FDA Authorizes Shelf-Life Extension for Humacyte’s Symvess ATEV to 36 Months

September 15, 2026—Humacyte, Inc. announced that the FDA has authorized an extension of the expiration dating period for Symvess, which is the company’s acellular tissue engineered vessel-tyod (ATEV), from 18 to 36 months when stored refrigerated at 2°C to 8°C (36°- 46°F).

According to the company, the expiration dating extension is supported by additional stability data demonstrating that Symvess continues to meet all established product quality specifications throughout the extended 36-month dating period when stored under approved conditions. The extended shelf life helps hospitals keep Symvess on hand for urgent vascular repairs while simplifying inventory planning and reducing product waste, noted Humacyte.

In December 2024, Humacyte announced FDA approval for Symvess as a vascular conduit for adults with extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and an autologous vein graft is not feasible. For use other than the FDA-approved extremity vascular trauma indication, Symvess is an investigational product and has not been approved for sale by the FDA or any other regulatory agency, advised Humacyte.

The company stated it expects to file a supplemental Biologics License Application with the FDA in November 2026, seeking to add dialysis access as the second approved indication for ATEV.

In August 2026, Humacyte announced that 1-year results from the V007 phase 3 clinical trial of the ATEV in arteriovenous access for hemodialysis patients were published by Mohamad A. Hussain, MD, et al in The Lancet Digital Health.