Humacyte (HUMA) said Acellular Tissue Engineered Vessel or ATEV has been granted the FDA's Regenerative Medicine Advanced Therapy designation for patients with advanced peripheral artery disease. It was previously announced that, the common name Acellular Tissue Engineered Vessel or ATEV replaced the term Human Acellular Vessel or HAV previously used for the engineered vessel product candidate.
The ATEV is an investigational product and has not been approved for sale by any regulatory agency. The company noted that the designation allows for close interactions with the FDA and potentially an expedited/priority review of a Biologics License Application.
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