Humacyte’s ATEV granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD

Acellular tissue engineered vessel

Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT designation was granted at the same time as the FDA cleared a new Investigational New Drug (IND) application for the PAD indication for ATEV, formerly referred to as the human acellular vessel (HAV).

According to Humacyte, this is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and arteriovenous (AV) access in haemodialysis.

“We are very pleased to receive our third RMAT designation from the Food and Drug Administration,” said Cindy Cao, chief regulatory officer at Humacyte. “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 [Biologics License Application]. 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.”

A press release notes that Humacyte’s ATEV is designed to be a universally implantable vascular conduit for use in vascular replacement and repair. Importantly, 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 whenever surgeons need it, potentially saving valuable time and improving patient outcomes.

The ATEV has been evaluated in two Phase 2 studies in PAD, with patients followed for as long as six years. In addition, The Mayo Clinic in Rochester, USA, is conducting a study in approximately 30 patients with chronic limb-threatening ischaemia (CLTI) 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 revascularisation, and hence the ATEV may represent an important therapeutic alternative for such patients.

Humacyte advises that the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.


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