– Positive results from the V012 Phase 3 study were presented at the Society for Vascular Surgery’s Vascular Annual Meeting in Boston
– Women who received Humacyte’s ATEV experienced an average of three more months without a dialysis catheter than women who received AV fistula, the current standard of care
– Company held investor event June 15th; replay available
On June 15, 2026, Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology company that develops bioengineered human tissues, presented detailed results from its V012 Phase 3 study showing that the Company’s bioengineered blood vessel – the acellular tissue engineered vessel, or ATEV – outperformed autologous arteriovenous (AV) fistula, the current standard of care, for women on dialysis. The results were presented at a Women’s Health seminar during the Society for Vascular Surgery’s (SVS’s) Vascular Annual Meeting (VAM) in Boston. “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. “This study shows that our bioengineered blood vessel can keep patients off catheters longer than the current standard of care, with fewer infections. That is a meaningful difference for patients, and we look forward to using this data to file a supplemental BLA with the FDA later this year.”
“Every day a patient spends on a catheter is a day at higher risk of infection,” added Shamik Parikh, MD, Chief Medical Officer of Humacyte. “Giving women an average of three more months without a catheter is exactly the kind of improvement these patients need. The Phase 3 results we shared at VAM tell a clear, compelling, and consistent story.”
Patients on dialysis need a reliable, long-lasting connection to their bloodstream so a machine can draw out blood, clean it, and return it. The most common approach today is an AV fistula, a connection a surgeon creates between an artery and a vein. But AV fistulas often fail to develop the way they should, especially in women. When that happens, patients rely on catheters, tubes placed in the body that carry a high risk of infection.
In the V012 study, women who received the ATEV were able to avoid catheter use three months longer than women who received the standard of care. Over the first year, women with the ATEV averaged 220 days free of a catheter, compared with 129 days for women who received an AV fistula, and the difference was statistically significant (p=0.00070). Infections were also less common in patients receiving the ATEV: patients had about 6 infections per 100 patient years, compared with 23 per 100 patient years for patients who received an AV fistula. None of the infections in the ATEV group were tied to the blood vessel itself, compared with three in the fistula group, and no ruptures occurred in either group.
“Fistulas often fail to develop in women, which forces too many patients to rely on catheters and risk the infections that often come with them,” said Mohamad A. Hussain, MD, PhD, a vascular and endovascular surgeon-scientist at Heart and Vascular Institute, Mass General Brigham, and Associate Professor of Surgery at Harvard Medical School. “An option that is ready to use off the shelf and that keeps patients off catheters will fill a real gap in how we care for these patients today.”
In V012 the ATEV was also observed to have consistent advantages over AV fistula in the secondary efficacy endpoints for the study. Six-month catheter-free days averaged 88 days for ATEV compared to 32 days for AV fistula (p=0.00009). Functional patency over 12 months averaged 250 days for ATEV compared to 152 days for AV fistula (p=0.00057). Six-month secondary patency was 87.5% for ATEV compared to 65.0% for AV fistula (p=0.0013). Twelve-month secondary patency was 77.5% for ATEV compared to 62.5% for AV fistula (p=0.16).
“Time on a catheter is time at risk, so keeping patients catheter-free for longer really matters,” added Young M. Erben, MD, a vascular surgeon at Mayo Clinic in Jacksonville, Florida, and Professor of Surgery at Mayo Clinic College of Medicine and Science. “A dependable, readily available access option could be especially valuable for women and others who are not good candidates for a fistula.”
The safety profile in both groups was comparable, with the ratio of all adverse events reported below adjusted for patient years of use. Serious adverse events were 1.73 for ATEV compared to 4.77 for AV fistula. Adverse events of special interest (AESI) were 2,71 for ATEV compared to 3.88 for AV fistula. Within AESIs, thrombotic events were 0.75 for ATEV compared to 0.51 for AV fistula, and 75.0% of ATEV thrombosis cases successfully resolved compared to 37.5% for AV fistula. Stenotic events were 1.62 for ATEV compared to 2.29 for AV fistula.
In accordance with the study protocol, as a result of meeting the primary superiority endpoint of catheter-free days, study enrollment will terminate and existing patients will continue to be followed as per protocol. Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026. The currently planned target indication is focused on adult patients with end-stage kidney disease who are at increased risk of AV fistula maturation failure.
Humacyte hosted an investor event June 15, 2026 to discuss the V012 Phase 3 results and what they mean for patients. A replay is available by clicking here.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6 mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6 mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Humacyte is a Duke University start-up out of the lab of Dr. Laura Niklason (formerly Anesthesiology, School of Medicine), co-founded with Drs. Juliana Blum and Shannon Dahl. It went public in 2021.