Humacyte's bioengineered vessel outperforms fistulas in Lancet Digital Health dialysis-access data
Humacyte announced on 19 August 2026 the publication of one-year results from its V007 Phase 3 clinical trial in The Lancet Digital Health.
The trial evaluated Humacyte's acellular tissue engineered vessel (ATEV) for haemodialysis access. The published results highlight the benefit of ATEV for patients at higher risk of fistula failure — including all women, and men with obesity and diabetes — groups in whom conventional arteriovenous fistulas frequently fail to mature. In these higher-risk subgroups, the off-the-shelf bioengineered vessel outperformed fistulas on access outcomes.
Humacyte plans a supplemental Biologics License Application for a second dialysis indication in the second half of 2026, after its V012 trial met its primary endpoint. ATEV is already the company's lead commercial product.
