Humacyte Acellular Tissue Engineered Vessel Gets Regenerative Medicine Tag for Peripheral Artery Disease

 Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration’s (FDA’s) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Investigational New Drug (IND) application for the PAD indication for Humacyte’s investigational Acellular Tissue Engineered Vessel (ATEV), formerly referred to as the “HAV”. The RMAT designation is designed to provide pathways for expedited development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. The designation allows for close interactions with the FDA and potentially an expedited/priority review of a Biologics License Application (BLA). This is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and arteriovenous (AV) access in hemodialysis.

https://www.biospace.com/article/releases/humacyte-acellular-tissue-engineered-vessel-atev-receives-fda-s-regenerative-medicine-advanced-therapy-rmat-designation-for-patients-with-advanced-peripheral-artery-disease-pad-/