Core Insights - Humacyte, Inc. announced positive long-term results from its humanitarian program using Symvess to treat wartime vascular trauma injuries in Ukraine, with zero infections, amputations, or deaths reported in patients followed for up to 18 months [2][4][5] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [2][14] - The company aims to improve patient outcomes and reduce complications through innovative medical solutions [5][14] Product Details - Symvess is an acellular tissue engineered vessel indicated for use in adults with extremity arterial injury when urgent revascularization is needed and autologous vein graft is not feasible [6][14] - The product is designed to be immediately available off-the-shelf, which is critical in wartime situations [3][4] Clinical Results - In a study involving 17 patients with combat-related extremity vascular trauma, Symvess demonstrated a 30-day primary and secondary patency rate of 93.8% and a long-term patency rate of 87.1% [4] - At the 30-day follow-up, there were zero deaths, amputations, or infections, and these outcomes were sustained over the 18-month follow-up period [4][5] Expert Commentary - Dr. Oleksandr Sokolov emphasized the importance of biologic conduits like Symvess in advancing vascular trauma care, particularly in the context of modern warfare [3] - Dr. Laura Niklason highlighted the sustained benefits of Symvess for patients with severe combat injuries, reinforcing the product's potential in improving surgical outcomes [5] Regulatory Status - Humacyte's Biologics License Application for Symvess in the vascular trauma indication was approved by the FDA in December 2024 [14] - The product has received various designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for other vascular applications [15]
Humacyte Announces Publication of Long-Term Results for Ukrainian Patients Treated in Real-World Combat Setting with Symvess™