20 March 2017 - Humacyte announced today that the U.S. FDA has granted Humacyl, its investigational human acellular vessel, the regenerative medicine advanced therapy designation. 

This designation means that the FDA will help facilitate the efficient development and expedited review of the human acellular vessel for vascular access to patients in need of life-sustaining haemodialysis. 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.

Since receiving the FDA’s fast track designation in 2014, Humacyte has continued to develop clinical evidence indicating that Humacyl has the potential to address unmet medical needs for haemodialysis patients by decreasing vascular access complications, that in turn may result in more favourable morbidity and mortality outcomes. More than 400,000 people with end-stage renal disease undergo haemodialysis procedures to eliminate deadly toxins from blood when their kidneys fail. Alternative methods are needed to establish durable long-term vascular access for dialysis with infection rates, and other complications as low as possible, to help patients obtain better health care.

Read Humacyte press release