With the help of a quick response from the US FDA, Humacyte Inc. appears to have become the first company to receive a Regenerative Medicine Advanced Therapy (RMAT) designation from the agency for its investigational human acellular vessel Humacyl.
Although FDA is not able to explicitly confirm whether the RMAT designation was the first issued, Center for Biologics and Evaluation and Research (CBER) Director Peter Marks did point to Humacyte's March 20 announcement when testifying before the Senate HELP Committee March 21. Marks also authored an FDA Voice Blog