Humacyte’s V007 Phase 3 Hemodialysis Access Trial Results Published

August 25, 2026—Humacyte, Inc. announced the publication of 1-year results from the V007 phase 3 clinical trial of the acellular tissue-engineered vessel (ATEV) in arteriovenous (AV) access for hemodialysis patients. ATEV is a bioengineered human tissue designed to be a universally implantable vascular conduit for use in vascular replacement and repair and as hemodialysis access. The study was published by Mohamad A Hussain, MD, et al in The Lancet Digital Health.

According to Humacyte, the published V007 study data showed the superiority of ATEV over autogenous arteriovenous fistula (AVF) for hemodialysis vascular access after 1 year of follow-up, particularly for patients with obesity and diabetes, groups that often have higher rates of AVF failure.

The 6- and 12-month results from the trial were presented in October 2024 by Dr. Hussain at the American Society of Nephrology’s Kidney Week 2024 meeting. In July 2024, the company announced the top-line results from the trial.

The company advised that the 2-year results from the V007 phase 3 trial were presented in November at Kidney Week 2025, further demonstrating the durability of ATEV’s benefits over time. Additionally, Humacyte recently reported top-line interim results from its V012 phase 3 study that specifically focused on female patients with end-stage renal disease needing hemodialysis, a population in which the V007 1-year data already showed meaningful advantages for ATEV over traditional fistulas. The V012 data were presented in June 2026 at the Society of Vascular Surgery’s Vascular Annual Meeting in Boston, Massachusetts.

As a result of meeting the primary superiority endpoint in V012, Humacyte plans to submit a supplemental Biologics License Application to expand the Symvess label to include a second indication in AV access for hemodialysis in the second half of 2026, stated the company.