Humacyte's acellular tissue-engineered vessel (ATEV) has shown promising results in repairing arterial injuries sustained by civilians and soldiers in emergency situations. Data from two non-randomized clinical trials, published in the Journal of the American Medical Association: Surgery, indicate that ATEV is more effective at limb preservation and infection prevention compared to the current standard of care.
The trials, V005 (NCT03005418) and V017 (NCT03183245), assessed the ATEV system in patients with vascular injuries from gunshots, workplace accidents, car crashes, and wartime trauma in the US, Israel, and Ukraine. All patients faced vascular injuries that precluded revascularization, placing them at high risk of limb loss and infection.
A key finding was the superior patency of ATEV, a measure of the durability of vascular reconstructions. The 30-day secondary patency rate for extremity patients treated with ATEV was 91.5%, significantly higher than the 78.9% historically reported for synthetic grafts.
Expert Commentary
Rishi Kundi, chief of vascular and endovascular trauma at the University of Maryland’s R Adams Cowley Shock Trauma Center, expressed enthusiasm about the technology: "I believe that the ATEV will revolutionise vascular trauma care and be profoundly beneficial to our patients... the ATEV will allow reconstruction that is currently impracticable because of contamination or infection; moreover, it will make reconstruction that we are now forced to perform with prosthetic or even biologic grafts more successful."
Advantages of ATEV
One of the primary advantages of Humacyte's engineered tissue is its immediate availability. Unlike traditional methods that require harvesting a vein from the trauma patient—a process that consumes valuable surgical time—ATEV can be used directly off the shelf.
Regulatory Pathway
Humacyte is now pursuing a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) to gain market approval for ATEV.
