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StocksMedium•8 April 2026•

1 min read

United Therapeutics Receives FDA RMAT Designation for Liver Failure Treatment

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Key Facts

1The U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to United Therapeutics' miroliverELAP.

United Therapeutics Corporation announced that its investigational product, miroliverELAP, has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA. This designation is specifically aimed at accelerating the development and review process for the external liver assist device designed to treat acute liver failure. The technology behind miroliverELAP was developed by Miromatrix Medical, a wholly owned subsidiary of United Therapeutics. Acute liver failure is a life-threatening condition with limited treatment options, making this regulatory milestone significant for patient care. The RMAT status provides the company with intensive FDA guidance and potential eligibility for priority review and accelerated approval. This development is expected to strengthen United Therapeutics' position in the regenerative medicine sector and potentially shorten the time to market.