Humacyte , a Durham, North Carolina-based commercial-stage biotechnology company developing universally implantable, bioengineered human tissues, announced on October 12, 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. ASN Kidney Week is the world’s largest nephrology meeting, drawing more than 12,000 kidney professionals each year.
“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.”
Inside the V012 Trial
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 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
- Authors: Mohamad A. Hussain (Mass General Brigham); Prabir Roy-Chaudhury (UNC 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
Toward a Label Expansion
The V012 results, supported by 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. The company is targeting submission to the FDA this quarter.
The ATEV was approved by the FDA in December 2024 for extremity vascular trauma. For all other uses, it remains an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
About Humacyte
Humacyte develops and manufactures acellular, bioengineered human tissues to treat a range of diseases, injuries, and chronic conditions. Beyond its approved vascular trauma indication, its ATEVs are in late-stage clinical trials for AV access for hemodialysis and peripheral artery disease, with preclinical work underway in coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes, and other cell and tissue applications. Humacyte’s 6mm ATEV for AV access was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation.
