Baxter (NYSE:BAX) and Miromatrix Medical (Nasdaq:MIRO) today announced a collaborative research agreement on acute liver failure (ALF) treatments.
As part of the collaboration, Eden Prairie, Minnesota-based Miromatrix created a new liver therapy. The therapy, called MiroLiverELAP, combines a Miromatrix single-use bioengineered liver with Baxter’s PrisMax system.
Miromatrix designed the MiroLiverELAP to provide external support to the patient’s native liver. As a bridge-to-transplant or bridge-to-recover option, it potentially helps to avoid a liver transplant.
Baxter is both a collaborator and shareholder of Miromatrix.
Miromatrix submitted an investigational new drug (IND) application for the therapy to the FDA in November 2022. The company said in a news release that it “appears to be” the first IND for a bioengineered organ. It also plans to commence a Phase 1 clinical trial using MiroLiverELAP to treat patients suffering from ALF.
The company’s bioengineering technology involves turning a pig organ into a non-cellular matrix, introducing human cells into the matrix, and then growing a new organ made of human cells on the matrix. It’s then possible to implant the new organ into a patient using existing transplantation techniques and equipment.
“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, Miromatrix CEO. “We are excited to be partnering with Baxter to pioneer this next-generation innovation in acute care and liver disease.”
How the bioengineered liver works with the Baxter PrisMax system
The company designed its bioengineered liver to replicate key functions of a human liver. It connects to the Baxter PrisMax system outside the patient’s body to create the MiroLiverELAP system.
Baxter designed the PrisMax system to simplify the delivery of continuous renal replacement therapy (CRRT) and other therapies. The company designed custom software and disposables to run treatments with PrisMax and the bioengineered liver during the Phase 1 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, VP of 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.”