Humacyte, Inc. (NASDAQ: HUMA) has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Symvess (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
The company's chief executive officer, Laura Niklason, M.D., Ph.D., expressed excitement and pride in providing patients suffering from arterial injury with a novel treatment option. The approval of Symvess in this first indication for arterial injury repair is a milestone for regenerative medicine and for Humacyte.
Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair. The company's Biologics License Application (BLA) included positive results from the V005 pivotal phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. Symvess was observed to have high rates of patency, or blood flow, and low rates of amputation and infection in clinical studies, and was published in JAMA Surgery on November 20, 2024.
The Symvess trauma program was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in May 2023, and a BLA was submitted to the FDA in December 2023. The FDA granted a priority review in February 2024. The FDA completed its review, granting full approval in December 2024.
Symvess is contraindicated in patients who have a medical condition that would preclude long-term antiplatelet therapy and carries warnings and precautions related to graft rupture, anastomotic failure, thrombosis, and the potential transmission of infectious diseases. The most common adverse reactions were vascular graft thrombosis, pyrexia (fever), and pain.
Humacyte is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. Their initial product candidates, a portfolio of acellular tissue engineered vessels (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A BLA for the ATEV in the vascular trauma indication was approved by the FDA in December 2024. Today the company's shares have moved 34.1% to a price of $4.64. For more information, read the company's full 8-K submission here.
