Humacyte Inc. (NASDAQ: HUMA) said it intends to file a supplemental Biologics License Application with the U.S. Food and Drug Administration in November 2026 for its acellular tissue engineered vessel (ATEV) in dialysis access.
The Durham, North Carolina-based company’s 6mm ATEV is designed for arteriovenous access in hemodialysis patients. Humacyte noted it has received prior FDA approval for vascular trauma treatment in December 2024 and holds Regenerative Medicine Advanced Therapy and Fast Track designations for the ATEV program.
The filing will draw on results from three clinical studies. The V012 Dialysis Access Study reported that women receiving the ATEV experienced an average of three additional months without a dialysis catheter compared with those receiving standard arteriovenous fistulas. Top-line interim results from V012 were presented at the Society of Vascular Surgery’s Vascular Annual Meeting in June 2026. Humacyte also plans to include data from completed Phase 3 trials V007 and V006, which enrolled male and female dialysis access patients, in its submission.
Nearly 500,000 Americans rely on hemodialysis for survival, according to the company. Humacyte’s CEO Laura Niklason said discussions with the FDA reinforced confidence in the regulatory pathway for the ATEV in dialysis access.
