ATEV - (V007)

August 19, 2026: Humacyte (NASDAQ: HUMA) announced publication in The Lancet Digital Health of one-year Phase 3 V007 results for its acellular tissue engineered vessel (ATEV) in arteriovenous access for hemodialysis. The randomized multicenter trial versus autogenous arteriovenous fistula (AVF) showed ATEV superiority after one year, particularly in all female patients and in male patients with obesity and diabetes, groups described as having higher AVF failure risk.

The company said the publication provides peer-reviewed validation of V007 and complements V012 Phase 3 data. It also highlighted positive two-year V007 results previously announced in November 2025 at ASN Kidney Week 2025, supporting durability over time.

For V012, Humacyte said top-line interim Phase 3 results were reported June 11, 2026 at the Society of Vascular Surgery’s Vascular Annual Meeting. V012 is focused on women with end-stage renal disease needing hemodialysis, and Humacyte said the study met its primary superiority endpoint.

Upcoming catalyst: Humacyte plans to submit a supplemental BLA in 2H 2026 to expand the Symvess label to a second indication, AV access for hemodialysis. The release notes ATEV is investigational for uses other than its FDA-approved extremity vascular trauma indication, approved in December 2024.