Humacyte ATEV Receives FDA Regenerative Medicine Advanced Therapy Designation for Advanced PAD

July 1, 2024—Humacyte, Inc. has been granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational acellular tissue engineered vessel (ATEV) for treatment of patients with advanced peripheral artery disease (PAD). Additionally, the FDA cleared an Investigational New Drug (IND) application for the PAD indication for the ATEV.

Formerly referred to as HAV (human acellular vessel), Humacyte’s ATEV has received previous RMAT designations for vascular trauma repair and arteriovenous access in hemodialysis.

According to Humacyte, the ATEV is intended to be a universally implantable vascular conduit for use in vascular replacement and repair. The company stated that the ATEV has been observed to have a low rate of infection in clinical trials and is designed to be available off the shelf and ready for use whenever surgeons need it.

The company noted that the ATEV has been evaluated in two phase 2 studies in PAD, with patients followed for up to 6 years. In addition, the Mayo Clinic in Rochester, Minnesota, is conducting a study in approximately 30 patients with chronic limb-threatening ischemia under an investigator IND cleared by the FDA. All patients treated with the ATEV for PAD to date have not had autologous vein available for revascularization; hence, the ATEV may represent a therapeutic alternative for such patients, stated Humacyte.

In September 2023, the company announced the presentation of findings from ATEV studies.

The company advised that the FDA’s RMAT designation is designed to provide pathways for expedited development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. The designation allows for close interactions with FDA and potentially an expedited/priority review of a biologics license application, stated Humacyte.