Humacyte Announces Phase 3 V012 Trial Results for ATEV in Women Requiring Hemodialysis Access Accepted for a Late-Breaking Session Presentation at ASN Kidney Week 2026
Globe Newswire•12/10/2026•08:00 ET
0
Key Highlights
- ➤V012 Phase 3 interim results accepted for ASN Kidney Week late-breaking oral presentation
- ➤V012 randomizes female ESKD patients to ATEV versus autogenous arteriovenous fistula
- ➤Supplemental BLA for Symvess AV hemodialysis access targeted for FDA submission this quarter
- ➤V012 results plus two completed Phase 3 trials underpin planned label expansion
Expert Statements
Laura Niklason, Founder, President and Chief Executive Officer of Humacyte
“Women on dialysis are more likely than men to experience fistula failure and to remain dependent on catheters”
Laura Niklason, Founder, President and Chief Executive Officer of Humacyte
“V012 was built to test whether the ATEV can offer a better option for these patients, and we look forward to Dr. Roy-Chaudhury sharing the Phase 3 results with the nephrology community at ASN Kidney Week.”
- Interim Phase 3 findings will be presented in a prestigious late-breaking oral session at the leading meeting for kidney health professionals.
– Randomized trial compares the acellular tissue engineered vessel (ATEV) with autogenous arteriovenous fistula in female patients with end-stage kidney disease.
Get started
Create a free account to read the full story.