Humacyte's ATEV increases catheter-free days in women in Phase 3 dialysis trial
HUMA•Humacyte said interim Phase 3 V012 results showed its bioengineered vessel outperformed fistulas for dialysis access in women and met the primary endpoint. The findings support a planned FDA application this quarter to expand Symvess’ label to include dialysis access.
1. Trial meets endpoint
Interim results from Humacyte’s Phase 3 V012 trial showed its bioengineered vessel outperformed fistulas for dialysis access in women, meeting the primary endpoint. The results, presented October 22, 2026, showed faster usable access and less catheter dependence; safety was comparable to fistulas, with fewer dialysis access infections observed among vessel recipients. Enrollment stopped because the trial met its primary endpoint.
2. Planned FDA application
Humacyte said the findings support a planned FDA application this quarter to expand Symvess’ label to include dialysis access.
