# EDGAR Filing Document

**Accession Number:** 0001417926
**File Stem:** 0001493152-23-009047
**Filing Date:** 2023-3
**Character Count:** 282195
**Document Hash:** 97a5afb2eb6ddee4d7ff33dc61587962
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-009047.hdr.sgml**: 20230327

**ACCESSION NUMBER**: 0001493152-23-009047

**CONFORMED SUBMISSION TYPE**: 424B5

**PUBLIC DOCUMENT COUNT**: 1

**FILED AS OF DATE**: 20230327

**DATE AS OF CHANGE**: 20230327

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** INVO Bioscience, Inc.
- **CENTRAL INDEX KEY:** 0001417926
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 204036208
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 424B5
- **SEC ACT:** 1933 Act
- **SEC FILE NUMBER:** 333-255096
- **FILM NUMBER:** 23763211

**BUSINESS ADDRESS:**
- **STREET 1:** 5582 BROADCAST COURT
- **CITY:** SARASOTA
- **STATE:** FL
- **ZIP:** 34240
- **BUSINESS PHONE:** (978) 878-9505

**MAIL ADDRESS:**
- **STREET 1:** 5582 BROADCAST COURT
- **CITY:** SARASOTA
- **STATE:** FL
- **ZIP:** 34240

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** EMY'S SALSA AJI DISTRIBUTION COMPANY, INC.
- **DATE OF NAME CHANGE:** 20071108

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| |
|:---|
| **Filed pursuant to Rule 424(b)(5)** |
| **Registration No. 333-255096** |

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Prospectus Supplement

(to Prospectus dated April 16, 2021)

**INVO BIOSCIENCE, INC.**

**1,380,000 Shares of Common Stock**

**Pre-Funded Warrants to Purchase 2,300,000 Shares of Common Stock**

We are offering 1,380,000 shares of our common stock, par value $0.0001 per share, and pre-funded warrants to purchase 2,300,000 shares of our common stock (and the shares of common stock underlying such pre-funded warrants) directly to certain institutional investors pursuant to this prospectus supplement and the accompanying prospectus. The offering price of the shares and pre-funded warrants is $0.815 and $0.805, respectively (each being coupled with one and a half (1.5) private placement warrants).

The purchase price of each pre-funded warrant is equal to the price per one share of common stock, minus $0.01, and the remaining exercise price of each pre-funded warrant will equal $0.01 per share. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. This prospectus supplement also relates to the offering of shares of common stock issuable upon exercise of such pre-funded warrants.

In a concurrent private placement, we are also selling to the investors private placement warrants to purchase 5,520,000 shares of our common stock at an exercise price of $0.63 per share. The private placement warrants and the shares of common stock issuable upon the exercise of such warrants are not being registered under the Securities Act of 1933, as amended, or the Securities Act, and are not being offered pursuant to this prospectus supplement and the accompanying prospectus and are being offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder. The private placement warrants are immediately exercisable, and will expire eight years from the issuance date.

Our common stock is listed on The Nasdaq Capital Market, or Nasdaq, under the symbol "INVO." On March 22, 2023, the last reported sale price of our common stock on The Nasdaq Capital Market was $0.8143 per share.

As of the date of this prospectus supplement, the aggregate market value of our outstanding common stock held by non-affiliates, or our public float, was approximately $9,860,238, based on 12,108,852 outstanding shares of common stock held by non-affiliates and a per share price of $0.8143, which was the closing price of our common stock on March 22, 2023 and is the highest closing sale price of our common stock on The Nasdaq Capital Market within the prior 60 days. In no event will we sell securities pursuant to a Registration Statement on Form S-3 in a public primary offering with value exceeding more than one-third of our public float in any 12-month calendar period so long as our public float remains below $75 million and General Instruction I.B.6 of Registration Statement on Form S-3 continues to apply to us. As of the date of this prospectus supplement, we have not sold any securities pursuant to General Instruction I.B.6. of Registration Statement on Form S-3 during the prior 12-month calendar period that ends on, and includes, the date of this prospectus supplement (but excluding this offering). We are thus currently eligible to offer and sell up to an aggregate of $3,286,746 of our securities pursuant to General Instruction I.B.6 of Form S-3.

**Investing in our securities involves a high degree of risk. Before buying any of our securities, you should carefully read "Risk Factors" on page S-9 of this prospectus supplement, on page 6 of the accompanying prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus.**

We have engaged Maxim Group LLC to act as our exclusive placement agent in connection with this offering to use its reasonable best efforts to place the securities offered by this prospectus supplement. We have agreed to pay the placement agent the fees set forth in the table below.

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| | | | |
|:---|:---|:---|:---|
|  | **Per Share of Common Stock** | **Per Pre- Funded Warrant** | **Total** |
| Offering price | $0.81500 | $0.80500 | $2976200 |
| Placement agent's fees <sup>(1)</sup> | $0.04075 | $0.04025 | $148810 |
| Proceeds, before expenses, to us | $0.77425 | $0.76475 | $2827390 |

---

(1) We have agreed to reimburse the placement agent for certain offering-related expenses up to an aggregate of $55,000, which are not included herein. See "Plan of Distribution."

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

Delivery of the shares of common stock and pre-funded warrants being offered pursuant to this prospectus supplement and the accompanying prospectus is expected to be made on or about March 27, 2023, subject to customary closing conditions.

**MAXIM GROUP LLC**

***Sole Placement Agent***

 

**The date of this prospectus supplement is March 23, 2023**

**TABLE OF CONTENTS**

**Prospectus Supplement**

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| | |
|:---|:---|
|  | **Page** |
| [ABOUT THIS PROSPECTUS SUPPLEMENT](#A_001) | S-1 |
| [SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS](#A_002) | S-2 |
| [PROSPECTUS SUPPLEMENT SUMMARY](#A_004) | S-3 |
| [THE OFFERING](#A_005) | S-8 |
| [RISK FACTORS](#A_006) | S-9 |
| [USE OF PROCEEDS](#A_007) | S-15 |
| [CAPITALIZATION](#kuttyma_001) | S-15 |
| [DILUTION](#A_008) | S-16 |
| [DESCRIPTION OF SECURITIES THAT WE ARE OFFERING](#A_009) | S-16 |
| [PRIVATE PLACEMENT TRANSACTION](#A_010) | S-17 |
| [PLAN OF DISTRIBUTION](#A_011) | S-19 |
| [LEGAL MATTERS](#A_012) | S-22 |
| [EXPERTS](#A_013) | S-22 |
| [WHERE YOU CAN FIND MORE INFORMATION](#A_014) | S-22 |
| [INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE](#A_015) | S-23 |
| [INDEX TO COMBINED FINANCIAL STATEMENTS](#A_016) | S-F-1 |

---

**Prospectus**

---

| | |
|:---|:---|
|  | **Page** |
| [ABOUT THIS PROSPECTUS](#B_001) | 1 |
| [WHERE YOU CAN FIND MORE INFORMATION](#B_002) | 2 |
| [INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE](#B_003) | 2 |
| [THE COMPANY](#B_004) | 4 |
| [RISK FACTORS](#B_005) | 6 |
| [USE OF PROCEEDS](#B_006) | 6 |
| [DESCRIPTION OF CAPITAL STOCK WE MAY OFFER](#B_007) | 7 |
| [DESCRIPTION OF DEBT SECURITIES WE MAY OFFER](#B_008) | 9 |
| [DESCRIPTION OF WARRANTS WE MAY OFFER](#B_009) | 17 |
| [DESCRIPTION OF UNITS WE MAY OFFER](#B_010) | 20 |
| [GLOBAL SECURITIES](#B_011) | 21 |
| [PLAN OF DISTRIBUTION](#B_012) | 24 |
| [LEGAL MATTERS](#B_013) | 25 |
| [EXPERTS](#B_014) | 25 |

---

**No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus supplement or the accompanying prospectus. You must not rely on any unauthorized information or representations. This prospectus supplement and the accompanying prospectus are an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus supplement and the accompanying prospectus is current only as of their respective dates.**

S-i

**ABOUT THIS PROSPECTUS SUPPLEMENT**

We have filed with the SEC a Registration Statement on Form S-3 (File No. 333-255096) utilizing a shelf registration process relating to the securities described in this prospectus supplement, which registration statement was declared effective on April 16, 2021. Under this shelf registration process, we may, from time to time, sell up to $35 million in the aggregate of shares of common stock, shares of preferred stock, debt securities, warrants, rights or units.

This document consists of two parts. The first part is the prospectus supplement, including the documents incorporated by reference herein, which describes the specific terms of this offering. The second part, the accompanying prospectus, including the documents incorporated by reference therein, provides more general information. In general, when we refer only to the prospectus, we are referring to both parts of this document combined. Before you invest, you should carefully read this prospectus supplement, the accompanying prospectus, all information incorporated by reference herein and therein, as well as the additional information described under the heading "Where You Can Find More Information." These documents contain information you should carefully consider when deciding whether to invest in our securities.

This prospectus supplement may add, update or change information contained in the accompanying prospectus. To the extent there is a conflict between the information contained in this prospectus supplement and the accompanying prospectus, you should rely on information contained in this prospectus supplement, provided that if any statement in, or incorporated by reference into, one of these documents is inconsistent with a statement in another document having a later date, the statement in the document having the later date modifies or supersedes the earlier statement. Any statement so modified will be deemed to constitute a part of this prospectus only as so modified, and any statement so superseded will be deemed not to constitute a part of this prospectus.

You should rely only on the information contained in this prospectus supplement, the accompanying prospectus, any document incorporated by reference herein or therein, or any free writing prospectuses we may provide to you in connection with this offering. Neither we nor the sales agent has authorized anyone to provide you with any different information. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may provide to you. The information contained in this prospectus supplement, the accompanying prospectus, and in the documents incorporated by reference herein or therein is accurate only as of the date such information is presented. Our business, financial condition, results of operations and prospects may have changed since that date.

This prospectus supplement and the accompanying prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the securities to which it relates, nor do this prospectus supplement and the accompanying prospectus constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction.

Securities offered pursuant to the registration statement to which this prospectus supplement relates may only be offered and sold if not more than three years have elapsed since April 16, 2021, the initial effective date of the registration statement, subject to the extension of this period in compliance with applicable SEC rules.

We note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference herein were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreement, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

Unless the context indicates otherwise, as used in this prospectus supplement, the terms "INVO," the "Company," "we," "us" and "our" refer to INVO Bioscience, Inc. and its subsidiaries on a consolidated basis.

**SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS**

This prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein and therein, including the sections entitled "Risk Factors", contain "forward-looking statements" within the meaning of Section 21(E) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Section 27A of the Securities Act. These forward-looking statements include, without limitation: statements regarding proposed new products or services; statements concerning litigation or other matters; statements concerning projections, predictions, expectations, estimates or forecasts for our business, financial and operating results and future economic performance; statements of our management's goals and objectives; statements concerning our competitive environment, availability of resources and regulation; trends affecting our financial condition, results of operations or future prospects; our financing plans or growth strategies; and other similar expressions concerning matters that are not historical facts. Words such as "may", "will", "should", "could", "would", "predicts", "potential", "continue", "expects", "anticipates", "future", "intends", "plans", "believes" and "estimates," and variations of such terms or similar expressions, are intended to identify such forward-looking statements.

Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by which, that performance or those results will be achieved. Forward-looking statements are based on information available at the time they are made and/or our management's good faith belief as of that time with respect to future events. Our actual results may differ materially from those expressed in, or implied by, the forward-looking statements due to a number of factors including, but not limited to, those set forth under the heading "Risk Factors" in this prospectus supplement and the accompanying prospectus, as well as other risks discussed in documents that we file with the SEC.

Forward-looking statements speak only as of the date they are made. You should not put undue reliance on any forward-looking statements. We assume no obligation to update forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. If we do update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. You should review our subsequent reports filed with the SEC described in the sections of this prospectus supplement and the accompanying prospectus entitled "Where You Can Find More Information" and "Incorporation of Certain Documents by Reference," all of which are accessible on the SEC's website at *www.sec.gov*.

**INDUSTRY AND MARKET DATA**

Unless otherwise indicated, information contained in this this prospectus supplement and the accompanying prospectus concerning our industry and the market in which we operate, including our market position, market opportunity and market size, is based on information from various sources, on assumptions that we have made based on such data and other similar sources and on our knowledge of the markets for our products. These data sources involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

We have not independently verified any third-party information. While we believe the market position, market opportunity and market size information included in this prospectus supplement and the accompanying prospectus is generally reliable, such information may be imprecise. In addition, projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate is necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled "Risk Factors" and elsewhere in this prospectus supplement. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

**PROSPECTUS SUPPLEMENT SUMMARY**

*This summary highlights selected information about the Company, this offering and information appearing elsewhere in this prospectus supplement, in the accompanying prospectus, and in the documents we incorporate by reference. This summary is not complete and does not contain all the information that you should consider before investing in our securities. You should read this entire prospectus supplement and the accompanying prospectus carefully, including the "Risk Factors" contained in this prospectus supplement beginning on page S-9, and the risk factors, financial statements and notes incorporated by reference herein as well as the combined financial statements of our prospective acquisition of the Wisconsin Fertility Institute beginning on page S-F-1, before making an investment decision. This prospectus supplement may add to, update or change information in the accompanying prospectus.*

**Company Overview**

We are a commercial-stage fertility company dedicated to expanding the assisted reproductive technology ("ART") marketplace by making fertility care accessible and inclusive to people around the world. Our flagship product is INVOcell, a revolutionary medical device that allows fertilization and early embryo development to take place *in vivo* within the woman's body. Our primary mission is to implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. This treatment solution is the world's first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as "IVC", provides patients a more natural, intimate and more affordable experience in comparison to other ART treatments. The IVC procedure can deliver comparable results at a lower cost than traditional *in vitro* fertilization ("IVF") and is a significantly more effective treatment than intrauterine insemination ("IUI"). Our commercialization strategy is focused on the opening of dedicated "INVO Centers" offering the INVOcell and IVC procedure (with three centers in North America now operational) and the acquisition of existing IVF clinics, in addition to continuing to sell our technology solution into existing fertility clinics.

**Operations**

We operate with a core internal team and outsource certain operational functions in order to help accelerate our efforts as well as reduce internal fixed overhead needs and in-house capital equipment requirements. Our most critical management and leadership functions are carried out by our core management team. We have contracted out the manufacturing, packaging/labeling and sterilization of the device to a contract medical manufacturing company that completes final product manufacturing as well as manages the gamma sterilization process at a U.S. Food and Drug Administration ("FDA") registered contract sterilization facility.

**Market Opportunity**

The global ART marketplace is a large, multi-billion industry growing at a strong pace in many parts of the world as increased infertility rates, increased patient awareness, acceptance of treatment options, and improving financial incentives such as insurance and governmental assistance continue to drive demand. According to the European Society for Human Reproduction 2020 ART Fact Sheet, one in six couples worldwide experience infertility problems. Additionally, the worldwide market remains vastly underserved as a high percentage of patients in need of care continue to go untreated each year for many reasons, but key among them are capacity constraints and cost barriers. While there have been large increases in the use of IVF, there are still only approximately 2.6 million ART cycles, including IVF, IUI and other fertility treatments, performed globally each year, producing around 500,000 babies. This amounts to less than 3% of the infertile couples worldwide being treated and only 1% having a child though IVF. The industry remains capacity constrained which creates challenges in providing access to care to the volume of patients in need. A survey by "Resolve: The National Infertility Association," indicates the two main reasons couples do not use IVF is cost and geographical availability (and/or capacity).

In the United States, infertility, according to the American Society of Reproductive Medicine (2017), affects an estimated 10%-15% of the couples of childbearing-age. According to the Centers for Disease Control ("CDC"), there are approximately 6.7 million women with impaired fertility. Based on preliminary 2020 data from the CDC's National ART Surveillance System, approximately 326,000 IVF cycles were performed at 449 IVF centers, leaving the U.S. with a large, underserved patient population, which is similar to most markets around the world.

**Competitive Advantages**

We believe that the INVOcell, and the IVC procedure it enables, have the following key advantages:

<u>Lower cost than IVF with equivalent efficacy</u>. The IVC procedure can be offered for less than IVF due to lower cost of supplies, labor, capital equipment and general overhead. The laboratory equipment needed to perform an IVF cycle is expensive and requires ongoing costs as compared to what is required for an IVC cycle. As a result, we also believe INVOcell and the IVC procedure enable a clinic and its laboratory to be more efficient as compared to conventional IVF.

The IVC procedure is currently being offered at practicing clinics at a range of $5,000 - $11,000 per cycle and from $4,500 to $7,000 at the existing INVO Centers, thereby making it more affordable than conventional IVF (which tends to average $12,000 to $17,000 per cycle or higher).

<u>Improved efficiency providing for greater capacity and improved access to care and geographic availability</u>. In many parts of the world, including the U.S., IVF clinics tend to be concentrated in higher population centers and are often capacity constrained in terms of how many patients a center can treat, with volume often limited by the number of capital-intensive incubators available in IVF clinic labs. With the significant number of untreated patients along with the growing interest and demand for services, the industry remains challenged to provide sufficient access to care and to do so at an economical price. We believe INVOcell, and the IVC procedure it enables, can play a significant role in helping to address these challenges. According to the 2020 CDC Report, there are approximately 449 IVF centers in the U.S. We estimate that by adopting the INVOcell, IVF clinics can increase fertility cycle volume by up to 30% without adding to personnel, space and/or equipment costs. Our own INVO Centers also address capacity constraints by adding to the overall ART cycle capacity and doing so with comparable efficacy to IVF outcomes as well as at a lower per cycle price. Moreover, we believe that we are uniquely positioned to drive more significant growth in fertility treatment capacity in the future by partnering with existing OB/GYN practices. In the U.S., there are an estimated 5,000 OB/GYN offices, many of which offer fertility services (usually limited to consultation and IUI, but not IVF). Since the IVC procedure requires a much smaller lab facility, less equipment, and fewer lab personnel (in comparison to conventional IVF), it could potentially be offered as an extended service in an OB/GYN office. With proper training and a lighter lab infrastructure, the INVOcell could expand the business for these physicians and allow them to treat patients that are unable to afford IVF and provide patients with a more readily accessible, convenient, and cost-effective solution. With our three-pronged strategy (IVF clinics, INVO Centers and OB/GYN practices), in addition to lowering costs, we believe INVOcell and the IVC procedure can address our industry's key challenges, capacity and cost, by their ability to expand and decentralize treatment and increase the number of points of care for patients in need. This powerful combination of lower cost and added capacity has the potential to dramatically open up access to care for patients around the world.

<u>Greater patient involvement</u>. With the IVC procedure, the patient uses their own body for fertilization, incubation and early embryo development which creates a greater sense of involvement, comfort and participation. In some cases, this may also free people from barriers related to ethical or religious concerns, or fears of laboratory mix-ups.

**Corporate History**

We were formed on January 5, 2007 under the laws of the Commonwealth of Massachusetts under the name Bio X Cell, Inc. to acquire the assets of Medelle Corporation ("Medelle"). Dr. Claude Ranoux purchased all of the assets of Medelle, and then he contributed those assets, including four patents (which have since expired) relating to the INVOcell technology, to Bio X Cell, Inc. upon its formation in January 2007.

On December 5, 2008, Bio X Cell, Inc., doing business as INVO Bioscience, and each of the shareholders of INVO Bioscience entered into a share exchange agreement and consummated a share exchange with Emy's Salsa AJI Distribution Company, Inc., a Nevada corporation ("Emy's"). Upon the closing of the share exchange on December 5, 2008, the INVO Bioscience shareholders transferred all of their shares of common stock in INVO Bioscience to Emy's. In connection with the share exchange, Emy's changed its name to INVO Bioscience, Inc. and Bio X Cell, Inc. became a wholly owned subsidiary of Emy's (re-named INVO Bioscience, Inc.).

On November 2, 2015 we were notified by the FDA that the INVOcell and INVO Procedure were granted clearance via the de novo classification (as a Class II device) allowing us to market the INVOcell in the United States. Following this approval, we began marketing and selling INVOcell in many locations across the U.S. We currently have approximately 140 trained clinics or satellite facilities in the U.S. where patients can receive guidance and treatment for the INVO Procedure.

**Recent Developments**

*Execution of Definitive Agreements to Acquire the Wisconsin Fertility Institute*

On March 16, 2023, INVO Bioscience Inc., a Nevada corporation ("INVO"), through Wood Violet Fertility LLC, a Delaware limited liability company ("Buyer") and wholly owned subsidiary of INVO Centers LLC, a Delaware company wholly-owned by INVO, entered into binding purchase agreements to acquire Wisconsin Fertility Institute (the "Clinic") for a combined purchase price of $10 million, including an asset purchase agreement with Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional service corporation d/b/a Wisconsin Fertility Institute ("WFRSA") and The Elizabeth Pritts Revocable Living Trust and a Membership Interest Purchase Agreement with Fertility Labs of Wisconsin, LLC, a Wisconsin limited liability company ("FLOW")., IVF Science, LLC owned by Wael Megid Ph.D. and Dr. Elizabeth Pritts as trustee forteh Elizabeth Pritts Revocable Living Trust.

The purchase price is payable in four installments of $2.5 million each (which payments may be offset by assumption of certain Clinic liabilities, payable at closing and on each of the subsequent three anniversaries of closing. The sellers have the option to take all or a portion of the final three installments in shares of INVO common stock valued at $6.25, $9.09, and $14.29, for the second, third, and final installments, respectively. The additional $7.5 million in payments are secured by the Clinic having a lien on the assets purchased to acquire the Clinic.

The Clinic is comprised of (a) a medical practice, WFRSA, and (b) a laboratory services company, FLOW. WFRSA owns, operates and manages the Clinic's fertility practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory services. The combined financial statements of WFRSA and FLOW are included in this prospectus supplement beginning on page S-F-1.

*February 2023 Convertible Debenture and Warrant Financing*

 

In February 2023, we sold convertible debentures in the aggregate amount of $500,000 for an aggregate purchase price of $450,000 with warrants to purchase 250,000 shares of common stock at an initial exercise price of $0.75 and 83,333 shares of our common stock. The debentures The debentures are initially convertible into Common Stock at an initial fixed conversion price of $0.52 per share. This conversion price is subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments; provided, however, the adjustment for issuances of additional securities has a floor price as set forth in the Debenture. accrue interest at a rate of 8% and are payable on maturity dates of February 3, 2024 and February 17, 2024.

The debentures may not be converted and shares of Common Stock may not be issued under the debentures if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 9.99% of the outstanding Common Stock. In addition to the beneficial ownership limitations in the debentures, the sum of the number of shares of Common Stock that may be issued under that certain securities purchase agreement (including the debenture and warrant and commitment shares issued thereunder) and the equity purchase agreement entered into by the Company both dated February 3, 2023 with the securities purchase agreement dated February 17, 2023, is limited to 19.99% of the outstanding Common Stock as of February 3, 2023 (the "Exchange Cap", which is equal to 2,436,045 shares of Common Stock, subject to adjustment as described in the Purchase Agreement), unless shareholder approval (as defined in the Purchase Agreement) ("Shareholder Approval") is obtained by the Company to issue more than the Exchange Cap. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction.

While any portion of the debentures are outstanding, if we receive cash proceeds of more than $2,000,000.00 (the "Minimum Threshold") in the aggregate from any source or series of related or unrelated sources, including but not limited to the issuance of equity or debt (except with respect to the issuance of equity or debt to officers and directors of the Company), the exercise of outstanding warrants for cash, the issuance of securities pursuant to an equity line of credit, or the sale of assets (for the avoidance of doubt, each time that the Company receives cash proceeds from any of the aforementioned sources, then such amount shall be aggregated together), we shall, within two (2) business days of our receipt of such proceeds, inform the Buyer of such receipt, following which the holders of debentures shall have the right in their sole discretion to require us to immediately apply up to 50% of all proceeds received by us above the Minimum Threshold to repay the outstanding amounts owed under the debentures.

*January and March 2023 Convertible Note and Warrant Financings*

In January and March 2023, we sold unsecured convertible notes of the Company in the aggregate original principal amount of $410,000 (the "Notes") with a fixed conversion prices of $0.50 (for the $275,000 of January 2023 Notes) and $0.60 (for the $135,000 of March 2023 Notes) and (ii) 5-year warrants (the "Warrants") to purchase 387,500 shares of the Company's common stock at an exercise price of $1.00 (subject to adjustments) (the "Private Placement"). The proceeds were used for working capital and general corporate purposes.

Interest on the Notes accrues at a rate of ten percent (10%) per annum and is payable at the holder's option either in cash or in shares of the Company's common stock at the conversion price set forth in the Notes on December 31, 2023 (the "Maturity Date"), unless converted earlier.

All amounts due under the Notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders into the Company's common stock at a fixed conversion price for the Notes as described above.

Upon any issuance by the Company of any of its equity securities in an underwritten offering, including Common Stock, for cash consideration, indebtedness or a combination thereof after the date hereof (a "Subsequent Equity Financing"), each holder shall have the option to convert the outstanding principal and accrued but unpaid interest of its Note into the number of fully paid and non-assessable shares of securities issued in the Subsequent Equity Financing ("Conversion Securities") equal to the product of unpaid principal, together with the balance of unpaid and accrued interest and other amounts payable hereunder, divided by the price per share paid by the investors in the Subsequent Equity Financing multiplied by 80%, provided however, that any conversion shall only be allowed if the Subsequent Equity Financing conversion price is equal to or greater than the Minimum Price (as defined in the Note) including an appropriate allocation any warrants offered.

A Note may not be converted and shares of common stock may not be issued under the Notes if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 9.99% of the Company's outstanding ordinary shares.

The Company may prepay the Notes at any time in whole or in part by paying a s sum of money equal to 100% of the principal amount to be redeemed, together with accrued and unpaid interest.

The Company entered into a Registration Rights Agreement with the holders of the Notes as of the date of Closing (the "Registration Rights Agreement"). Pursuant to the terms of Registration Rights Agreement, if the Company determines to register any of its securities, either for its own account or the account of a security holder or holders, other than (i) a registration relating solely to employee benefit plans on Form S-8 (or any successor form) or (ii) a registration relating solely to a Commission Rule 145 transaction on Form S-4 (or any successor form), the Company will include in such registration, and in any underwriting involved therein, the shares underlying the Notes and Warrants delivered pursuant to the Purchase Agreements, subject to, in the case of an underwritten registration, the discretion of the managing underwriter to reduce any or all piggyback registration shares if in its good faith judgment such inclusion would affect the successful marketing of the underwritten offering. The Registration Rights Agreement is subject to the terms and conditions of the Registration Rights Agreement attached hereto as Exhibit 10.2 and incorporated herein by reference

*Notices from Nasdaq of Failure o Satisfy Continued Listing Rules.*

<u>Notice Regarding Non-Compliance with Minimum Stockholders' Equity</u>

On November 23, 2022, we received notice (the "Stockholders' Equity Notice") from The Nasdaq Stock Market LLC ("Nasdaq") advising us that we were not in compliance with the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders' equity of at least $2,500,000 (the "Stockholders' Equity Requirement). In our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, we reported stockholders' equity of $1,287,224, which is below the Stockholders' Equity Requirement for continued listing. Additionally, as of the date of the Notice, we did not meet either of the alternative Nasdaq continued listing standards under the Nasdaq Listing Rules, market value of listed securities of at least $35 million, or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

The Notice has no immediate effect on the listing of our common stock and our common stock continues to trade on The Nasdaq Capital Market under the symbol "INVO" subject to our compliance with the other continued listing requirements.

Pursuant to the Notice, Nasdaq gave us 45 calendar days, or until January 7, 2023, to submit to Nasdaq a plan to regain compliance. If our plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance.

On January 18, 2023, we received a letter from Nasdaq under which it stated that based on our submission that Nasdaq has determined to grant us an extension of time to regain compliance with Nasdaq Listing Rule 5550(b) until May 22, 2023. We must furnish to the SEC and Nasdaq a publicly available report (e.g. a Form 8-K) which report, among other things, includes a description of the completed transaction or event that enabled us to satisfy the stockholders' equity requirement for continued listing After filing the publicly available report described above, if we fail to evidence compliance upon filing its periodic report for the June 30, 2023, with the SEC and Nasdaq, we may be subject to delisting. In the event we do not satisfy these terms, Nasdaq will provide written notification that its securities will be delisted. At that time, we may appeal Nasdaq's determination to a Hearings Panel.

<u>Notice Regarding Failure to Maintain Minimum Bid Price</u>

On January 11, 2023, we received a letter from the staff (the "Staff") of Nasdaq listing qualifications group indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing under Nasdaq Listing Rule 5550(a)(2).

The notice has no immediate effect on the listing of our common stock, and our common stock will continue to trade on The Nasdaq Capital Market under the symbol "INVO."

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until July 10, 2023, to regain compliance with the minimum bid price requirement. If at any time before July 10, 2023, the closing bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we do not regain compliance prior to July 10, 2023, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and (ii) notifies Nasdaq of its intent to cure the deficiency within such second 180 calendar day period, by effecting a reverse stock split, if necessary.

We will continue to monitor the closing bid price of our common stock and will consider implementing available options to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules. If we do not regain compliance with the minimum bid price requirement within the allotted compliance periods, we will receive a written notification from Nasdaq that its securities are subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance during either compliance period, or maintain compliance with the other Nasdaq listing requirements.

**Available Information**

Our principal executive offices 5582 Broadcast Court Sarasota, Florida 34240 and our telephone number is (978) 878-9505.

Our common stock trades on the Nasdaq Capital Market under the symbol "INVO".

Our principal Internet address is www.invobio.com. Information contained on, or that can be accessed through, our website, is not, and shall not be deemed to be, incorporated in this prospectus supplement or considered a part thereof. We make available free of charge on www.invobio.com our annual, quarterly and current reports, and amendments to those reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov.

**THE OFFERING**

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| | |
|:---|:---|
| Securities offered by us in this offering | 1,380,000 shares of common stock |
|  | Pre-funded warrants to purchase 2,300,000 shares of common stock at an exercise price of $0.01 per share. Each pre-funded warrant will be exercisable immediately upon issuance and will not expire.<br>|
|  | This prospectus supplement also relates to the offering of the shares of common stock issuable upon exercise of such pre-funded warrants. See "Description of Securities that We Are Offering–Description of Pre-Funded Warrants" for a discussion on the terms of the pre-funded warrants. |
| Offering price per security | $0.815 per share and $0.805 per pre-funded warrant |
| Common stock outstanding immediately before this offering | 12,591,283 shares<sup>(1)</sup> |
| Common stock outstanding immediately after this offering (including the shares issuable upon exercise of the pre-funded warrants) | 16,271,283 shares<sup>(1)</sup> |
| Use of proceeds | We estimate that the net proceeds from this offering and the concurrent private placement will be approximately $2.7 million (assuming no exercise of the pre-funded warrants issued in connection with this offering or the warrants issued in the concurrent private placement after deducting the placement agent fees and estimated offering expenses payable by us. We may use a portion of the net proceeds of this offering to repay the outstanding principal amount at 105% of certain convertible debentures issued in February 2023, if requested by such holders. A portion of the net proceeds of this offering may be used to pay the down payment for the Wisconsin Facility. We intend to use the remainder of the net proceeds for working capital, capital expenditures, product development, and other general corporate purposes, including investments in sales and marketing in the United States and internationally. See "Use of Proceeds" on page S-15 of this prospectus supplement. |
| Risk factors | An investment in our securities involves substantial risks. You should read carefully the "Risk Factors" on page S-9 of this prospectus supplement, on page 6 of the accompanying prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus supplement and the accompanying prospectus. |
| Nasdaq symbol for common stock | "INVO" |
| Concurrent private placement | In a concurrent private placement, we are selling to the purchasers of securities in this offering warrants to purchase up to 5,520,000 shares of our common stock at an exercise price of $0.63 per share. We will receive proceeds from such warrants solely to the extent they are exercised for cash. The warrants and the shares of our common stock issuable upon the exercise of the warrants are not being offered pursuant to this prospectus supplement and the accompanying prospectus. The private placement warrants are immediately exercisable and will expire five years from the issuance date. See "Private Placement Transaction." |

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(1) The number of shares of our common stock outstanding immediately before this offering and to be outstanding after this offering is based on 12,591,283 shares of common stock outstanding as of March 23, 2023, but excludes the following as of such date: (a) up to an aggregate of 1,247,665 shares of common stock issuable upon exercise of our outstanding warrants; (b) up to an aggregate of 1,736,540 shares of common stock issuable upon exercise of our outstanding convertible notes; (c) an aggregate of 1,630,140 shares of common stock reserved for future issuance under the 2019 Stock Option Plan; and (d) up to an aggregate of 5,520,000 shares of common stock issuable upon exercise of the warrants issued on the private placement concurrent with this offering.

**RISK FACTORS**

*Investing in our securities involves a high degree of risk. You should carefully consider and evaluate all of the information contained in this prospectus supplement, the accompanying prospectus and in the documents that we incorporate by reference into this prospectus supplement and the accompanying prospectus before you decide to accept any securities offered hereby. In particular, you should carefully consider and evaluate the risks and uncertainties described under the heading "Risk Factors" in this prospectus supplement and the accompanying prospectus, or in the documents incorporated by reference herein and therein. Any of the risks and uncertainties set forth in this prospectus supplement and the accompanying prospectus, as updated by annual, quarterly and other reports and documents that we file with the SEC and incorporate by reference into this prospectus supplement or the accompanying prospectus, could materially and adversely affect our business, results of operations and financial condition, which in turn could materially and adversely affect the value of our securities.*

**Risks Related to the Proposed Acquisition of the Wisconsin Fertility Institute**

***Our potential acquisition of the Wisconsin Fertility Institute may not close.***

On March 16, 2023, we signed definitive acquisition agreement to acquire the Wisconsin Fertility Clinic ("WFI"). This transaction is subject to certain customary closing conditions, as well as an initial cash payment of approximately $2.5 million less certain assumed liabilities and a holdback. We have not currently secured sufficient funds to make the initial closing payment which may impact our ability to close the transaction. In the event that we are unable to consummate our acquisition of the Wisconsin Fertility Institute, it will have a material adverse effect on our business, financial condition and results of operation.

***We may not be able to successfully integrate the Wisconsin Fertility Institute into INVO Bioscience and achieve the benefits expected to result from the acquisition.***

The proposed acquisition of the Wisconsin Fertility Institute may present challenges to management, including the integration of the operations, and personnel of INVO Bioscience and the Wisconsin Fertility Institute and special risks, including possible unanticipated liabilities, unanticipated integration costs and diversion of management attention.

We cannot assure you that we will successfully integrate or profitably manage WFI's businesses. Even if we are able to integrate and profitably manage WFI's business, we cannot assure you that, following the transaction, our business will achieve sales levels, profitability, efficiencies or synergies that justify the acquisition or that the acquisition will result in increased earnings for us in any future period.

***If we close our acquisition of the Wisconsin Fertility Institute and fail to make the required $7.5 million in additional payments, our business would be adversely affected.***

 ****

Following closing of our pending acquisition of the Wisconsin Fertility Institute, if consummated, we would be required to make additional payments of approximately $7.5 million, which payments are secured the sellers having a lien on the assets purchased to acquire Wisconsin Fertility Institute. If we default on our additional payment obligations to the sellers of the Wisconsin Fertility Institute, such sellers could exercise their rights and remedies under acquisition agreements, which could include seizing the assets sold to us to acquire the Wisconsin Fertility Institute. Any such action would have a material adverse effect on our business and prospects.

 ****

 ****

***We may incur debt financing to provide the cash proceeds necessary to acquire the Wisconsin Fertility Institute. If we were unable to service any such debt, our business would be adversely affected.***

In order to finance our proposed acquisition of the Wisconsin Fertility Institute, we may look to secure debt financing. Any such debt financing would likely require us to pledge all or substantially all of our assets as collateral. If we were unable to any such debt obligation and fail to pay such debt obligations in a timely fashion, we would be in default under such debt financing agreement and such lender could exercise its rights and remedies under such debt financing agreements, which could include seizing all of our assets. Any such action would have a material adverse effect on our business and prospects.

**Risks Related to Our Need for Additional Capital**

***We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate operations.***

We do not expect that our current cash position will be sufficient to fund our current operations for the next 12 months and we do not have sufficient funds to consummate our acquisition of the Wisconsin Fertility Institute. Our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding or a combination of these approaches. Raising funds in the current economic environment may present additional challenges. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities may dilute our existing stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

***Even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.***

The capital markets have been unpredictable in the past for unprofitable companies such as ours. In addition, it is generally difficult for development stage companies to raise capital under current market conditions. The amount of capital that a company such as ours is able to raise often depends on variables that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at all. If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate funds are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued viability will be materially adversely affected.

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

***The market price for our common stock is particularly volatile given our status as a relatively unknown company with a small and thinly traded public float, and lack of profits, which could lead to wide fluctuations in our share price.***

The market for our common stock is characterized by significant price volatility when compared to the shares of larger, more established companies that have large public floats, and we expect that our share price will continue to be more volatile than the shares of such larger, more established companies for the indefinite future, although such fluctuations may not reflect a material change to our financial condition or operations during any such period. Such volatility can be attributable to a number of factors. First, as noted above, our common stock is, compared to the shares of such larger, more established companies, sporadically and thinly traded. The price for our common stock could, for example, decline precipitously in the event that a large number of our shares are sold on the market without commensurate demand. Secondly, we are a speculative or "risky" investment due to our lack of profits to date. As a consequence of this enhanced risk, more risk-adverse investors may, under the fear of losing all or most of their investment in the event of negative news or lack of progress, be more inclined to sell their shares on the market more quickly and at greater discounts than would be the case with the stock of a larger, more established company that has a large public float. Many of these factors are beyond our control and may decrease the market price of our common stock regardless of our operating performance.

In addition to being highly volatile, our common stock could be subject to wide fluctuations in response to a number of factors that are beyond our control, including, but not limited to:

● variations
 in our revenues and operating expenses;

● actual
 or anticipated changes in the estimates of our operating results or changes in stock market analyst recommendations regarding our
 common stock, other comparable companies or our industry generally;

● market
 conditions in our industry, the industries of our customers and the economy as a whole;

● actual
 or expected changes in our growth rates or our competitors' growth rates;

● developments
 in the financial markets and worldwide or regional economies;

● announcements
 of innovations or new products or services by us or our competitors;

● announcements
 by the government relating to regulations that govern our industry;

● sales
 of our common stock or other securities by us or in the open market;

● changes
 in the market valuations of other comparable companies; and

● other
 events or factors, many of which are beyond our control, including those resulting from such events, or the prospect of such events,
 including war, terrorism and other international conflicts, public health issues including health epidemics or pandemics, such as
 the COVID-19 pandemic, and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate
 conditions, whether occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations of our suppliers
 or result in political or economic instability.

In addition, if the market for healthcare stocks or the stock market in general experiences loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition or operating results. The trading price of our shares might also decline in reaction to events that affect other companies in our industry, even if these events do not directly affect us. Each of these factors, among others, could harm the value of our common stock. In the past, following periods of volatility in the market, securities class-action litigation has often been instituted against companies. Such litigation, if instituted against us, could result in substantial costs and diversion of management's attention and resources, which could materially and adversely affect our business, operating results and financial condition.

 ****

***We have been notified by Nasdaq of our failure to comply with certain continued listing requirements and, if we are unable to regain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock could be delisted from Nasdaq. Additionally, if Nasdaq does not grant us an extension or if a favorable decision is not be obtained from a hearings panel, or the Panel, after the hearing, our common stock would be delisted from Nasdaq.***

Our common stock is currently listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders' equity, minimum share price, and certain corporate governance requirements.

On November 23, 2022, we received notice (the "Stockholders' Equity Notice") from The Nasdaq Stock Market LLC ("Nasdaq") advising us that we were not in compliance with the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders' equity of at least $2,500,000 (the "Stockholders' Equity Requirement). In our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, we reported stockholders' equity of $1,287,224, which is below the Stockholders' Equity Requirement for continued listing. Additionally, as of the date of the Notice, we did not meet either of the alternative Nasdaq continued listing standards under the Nasdaq Listing Rules, market value of listed securities of at least $35 million, or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

The Notice has no immediate effect on the listing of our common stock and our common stock continues to trade on The Nasdaq Capital Market under the symbol "INVO" subject to our compliance with the other continued listing requirements.

Pursuant to the Stockholders' Equity Notice, Nasdaq gave us 45 calendar days, or until January 7, 2023, to submit to Nasdaq a plan to regain compliance. If our plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance.

On January 18, 2023, we received a letter from Nasdaq under which it stated that based on our submission that Nasdaq has determined to grant us an extension of time to regain compliance with Nasdaq Listing Rule 5550(b) until May 22, 2023. We must furnish to the SEC and Nasdaq a publicly available report (e.g. a Form 8-K) which report, among other things, includes a description of the completed transaction or event that enabled us to satisfy the stockholders' equity requirement for continued listing After filing the publicly available report described above, if we fail to evidence compliance upon filing its periodic report for the June 30, 2023, with the SEC and Nasdaq, the Company may be subject to delisting. In the event we do not satisfy these terms, Nasdaq will provide written notification that its securities will be delisted. At that time, the Company may appeal Nasdaq's determination to a Hearings Panel.

In addition, on January 11, 2023, we received a letter from the staff (the "Staff") of Nasdaq listing qualifications group indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing under Nasdaq Listing Rule 5550(a)(2).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until July 10, 2023, to regain compliance with the minimum bid price requirement. If at any time before July 10, 2023, the closing bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we do not regain compliance prior to July 10, 2023, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and (ii) notifies Nasdaq of its intent to cure the deficiency within such second 180 calendar day period, by effecting a reverse stock split, if necessary.

We will continue to monitor the closing bid price of our common stock and will consider implementing available options to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules. If we do not regain compliance with the minimum bid price requirement within the allotted compliance periods, we will receive a written notification from Nasdaq that its securities are subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance during either compliance period, or maintain compliance with the other Nasdaq listing requirements.

In the event that our common stock is delisted from Nasdaq, as a result of our failure to comply with either the Stockholders' Equity Requirement or the Minimum Bid Price Requirement, or as a result of Nasdaq not granting us an extension or the Panel not granting us a favorable decision, or due to our failure to continue to comply with any other requirement for continued listing on Nasdaq, and is not eligible for listing on another exchange, trading in the shares of our common stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and it would likely be more difficult to obtain coverage by securities analysts and the news media, which could cause the price of our common stock to decline further. Also, it may be difficult for us to raise additional capital if we are not listed on a national exchange.

***There is no public market for the pre-funded warrants being offered in this offering.***

There is no established public trading market for the pre-funded warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the pre-funded warrants on any national securities exchange or other nationally recognized trading system, including The Nasdaq Capital Market. Without an active trading market, the liquidity of the pre-funded warrants will be limited.

***The pre-funded warrants purchased in this offering do not entitle the holder to any rights as common stockholders until the holder exercises the pre-funded warrant for shares of our common stock.***

Until you acquire shares of our common stock upon exercise of your pre-funded warrants purchased in this offering, such pre-funded warrants will not provide you any rights as a common stockholder, except as set forth therein. Upon exercise of your pre-funded warrants purchased in this offering, you will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs on or after the exercise date.

***We will have broad discretion as to the use of the proceeds from this offering, and we may not use the proceeds effectively.***

We intend to use the net proceeds from this offering for working capital and general corporate purposes. We have considerable discretion in the application of the net proceeds of this offering; provided that we may be required to use up to approximately $525,000 for the repayment of certain outstanding convertible notes if requested by such note holders. You will not have the opportunity, as part of your investment decision, to assess whether such proceeds are being used in a manner agreeable to you. You must rely on our judgment regarding the application of the net proceeds of this offering, which may be used for corporate purposes that do not improve our profitability or increase the price of our shares of common stock. Such proceeds may also be placed in investments that do not produce income or that lose value. The failure to use such funds by us effectively could have a material adverse effect on our business, financial condition, operating results and cash flow.

***You will experience immediate and substantial dilution in the net tangible book value per share of our common stock sold in this offering and may experience additional dilution of your investment in the future.***

The effective price per share of common stock sold in this offering is substantially higher than the net tangible book value per share of our common stock outstanding prior to this offering. Assuming the exercise of all pre-funded warrants, you will suffer immediate and substantial dilution of $0.5087 per share, with respect to the pro forma net tangible book value of our common stock as of September 30, 2022. Furthermore, if outstanding warrants or notes are exercised or converted, as applicable, you could experience further dilution. See the section titled "Dilution" below for a more detailed discussion of the dilution you will incur if you purchase securities in this offering. Further, because we may need to raise additional capital to fund our anticipated level of operations, we may in the future sell substantial amounts of common stock or securities convertible into or exchangeable for common stock. These future issuances of equity or equity-linked securities, together with the exercise or conversion of outstanding options, warrants, notes and/or any additional shares issued in connection with acquisitions, if any, will likely result in further dilution to investors.

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***You may experience future dilution as a result of future equity offerings and other issuances of our common stock or other securities. In addition, this offering and future equity offerings and other issuances of our common stock or other securities may adversely affect our common stock price.***

In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. We may not be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by the investor in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock or securities convertible into common stock in future transactions may be higher or lower than the price per share in this offering. You will incur dilution upon exercise of any outstanding stock options, warrants or upon the issuance of shares of common stock under our stock incentive programs. In addition, the sale of shares in this offering and any future sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could adversely affect the price of our common stock. We cannot predict the effect, if any, that market sales of those shares of common stock or the availability of those shares for sale will have on the market price of our common stock.

***Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price of our common stock to decline, and any issuance of additional common stock, or securities convertible into common stock, could dilute common stockholders. We may issue additional common stock, or securities convertible into common stock, pursuant to our shelf registration statement (including our at-the-market facility), upon exercise of outstanding warrants, for additional financing purposes, in connection with strategic transactions such as acquisitions or collaboration agreements, or otherwise, any of which could result in dilution to existing stockholders.***

The sale of shares of our common stock in the public market, or the perception that such sales could occur, could harm the prevailing market price of shares of our common stock. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

Shares of our common stock held by certain other of our stockholders are eligible for resale, subject to volume, manner of sale and other limitations under Rule 144 under the Securities Act ("Rule 144"). By exercising their registration rights and selling a large number of shares, these stockholders could cause the prevailing market price of our common stock to decline.

As restrictions on resale end or if these stockholders exercise their registration rights, the market price of shares of our common stock could drop significantly if the holders of these shares sell them or are perceived by the market as intending to sell them. These factors could also make it more difficult for us to raise additional funds through future offerings of shares of our common stock or other securities.

In addition, the shares of our common stock reserved for future issuance under our equity incentive plans will become eligible for sale in the public market once those shares are issued, subject to provisions relating to various vesting agreements, lock-up agreements and, in some cases, limitations on volume and manner of sale applicable to affiliates under Rule 144, as applicable. We have filed registration statements on Form S-8 under the Securities Act to register shares of our common stock issuable pursuant to our equity incentive plan and our employee stock purchase plan, and may in the future file one or more additional registration statements on FormS-8 for the same or similar purposes. Any such Form S-8 registration statements will automatically become effective upon filing. Accordingly, shares registered under such registration statements will be available for sale in the open market.

***Substantial future sales of shares of our common stock could cause the market price of our common stock to decline.***

We expect that significant additional capital will be needed in the near future to continue our planned operations. Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our shares.

We have financed our operations, and we expect to continue to finance our operations, acquisitions, if any, and the development of strategic relationships by issuing equity, warrants and/or convertible securities, which could significantly reduce the percentage ownership of our existing stockholders. Further, any additional financing that we secure may require the granting of rights, preferences or privileges senior to, or pari passu with, those of our common stock. Additionally, we may finance strategic alliances and/or acquisitions by issuing our equity or equity-linked securities, which may result in additional dilution. Any issuances by us of equity securities may be at or below the prevailing market price of our common stock and in any event may have a dilutive impact on your ownership interest, which could cause the market price of our common stock to decline. We may also raise additional funds through the incurrence of debt or the issuance or sale of other securities or instruments senior to our shares of common stock. The holders of any securities or instruments we may issue may have rights superior to the rights of our holders of our common stock. If we experience dilution from issuance of additional securities and we grant superior rights to new securities over common stockholders, it may negatively impact the trading price of our shares of common stock.

***We could issue "blank check" preferred stock without stockholder approval with the effect of diluting then current stockholder interests and impairing their voting rights; and provisions in our charter documents could discourage a takeover that stockholders may consider favorable.***

Our Certificate of Incorporation authorizes the issuance of "blank check" preferred stock with designations, rights and preferences as may be determined from time to time by the Board. The Board is empowered, without stockholder approval, to issue a series of preferred stock with dividend, liquidation, conversion, voting or other rights which could dilute the interest of, or impair the voting power of, our common stockholders. The issuance of a series of preferred stock could be used as a method of discouraging, delaying or preventing a change in control. For example, it would be possible for the Board to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of our Company.

**USE OF PROCEEDS**

We estimate that the net combined proceeds from this offering and the concurrent private placement will be approximately $2.7 million, after deducting the placement agent fees and the estimated offering expenses payable by us. This estimate excludes the proceeds, if any, from the exercise of the pre-funded warrants sold in this offering and the private placement warrants sold in the concurrent private placement. If all of the pre-funded warrants sold in this offering and the private placement warrants sold in the concurrent private placement were exercised for cash, we would receive additional net proceeds of approximately $3.5 million. We cannot predict when or if these pre-funded warrants or private placement warrants will be exercised. It is possible that these pre-funded warrants and private placement warrants may never be exercised.

As of the date of this prospectus supplement, we cannot predict with certainty all the uses for the net proceeds to be received upon the completion of this offering. We intend to use a portion of the net proceeds of this offering for working capital, capital expenditures, product development, and other general corporate purposes, including investments in sales and marketing in the United States and internationally. In addition, we may be required to use up to approximately $525,000 to repay those certain 8% convertible debentures with maturity dates of February 3, 2024 and February 17, 2024, if requested to repay such debentures following consummation of this offering and provided, further that a portion of the net proceeds of this offering may be used to pay the down payment for the Wisconsin Facility.

**CAPITALIZATION**

The following table sets forth our capitalization:

● on an actual basis as of September 30, 2022;

● on a pro forma basis to give effect to: (a) $200,000 in related party demand notes with a 10% financing fee and 10% annual interest, callable starting January 31, 2023; (b) $500,000 in related party demand notes with a 10% financing fee and 10% annual interest, callable starting March 31, 2023 with 350,000 warrants at a $0.50 exercise price; and (c) $910,000 in convertible notes with conversion price from $0.50 to $0.60 and 637,500 warrants with exercise price from $0.52 to $1.00; and

● on pro forma as adjusted basis to give effect to: (a) the issuance and sale by us of 1,380,000 shares of common stock at an offering price of $0.815, 2,300,000 pre-funded warrant shares at an offering price of $0.805 and a warrant to purchase 5,520,000 shares of common stock with a strike price of $0.63; and (b) the receipt of approximately $2.7 million in net proceeds after deducting the underwriting discounts and commissions and estimated offering costs payable by us.

You should read the following table in conjunction with "Use of Proceeds," "Selected Historical Consolidated Financial Data," "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Description of Securities" and other financial information contained in this prospectus, including the financial statements and related notes appearing elsewhere in this prospectus.

---

| | | | |
|:---|:---|:---|:---|
| | **As of September 30, 2022** | **As of September 30, 2022** | **As of September 30, 2022** |
| <br>**Capitalization in U.S. Dollars** | **Actual** | **Pro Forma** | **Pro Forma <br> As Adjusted <sup>(1)</sup>** |
| **Current Debt** |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Related party demand notes | $- | $700000 | $700000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Convertible notes |  | 910000 | 910000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total Debt |  | 1610000 | 1610000 |
| &nbsp;&nbsp;&nbsp;**Shareholders' Equity** |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Common stock, $.0001 par value, 125,000,000 authorized, 12,165,964, 12,165,964 and 13,545,964 shares issued and outstanding on an actual, pro forma and pro forma as adjusted basis, respectively | 1217 | 1217 | 1355 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in capital | 48302505 | 48302505 | 51004757 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accumulated deficit | (47016498) | (47016498) | (47016498) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total shareholders' equity | 1287224 | 1287224 | 3989614 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total capitalization | $1287224 | $2897224 | $5599614 |

---

(1) The
 pro forma as adjusted number of shares of common stock outstanding after this offering includes the following:

● 12,165,964 shares of common stock outstanding as of November 14, 2022; and

● 1,380,000 shares of common stock to be issued at the closing of this offering;

 and excludes the following:

● 1,555,583 shares of common stock reserved as of September 30, 2022 for future issuance under our 2019 Equity Incentive Plan;

● 260,165 shares of common stock issuable upon exercise of outstanding warrants as of September 30, 2022 with a weighted average strike price of $3.3019 per share;

● 233,333 shares of common stock issued after September 30, 2022;

● 3,029,027 shares of common stock underlying convertible notes, warrants and equity grants under the 2019 Equity Incentive Plan issued after September 30, 2022; and

● shares of common stock underlying the pre-funded warrants and warrants issuable in this offering.

**DILUTION**

If you purchase securities in the offering, you will experience immediate dilution to the extent of the difference between the effective public offering price per share of $0.815 per share of common stock and our pro forma net tangible book value per share immediately after the offering. Net tangible book value per share is equal to the amount of our total tangible assets, less total liabilities, divided by the number of outstanding shares of our common stock. As of September 30, 2022, our net tangible book value was approximately $1,154,545 or approximately $0.0949 per share.

Based on the sale by us in this offering of 1,380,000 shares of common stock at an offering price of $0.815 per share and pre-funded warrants exercisable for 2,300,000 shares of common stock at an offering price of $0.805 per pre-funded warrant, after deducting estimated offering expenses and placement agent fees and expenses payable by us, and assuming the exercise of all pre-funded warrants, our as adjusted pro forma net tangible book value as of September 30, 2022 was approximately $3,856,935, or 0.3063 per share of our common stock. This represents an immediate increase in as adjusted pro forma net tangible book value to existing stockholders of $0.2114 per share of our common stock and an immediate dilution to purchasers in this offering of $0.5087 per share of our common stock.

The following table illustrates this per-share of our common stock dilution:

---

| | |
|:---|:---|
| Effective offering price per share of common stock and pre-funded warrant | $0.815 |
| Pro forma net tangible book value per share as of September 30, 2022 | $0.0949 |
| Increase in pro forma net tangible book value per share attributable to this offering | $0.2114 |
| As adjusted pro forma net tangible book value per share as of September 30, 2022 after giving effect to this offering | $0.3063 |
| Dilution per share to the new investor in this offering | $0.5087 |

---

The total number of shares of our common stock reflected in the discussion and tables above is based on 12,165,964 shares of our common stock outstanding as of September 30, 2022, but excludes the following as of such date: (a) up to an aggregate of 260,135 shares of common stock issuable upon exercise of our outstanding warrants with an weighted average exercise price of $3.3019, and (b) 1,555,583 shares of common stock reserved for future issuance under our 2019 Stock Incentive Plan.

As of March 23, 2023, there were (a) warrants outstanding for the purchase of up to an aggregate of 1,247,665 shares of common stock, (b) convertible notes outstanding, convertible into 1,736,540 shares of common stock, and (d) 1,630,140 shares of common stock reserved for future issuance under our 2019 Stock Incentive Plan. In addition, as of the closing date of this offering, we will issue warrants to purchase 5,520,000 shares of common stock in a concurrent private placement. To the extent that warrants are exercised, the notes are converted, new options or other securities are issued under our equity incentive plans, or we issue additional shares of common stock or preferred stock in the future, there will be further dilution to the persons being issued shares of common stock in this offering. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of such securities could result in further dilution to our stockholders.

**DESCRIPTION OF SECURITIES THAT WE ARE OFFERING**

**Description of our Common Stock**

We are offering 1,380,000 shares of our common stock, par value $0.0001 per share, and pre-funded warrants to purchase 2,300,000 shares of our common stock (and the shares of common stock underlying such pre-funded warrants) directly to certain institutional investors pursuant to this prospectus supplement and the accompanying prospectus. The offering price of the shares and pre-funded warrants is $0.815 and $0.805, respectively (each being coupled with one and one half (1.5) private placement warrants). The material terms and provisions of our common stock are described under the caption "Description of Capital Stock" beginning on page 7 of the accompanying prospectus. As of the date of this prospectus supplement, our authorized capital consists of 125,000,000 shares of common stock, par value $0.0001 per share, and up to 100,000,000 shares of blank check preferred stock, par value $0.0001 per share.

**Description of Pre-Funded Warrants**

The following summary of certain terms and provisions of the pre-funded warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by the provisions of, the pre-funded warrant. You should carefully review the terms and provisions of the form of pre-funded warrant for a complete description of the terms and conditions of the pre-funded warrants.

The term "pre-funded" refers to the fact that the purchase price of our common stock in this offering includes almost the entire exercise price that will be paid under the pre-funded warrants, except for a nominal remaining exercise price of $0.01. The purpose of the pre-funded warrants is to enable the investors that may have restrictions on its ability to beneficially own more than 4.99% (or, upon election of the holder, 9.99%) of our outstanding common stock following the consummation of this offering the opportunity to invest capital into our company without triggering their ownership restrictions, by receiving pre-funded warrants in lieu of our common stock which would result in such ownership of more than 4.99% (or 9.99%), and receive the ability to exercise their option to purchase the shares underlying the pre-funded warrants at such nominal price at a later date.

*Duration and Exercise Price*. The pre-funded warrants offered hereby will entitle the holder thereof to purchase up to an aggregate of 2,300,000 shares of our common stock at a nominal exercise price of $0.01 per share, commencing on the date of issuance.

*Exercise Limitation*. The holder will not have the right to exercise any portion of the pre-funded warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% (or, upon election of the holder, 9.99%) of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. However, the holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st day after such election.

*Exercise Price Adjustment*. The exercise price of the pre-funded warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders.

*Transferability*. Subject to applicable laws, the pre-funded warrants may be offered for sale, sold, transferred or assigned without our consent.

*Exchange Listing*. There is no established trading market for the pre-funded warrants and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the pre-funded warrants on any national securities exchange or other trading market. Without an active trading market, the liquidity of the pre-funded warrants will be limited.

*Fundamental Transactions*. If a fundamental transaction occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every right and power that we may exercise and will assume all of our obligations under the pre-funded warrants with the same effect as if such successor entity had been named in the pre-funded warrant itself. If holders of our common stock are given a choice as to the securities, cash or property to be received in a fundamental transaction, then the holder shall be given the same choice as to the consideration it receives upon any exercise of the pre-funded warrant following such fundamental transaction.

*Rights as a Stockholder*. Except as otherwise provided in the pre-funded warrants or by virtue of such holder's ownership of shares of our common stock, the holder of a pre-funded warrants does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises the pre-funded warrant.

**PRIVATE PLACEMENT TRANSACTION**

Concurrently with the sale of shares of common stock and pre-funded warrants in this offering, we will issue and sell to the investors in this offering the private placement warrants to purchase up to an aggregate of 5,520,000 shares of common stock at an exercise price equal to $0.63 per share.

The private placement warrants and the shares of common stock issuable upon the exercise of such warrants have not been registered under the Securities Act are not being offered pursuant to this prospectus supplement and the accompanying prospectus and are being offered pursuant to an exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. Accordingly, purchasers may only sell the private placement warrants and the shares of common stock issued upon exercise of the private placement warrants pursuant to an effective registration statement under the Securities Act covering the resale of those shares, an exemption under Rule 144 under the Securities Act or another applicable exemption under the Securities Act.

The following sets forth the material terms of the private placement warrants.

***Exercisability***. The private placement warrants will be immediately exercisable and will expire eight years from the issuance date. The private placement warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and, at any time a registration statement registering the issuance of the shares of common stock underlying the private placement warrants under the Securities Act is effective and available for the issuance of such shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of shares of common stock purchased upon such exercise. If a registration statement registering the issuance of the shares of common stock underlying the private placement warrants under the Securities Act is not effective or available, the holder may, in its sole discretion, beginning six months from the issuance date, elect to exercise the private placement warrants through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the warrant.

***Exercise Limitation***. A holder will not have the right to exercise any portion of the private placement warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% (or, upon election of the holder, 9.99%) of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the private placement warrants. However, any holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st day after such election.

***Exercise Price Adjustment***. The exercise price of the private placement warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders.

***Exchange Listing***. There is no established trading market for the private placement warrants and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the private placement warrants on any national securities exchange or other trading market.

***Fundamental Transactions***. If a fundamental transaction occurs, then the successor entity will succeed to, and be substituted for us, and may exercise every right and power that we may exercise and will assume all of our obligations under the private placement warrants with the same effect as if such successor entity had been named in the warrant itself. If holders of our common stock are given a choice as to the securities, cash or property to be received in a fundamental transaction, then the holder shall be given the same choice as to the consideration it receives upon any exercise of the private placement warrants following such fundamental transaction. Additionally, as more fully described in the private placement warrants, in the event of certain fundamental transactions, the holders of those warrants will be entitled to receive consideration in an amount equal to the Black Scholes value of the remaining unexercised portion of the warrants on the date of consummation of such transaction.

***Rights as a Stockholder***. Except as otherwise provided in the private placement warrants or by virtue of such holder's ownership of shares of our common stock, the holder of private placement warrants will not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises the warrant.

***Resale/Registration Rights***. We are required within 30 days of the offering to file a registration statement on Form S-1 providing for the resale of the shares of common stock issued and issuable upon the exercise of the private placement warrants. We are required to use commercially reasonable efforts to cause such registration to become effective within 75 days of the offering (or 120 days in the event of a full review by the Securities and Exchange Commission, and to keep such registration statement effective at all times until no investor owns any warrants or shares issuable upon exercise thereof.

**PLAN OF DISTRIBUTION**

Maxim Group LLC, or Maxim, has agreed to act as the sole placement agent (the "Placement Agent") in connection with this offering subject to the terms and conditions of the placement agency agreement dated March 23, 2023. We refer to Maxim Group LLC as the placement agent. The placement agent is not purchasing or selling any of the shares of our common stock or pre-funded warrants offered by this prospectus supplement, nor is it required to arrange the purchase or sale of any specific number or dollar amount of shares of our common stock or pre-funded warrants, but have agreed to use its reasonable best efforts to arrange for the sale of all of the shares of our common stock and pre-funded warrants offered hereby. We entered into a securities purchase agreement, dated March 23, 2023, directly with the investors in connection with this offering, directly with certain institutional and accredited investors in connection with this offering, and we will only sell to the investors who have entered into the securities purchase agreement with us. Maxim Group LLC is also acting as the placement agent for the private placement transaction and is being paid a fee related to the placement of the private placement warrants.

We expect to deliver the 1,380,000 shares of common stock and pre-funded warrants to purchase up to an aggregate of 2,300,000 shares of common stock sold in this offering and being offered pursuant to this prospectus supplement on or about March 27, 2023, subject to customary closing conditions. Each share of common stock and pre-funded warrant sold in this offering is being sold together with a private placement warrant to purchase one share of common stock.

**Determination of Offering Price**

The offering price of the securities we are offering was negotiated between us and the investors in the offering based on the trading price of our common stock prior to the offering, among other things.

**Placement Agent's Warrants**

We have also agreed to issue to the Placement Agent warrants ("Placement Agent's Warrants") to purchase up to an aggregate of 147,200 shares of our common stock (4.0% of the shares of common stock and pre-funded warrants sold in the offering). The Placement Agent's Warrants are exercisable at a per share price equal to 110% of the aggregate purchase price of the shares of our common stock and pre-funded warrants sold in this offering. The Placement Agent's Warrants are exercisable at any time and from time to time, in whole or in part, commencing on the six-month anniversary of the commencement of sales in this offering and expiring on the date that is four and a half years following the date that such warrants become exercisable. The Placement Agent's Warrants are not being registered under the Securities Act of 1933, as amended, or the Securities Act, and are not being offered pursuant to this prospectus supplement and the accompanying prospectus and are being offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

**Right of First Refusal**

We have granted the Placement Agent a right of first refusal, for a period of fifteen (15) months from the date of closing of the offering covered by this prospectus supplement, to act as lead managing underwriter and book runner, lead placement agent, or lead sales agent, with minimum management/underwriting economics of 90% for any and all future public or private equity, equity-linked or debt (excluding commercial bank debt) offerings for which the Company retains the service of an underwriter, agent, advisor, finder or other person or entity in connection with such offering during such fifteen (15) month period of the Company, or any successor to or any subsidiary of the Company. We shall not offer to retain any entity or person in connection with any such offering on terms more favorable than terms on which it offers to retain the Placement Agent. Such offer to the Placement Agent shall be made in writing in order to be effective. The Placement Agent shall notify us within ten (10) business days of its receipt of the written offer contemplated above as to whether or not it agrees to accept such retention. If the Placement Agent should decline such retention, we shall have no further obligations to the Placement Agent with respect to the offering for which it has offered to retain the Placement Agent.

**Indemnification**

We have agreed to indemnify Maxim Group LLC against specified liabilities, including liabilities under the Securities Act, and to contribute to payments Maxim Group LLC may be required to make in respect thereof.

**Lock-Up Agreements**

Pursuant to the terms of the securities purchase agreement, from the date hereof until 45 days after the effective date of a registration statement for the resale by the purchasers of securities pursuant to the securities purchase agreement of shares of common stock issued or issuable upon exercise of the private placement warrants (the "Resale Registration Statement"), subject to certain exceptions, we may not issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or common stock equivalents, or file any registration statement or any amendment or supplement thereto, other than (A) this prospectus supplement and (B) a Resale Registration Statement. In addition, from the date of this prospectus supplement until the one year anniversary of the closing date of the offering, we are prohibited from effecting or entering into an agreement to effect any issuance of common stock or common stock equivalents involving a variable rate transaction (as defined in the securities purchase agreement); provided, that an "at the market offering" shall not constitute a variable rate transaction. Each of our officers and directors have agreed, subject to certain exceptions, not to offer, issue, sell, contract to sell, encumber, grant any option for the sale of or otherwise dispose of any shares of our common stock or other securities convertible into or exercisable or exchangeable for our common stock for a period of 45 days after this offering.

In addition, pursuant to certain "lock-up" agreements, our officers and directors have agreed, for a period of 180 days from the date of this prospectus supplement, for, not to engage in any of the following, whether directly or indirectly, without the consent of the purchaser purchasing the shares of common stock and pre-funded warrants under this prospectus supplement: offer to sell, sell, contract to sell pledge, grant, lend, or otherwise transfer or dispose of our common stock or any securities convertible into or exercisable or exchangeable for our common stock (the "Lock-Up Securities"); enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Lock-Up Securities; 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 Lock-Up Securities; enter into any transaction, swap, hedge, or other arrangement relating to any Lock-Up Securities subject to customary exceptions; or publicly disclose the intention to do any of the foregoing.

**Placement Agent Fees, Commissions and Expenses**

We have agreed to pay the placement agent a placement agent fee equal to 5% of the aggregate purchase price of the shares of our common stock and pre-funded warrants sold in this offering. The following table shows the per share, per pre-funded warrant and total cash placement agent's fees we will pay to the placement agent in connection with the sale of the shares of our common stock and pre-funded warrants offered pursuant to this prospectus supplement and the accompanying prospectus.

---

| | | | |
|:---|:---|:---|:---|
|  | **Per Share** | **Per Pre-**<br> **Funded**<br> **Warrant** | **Total** |
| Offering price | $0.81500 | $0.80500 | $2976200 |
| Placement agent's fees | $0.04075 | $0.04025 | $148810 |
| Proceeds, before expenses, to us | $0.77425 | $9.76475 | $2827390 |

---

In addition, we have agreed to reimburse Placement actual out-of-pocket expenses up to $55,000.

We estimate that the total expenses of the offering payable by us, excluding the placement agent's fees and the reimbursement noted above, will be approximately $70,000.

**Regulation M**

The placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale of the shares sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. As underwriter, the placement agent would be required to comply with the requirements of the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares by the placement agent acting as principal. Under these rules and regulations, the placement agent:

● may
 not engage in any stabilization activity in connection with our securities; and

● may
 not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted
 under the Exchange Act, until it has completed its participation in the distribution.

**Electronic Distribution**

This prospectus supplement and the accompanying prospectus may be made available in electronic format on websites or through other online services maintained by the placement agent or by an affiliate. Other than this prospectus supplement and the accompanying prospectus, the information on the placement agent's website and any information contained in any other website maintained by the placement agent is not part of this prospectus supplement and the accompanying prospectus or the registration statement of which this prospectus supplement and the accompanying prospectus form a part, has not been approved and/or endorsed by us or the placement agent, and should not be relied upon by investors.

**Other**

The foregoing does not purport to be a complete statement of the terms and conditions of the placement agency agreement and the form of securities purchase agreement. A copy of the form of securities purchase agreement with the purchasers will be included as an exhibit to our Current Report on Form 8-K to be filed with the SEC and incorporated by reference into the registration statement of which this prospectus supplement and the accompanying prospectus form a part. See "Incorporation of Certain Documents by Reference" and "Where You Can Find More Information."

No action has been or will be taken in any jurisdiction (except in the United States) that would permit a public offering of the securities offered by this prospectus supplement and accompanying prospectus, or the possession, circulation or distribution of this prospectus supplement and accompanying prospectus or any other material relating to us or the securities offered hereby in any jurisdiction where action for that purpose is required. Accordingly, the securities offered hereby may not be offered or sold, directly or indirectly, and neither of this prospectus supplement and accompanying prospectus nor any other offering material or advertisements in connection with the securities offered hereby may be distributed or published, in or from any country or jurisdiction except in compliance with any applicable rules and regulations of any such country or jurisdiction. The placement agent may arrange to sell securities offered by this prospectus supplement and accompanying prospectus in certain jurisdictions outside the United States, either directly or through affiliates, where they are permitted to do so.

**Certain Relationships**

The placement agent and its affiliates may provide from time to time in the future certain commercial banking, financial advisory, investment banking and other services for us in the ordinary course of their business, for which they may receive customary fees and commissions. In addition, from time to time, the placement agent and its affiliates may effect transactions for their own account or the account of customers, and hold on behalf of themselves or their customers, long or short positions in our debt or equity securities or loans, and may do so in the future. However, except as disclosed in this prospectus supplement, we have no present arrangements with the placement agent for any further services.

**Transfer Agent and Registrar**

We have engaged the services of Transfer Online, Inc. as our transfer agent and registrar whose address is 512 SE Salmon Street, Portland, OR 97214, telephone no. (503) 227-2950.

**Listing**

Our common stock is traded on Nasdaq under the symbol "INVO."

**LEGAL MATTERS**

The validity of the shares of common stock and pre-funded warrants being offered by this prospectus supplement will be passed upon for us by Sheppard Mullin Richter & Hampton LLP, New York, New York. Loeb & Loeb LLP, New York, New York, is acting as counsel for the placement agent in connection with the securities offered hereby.

**EXPERTS**

The consolidated financial statements of INVO Bioscience, Inc. as of December 31, 2021 and 2020 and for each of the two years in the period ended December 31, 2021, incorporated in this prospectus supplement by reference to the Annual Report on Form 10-K for the year ended December 31, 2021, have been so incorporated in reliance on the report of M&K CPAs, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.

**WHERE YOU CAN FIND MORE INFORMATION**

We have filed with the SEC a Registration Statement on Form S-3 under the Securities Act with respect to the securities offered by this prospectus supplement. This prospectus supplement and the accompanying prospectus, which are part of the registration statement, omits certain information, exhibits, schedules and undertakings set forth in the registration statement, as permitted by the SEC. For further information pertaining to us and the securities offered in this prospectus supplement, reference is made to that registration statement and the exhibits and schedules to the registration statement. Statements contained in this prospectus supplement and the accompanying prospectus as to the contents or provisions of any documents referred to in this prospectus are not necessarily complete, and in each instance where a copy of the document has been filed as an exhibit to the registration statement, reference is made to the exhibit for a more complete description of the matters involved.

We file annual, quarterly and current reports, proxy statements and other information with the SEC. You can read our electronic SEC filings, including such registration statement, on the internet at the SEC's website at *www.sec.gov*. We are subject to the information reporting requirements of the Exchange Act, and we file reports, proxy statements and other information with the SEC. These reports, proxy statements and other information will be available at the website of the SEC referred to above. We also maintain a website at *www.wisatechnologies.com*, at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. However, the information contained in or accessible through our website is not part of this prospectus supplement, the accompanying prospectus or any other prospectus supplement that we file, and investors should not rely on such information in making a decision to purchase our securities in this offering.

**INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE**

We incorporate by reference the filed documents listed below (excluding those portions of any Current Report on Form 8-K that are not deemed "filed" pursuant to the General Instructions of Form 8-K), except as superseded, supplemented or modified by this Prospectus Supplement or any subsequently filed document incorporated by reference herein as described below:

● our
 Annual Report on [Form 10-K](https://www.sec.gov/Archives/edgar/data/1417926/000149315222008421/form10-k.htm) for the fiscal year ended December 31, 2021, filed with the SEC on March 31, 2022 and our Annual Report
 on [Form 10-K/A](https://www.sec.gov/Archives/edgar/data/1417926/000149315222009731/form10-ka.htm) for the fiscal year ended December 31, 2021 filed with the SEC on April 12, 2022;

● our
 Quarterly Reports on Form 10-Q for the fiscal quarters ended [March 31, 2022](https://www.sec.gov/Archives/edgar/data/1417926/000149315222013778/form10-q.htm) , [June 30, 2022](https://www.sec.gov/Archives/edgar/data/1417926/000149315222022890/form10-q.htm) and [September 30, 2022](https://www.sec.gov/Archives/edgar/data/1417926/000149315222032023/form10-q.htm) , filed with the
 SEC on May 16, 2022, August 15, 2022 and November 14, 2022, respectively;

● our
 Definitive Proxy Statement on [Schedule 14A](https://www.sec.gov/Archives/edgar/data/1417926/000149315222024038/formdef14a.htm) for our annual meeting of stockholders held on October 12, 2022, filed with the SEC on
 August 25, 2022;

● our
 Current Reports on Forms 8-K filed with the SEC on [May 26, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315222015219/form8-k.htm) , [October 14, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315222028489/form8-k.htm) , [November 28, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315222033824/form8-k.htm) , [December 5, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315222034493/form8-k.htm) , [December 19, 2022](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315222035812/form8-k.htm) , [January 5, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223000622/form8-k.htm) , [January 5, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223000632/form8-k.htm) , [January 12, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223001271/form8-k.htm) , [January 23, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223002209/form8-ka.htm) , [February 9, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223004074/form8-k.htm) , [February 23, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223005872/form8-k.htm) , [March 20, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223008217/form8-ka.htm) , [March 20, 2023](https://www.sec.gov/Archives/edgar/data/1417926/000149315223008197/form8-k.htm) and [March 23, 2023](https://www.sec.gov/ix?doc=/Archives/edgar/data/1417926/000149315223008723/form8-k.htm) (except for Item 2.02 and Item 7.01 of any Current Report on Form 8-K which are not deemed "filed" for
 purposes of Section 18 of the Exchange Act and are not incorporated by reference in this prospectus); and

● the
 description of the Registrant's securities, which is contained in the Registrant's Registration Statement on Form S-1
 (File No. 333-228928), as amended, filed with the Securities and Exchange Commission on December 20, 2018, pursuant to the Securities
 Act of 1933, as amended and [Exhibit 4.3](https://www.sec.gov/Archives/edgar/data/1417926/000118518509000691/ex10-2.htm) to the Registrant's Annual Report on Form 10-K form 10-K for the year ended December 31, 2021
 filed on March 31, 2022.

We also incorporate by reference in this prospectus supplement and the accompanying prospectus any future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date hereof but before the completion or termination of this offering (excluding any information not deemed "filed" with the SEC).

Any statement contained in a document incorporated by reference herein or therein shall be deemed to be modified or superseded for all purposes to the extent that a statement contained in this Prospectus Supplement and the Base Prospectus or in any other subsequently filed document which is also incorporated or deemed to be incorporated by reference herein or therein, modifies or supersedes such statement. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Prospectus Supplement and the Base Prospectus. You may request a copy of these filings (other than an exhibit to a filing unless that exhibit is specifically incorporated by reference into that filing) at no cost by writing, telephoning or e-mailing us at the following address, telephone number or e-mail address:

INVO Bioscience, Inc.

5582 Broadcast Court

Sarasota, Florida 34240

(978) 878-9505

<u>info@invobio.com</u>

Copies of these filings are also available through the "Investor Relations" section of our website at *www.invobio.com.* For other ways to obtain a copy of these filings, please refer to "Where You Can Find More Information" above.

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.<br> AND FERTILITY LABS OF WISCONSIN, LLC<br> INDEX TO COMBINED FINANCIAL STATEMENTS**

---

| | |
|:---|:---|
|  | **Page** |
| AUDITED FINANCIAL STATEMENTS: |  |
| For years ended December 31, 2021 and 2020 |  |
| [Report of Independent Registered Public Accounting Firm](#S1_001) | S-F-3 |
| [Combined Balance Sheets as of December 31, 2021and 2020](#S1_002) | S-F-4 |
| [Combined Statements of Operations for the periods ended December 31, 2021 and 2020](#S1_003) | S-F-5 |
| [Combined Statements of Member's Capital (Deficit) for period January 1, 2020 to December 31, 2021](#S1_004) | S-F-6 |
| [Combined Statement of Cash Flows for the period ended December 31, 2021 and 2020](#S1_005) | S-F-7 |
| [Notes to Combined Financial Statements](#S1_006) | S-F-8 |
| UNAUDITED FINANCIAL STATEMENTS |  |
| Quarterly Financial Statements |  |
| For the three and nine months ended September 30, 2022 and September 30, 2021 |  |
| [Combined Balance Sheets as of September 30, 2022 and December 31, 2021](#S1_007) | S-F-13 |
| [Combined Statements of Operations for the periods ended September 30, 2022 and 2021](#S1_008) | S-F-14 |
| [Combined Statements of Member's Capital (Deficit) for period January 1, 2021 to September 30, 2022](#S1_009) | S-F-15 |
| [Combined Statements of Cash Flows for the periods ended September 30, 2022 and 2021](#S1_010) | S-F-16 |
| [Notes to Combined Financial Statements](#S1_011) | S-F-17 |
| PRO FORMA FINANCIAL STATEMENTS |  |
| [Pro Forma Combined Balance Sheet as of September 30, 2022](#C_001) | S-F-23 |
| [Pro Forma Condensed Combined Statement of Operations for the Nine Months Ended September 30, 2022](#C_002) | S-F-24 |
| [Pro Form Condensed Combined Statement of Operations For the Year Ended December 31, 2021](#C_003) | S-F-25 |
| [Notes to Combined Financial Statements](#C_004) | S-F-26 |

---

S-F-1

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**AUDITED COMBINED FINANCIAL STATEMENTS**

As of and for the years ended December 31, 2021 and 2020 with Report of Independent Registered Public Accounting Firm.

**TABLE OF CONTENTS**

---

| | |
|:---|:---|
|  | **Page** |
| [REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM](#S1_001) | S-F-3 |
| COMBINED FINANCIAL STATEMENTS |  |
| &nbsp;&nbsp;&nbsp;[Combined Balance Sheets](#S1_002) | S-F-4 |
| &nbsp;&nbsp;&nbsp;[Combined Statements of Operations](#S1_003) | S-F-5 |
| &nbsp;&nbsp;&nbsp;[Combined Statements of Member's Capital (Deficit)](#S1_004) | S-F-6 |
| &nbsp;&nbsp;&nbsp;[Combined Statements of Cash Flows](#S1_005) | S-F-7 |
| &nbsp;&nbsp;&nbsp;[Notes to Combined Financial Statements](#S1_006) | S-F-8 |

---

S-F-2

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Members

Fertility Labs of Wisconsin, LLC and Wisconsin Fertility and Reproductive Surgery Associates, S.C.

**Opinion on the Combined Financial Statements**

We have audited the accompanying combined balance sheets of Fertility Labs of Wisconsin, LLC and Wisconsin Fertility and Reproductive Surgery Associates, S.C. (the Companies) as of December 31, 2021 and 2020, and the related combined statements of operations, members' capital/(deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the "financial statements"). In our opinion, the combined financial statements present fairly, in all material respects, the financial position of the Companies as of December 31, 2021 and 2020, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

**Basis for Opinion**

These combined financial statements are the responsibility of the Companies' management. Our responsibility is to express an opinion on the Companies' combined 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 combined financial statements are free of material misstatement, whether due to error or fraud. The Companies are not required to have, nor were we engaged to perform, an audit of their 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 Companies' 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 combined 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 combined financial statements. Our audits also included evaluating the accounting principles used and the significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe our audits provide a reasonable basis for our opinion.

**Critical Audit Matter**

The critical audit matter communicated below is a matter arising from the current period audit of the combined financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the combined 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 combined financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.

*Revenue Recognition*

As discussed in Note 1 to the combined financial statements, the Companies recognize revenue in accordance with ASC 606, Revenue from Contracts with Customers. Revenue from clinical and lab services is recognized based on the date the service is performed.

Auditing management's evaluation of the service revenue from its agreements with patients involves significant judgment based on the estimates of the revenue recorded and their subsequent true-up once payment is received.

To evaluate the appropriateness and accuracy of the revenue recorded by management, we evaluated management's assessment of the revenue recorded based on the Companies' service agreements.

/s/ M&K CPAS, PLLC

M&K CPAS, PLLC

We have served as the Company's auditor since 2022

Houston, TX

March 20, 2023

S-F-3

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**AUDITED COMBINED BALANCE SHEETS**

---

| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2021** | **December 31,**<br>**2020** |
| ASSETS |  |  |
| Current assets |  |  |
| &nbsp;&nbsp;&nbsp;Cash | $627949 | $462093 |
| &nbsp;&nbsp;&nbsp;Accounts receivable | 136588 | 164978 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | - | 5000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 764537 | 632071 |
| Property and equipment, net | 66261 | 9531 |
| Total assets | $830798 | $641602 |
| LIABILITIES AND MEMBERS' DEFICIT |  |  |
| Current liabilities |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $22926 | $17698 |
| &nbsp;&nbsp;&nbsp;Accrued liabilities | 75605 | 88198 |
| &nbsp;&nbsp;&nbsp;Distribution payable | 426734 | 363368 |
| &nbsp;&nbsp;&nbsp;Deferred revenue | 394066 | 420275 |
| &nbsp;&nbsp;&nbsp;PPP Loan | - | 181600 |
| Total liabilities | 919331 | 1071139 |
| Members' capital (deficit) |  |  |
| &nbsp;&nbsp;&nbsp;Members' capital (deficit) - beginning | (429537) | (25662) |
| &nbsp;&nbsp;&nbsp;Members' capital (deficit) - current year | 341004 | (403875) |
| Total members' capital (deficit) | (88533) | (429537) |
| Total liabilities and members' capital (deficit) | $830798 | $641602 |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-4

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**AUDITED COMBINED STATEMENTS OF OPERATIONS**

---

| | | |
|:---|:---|:---|
|  | **For the Years Ended** | **For the Years Ended** |
|  | **December 31,** | **December 31,** |
|  | **2021** | **2020** |
| Revenue | $5676804 | $4452394 |
| Cost of revenue | 2335774 | 2100705 |
| Gross profit | 3341030 | 2351689 |
| Operating expenses | 1216069 | 1073292 |
| Income from operations | 2124961 | 1278397 |
| Other income (expense): |  |  |
| &nbsp;&nbsp;&nbsp;Other income | 182719 | 5450 |
| &nbsp;&nbsp;&nbsp;Interest expense | (360) | (236) |
| Total other income (expense) | 182359 | 5214 |
| Net income | $2307320 | $1283611 |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-5

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**AUDITED COMBINED STATEMENTS OF MEMBERS' DEFICIT**

---

| | |
|:---|:---|
| **Balance at January 1, 2020** | $(25662) |
| &nbsp;&nbsp;&nbsp;Member capital distribution | (1687486) |
| &nbsp;&nbsp;&nbsp;Net income | 1283611 |
| **Balance at December 31, 2020** | $(429537) |
| &nbsp;&nbsp;&nbsp;Member capital distribution | (1966316) |
| &nbsp;&nbsp;&nbsp;Net income | 2307320 |
| **Balance at December 31, 2021** | $(88533) |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-6

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**AUDITED COMBINED STATEMENTS OF CASH FLOWS**

---

| | | |
|:---|:---|:---|
|  | **For the Years Ended** | **For the Years Ended** |
|  | **December 31,** | **December 31,** |
|  | **2021** | **2020** |
| Cash flows from operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Net income | $2307320 | $1283611 |
| Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Extinguishment of debt | (181600) |  |
| &nbsp;&nbsp;&nbsp;Depreciation and amortization | 6660 | 1254 |
| Changes in assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Accounts receivable | 28390 | 15987 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 5000 | 12344 |
| &nbsp;&nbsp;&nbsp;Accounts payable | 5228 | (23142) |
| &nbsp;&nbsp;&nbsp;Accrued liabilities | (12593) | 39807 |
| &nbsp;&nbsp;&nbsp;Deferred revenue | (26209) | 81311 |
| **Net cash used in operating activities** | 2132196 | 1411172 |
| Cash from investing activities: |  |  |
| &nbsp;&nbsp;&nbsp;Payments to acquire property, plant, and equipment | (63390) | (10785) |
| **Net cash used in investing activities** | (63390) | (10785) |
| Cash from financing activities: |  |  |
| &nbsp;&nbsp;&nbsp;Proceeds from PPP loan |  | 181600 |
| &nbsp;&nbsp;&nbsp;Member capital distribution | (1902950) | (1679968) |
| **Net cash provided by financing activities** | (1902950) | (1498368) |
| Increase (decrease) in cash | 165856 | (97981) |
| Cash at beginning of period | 462093 | 560074 |
| Cash at end of period | $627949 | $462093 |
| Supplemental disclosure of cash flow information: |  |  |
| &nbsp;&nbsp;&nbsp;Cash paid during the period for: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest | $360 | $236 |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-7

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**NOTES TO THE AUDITED COMBINED FINANCIAL STATEMENTS**

**Note 1 – Summary of Significant Accounting Policies**

***Description of Business***

These audited combined financial statements include the following business entities: Wisconsin Fertility and Reproductive Surgery Associates, S.C. ("WFRSA"), a clinic that provides fertility services and advanced gynecology care and Fertility Labs of Wisconsin, LLC ("FLOW"), a limited liability company that provides lab services exclusively to WFRSA (the "Companies").

***Basis of Presentation***

The Companies' accounting and financial reporting policies conform to accounting principles generally accepted in the United States ("U.S. GAAP").

***Use of Estimates***

In preparing financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenue and expenses during the reported period. Actual results could differ from those estimates. The more significant estimates and assumptions by management include among others: useful life of property and equipment, collectability of accounts receivable and accrued liabilities.

***Cash and Cash Equivalents***

For financial statement presentation purposes, the Companies consider time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. The Companies had no cash equivalents at December 31, 2021 or December 31, 2020.

***Accounts Receivables and Allowances for Doubtful Accounts***

The allowance for doubtful accounts is based on the Companies' assessment of the collectability of customer accounts and the aging of the related invoices and represents the Companies' best estimate of probable credit losses in its existing trade accounts receivable. The Companies regularly review the allowance by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer's ability to pay. The allowance for doubtful accounts is included in accounts receivables, net on the Companies' combined balance sheet. The Companies' allowance for doubtful accounts balance was $33,372 and $0 as of December 31, 2021 and December 31, 2020 respectively.

***Property and Equipment***

The Companies record property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 to 10 years. The Companies capitalize the expenditures for major renewals and improvements that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred. The Companies review the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of long-lived assets is measured by a comparison of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its fair market value.

S-F-8

 ****

***Fair Value of Financial Instruments***

Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP established a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

● Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;

● Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

● Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

The Companies had no assets or liabilities which were measured at fair value on a nonrecurring basis during the reporting periods.

***Income Taxes***

The Companies are limited liability companies and do not incur federal taxes. For tax purposes, the earnings and losses of the Companies are included in the members' personal income tax returns and are taxed based on their personal tax strategies. Therefore, there is no provision or liability for federal income taxes reflected in the accompanying financial statements.

***Concentration of Credit Risk***

Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation ("FDIC") limits. The Companies did not have cash balances in excess of FDIC limits at December 31, 2021 or December 31, 2020.

S-F-9

 ****

***Revenue Recognition***

The Companies recognize revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers ("ASC 606"). The core principle of ASC 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:

1. Identify the contract with
 the customer.

2. Identify the performance
 obligations in the contract.

3. Determine the total transaction
 price.

4. Allocate the total transaction
 price to each performance obligation in the contract.

5. Recognize as revenue when
 (or as) each performance obligation is satisfied.

Revenue generated from clinical and lab services is recognized at the time the service is performed. The Companies' performance obligations related to the delivery of services to patients are satisfied at the time of service. Accordingly, there are no performance obligations that are unsatisfied or partially unsatisfied at the end of the reporting period with respect to patient service revenue.

A portion of the Companies' service revenue is reimbursed by third party insurance payors. Payments for services rendered to the Companies' patients are generally less than billed charges. The Companies monitor revenue and receivables from these sources and record an estimated contractual allowance to properly account for the anticipated differences between billed and reimbursed amounts.

Patient service revenue is presented net of an estimated provision for contractual adjustments and write offs. adjustments result from the difference between the physician rates for services performed and the reimbursements by third-party insurance payors for such services. Collection of patient service revenue the Companies expect to receive is normally a function of providing complete and correct billing information to third-party insurance payors within the various filing deadlines and typically occurs within 30 to 60 days of billing. Third-party insurance payors account for approximately 15% of the Companies' revenue.

For patient fees that are not covered by third party insurance payors, the Companies require patients to pay for services prior to the services being rendered. The Companies record these prepayments as deferred revenue until the services are rendered. Once services are rendered the Companies recognize the revenue in accordance with ASC 606.

As of December 31, 2021 and 2020 the Companies had $394,066 and $420,275 of deferred revenue, respectively.

***Advertising Expense***

 ****

The Companies expense advertising costs as incurred. These costs are included in the operating costs for the Companies on the statement of operations. For the years ended December 31, 2021 and 2020 the Companies incurred in advertising costs $10,827 and $17,559 respectively.

***Recently Adopted Accounting Pronouncements***

Leases (Topic 842). In February 2016, FASB issued ASU 2016-02, Leases ("ASU 2016-02"). The new standard establishes a right-of-use ("ROU") model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. For private companies the new standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Companies will adopt the standard effective January 1, 2022.

S-F-10

**Note 2 – Property and Equipment**

Property and equipment consists of the following:

---

| | | |
|:---|:---|:---|
|  | **December 31,**<br> **2021** | **December 31,**<br> **2020** |
| Furniture and equipment | $10784 | 10784 |
| Leasehold improvements | 63389 |  |
| Less: accumulated depreciation | (7912) | (1253) |
| Total equipment, net | $66261 | 9531 |

---

During the years ended December 31, 2021, and 2020, the Companies recorded depreciation expense of $6,660 and $1,254 respectively.

**Note 3 – Notes Payable**

<u>Paycheck Protection Program</u>

On April 15, 2020, the Companies received a loan in the principal amount of $181,600 pursuant to the U.S. Small Business Administration's Paycheck Protection Program. The loan matured 18 months from the date of funding, was payable over 18 equal monthly installments, and had an interest of 1% per annum. Up to 100% of the principal balance of the loan was forgivable based upon satisfaction of certain criteria under the Paycheck Protection Program. On February 24, 2021, the principal of the loan as well as $1,567 of accrued interest was forgiven and the note was extinguished. The Companies recognized a gain of $181,600 on extinguishment of debt during the year ended December 31, 2021.

**Note 4 – Members' Distributions**

Members' distributions totaling $1,902,950 and $1,679,968 were paid out during the years ended December 31, 2021 and 2020, respectively. Distributions payable to the members totaled $426,734 and $363,368 at December 31, 2021 and 2020, respectively.

**Note 5 – Commitments and Contingencies**

*Insurance*

The Companies' insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party exposures; (ii) statutory workers' compensation insurance; (iv) excess liability insurance above the established primary limits for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal property and includes business interruption; and (vi) malpractice insurance covering our physicians for acts related to our business activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with similar types of operations.

*Legal Matters*

The Companies are not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources.

**Note 6 – Subsequent Events**

The Companies have evaluated all other subsequent events from the balance sheet date through the date the financial statements were issued and has determined there are no additional events required to be disclosed.

S-F-11

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**UNAUDITED COMBINED FINANCIAL STATEMENTS**

As of September 30, 2022 and for the nine months ended September 30, 2022 and 2021.

**TABLE OF CONTENTS**

---

| | |
|:---|:---|
|  | **Page** |
| COMBINED FINANCIAL STATEMENTS |  |
| &nbsp;&nbsp;&nbsp;[Combined Balance Sheets](#S1_007) | S-F-13 |
| &nbsp;&nbsp;&nbsp;[Combined Statements of Operations](#S1_008) | S-F-14 |
| &nbsp;&nbsp;&nbsp;[Combined Statements of Member's Capital (Deficit)](#S1_009) | S-F-15 |
| &nbsp;&nbsp;&nbsp;[Combined Statements of Cash Flows](#S1_010) | S-F-16 |
| &nbsp;&nbsp;&nbsp;[Notes to Combined Financial Statements](#S1_011) | S-F-17 |

---

S-F-12

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**COMBINED BALANCE SHEETS**

---

| | | |
|:---|:---|:---|
|  | **September 30,**<br>**2022** | **December 31,**<br>**2021** |
|  | (unaudited) | |
| ASSETS |  |  |
| Current assets |  |  |
| &nbsp;&nbsp;&nbsp;Cash | $621220 | $627949 |
| &nbsp;&nbsp;&nbsp;Accounts receivable | 275036 | 136588 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 526 | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 896782 | 764537 |
| Property and equipment, net | 56764 | 66261 |
| Lease right of use | 1021588 | - |
| Total assets | $1975134 | $830798 |
| LIABILITIES AND MEMBERS' DEFECIT |  |  |
| Current liabilities |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $19850 | $22926 |
| &nbsp;&nbsp;&nbsp;Accrued liabilities | 34185 | 75605 |
| &nbsp;&nbsp;&nbsp;Distributions payable | 467702 | 426734 |
| &nbsp;&nbsp;&nbsp;Deferred revenue | 497922 | 394066 |
| &nbsp;&nbsp;&nbsp;Lease liability, current portion | 196200 | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 1215859 | 919331 |
| Lease liability, net of current portion | 834746 | - |
| Total liabilities | 2050605 | 919331 |
| Members' capital (deficit) |  |  |
| &nbsp;&nbsp;&nbsp;Members' capital (deficit)- beginning | (88533) | (429537) |
| &nbsp;&nbsp;&nbsp;Members' capital (deficit)- current year | 13062 | 341004 |
| Total members' capital (deficit) | (75471) | (88533) |
| Total liabilities and members' capital (deficit) | $1975134 | $830798 |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-13

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**UNAUDITED COMBINED STATEMENTS OF OPERATIONS**

---

| | | |
|:---|:---|:---|
|  | **For the Nine Months** | **For the Nine Months** |
|  | **Ended September 30,** | **Ended September 30,** |
|  | **2022** | **2021** |
| Revenue | $3971254 | $4169486 |
| Cost of revenue | 1697111 | 1697280 |
| Gross profit | 2274143 | 2472206 |
| Operating expenses | 953189 | 886110 |
| Income from operations | 1320954 | 1586096 |
| Other income (expense): |  |  |
| &nbsp;&nbsp;&nbsp;Other income | 119 | 182635 |
| &nbsp;&nbsp;&nbsp;Interest expense | (248) | (124) |
| Total other income (expense) | (129) | 182511 |
| Net income | $1320825 | $1768607 |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-14

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**UNAUDITED COMBINED STATEMENTS OF MEMBERS' DEFICIT**

---

| | |
|:---|:---|
| **Balance at January 1, 2021** | $(429537) |
| &nbsp;&nbsp;&nbsp;Member capital distribution | (1538983) |
| &nbsp;&nbsp;&nbsp;Net income – nine months ended September 30, 2021 | 1768607 |
| **Balance at September 30, 2021** | (199913) |
| **Balance at January 1, 2022** | $(88533) |
| &nbsp;&nbsp;&nbsp;Member capital distribution | (1307763) |
| &nbsp;&nbsp;&nbsp;Net income – nine months ended September 30, 2022 | 1320825 |
| **Balance at September 30, 2022** | $(75471) |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-15

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**UNAUDITED COMBINED STATEMENTS OF CASH FLOWS**

---

| | | |
|:---|:---|:---|
|  | **For the Nine Months Ended** | **For the Nine Months Ended** |
|  | **September 30,** | **September 30,** |
|  | **2022** | **2021** |
| Cash flows from operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Net income | $1320825 | $1768607 |
| Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Extinguishment of debt |  | (181600) |
| &nbsp;&nbsp;&nbsp;Depreciation and amortization | 9497 | 3468 |
| Changes in assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Accounts receivable | (138448) | (109329) |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | (526) | (60658) |
| &nbsp;&nbsp;&nbsp;Accounts payable | (3076) | 3641 |
| &nbsp;&nbsp;&nbsp;Accrued liabilities | (41420) | (35347) |
| &nbsp;&nbsp;&nbsp;Deferred revenue | 103856 | 148346 |
| &nbsp;&nbsp;&nbsp;Leasehold liability | 9358 | - |
| **Net cash used in operating activities** | 1260066 | 1537128 |
| Cash from investing activities: |  |  |
| &nbsp;&nbsp;&nbsp;Payments to acquire property, plant, and equipment | - | (63389) |
| **Net cash used in investing activities** |  | (63389) |
| Cash from financing activities: |  |  |
| &nbsp;&nbsp;&nbsp;Member capital distribution | (1266795) | (1330343) |
| **Net cash provided by financing activities** | (1266795) | (1330343) |
| Increase (decrease) in cash | (6729) | 143396 |
| Cash at beginning of period | 627949 | 462093 |
| Cash at end of period | $621220 | $605489 |
| Supplemental disclosure of cash flow information: |  |  |
| &nbsp;&nbsp;&nbsp;Cash paid during the period for: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Interest | $248 | $124 |
| Supplemental disclosure of non-cash transactions: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Recognition of right of use asset and lease liability | $1185824 | - |

---

The accompanying notes are an integral part of these combined financial statements.

S-F-16

**WISCONSIN FERTILITY AND REPRODUCTIVE SURGERY ASSOCIATES, S.C.**

**AND FERTILITY LABS OF WISCONSIN, LLC**

**NOTES TO THE UNAUDITED COMBINED FINANCIAL STATEMENTS**

**Note 1 – Summary of Significant Accounting Policies**

***Description of Business***

The unaudited combined financial statements for Wisconsin Fertility Institute include the following business operations: Wisconsin Fertility and Reproductive Surgery Associates, S.C. ("WFRSA"), a clinic that provides fertility services and advanced gynecology care and Fertility Labs of Wisconsin, LLC ("FLOW"), a limited liability company that provides lab services exclusively to WFRSA (the "Companies").

***Basis of Presentation***

The Companies' accounting and financial reporting policies conform to accounting principles generally accepted in the United States ("U.S. GAAP").

***Use of Estimates***

In preparing financial statements in conformity with U.S GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenue and expenses during the reported period. Actual results could differ from those estimates. The more significant estimates and assumptions by management include among others: useful life of property and equipment, collectability of accounts receivable and accrued liabilities.

***Cash and Cash Equivalents***

For financial statement presentation purposes, the Companies consider time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. The Companies had no cash equivalents at September 30, 2022.

***Accounts Receivables and Allowances for Doubtful Accounts***

The allowance for doubtful accounts is based on the Companies' assessment of the collectability of customer accounts and the aging of the related invoices and represents the Companies' best estimate of probable credit losses in its existing trade accounts receivable. The Companies regularly review the allowance by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a customer's ability to pay. The allowance for doubtful accounts is included in accounts receivables, net on the Companies' balance sheet. The Companies' allowance for doubtful accounts balance was $33,372 and $24,071 as of September 30, 2022 and September 30, 2021 respectively.

S-F-17

 ****

***Property and Equipment***

The Companies record property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 to 10 years. The Companies capitalize the expenditures for major renewals and improvements that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred. The Companies review the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of long-lived assets is measured by a comparison of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its fair market value.

***Fair Value of Financial Instruments***

Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP established a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

● Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;

● Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

● Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

The Companies had no assets or liabilities which were measured at fair value on a nonrecurring basis during the reporting periods.

***Income Taxes***

The Companies are limited liability companies and do not incur federal taxes. For tax purposes, the earnings and losses of the Companies are included in the members' personal income tax returns and are taxed based on their personal tax strategies. Therefore, there is no provision or liability for federal income taxes reflected in the accompanying financial statements.

***Concentration of Credit Risk***

Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation ("FDIC") limits. The Companies did not have cash balances in excess of FDIC limits at September 30, 2022.

S-F-18

 ****

***Revenue Recognition***

The Companies recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers ("ASC 606"). The core principle of ASC 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. Identify
 the contract with the customer.

2. Identify
 the performance obligations in the contract.

3. Determine
 the total transaction price.

4. Allocate
 the total transaction price to each performance obligation in the contract.

5. Recognize
 as revenue when (or as) each performance obligation is satisfied.

Revenue generated from clinical and lab services is recognized at the time the service is performed. The Companies' performance obligations related to the delivery of services to patients are satisfied at the time of service. Accordingly, there are no performance obligations that are unsatisfied or partially unsatisfied at the end of the reporting period with respect to patient service revenue.

A portion of the Companies' service revenue is reimbursed by third party insurance payors. Payments for services rendered to the Companies' patients are generally less than billed charges. The Companies monitor revenue and receivables from these sources and record an estimated contractual allowance to properly account for the anticipated differences between billed and reimbursed amounts.

Patient service revenue is presented net of an estimated provision for contractual adjustments and write offs. adjustments result from the difference between the physician rates for services performed and the reimbursements by third-party insurance payors for such services. Collection of patient service revenue the Companies expect to receive is normally a function of providing complete and correct billing information to third-party insurance payors within the various filing deadlines and typically occurs within 30 to 60 days of billing. Third-party insurance payors account for approximately 15% of the Companies' revenue.

For patient fees that are not covered by third party insurance payors, the Companies require patients to pay for services prior to the services being rendered. The Companies record these prepayments as deferred revenue until the services are rendered. Once services are rendered the Companies recognize the revenue in accordance with ASC 606.

As of September 30, 2022 and December 31, 2021 the Companies had $497,922 and $394,066 of deferred revenue, respectively.

***Advertising Expense***

 ****

The Companies expense advertising costs as incurred. These costs are included in the operating costs for the Companies on the statement of operations. For the nine months ended September 30, 2022 and 2021 the Companies incurred in advertising costs $7,325 and $7,991 respectively.

 **

***Recently Adopted Accounting Pronouncements***

 **

Leases (Topic 842). In February 2016, FASB issued ASU 2016-02, Leases ("ASU 2016-02"). The new standard establishes a right-of-use ("ROU") model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. For private companies the new standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available.

The Companies adopted the standard effective January 1, 2022. The standard allows a number of optional practical expedients to use for transition. The Companies chose the certain practical expedients allowed under the transition guidance which permitted us to not to reassess any existing or expired contracts to determine if they contain embedded leases, to not to reassess our lease classification on existing leases, to account for lease and non-lease components as a single lease component for equipment leases, and whether initial direct costs previously capitalized would qualify for capitalization under FASB ASC 842. The new standard also provides practical expedients and recognition exemptions for an entity's ongoing accounting policy elections. The Companies have elected the short-term lease recognition for all leases that qualify, which means that we do not recognize a ROU asset and lease liability for any lease with a term of twelve months or less. See Note 3 for more details.

The most significant impact of adopting the standard was the recognition of ROU assets and lease liabilities for operating leases on the Companies' consolidated balance sheet but it did not have an impact on the Companies' consolidated statements of operations or consolidated statements of cash flows. The Companies did not have a cumulative effect on adoption prior to January 1, 2022.

S-F-19

**Note 2 – Property and Equipment**

Property and equipment consists of the following:

---

| | | |
|:---|:---|:---|
|  | **September 30,**<br> **2022** | **December 31,**<br> **2021** |
| Furniture and equipment | $10784 | $10784 |
| Leasehold improvements | 63390 | 63389 |
| Less: accumulated depreciation | (17410) | (7912) |
| Total equipment, net | $56764 | $66261 |

---

During the nine months ended September 30, 2022, and 2021, the Companies recorded depreciation expense of $9,497 and $3,468.

**Note 3 – Leases**

The Companies have an operating lease agreement in place for its office. Per FASB's ASU 2016-02, Leases Topic 842 ("ASU 2016-02"), effective January 1, 2022, the Companies are required to report a right-of-use asset and corresponding liability to report the present value of the total lease payments, with appropriate interest calculation. Per the terms of ASU 2016-02, the Companies can use its implicit interest rate, if known, or applicable federal rate otherwise. Since the Companies' implicit interest rate was not readily determinable, the Companies utilized the applicable federal rate, as of the commencement of the lease. Lease renewal options included in any lease are considered in the lease term if it is reasonably certain the Companies will exercise the option to renew. The Companies' operating lease agreements do not contain any material restrictive covenants.

As of September 30, 2022, the Companies' lease components included in the combined balance sheet were as follows:

---

| | | |
|:---|:---|:---|
| **Lease component** | **Balance sheet classification** | **September 30,**<br> **2022** |
| Assets |  |  |
| ROU assets – operating lease | Other assets | $1021588 |
| Total ROU assets |  | $1021588 |
| Liabilities |  |  |
| Current operating lease liability | Current liabilities | $196200 |
| Long-term operating lease liability | Other liabilities | 834746 |
| Total lease liabilities |  | $1030946 |

---

Future minimum lease payments as of September 30, 2022 were as follows:

---

| | |
|:---|:---|
| 2022 | $55903 |
| 2023 | 227804 |
| 2024 | 233499 |
| 2025 | 239337 |
| 2026 and beyond | 307026 |
| Total future minimum lease payments | $1063569 |
| Less: Interest | (32623) |
| Total operating lease liabilities | $1030946 |

---

S-F-20

**Note 4 – Notes Payable**

<u>Paycheck Protection Program</u>

On April 15, 2020, the Companies received a loan in the principal amount of $181,600 pursuant to the U.S. Small Business Administration's Paycheck Protection Program. The loan matured 18 months from the date of funding, was payable over 18 equal monthly installments, and had an interest of 1% per annum. Up to 100% of the principal balance of the loan was forgivable based upon satisfaction of certain criteria under the Paycheck Protection Program. On February 24, 2021, the principal of the loan as well as $1,567 of accrued interest was forgiven and the note was extinguished. The Companies recognized a gain of $181,600 on extinguishment of debt during the nine months ended September 30, 2021.

**Note 5 – Members' Distributions**

Members' distributions totaling $1,266,795 and $1,330,343 were paid out during the nine months ended September 30, 2022 and 2021, respectively. Distributions payable to the members totaled $467,702 and $572,608 at September 30, 2022 and 2021, respectively.

**Note 6 – Commitments and Contingencies**

*Insurance*

The Companies' insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party exposures; (ii) statutory workers' compensation insurance; (iv) excess liability insurance above the established primary limits for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal property and includes business interruption; and (vi) malpractice insurance covering our physicians for acts related to our business activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with similar types of operations.

*Legal Matters*

The Companies are not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources.

**Note 7 – Subsequent Events**

On March 16, 2023, INVO Bioscience Inc., a Nevada corporation ("INVO"), through Wood Violet Fertility LLC, a Delaware limited liability company ("Buyer") and wholly-owned subsidiary of INVO Centers LLC, a Delaware company wholly-owned by INVO, entered into an Asset Purchase Agreement (the "APA") with WFRSA and The Elizabeth Pritts Revocable Living Trust (the "Seller," together with WFRSA, the "Seller Parties") pursuant to which Buyer agreed to acquire the Purchased Assets (as defined in the APA) related to WFRSA's business. Buyer also agreed to assume certain liabilities of WFRSA as set forth in the APA. Certain non-clinical assets, properties and rights of WFRSA shall be excluded from the Purchased Assets including patient lists, charts, records and ledgers, all contracts with Payors (as defined in the APA); all Health Care Permits (as defined in the APA).

The Buyer will deliver to WFRSA an amount equal to (all capitalized terms as defined in the APA) the Closing Payment at closing consisting of $500,000 less Target Closing Date Debt less the Holdback Amount of $280,000. Buyer has agreed to make the following Post-Closing Additional Payments of $500,000 on each of the first three anniversaries of closing provided that Seller may elect to receive shares of INVO common stock in lieu of such cash payments as follows: (i) 80,000 shares of INVO common stock on the first additional payment date; (ii) 55,000 shares of INVO common stock on the second additional payment date and (iii) 35,000 shares of INVO common stock on the third additional payment date. The Additional Payments are secured by Seller having a subordinated lien on the Purchased Assets.

On March 16, 2023, Buyer entered into a Membership Interest Purchase Agreement (the "MIPA") with FLOW, IVF Science, LLC, a Wisconsin limited liability company owned by Wael Megid, Ph.D., and Dr. Elizabeth Pritts as trustee for the Elizabeth Pritts Revocable List Trust, a Trust created under the laws of the State of Wisconsin (each, a "Selling Member" and collectively, the "Selling Members"). Under the MIPA the Selling Members agreed to sell to Buyer 100% of the Membership Interests of FLOW for a purchase price equal to (all capitalized terms as defined in the MIPA) the Initial Purchase Price, which is equal to (i) two million dollars ($2,000,000) minus (ii) the Closing Indebtedness minus (iii) any Transaction Expenses minus (iv) the Holdback Amount of $70,000. In addition to the Initial Closing Payment, Purchaser has agreed to pay to the Selling Members additional payments of $2,000,000 within 90-days of each of the first three anniversaries of closing provided that Selling Members may elect to receive shares of INVO common stock in lieu of such cash payments as follows: (i) 320,000 shares of INVO common stock on the first additional payment date; (ii) 220,000 shares of INVO common stock on the second additional payment date and (iii) 140,000 shares of INVO common stock on the third additional payment date. These additional payments are secured by the Selling Members having a lien on the assets of FLOW.

S-F-21

**INVO BIOSCIENCE, INC.**

**UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS**

On March 16, 2023, INVO Bioscience Inc., a Nevada corporation ("INVO"), through Wood Violet Fertility LLC, a Delaware limited liability company ("Buyer") and wholly owned subsidiary of INVO Centers LLC, a Delaware company wholly-owned by INVO, entered into binding purchase agreements to acquire Wisconsin Fertility Institute (the "Clinic") for a combined purchase price of $10 million (the "WFI Acquisition").

The purchase price is payable in four installments of $2.5 million each, payable at closing and on each of the subsequent three anniversaries of closing. The sellers have the option to take all or a portion of the final three installments in shares of INVO common stock valued at $6.25, $9.09, and $14.29, for the second, third, and final installments, respectively.

The Clinic is comprised of (a) a medical practice, Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional service corporation d/b/a Wisconsin Fertility Institute ("WFRSA"), and (b) a laboratory services company, Fertility Labs of Wisconsin, LLC, a Wisconsin limited liability company ("FLOW"). WFRSA owns, operates and manages the Clinic's fertility practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory services.

As described in greater detail in the Current Report on Form 8-K (the "Report") to which these pro forma condensed combined financial statements are an exhibit, INVO is purchasing the non-medical assets of WFRSA and one hundred percent of FLOW's membership interests.

On March 16, 2023, Buyer entered into an Asset Purchase Agreement (the "APA") with WFRSA and The Elizabeth Pritts Revocable Living Trust (the "Seller," together with the WFRSA, the "Seller Parties") pursuant to which Buyer agreed to acquire the Purchased Assets (as defined in the APA) related to WFRSA's business. Buyer also agreed to assume certain liabilities of WFRSA as set forth in the APA. Certain non-clinical assets, properties and rights of WFRSA shall be excluded from the Purchased Assets including patient lists, charts, records and ledgers, all contracts with Payors (as defined in the APA); all Health Care Permits (as defined in the APA).

The Buyer will deliver to WFRSA an amount equal to (all capitalized terms as defined in the APA) the Closing Payment at closing consisting of $500,000 less Target Closing Date Debt less the Holdback Amount of $280,000. Buyer has agreed to make the following Post-Closing Additional Payments of $500,000 on each of the first three anniversaries of closing provided that Seller may elect to receive shares of INVO common stock in lieu of such cash payments as follows: (i) 80,000 shares of INVO common stock on the first additional payment date; (ii) 55,000 shares of INVO common stock on the second additional payment date and (iii) 35,000 shares of INVO common stock on the third additional payment date. The Additional Payments are secured by Seller having a subordinated lien on the Purchased Assets.

On March 16, 2023, Buyer entered into a Membership Interest Purchase Agreement (the "MIPA") with FLOW, IVF Science, LLC, a Wisconsin limited liability company, owned by Wael Megid, Ph.D., and Dr. Elizabeth Pritts as trustee for the Elizabeth Pritts Revocable List Trust, a Trust created under the laws of the State of Wisconsin (each, a "Selling Member" and collectively, the "Selling Members"). Under the MIPA, the Selling Members agreed to sell to Buyer 100% of the Membership Interests of FLOW for a purchase price equal to (all capitalized terms as defined in the MIPA) the Initial Purchase Price, which is equal to (i) two million dollars ($2,000,000) minus (ii) the Closing Indebtedness minus (iii) any Transaction Expenses minus (iv) the Holdback Amount of $70,000. In addition to the Initial Closing Payment, Purchaser has agreed to pay to the Selling Members additional payments of $2,000,000 within 90-days of each of the first three anniversaries of closing provided that Selling Members may elect to receive shares of INVO common stock in lieu of such cash payments as follows: (i) 320,000 shares of INVO common stock on the first additional payment date; (ii) 220,000 shares of INVO common stock on the second additional payment date and (iii) 140,000 shares of INVO common stock on the third additional payment date. These additional payments are secured by the Selling Members having a lien on the assets of FLOW.

The following unaudited pro forma condensed combined financial statements are based on the INVO's historical consolidated financial statements and the historical combined financial statements of WFRSA and FLOW (the "Companies") as adjusted to give effect to the WFI Acquisition and related financing transactions. The unaudited pro forma condensed combined statements of operations for the nine months ended September 30, 2022 and the year ended December 31, 2021 give effect to these transactions as if they had occurred on January 1, 2021. The unaudited pro forma condensed combined balance sheet as of September 30, 2022 gives effect to these transactions as if they had occurred on September 30, 2022.

The unaudited pro forma combined balance sheet and unaudited combined statement of operations are presented for informational purposes only and do not purport to be indicative of the combined financial condition that would have resulted if the acquisition would have occurred on January 1, 2021.

The unaudited pro forma condensed combined financial statements should be read together with INVO's historical financial statements, which are included in INVO's latest Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the Companies' historical financial statements, which are included in the Report.

S-F-22

**INVO BIOSCIENCE, INC.**

**PRO FORMA COMBINED BALANCE SHEET**

**(UNAUDITED)**

**AS OF SEPTEMBER 30, 2022**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **INVO**<br>**September 30, <br> 2022** | **WFI**<br>**September 30,<br> 2022** |<br>**Pro Forma<br> Adjustments** |<br>**Pro Forma <br>Balances** |
| ASSETS |  |  |  |  |
| Current assets |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Cash | $285697 | $621220 | $- | $906917 |
| &nbsp;&nbsp;&nbsp;Accounts receivable | 71311 | 275036 |  | 346347 |
| &nbsp;&nbsp;&nbsp;Inventory | 280131 |  |  | 280131 |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 305151 | 526 | - | 305677 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 942290 | 896782 |  | 1839072 |
| Property and equipment, net | 456352 | 56764 |  | 513116 |
| Goodwill |  |  | 10075471 (a) | 10075471 |
| Intangible assets, net | 132679 |  |  | 132679 |
| Investment in joint ventures | 1281306 |  |  | 1281306 |
| Lease right of use | 1865648 | 1021588 | - | 2887236 |
| Total assets | $4678275 | $1975134 | $10075471 | 16728880 |
| LIABILITIES AND STOCKHOLDERS' EQUITY |  |  |  |  |
| Current liabilities |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable and accrued liabilities | $689558 | $54035 | $- | 743593 |
| &nbsp;&nbsp;&nbsp;Accrued compensation | 643608 |  |  | 643608 |
| &nbsp;&nbsp;&nbsp;Deferred revenue, current portion | 98659 | 497922 |  | 596581 |
| &nbsp;&nbsp;&nbsp;Distributions payable |  | 467702 |  | 467702 |
| &nbsp;&nbsp;&nbsp;Lease liability, current portion | 229169 | 196200 | - | 425369 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 1660994 | 1215859 |  | 2876853 |
| Deferred tax liability | 1139 |  |  | 1139 |
| Long-term liability |  |  | 7500000 (b) | 7500000 |
| Lease liability, net of current portion | 1728918 | 834746 | - | 2563664 |
| Total liabilities | 3391051 | 2050605 | 7500000 | 12941656 |
| Stockholders' equity |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Common stock | 1217 |  | 417<br> (c) | 1634 |
| &nbsp;&nbsp;&nbsp;Additional paid-in capital | 48302505 |  | 2499583<br> (c) | 50802088 |
| &nbsp;&nbsp;&nbsp;Accumulated deficit | (47016498) |  |  | (47016498) |
| &nbsp;&nbsp;&nbsp;Members' capital - beginning |  | (88533) | 88533 |  |
| &nbsp;&nbsp;&nbsp;Members' capital - current year | - | 13062 | (13062) | - |
| Total stockholders' equity | 1287224 | (75471) | 2575471 | 3787224 |
| Total liabilities and stockholders' equity | $4678275 | $1975134 | $10075471 | 16728880 |

---

S-F-23

**INVO BIOSCIENCE, INC.**

**PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS**

**(UNAUDITED)**

**FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2022**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  |<br>**INVO<br> September 30,<br> 2022** |<br>**WFI<br> September 30,<br> 2022** |<br>**Pro Forma<br> Adjustments** | **Pro Forma**<br>**Combined<br> September 30,<br> 2022** |
| Revenue: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Product revenue | $149453 | $- | $- | $149453 |
| &nbsp;&nbsp;&nbsp;Clinic revenue | 394601 | 3971254 | - | 4365855 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total revenue | 544054 | 3971254 |  | 4515308 |
| Cost of revenue | 252329 | 1697111 | - | 1949440 |
| Gross profit | 291725 | 2274143 |  | 2565868 |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Selling, general and administrative | $7729694 | $953189 | $- | 8682883 |
| &nbsp;&nbsp;&nbsp;Research and development | 470208 | - | - | 470208 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 8199902 | 953189 | - | 9153091 |
| Income (loss) from operations | (7908177) | 1320954 |  | (6587223) |
| Other income (expense): |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Loss from equity method investment | $(210565) | $- | $- | (210565) |
| &nbsp;&nbsp;&nbsp;Other income |  | 119 |  | 119 |
| &nbsp;&nbsp;&nbsp;Interest income | 307 |  |  | 307 |
| &nbsp;&nbsp;&nbsp;Interest expense | (3319) | (248) |  | (3567) |
| &nbsp;&nbsp;&nbsp;Foreign currency exchange loss | (2922) | - | - | (2922) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other expense, net | (216499) | (129) | - | (216628) |
| Income (loss) before income taxes | (8124676) | 1320825 |  | (6803851) |
| Provision for income taxes | 800 | - | - (d) | 800 |
| Net income (loss) | (8124676) | 1320825 | - | (6804651) |
| Net profit (loss) per common share |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Basic | (0.67) |  |  | (0.56) |
| &nbsp;&nbsp;&nbsp;Diluted | (0.67) |  |  | (0.56) |
| Weighted average number of common shares outstanding: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Basic | 12107124 |  |  | 12107124 |
| &nbsp;&nbsp;&nbsp;Diluted | 12107124 |  | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;- | 12107124 |

---

S-F-24

**INVO BIOSCIENCE, INC.**

**PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS**

**(UNAUDITED)**

**FOR THE YEAR ENDED DECEMBER 31, 2021**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  |<br>**INVO<br> December 31,<br> 2021** |<br>**WFI<br> December 31,<br> 2021** |<br>**Pro Forma<br> Adjustments** | **Pro Forma**<br>**Combined<br> December 31,<br> 2021** |
| Revenue: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Product Revenue | $544942 | $- | $- | $544942 |
| &nbsp;&nbsp;&nbsp;Clinic Revenue | 43745 | 5676804 |  | 5720549 |
| &nbsp;&nbsp;&nbsp;License revenue | 3571429 | - | - | 3571429 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total revenue | 4160116 | 5676804 |  | 9836920 |
| Cost of revenue | 145052 | 2335774 | - | 2480826 |
| Gross profit | 4015064 | 3341030 |  | 7356094 |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Selling, general and administrative | $9015158 | $1216069 | $- | 10231227 |
| &nbsp;&nbsp;&nbsp;Research and development | 216430 | - | - | 216430 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 9231588 | 1216069 | - | 10447657 |
| Income (loss) from operations | (5216524) | 2124961 |  | (3091563) |
| Other income (expense): |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Loss from equity method investment | $(327542) | $- | $- | (327542) |
| &nbsp;&nbsp;&nbsp;Other income | 159126 | 182719 |  | 341845 |
| &nbsp;&nbsp;&nbsp;Interest income | 3657 |  |  | 3657 |
| &nbsp;&nbsp;&nbsp;Interest expense | (1265359) | (360) |  | (1264719) |
| &nbsp;&nbsp;&nbsp;Foreign currency exchange loss | (3534) | - | - | (3534) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other expense, net | (1433652) | 182359 | - | (1251293) |
| Income (loss) before income taxes | (6650176) | 2307320 |  | (4342856) |
| Provision for income taxes | 4764 | - | - (d) | 4764 |
| Net income (loss) | (6654940) | 2307320 | - | (4347620) |
| Net profit (loss) per common share |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Basic | (0.63) |  |  | (0.41) |
| &nbsp;&nbsp;&nbsp;Diluted | (0.63) |  |  | (0.41) |
| Weighted average number of common shares outstanding: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Basic | 10632413 |  |  | 10632413 |
| &nbsp;&nbsp;&nbsp;Diluted | 10632413 |  | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;- | 10632413 |

---

S-F-25

**INVO BIOSCIENCE, INC.**

**NOTES TO COMBINED FINANCIAL STATEMENTS**

**Note 1 – Basis of presentation**

 ****

The WFI Acquisition will be accounted for under the acquisition method of accounting in accordance with ASC Topic 805, Business Combinations. As the acquirer for accounting purposes, the Company has estimated the fair value of WFI's assets acquired and liabilities assumed and conformed the accounting policies of WFI to its own policies.

**Note 2 – Calculation of purchase consideration and preliminary purchase price allocation**

The following table summarizes the fair value of purchase consideration that will be transferred on the Closing Date:

---

| | |
|:---|:---|
| Proceeds from the sale of INVO common stock | $2500000 |
| Total upfront cash consideration | 2500000 |
| Future cash or equity consideration(1) | 7500000 |
| Total purchase consideration | $10000000 |

---

&nbsp;&nbsp;&nbsp;&nbsp;(1) Sellers
 may elect to receive shares of INVO common stock in lieu of cash payments. See Note 3.

The Company has performed a preliminary valuation analysis of the fair market value of the Companies' assets and liabilities. The following table summarizes the preliminary allocation of the purchase price as of September 30, 2022:

---

| | |
|:---|:---|
| Cash | $621220 |
| Accounts receivable | 275036 |
| Prepaid expenses and other current assets | 526 |
| Property and equipment, net | 56764 |
| Lease right of use asset | 1021588 |
| Goodwill | 10075471 |
| Accounts payable and accrued expenses | (54035) |
| Distributions payable | (467702) |
| Deferred revenue | (497922) |
| Lease liability | (1030946) |
| Total consideration | $10000000 |

---

This preliminary purchase price allocation has been used to prepare pro forma adjustments in the unaudited pro forma condensed combined balance sheet and income statements. The final purchase price allocation will be determined when INVO has completed all detailed valuations and necessary calculations, which are expected to be finalized within the next twelve months. The final allocation could differ materially from the preliminary allocation used in the pro forma adjustments. The final allocation may include (i) changes in identifiable net assets, (ii) changes in fair values of property, plant and equipment, and (iii) other changes to assets and liabilities.

**Note 3 – Pro forma adjustments**

The pro forma adjustments are based on the INVO's preliminary estimates and assumptions that are subject to change. The following adjustments have been reflected in the unaudited pro forma condensed combined financial statements:

(a) Represents the preliminary goodwill associated with the WFI Acquisition as presented in Note 2. Goodwill represents the estimate of the excess of the purchase price over the fair value of the assets acquired and liabilities assumed.

(b) Represents the future cash payments owed for the WFI acquisition. INVO has agreed to make additional payments of $2,500,000 within 90-days of each of the first three anniversaries of closing. The sellers may elect to receive shares of INVO common stock in lieu of cash payments as follows: (i) 400,000 shares of INVO common stock on the first additional payment date; (ii) 275,000 shares of INVO common stock on the second additional payment date and (iii) 175,000 shares of INVO common stock on the third additional payment date.

(c) Represents estimated proceeds from common stock sold by INVO to meet the initial $2.5 million due upon closing of the WFI acquisition. As an alternative, INVO may decide to fund the upfront consideration using debt financing, if available on reasonable terms.

(d) WFRSA and FLOW are taxed at the partnership level and as such no provision for income taxes has been recorded for the WFI Acquisition.

S-F-26

**PROSPECTUS**

**INVO BIOSCIENCE, INC.**

**Common Stock**

**Preferred Stock**<br> **Debt Securities**

**Warrants**<br> **Units**

**$35,000,000**

------

We may offer and sell up to $35,000,000 in the aggregate of the securities identified above from time to time in one or more offerings. This prospectus provides you with a general description of the securities.

Each time we offer and sell securities, we will provide a supplement to this prospectus that contains specific information about the offering and the amounts, prices and terms of the securities. The supplement may also add, update or change information contained in this prospectus with respect to that offering. You should carefully read this prospectus and the applicable prospectus supplement before you invest in any of our securities.

We may offer and sell the securities described in this prospectus and any prospectus supplement to or through one or more underwriters, dealers and agents, or directly to purchasers, or through a combination of these methods. If any underwriters, dealers or agents are involved in the sale of any of the securities, their names and any applicable purchase price, fee, commission or discount arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus supplement. See the sections of this prospectus entitled "About this Prospectus" and "Plan of Distribution" for more information. No securities may be sold without delivery of this prospectus and the applicable prospectus supplement describing the method and terms of the offering of such securities.

**INVESTING IN OUR SECURITIES INVOLVES RISKS. SEE THE "RISK FACTORS" SECTION ON PAGE 6 OF THIS PROSPECTUS AND ANY SIMILAR SECTION CONTAINED IN THE APPLICABLE PROSPECTUS SUPPLEMENT AND THE OTHER DOCUMENTS THAT ARE INCORPORATED BY REFERENCE INTO THIS PROSPECTUS CONCERNING FACTORS YOU SHOULD CONSIDER BEFORE INVESTING IN OUR SECURITIES.**

Our common stock is listed on the Nasdaq Capital Market under the symbol "INVO." On April 6, 2021 the last reported sale price of our common stock on the Nasdaq Capital Market was $4.20 per share.

**Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.**

------

**The date of this prospectus is April 16, 2021.**

**TABLE OF CONTENTS**

---

| | |
|:---|:---|
|  | **Page** |
| [ABOUT THIS PROSPECTUS](#B_001) | 1 |
| [WHERE YOU CAN FIND MORE INFORMATION](#B_002) | 2 |
| [INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE](#B_003) | 2 |
| [THE COMPANY](#B_004) | 4 |
| [RISK FACTORS](#B_005) | 6 |
| [USE OF PROCEEDS](#B_006) | 6 |
| [DESCRIPTION OF CAPITAL STOCK WE MAY OFFER](#B_007) | 7 |
| [DESCRIPTION OF DEBT SECURITIES WE MAY OFFER](#B_008) | 9 |
| [DESCRIPTION OF WARRANTS WE MAY OFFER](#B_009) | 17 |
| [DESCRIPTION OF UNITS WE MAY OFFER](#B_010) | 20 |
| [GLOBAL SECURITIES](#B_011) | 21 |
| [PLAN OF DISTRIBUTION](#B_012) | 24 |
| [LEGAL MATTERS](#B_013) | 25 |
| [EXPERTS](#B_014) | 25 |

---

**ABOUT THIS PROSPECTUS**

This prospectus is part of a registration statement that we filed with the U.S. Securities and Exchange Commission (the "SEC"), using a "shelf" registration process. By using a shelf registration statement, we may sell securities from time to time and in one or more offerings up to a total dollar amount of $35,000,000 of securities as described in this prospectus. Each time that we offer and sell securities, we will provide a prospectus supplement to this prospectus that contains specific information about the securities being offered and sold and the specific terms of that offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings. The prospectus supplement or free writing prospectus may also add, update or change information contained in this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus and the applicable prospectus supplement or free writing prospectus, you should rely on the prospectus supplement or free writing prospectus, as applicable. Before purchasing any securities, you should carefully read both this prospectus and the applicable prospectus supplement (and any applicable free writing prospectuses), together with the additional information described under the headings "Where You Can Find More Information" and "Incorporation by Reference."

We have not authorized anyone to provide you with any information or to make any representations other than those contained in this prospectus, any applicable prospectus supplement or any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We will not make an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus and the applicable prospectus supplement to this prospectus is accurate only as of the date on its respective cover, that the information appearing in any applicable free writing prospectuses is accurate only as of the date of that free writing prospectus, and that any information incorporated by reference is accurate only as of the date of the document incorporated by reference, unless we indicate otherwise. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus incorporates by reference, and any prospectus supplement or free writing prospectus may contain and incorporate by reference, market data and industry statistics and forecasts that are based on independent industry publications and other publicly available information. Although we believe these sources are reliable, we do not guarantee the accuracy or completeness of this information and we have not independently verified this information. In addition, the market and industry data and forecasts that may be included or incorporated by reference in this prospectus, any prospectus supplement or any applicable free writing prospectuses may involve estimates, assumptions and other risks and uncertainties and are subject to change based on various factors, including those discussed under the heading "Risk Factors" contained in this prospectus, the applicable prospectus supplement and any applicable free writing prospectus, and under similar headings in other documents that are incorporated by reference into this prospectus. Accordingly, investors should not place undue reliance on this information.

When we refer to "we," "our," "us" and the "Company" in this prospectus, we mean INVO Bioscience, Inc., unless otherwise specified. When we refer to "you," we mean the potential holders of the applicable series of securities.

This prospectus contains references to our trademarks and to trademarks belonging to other entities, which are protected under applicable intellectual property laws. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the® or™ symbols, but such references are not intended to indicate that we or their respective owners will not assert, to the fullest extent 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 or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any such companies.

**WHERE YOU CAN FIND MORE INFORMATION**

We file annual, quarterly and other reports, proxy statements and other information with the SEC. The SEC maintains a website that contains reports, proxy and information statements and other information about issuers, such as us, who file electronically with the SEC. The address of that website is http://www.sec.gov.

Our website address is www.invobioscience.com. The information on our website, however, is not, and should not be deemed to be, a part of this prospectus.

This prospectus and any prospectus supplement are part of a registration statement that we filed with the SEC and do not contain all of the information in the registration statement. The full registration statement may be obtained from the SEC or us, as provided below. Forms of the indenture and other documents establishing the terms of the offered securities are or may be filed as exhibits to the registration statement or documents incorporated by reference in the registration statement. Statements in this prospectus or any prospectus supplement about these documents are summaries and each statement is qualified in all respects by reference to the document to which it refers. You should refer to the actual documents for a more complete description of the relevant matters. You may obtain a copy of the registration statement through the SEC's website, as provided above.

**INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE**

The SEC's rules allow us to "incorporate by reference" information into this prospectus, which means that we can disclose important information to you by referring you to another document filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus, and subsequent information that we file with the SEC will automatically update and supersede that information. Any statement contained in this prospectus or a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or a subsequently filed document incorporated by reference modifies or replaces that statement.

This prospectus and any accompanying prospectus supplement incorporate by reference the documents set forth below that have previously been filed with the SEC (but excluding any information in such documents that has been furnished to, rather than filed with, the SEC):

● Our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on [March 30, 2021](http://www.sec.gov/Archives/edgar/data/1417926/000118518521000413/invobio20201231_10k.htm) ;

● our Current Reports on Form 8-K filed with the SEC on [January 4, 2021](http://www.sec.gov/Archives/edgar/data/1417926/000118518521000002/invobio20210104_8k.htm) ; [March 8, 2021](http://www.sec.gov/Archives/edgar/data/1417926/000118518521000301/invobio20210305_8k.htm) ; [March 15, 2021;](http://www.sec.gov/Archives/edgar/data/1417926/000118518521000327/invobio20210315_8k.htm) and [March 30, 2021](http://www.sec.gov/Archives/edgar/data/1417926/000118518521000416/invobio20210329_8k.htm) .

● the description of our common stock contained in our registration statement on Form 8-A12B, filed with the SEC on [November 12, 2020](http://www.sec.gov/Archives/edgar/data/1417926/000118518520001558/invobio20201020_8a12b.htm) (File No. 001-39701), and all amendments or reports filed for the purpose of updating such description.

All reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), prior to the termination of this offering, including all such documents we may file with the SEC after the date of the initial registration statement and prior to the effectiveness of the registration statement, but excluding any information furnished to, rather than filed with, the SEC, will also be incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of such reports and documents.

You may request a free copy of any of the documents incorporated by reference in this prospectus by writing or telephoning us at the following address:

INVO Bioscience, Inc.

Attn: CEO

5582 Broadcast Court

Sarasota, Florida 34240

(978) 878-9505

Exhibits to the filings will not be sent, however, unless those exhibits have specifically been incorporated by reference in this prospectus or any accompanying prospectus supplement.

**THE COMPANY**

We are a medical device company focused on the Assisted Reproductive Technology (ART) marketplace. Our mission is to increase access to care and expand fertility treatment and patient care across the globe. Our patented device, the INVOcell, is the first Intravaginal Culture (IVC) system in the world used for the natural *in vivo* incubation of eggs and sperm during fertilization and early embryo development. The U.S. Food and Drug Administration ("FDA") granted our request for de novo classification of the INVOcell Intravaginial Culture System (INVOcell) in November 2015. INVOcell also received the CE mark in October 2019 and is now positioned to help provice millsions of infertile couples across the globe access to a new infertility treatment. We believe this novel device and procedure (the "INVO Procedure") provides a more natural, safe, effective and economical fertility treatment compared to current infertility treatments, including in-vitro fertilization ("IVF") and intrauterine insemination ("IUI"). Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women's vaginal cavity as the incubator to support a more natural fertilization process. This novel device promotes *in vivo* conception and early embryo development.

In both commercial utilization of the INVOcell and in clinical studies, the INVO Procedure has proven to have equivalent pregnancy success and live birth rates as IVF1. Additionally, we believe there are emotional benefits with the mother's participation in fertilization and early embryo development by vaginal incubation compared to that of traditional IVF treatment by offering patients a more connected and personalized way to achieve pregnancy.

For many couples struggling with infertility, access to treatment is often unavailable. Financial challenges (i.e. cost of treatment) and limited availability (or capacity) of fertility medical care are two of the main challenges in the ART marketplace that contribute to the large percentage of untreated patients. Religious, social and cultural roadblocks can also prevent hopeful couples from realizing their dream to have a baby with conventional IVF. We believe INVOcell can address many of the key challenges in the ART market, particularly patient cost and infrastructure capacity constraints. The many benefits of the INVO Solution include:

● Cost: Current U.S.-based clinics offering INVOcell are doing so at approximately half the cost of IVF treatment, due to less drugs often being prescribed for INVOcell, fewer office visits and less laboratory time needed as incubation is occurring inside the body rather than a lab incubator.

● Enhances Industry Capacity: The INVOcell device eliminates the need for a lab incubator as well as helps reduce the overall need for lab-support resources during the incubation period. We believe this generally supports the ability to lower costs as well as enable a clinic to handle a higher volume of patients.

● Promotes greater involvement by couples in the treatment and conception.

● Reduces the risk of errors of wrong embryo transfers since the embryos are never separated from the woman.

● Creates a more natural and environmentally stable incubation than traditional IVF in the laboratory.

In the second quarter of 2016, the first U.S. baby from the INVOcell and INVO Procedure following FDA clearance was born in Texas.

------

1 Journal of Assisted Reproduction and Genetics: Comparing Blastocyst Quality and Live Birth Rates of Intravaginal Culture Using INVOcell™ to Traditional in Vitro Incubation in a Randomized Open-Label Prospective Controlled Trial, Kevin J. Doody & E. Jason Broome & Kathleen M. Doody; January 13, 2016. https://invobioscience.com/wp-content/uploads/2016/07/Doody-Report.pdf

The original de novo classification request for INVOcell was based on a 3-day incubation period. We intend to collect additional data to seek FDA clearance for 5-day incubation.

**The Ferring Distribution Agreement**

On November 12, 2018, we entered into a Distribution Agreement (the "Distribution Agreement") with Ferring, pursuant to which, among other things, we granted to Ferring an exclusive license in the United States (the "Territory") with rights to sublicense under patents related to our proprietary intravaginal culture device known as INVOcell™, together with the retention device and any other applicable accessories (collectively, the "Licensed Product") to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including infertility treatment) in humans (the "Field"). Ferring is responsible, at its own cost, for all commercialization activities for the Licensed Product in the Field in the Territory. The Company does retain a limited exception to the exclusive license granted to Ferring allowing us, subject to certain restrictions, to establish up to five clinics (which was subsequently amended to seven) that will commercialize the INVO Procedure in the Territory. We retain all commercialization rights for the Licensed Product outside of the United States.

Under the terms of the Distribution Agreement, Ferring made an initial payment to us of $5 million upon the completion of certain closing conditions, which included an agreement from all current manufacturers of the Licensed Product that Ferring would have the right to assume a direct purchase relationship with such manufacturers upon a material supply default us. The Distribution Agreement transaction closed on January 14, 2019. Ferring is obligated to make a milestone payment to us of $3 million if we are successful in obtaining a five (5) day label enhancement from the FDA for the current incubation period for the Licensed Product at least three (3) years prior to the expiration of the term of the license for the Licensed Product, provided that Ferring has not previously exercised its right to terminate the Distribution Agreement. There can be no assurance that we will successfully complete the milestone required to receive this $3 million payment. In addition, under the terms of a separate Supply Agreement, Ferring is obligated to pay us a specified supply price for each Licensed Product it purchases for distribution.

The Distribution Agreement has an initial term expiring on December 31, 2025 upon which it may be terminated by the Company if Ferring fails to generate specified minimum revenues to the Company from the sale of the Licensed Product during the final two years of the initial term. Provided that no such termination occurs at the end of the initial term, thereafter the term of the Distribution Agreement will automatically be renewed for successive three (3) years terms unless terminated by mutual consent. The Distribution Agreement is subject to termination upon a material breach by either party, or by Ferring for convenience. In addition, if the closing under the Distribution Agreement does not occur within seventy-five (75) days, a non-breaching party may elect to terminate the Distribution Agreement.

On March 2, 2021, we entered into Amendment No. 1 to Distribution Agreement (the "Amendment") with Ferring. Pursuant to the Amendment, Ferring agreed to purchase a 2,004 count of product for $501,000 pursuant to the Distribution Agreement in March 2021, at which point the minimum annual target for 2020 set forth in Section 2.4 of the Distribution Agreement will be deemed to be satisfied in full as a result of such purchase. The Amendment provides for added flexibility by increasing the number of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements.

**The INVOcell Technology**

Our product, the INVOcell**,** is the first *in vivo* Intravaginal Culture (IVC) system granted FDA clearance in the United States. We believe our novel device and procedure provide a more natural, safe, effective and economical fertility treatment for patients. The patented INVOcell device is used for the incubation of eggs and sperm during fertilization and early embryo development. Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women's vagina as an incubator to support a more natural fertilization and embryo development environment, and infertility treatment. The device promotes *in vivo* conception for early embryo development. In clinical studies, the INVO Procedure produced substantially equivalent efficacy and pregnancy rates to traditional IVF treatments.

<u>The INVOcell system consists of the following components</u>:

The **INVOcell Culture Device** is used in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture and Intra-cytoplasmic Sperm Injection Fertilization/Intravaginal Culture (ICSI/IVC) procedures. The INVOcell Culture Device is positioned in the INVOcell Retention Device prior to placement in the patient's vaginal cavity.

The **INVOcell Retention Device** is used in conjunction with the INVOcell Culture Device to aid in retention of the INVOcell Device in the vaginal cavity during the incubation period. The INVOcell Culture Device is positioned in the INVOcell Retention Device prior to placement in the patient's vaginal cavity.

During an INVO Procedure, the patient undergoes a ovarian stimulation cycle. Once the eggs are retrieved and sperm is collected, they are placed into the single use INVOcell Culture. Sperm collection and preparation generally occur before egg retrieval. Culture medium (~1ml) is placed in the inner vessel of the INVOcell. Eggs and a low concentration of motile sperm are placed into the medium and the inner vessel is closed and secured in the protective outer vessel. The INVOcell device is then immediately positioned in the upper vaginal cavity for incubation, where natural fertilization and early development of the embryos take place for a period of three (3) to five (5) days. A retention system can be used to maintain the INVOcell Culture Device in the vagina during the incubation period. The INVOcell Retention Device consists of a diaphragm type device with holes in the membrane to allow natural elimination of vaginal secretions. The INVOcell is designed so that no vaginal fluids penetrate the outer vessel thus ensuring that the inner vessel is not contaminated while allowing the necessary CO2 for fertilization to pass through.

After the three (3) to five (5) day incubation period, the patient returns to the physician's office where the retention system and the INVOcell are removed. The protective outer vessel is discarded and the contents of the inner vessel are placed into a petri plate for an embryologist to evaluate the best embryos for transfer. The embryos to be transferred are aspirated into a standard transfer catheter for transfer into the patient's uterus. The INVO procedures can be performed in a physician's office furnished with the necessary equipment.

**Corporate History**

We were formed on January 5, 2007 under the laws of the Commonwealth of Massachusetts under the name Bio X Cell, Inc. to acquire the assets of Medelle Corporation ("Medelle"). Dr. Claude Ranoux purchased all of the assets of Medelle, and then he contributed those assets, including four patents relating to the INVOcell technology, to Bio X Cell, Inc. upon its formation in January 2007.

On December 5, 2008, Bio X Cell, Inc., doing business as INVO Bioscience, and each of the shareholders of INVO Bioscience entered into a share exchange agreement and consummated a share exchange with Emy's Salsa AJI Distribution Company, Inc., a Nevada corporation ("Emy's"). Upon the closing of the share exchange on December 5, 2008, the INVO Bioscience shareholders transferred all of their shares of common stock in INVO Bioscience to Emy's. In connection with the share exchange, Emy's changed its name to INVO Bioscience, Inc. and Bio X Cell, Inc. became a wholly owned subsidiary of Emy's (re-named INVO Bioscience, Inc.).

On November 2, 2015 we were notified by the United States Food & Drug Administration ("FDA") that the INVOcell and INVO Procedure were granted clearance via the de novo classification (as a Class II device) allowing us to market the INVOcell in the United States. Following this approval, we began marketing and selling INVOcell in many locations across the U.S. We currently have approximately 140 trained clinics or satellite facilities in the U.S. where patients can receive guidance and treatment for the INVO Procedure.

Our principal executive offices are located at 5582 Broadcast Court Sarasota, Florida 34240 and our telephone number is (978) 878-9505. The address of our website is www.INVOBioscience.com. The information provided on our website is not part of this prospectus and you should not consider the contents of our website in making an investment decision regarding out stock.

**RISK FACTORS**

Investment in any securities offered pursuant to this prospectus and the applicable prospectus supplement involves risks. You should carefully consider the risk factors incorporated by reference to our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and any subsequent Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q or Current Reports on Form 8-K we file after the date of this prospectus, and all other information contained or incorporated by reference into this prospectus, as updated by our subsequent filings under the Exchange Act, and the risk factors and other information contained in the applicable prospectus supplement and any applicable free writing prospectuses before acquiring any of such securities. The occurrence of any of these risks might cause you to lose all or part of your investment in the offered securities.

**USE OF PROCEEDS**

We intend to use the net proceeds from the sale of the securities as set forth in the applicable prospectus supplement.

**DESCRIPTION OF CAPITAL STOCK WE MAY OFFER**

**General**

Our authorized capital stock consists of 125,000,000 shares of common stock, par value $0.0001 per share, and 100,000,000 shares of preferred stock, par value $0.0001 per share.

The following description of our common stock and preferred stock, together with the additional information included in any applicable prospectus supplements or related free writing prospectuses, summarizes the material terms and provisions of these types of securities, but it is not complete. For the complete terms of our common stock and preferred stock, please refer to our articles of incorporation and our bylaws that are incorporated by reference into the registration statement which includes this prospectus and, with respect to preferred stock, any certificate of designation that we may file with the SEC for a series of preferred stock we may designate, if any.

We will describe, in a prospectus supplement or related free writing prospectuses, the specific terms of any common stock or preferred stock we may offer pursuant to this prospectus. If indicated in a prospectus supplement, the terms of such common stock or preferred stock may differ from the terms described below.

**Common Stock**

As of March 31, 2021, there were 10,424,229 shares of common stock outstanding. The holders of our common stock are entitled to one vote for each share held of record on all matters submitted to a vote of the stockholders. The holders of common stock are not entitled to cumulative voting rights with respect to the election of directors, and as a consequence, minority stockholders will not be able to elect directors on the basis of their votes alone.

Subject to preferences that may be applicable to any then outstanding shares of preferred stock, holders of common stock are entitled to receive ratably such dividends as may be declared by the board of directors out of funds legally available therefor. In the event of a liquidation, dissolution or winding up of us, holders of the common stock are entitled to share ratably in all assets remaining after payment of liabilities and the liquidation preferences of any then outstanding shares of preferred stock. Holders of common stock have no preemptive rights and no right to convert their common stock into any other securities. There are no redemption or sinking fund provisions applicable to our common stock. All outstanding shares of common stock are, and all shares of common stock to be issued under this prospectus will be, fully paid and non-assessable. The rights, preferences and privileges of holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any of our outstanding preferred stock.

***Listing***

Our common stock is listed on the Nasdaq Capital Market under the symbol "INVO."

***Transfer Agent and Registrar***

We have engaged the services of Transfer Online, Inc. as our transfer agent and registrar.

***Dividends***

We have not declared any cash dividends on our common stock since inception and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.

**Preferred Stock**

We are authorized to issue a total of 100,000,000 shares of preferred stock. As of March 31, 2021, there were no shares of preferred stock issued and outstanding.

Preferred stock may be issued from time to time, in one or more series, as authorized by the board of directors, without stockholder approval. The prospectus supplement relating to the preferred shares offered thereby will include specific terms of any preferred shares offered, including, if applicable:

● the title of the shares of preferred stock;

● the number of shares of preferred stock offered, the liquidation preference per share and the offering price of the shares of preferred stock;

● the dividend rate(s), period(s) and/or payment date(s) or method(s) of calculation thereof applicable to the shares of preferred stock;

● whether the dividends on shares of preferred stock are cumulative or not and, if cumulative, the date from which dividends on the shares of preferred stock shall accumulate;

● the procedures for any auction and remarketing, if any, for the shares of preferred stock;

● the provision for a sinking fund, if any, for the shares of preferred stock;

● the provision for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase rights of the shares of preferred stock;

● any listing of the shares of preferred stock on any securities exchange;

● the terms and conditions, if applicable, upon which the shares of preferred stock will be convertible into common shares, including the conversion price (or manner of calculation thereof);

● discussion of federal income tax considerations applicable to the shares of preferred stock;

● the relative ranking and preferences of the shares of preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of our affairs;

● any limitations on issuance of any series or class of shares of preferred stock ranking senior to or on a parity with such series or class of shares of preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of our affairs;

● any other specific terms, preferences, rights, limitations or restrictions of the shares of preferred stock; and

● any voting rights of such preferred stock.

The transfer agent and registrar for any series or class of preferred stock will be set forth in the applicable prospectus supplement.

**Effect of Certain Provisions of our Amended and Restated Articles of Incorporation and Bylaws and the Nevada Anti-Takeover Provisions**

Some provisions of Nevada law and our amended and restated articles of incorporation and bylaws contain provisions that could make our acquisition by means of a tender offer, a proxy contest or otherwise, and the removal of incumbent officers and directors more difficult. These provisions, summarized below, are expected to discourage coercive takeover practices and inadequate takeover bids and to promote stability in our management. These provisions are also designed to encourage persons seeking to acquire control of us to first negotiate with our board of directors.

<u>*Amended and Restated Articles of Incorporation and Bylaws*</u>

Our amended and restated articles of incorporation and bylaws provide for the following:

*●* *Preferred Stock*. The ability to authorize preferred stock makes it possible for our board of directors to issue one or more series of preferred stock with voting or other rights or preferences that could impede the success of any attempt to change control of the Company. These and other provisions may have the effect of deferring hostile takeovers or delaying changes in control or management of us.

*●* *Requirements for Advance Notification of Stockholder Nominations.* Our bylaws establish advance notice procedures with respect to stockholder proposals and the nomination of candidates for election as directors, other than nominations made by or at the direction of the board of directors.

*●* *Stockholder Meetings*. Our charter documents provide that a special meeting of stockholders may be called only by resolution adopted by the majority board of directors, the chairman of the board of directors or the chief executive officer.

*●* *Amendment of Bylaws.* Our board of directors have the sole power to amend the bylaws.

 

<u>*Nevada Anti-Takeover Provision*</u>

 

Section 78.438 of the Nevada Revised Statutes ("NRS") prohibits a publicly held Nevada corporation from engaging in a business combination with an interested stockholder, generally a person that together with its affiliates owns or within the last two years has owned 10% of the outstanding voting stock, for a period of two years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner, or falls within certain exemptions under the NRS. As a result of these provisions in our charter documents under Nevada law, the price investors may be willing to pay in the future for shares of our common stock may be limited. 

**DESCRIPTION OF DEBT SECURITIES WE MAY OFFER**

The following description, together with the additional information we include in any applicable prospectus supplements or free writing prospectuses, summarizes the material terms and provisions of the debt securities that we may offer under this prospectus. We may issue debt securities, in one or more series, as either senior or subordinated debt or as senior or subordinated convertible debt. While the terms we have summarized below will apply generally to any future debt securities we may offer under this prospectus, we will describe the particular terms of any debt securities that we may offer in more detail in the applicable prospectus supplement or free writing prospectus. The terms of any debt securities we offer under a prospectus supplement may differ from the terms we describe below. Unless the context requires otherwise, whenever we refer to the "indentures," we also are referring to any supplemental indentures that specify the terms of a particular series of debt securities.

We will issue any senior debt securities under the senior indenture that we will enter into with the trustee named in the senior indenture. We will issue any subordinated debt securities under the subordinated indenture and any supplemental indentures that we will enter into with the trustee named in the subordinated indenture. We have filed forms of these documents as exhibits to the registration statement, of which this prospectus is a part, and supplemental indentures and forms of debt securities containing the terms of the debt securities being offered will be filed as exhibits to the registration statement of which this prospectus is a part or will be incorporated by reference to reports that we file with the SEC.

The indentures will be qualified under the Trust Indenture Act of 1939, as amended (the "Trust Indenture Act"). We use the term "trustee" to refer to either the trustee under the senior indenture or the trustee under the subordinated indenture, as applicable.

The following summaries of material provisions of the senior debt securities, the subordinated debt securities and the indentures are subject to, and qualified in their entirety by reference to, all of the provisions of the indenture and any supplemental indentures applicable to a particular series of debt securities. We urge you to read the applicable prospectus supplements and any related free writing prospectuses related to the debt securities that we may offer under this prospectus, as well as the complete indenture that contains the terms of the debt securities. Except as we may otherwise indicate, the terms of the senior indenture and the subordinated indenture are identical.

**General**

The terms of each series of debt securities will be established by or pursuant to a resolution of our board of directors and set forth or determined in the manner provided in an officers' certificate or by a supplemental indenture. Debt securities may be issued in separate series without limitation as to aggregate principal amount. We may specify a maximum aggregate principal amount for the debt securities of any series. We will describe in the applicable prospectus supplement the terms of the series of debt securities being offered, including:

● the title;

● the principal amount being offered, and if a series, the total amount authorized and the total amount outstanding;

● any limit on the amount that may be issued;

● whether or not we will issue the series of debt securities in global form, and, if so, the terms and who the depositary will be;

● the maturity date;

● whether and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a U.S. person for tax purposes, and whether we can redeem the debt securities if we have to pay such additional amounts;

● the annual interest rate, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates;

● whether or not the debt securities will be secured or unsecured, and the terms of any secured debt;

● the terms of the subordination of any series of subordinated debt;

● the place where payments will be payable;

● restrictions on transfer, sale or other assignment, if any;

● our right, if any, to defer payment of interest and the maximum length of any such deferral period;

● the date, if any, after which, and the price at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions;

● provisions for a sinking fund purchase or other analogous fund, if any, including the date, if any, on which, and the price at which we are obligated, pursuant thereto or otherwise, to redeem, or at the holder's option, to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable;

● provisions relating to modification of the terms of the security or the rights of the security holder;

● whether the indenture will restrict our ability or the ability of our subsidiaries to:

● incur additional indebtedness;

● issue additional securities;

● create liens;

● pay dividends or make distributions in respect of our capital stock or the capital stock of our subsidiaries;

● redeem capital stock;

● place restrictions on our subsidiaries' ability to pay dividends, make distributions or transfer assets;

● make investments or other restricted payments;

● sell, transfer or otherwise dispose of assets;

● enter into sale-leaseback transactions;

● engage in transactions with stockholders or affiliates;

● issue or sell stock of our subsidiaries; or

● effect a consolidation or merger;

● whether the indenture will require us to maintain any interest coverage, fixed charge, cash flow-based, asset-based or other financial ratios;

● information describing any book-entry features;

● the applicability of the provisions in the indenture on discharge;

● whether the debt securities are to be offered at a price such that they will be deemed to be offered at an "original issue discount" as defined in paragraph (a) of Section 1273 of the Internal Revenue Code of 1986, as amended;

● the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof;

● the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars; and

● any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, including any additional events of default or covenants provided with respect to the debt securities, and any terms that may be required by us or advisable under applicable laws or regulations.

U.S. federal income tax consequences applicable to debt securities sold at an original issue discount will be described in the applicable prospectus supplement. In addition, U.S. federal income tax or other consequences applicable to any debt securities which are denominated in a currency or currency unit other than U.S. dollars may be described in the applicable prospectus supplement.

**Conversion or Exchange Rights**

We will set forth in the applicable prospectus supplement the terms under which a series of debt securities may be convertible into or exchangeable for our common stock, our preferred stock or other securities (including securities of a third party). We will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or at our option. We may include provisions pursuant to which the number of shares of our common stock, our preferred stock or other securities (including securities of a third party) that the holders of the series of debt securities receive would be subject to adjustment.

**Consolidation, Merger or Sale**

Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the indentures will not contain any covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all of our assets. However, any successor to or acquirer of such assets must assume all of our obligations under the indentures or the debt securities, as appropriate. If the debt securities are convertible into or exchangeable for our other securities or securities of other entities, the person with whom we consolidate or merge or to whom we sell all of our assets must make provisions for the conversion of the debt securities into securities that the holders of the debt securities would have received if they had converted the debt securities before the consolidation, merger or sale.

**Events of Default under the Indenture**

Unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the following are events of default under the indentures with respect to any series of debt securities that we may issue:

● if we fail to pay interest when due and payable and our failure continues for 90 days and the time for payment has not been extended;

● if we fail to pay the principal, premium or sinking fund payment, if any, when due and payable and the time for payment has not been extended;

● if we fail to observe or perform any other covenant contained in the debt securities or the indentures, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90 days after we receive notice from the trustee or we and the trustee receive notice from the holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and

● if specified events of bankruptcy, insolvency or reorganization occur.

We will describe in each applicable prospectus supplement any additional events of default relating to the relevant series of debt securities. If an event of default with respect to debt securities of any series occurs and is continuing, other than an event of default specified in the last bullet point above, the trustee or the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series, by notice to us in writing, and to the trustee if notice is given by such holders, may declare the unpaid principal, premium, if any, and accrued interest, if any, due and payable immediately. If an event of default arises due to the occurrence of certain specified bankruptcy, insolvency or reorganization events, the unpaid principal, premium, if any, and accrued interest, if any, of each issue of debt securities then outstanding shall be due and payable without any notice or other action on the part of the trustee or any holder.

The holders of a majority in principal amount of the outstanding debt securities of an affected series may waive any default or event of default with respect to the series and its consequences, except defaults or events of default regarding payment of principal, premium, if any, or interest, unless we have cured the default or event of default in accordance with the indenture. Any such waiver shall cure the default or event of default.

Subject to the terms of the applicable indenture, if an event of default under an indenture shall occur and be continuing, the trustee will be under no obligation to exercise any of its rights or powers under such indenture at the request or direction of any of the holders of the applicable series of debt securities, unless such holders have offered the trustee reasonable indemnity or security satisfactory to it against any loss, liability or expense. The holders of a majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method and place of conducting any proceeding for any remedy available to the trustee, or exercising any trust or power conferred on the trustee, with respect to the debt securities of that series, provided that:

● the direction so given by the holders is not in conflict with any law or the applicable indenture; and

● subject to its duties under the Trust Indenture Act, the trustee need not take any action that might subject it to personal liability or might be unduly prejudicial to the holders not involved in the proceeding.

The indentures provide that if an event of default has occurred and is continuing, the trustee will be required in the exercise of its powers to use the degree of care that a prudent person would use in the conduct of its own affairs. The trustee, however, may refuse to follow any direction that conflicts with law or the indenture, or that the trustee determines is unduly prejudicial to the rights of any other holder of the relevant series of debt securities, or that would subject the trustee to personal liability. Prior to taking any action under the indentures, the trustee will be entitled to indemnification against all costs, expenses and liabilities that would be incurred by taking or not taking such action.

A holder of the debt securities of any series will have the right to institute a proceeding under the indentures or to appoint a receiver or trustee, or to seek other remedies only if:

● the holder has given written notice to the trustee of a continuing event of default with respect to that series;

● the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made a written request and such holders have offered reasonable indemnity to the trustee or security satisfactory to it against any loss, liability or expense to be incurred in compliance with instituting the proceeding as trustee; and

● the trustee does not institute the proceeding, and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting directions within 60 days after the notice, request and offer.

These limitations do not apply to a proceeding instituted by a holder of debt securities if we default in the payment of the principal, premium, if any, or interest on, the debt securities.

We will periodically file statements with the trustee regarding our compliance with specified covenants in the indentures.

The indentures provide that if a default occurs and is continuing and is actually known to a responsible officer of the trustee, the trustee must mail to each holder notice of the default within 45 days after it occurs, unless such default has been cured. Except in the case of a default in the payment of principal or premium of, or interest on, any debt security or certain other defaults specified in an indenture, the trustee shall be protected in withholding such notice if and so long as the board of directors, the executive committee or a trust committee of directors, or responsible officers of the trustee, in good faith determine that withholding notice is in the best interests of holders of the relevant series of debt securities.

**Modification of Indenture; Waiver**

Subject to the terms of the indenture for any series of debt securities that we may issue, we and the trustee may change an indenture without the consent of any holders with respect to the following specific matters:

● to fix any ambiguity, defect or inconsistency in the indenture;

● to comply with the provisions described above under "-Consolidation, Merger or Sale";

● to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act;

● to add to, delete from or revise the conditions, limitations and restrictions on the authorized amount, terms or purposes of issue, authentication and delivery of debt securities, as set forth in such indenture;

● to provide for the issuance of, and establish the form and terms and conditions of, the debt securities of any series as provided above under "-General," to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities;

● to evidence and provide for the acceptance of appointment hereunder by a successor trustee;

● to provide for uncertificated debt securities in addition to or in place of certificated debt securities and to make all appropriate changes for such purpose;

● to add such new covenants, restrictions, conditions or provisions for the protection of the holders, and to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default or to surrender any right or power conferred to us in the indenture; or

● to change anything that does not materially adversely affect the interests of any holder of debt securities of any series in any material respect; provided that any amendment made solely to conform the provisions of the indenture to the corresponding description of the debt securities contained in the applicable prospectus or prospectus supplement shall be deemed not to adversely affect the interests of the holders of such debt securities; provided further, that in connection with any such amendment we will provide the trustee with an officers' certificate certifying that such amendment will not adversely affect the rights or interests of the holders of such debt securities.

In addition, under the indentures, the rights of holders of a series of debt securities may be changed by us and the trustee with the written consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of each series that is affected. However, unless we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, we and the trustee may only make the following changes with the consent of each holder of any outstanding debt securities affected:

● extending the fixed maturity of the series of debt securities;

● reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any debt securities;

● reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver;

● changing any of our obligations to pay additional amounts;

● reducing the amount of principal of an original issue discount security or any other note payable upon acceleration of the maturity thereof;

● changing the currency in which any note or any premium or interest is payable;

● impairing the right to enforce any payment on or with respect to any note;

● adversely changing the right to convert or exchange, including decreasing the conversion rate or increasing the conversion price of, such note, if applicable;

● in the case of the subordinated indenture, modifying the subordination provisions in a manner adverse to the holders of the subordinated debt securities;

● if the debt securities are secured, changing the terms and conditions pursuant to which the debt securities are secured in a manner adverse to the holders of the secured debt securities;

● reducing the requirements contained in the applicable indenture for quorum or voting;

● changing any of our obligations to maintain an office or agency in the places and for the purposes required by the indentures; or

● modifying any of the above provisions set forth in this paragraph.

**Discharge**

Each indenture provides that, subject to the terms of the indenture and any limitation otherwise provided in the prospectus supplement applicable to a particular series of debt securities, we may elect to be discharged from our obligations with respect to one or more series of debt securities, except for specified obligations, including obligations to:

● register the transfer or exchange of debt securities of the series;

● replace stolen, lost or mutilated debt securities of the series;

● maintain paying agencies;

● hold monies for payment in trust;

● recover excess money held by the trustee;

● compensate and indemnify the trustee; and

● appoint any successor trustee.

In order to exercise our rights to be discharged, we must deposit with the trustee money or government obligations sufficient to pay all the principal of, and any premium and interest on, the debt securities of the series on the dates payments are due.

**Form, Exchange and Transfer**

We will issue the debt securities of each series only in fully registered form without coupons and, unless we otherwise specify in the applicable prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indentures provide that we may issue debt securities of a series in temporary or permanent global form and as book-entry securities that will be deposited with, or on behalf of, The Depository Trust Company or another depositary named by us and identified in a prospectus supplement with respect to that series.

At the option of the holder, subject to the terms of the indentures and the limitations applicable to global securities described in the applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities for other debt securities of the same series, in any authorized denomination and of like tenor and aggregate principal amount.

Subject to the terms of the indentures and the limitations applicable to global securities set forth in the applicable prospectus supplement, holders of the debt securities may present the debt securities for exchange or for registration of transfer, duly endorsed or with the form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office of the security registrar or at the office of any transfer agent designated by us for this purpose. Unless otherwise provided in the debt securities that the holder presents for transfer or exchange, we will impose no service charge for any registration of transfer or exchange, but we may require payment of any taxes or other governmental charges.

We will name in the applicable prospectus supplement the security registrar, and any transfer agent in addition to the security registrar, that we initially designate for any debt securities. We may at any time designate additional transfer agents or rescind the designation of any transfer agent or approve a change in the office through which any transfer agent acts, except that we will be required to maintain a transfer agent in each place of payment for the debt securities of each series.

If we elect to redeem the debt securities of any series, we will not be required to:

● issue, register the transfer of, or exchange any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or

● register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part.

**Information Concerning the Trustee**

The trustee, other than during the occurrence and continuance of an event of default under an indenture, undertakes to perform only those duties as are specifically set forth in the applicable indenture and is under no obligation to exercise any of the powers given it by the indentures at the request of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities that it might incur. However, upon an event of default under an indenture, the trustee must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs.

**Payment and Paying Agents**

Unless we otherwise indicate in the applicable prospectus supplement, we will make payment of the interest on any debt securities on any interest payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered at the close of business on the regular record date for the interest payment.

We will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents designated by us, except that unless we otherwise indicate in the applicable prospectus supplement, we will make interest payments by check that we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in the applicable prospectus supplement, we will designate the corporate trust office of the trustee in the City of New York as our sole paying agent for payments with respect to debt securities of each series. We will name in the applicable prospectus supplement any other paying agents that we initially designate for the debt securities of a particular series. We will maintain a paying agent in each place of payment for the debt securities of a particular series.

All money we pay to a paying agent or the trustee for the payment of the principal of or any premium or interest on any debt securities that remains unclaimed at the end of two years after such principal, premium or interest has become due and payable will be repaid to us, and the holder of the debt security thereafter may look only to us for payment thereof.

**Governing Law**

The indentures and the debt securities will be governed by and construed in accordance with the laws of the State of New York, except to the extent that the Trust Indenture Act is applicable.

**Ranking Debt Securities**

The subordinated debt securities will be unsecured and will be subordinate and junior in priority of payment to certain of our other indebtedness to the extent described in a prospectus supplement. The subordinated indenture does not limit the amount of subordinated debt securities that we may issue. It also does not limit us from issuing any other secured or unsecured debt.

The senior debt securities will be unsecured and will rank equally in right of payment to all of our other senior unsecured debt. The senior indenture does not limit the amount of senior debt securities that we may issue. It also does not limit us from issuing any other secured or unsecured debt.

**DESCRIPTION OF WARRANTS WE MAY OFFER**

We may issue warrants to purchase debt securities, preferred stock, common stock or any combination of the foregoing. We may issue warrants independently or together with any other securities we offer under a prospectus supplement. The warrants may be attached to or separate from the securities. We will issue each series of warrants under a separate warrant agreement to be entered into between a warrant agent and us. The warrant agent will act solely as our agent in connection with the warrants and will not have any obligations or relationship of agency or trust for or with holders or beneficial owners of warrants. The following outlines some of the general terms and provisions of the warrants that we may issue from time to time. When we issue warrants, we will provide the specific terms of the warrants and the applicable warrant agreement in a prospectus supplement and any related free writing prospectuses and such terms may differ from those described below. To the extent the information contained in the prospectus supplement differs or free writing prospectuses from this summary description, you should rely on the information in the prospectus supplement or free writing prospectuses.

The following description, and any description of the warrants included in a prospectus supplement, may not be complete and is subject to and qualified in its entirety by reference to the terms and provisions of the applicable warrant agreement.

**Equity Warrants**

We will describe in the applicable prospectus supplement and any related free writing prospectuses the terms of the preferred stock warrants or common stock warrants being offered, the warrant agreement relating to the preferred stock warrants or common stock warrants and the warrant certificates representing the preferred stock warrants or common stock warrants, including, as applicable:

● the title of the warrants;

● the securities for which the warrants are exercisable;

● the price or prices at which the warrants will be issued;

● if applicable, the number of warrants issued with each share of preferred stock or share of common stock;

● if applicable, the date on and after which the warrants and the related preferred stock or common stock will be separately transferable;

● the date on which the right to exercise the warrants will commence, and the date on which the right will expire;

● the maximum or minimum number of warrants which may be exercised at any time;

● information with respect to book-entry procedures, if any;

● a discussion of the material U.S. federal income tax considerations applicable to exercise of the warrants; and

● any other terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants.

Unless otherwise provided in the applicable warrant agreement and corresponding prospectus supplement or any related free writing prospectuses, holders of equity warrants will not be entitled, by virtue of being such holders, to vote, consent, receive dividends, receive notice as stockholders with respect to any meeting of stockholders for the election of our directors or any other matter, or to exercise any rights whatsoever as stockholders.

Except as provided in the applicable warrant agreement and corresponding prospectus supplement or any related free writing prospectuses, the exercise price payable and the number of shares of common stock or preferred stock purchasable upon the exercise of each warrant will be subject to adjustment in certain events, including the issuance of a stock dividend to holders of common stock or preferred stock or a stock split, reverse stock split, combination, subdivision or reclassification of common stock or preferred stock. In lieu of adjusting the number of shares of common stock or preferred stock purchasable upon exercise of each warrant, we may elect to adjust the number of warrants. Unless otherwise provided in the applicable warrant agreement and corresponding prospectus supplement or any related free writing prospectuses, no adjustments in the number of shares purchasable upon exercise of the warrants will be required until all cumulative adjustments require an adjustment of at least 1% thereof. No fractional shares will be issued upon exercise of warrants, but we will pay the cash value of any fractional shares otherwise issuable. Notwithstanding the foregoing, except as otherwise provided in the applicable warrant agreement and corresponding prospectus supplement or any related free writing prospectuses, in the event of any consolidation, merger, or sale or conveyance of our assets as an entirety or substantially as an entirety, the holder of each outstanding warrant will have the right to the kind and amount of shares of stock and other securities and property, including cash, receivable by a holder of the number of shares of common stock or preferred stock into which each warrant was exercisable immediately prior to the particular triggering event.

**Debt Warrants**

We will describe in the applicable prospectus supplement and any related free writing prospectuses the terms of the debt warrants being offered, the warrant agreement relating to the debt warrants and the debt warrant certificates representing the debt warrants, including, as applicable:

● the title of the debt warrants;

● the aggregate number of the debt warrants;

● the price or prices at which the debt warrants will be issued;

● the designation, aggregate principal amount and terms of the debt securities purchasable upon exercise of the debt warrants, and the procedures and conditions relating to the exercise of the debt warrants;

● the designation and terms of any related debt securities with which the debt warrants are issued, and the number of the debt warrants issued with each security;

● the date, if any, on and after which the debt warrants and the related debt securities will be separately transferable;

● the principal amount of debt securities purchasable upon exercise of each debt warrant, and the price at which the principal amount of the debt securities may be purchased upon exercise;

● the date on which the right to exercise the debt warrants will commence, and the date on which the right will expire;

● the maximum or minimum number of the debt warrants that may be exercised at any time;

● information with respect to book-entry procedures, if any;

● changes to or adjustments in the exercise price of the debt warrants;

● a discussion of the material U.S. federal income tax considerations applicable to the exercise of the debt warrants; and

● any other terms of the debt warrants and terms, procedures and limitations relating to the exercise of the debt warrants.

As may be permitted under the warrant agreement, holders may exchange debt warrant certificates for new debt warrant certificates of different denominations, and may exercise debt warrants at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement and any related free writing prospectuses. Prior to the exercise of their debt warrants, holders of debt warrants will not have any of the rights of holders of the securities purchasable upon the exercise and will not be entitled to payments of principal, premium or interest on the securities purchasable upon the exercise of debt warrants.

**Exercise of Warrants**

Each warrant will entitle the holder of the warrant to purchase for cash at the exercise price provided in the applicable warrant agreement and corresponding prospectus supplement or any related free writing prospectuses the principal amount of debt securities or shares of preferred stock or shares of common stock being offered. Holders may exercise warrants at any time up to the close of business on the expiration date provided in the applicable warrant agreement and corresponding prospectus supplement or any related free writing prospectuses. After the close of business on the expiration date, unexercised warrants will be void.

Holders may exercise warrants as described in the applicable warrant agreement and corresponding prospectus supplement or any free writing prospectuses relating to the warrants being offered. Upon receipt of payment and the warrant certificate properly completed and duly executed at the corporate trust office of the warrant agent or any other office indicated in the applicable warrant agreement and corresponding prospectus supplement or any related free writing prospectuses, we will, as soon as practicable, forward the debt securities, shares of preferred stock or shares of common stock purchasable upon the exercise of the warrant. If less than all of the warrants represented by the warrant certificate are exercised, we will issue a new warrant certificate for the remaining warrants.

**DESCRIPTION OF UNITS WE MAY OFFER**

The following description, together with the additional information we may include in any applicable prospectus supplements and free writing prospectuses, summarizes the material terms and provisions of the units that we may offer under this prospectus. While the terms we have summarized below will apply generally to any units that we may offer under this prospectus, we will describe the particular terms of any series of units in more detail in the applicable prospectus supplement. The terms of any units offered under a prospectus supplement may differ from the terms described below. However, no prospectus supplement will fundamentally change the terms that are set forth in this prospectus or offer a security that is not registered and described in this prospectus at the time of its effectiveness.

We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from a current report on Form 8-K that we file with the SEC, the form of unit agreement that describes the terms of the series of units we are offering, and any supplemental agreements, before the issuance of the related series of units. The following summaries of material terms and provisions of the units are subject to, and qualified in their entirety by reference to, all the provisions of the unit agreement and any supplemental agreements applicable to a particular series of units. We urge you to read the applicable prospectus supplements related to the particular series of units that we sell under this prospectus, as well as the complete unit agreement and any supplemental agreements that contain the terms of the units.

**General**

We may issue units comprised of one or more shares of common stock, shares of preferred stock, debt securities and warrants in any combination. Each unit will be issued so that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities included in the unit may not be held or transferred separately, at any time or at any time before a specified date.

We will describe in the applicable prospectus supplement the terms of the series of units, including:

● the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately;

● any provisions of the governing unit agreement that differ from those described below; and

● any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.

The provisions described in this section, as well as those described under "Description of Capital Stock We May Offer," "Description of Debt Securities We May Offer" and "Description of Warrants We May Offer" will apply to each unit and to any common stock, preferred stock, debt security or warrant included in each unit, respectively.

**Issuance in Series**

We may issue units in such amounts and in numerous distinct series as we determine.

**Enforceability of Rights by Holders of Units**

Each unit agent will act solely as our agent under the applicable unit agreement and will not assume any obligation or relationship of agency or trust with any holder of any unit. A single bank or trust company may act as unit agent for more than one series of units. A unit agent will have no duty or responsibility in the event of any default by us under the applicable unit agreement or unit, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a unit may, without the consent of the related unit agent or the holder of any other unit, enforce by appropriate legal action its rights as holder under any security included in the unit.

We, the unit agents and any of their agents may treat the registered holder of any unit certificate as an absolute owner of the units evidenced by that certificate for any purpose and as the person entitled to exercise the rights attaching to the units so registered, despite any notice to the contrary.

**GLOBAL SECURITIES**

**Book-Entry, Delivery and Form**

Unless we indicate differently in any applicable prospectus supplement or free writing prospectus, the securities initially will be issued in book-entry form and represented by one or more global notes or global securities, or, collectively, global securities. The global securities will be deposited with, or on behalf of, The Depository Trust Company, New York, New York, as depositary ("DTC"), and registered in the name of Cede & Co., the partnership nominee of DTC. Unless and until it is exchanged for individual certificates evidencing securities under the limited circumstances described below, a global security may not be transferred except as a whole by the depositary to its nominee or by the nominee to the depositary, or by the depositary or its nominee to a successor depositary or to a nominee of the successor depositary.

DTC has advised us that it is:

● a limited-purpose trust company organized under the New York Banking Law;

● a "banking organization" within the meaning of the New York Banking Law;

● a member of the Federal Reserve System;

● a "clearing corporation" within the meaning of the New York Uniform Commercial Code; and

● a "clearing agency" registered pursuant to the provisions of Section 17A of the Exchange Act.

DTC holds securities that its participants deposit with DTC. DTC also facilitates the settlement among its participants of securities transactions, such as transfers and pledges, in deposited securities through electronic computerized book-entry changes in participants' accounts, thereby eliminating the need for physical movement of securities certificates. "Direct participants" in DTC include securities brokers and dealers, including underwriters, banks, trust companies, clearing corporations and other organizations. DTC is a wholly-owned subsidiary of The Depository Trust & Clearing Corporation ("DTCC"). DTCC is the holding company for DTC, National Securities Clearing Corporation and Fixed Income Clearing Corporation, all of which are registered clearing agencies. DTCC is owned by the users of its regulated subsidiaries. Access to the DTC system is also available to others, which we sometimes refer to as indirect participants, that clear through or maintain a custodial relationship with a direct participant, either directly or indirectly. The rules applicable to DTC and its participants are on file with the SEC.

Purchases of securities under the DTC system must be made by or through direct participants, which will receive a credit for the securities on DTC's records. The ownership interest of the actual purchaser of a security, which we sometimes refer to as a beneficial owner, is in turn recorded on the direct and indirect participants' records. Beneficial owners of securities will not receive written confirmation from DTC of their purchases. However, beneficial owners are expected to receive written confirmations providing details of their transactions, as well as periodic statements of their holdings, from the direct or indirect participants through which they purchased securities. Transfers of ownership interests in global securities are to be accomplished by entries made on the books of participants acting on behalf of beneficial owners. Beneficial owners will not receive certificates representing their ownership interests in the global securities, except under the limited circumstances described below.

To facilitate subsequent transfers, all global securities deposited by direct participants with DTC will be registered in the name of DTC's partnership nominee, Cede & Co., or such other name as may be requested by an authorized representative of DTC. The deposit of securities with DTC and their registration in the name of Cede & Co. or such other nominee will not change the beneficial ownership of the securities. DTC has no knowledge of the actual beneficial owners of the securities. DTC's records reflect only the identity of the direct participants to whose accounts the securities are credited, which may or may not be the beneficial owners. The participants are responsible for keeping account of their holdings on behalf of their customers.

So long as the securities are in book-entry form, you will receive payments and may transfer securities only through the facilities of the depositary and its direct and indirect participants. We will maintain an office or agency in the location specified in the prospectus supplement for the applicable securities, where notices and demands in respect of the securities and the indenture may be delivered to us and where certificated securities may be surrendered for payment, registration of transfer or exchange.

Conveyance of notices and other communications by DTC to direct participants, by direct participants to indirect participants and by direct participants and indirect participants to beneficial owners will be governed by arrangements among them, subject to any legal requirements in effect from time to time.

Redemption notices will be sent to DTC. If less than all of the securities of a particular series are being redeemed, DTC's practice is to determine by lot the amount of the interest of each direct participant in the securities of such series to be redeemed.

Neither DTC nor Cede & Co. (or such other DTC nominee) will consent or vote with respect to the securities. Under its usual procedures, DTC will mail an omnibus proxy to us as soon as possible after the record date. The omnibus proxy assigns the consenting or voting rights of Cede & Co. to those direct participants to whose accounts the securities of such series are credited on the record date, identified in a listing attached to the omnibus proxy.

So long as securities are in book-entry form, we will make payments on those securities to the depositary or its nominee, as the registered owner of such securities, by wire transfer of immediately available funds. If securities are issued in definitive certificated form under the limited circumstances described below and unless otherwise provided in the description of the applicable securities herein or in the applicable prospectus supplement, we will have the option of making payments by check mailed to the addresses of the persons entitled to payment or by wire transfer to bank accounts in the United States designated in writing to the applicable trustee or other designated party at least 15 days before the applicable payment date by the persons entitled to payment, unless a shorter period is satisfactory to the applicable trustee or other designated party.

Redemption proceeds, distributions and dividend payments on the securities will be made to Cede & Co., or such other nominee as may be requested by an authorized representative of DTC. DTC's practice is to credit direct participants' accounts upon DTC's receipt of funds and corresponding detail information from us on the payment date in accordance with their respective holdings shown on DTC records. Payments by participants to beneficial owners will be governed by standing instructions and customary practices, as is the case with securities held for the account of customers in bearer form or registered in "street name." Those payments will be the responsibility of participants and not of DTC or us, subject to any statutory or regulatory requirements in effect from time to time. Payment of redemption proceeds, distributions and dividend payments to Cede & Co., or such other nominee as may be requested by an authorized representative of DTC, is our responsibility, disbursement of payments to direct participants is the responsibility of DTC, and disbursement of payments to the beneficial owners is the responsibility of direct and indirect participants.

Except under the limited circumstances described below, purchasers of securities will not be entitled to have securities registered in their names and will not receive physical delivery of securities. Accordingly, each beneficial owner must rely on the procedures of DTC and its participants to exercise any rights under the securities and the indenture.

The laws of some jurisdictions may require that some purchasers of securities take physical delivery of securities in definitive form. Those laws may impair the ability to transfer or pledge beneficial interests in securities.

DTC may discontinue providing its services as securities depositary with respect to the securities at any time by giving reasonable notice to us. Under such circumstances, in the event that a successor depositary is not obtained, securities certificates are required to be printed and delivered.

As noted above, beneficial owners of a particular series of securities generally will not receive certificates representing their ownership interests in those securities. However, if:

● DTC notifies us that it is unwilling or unable to continue as a depositary for the global security or securities representing such series of securities or if DTC ceases to be a clearing agency registered under the Exchange Act at a time when it is required to be registered and a successor depositary is not appointed within 90 days of the notification to us or of our becoming aware of DTC's ceasing to be so registered, as the case may be;

● we determine, in our sole discretion, not to have such securities represented by one or more global securities; or

● an event of default has occurred and is continuing with respect to such series of securities,

we will prepare and deliver certificates for such securities in exchange for beneficial interests in the global securities. Any beneficial interest in a global security that is exchangeable under the circumstances described in the preceding sentence will be exchangeable for securities in definitive certificated form registered in the names that the depositary directs. It is expected that these directions will be based upon directions received by the depositary from its participants with respect to ownership of beneficial interests in the global securities.

**Euroclear and Clearstream**

If so provided in the applicable prospectus supplement, you may hold interests in a global security through Clearstream Banking S.A. ("Clearstream"), or Euroclear Bank S.A./N.V., as operator of the Euroclear System ("Euroclear"), either directly if you are a participant in Clearstream or Euroclear or indirectly through organizations which are participants in Clearstream or Euroclear. Clearstream and Euroclear will hold interests on behalf of their respective participants through customers' securities accounts in the names of Clearstream and Euroclear, respectively, on the books of their respective U.S. depositaries, which in turn will hold such interests in customers' securities accounts in such depositaries' names on DTC's books.

Clearstream and Euroclear are securities clearance systems in Europe. Clearstream and Euroclear hold securities for their respective participating organizations and facilitate the clearance and settlement of securities transactions between those participants through electronic book-entry changes in their accounts, thereby eliminating the need for physical movement of certificates.

Payments, deliveries, transfers, exchanges, notices and other matters relating to beneficial interests in global securities owned through Euroclear or Clearstream must comply with the rules and procedures of those systems. Transactions between participants in Euroclear or Clearstream, on one hand, and other participants in DTC, on the other hand, are also subject to DTC's rules and procedures.

Investors will be able to make and receive through Euroclear and Clearstream payments, deliveries, transfers and other transactions involving any beneficial interests in global securities held through those systems only on days when those systems are open for business. Those systems may not be open for business on days when banks, brokers and other institutions are open for business in the United States.

Cross-market transfers between participants in DTC, on the one hand, and participants in Euroclear or Clearstream, on the other hand, will be effected through DTC in accordance with DTC's rules on behalf of Euroclear or Clearstream, as the case may be, by their respective U.S. depositaries; however, such cross-market transactions will require delivery of instructions to Euroclear or Clearstream, as the case may be, by the counterparty in such system in accordance with the rules and procedures and within the established deadlines (European time) of such system. Euroclear or Clearstream, as the case may be, will, if the transaction meets its settlement requirements, deliver instructions to its U.S. depositary to take action to effect final settlement on its behalf by delivering or receiving interests in the global securities through DTC, and making or receiving payment in accordance with normal procedures for same-day fund settlement. Participants in Euroclear or Clearstream may not deliver instructions directly to their respective U.S. depositaries.

Due to time zone differences, the securities accounts of a participant in Euroclear or Clearstream purchasing an interest in a global security from a direct participant in DTC will be credited, and any such crediting will be reported to the relevant participant in Euroclear or Clearstream, during the securities settlement processing day (which must be a business day for Euroclear or Clearstream) immediately following the settlement date of DTC. Cash received in Euroclear or Clearstream as a result of sales of interests in a global security by or through a participant in Euroclear or Clearstream to a direct participant in DTC will be received with value on the settlement date of DTC but will be available in the relevant Euroclear or Clearstream cash account only as of the business day for Euroclear or Clearstream following DTC's settlement date.

**Other**

The information in this section of this prospectus concerning DTC, Clearstream, Euroclear and their respective book-entry systems has been obtained from sources that we believe to be reliable, but we do not take responsibility for this information. This information has been provided solely as a matter of convenience. The rules and procedures of DTC, Clearstream and Euroclear are solely within the control of those organizations and could change at any time. Neither we nor the trustee nor any agent of ours or of the trustee has any control over those entities and none of us takes any responsibility for their activities. You are urged to contact DTC, Clearstream and Euroclear or their respective participants directly to discuss those matters. In addition, although we expect that DTC, Clearstream and Euroclear will perform the foregoing procedures, none of them is under any obligation to perform or continue to perform such procedures and such procedures may be discontinued at any time. Neither we nor any agent of ours will have any responsibility for the performance or nonperformance by DTC, Clearstream and Euroclear or their respective participants of these or any other rules or procedures governing their respective operations.

**PLAN OF DISTRIBUTION**

We may sell the securities from time to time pursuant to underwritten public offerings, negotiated transactions, block trades or a combination of these methods or through underwriters or dealers, through agents and/or directly to one or more purchasers. The securities may be distributed from time to time in one or more transactions:

● at a fixed price or prices, which may be changed;

● at market prices prevailing at the time of sale;

● at prices related to such prevailing market prices; or

● at negotiated prices.

Each time that we sell securities covered by this prospectus, we will provide a prospectus supplement or supplements that will describe the method of distribution and set forth the terms and conditions of the offering of such securities, including the offering price of the securities and the proceeds to us, if applicable.

Offers to purchase the securities being offered by this prospectus may be solicited directly. Agents may also be designated to solicit offers to purchase the securities from time to time. Any agent involved in the offer or sale of our securities will be identified in a prospectus supplement.

If a dealer is utilized in the sale of the securities being offered by this prospectus, the securities will be sold to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to be determined by the dealer at the time of resale.

If an underwriter is utilized in the sale of the securities being offered by this prospectus, an underwriting agreement will be executed with the underwriter at the time of sale and the name of any underwriter will be provided in the prospectus supplement that the underwriter will use to make resales of the securities to the public. In connection with the sale of the securities, we or the purchasers of securities for whom the underwriter may act as agent, may compensate the underwriter in the form of underwriting discounts or commissions. The underwriter may sell the securities to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions from the underwriters and/or commissions from the purchasers for which they may act as agent. Unless otherwise indicated in a prospectus supplement, an agent will be acting on a best efforts basis and a dealer will purchase securities as a principal, and may then resell the securities at varying prices to be determined by the dealer.

Any compensation paid to underwriters, dealers or agents in connection with the offering of the securities, and any discounts, concessions or commissions allowed by underwriters to participating dealers will be provided in the applicable prospectus supplement. Underwriters, dealers and agents participating in the distribution of the securities may be deemed to be underwriters within the meaning of the Securities Act of 1933, as amended (the "Securities Act"), and any discounts and commissions received by them and any profit realized by them on resale of the securities may be deemed to be underwriting discounts and commissions. We may enter into agreements to indemnify underwriters, dealers and agents against civil liabilities, including liabilities under the Securities Act, or to contribute to payments they may be required to make in respect thereof and to reimburse those persons for certain expenses.

Any common stock will be listed on the Nasdaq Global Select Market, but any other securities may or may not be listed on a national securities exchange. To facilitate the offering of securities, certain persons participating in the offering may engage in transactions that stabilize, maintain or otherwise affect the price of the securities. This may include over-allotments or short sales of the securities, which involve the sale by persons participating in the offering of more securities than were sold to them. In these circumstances, these persons would cover such over-allotments or short positions by making purchases in the open market or by exercising their over-allotment option, if any. In addition, these persons may stabilize or maintain the price of the securities by bidding for or purchasing securities in the open market or by imposing penalty bids, whereby selling concessions allowed to dealers participating in the offering may be reclaimed if securities sold by them are repurchased in connection with stabilization transactions. The effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might otherwise prevail in the open market. These transactions may be discontinued at any time.

We may engage in at the market offerings into an existing trading market in accordance with Rule 415(a)(4) under the Securities Act. In addition, we may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If the applicable prospectus supplement so indicates, in connection with those derivatives, the third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including in short sale transactions. If so, the third party may use securities pledged by us or borrowed from us or others to settle those sales or to close out any related open borrowings of stock, and may use securities received from us in settlement of those derivatives to close out any related open borrowings of stock. The third party in such sale transactions will be an underwriter and, if not identified in this prospectus, will be named in the applicable prospectus supplement (or a post-effective amendment). In addition, we may otherwise loan or pledge securities to a financial institution or other third party that in turn may sell the securities short using this prospectus and an applicable prospectus supplement. Such financial institution or other third party may transfer its economic short position to investors in our securities or in connection with a concurrent offering of other securities.

The specific terms of any lock-up provisions in respect of any given offering will be described in the applicable prospectus supplement.

The underwriters, dealers and agents may engage in transactions with us, or perform services for us, in the ordinary course of business for which they receive compensation.

**LEGAL MATTERS**

The validity of the securities being offered hereby will be passed on by Dentons US LLP. Any underwriters, dealers or agents will also be advised about the validity of the securities and other legal matters by their own counsel, which will be named in the prospectus supplement.

**EXPERTS**

The financial statements for the fiscal year ended December 31, 2020 and 2019 has been audited by M&K CPAs, an independent registered public accounting firm, to the extent and for the period set forth in their report, appearing elsewhere in the registration statement, and are included in reliance upon such report given upon the authority of said firms as experts in auditing and accounting.

**1,380,000 Shares of Common Stock**

**Pre-Funded Warrants to Purchase 2,300,000 Shares of Common Stock**

**INVO Bioscience, Inc.**

**Prospectus Supplement**

**Maxim Group LLC**

Sole Placement Agent

March 23, 2023