FDA approves Symvess for urgent limb revascularization

“We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. Symvess has been made possible by our innovative bioengineering science along with the contributions of many patients, healthcare providers and Humacyte team members.” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Symvess approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte. The FDA’s full approval of Symvess is a transformational event for the Company and our bioengineering technology platform. Even more importantly, we believe Symvess provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades. We look forward with great excitement to our upcoming commercial launch of Symvess, and we have recruited and trained a terrific team to execute on our sales and marketing missions.”

“The approval of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will have a huge impact on the quality of trauma care around the world,” said Charles J. Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 clinical trial. Symvesss perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. The Humacyte team has responsibly and scientifically solved a major clinical problem that I believe will reduce the amputation rate for traumatic vascular injury. They should be congratulated on an accomplishment that will undoubtedly advance our specialty to the next level.”

 " I believe that Symvess will revolutionize vascular trauma care and be profoundly beneficial to our patients,” said Rishi Kundi, MD, Surgical Critical Care, Vascular Surgery, University of Maryland Medical System. “From my experience so far, Symvess  will allow reconstructions that are currently impracticable because of contamination and infection. It will make reconstructions that we now perform with prosthetic or even biologic grafts more successful. I am most excited about the promise that Symvess holds for the long-term experience of our patients. I hope that, with Symvess , the 19-year-old patient with vascular reconstruction after trauma will no longer spend the six decades after their surgery anticipating disaster, but that their chances for reintervention will be no different than if they had autologous conduit.”

The Symvess trauma program was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in May 2023, a Biologic License Application (BLA) was submitted to the FDA in December 2023, and in February 2024 the FDA granted a Priority Review. On August 9, 2024, the FDA informed Humacyte that it needed additional time to complete its review of the BLA, although there were no outstanding pre-approval requirements for Symvess as of that date. The FDA completed its review today, granting full approval.