Humacyte’s ATEV Receives FDA Designation for PAD Treatment, Stock Soars 24%

Humacyte, Inc. (Nasdaq: HUMA) has announced significant regulatory progress for its Acellular Tissue Engineered Vessel (ATEV), receiving the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for treating advanced Peripheral Artery Disease (PAD). This marks the third RMAT designation for ATEV, reflecting its potential in various medical applications.

Key Highlights:

• FDA RMAT Designation: Humacyte’s ATEV has received its third RMAT designation for use in patients with advanced PAD, facilitating expedited development and potential faster review of the therapy.
• Clinical Progress: The FDA has also cleared a new Investigational New Drug (IND) application for ATEV in PAD, advancing it further in the clinical trial process.
• Potential Impact: ATEV is designed to be a universally implantable vascular conduit, which could significantly enhance patient outcomes, especially for those who lack suitable veins for revascularization procedures.

Dr. Cindy Cao, Chief Regulatory Officer at Humacyte, expressed her enthusiasm: “We are very pleased to receive our third RMAT designation from the Food and Drug Administration. The RMAT designation we previously received in our lead indication of vascular trauma was very helpful in enhancing our communication with the FDA review team during the filing and review of our BLA. We are excited that this additional designation has been granted in advanced PAD, as we expect that it will further strengthen our communication with the FDA and expedite the development of our ATEV in this important indication.”

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 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 is currently under review by the FDA and was granted Priority Review with a PDUFA date of August 10, 2024. 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 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. For more information, visit www.Humacyte.com.