ATEV - (V007)

October 12, 2026: Humacyte (NASDAQ: HUMA) said interim results from the Phase 3 V012 trial of its acellular tissue engineered vessel (ATEV) have been accepted for a late-breaking oral presentation at ASN Kidney Week 2026. V012 is a randomized controlled trial comparing ATEV versus autogenous arteriovenous fistula for hemodialysis access in female patients with end-stage kidney disease.

The presentation, titled “Randomized Controlled Trial of an Acellular Tissue Engineered Vessel vs. Arteriovenous Fistula for Hemodialysis Access in Female Patients with ESKD: A Phase 3 CLN-PRO-V012 Interim Analysis,” is scheduled for October 22, 2026, 4:40–4:50 PM MT in Denver, with Prabir Roy-Chaudhury, M.D., Ph.D., presenting.

No efficacy or safety data are disclosed in the release. Humacyte said V012 results, together with two previously completed Phase 3 hemodialysis access trials, will support a planned supplemental BLA to expand the Symvess label to include AV access for hemodialysis, with FDA submission targeted this quarter.

The company also noted that ATEV is investigational for uses other than its already approved vascular trauma indication, and that the BLA for ATEV in vascular trauma was approved by FDA in December 2024.