Humacyte Announces Planned Marketing Authorization Application for Symvess® in Israel

Core Viewpoint - Humacyte, Inc. plans to file a Marketing Authorization Application (MAA) with the Israel Ministry of Health for its acellular tissue engineered vessel (ATEV™ or Symvess) aimed at arterial trauma repair, with expectations for expedited commercialization in other regions following FDA approval [1][2]. Group 1: Expansion Plans - The expansion of Symvess is driven by requests from surgeons and hospitals in Israel, with plans to extend into Europe and the Middle East [1][2]. - The company anticipates that the FDA approval of Symvess will facilitate faster commercialization pathways in these new territories [2]. Group 2: Clinical Data and Product Features - Positive three-year results from the V005 Phase 2/3 study of Symvess in extremity vascular repair provide the first long-term data in traumatic arterial repair using a biologic conduit [2]. - Symvess is designed to be available off-the-shelf, which is crucial for saving surgical time in emergency situations, and has shown low infection rates and high limb salvage rates [2]. Group 3: Company Overview - Humacyte is focused on developing universally implantable bioengineered human tissues and has received FDA approval for its ATEV in December 2024 for vascular trauma [3]. - The company is also conducting late-stage clinical trials for other vascular applications and has received various designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) [3].