MIRO - Baxter teams up with Miromatrix for bioengineered liver

Miromatrix Medical ( NASDAQ: MIRO ) announced Wednesday that Baxter International ( NYSE: BAX ) has partnered with it to develop a new liver therapy comprising the company's single-use bioengineered liver miroliverELAP with Baxter's continuous renal replacement therapy PrisMax system.

The research collaboration aims to develop miroliverELAP as a new treatment option for patients with acute liver failure (ALF) who require organ support therapies.

More than 50K Americans die from ALF annually, many due to lack of a timely liver transplant. "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," Miromatrix ( MIRO ) Chief Executive Jeff Ross remarked.

In December, the company announced that the FDA put on hold its clinical trial application for miroliverELAP. Miromatrix ( MIRO ) said Wednesday that in a subsequent formal clinical hold letter in January, the FDA had requested additional non-clinical and clinical data from the company to consider its position.

"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," Dr. Ross added.

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