United Therapeutics receives FDA regenerative medicine designation for liver device
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United Therapeutics Receives FDA Regenerative Medicine Advanced Therapy Designation for miroliverELAP® for Treatment of Acute Liver Failure
April 8, 2026 7:00 AM EDTSILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to the companys investigational miroliverELAP®, an external liver assist product.
Developed 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... More
