Humacyte Provides Update on Commercial Launch and Pricing of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma

Core Insights - Humacyte, Inc. has announced plans for the commercial launch of Symvess, a bioengineered human tissue designed for arterial replacement and repair, following FDA approval [2][6] - The company has established a highly experienced sales team to support the launch, with members having an average of over 15 years in medical device and biotech sales [3] - Symvess is priced at $29,500 per unit, with a Budget Impact Model indicating potential cost savings compared to current treatment options [4] FDA Approval and Market Readiness - The FDA granted full approval for Symvess on December 19, 2024, for use in adults with extremity arterial injury when urgent revascularization is needed [2] - Humacyte expects to begin product shipments early in the current quarter and is building product supply to support the market launch [2] Sales and Marketing Strategy - The sales team consists of ten members, all of whom are top achievers in their previous organizations, with experience in vascular and trauma surgery [3] - The team has a strong background in selling clinically differentiated technologies and regenerative therapies [3] Pricing and Cost Savings - Symvess is priced at $29,500 per unit, and the Budget Impact Model suggests that treating patients with Symvess may be less costly than using synthetic grafts or other alternatives [4] - Key cost savings are attributed to reduced rates of amputation and vascular conduit infection [4] Reimbursement and Financial Support - Humacyte submitted an NTAP application to CMS in October 2024, which, if approved, would provide additional payment to hospitals for costs associated with Symvess starting October 1, 2025 [5] Clinical Evidence and Applications - Symvess has shown positive results in clinical studies, including high rates of patency and low rates of amputation and infection [7] - The product has been used in various traumatic injury cases, including wartime injuries in Ukraine, demonstrating its versatility and effectiveness [6][7]