Humacyte to Seek FDA Dialysis Approval, Following Positive Phase 3 Results

Humacyte (Nasdaq: HUMA) plans to file a supplemental Biologics License Application (sBLA) with the FDA in the second half of 2026. The submission seeks to expand the use of its acellular tissue engineered vessel (ATEV) for hemodialysis patients at high risk of fistula failure.

The decision follows positive results from the V012 Phase 3 clinical trial. Female patients using the ATEV averaged 220 catheter-free days over 12 months. Patients using the standard-of-care AV fistula averaged 129 days.

The ATEV group also experienced a significantly lower rate of infections. The FDA previously approved the ATEV product for vascular trauma in December 2024.