Humacyte Inc. announced plans to file a Marketing Authorization Application $(MAA)$ with the Israel Ministry of Health for its acellular tissue engineered vessel (ATEV™ or Symvess) for arterial trauma repair in the first quarter of 2026. The review period is expected to be 120 working days, facilitated by the existing FDA approval of Symvess. The company is coordinating with Israeli surgeons who participated in the V005 Phase 2/3 trial and are seeking access to the product. Additionally, Humacyte's Biologics License Application for ATEV in vascular trauma was approved by the FDA in December 2024.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Humacyte Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9619349) on January 05, 2026, and is solely responsible for the information contained therein.

