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

February 1, 2023

• 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., Feb. 01, 2023 (GLOBE NEWSWIRE) -- 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 miroliverELAP that combines a Miromatrix single-use bioengineered liver with Baxter’s PrisMax system. Miromatrix submitted an Investigational New Drug (IND) application for miroliverELAP 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 miroliverELAP 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 miroliverELAP 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,i often because they cannot receive a liver transplant in time.ii 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. MiroliverELAP 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 miroliverELAP 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 miroliverELAP system. MiroliverELAP 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 miroliverELAP 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.”

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.

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.

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.

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