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Humacyte Submits Marketing Authorization Application for Symvess® in Israel for Vascular Trauma Repair
- Humacyte is also pursuing a mechanism for making Symvess available in Israel on a hospital-by-hospital basis in advance of MAA approval - - Preparation is
About this update from Humacyte, Inc.
[{"type":"text","content":"- Humacyte is also pursuing a mechanism for making Symvess available in Israel on a hospital-by-hospital basis in advance of MAA approval - - Preparation is underway for expansion of Symvess into other countries, including in the Middle East - DURHAM, N.C., March 17, 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 submitted 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. In response to surgeon request, Humacyte is also pursuing a mechanism for making Symvess available in Israel on a hospital-by-hospital basis in advance of MAA approval. “Surgeons, hospitals and patients in Israel have made an important contribution to the development of Symvess, and we are pleased to have taken an important step to gaining potential approval in this country,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “The MAA submission represents just the first step in our planned global expansion of Symvess as we expect that our FDA approval and strong body of clinical results provide opportunities for expedited commercialization pathways in multiple countries, including others in the Middle East.” Vascular trauma wounds are challenging for surgeons to treat, and autologous vein grafts have traditionally served as the standard of care due to their durability and low infection rates. However, autologous grafts are not always feasible in trauma settings where veins are damaged or there is little time to harvest vein. Symvess is designed to be immediately available off-the-shelf — saving critical surgical time in emergency situations — and has also consistently demonstrated low rates of infection and high rates of limb salvage. In addition to a civilian Phase 2/3 trial conducted in the U.S. and Israel which supported the FDA approval Symvess, the product was evaluated on the battlefield in Ukraine, where patients with gunshots, shrapnel, blasts, and accidents were treated as part of a humanitarian program. Sixteen patients from this program followed in a retrospective, observational study had 100% survival, zero amputations and ...