United Therapeutics announces FDA granted RMAT designation to miroliverELAP

United Therapeutics (UTHR) announced that the U.S. Food and Drug Administration, FDA, has granted Regenerative Medicine Advanced Therapy, RMAT, designation to the company’s investigational miroliverELAP, an external liver assist product. Developed by Miromatrix Medical, 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 allogeneic human endothelial 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.