Humacyte (HUMA) has announced that its Acellular Tissue Engineered Vessel (ATEV) has been awarded the Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA for its application in patients with advanced peripheral artery disease. Previously, the product was known as the Human Acellular Vessel (HAV), a term that has been replaced by ATEV.
While ATEV remains an investigational product and has not received approval for sale by any regulatory agency yet, this RMAT designation facilitates closer collaboration with the FDA. Additionally, it may lead to an expedited or priority review of a Biologics License Application.
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