Humacyte Announces FDA Communication of Additional Time Required to Complete Review of acellular tissue engineered vessel (ATEV™) BLA for the Treatment of Vascular Trauma

Core Viewpoint - Humacyte, Inc. announced that the FDA requires additional time to review its Biologic License Application for the acellular tissue engineered vessel (ATEV) intended for vascular trauma, which was initially set for a PDUFA date of August 10, 2024 [1][2] Company Overview - Humacyte is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][4] - The company is working on a portfolio of ATEVs targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease [4][5] - The ATEV is designed to be a first-in-class bioengineered human tissue that serves as a universally implantable vascular conduit for arterial replacement and repair [2][4] FDA Review Process - The FDA granted a Priority Review for the ATEV, which typically allows for a six-month review cycle compared to the standard ten-month cycle for most products [2] - The BLA for ATEV was submitted in December 2023, and the FDA has conducted inspections and engaged in discussions regarding the application [2][4] - The company remains confident in the approvability of the ATEV based on positive results from clinical studies and real-world evidence [2][4] Clinical Evidence - The BLA included results from the V005 pivotal Phase 2/3 clinical study and evidence from treating wartime injuries in Ukraine [2] - ATEV has been used in various traumatic injury cases, demonstrating high rates of patency and low rates of amputation and infection [2][4]