Humacyte Plans To File MAA With Israel Ministry Of Health For Approval Of Acellular Tissue Engineered Vessel For Arterial Trauma Repair During Q1 2026

Benzinga · 01/05 13:02

- Expansion plans are based on requests for product access received from surgeons and hospitals in Israel - 

- Expansion of Symvess into other territories, including those in Europe and the Middle East, is also planned -

DURHAM, N.C., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it plans to file a Marketing Authorization Application (MAA) with the Israel Ministry of Health for approval of the acellular tissue engineered vessel (ATEV™ or Symvess) 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 (FDA) 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.