Humacyte announces planned MAA for Symvess in Israel

Humacyte (HUMA) plans to file a Marketing Authorization Application with the Israel Ministry of Health for approval of the acellular tissue engineered vessel for arterial trauma repair during the first quarter of 2026. The Company currently expects that the MAA will be evaluated by the Ministry of Health in a review period of 120 working days due to the existing Food and Drug Administration approval of Symvess. Humacyte is working in coordination with Israeli surgeons who participated in the V005 Phase 2/3 trial of Symvess in vascular trauma and who are petitioning the Ministry of Health seeking access to the product.