FDA продлила срок годности биоинженерного сосуда Humacyte Symvess с 18 до 36 месяцев

Humacyte Inc. (HUMA), announced that the U.S. FDA has authorized an extension of the expiration dating period for Symvess, its acellular tissue-engineered vessel (ATEV), from 18 months to 36 months when stored under approved refrigerated conditions. About Symvess 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 can be used on demand in the operating room, sparing surgeons the time required to harvest a vein and avoiding a second surgical site in critically injured patients. Supporting Evidence The extension was supported by additional stability data showing that Symvess continues to meet all established quality specifications throughout the 36-month dating period. The longer shelf life is expected to help hospitals maintain inventory for urgent vascular repairs while reducing product waste. Company Comments Laura Niklason, MD, PhD, Founder, President and Chief Executive Officer of Humacyte, said the FDA authorization represents an important advancement in supporting hospital adoption. She emphasized that extending shelf life provides greater inventory flexibility while ensuring surgeons have access to Symvess when urgent vascular repair is needed. Next Steps Humacyte expects to file a supplemental Biologics License Application in November 2026 to add dialysis access as the second approved indication for the ATEV. For use beyond the current FDA approval in extremity vascular trauma, Symvess remains investigational. HUMA has traded between $0.52 and $2.55 over the past year. The stock is currently trading at $0.58, down 1.13%. For comments and feedback contact: [email protected] Business News September 11, 2026 16:26 ET Consumer prices data was the main news on the economic front in the U.S. this week. In Europe, the latest interest rate decision from the European Central Bank was the focus along with the revised second quarter economic growth data for the euro area. In Asia, the monthly foreign trade data from China drew attention.