Humacyte

Humacyte receives FDA RMAT designation for Humacyl in vascular access for hemodialysis

Monday, March 27, 2017

Humacyte, an innovator in biotechnology and regenerative medicine, announced that the FDA has granted Humacyl, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate the efficient development and expedited review of the HAV for vascular access to patients in need of life-sustaining hemodialysis. Carved from the model of other FDA expedited programs such as Breakthrough Therapy, the RMAT designation is a new expedited program for regenerative medicine products.

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