Humacyte Presents Positive Phase 3 Results for ATEV™ in Hemodialysis Access

Humacyte, Inc. (Nasdaq: HUMA) has presented encouraging Phase 3 clinical results for its acellular tissue-engineered vessel (ATEV™) in hemodialysis access, demonstrating superior efficacy over the current standard of care, autogenous fistula, at six and 12 months. The findings, shared at the American Society of Nephrology’s Kidney Week 2024, highlight ATEV’s enhanced performance, especially in patient groups—female, obese, and diabetic patients—who historically face poorer outcomes with standard procedures.

Key Results

• Superior Primary Endpoints: ATEV achieved statistically significant improvements in both function and patency at six and 12 months versus autogenous fistula.
• Enhanced Outcomes in High-Need Subgroups: Female, obese, and diabetic patients treated with ATEV demonstrated better function, patency, and longer hemodialysis durations compared to those receiving a fistula.
• Study Parameters: The study followed 242 patients over 24 months, comparing ATEV’s functional and secondary patency with those of autogenous fistula, with ATEV outperforming on key metrics at both six and 12 months.

During the recent quarter, Humacyte reported a net loss of $56.7 million. To support ongoing operations and growth, the company raised approximately $30 million through a direct offering of common stock and warrants.

Dr. Mohamad A. Hussain of Brigham and Women’s Hospital, the study’s presenter, noted, “ATEV’s positive results in challenging subgroups signal a potentially game-changing option for patients with limited alternatives for hemodialysis access.”

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. Humacyte develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review. 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 6mm 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 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.