Humacyte, Inc. (Nasdaq: HUMA) announced the presentation of positive Phase 3 clinical trial results for its acellular tissue engineered vessel (ATEV) at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH) in New York, NY on November 23, 2024. The study compared the efficacy and safety of Humacyte's ATEV with autologous arteriovenous (AV) fistulas in patients with end-stage renal disease requiring hemodialysis access.
Phase 3 Trial Details
The presentation, titled "Results of a Phase 3 Study Comparing Efficacy and Safety of Humacyte Tissue-Engineered Vessel with Autologous AV Fistulas in Patients with End Stage Renal Disease," was delivered by Dr. Charles Keith Ozaki, MD, a vascular surgeon and Director of Vascular Surgery Research at Brigham and Women’s Hospital and John A. Mannick Professor of Surgery at Harvard Medical School.
The trial focused on patients with end-stage renal disease, a population that often faces challenges in establishing and maintaining reliable vascular access for hemodialysis. AV fistulas are the preferred method, but their creation and maintenance can be problematic for many patients.
Humacyte's ATEV: A Novel Approach
Humacyte's ATEV represents a novel approach to vascular access. It is a bioengineered human tissue designed to be universally implantable, potentially overcoming the limitations of autologous vessels. The ATEV is currently under review by the FDA for vascular trauma repair and is being investigated for other vascular applications, including peripheral artery disease and coronary artery bypass grafts.
The 6mm ATEV for AV access in hemodialysis has received Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation from the FDA, underscoring its potential to address significant unmet needs in this patient population. The ATEV has also received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.
Humacyte is also conducting preclinical development in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications.
