Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma

In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries.

Dr. Rishi Kundi, a clinical investigator at the University of Maryland Medical System, believes Symvess holds the potential to transform vascular trauma care by overcoming longstanding challenges like infection control and graft failure that have plagued traditional repair methods.

Symvess is a one-time, single-use, acellular tissue-engineered vessel (ATEV) composed of human extracellular matrix proteins. Manufactured using vascular smooth muscle cells derived from human aortic tissue, Symvess offers a novel solution for patients with traumatic vascular injuries.

When an artery is damaged, restoring blood flow quickly is crucial. The standard approach often involves using the patient’s veins, but this method isn’t always feasible due to vein damage or the invasiveness of the procedure.

Unlike traditional treatments, Symvess is ready for implantation within minutes and directly off-the-shelf, eliminating the need to harvest veins from the patient’s body. This innovation not only reduces surgery time but also prevents further damage to the patient, with Symvess being universally applicable — especially for patients who lack suitable veins for harvesting, thanks to its acellular nature.

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While Symvess focuses on arterial repair, other developments like AQUACEL Ag+ Extra, Molnlycke Health Care’s wound management technologies and Traumagel are advancing care in related areas.

AQUACEL, currently undergoing clinical studies, aims to heal venous leg ulcers, while Molnlycke is improving chronic wound care. In addition, Traumagel, an FDA-cleared plant-based hemostatic gel, is designed to rapidly control bleeding, demonstrating the variety of solutions emerging in trauma and wound care.

In the pivotal V005 Phase II/III clinical trial, 67 percent of patients treated with Symvess retained primary patency (blood flow without intervention), and 72 percent maintained secondary patency (blood flow with some intervention) at 30 days post-implantation. These results were compared to traditional grafts, including synthetic options, where Symvess demonstrated superior performance in maintaining blood flow and reducing complications.

Secondary endpoints, such as infection rates, amputation and limb salvage, also favored Symvess, with the trial covering traumatic injuries from car accidents, gunshot wounds and industrial accidents.

Symvess has already been used in level 1 trauma centers across the US, Israel and front-line hospitals in Ukraine to treat severe limb-threatening injuries, demonstrating real-world potential.

Symvess does carry risks, including thrombosis, graft rupture and infection.

Looking ahead, Humacyte plans to expand Symvess’ use to conditions like peripheral artery disease and pediatric heart surgery. With FDA approval granted, Humacyte is working to make Symvess widely available in hospitals, trauma centers and military facilities, offering new treatment options for patients with vascular injuries.