Humacyte ATEV Delivers 91 More Catheter-Free Days Than AV Fistula
HUMA•Humacyte’s V012 Phase 3 study showed women on dialysis using its ATEV averaged 220 catheter-free days over 12 months versus 129 days with AV fistula (p=0.00070), plus six infections per 100 patient years vs. 23. The company will file a supplemental BLA in H2 2026.
1. V012 Phase 3 Study Outcomes
The V012 trial enrolled women on dialysis and met its primary endpoint, showing ATEV recipients averaged 220 catheter-free days over 12 months compared with 129 days for AV fistula recipients (p=0.00070). Enrollment will close following this superiority result, with ongoing follow-up per protocol.
2. Clinical Metrics and Safety Profile
ATEV patients experienced six infections per 100 patient years versus 23 for fistula, with no vessel-related infections or ruptures in the ATEV group. Secondary endpoints also favored ATEV: six-month catheter-free days of 88 versus 32 (p=0.00009), and 12-month functional patency of 250 versus 152 days (p=0.00057). Serious adverse events were lower for ATEV (1.73 vs. 4.77 events per patient year).
3. Regulatory Pathway and Upcoming Event
Humacyte plans to file a supplemental Biologics License Application in the second half of 2026 targeting adult end-stage kidney disease patients at high risk of AV fistula failure. The company will host an investor event on June 15 to discuss the Phase 3 results and anticipated commercial strategy.
