Humacyte Phase 3 ATEV trial in women meets primary endpoint
Humacyte has reported positive interim results from V012, its Phase 3 randomised controlled trial comparing its acellular tissue engineered vessel (ATEV) against arteriovenous fistula for haemodialysis access in women with end-stage kidney disease. The data were presented as a late-breaking oral at the American Society of Nephrology's Kidney Week 2026 in Denver.
The trial, the first randomised study designed specifically to test any haemodialysis access option against AV fistula in a female-only population, met its primary efficacy endpoint of superiority on catheter-free days. Women in the ATEV arm averaged 220 days free of catheters in the first 12 months, compared with 129 days for those who received an AV fistula, a difference of 91 days (p<0.001). Functional access was achieved in a median of 1.7 months with the ATEV versus 5.3 months with the fistula.
Trial design and safety
The prespecified interim analysis covered the first 80 of an intended 150 patients, randomised 1:1. Because the trial met its primary endpoint at interim, enrolment was halted. All participants were already receiving haemodialysis through a catheter and were assessed by their treating surgeons as suitable fistula candidates, which makes the maturation failure rate in the control arm particularly striking: only approximately 65% of AV fistulas achieved functional maturation by month 12, with maturation largely plateauing by month nine.
The safety profile was reported as comparable between arms. Dialysis access infections were notably lower in the ATEV group, at roughly six episodes per 100 patient-years against 23 per 100 patient-years for AV fistula. No ATEV-related infections or spontaneous ruptures were recorded.
Presenting author Prabir Roy-Chaudhury, a past president of the American Society of Nephrology and co-director of the University of North Carolina Kidney Center, said: "Every woman in this study was judged by her surgeon to be a candidate for a fistula, but more than a third of those fistulas failed to mature within a year in this study. In V012, women with the ATEV reached usable access months sooner and spent significantly less time on a catheter."
Regulatory path and market context
Humacyte has stated it plans to submit a supplemental Biologics Licence Application to the FDA this quarter to expand the Symvess label from its current approval in extremity vascular trauma to include AV access for haemodialysis. The V012 interim data, alongside two previously completed Phase 3 haemodialysis access trials, form the clinical package for that filing. The ATEV carries both RMAT designation and FDA Fast Track status in the haemodialysis indication.
The commercial opportunity is meaningful. Roughly 800,000 patients in the United States are currently on haemodialysis, and women represent a disproportionately high-risk subgroup for fistula failure, a problem that has been documented in the nephrology literature for over a decade but has attracted limited dedicated clinical trial investment until now. Several established synthetic grafts are already used when fistula creation fails, but Humacyte is positioning the ATEV as a biologically distinct alternative, on the basis that its acellular human tissue scaffold is colonised by host cells after implantation and may behave more like native vasculature over time.
The supplemental BLA outcome will determine whether Humacyte can broaden a commercial footprint that, at present, rests on a single approved trauma indication. Investors will also be watching for the full V012 dataset, including longer-term patency and adverse-event data beyond the 12-month interim window.