Humacyte V012 Trial Results Accepted for ASN Presentation

The company will present late-breaking data from its V012 trial in Denver on October 22.

Updated on Oct. 12, 2026 in Stroke

Humacyte V012 Trial Results Accepted for ASN Presentation

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Humacyte received acceptance for a late-breaking oral presentation of its V012 Phase 3 trial results at the upcoming ASN Kidney Week 2026 conference. The study evaluates the effectiveness of acellular tissue engineered vessels compared to autogenous arteriovenous fistulas in female patients with end-stage kidney disease.

Why it matters

The study was specifically designed to address higher rates of fistula failure in women on dialysis, who are more likely than men to remain dependent on catheters. Data from this trial could support the expanded use of the company's investigational vessel technology for hemodialysis access.

The V012 study compares the performance of Humacyte's 6mm diameter acellular tissue engineered vessel against standard autogenous arteriovenous fistulas in female hemodialysis patients.

The players

Humacyte

This biotechnology company develops universal, off-the-shelf, acellular tissue-engineered products for vascular, reconstructive, and metabolic applications.

Prabir Roy-Chaudhury

He is the lead presenter for the V012 Phase 3 clinical trial results at the ASN Kidney Week conference.

ASN Kidney Week

This is a major annual scientific meeting focused on the latest research and clinical practices in nephrology.

The details

The oral presentation will feature data from the randomized controlled trial aimed at improving hemodialysis access for women. Humacyte intends to utilize these findings to support a supplemental Biologics License Application submission to the FDA later this quarter.

December 2024: The FDA approved Humacyte's ATEV for vascular trauma.
October 21-25, 2026: ASN Kidney Week 2026 takes place in Denver.
October 22, 2026: The late-breaking oral presentation of the V012 trial results is scheduled.
Q4 2026: Humacyte plans to submit a supplemental BLA to the FDA.

Health Landscape

The presentation of the V012 results marks the latest step in navigating the FDA's Biologics License Application process to broaden treatment indications. This expansion follows the company's existing authorization for vascular trauma, aiming to address critical gaps in hemodialysis care for female patients.

This development could eventually provide female dialysis patients with a more reliable alternative to traditional fistulas, potentially reducing long-term dependence on catheters. Clinical data remains under review, and the treatment is not yet cleared for general hemodialysis use.

The takeaway

The upcoming trial presentation provides a critical look at whether engineered vessels can improve access options for women undergoing dialysis. Patients should wait for full clinical results to understand how these findings might impact future standard-of-care treatments.

What happens next

Humacyte is scheduled to submit a supplemental Biologics License Application to the FDA during the fourth quarter of 2026 to seek approval for arteriovenous access indications.