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United Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for miroliverELAP® for Treatment of Acute Liver Failure

UTHR
  • United Therapeutics Corporation announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to miroliver ELAP, an investigational external liver assist product developed by its subsidiary Miromatrix Medical Inc.
  • miroliver ELAP utilizes a bioengineered liver created by seeding a decellularized porcine scaffold with human endothelial and liver cells from donated livers unsuitable for transplantation.
  • The device functions as an external blood circuit to provide temporary liver support for patients with acute liver failure (ALF).
  • United Therapeutics reported positive Phase 1 study results in January for miroliver ELAP treating ALF, acute-on-chronic liver failure, and severe acute alcoholic hepatitis, with full results scheduled for publication in the second half of 2026.
  • The RMAT designation is intended to accelerate development for serious conditions with unmet medical needs, offering benefits such as intensive FDA guidance, priority review eligibility, rolling review of application materials, and expedited approval pathways.
  • Approximately 30% of ALF patients die due to organ shortages or ineligibility for transplant, as only 25% receive transplants while 45% achieve spontaneous recovery.
  • United Therapeutics is also developing mirokidney, a fully transplantable bioengineered kidney, using the same decellularization technology as miroliver ELAP.
  • The company's organ manufacturing efforts include three platforms targeting hearts, kidneys, livers, and lungs to address global organ shortages.
  • miroliver ELAP remains investigational and is not approved for any use in any country as of April 8, 2026.