Humacyte’s Symvess ATEV Approved by FDA for Treatment of Extremity Vascular Trauma

December 19, 2024—Humacyte, Inc. announced that the FDA has granted full approval for the company’s Symvess—acellular tissue engineered vessel-tyod (ATEV)—for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and when autologous vein graft is not feasible.

According to the company, Symvess is a bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. It is available off-the-shelf and does not require further injuring the patient to obtain vascular repair material.

Humacyte’s Biologic License Application, which was submitted to the FDA in December 2023, included positive results from the V005 pivotal phase 2/3 clinical study, as well as real-world evidence in Ukraine under a humanitarian aid program, stated the company.

The company noted that Symvess ATEV was used to repair many types of traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents. It was utilized by vascular and trauma surgeons in Level 1 trauma centers throughout the United States and Israel to repair severe limb-threatening and life-threatening injuries, and in front-line hospitals in Ukraine to treat wartime injuries.

Humacyte stated that in the civilian and military clinical studies, Symvess was observed to have high rates of patency and low rates of amputation and infection. On November 20, 2024, the results from these studies were published by Ernest E. Moore, MD, et al online in JAMA Surgery.

Dr. Moore, who served as a clinical investigator in the V005 trial, is Director of Research at the Ernest E. Moore Shock Trauma Center at Denver Health in Denver, Colorado.

“The FDA approval of Symvess will make it the preferred conduit for complex vascular injuries, and particularly those at risk for infection,” commented Dr. Moore in Humacyte’s press release. “I look forward to using Symvess in my practice.”

Rishi Kundi, MD, and Charles J. Fox from the University of Maryland Medical System in Baltimore, Maryland, also discussed the FDA approval of Symvess in the company’s press release.

“I believe that Symvess will revolutionize vascular trauma care and be profoundly beneficial to our patients,” stated Dr. Kundi. “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.”

Dr. Fox, who served as a clinical investigator in the V005 clinical trial, commented, “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. 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.”

Dr. Fox continued, “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. 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.”