Miromatrix Submits Pre-IND Request to the FDA for Its External Liver Assist Product to Treat Acute Liver Failure

The request puts Miromatrix on the path for Phase I IND submission and an in-human trial in 2H2022

EDEN PRAIRIE, Minn., Dec. 17, 2021 (GLOBE NEWSWIRE) — 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 announced it has submitted a pre-IND request 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 in-human clinical trial slated for the second half of 2022, which will assess the function of a bioengineered liver graft in humans via an external application.

“This is the first of many major milestones Miromatrix has planned for 2022, as we move closer to in-human implants of bioengineered organs,” said Jeff Ross, Ph.D., Miromatrix CEO. “Our large animal study published earlier this year demonstrated that organs developed in a lab can be successfully transplanted in pre-clinical models. We are excited to build upon that body of research and work with the FDA on our Phase I IND submission to secure our first human clinical use of a bioengineered liver graft in the second half of 2022.”

Acute liver failure, acute on chronic liver failure, and severe acute alcoholic hepatitis affect 80,000 people in the U.S. each year, with no approved drug or medical device interventions. Liver transplantation is the only curative therapy for acute and chronic liver failure, yet just half of the patients on the organ transplant waitlist will receive one in time. The use of an external bioengineered liver graft to support a patients’ internal organ generally poses less risk than a full transplant and is intended to demonstrate the safety and tolerability of Miromatrix’s technology before moving to full transplantation.

In October, Miromatrix announced it had successfully completed the first ever heterotopic implant of its bioengineered liver into a large animal in a pre-clinical study in collaboration with researchers at Mayo Clinic. The results, published in Nature Communications Biology, showed that pigs that received the bioengineered livers maintained detectable hepatic health in the graft, sustained blood perfusion, and demonstrated early liver function post transplantation.

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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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, including statements regarding our first ever transplant of a bioengineered liver transplant into a large animal. 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.

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Investor Contact
Greg Chodaczek
347-620-7010
ir@miromatrix.com

Media Contact:
press@miromatrix.com