United Therapeutics announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to Miroliver ELAP, an external liver assist product developed by Miromatrix Medical Inc., a wholly owned subsidiary.
Miroliver ELAP combines an external blood circuit with a single-use bioengineered liver manufactured by seeding a decellularized porcine liver scaffold with allogeneic human endothelial cells and human liver cells isolated from donated human livers that are not suitable for transplantation and provided by organ procurement organizations.
According to the company, United Therapeutics reported positive phase 1 results in January and said full study results will be published in the second half of 2026. Miroliver ELAP is investigational and is not approved for any use.
The FDA designation provides intensive regulatory guidance and could enable priority review, rolling review of biologics license application materials, and other pathways intended to shorten development timelines.
United Therapeutics and Miromatrix are also developing Mirokidney using the same decellularization and seeding technology, and the companies group these efforts into platforms aimed at expanding the supply of transplantable organs for patients with end-stage organ disease.
The company cites that roughly 45% of acute liver failure patients recover spontaneously, 25% receive transplants and about 30% die due to ineligibility or organ shortages.
