Humacyte’s Phase 3 ATEV Results in Women on Hemodialysis Accepted as ASN Kidney Week Late-Breaker
Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced (12th October 2026) that interim results from its V012 Phase 3 clinical trial have been accepted for a late-breaking oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026, taking place October 21–25 in Denver, Colorado.
ASN Kidney Week is the world’s largest nephrology meeting, bringing together more than 12,000 kidney professionals each year. The late-breaking presentation provides the opportunity to share the V012 data directly with the clinicians who manage dialysis access every day.
V012 is a Phase 3 randomized controlled trial comparing Humacyte’s acellular tissue engineered vessel (ATEV) with autogenous arteriovenous fistula (AVF) for hemodialysis access in female patients with end-stage kidney disease (ESKD). The Phase 3 results will be presented by Prabir Roy-Chaudhury, M.D., Ph.D., of the University of North Carolina at Chapel Hill School of Medicine.
Presentation details:
- Title: 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
- Presenter: Prabir Roy-Chaudhury, M.D., Ph.D., University of North Carolina at Chapel Hill School of Medicine
- Authors: Mohamad A. Hussain (Mass General Brigham); Prabir Roy-Chaudhury (University of North Carolina at Chapel Hill School of Medicine); Sophia Bou-Ghannam, Laura E. Niklason and Shamik J. Parikh (Humacyte)
- Session: Late-Breaking Research Orals: Dialysis and Transplantation
- Date and time: Thursday, October 22, 2026, 4:40–4:50 PM MT
- Location: Four Seasons Ballroom 2, Colorado Convention Center, Denver
- Abstract number: TH-OR113
“Women on dialysis are more likely than men to experience fistula failure and to remain dependent on catheters,” said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. “V012 was built to test whether the ATEV can offer a better option for these patients, and we look forward to Dr. Roy-Chaudhury sharing the Phase 3 results with the nephrology community at ASN Kidney Week.”
The results from V012, supported by the results from two previously completed Phase 3 trials in hemodialysis access, form the clinical foundation for Humacyte’s planned supplemental Biologics License Application to expand the Symvess® label to include AV access for hemodialysis, which the Company has targeted for submission to the FDA this quarter.
For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
– Interim Phase 3 findings will be presented in a prestigious late-breaking oral session at the leading meeting for kidney health professionals.
– Randomized trial compares the acellular tissue engineered vessel (ATEV) with autogenous arteriovenous fistula in female patients with end-stage kidney disease.
– Supplemental BLA in AV access for hemodialysis expected to be submitted to FDA this quarter.
(GLOBE NEWSWIRE)
