Humacyte Launches Symvess ATEV for Extremity Vascular Trauma

February 26, 2025—Humacyte, Inc. announced the commercial launch of Symvess, an acellular tissue engineered vessel-tyod (ATEV) indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and autologous vein graft is not feasible.

According to the company, Symvess is a bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair.

In clinical studies, Symvess ATEV has been used by vascular and trauma surgeons in level 1 trauma centers throughout the United States and Israel to repair severe limb- and life-threatening injuries. Additionally, it has been used in frontline hospitals in Ukraine to treat wartime injuries, reported Humacyte.

The company advised that Symvess is available off the shelf and does not require further injury to the patient to obtain vascular repair material, in contrast to harvesting a vein from the patient. In clinical studies, Symvess was observed to have high rates of patency and resulted in low rates of limb amputation and infection, noted Humacyte.

On December 19, 2024, the company announced FDA approval for Symvess. In that announcement, Humacyte stated that its Biologic License Application 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.

The FDA has now completed its required review of commercial batch information and has authorized Humacyte to commence commercial shipments, advised the company’s press release.