Humacyte hits primary endpoint in Phase 3 dialysis access trial for women

Humacyte (NASDAQ:HUMA) announced positive top-line interim results from its V012 Phase 3 clinical trial evaluating its Acellular Tissue Engineered Vessel (ATEV) as a universally implantable conduit for hemodialysis access in female patients.

The Durham, North Carolina-based biotechnology platform company reported that a prespecified interim analysis of the first 80 randomized patients met the trial's primary endpoint.

Patients implanted with the bioengineered ATEV achieved an average of 220 catheter-free days during the first year of treatment, compared to 129 days for those who received an autologous arteriovenous (AV) fistula—the current standard of care.

This represent an average increase of 91 catheter-free days, yielding a strong statistical significance (p=0.00070).

Because the primary efficacy threshold was met early, study enrollment will terminate at the current 120 patients, and existing participants will complete their scheduled follow-up timelines.

Establishing reliable circulatory access is a persistent challenge for the nearly 500,000 Americans depending on hemodialysis.

While autologous AV fistulas (constructed from a patient's own native vein) are standard, they are highly prone to surgical maturation failure in female patients due to smaller average vessel anatomy, advanced age, and comorbidities.

This forces long-term reliance on central venous catheters, which carry severe risks of bloodstream infections and thrombosis.

The V012 trial data also demonstrated favorable secondary safety metrics.

Patients who received the ATEV incurred access-related infections at a rate of six per 100 patient-years, compared to a significantly higher rate of 23 per 100 patient-years in the AV fistula cohort.

Notably, zero access-associated infections were reported directly within the ATEV group, compared to three infections in the standard-of-care arm, with no instances of spontaneous tissue rupture recorded in either group.

Humacyte plans to file a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) during the second half of 2026, targeting adult end-stage kidney disease (ESRD) patients at high risk of fistula failure.

The asset is currently approved and marketed under the brand name Symvess for extremity vascular trauma following its initial FDA clearance in December 2024.

Outside of that acute arterial repair indication, the ATEV remains an investigational product.

Humacyte is scheduled to present the full V012 data package during the Society for Vascular Surgery’s Vascular Annual Meeting in Boston.