Miromatrix Announces FDA Clinical Hold on IND Application for miroliverELAP
Miromatrix Medical Inc. a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients’ lives, today announced that it was informed via e-mail from the U.S. Food and Drug Administration that the miroliverELAPtm Investigational New Drug application for the treatment of acute liver failure has been placed on clinical hold. The miroliverELAP IND application was submitted in mid-November. The FDA indicated they will provide an official clinical hold letter to Miromatrix within 30 days. Miromatrix plans to provide additional updates pending communication with the FDA.