Humacyte’s ATEV Improves Dialysis Access and Reduces Infections in Women

Humacyte has reported positive Phase 3 results from its V012 clinical trial (NCT05908084), showing that its Acellular Tissue Engineered Vessel (ATEV) significantly improved vascular access outcomes for women undergoing hemodialysis compared with traditional autologous arteriovenous (AV) fistulas.

The findings were presented at the Society for Vascular Surgery’s Vascular Annual Meeting in Boston and support the company’s plans to seek an expanded U.S. regulatory indication for the bioengineered vessel.

Addressing a Major Unmet Need

Patients with end-stage kidney disease who require hemodialysis depend on reliable vascular access to remove and return blood during treatment. The current standard approach involves creating an AV fistula, a surgical connection between an artery and vein. However, AV fistulas often fail to mature adequately, particularly in women, resulting in prolonged dependence on central venous catheters and a higher risk of infection.

Humacyte developed the ATEV as an off-the-shelf bioengineered human tissue vessel designed to provide a more durable vascular access option for patients at increased risk of fistula maturation failure.

Phase 3 Trial Meets Primary Endpoint

The randomized V012 Phase 3 trial evaluated the efficacy and safety of the ATEV compared with autologous AV fistulas in patients requiring vascular access for hemodialysis. The study achieved its primary superiority endpoint, demonstrating significantly greater catheter-free time among women treated with the bioengineered vessel.

Women receiving the ATEV remained free from catheter use for an average of 220 days during the first year after access creation, compared with 129 days for patients receiving AV fistulas. This translated into approximately three additional months without catheter dependence, a clinically meaningful benefit given the complications associated with long-term catheter use.

Reduced Infections and Improved Patency

The study also showed substantially lower infection rates among women treated with the ATEV. Infection incidence was approximately 6 infections per 100 patient-years compared with 23 infections per 100 patient-years among patients receiving AV fistulas. Notably, none of the infections reported in the ATEV group were linked to the implanted vessel itself.

The bioengineered vessel demonstrated benefits across multiple secondary efficacy measures. At six months, patients receiving the ATEV achieved significantly more catheter-free days than those treated with AV fistulas. Functional patency, a measure of how effectively the access site remains usable for dialysis, was also reported to be significantly higher over 12 months.

Secondary patency findings further supported the durability of the ATEV. At six months, secondary patency reached 87.5% compared with 65.0% for AV fistulas. At 12 months, secondary patency remained higher at 77.5% versus 62.5%, respectively.

Safety and Regulatory Outlook

Humacyte reported a comparable overall safety profile between treatment groups, with fewer serious adverse events observed among patients receiving the ATEV. No new safety concerns were identified.

“For too long, women on dialysis have had to settle for access options that often don’t work well for them,” said Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte. She noted that the study demonstrates the potential of the bioengineered vessel to keep patients off catheters longer while reducing infections.

Following achievement of the study’s primary endpoint, Humacyte announced that enrollment in V012 will conclude according to protocol while enrolled participants continue long-term follow-up.

The company plans to submit a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration in the second half of 2026 for adult patients with end-stage kidney disease who are at increased risk of AV fistula maturation failure.

What This Means for Patients

People receiving dialysis need a reliable way to move blood in and out of the body during treatment. Standard AV fistulas often do not develop properly, especially in women, which can lead to long-term use of dialysis catheters and a higher risk of infections. This study suggests that Humacyte’s laboratory-grown blood vessel may help patients spend more time without catheters, reduce infections, and provide more dependable access for dialysis treatment.

Reference

Humacyte’s Bioengineered Blood Vessel Outperforms the Standard of Care for Women on Dialysis in Phase 3 Results Presented at the Society for Vascular Surgery Vascular Annual Meeting | Humacyte, Inc.