Press release
United Therapeutics Announces Positive Results from Phase 1 Study of miroliverELAP® in Patients with Acute Liver Failure
This study was the world’s first FDA-cleared clinical trial using a bioengineered liver. Based on these positive results, United Therapeutics will initiate a
About this update from United Therapeutics Corporation
[{"type":"text","content":"\nThis study was the world’s first FDA-cleared clinical trial using a bioengineered liver. Based on these positive results, United Therapeutics will initiate a phase 2 study\n\n\nApproximately 30% of acute liver failure patients die because they are ineligible for a liver transplant or a donated liver is not available1, demonstrating the critical need for organ alternatives\n\n\n SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--\nUnited Therapeutics Corporation (Nasdaq: UTHR) today announced positive results from its phase 1 study of miroliverELAP®, an external liver assist product, in patients with acute forms of liver failure, acute-on-chronic liver failure, and severe acute alcoholic hepatitis, collectively called acute liver failure (ALF).2\n\n\nDeveloped by Miromatrix Medical Inc., a wholly owned subsidiary of United Therapeutics, miroliverELAP consists of an external blood circuit and a single-use bioengineered liver sustained outside of the human body to provide temporary liver support to ALF patients. The bioengineered liver is manufactured by seeding a decellularized porcine liver scaffold with allogeneic3 human endothelial4 cells and human liver cells isolated from donated human livers. The donated human livers are not suitable for transplantation and are provided by organ procurement organizations (OPOs).\n\n\nIn the study, five ALF patients who were not candidates for a liver transplant were continuously treated with miroliverELAP for at least 44 hours. The single-arm, open label, safety study met the primary endpoint of survival during miroliverELAP treatment and there were no reports of unexpected serious adverse events attributable to the miroliverELAP over a subsequent 32-day follow-up period. Full study results will be presented and published in the second half of 2026.\n\n\n“This study provides early evidence that miroliverELAP, an innovative bioengineered organ alternative product, has the potential to provide liver support for patients experiencing ALF, giving their native livers more time to recover. Achieving this important milestone allows us to continue advancing miroliverELAP to help save and improve the lives of ALF patients, who face poor outcomes and a desperate need for therapies,” said Jeff Ross, Ph.D., President of Miromatrix.\n\n\n“United Therapeutics is committed to developing ...