Humacyte's Bioengineered Blood Vessel Beats the Standard AV Fistula in Phase 3 Dialysis Trial, Adding 91 Catheter-Free Days for Women
An interim analysis of Humacyte's V012 Phase 3 trial found its acellular tissue engineered vessel gave women on dialysis 220 catheter-free days versus 129 for an AV fistula.
Overview
Humacyte’s lab-grown blood vessel outperformed the surgical standard of care in an interim analysis of a Phase 3 dialysis-access trial, the company announced. According to the company’s press release, women on dialysis who received the acellular tissue engineered vessel (ATEV) achieved an average of 220 catheter-free days compared with 129 catheter-free days for patients who received an arteriovenous (AV) fistula, the current standard of care. The difference of 91 days was statistically significant (p=0.00070).
The result, drawn from the company’s V012 study, was scheduled for presentation the evening of June 11, 2026 at the Society for Vascular Surgery’s Vascular Annual Meeting in Boston, in the Women’s Health seminar, the company said.
What We Know
The ATEV is an acellular tissue engineered vessel — a blood vessel grown in the laboratory from human cells that are then washed away, leaving a vessel that is implanted into the patient, according to Humacyte. The same product already carries an FDA approval: the agency cleared Humacyte’s Biologics License Application for the ATEV in the vascular injury indication in December 2024, as the company noted. The V012 trial is aimed at a separate use: vascular access for hemodialysis.
The interim analysis covered the first 80 patients enrolled in the study — 40 who received the ATEV and 40 who received an AV fistula, according to a summary of Humacyte’s filing. The study currently has 120 patients enrolled and is designed to enroll up to 150, the company said. The trial enrolled women with end-stage kidney disease, a population Humacyte describes as adult patients at increased risk of AV fistula maturation failure, per BioSpace.
Beyond the primary endpoint, the interim analysis reported gains across several secondary measures. At six months, ATEV patients accrued 88.4 catheter-free days versus 32.3 for the fistula group (p=0.00009), and 12-month functional patency reached 250.1 days for the ATEV versus 151.7 days for the fistula (p=0.00057), according to the filing summary. Six-month secondary patency was 87.5% for the ATEV versus 65.0% for the fistula (p=0.0013). One secondary measure did not reach significance: 12-month secondary patency was 77.5% for the ATEV versus 62.5% for the fistula (p=0.16), the same summary reported.
On safety, infections were less frequent in the ATEV arm. The infection rate was six per 100 patient-years for the ATEV compared with 23 per 100 patient-years for the AV fistula, according to Humacyte. In absolute terms, there were zero access-associated infections in the ATEV group versus three in the AV fistula group, and no spontaneous ruptures were reported in either group, according to BioSpace.
Shamik Parikh, MD, Humacyte’s Chief Medical Officer, framed the headline result in clinical terms: “Patients receiving an ATEV had an average of three months additional catheter-free time as compared to AV fistula, a highly significant outcome,” he said.
Because the trial met its primary endpoint at the interim analysis, Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026, the company said.
What We Don’t Know
The announced results come from an interim analysis of a single trial restricted to female patients, and the data have been disclosed through a company press release and conference presentation rather than a peer-reviewed publication. The full study results across all enrolled patients, and detailed peer review of the secondary endpoints, are not yet available. One secondary endpoint — 12-month secondary patency — did not reach statistical significance, and the longer-term durability of the catheter-free advantage beyond the reported follow-up window has not been established. Humacyte has not disclosed a precise filing date or an FDA decision timeline beyond its stated plan to submit a supplemental BLA in the second half of 2026.