Miromatrix Medical Inc. provided a program update on miroliverELAP™. Miromatrix previously announced the submission of its miroliverELAP Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in November 2022. In December, Miromatrix announced that the FDA had informed the Company via e-mail that the IND application was placed on clinical hold prior to the initiation of patient dosing and noted that a formal clinical hold letter would follow.

In January 2023, Miromatrix received the formal clinical hold letter from the FDA detailing the specific items to be addressed in the IND submission and the information needed to resolve them. In the letter, the FDA requested additional non-clinical and clinical information. The information provided by the FDA also provides valuable insights relating to certain chemistry, manufacturing and control (CMC) and clinical protocol topics unrelated to the clinical hold.