India, April 8 -- United Therapeutics Corporation (UTHR), Wednesday announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to the company's investigational miroliverELAP for treatment of acute liver failure.
Developed by Miromatrix Medical Inc., a subsidiary of United Therapeutics, miroliverELAP comprises 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.
Early this year, the company announced positive results from its phase 1 study of miroliverELAP. However, the full study findings will be published in the second half of 2026.
"Receiving this designation from the FDA highligh...