# EDGAR Filing Document

**Accession Number:** 0001527096
**File Stem:** 0001558370-23-000731
**Filing Date:** 2023-2
**Character Count:** 23366
**Document Hash:** d80ef6bc978ca9070da1d023ff834f7b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001558370-23-000731.hdr.sgml**: 20230201

**ACCESSION NUMBER**: 0001558370-23-000731

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 17

**CONFORMED PERIOD OF REPORT**: 20230201

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230201

**DATE AS OF CHANGE**: 20230201

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Miromatrix Medical Inc.
- **CENTRAL INDEX KEY:** 0001527096
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 271285782
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40518
- **FILM NUMBER:** 23574781

**BUSINESS ADDRESS:**
- **STREET 1:** 6455 FLYING CLOUD DRIVE
- **STREET 2:** SUITE 107
- **CITY:** EDEN PRAIRIE
- **STATE:** MN
- **ZIP:** 55344
- **BUSINESS PHONE:** (612)202-7026

**MAIL ADDRESS:**
- **STREET 1:** 6455 FLYING CLOUD DRIVE
- **STREET 2:** SUITE 107
- **CITY:** EDEN PRAIRIE
- **STATE:** MN
- **ZIP:** 55344

?xml version='1.0' encoding='UTF-8'?

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**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

Date of Report (Date of earliest event reported): **February 1, 2023**

**Miromatrix Medical Inc.**

*(Exact name of registrant as specified in its charter)*

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-40518** | **27-1285782** |
| *(State or other jurisdiction of incorporation)* | *(Commission File Number)* | *(IRS Employer Identification Number)* |

---

**6455 Flying Cloud Drive, Suite 107**

**Eden Prairie, MN 55344**

*(Address of principal executive offices, including zip code)*

**(952) 942-6000**

*(Registrant's telephone number, including area code)*

**Not Applicable**

*(Former Name or Former Address, if Changed Since Last Report)*

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered or to be registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading symbol** | **Name of each exchange on which registered** |
| Common stock, $0.00001 par value per share | MIRO | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

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On February 1, 2023, Miromatrix Medical Inc. (the "Company") issued a press release providing an update on miroliver*ELAP*. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On February 1, 2023, the Company issued a joint press release regarding entry into a collaborative research agreement for patients with acute liver failure. The full text of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 7.01 and Exhibits 99.1 and 99.2 is being furnished, and shall not be deemed to be "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to liability under Section 18. Furthermore, the information contained in this Item 7.01 and Exhibits 99.1 and 99.2 shall not be deemed to be incorporated by reference into the Company's filings under the Securities Act of 1933, as amended, or the Exchange Act.

**Item 9.01** **Financial Statements and Exhibits**

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| | |
|:---|:---|
| &nbsp;&nbsp;**(d)** | &nbsp;&nbsp;**Exhibits.** |
| &nbsp;&nbsp;**Exhibit No.** | &nbsp;&nbsp;**Description** |
| &nbsp;&nbsp;[99.1](tmb-20230201xex99d1.htm) | &nbsp;&nbsp;[Press Release, dated February 1, 2023](tmb-20230201xex99d1.htm) |
| &nbsp;&nbsp;[99.2](tmb-20230201xex99d2.htm) | &nbsp;&nbsp;[Joint Press Release, dated February 1, 2023](tmb-20230201xex99d2.htm) |
| &nbsp;&nbsp;104 | &nbsp;&nbsp;Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document) |

---

#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
| Dated: February 1, 2023 | **Miromatrix Medical Inc.** | **Miromatrix Medical Inc.** |
|  | By: | /s/ James Douglas |
|  |  | James Douglas |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![Logo, company name Description automatically generated](tmb-20230201xex99d1001.jpg)

**Miromatrix Provides Update on miroliver*ELAP***

EDEN PRAIRIE, MN, February 1, 2023 - Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients' lives, today provided a program update on miroliverELAP<sup>tm</sup>.

Miromatrix previously announced the submission of its miroliverELAP Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in November 2022. In December, Miromatrix announced that the FDA had informed the Company via e-mail that the IND application was placed on clinical hold prior to the initiation of patient dosing and noted that a formal clinical hold letter would follow. In January 2023, Miromatrix received the formal clinical hold letter from the FDA detailing the specific items to be addressed in the IND submission and the information needed to resolve them. In the letter, the FDA requested additional non-clinical and clinical information. The information provided by the FDA also provides valuable insights relating to certain chemistry, manufacturing and control (CMC) and clinical protocol topics unrelated to the clinical hold.

"Miromatrix is bioengineering organs with the goal of providing organ failure patients with treatment alternatives that do not exist today," said Dr. Jeff Ross, Chief Executive Officer of Miromatrix. "miroliverELAP is a novel first-in-class therapeutic and the clinical hold letter provides us with a defined path forward from the FDA as we strive to solve one of the greatest unmet medical needs facing the world today. We also believe certain items noted by the FDA may be helpful towards the advancement of our other pipeline programs as well."

"Having evaluated the matters identified in the clinical hold letter, we plan to submit our response to the FDA in the second half of 2023 and initiate a first-in-human clinical trial shortly after IND clearance," continued Dr. Ross. "We will maintain our disciplined operational approach and continue to expect our strong cash position to fund operations through 2023."

"Miromatrix is dedicated to bringing therapeutic alternatives to people living with organ failure and we continue to believe in our entire bioengineered organ platform," concluded Dr. Ross. "Our team is committed to working with the FDA to resolve the clinical hold and we appreciate the continued support of the transplant community as we make strides toward treating patients."

**About Miromatrix**

Miromatrix Medical Inc. is a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs to help save and improve patients' lives. The Company has developed a proprietary perfusion technology platform for bioengineering organs that it believes will efficiently scale to address the shortage of available human organs. The Company's initial development focus is on human livers and kidneys. For more information, visit miromatrix.com.

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**Cautionary Statement Regarding Forward-Looking Statements**

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "dedicated," "expects," "future," "intends," "may," "plans," "potential," "projects," and "would," or similar expressions, are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to: the FDA's communication plans related to the clinical hold on miroliverELAP, resolution of the clinical hold, and our plans and expectations for discussions with the FDA and the outcomes from the same, and future market position. Each of these forward-looking statements involves substantial risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by such forward-looking statements, including, without limitation, risks and uncertainties related to: statements regarding the initiation, timing, progress and results of our current and future preclinical studies and future clinical trials, including statements regarding the potential timing of the clearance of the IND application and other regulatory documents for our miroliverELAP product candidate and the potential timing of pre-IND meetings or submissions of regulatory documents for our mirokidney™ and miroliver™ product candidates; the initiation of the related clinical trials; the expected timing of program updates and data disclosures; statements regarding the timing and likelihood of seeking regulatory approval for our product candidates; the competitive landscape for our product candidates; and our estimates regarding expenses, future revenue, capital requirements, cash runway and needs for additional financing. These forward-looking statements reflect our current beliefs and expectations.

There are several important factors that could cause our actual results to differ materially from those indicated by such forward looking statements, including a deterioration in our business or prospects; further assessment of preliminary data, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and completion of clinical trials, availability and timing of data from ongoing clinical trials, timing and completion of steps required in the regulatory review process, including our ability to obtain regulatory clearance to commence clinical trials, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of our product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID- 19), and geopolitical risks, including the current war between Russian and Ukraine. These risks are not exhaustive, we face known and unknown risks. Additional risks and factors that may affect results are set forth in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and our subsequent quarterly reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.

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**Investor Contact**

Greg Chodaczek

347-620-7010

<u>ir@miromatrix.com</u>

**Media Contact:**

Christina Campbell

612-280-0249

<u>christina@media-minefield.com</u>

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## Exhibit 99.2

**Exhibit 99.2**

![Logo, company name Description automatically generated](tmb-20230201xex99d2001.jpg) ![A picture containing text, clipart Description automatically generated](tmb-20230201xex99d2002.jpg)

**Miromatrix and Baxter Announce Collaborative Research Agreement <br>Aiming to Advance Care for Patients with Acute Liver Failure**

● Combines Miromatrix's expertise in bioengineered organs with Baxter's leadership in critical care delivery and organ support therapies

● Includes intended Phase I clinical trial designed to generate key evidence to support additional therapeutic options for patients suffering from acute liver failure

EDEN PRAIRIE, Minn. and DEERFIELD, Ill., February 1, 2023 - Miromatrix Medical Inc. (NASDAQ: MIRO) and Baxter International Inc. (NYSE:BAX) today announced a collaborative research agreement to help support additional treatment options for patients with acute liver failure (ALF) in need of organ support therapies. As part of the collaboration, Miromatrix has created a new liver therapy called **miroliver*ELAP*** that combines a Miromatrix single-use bioengineered liver with Baxter's **PrisMax** system. Miromatrix submitted an Investigational New Drug (IND) application for **miroliver*ELAP*** to the U.S. Food and Drug Administration (FDA) in November 2022, which appears to be the first IND for a bioengineered organ. Miromatrix intends to commence a Phase I clinical trial using **miroliver*ELAP*** to treat patients suffering from ALF, following FDA's decision that the trial may proceed. Baxter is both a collaborator and shareholder of Miromatrix.

"Miromatrix believes that **miroliver*ELAP*** has the potential to save and improve the lives of ALF patients while simultaneously increasing the availability of livers for transplant into other patients," said Jeff Ross, Ph.D., Miromatrix CEO. "We are excited to be partnering with Baxter to pioneer this next generation innovation in acute care and liver disease."

ALF is a serious condition with limited clinical interventions. Over 50,000 people in the United States die from liver failure each year,<sup>[i](#endnote-2)</sup> often because they cannot receive a liver transplant in time.<sup>[ii](#endnote-3)</sup> However, the liver is capable of regenerating itself back to health in certain circumstances, making therapy to support the native liver during ALF highly clinically relevant. **Miroliver*ELAP*** is designed to provide external support to the patient's native liver as a bridge-to-transplant or bridge-to-recovery, potentially helping to avoid a liver transplant. The **miroliver*ELAP*** Phase I clinical trial will serve as a foundational building block to start generating evidence on how this pioneering therapy may help support patients with ALF.

Miromatrix's bioengineered liver is designed to replicate key functions of a human liver and is connected to Baxter's **PrisMax** system outside of the patient's body to create the **miroliver*ELAP*** system. **Miroliver*ELAP*** is designed to provide therapeutic support to ALF patients in hopes their native livers will regenerate themselves back to health. Baxter's **PrisMax** system is designed to help simplify delivery of continuous renal replacement therapy (CRRT) and other therapies, while providing hospitals the flexibility to meet the unique demands of the intensive care unit (ICU). As part of this collaboration, Baxter has created custom software and disposables to run the **miroliver*ELAP*** treatments during the Phase I clinical trial.

"Baxter is focused on promoting continuous innovation to advance our organ support therapies and further elevate care for patients with ALF and other critical conditions," said Brian Tufts, Vice President, Acute Therapies at Baxter. "Combining Miromatrix's pioneering bioengineered organ technology with Baxter's expertise in critical care delivery and industry-leading **PrisMax** system has the potential to transform care for ALF patients."

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**About Miromatrix**

Miromatrix Medical Inc. is a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs to help save and improve patients' lives. The Company has developed a proprietary perfusion technology platform for bioengineering organs that it believes will efficiently scale to address the shortage of available human organs. The Company's initial development focus is on human livers and kidneys. For more information, visit miromatrix.com.

**<br>About Baxter**

Every day, millions of patients, caregivers and healthcare providers rely on Baxter's leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company's rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

**<br>Intended Use for PrisMax in the U.S.**

The **PrisMax** control unit is intended for:

Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kg or more with acute renal failure and/or fluid overload.

Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kg or more with diseases where removal of plasma components is indicated.

All treatments administered via the **PrisMax** control unit must be prescribed by a physician.

**<br>Rx Only.** For safe and proper use of the **PrisMax** device, refer to the full Instructions for Use.

**<br>Cautionary Statement Regarding Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward looking statements of Miromatrix Medical Inc., including statements regarding the potential initiation of **miroliver*ELAP*** clinical trials. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "outlook," "guidance," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on Miromatrix's current business plans, expectations, and projections about future events and financial trends that Miromatrix believes may affect its business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, Miromatrix's history of significant losses, which it expects to continue; Miromatrix's limited history operating as a commercial company; Miromatrix's expectations with respect to the regulatory pathway of its product candidates, Miromatrix's ability to obtain regulatory approvals for such product candidates, and the anticipated effect of delays in obtaining any such regulatory approvals; Miromatrix's expectations with respect to preclinical and clinical trial plans for our product candidates, the results of such activities and the safety and efficacy of Miromatrix's product candidates; Miromatrix's ability to commercialize its product candidates; Miromatrix's ability to compete successfully with larger competitors in its highly competitive industry; Miromatrix's ability to achieve and maintain adequate levels of

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coverage or reimbursement for any future products it may seek to commercialize; Miromatrix's expectations regarding its manufacturing capabilities; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide, including the outbreak of the novel strain of coronavirus, COVID-19; product liability claims; Miromatrix's ability to establish and maintain intellectual property protection for its products, as well as its ability to operate itsour business without infringing the intellectual property rights of others; Miromatrix's ability to attract and retain senior management and key scientific personnel; and other important factors that could cause actual results, performance or achievements to differ materially from those expected or projected. For information identifying important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the Risk Factors section of Miromatrix's Form 10-K filed with the U.S. Securities and Exchange Commission and any additional risks presented in its Quarterly Reports on Form 10-Q and its Current Reports on Form 8-K. Except as expressly required by applicable securities law, Miromatrixdisclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

**Miroliver** and **miroliver*ELAP*** are registered trademarks of Miromatrix Medical Inc. Baxter and **PrisMax** are registered trademarks of Baxter International Inc.

**<br>Miromatrix Investor Contact:**

Greg Chodaczek

347-620-7010

<u>ir@miromatrix.com</u>**<br>Miromatrix Media Contact:**

Christina Campbell

612-280-0249

<u>Christina@media-minefield.com</u>

**Baxter Investor Contact:**<br> Clare Trachtman<br>224-948-3020<br>**<br>Baxter Media Contact:**<br> Andrea Johnson<br>224-948-5353<br><u>media@baxter.com</u> 

<sup>i</sup> American Liver Foundation: <u>How Many People Have Liver Disease?</u>

<sup>ii</sup> American Liver Foundation: <u>Liver Transplantation</u>

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