Humacyte Inc. (NASDAQ: HUMA) plans to submit a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration in November 2026, seeking approval for its acellular tissue engineered vessel (ATEV) as a dialysis access solution.
The filing would expand the ATEV's current indication, which was granted FDA approval in December 2024 for treating extremity vascular trauma. The company's 6mm ATEV for arteriovenous access in hemodialysis has already received the FDA's Regenerative Medicine Advanced Therapy and Fast Track designations.
Supporting the supplemental BLA are data from multiple studies. Interim results from the V012 dialysis access trial presented at the Society of Vascular Surgery's Vascular Annual Meeting in June 2026 showed that women receiving the ATEV experienced an average of three additional months without a dialysis catheter compared to those treated with standard arteriovenous fistulas. The company also cited completed Phase 3 trials V007 and V006 evaluating efficacy and safety across male and female dialysis patients.
Nearly 500,000 Americans rely on hemodialysis for survival, creating a substantial market opportunity for an improved access solution. Humacyte's CEO Laura Niklason noted that recent FDA discussions reinforced confidence in the regulatory pathway for the ATEV in dialysis access.
