V012 Trial Results Set for Presentation in Denver
New findings on engineered blood vessels for dialysis access will be shared with the medical community in Denver.
Updated on Oct. 12, 2026 in Stroke
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Humacyte has received acceptance for a late-breaking presentation of its V012 Phase 3 clinical trial results at the upcoming ASN Kidney Week 2026. The presentation will detail findings from the trial, which focuses on comparing acellular tissue engineered vessels (ATEV) to standard fistulas in female patients with end-stage kidney disease.
Why it matters
Women undergoing dialysis currently face a higher likelihood of fistula failure compared to men, often leading to continued reliance on catheters. This trial aims to address these access challenges, potentially offering a new standard for hemodialysis care.
The V012 randomized controlled trial assesses the performance of Humacyte's acellular tissue engineered vessels against traditional autogenous arteriovenous fistulas. The results, currently preliminary, specifically target the population of female patients experiencing end-stage kidney disease.
The players
Humacyte
A regenerative medicine company developing acellular tissue-engineered products for vascular repair and replacement.
Prabir Roy-Chaudhury
A researcher specializing in nephrology and dialysis access who is the lead presenter for the V012 trial findings.
The details
The study evaluates an investigational 6mm acellular tissue engineered vessel designed to serve as an alternative to autogenous arteriovenous fistulas for hemodialysis access. By replacing traditional fistula creation with this engineered vessel, researchers hope to overcome the anatomical and physiological barriers that often cause higher failure rates in women requiring long-term dialysis access.
Timeline
December 2024: FDA approved the ATEV for vascular trauma.
October 21-25, 2026: ASN Kidney Week 2026 conference dates.
October 22, 2026: Late-breaking oral presentation of V012 trial results.
Q4 2026: Planned submission of supplemental BLA to the FDA.
Health Landscape
This development follows the trajectory of innovation presented annually at ASN Kidney Week 2026, where new vascular access technologies are introduced to the field. It marks a critical step toward potentially expanding the FDA-approved use of acellular vessels beyond existing vascular trauma indications.
If you or a loved one are managing end-stage kidney disease and hemodialysis, it is worth discussing these evolving access options with your nephrologist. As new technologies move toward FDA review, your care team can help you understand how these developments might eventually fit into your treatment plan.
The takeaway
The V012 trial results reflect a focused effort to address the distinct anatomical challenges women face in maintaining reliable dialysis access. Patients interested in future treatment innovations should monitor updates regarding the upcoming FDA supplemental application for arteriovenous access indications.
What happens next
Humacyte intends to submit a supplemental Biologics License Application to the FDA during the fourth quarter of 2026 to expand the label for its product, Symvess, to include hemodialysis arteriovenous access.
Further reading
For more information on vascular health developments, visit our Stroke section.
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