Humacyte says Phase 3 V012 trial shows ATEV extends catheter-free dialysis time in women - HUMA News | RalliesHumacyte says Phase 3 V012 trial shows ATEV extends catheter-free dialysis time in women
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HUMA• Phase 3 V012 results and planned supplemental filing
- Humacyte set a November 2026 supplemental BLA filing to expand its ATEV into dialysis access, following FDA discussions.
- Clinical results were already presented in June 2026, highlighting improved access durability for women versus standard-of-care fistula.
- The filing package will also draw on completed Phase 3 studies in broader dialysis-access populations, supporting efficacy and safety for the new use.
- The move targets a second U.S. indication for ATEV, following its December 2024 FDA clearance in vascular trauma.
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