Humacyte to Seek Israeli Approval for Symvess in Vascular Trauma Repair

Reuters
2026.01.05 13:02
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Humacyte Inc. plans to file a Marketing Authorization Application with the Israel Ministry of Health for its acellular tissue engineered vessel, Symvess, aimed at arterial trauma repair by Q1 2026. The review is expected to take 120 working days, leveraging its existing FDA approval. The company is collaborating with Israeli surgeons from the V005 Phase 2/3 trial for product access. The FDA approved Humacyte's Biologics License Application for ATEV in vascular trauma in December 2024.