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Humacyte's Human Acellular Vessel™ (HAV™) receives FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for urgent arterial repair following vascular trauma



May 4, 2023


  • HAV granted second RMAT designation by the FDA
  • RMAT will support Humacyte’s lead indication in Vascular Trauma

 

DURHAM, N.C., May 04, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, has been recently granted the U.S. Food and Drug Administration’s (FDA’s) Regenerative Medicine Advanced Therapy (RMAT) designation for its Human Acellular Vessel (HAV) for urgent arterial repair following extremity vascular trauma. The FDA’s RMAT designation is for breakthrough therapy of regenerative medicine. The designation allows for more interactions with the FDA and expedited development and review of regenerative medicine products within the U.S., including the potential for priority review process for a Biologics License Application (BLA). This is the second RMAT designation granted by the FDA for Humacyte’s HAV, in addition to a previous RMAT granted for arteriovenous (AV) access in hemodialysis.

 

“We are delighted to receive our second RMAT designation from the Food and Drug Administration,” said Dr. Cindy Cao, Chief Regulatory Officer at Humacyte. “The RMAT designation for the HAV in our lead indication of vascular trauma is an important milestone. This designation will further enhance our communication with the FDA and will provide us with a higher likelihood for an expedited review of our planned upcoming BLA filing."

 

Humacyte’s HAV is designed to be a universally implantable vascular conduit for use in vascular repair. Importantly, the HAV has shown a low rate of infection in clinical trials, making it well-suited for use in settings such as vascular trauma where wounds may be contaminated with foreign material. The HAV is designed to be available off-the-shelf and ready whenever surgeons need it, potentially saving valuable time and potentially improving patient outcomes in cases requiring urgent vascular repair, for both civilians and military personnel.

 

Humacyte is nearing the completion of enrollment in its Phase 2/3 V005 clinical trial of the HAV in the repair of civilian vascular trauma, a study that is being conducted at Level 1 Trauma Centers in the U.S. and Israel. Currently, a total of 66 patients have received the HAV in the V005 trial, including 49 patients comprising the primary endpoint population. Humacyte plans to file a BLA with the FDA later in 2023.

 

The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.