Women on hemodialysis face a persistent challenge in vascular access: arteriovenous (AV) fistulas, the current standard of care, are more likely to fail to mature adequately in women than in men. When fistula maturation is delayed or unsuccessful, patients may remain dependent on central venous catheters, which are associated with an increased risk of infection and other complications.

New Phase 3 results from Humacyte, presented in June at the Society for Vascular Surgery's Vascular Annual Meeting in Boston, suggest a bioengineered blood vessel may offer another option for women at high risk of fistula maturation failure.

In the V012 trial, women who received Humacyte's acellular tissue engineered vessel (ATEV) averaged 220 catheter-free days during the first year, compared with 129 days among women who received a standard AV fistula, a difference of about 3 months (P = .00070). Infection rates were also lower with ATEV, at approximately one-quarter the rate observed with AV fistula, and none of the infections reported among ATEV recipients were attributed to the vessel itself. Based on the results, enrollment was terminated in accordance with the trial protocol after the prespecified primary superiority endpoint was met. Humacyte said it plans to seek FDA approval later this year for adults with end-stage kidney disease who are at high risk of AV fistula maturation failure.

Mohamad Hussain, MD, PhD, a vascular and endovascular surgeon-scientist at the Heart and Vascular Institute, Mass General Brigham, and associate professor of surgery at Harvard Medical School, was an investigator on the study. In an interview with HCPLive, Hussain discussed why AV fistulas are more likely to fail to mature in women, what the V012 findings could mean for patients, and how ATEV may expand vascular access options for patients at high risk of fistula failure if approved.

Q&A: Bioengineered Vessel Increases Catheter-Free Time in Women on Dialysis

Why Fistulas Fail to Mature More Often in Women

HCPLive: Why do AV fistulas fail to mature more often in women than in men?

Hussain: Women tend to have smaller blood vessels, including both the arteries that provide inflow and the veins used to create a fistula. Smaller vessels can result in lower blood flow and make successful fistula maturation more challenging. There are also likely biological factors at play, including hormonal and vascular differences, that may influence how blood vessels remodel after fistula creation, although we do not yet fully understand these mechanisms.

Testing the ATEV Against the Gold Standard

What did the V012 study evaluate, and how was it designed to test whether the ATEV could close this gap?

Hussain: The V012 trial asked an important and ambitious question: in women with advanced kidney disease who need vascular access for hemodialysis, can an ATEV perform better than an autogenous arteriovenous fistula, which has traditionally been considered the gold standard? The study directly compared ATEVs with fistulas in a randomized controlled trial, providing a rigorous way to determine whether the ATEV could improve outcomes in a population known to have higher rates of fistula maturation failure.

What 220 vs 129 Catheter-Free Days Means for Patients

Women who received the ATEV averaged 220 catheter-free days in the first year versus 129 days with a fistula. What does this finding show?

Hussain: For patients, this is a very meaningful finding. Women who received an ATEV were able to use their permanent dialysis access earlier and spent substantially less time dependent on a catheter. Reducing catheter exposure matters because catheters carry risks such as bloodstream infection and vein injury. It can also improve quality of life by removing many of the restrictions that come with having a catheter, whether that means being able to shower more easily, swim, or simply go about everyday life with fewer limitations.

A Quarter the Infection Rate, With None Tied to the Vessel

Infection rates were also lower with the ATEV, roughly a quarter that of fistula, with none tied to the vessel itself. What does this tell you about how the ATEV performs compared with the current standard?

Hussain: Infection is one of the most serious complications we worry about in dialysis access. It can result in loss of the access, hospitalization, sepsis, and even death. It is therefore very encouraging that there were no infections involving the ATEV itself in this trial. The ATEV is designed to become repopulated with the patient's own cells over time, which may contribute to its resistance to infection. Just as importantly, earlier use of the ATEV reduced the amount of time patients remained dependent on dialysis catheters, which may help reduce catheter-related infections and their associated morbidity.

Weighing a Higher Rate of Thrombotic Events

The study also showed a slightly higher rate of thrombotic events with the ATEV, though more resolved successfully. How does this affect the overall risk-benefit picture?

Hussain: Thrombosis is a known complication of non-autogenous dialysis access, so a higher rate compared with native fistulas is not entirely unexpected. The important point is that we have well-established, minimally invasive techniques to treat access thrombosis, and maintaining dialysis access often requires these types of interventions. In the trial, ATEV thrombosis could generally be treated successfully using standard techniques, allowing the access to remain usable. That needs to be weighed against the potential benefits of earlier access use, fewer catheter-dependent days, and lower infection risk when considering the overall risk-benefit profile.

What FDA Approval Could Mean in Practice

With Humacyte pursuing FDA approval later this year for patients at high risk of fistula maturation failure, what would this mean in practice, who stands to benefit most, and how might it change how clinicians approach access decisions for women on dialysis?

Hussain: If approved, I see the ATEV as potentially expanding the options available to patients who have a high likelihood of fistula maturation failure. That includes women, patients with small arteries or veins, patients with diabetes, and patients with obesity or deep vessels who may otherwise require multiple procedures before a fistula can be used. It may also be particularly valuable in patients at elevated risk for infection, such as those receiving immunosuppressive therapy or with a history of access infections.

Ultimately, vascular access should be individualized. Rather than assuming that a fistula is always the best first choice for everyone, the ATEV could give clinicians another option to match the right access to the right patient, particularly for women and others in whom we know traditional fistulas are less likely to succeed.
Editor’s Note: Hussain reports relevant disclosures with Humacyte and Venova.

References

1. Humacyte, Inc. Humacyte ATEV Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in Female Dialysis Access Patients. News release. Humacyte, Inc; June 10, 2026. Accessed August 17, 2026. https://www.globenewswire.com/news-release/2026/06/10/3310082/0/en/humacyte-atev-met-superiority-primary-endpoint-compared-to-standard-of-care-av-fistula-in-interim-analysis-of-v012-phase-3-study-in-female-dialysis-access-patients.html

2. Humacyte, Inc. 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. News release. Humacyte, Inc; June 15, 2026. Accessed August 17, 2026. https://www.globenewswire.com/news-release/2026/06/15/3311737/0/en/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-Meetin.html