Humacyte, Inc. (Nasdaq: HUMA) announced that its late-breaking abstract regarding the V007 Phase 3 clinical trial of its acellular tissue engineered vessel (ATEV™) for arteriovenous (AV) access in patients with end-stage renal disease (ESRD) has been selected for oral presentation at the American Society of Nephrology’s (ASN) Kidney Week 2024. The presentation, titled "Prospective Randomized Trial of Humacyte’s Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access," will take place on October 26, 2024, in San Diego.
The study evaluates the ATEV compared to the current standard of care, autologous arteriovenous fistula, for hemodialysis access. The primary endpoint likely focuses on the patency and functionality of the ATEV in facilitating hemodialysis, a critical procedure for patients with ESRD.
Dr. Mohamad A. Hussain, a vascular and endovascular surgeon-scientist at Brigham and Women’s Hospital and Assistant Professor of Surgery at Harvard Medical School, will present the findings. The session, titled "High-Impact Clinical Trials - 2," suggests the trial's potential significance in the field of nephrology and vascular surgery.
Humacyte's ATEV represents a novel approach to creating vascular access for hemodialysis. Traditional AV fistulas require a surgical connection between an artery and a vein in the patient's arm, which can take time to mature and may not be suitable for all patients. The ATEV, as a bioengineered vessel, offers a potential off-the-shelf solution that could provide more immediate and reliable access.
Humacyte anticipates releasing additional information from the oral presentation in a future press release. The ATEV is currently an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
