ATEV V012

Aug. 24, 2026: Humacyte (NASDAQ: HUMA) said recent FDA discussions support its plan to file a supplemental BLA in November 2026 for its acellular tissue engineered vessel (ATEV) in dialysis access, seeking a second approved indication after the December 2024 FDA approval in vascular trauma.

The filing will be supported by three Phase 3 studies: V012, V007, and V006. Humacyte highlighted top-line interim V012 results in female dialysis access patients, presented at the Society of Vascular Surgery’s Vascular Annual Meeting in June 2026, showing ATEV outperformed autologous arteriovenous (AV) fistula, the current standard of care. In V012, women receiving ATEV experienced an average of three more months without a dialysis catheter than women receiving AV fistula.

The company said V007 and V006, previously completed Phase 3 studies in male and female dialysis access patients, will provide additional efficacy and safety support for the submission. Humacyte noted ATEV remains investigational for dialysis access and other uses beyond its FDA-approved extremity vascular trauma indication.