Humacyte Announces Publication of the Budget Impact Model (BIM) for Symvess™ (acellular tissue engineered vessel-tyod) in the Journal of Medical Economics

Core Insights - Humacyte, Inc. has published a Budget Impact Model for its bioengineered human tissue product, Symvess, indicating its economic value for hospitals and payers [1][2] - The FDA granted full approval for Symvess as a vascular conduit for extremity arterial injury in December 2024, highlighting its potential in urgent revascularization scenarios [3] Economic Value - The Budget Impact Model published in the Journal of Medical Economics shows that Symvess is projected to be cost-saving for trauma centers and third-party payers due to reduced costs associated with amputations and conduit infections [1][2] - Per-patient costs for treating patients with Symvess are estimated at $121,615, which is lower than other graft options such as cryopreserved allograft ($154,722), bovine xenograft ($140,428), and prosthetic graft ($137,213) [2] Clinical Efficacy - Symvess has demonstrated high rates of patency and low rates of amputation and infection in clinical studies, including wartime injuries treated under humanitarian aid programs [3] - The product is designed to be available off-the-shelf, eliminating the need for harvesting veins from trauma patients, thus saving surgical time [3] Regulatory Approval - The FDA's approval of Symvess was based on positive results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from its use in various traumatic injuries [3] - The product has received multiple designations, including Regenerative Medicine Advanced Therapy (RMAT) and priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense [14]