Extension for Symvess (acellular tissue engineered vessel-tyod, or ATEV) from 18 months to 36 months when stored refrigerated at 2°C to 8°C (36°F to 46°F).

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.

"This FDA authorization represents an important advancement in supporting the commercial availability of Symvess for hospitals and healthcare systems," said Laura Niklason, MD, PhD, Founder, President and Chief Executive Officer of Humacyte. "Extending the shelf life to 36 months provides greater inventory flexibility while maintaining the same storage requirements and approved clinical use. We believe this enhancement will further facilitate hospital adoption and ensure surgeons have access to Symvess when urgent vascular repair is needed."

Symvess was approved by the FDA in December 2024 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. As a first-in-class, off-the-shelf bioengineered human tissue, Symvess is available for use on-demand in the operating room, sparing surgeons the time required to harvest a vein from the patient and avoiding a second surgical site on a patient who is often already critically injured. Humacyte expects to file a supplemental Biologics License Application during November 2026, seeking to add dialysis access as the second approved indication for the ATEV.