Humacyte recently shared that the Food and Drug Administration (FDA) has granted a full approval for the Symvess acellular tissue-engineered vessel.
A press release notes that Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularisation is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.
“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, 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 (University of Maryland Capital Region, Lake Arbor, USA), a clinical investigator in the V005 clinical trial. “Symvess is 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 revolutionise vascular trauma care and be profoundly beneficial to our patients,” said Rishi Kundi (University of Maryland Medical System, Baltimore, USA). “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.”
A press release details that Symvess is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. “While harvesting vein from a trauma patient takes valuable surgical time, Symvess is available off-the-shelf, and does not require further injuring the patient to obtain vascular repair material,” the release notes.
Humacyte’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 programme. Symvess was used to repair many types of traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents. It was utilised by vascular and trauma surgeons in level-one trauma centres throughout the USA and Israel to repair severe limb-threatening and life-threatening injuries, and in frontline hospitals in Ukraine to treat wartime injuries. Results from these studies were published in JAMA Surgery in November 2024. In the civilian and military clinical studies, Symvess was observed to have high rates of patency, or blood flow, and low rates of amputation and infection.
“Finally, we have an innovative technology for battlefield vascular injuries using a tissue-engineered human arterial replacement that can resist infections that are so prevalent in modern combat zones,” added Fox. “Symvess shows promise to reduce amputation rates since an alternative conduit for war injuries is often needed but up until now has not been a good option.”
“The FDA approval of Symvess will make it the preferred conduit for complex vascular injuries, and particularly those at risk for infection,” said Ernest E Moore (Denver Health, Denver, USA), a clinical investigator in the V005 trial. “I look forward to using Symvess in my practice.”
Humacyte shares that the Symvess trauma programme was granted regenerative medicine advanced therapy (RMAT) designation by the FDA in May 2023, a BLA was submitted to the FDA in December 2023, and in February 2024 the FDA granted a priority review. On 9 August 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 on 19 December, granting full approval.
