ATEV V012

Oct. 23, 2026: Humacyte (NASDAQ: HUMA) reported positive prespecified interim Phase 3 V012 data for its acellular tissue engineered vessel (ATEV) in arteriovenous access for female hemodialysis patients with end-stage kidney disease, presented at ASN Kidney Week 2026 on Oct. 22. In the first 80 randomized patients, ATEV met the primary endpoint of superiority on catheter-free days through 12 months: 220.4 vs 129.3 days for AV fistula (91.1 more days; p<0.001). Median time to functional access was 1.7 months with ATEV vs 5.3 months with AV fistula. About 65% of AV fistulas achieved functional maturation by Month 12, with maturation largely plateauing by Month 9.

The safety profile was described as comparable to AV fistula; dialysis access infections were about 6 per 100 patient-years with ATEV vs 23 per 100 patient-years with AV fistula, with no ATEV-related infections and no spontaneous ruptures in either group. Because the trial met its primary endpoint, enrollment was stopped.

Humacyte said these V012 results, together with two previously completed Phase 3 hemodialysis access trials, support a planned supplemental BLA to expand the Symvess label to include AV access for hemodialysis, targeted for FDA submission this quarter.