Miromatrix Medical to submit response to clinical hold letter in 2H23

Miromatrix Medical provided a program update on miroliverELAP. Miromatrix previously announced the submission of its miroliverELAP Investigational New Drug application to the U.S. Food and Drug Administration 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 and clinical protocol topics unrelated to the clinical hold. "Miromatrix is bioengineering organs with the goal of providing organ failure patients with treatment alternatives that do not exist today," said Dr. Jeff Ross, Chief Executive Officer of Miromatrix. "miroliverELAP is a novel first-in-class therapeutic and the clinical hold letter provides us with a defined path forward from the FDA as we strive to solve one of the greatest unmet medical needs facing the world today. We also believe certain items noted by the FDA may be helpful towards the advancement of our other pipeline programs as well. Having evaluated the matters identified in the clinical hold letter, we plan to submit our response to the FDA in the second half of 2023 and initiate a first-in-human clinical trial shortly after IND clearance," continued Dr. Ross. "We will maintain our disciplined operational approach and continue to expect our strong cash position to fund operations through 2023."