February 6, 2023 – Miromatrix Medical and Baxter 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.
ALF is a serious condition with limited clinical interventions. Over 50,000 people in the United States die from liver failure each year, often because they cannot receive a liver transplant in time. 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.