costs or other monies owed to HFHS are not received by HFHS when due, the Licensee will pay to HFHS interest at a rate of ten percent (10%) simple interest per annum. Such interest will be calculated from the date payment was due until actually received by HFHS. Such accrual of interest will be in addition to and not in lieu of, enforcement of any other rights of HFHS due to such late payment.

4. LICENSE FEES

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1 The Licensee shall pay to HFHS a license issue fee of thirty-five thousand dollars ($35,000) payable within thirty (30) days of execution of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2 Within thirty (300) days of the Effective Date, the Licensee shall reimburse HFHS $36,000 for legal fees and expenses incurred in relation to the assignment of the assets of LoneStar Heart, Inc./Cardiopolymers, Inc. for the benefit of creditors, and legal fees and expenses incurred in relation to efforts to preserve patent rights and further prosecute patent rights, the bills for which have been received by the date of computation of the above-specified sum. Licensee also shall pay any additional legal fees and expenses to preserve and/or prosecute patent rights that may have been accrued, or that accrue in the future. Licensee shall pay all future patent prosecution duties and costs after the date of this Agreement. The above fees are not creditable against any other payments required to be paid under the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3 The Licensee shall pay to HFHS a license maintenance fee of twenty- five thousand dollars ($25,000) beginning on the one (1) year anniversary of the Effective Date and continuing annually thereafter on each anniversary of the Effective Date. The license maintenance fee is no longer due once the Licensee begins paying an Earned Royalty to HFHS on the Net Sales.

5. EARNED ROYALTIES

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1 The Licensee will also pay to HFHS an earned royalty of one percent (1.0%) of the Net Sales of Licensed Product or Licensed Method by the Licensee or any Affiliate or Joint Venture ("Earned Royalty").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2 In the event the Licensee is obligated to license patent rights owned by an unaffiliated third party or parties in addition to the licenses obtained from HFHS in order to practice Licensed Methods and to make, use or Sell Licensed Products, and the Licensee is required to pay a royalty to both HFHS and the unaffiliated third party under that separate license agreement and the combined Earned Royalty due HFHS and the unaffiliated third party(s) exceeds nine percent (9%), then the Earned Royalties to be paid to HFHS under this Agreement by Licensee shall be reduced by an amount equal to the excess over nine percent (9%) of the combined royalty rate(s) due under any such separate license agreements on a going-forward basis, multiplied by a fraction, the numerator of which is one and the denominator of which is the total number of unaffiliated third parties entitled to royalty payments in connection with the Licensed Product and/or Licensed Method. However, in no event shall the amount paid to HFHS be reduced below three-quarters of a percent (0.75%).

6. DUE DILIGENCE AND MILESTONE PAYMENTS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1 Licensee shall use its best efforts to effect introduction of Licensed Technology into the commercial market as soon as possible. Thereafter, until the termination of this Agreement, Licensee shall keep Licensed Technology reasonably available to the public and actively promoted in commerce.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2 Licensee will deliver to HFHS written reports on Licensee's progress towards achieving such Diligence Milestones at the end of each Fiscal Quarter in sufficient detail to enable HFHS to determine whether Licensee is making sufficient and reasonable progress towards the Diligence Milestones. Licensee agrees to promptly provide HFHS with any additional information HFHS may request from time to time following HFHS' receipt of a written report.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3 Licensee's failure to achieve the Diligence Milestones in accordance with the timeframes and associated terms and conditions set forth in Section 6.4 shall be grounds for HFHS to terminate this Agreement pursuant to Section 11.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4 With respect to the Licensed Product or Licensed Method, the Licensee will pay to HFHS the following non-refundable, non-creditable amounts upon attainment of the milestones set forth below:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4.1 Two-hundred
 thousand dollars ($200,000) upon approval of first IND, IDE, or equivalent with the U.S.
 FDA; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4.2 Five-hundred
 thousand dollars ($500,000) upon grant of first U.S. regulatory market approval; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4.3 One-hundred-twenty-five
 thousand dollars ($125,000) upon approval of second IND, IDE, or equivalent with the U.S.
 FDA; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4.4 Two-hundred-fifty
 thousand dollars ($250,000) upon grant of second U.S. regulatory market approval.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5 For the avoidance of doubt, each of the payments set forth in Paragraphs 6.1 through 6.4 will be payable only once under this Agreement. Furthermore, each such milestone payment will be payable regardless of whether the applicable milestone event has been achieved by the Licensee or any Affiliate, Joint Venture or Sublicensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6 All milestone payments are due to HFHS within ninety (90) days of the occurrence of the applicable milestone event.

7. DEVELOPMENT AND COMMERCIALIZATION

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1 The Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture and Sale of Licensed Products and Licensed Methods and will diligently market the same in quantities sufficient to meet the market demands. The Licensee will obtain all necessary governmental approvals in each country where Licensed Products and Licensed Methods are manufactured, used, Sold, offered for Sale or imported.

8. ROYALTY REPORTS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1 Beginning on June 30, 2022 and annually thereafter until the First Commercial Sale of a Licensed Product or Licensed Method occurs, the Licensee will submit to HFHS a written progress report covering the Licensee's activities related to the development of all Licensed Products and Licensed Methods, the obtaining of the governmental approvals necessary for marketing and the activities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2 The Licensee will report to HFHS the date of First Commercial Sale of a Licensed Product or Licensed Method.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3 Beginning with the First Commercial Sale of a Licensed Product or Licensed Method, the Licensee will make quarterly royalty reports to HFHS on or before each February 28 (for the quarter ending December 31), May 31 (for the quarter ending March 31), August 31 (for the quarter ending June 30) and November 30 (for the quarter ending September 30) of each year. Each royalty report will cover Licensee's most recently completed calendar quarter and will show:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.1 the
 gross invoice prices and Net Sales of Licensed Products or Licensed Methods Sold (itemizing
 the applicable gross proceeds and any deductions therefrom);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.2 the
 quantity of each type of Licensed Product or Licensed Method Sold;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.3 the
 Earned Royalties, in United States dollars, payable with respect to Net Sales;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.4 the
 method used to calculate the Earned Royalty, specifying all deductions taken and the dollar
 amount of each such deduction;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.5 the
 exchange rates used, if any; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.6 any
 other information reasonably necessary to confirm Licensee's calculation of its financial
 obligations hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4 If no Sales of Licensed Products or Licensed Methods have been made during any reporting period, then a statement to this effect must be provided by the Licensee in the immediately subsequent royalty report.

9. BOOKS AND RECORDS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1 Licensee shall keep, and shall cause its Affiliates and Permitted Sublicensees to keep, complete and accurate records pertaining to the Disposition of Licensed Products and Licensed Methods in sufficient detail to permit HFHS to confirm the accuracy of royalty payments due hereunder. Such records shall be kept for no less than three (3) years following the end of the Fiscal Quarter to which they pertain. HFHS may cause an independent, certified public accountant reasonably acceptable to Licensee to audit such records to confirm Net Sales, royalties and other payments for a period covering not more than three (3) years following the Fiscal Quarter to which they pertain. Such audits may be exercised during normal business hours upon reasonable prior written notice to Licensee. The Parties shall make prompt adjustments to reflect the results of such audit. HFHS shall bear the full cost of such audit unless such audit discloses an underpayment by Licensee of more than five percent (5%) of the amount of royalties or other payments due under this Agreement for any applicable Fiscal Quarter, in which case, Licensee shall bear the cost of such audit. In any event, Licensee shall promptly remit to HFHS the amount of any underpayment. Any overpayment by Licensee revealed by an audit shall be credited against future payments owed by Licensee to HFHS (and if no further payments are due, shall be refunded by HFHS at the request of Licensee). In the event of a dispute with respect to any audit under this Section 9, Licensee and HFHS shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party's certified public accountants or to such other person or entity as the Parties shall mutually agree (the "Auditor"). The decision of the Auditor shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Auditor shall determine. Not later than ten (10) days after such decision and in accordance with such decision, Licensee shall pay the additional amounts, with interest from the date originally due as provided in Section 3.2 or HFHS shall reimburse the excess payments, as applicable.

10. LIFE OF THE AGREEMENT

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1 Unless otherwise terminated by operation of law, or by acts of the parties in accordance with the terms of this Agreement, this Agreement will remain in effect from the Effective Date until the expiration or abandonment of the last of the Patent Rights licensed hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2 Any termination or expiration of this Agreement will not affect the rights and obligations set forth in the following Articles, or in any Article which under its terms or by reasonable implication may be performed after termination or expiration of this Agreement:

---

| | |
|:---|:---|
| Article 1 | Definitions |
| Paragraph 3.7 | Late Payments |
| Article 4 | License Fees |
| Article 5 | Earned Royalties |
| Article 9 | Books and Records |
| Article 10 | Life of the Agreement |
| Article 12 | Disposition of Licensed Products and Licensed Methods upon Termination or Expiration |
| Article 13 | Use of Names and Trademarks |
| Article 14 | No Warranty and Limitation of Liability |
| Article 15 | Patent Prosecution and Maintenance |
| Article 18 | Indemnification and Insurance |
| Article 19 | Notices |
| Article 21 | Waiver |
| Article 23 | Governing Laws; Venue |
| Article 26 | Confidentiality |
| Article 27 | Miscellaneous |
| Article 28 | Taxes |
| Article 29 | Electronic Disposition |
| Article 30 | No Contest of Proprietary Rights |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.3 The termination or expiration of this Agreement will not relieve the Licensee of its obligation to pay any fees, royalties or other payments owed to HFHS at the time of such termination or expiration and will not impair any accrued right of HFHS, including the right to receive Earned Royalties in accordance with Articles 5 (Earned Royalties) and 12 (Disposition of Licensed Products and Licensed Methods Upon Termination or Expiration).

11. TERMINATION BY LICENSOR OR LICENSEE

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1 Termination by HFHS. If the Licensee fails to perform or violates any term of this Agreement, then HFHS may give written notice of such default ("Notice of Default") to the Licensee. If the Licensee fails to repair such default within sixty (60) days after the date of such notice, then HFHS will have the right to immediately terminate this Agreement and its licenses by providing a written notice of termination ("Notice of Termination") to the Licensee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2 Termination by Licensee. Licensee has the ability to terminate this License by a written Notice sent on a date subsequent to the third anniversary of Effective Date, providing ninety (90) days' notice of termination.

12. DISPOSITION OF LICENSED PRODUCTS AND LICENSED METHODS UPON TERMINATION OR EXPIRATION

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1 Upon termination (but not expiration) of this Agreement, within a period of one hundred and twenty (120) days after the date of termination, the Licensee is entitled to dispose of all previously made or partially made Licensed Product or Licensed Method, but no more, provided that the Sale or use of such Licensed Product or Licensed Method are made within one (1) year after the date of termination subject to the terms of this Agreement, including, but not limited to, the rendering of reports and payment of Earned Royalties and any other payments therefore required under this Agreement. The Licensee may not otherwise make, Sell, offer for Sale or import Licensed Products or practice the Licensed Method after the date of termination.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2 If applicable Patent Rights exist at the time of any making, Sale, offer for Sale, or import of a Licensed Product or Licensed Method or the time of any Sale or offer for Sale, then Earned Royalties shall be paid at the times provided herein and royalty reports shall be rendered in connection therewith, notwithstanding the absence of applicable Patent Rights with respect to such Licensed Product or Licensed Method at any later time. Any fees or other payments owed to HFHS at the time of expiration not based on the Sales of a Licensed Product or Licensed Method will be paid to HFHS at the time such fee or other payment would have been due had this Agreement not expired.

13. USE OF NAMES AND TRADEMARKS

Nothing contained in this Agreement will be construed as conferring any right to either party to use in advertising, publicity or other promotional activities any name, trade name, trademark or other designation of the other party (including a contraction, abbreviation or simulation of any of the foregoing). Without either party's consent, the Licensee may only list HFHS name as a licensor of technology and HFHS may only list Licensee's name as a licensee of technology from HFHS.

14. NO WARRANTY AND LIMITATION OF LIABILITY

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.1 PATENT RIGHTS WERE PREVIOUSLY LICENSED TO SYMPHONY MEDICAL, INC. HFHS SENT NOTICE OF TERMINATION TO CARDIOPOLYMERS (WHICH HAD MADE AN ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC AND LONESTAR (WHICH HAD MADE AN ASSIGNMENT FOR THE BENEFIT OF CREDITORS), LLC (AS SUCCESSORS TO THE THEN-CURRENT LICENSEE), AFTER THAT ENTITY HAD MADE AN ASSIGNMENT FOR THE BENEFIT OF CREDITORS FOR THE REASON THAT ASSIGNOR HAD BECOME INSOLVENT AND APPOINTED ASSIGNEE TO LIQUIDATE THE ASSETS OF ASSIGNOR. HFHS DOES NOT REPRESENT THAT ANY FORMER LICENSEE OR AN ASSIGNEE WILL NOT MAKE A CLAIM AS TO RIGHTS IN PATENT RIGHTS.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.2 ALL PATENT RIGHTS, INTELLECTUAL PROPERTY, INFORMATION, MATERIALS, SERVICES OR OTHER PROPERTY OR RIGHTS, LICENSED OR PROVIDED OR GENERATED BY HFHS PURSUANT TO THIS AGREEMENT ("DELIVERABLES") ARE PROVIDED ON AN "AS IS" BASIS. HFHS MAKES NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, AS TO ANY MATTER INCLUDING, BUT NOT LIMITED TO, WARRANTY OF FITNESS FOR PARTICULAR PURPOSE, OR MERCHANTABILITY, EXCLUSIVITY OR RESULTS OBTAINED FROM USE. HFHS MAKES NO WARRANTY OF ANY KIND WITH RESPECT TO FREEDOM FROM PATENT, TRADEMARK OR COPYRIGHT INFRINGEMENT OR THEFT OF TRADE SECRETS AND DOES NOT ASSUME ANY LIABILITY HEREUNDER FOR ANY INFRINGEMENT OF ANY PATENT, TRADEMARK OR COPYRIGHT ARISING THEREFROM. THE PARTIES AGREE THAT THEY WILL NOT MAKE ANY WARRANTY ON BEHALF OF THE OTHER PARTY, EXPRESSED OR IMPLIED, TO ANY ENTITY REGARDING PATENT RIGHTS, INCLUDING BUT NOT LIMITED TO CONCERNING THE APPLICATION OF OR THE RESULTS TO BE OBTAINED DURING PERFORMANCE OF THIS AGREEMENT. NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY SPECIAL, EXEMPLARY, INCIDENTIAL, INDIRECT, PUNITIVE, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, INABILITY TO USE PATENT RIGHTS OR ANY APPLICATIONS AND DERIVATIVES THEREOF, REVENUE, AND BUSINESS), WHETHER BASED ON BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), STATUTE, EQUITY, PRODUCT LIABILITY, BREACH, OR OTHERWISE ARISING OUT OF OR RELATED TO THIS AGREEMENT, REGARDLESS OF WHETHER OR NOT THAT PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF ANY SUCH DAMAGES.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 14.3 FOR THE AVOIDANCE OF DOUBT, THIS AGREEMENT DOES NOT:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3.1 EXPRESS
 OR IMPLY A WARRANTY OR REPRESENTATION AS TO THE VALIDITY, ENFORCEABILITY, OR SCOPE OF ANY PATENT RIGHTS; OR

14.3.2 EXPRESS
 OR IMPLY A WARRANTY OR REPRESENTATION THAT ANYTHING MADE, USED, SOLD, OFFERED FOR SALE OR IMPORTED UNDER ANY LICENSE GRANTED IN THIS
 AGREEMENT IS OR WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS, OR OTHER RIGHTS OF THIRD PARTIES; OR

14.3.3 OBLIGATE
 HFHS TO BRING OR PROSECUTE ACTIONS OR SUITS AGAINST THIRD PARTIES FOR PATENT INFRINGEMENT; OR

14.3.4 CONFER
BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS UNDER ANY PATENTS OR PATENT APPLICATIONS OR OTHER RIGHTS OF HFHS OTHER THAN
PATENT RIGHTS, REGARDLESS OF WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO PATENT RIGHTS.

15. PATENT PROSECUTION AND MAINTENANCE

Licensee will diligently prosecute and maintain the United States and foreign patents comprising the Patent Rights using counsel of its choice and bear the costs of preparing, filing, prosecuting and maintaining all United States and foreign patent applications contemplated by this Agreement ("Patent Prosecution Costs"). The Licensee shall use reasonable efforts to amend any patent application to include claims reasonably requested by the other Party to protect the Products contemplated to be Sold, or the Licensed Method to be practiced, under this Agreement. Licensee shall pay the attorneys' fees and other costs incurred if those efforts were incurred in the prosecution of the patents even if those efforts were incurred prior to the Effective Date but the bill therefor has not been included in the calculation of the amount to be paid pursuant to Section 4.2 above.

16. PATENT MARKING

The Licensee will mark all Licensed Products and Licensed Methods made, used or Sold under the terms of this Agreement or their containers in accordance with the applicable patent marking laws.

17. PATENT INFRINGEMENT

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.1 In the event that HFHS or the Licensee learns of infringement of potential commercial significance of any Patent Rights, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the "Infringement Notice").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.2 During the term of this Agreement, the Licensee shall prosecute and/or defend, at its own expense and utilizing counsel of its choice, any infringement of, and/or challenge to, the Patent Rights. Any recovery of damages shall be considered Earned Royalties for all purposes hereunder. The Licensee shall indemnify and hold HFHS harmless against any costs, expenses or liability that may be found or assessed against HFHS in any such suit. HFHS shall provide reasonable assistance to Licensee to enforce the Patent Rights with respect to any infringement, including being a named party in a lawsuit to enforce the Patent Rights.

18. INDEMNIFICATION AND INSURANCE

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1 The Licensee will, and will require its Sublicensees to, indemnify, hold harmless and defend HFHS and its officers, employees and agents, the sponsors of the research that led to Patent Rights and the inventors of the Patent Rights or any invention claimed in patents or patent applications under Patent Rights (including Licensed Products and Licensed Methods contemplated thereunder) and their employers against any and all claims, suits, losses, damage, costs, fees and expenses resulting from, or arising out of, the exercise of this license or any sublicense. This indemnification will include, but not be limited to, any product liability. If HFHS, in its reasonable judgement, believes that there will be a conflict of interest or it will not otherwise be adequately represented by counsel chosen by the Licensee to defend HFHS in accordance with this Paragraph 18.1, then HFHS may retain counsel of its choice to represent it and the Licensee will pay all expenses for such representation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.2 During the term of this Agreement and for three (3) years following its termination or expiration, the Licensee, at its sole cost and expense, shall obtain and maintain general liability insurance coverage in an amount no less than $250,000 to insure it against liability arising from the Patent Rights and/or activities in connection with this License and to its indemnification obligations assumed under this Agreement; evidence of which shall be provided to HFHS following execution of this agreement and subsequently on annual renewal of its policies of insurance, and License shall provide prompt notice to HFHS of any cancellation in its coverage.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.3 Upon the earlier occurrence of (i) clinical validation of the Licensed Products and/or Licensed Methods or (ii) the use, licensing or sublicensing of Licensed Products and Licensed Methods to diagnose or treat human beings, Licensee shall obtain and maintain appropriate coverage of commercial general liability, and product liability insurance in the amount of no less than Three Million Dollars ($3,000,000) per each occurrence/Five Million Dollars ($5,000,000) in the general aggregate to protect HFHS, its trustees, officers, employees, attorneys, and agents under the indemnification provided hereunder. HFHS, its trustees, officers, employees, attorneys, and agents shall be named as additional insureds on Licensee's insurance policies and shall be provided appropriate certificates of insurance thereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.4 HFHS will promptly notify the Licensee in writing of any claim or suit brought against HFHS for which HFHS intends to invoke the provisions of this Article 18 (Indemnification and Insurance). The Licensee will keep HFHS informed of its defense of any claims pursuant to this Article 18 (Indemnification and Insurance).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.5 HFHS may periodically evaluate the adequacy of the minimum coverage of insurance and deductible limits specified in this Section 18. HFHS reserves the right to require Licensee to adjust the insurance coverage by modifying the types of required coverages, the limits and/or financial rating and/or the method of financial rating of Licensee's insurers as such changes are required of HFHS by its insurance carrier. HFHS shall provide Licensee with reasonable notice, contingent on HFHS receiving timely notice from its insurance carrier, of any proposed modification and, if so requested by Licensee, discuss any proposed modifications in good faith. Should any of the requirements of this Section 18 not be available in the insurance market at commercially reasonable rates or at all, the parties shall work together in good faith to achieve a commercially reasonable resolution thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.6 Each policy of insurance which Licensee is required to obtain hereunder shall (a) be with reputable and financially secure insurance carriers having at least an A rating (A rating or above by A. M. Best) and an A. M. Best Class Size of at least VIII, (b) list each of HFHS, its trustees, officers, employees, faculty, staff, students, agents and their respective successors, heirs and assigns as additional insured, (c) be endorsed to provide that the insurer waives all subrogation rights which the insurer otherwise has or could have against any additional insured, (d) be primary in respect of all additional insured, and (e) provide that the identified insurer will not cancel or fail to renew the identified insurance without giving HFHS at least 30 days' prior written notice thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.7 Within thirty (30) days following the Effective Date, and thereafter, no later than the day on which any such policy of insurance is renewed or replaced, Licensee shall provide HFHS with a Certificate of Insurance from each such insurer which evidences compliance by Licensee with its obligations hereunder. Upon the from-time- to-time request of HFHS, Licensee shall provide HFHS with a copy of the policy, status of claims and claims history respecting any of the insurance required to be maintained by Licensee hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.8 Licensee will comply with all statutory workers' compensation and employers' liability requirements for activities performed under this Agreement.

19. NOTICES

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1 Any notice or payment required to be given to either party under this Agreement will be in writing and will be deemed to have been properly given and to be effective as of the date specified below if delivered to the respective address given below or to another address as designated by written notice given to the other party:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1.1 on
 the date of delivery if delivered in person;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1.2 on
 the date of mailing if mailed by first-class certified mail, postage paid;

or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1.3 on
 the date of mailing if mailed by any global express carrier service that requires the recipient
 to sign the documents demonstrating the delivery of such notice or payment.

---

| | |
|:---|:---|
| In the case of Licensee: | MateraCor, Inc. |
|  | 30965 La Brise |
|  | Laguna Niguel, CA. 92677 |
|  | Attention: Chief Executive Officer |
| In the case of HFHS: | Henry Ford Health System<br> Henry Ford Hospital,<br> ER-7 2799 W. Grand Blvd. |
|  | Detroit MI. 48202-3450 |
|  | Attention: |

---

---

| |
|:---|
| Lisa Prasad |
| Vice President & Chief Innovation Officer |
| Referring to: Exclusive License Agreement for stem cell products to treat heart failure, Inventor Hani Sabbah, Ph.D., et al. |
| Copy to: |
| Office of General Counsel |
| Henry Ford Health System |
| One Ford Place |
| Suite 4B |
| Detroit, MI 48202 |

---

20. ASSIGNABILITY

The Licensee may assign or transfer this Agreement, including by merger, operation of law, or otherwise, without HFHS' prior written consent provided, however, that Licensee and such assignee or transferee agrees to be bound by the terms and conditions of this Agreement at the time of the assignment or transfer. This Agreement is binding upon and will inure to the benefit of HFHS, its successors and assigns.

21. WAIVER

No waiver by either party of any breach or default of any of the agreements contained herein will be deemed a waiver as to any subsequent and/or similar breach or default. No waiver will be valid or binding upon the parties unless made in writing and signed by a duly authorized officer of each party.

22. FORCE MAJEURE

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.1 Except for the Licensee's obligation to make any payments to HFHS hereunder, the parties shall not be responsible for any failure to perform due to the occurrence of any events beyond their reasonable control which render their performance impossible or onerous, including, but not limited to: accidents (environmental, toxic spill, etc.); acts of God; biological or nuclear incidents; casualties; earthquakes; fires; floods; governmental acts; orders or restrictions; inability to obtain suitable and sufficient labor, transportation, fuel and materials; local, national or state emergency; power failure and power outages; acts of terrorism; strike; and war.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.2 Either party to this Agreement, however, will have the right to terminate this Agreement upon thirty (30) days' prior written notice if either party is unable to fulfill its obligations under this Agreement due to any of the causes specified in Paragraph 22.1 for a period of one (I) year after the Force Majeure event.

23. GOVERNING LAWS; VENUE

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.1 THIS AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF MICHIGAN, excluding any choice of law rules that would direct the application of the laws of another jurisdiction and without regard to which party drafted particular provisions of this Agreement, but the scope and validity of any patent or patent application will be governed by the applicable laws of the country of such patent or patent application.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23.2 Any legal action brought by the parties hereto relating to this Agreement will be conducted in Wayne County, Michigan. Each party consents to the jurisdiction of the state and federal courts located in Wayne County, Michigan.

24. GOVERNMENT APPROVAL OR REGISTRATION

If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, the Licensee will assume all legal obligations to do so. The Licensee will notify HFHS if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. The Licensee will make all necessary filings and pay all costs including fees, penalties and all other out-of-pocket costs associated with such reporting or approval process.

25. COMPLIANCE WITH LAWS

The Licensee shall comply with all applicable international, national, state, regional and local laws and regulations in performing its obligations hereunder and in its use, manufacture, Sale or import of the Licensed Products or practice of the Licensed Method. The Licensee will observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and/or Licensed Methods and related technical data of either to foreign countries, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations. The Licensee shall manufacture Licensed Products and practice the Licensed Methods in compliance with applicable government importation laws and regulations of a particular country for Licensed Products or Licensed Methods made outside the particular country in which such Licensed Products and Licensed Methods are used or Sold.

26. CONFIDENTIALITY

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.1 The Licensee and HFHS will treat and maintain the other party's proprietary business, patent prosecution, software, engineering drawings, process and technical information and other proprietary information, including the negotiated terms of this Agreement and any progress reports and royalty reports ("Proprietary Information") in confidence using at least the same degree of care as the receiving party uses to protect its own proprietary information of a like nature from the date of disclosure until five (5) years after the termination or expiration of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.2 The Licensee and HFHS may use and disclose Proprietary Information to their employees, agents, attorneys, consultants, contractors and, in the case of the Licensee, its Sublicensees, provided that such parties are bound by a like duty of confidentiality as that found in this Article 26 (Confidentiality). Notwithstanding anything to the contrary contained in this Agreement, HFHS may release this Agreement, including any terms contained herein and information regarding royalty payments or other income received in connection with this Agreement to the inventors, senior administrative officials employed by HFHS and attorneys and accountants who represent HFHS, upon their request. If such release is made, HFHS will request that such terms be kept in confidence in accordance with the provisions of this Article 26 (Confidentiality). In addition, notwithstanding anything to the contrary in this Agreement, if a third party inquires whether a license to Patent Rights is available or if legal proceedings are involved, then HFHS may disclose the existence of this Agreement and the extent of the grant in Article 2 (Grant) and related definitions to such third party, but will not disclose the name of the Licensee unless Licensee has already made such disclosure publicly.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.3 All written Proprietary Information will be labeled or marked confidential or proprietary. If the Proprietary Information is orally disclosed, it will be reduced to writing or some other physically tangible form, marked and labeled as confidential or proprietary by the disclosing party and delivered to the receiving party within thirty (30) days after the oral disclosure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.4 Nothing contained herein will in any way restrict or impair the right of the Licensee or HFHS to use or disclose any Proprietary Information:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.4.1 that
 recipient can demonstrate by written records was previously known to it prior to its disclosure
 by the disclosing party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.4.2 that
 recipient can demonstrate by written records is now, or becomes in the future, public knowledge
 other than through acts or omissions of recipient; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.4.3 that
 recipient can demonstrate by written records was lawfully obtained without restrictions on
 the recipient from sources independent of the disclosing party.

The Licensee or HFHS also may use or disclose Proprietary Information that is required to be disclosed (i) to a governmental entity or agency in connection with seeking any governmental or regulatory approval, governmental audit, or other governmental contractual requirement or (ii) to enforce a Party's rights hereunder or (iii) by law, provided that the recipient uses reasonable efforts to give the party owning the Proprietary Information sufficient notice of such required disclosure to allow the party owning the Proprietary Information reasonable opportunity to object to, and to take legal action to prevent, such disclosure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26.5 Upon termination of this Agreement, the Licensee and HFHS will destroy or return any of the disclosing party's Proprietary Information in its possession within fifteen (15) days following the termination of this Agreement. The Licensee and HFHS will provide each other, within thirty (30) days following termination, with written notice that such Proprietary Information has been returned or destroyed. Each party may, however, retain one copy of such Proprietary Information for archival purposes in non-working files.

27. MISCELLANEOUS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.1 The headings of the several paragraphs, articles and sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.2 This Agreement is not binding on the parties until it has been signed below on behalf of each party. It is then effective as of the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.3 No amendment or modification of this Agreement is valid or binding on the parties unless made in writing and signed on behalf of each party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.4 This Agreement embodies the entire understanding of the parties and supersedes all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof. ·

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.5 In case any of the provisions contained in this Agreement is held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect any other provisions of this Agreement and this Agreement will be construed as if such invalid, illegal or unenforceable provisions had never been contained in it.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.6 No provisions of this Agreement are intended or shall be construed to confer upon or give to any person or entity other than HFHS and the Licensee any rights, remedies or other benefits under, or by reason of, this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.7 Licensee agrees that HFHS shall have the right to audit the books and records of Licensee at any time, upon 3 days advance notice, to validate the calculation of amounts payable by Licensee to HFHS hereunder. In the event that the results of an audit reflect that Licensee has underpaid HFHS in the amount of $10,000 or more, then Licensee shall promptly pay HFHS the under payment amount, and Licensee shall reimburse HFHS for reasonable costs incurred in performing such audit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.8 In performing their respective duties under this Agreement, each of the parties will be operating as an independent contractor. Nothing contained herein will in any way constitute any association, partnership, or joint venture between the parties hereto, or be construed to evidence the intention of the parties to establish any such relationship. Neither party will have the power to bind the other party or incur obligations on the other party's behalf without the other party's prior written consent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27.9 All prior agreements between the Parties are revoked and all obligations and claims arising from the prior agreements are extinguished and waived.

28. TAXES

Other than taxes imposed by the United States of America or the State of Michigan, or jurisdictions within such State, Licensee shall pay all taxes which may be assessed or levied on, or on account of, the Patent Rights licensed hereunder, Licensed Products or Licensed Methods made, used or Sold hereunder and all taxes levied on or on account of the amounts payable to, or for the account of, HFHS under this Agreement.

29. ELECTRONIC DISPOSITION OF DOCUMENT

The Parties agree that a printout of the scanned executed version of this document may serve as the original of this writing. The electronically stored copy of this Agreement is considered to be the true, complete, valid, authentic and enforceable record, admissible in judicial, administrative or arbitration proceedings to the same extent as if the documents and records were originally generated and maintained in printed form. The Parties agree to not contest the admissibility or enforceability of this electronically stored copy of such documents in any proceeding between the Parties.

30. NO CONTEST OF PROPRIETARY RIGHTS

Licensee shall not contest HFHS's right to license Patent Rights based upon the prior license granted to Symphony Medical, Inc. or its successors.

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed in duplicate counterparts, each of which shall be deemed to constitute an original effective as of the latest date of signature below.

The undersigned verify, subject to the penalties of Section 750.423 of the Michigan Penal Code relating to perjury, that they have the authority to bind to this Agreement the Party on behalf of which they are executing below.

---

| | | | |
|:---|:---|:---|:---|
| MATERACOR. | MATERACOR. | HENRY FORD HEALTH SYSTEM | HENRY FORD HEALTH SYSTEM |
| BY: | ![](ex10-7_001.jpg) | BY: | ![](ex10-7_002.jpg) |
| Name: | Frank Ahmann | Name: | Lisa Prasad |
| Title: | President & CEO | Title: | Vice President & Chief Innovation Officer |

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**APPENDIX A**

List of Patents and Patent Applications

United States Patent US.9,782,258B2

Title: Intramyocardial patterning for global cardiac resizing and reshaping

US Patent Application Number: US11900005

Filing Date: 9/7/2007

US Publication Number: US9782258B2

US Related Applications: US60843475 Provisional Application, US20080065048 Prior Application

United States Patent US20160338831A1

Title: INTRAMYOCARDIAL PATTERNING FOR GLOBAL CARDIAC RESIZING AND RESHAPING

US Patent Application Number: US15161255

Filing Date: 5/22/2016

US Publication Number: US20160338831A1

US Related Applications: US11899962 Division, US60843475Provisional Application

United States Patent US.9,375,313B2

Title: Intramyocardial patterning for global cardiac resizing and reshaping

US Patent Application Number: US11899962

Filing Date: 9/7/2007

US Publication Number: US9375313B2

US Related Applications: US60843475 Provisional Application, US20080065046 Prior Application

United States Patent US20140330249A1

Title: Apparatus and Method for Controlled Depth of Injection into Myocardial Tissue

US Patent Application Number: US14333891

Filing Date: 7/17/2014

US Publication Number: US20140330249A1

US Related Applications: US12421541 Division, US61123661 Provisional Application

United States Patent US.8,801,665B2

Title: Apparatus and method for controlled depth of injection into myocardial tissue

US Patent Application Number: US12421541

Filing Date: 4/9/2009

US Publication Number: US8801665B2

US Related Applications: US61123661 Provisional Application, US20090259212Prior Application

United States Patent US.8,419,711B2

Title: Cardiac repair, resizing and reshaping using the venous system of the heart

US Patent Application Number: US12972186

Filing Date: 12/17/2010

US Publication Number: US8419711B2

US Related Applications: US12082368 Continuation, US60922930 Provisional Application, US60934042 Provisional Application, US60934109 Provisional Application, US60934111 Provisional Application, US20110087190 Prior Application

United States Patent US.7,875,017B2

Title: Cardiac repair, resizing and reshaping using the venous system of the heart US Patent Application Number: US12082368

Filing Date: 4/10/2008

US Publication Number: US7875017B2

US Related Applications: US60922930 Provisional Application, US60934042 Provisional Application, US60934109 Provisional Application, US60934111 Provisional Application, US20080269720 Prior Application

Patent WO2010028310A2

Title: APPARATUS AND METHOD FOR CAPSULE FORMATION IN TISSUE

US Patent Application Number: WOUS09056129 Filing Date: 9/4/2009

Publication Number: WO2010028310A2

Related Applications: JP5685190B2, CN104225763A, WO2010028310A2, WO2010028310A3, EP2331184B1, JP2014166585A, EP2331189B1, CN102202721A, AU2009289484A1, JP2012506718A, JP2014057889A, AU2009289479B2, JP5620384B2, CN102202721B, EP2331189A2, JP2015013198A, WO2010028305A2, EP2331189A4, WO2010028305A3, CN102202718A, EP2331184A2, CN104398315A, EP2331184A4. ES2617871T3, AU2009289484B2, CN102202718B, ES2569385T3, AU2009289479A1, JP5806726B2, US20120041393A1, US20110213400A1, JP2012501755A

United States Patent US.7,658,951B2

Title: Method of improving cardiac function of a diseased heart US Patent Application Number: US10700032

Filing Date: 11/3/2003

US Publication Number: US7658951B2

US Related Applications: WOUS0202959500 Continuation In Part, US60323351 Provisional Application, US20040180043 Prior Application

## Exhibit 23.1

**Exhibit 23.1**

**CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**

We consent to the inclusion in the foregoing Amendment No.1 to Form S-1 Regulation Statement of our report February 9, 2026, relating to our audit of the financial statements of Bioventrix, Inc. as of December 31, 2025 and 2024 and for the periods then ended, and the reference to our firm under the caption "Experts" in the Offering Statement.

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| |
|:---|
| /s/M&K CPAS, PLLC |
| The Woodlands, Texas |
| March 17, 2026 |

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## Exhibit 10.8

**Exhibit 10.8**

![](ex10-8_001.jpg)

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| | |
|:---|:---|
| **Lisa Prasad**<br> **Vice President &**<br> **Chief Innovation Officer**<br> **Henry Ford Health System** | February 12, 2025 |
| **Henry Ford Hospital**<br> **2799 W. Grand Blvd.**<br> **(313) 916-7044<br> Lprasad1@hfhs.org** | David S. Richmond<br> CEO<br> BioVentrix, Inc.<br> 120 Forbes Boulevard, Suite 125<br> Mansfield, MA 02048 |
|  | Subject: Agreement on Annual Minimum Payment Adjustment |
|  | Dear Mr. Richmond, |
|  | This letter serves to confirm the agreement between Henry Ford Health (HFH) and BioVentrix, Inc. (BioVentrix) regarding an adjustment to the annual minimum payment under the Exclusive License Agreement dated December 28, 2021. |
|  | Per our discussions, the parties agree to adjust the annual minimum payment to 65% of $25,000, which amounts to $16,250 per payment. This adjustment applies retroactively to the two payments currently owed to HFH, resulting in a total outstanding amount of $32,500. All future annual minimum payments shall also reflect this adjusted amount unless otherwise modified in writing by both parties. |
|  | As part of this agreement, HFH will not take further action to reinstate the lapsed German and Italian patents under EP2282798. |
|  | This letter serves as a formal record of our agreement. Please acknowledge your acceptance of these terms by signing below. |

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![](ex10-8_002.jpg)

![](ex10-8_001.jpg)

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| | |
|:---|:---|
| **Lisa Prasad**<br> **Vice President &**<br> **Chief Innovation Officer**<br> **Henry Ford Health System** | Should you have any questions or require further clarification, please do not hesitate to reach out.<br>Sincerely, |
| **Henry Ford Hospital** | /s/ Lisa Prasad |
| <br> **2799 W. Grand Blvd.**<br> **(313) 916-7044<br> Lprasad1@hfhs.org** | <br> Lisa Prasad<br>Vice President, and Chief Innovation Office<br> Henry Ford Innovations |

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| | |
|:---|:---|
| Acknowledged and Agreed: | Acknowledged and Agreed: |
| BioVentrix, Inc. | BioVentrix, Inc. |
| By: | /s/ Dave Richmond |
| Name: | Dave Richmond |
| Title: | Co-CEO |
| Date: | 2/14/2025 |

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![](ex10-8_002.jpg)