Humacyte Presents Interim Results From V012 Phase 3 Clinical Trial Of Acellular Tissue Engineered Vessel In Arteriovenous Access For Female Hemodialysis Patients, At ASN Kidney Week 2026

- The presenter, Dr. Roy-Chaudhury said, "These results give the nephrology community a strong reason to rethink our approach to access decisions for women and, once approved by the FDA, to consider the ATEV as a meaningful new option."

– In a planned interim analysis, women implanted with the ATEV averaged 220 catheter-free days in the first year compared to 129 days with arteriovenous fistula, meeting the trial’s primary endpoint of superiority.

– ATEV recipients achieved functional access significantly faster than AV fistula recipients, with a median of 1.7 months compared to 5.3 months with an AV fistula.

DURHAM, N.C., Oct. 23, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that positive interim results from the V012 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for female hemodialysis patients were presented at the American Society of Nephrology’s (ASN) Kidney Week 2026, one of the world’s premier nephrology meeting, held this year in Denver, Colorado. V012 is the first randomized clinical trial specifically designed to evaluate the ATEV against AV fistula for hemodialysis access in women with end-stage kidney disease (ESKD).

In the V012 Phase 3 trial, women implanted with the ATEV achieved functional access more than three months sooner and spent significantly more time free of dialysis catheters over the first year than women who received an AV fistula, which is the current standard of care for hemodialysis access across all patients. Women have historically had poorer outcomes with AV fistula procedures, including higher rates of maturation failure, longer times to functional access, and greater reliance on infection-prone catheters.

The late-breaking podium presentation, delivered in the Late-Breaking Research Orals: Dialysis and Transplantation session, titled "Randomized Controlled Trial of an Acellular Tissue Engineered Vessel vs. Arteriovenous Fistula for Hemodialysis Access in Female Patients with ESKD: A Phase 3 CLN-PRO-V012 Interim Analysis," was presented on Thursday, October 22, 2026 by Prabir Roy-Chaudhury, M.D., Ph.D., FASN, 2025 President of the American Society of Nephrology and Co-Director of the University of North Carolina Kidney Center.