Humacyte's bioengineered vessel has demonstrated superior performance compared to standard arteriovenous fistulas in high-risk hemodialysis patients, according to results from the company's pivotal Phase 3 clinical trial presented at the Society for Vascular Surgery Vascular Annual Meeting in New Orleans.
The CLN-PRO-V007 trial, a prospective, multicenter, two-arm, randomized controlled study, compared the efficacy and safety of Humacyte's acellular tissue engineered vessel (ATEV) against arteriovenous fistula (AVF) in end-stage kidney disease patients undergoing hemodialysis. The trial enrolled 242 patients, with 110 classified as high-risk for fistula non-maturation, defined as all females and males with a body mass index of 30 kg/m² or higher who also have diabetes.
Superior Outcomes in Challenging Patient Population
Dr. Mohamad A. Hussain from Brigham and Women's Hospital and Harvard Medical School presented the results, showing that ATEV demonstrated better functional patency, usability, and a comparable access-related complication profile compared to AVFs in the high-risk patient subgroup. The safety profile of ATEV was reported as comparable to AVF, with similarly low rates of infections.
"In our V007 trial, the ATEV was observed to have superior functional patency over the autologous fistula control group not only in the overall study population but in the important subgroups of women and men with diabetes and obesity," said Dr. Laura Niklason, President and CEO of Humacyte. "These two groups make up more than half of the dialysis access market and are historically underserved by the current standard of care, representing a clear unmet medical need."
Clinical Advantages and Trade-offs
The study revealed that patients treated with ATEV required fewer maturation and surgical revision procedures compared to those receiving AVF. However, the ATEV cohort experienced more thrombosis and stenosis events compared to AVF, though the majority of these complications were successfully treated.
AVF remains the preferred method for vascular access in hemodialysis patients when successful, as it reduces long-term catheter use and associated complications. However, women and patients with obesity and diabetes face higher risks of AVF maturation failure, meaning the fistula doesn't develop adequately for dialysis use, often resulting in prolonged catheter dependence and increased morbidity.
Regulatory Status and Market Potential
Humacyte's ATEV received FDA approval for vascular trauma indication in December 2024, marking the company's first commercial approval. The 6mm ATEV for arteriovenous 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.
The company estimates that the high-risk patient population represents a significant portion of the dialysis access market, with approximately 50% failure rate of standard of care in this group. Niklason noted that the efficacy and safety results in the subgroup, combined with this high failure rate, point to the potential of ATEV in addressing this underserved patient population.
Presentation Recognition
The presentation was one of only three selected for special mention by the Society of Vascular Surgery, highlighting the strength of the clinical data. The company expects to publish the complete V007 Phase 3 trial results in a major peer-reviewed medical journal in the near term.
For uses other than the FDA-approved extremity vascular trauma indication, ATEV remains an investigational product and has not been approved for sale by the FDA or other regulatory agencies.
