Humacyte announces presentation of results from Phase 3 AV access study of V007

Humacyte (HUMA) announced that the results from its V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel in arteriovenous access for patients at high risk of autologous arteriovenous fistula maturation failure with end-stage renal disease were presented in a plenary session at the Society for Vascular Surgery Vascular Annual Meeting, held in New Orleans, LA, on June 6, 2025.The results of the study, titled Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial, were presented by Dr. Mohamad Hussain, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School. The CLN-PRO-V007 trial was a prospective, multicenter, two-arm, randomized controlled trial comparing the efficacy and safety of ATEV and AVF in end-stage kidney disease patients on hemodialysis undergoing single-stage surgical vascular access creation. AVF, a surgical procedure that connects an artery to a vein, is the preferred method for vascular access in hemodialysis patients because, when successful, it reduces long-term catheter use and associated complications. However, women and patients with obesity and diabetes are at higher risk of AVF maturation failure, meaning the fistula doesn’t develop adequately for use in dialysis, often resulting in prolonged catheter dependence and increased morbidity. The trial enrolled a total of 242 ESKD patients, of which 110 were specified as high-risk of fistula non-maturation. Humacyte previously announced positive topline results from the trial in October 2024. As shown in the presentation, in this study ATEV was observed to have better functional patency, usability, and a comparable access-related complication profile compared to AVFs in this high-risk subgroup of patients. The safety profile of the ATEV was reported to be comparable to AVF, with similarly low rates of infections. The cohort of patients treated with ATEV had more thrombosis and stenosis events compared to AVF, however the majority were successfully treated. Patients treated with ATEV had a lower need for maturation and surgical revision procedures compared to AVF.