Miromatrix Medical Submits Pre-IND Application to FDA for Its External Liver Support Product to Treat Acute Liver Failure – Form 8-K

Miromatrix Submits Pre-IND Application to FDA for Its External Liver Support Product to Treat Acute Liver Failure

Request puts Miromatrix on track for IND Phase I submission and inhuman trial in 2H2022

EDEN PRAIRIE, Minnesota, December 17, 2021 – Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering new fully transplantable organ bioengineering technology to help save and improve patients’ lives, announced today have submitted a pre-IND application to the FDA for its External Liver Assist Product for the treatment of acute liver failure. The request will help streamline the Company’s Phase I IND submission for the external liver assist product, and the start of a first human clinical trial scheduled for the second half of 2022, which will assess the function of a bioengineered liver transplant in humans via external application.

“This is the first of many milestones Miromatrix has planned for 2022, as we move closer to inhuman bioengineered organ implants,” said Jeff Ross, Ph.D., CEO of Miromatrix. “Our large animal study published earlier this year demonstrated that organs developed in the laboratory can be successfully transplanted into preclinical models. first human clinical use of a bioengineered liver transplant in the second half of 2022. ”

Acute liver failure, acute or chronic liver failure, and severe acute alcoholic hepatitis affect 80,000 people in the United States each year without approved drug or medical device intervention. Liver transplantation is the only cure for acute and chronic liver failure, but only half of the patients on the waiting list for organ transplants will receive one on time. The use of a bioengineered external liver transplant to support a patient’s internal organ is generally less risky than a complete transplant and aims to demonstrate the safety and tolerability of Miromatrix technology prior to administration. move on to a full transplant.

In October, Miromatrix announced that it had successfully performed the first-ever heterotopic bioengineered liver implant in a large animal in a preclinical study in collaboration with researchers at the Mayo Clinic. The results, published in Nature Communications Biology, showed that pigs that received the bioengineered livers maintained detectable liver health in the graft, supported blood perfusion and exhibited early liver function after transplantation.

About Miromatrix

Miromatrix Medical Inc. is a life sciences company developing new technology for the bioengineering of fully transplantable human organs to save and improve the lives of patients. The Company has developed a proprietary perfusion technology platform for bioengineered organs that it believes will adapt effectively to deal with the shortage of available human organs. The initial development of the Company is focused on human livers and kidneys. For more information, visit miromatrix.com.

Caution 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 fact are forward-looking statements, including statements regarding our very first liver transplant transplant. by bioengineering in a large animal. In some cases, you can identify forward-looking statements by words such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “could”, “prospect”, “Direction,” “” intend “,” target “,” plan “,” consider “,” believe “,” estimate “,” predict “,” potential “or” continue “or the negative of these terms or other similar phrases, although not all forward-looking statements contain these words.

The forward-looking statements contained in this press release are only predictions and are based in large part on our current business plans, expectations and projections regarding future events and financial trends that we believe could affect our business, financial condition. and our operating results. 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 our history of significant losses, which we expect to continue; our limited operating history as a trading company; our expectations regarding the regulatory pathway for our product candidates, our ability to obtain regulatory approvals for these product candidates and the anticipated effect of delays in obtaining such regulatory approvals; our expectations regarding the preclinical and clinical trial plans for our product candidates, the results of these activities and the safety and efficacy of our product candidates; our ability to market our product candidates; our ability to compete successfully with larger competitors in our highly competitive industry; our ability to achieve and maintain adequate levels of coverage or reimbursement for any future product that we may seek to market; our ability to compete successfully with larger competitors in our highly competitive industry; our expectations regarding our manufacturing capabilities; a pandemic, epidemic or outbreak of infectious disease in the United States or worldwide, including the outbreak of the novel strain of coronavirus, COVID-19; product liability claims; our ability to establish and maintain the intellectual property protection of our products, as well as our ability to operate our business without infringing the intellectual property rights of others; our ability to attract and retain senior management and key scientific personnel; and other important factors which could cause actual results, performance or achievements to differ materially from those expected or projected. For information identifying material factors that could cause actual results to differ materially from those anticipated in forward-looking statements, please refer to the Risk Factors section of the Company’s registration statement on Form S- 1 (File No. 333-256649), as amended, filed with the United States Securities and Exchange Commission and any additional risks presented in our Quarterly Reports on Form 10-Q and our current reports on Form 8-K.

Unless expressly required by applicable securities laws, the Company disclaims any intention or obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

Investor contact

Greg Chodaczek

347-620-7010

[email protected]

Media contact:

[email protected]

Warning

Miromatrix Medical Inc. published this content on December 17, 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on December 17, 2021 12:18:07 PM UTC.

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