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Humacyte Announces Phase 3 V012 Trial Results for ATEV in Women Requiring Hemodialysis Access Accepted for a Late-Breaking Session Presentation at ASN Kidney Week 2026

HUMA
  • Humacyte announced that interim Phase 3 V012 trial results will be presented at a late-breaking oral session at the American Society of Nephrology Kidney Week 2026 in Denver.
  • The randomized controlled trial compares the acellular tissue engineered vessel (ATEV) with autogenous arteriovenous fistula for hemodialysis access in female patients with end-stage kidney disease.
  • The presentation titled "Randomized Controlled Trial of an Acellular Tissue Engineered Vessel vs. Arteriovenous Fistula for Hemodialysis Access in Female Patients with ESKD" will be delivered by Dr. Prabir Roy-Chaudhury on October 22, 2026.
  • The V012 results, combined with data from two prior Phase 3 trials, support the clinical foundation for a supplemental Biologics License Application to expand the Symvess label to include AV access for hemodialysis.
  • Humacyte plans to submit the supplemental BLA to the FDA during the current quarter.
  • The ATEV is currently approved by the FDA for extremity vascular trauma but remains an investigational product for hemodialysis access.