On June 9, 2025, Humacyte, Inc. announced that results from its V007 Pivotal Phase 3 clinical trial were presented in a plenary session at the Society for Vascular Surgery Vascular Annual Meeting (VAM25). The trial evaluated the acellular tissue engineered vessel (ATEV™) for arteriovenous access in high-risk patients with end-stage renal disease.
The study, titled 'Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis,' showed that ATEV had better functional patency, usability, and a comparable access-related complication profile compared to autologous arteriovenous fistulas (AVF) in this high-risk subgroup.
Specifically, the ATEV demonstrated superior functional patency during the first year in women and men with diabetes and obesity, patient groups that are historically underserved by the current standard of care. The safety profile was comparable to AVF, with similarly low rates of infections, despite more thrombosis and stenosis events that were mostly successfully treated.
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