Posted by Michael Wonder on 12 May 2017
Vericel receives FDA regenerative medicine advanced therapy designation for ixmyelocel-T for the treatment of advanced heart failure due to ischaemic dilated cardiomyopathy
10 May 2017 - Ixmyelocel-T is the first therapy to receive the RMAT designation for the treatment of a serious cardiovascular disease.
Vericel Corporation today announced that the U.S. FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation for ixmyelocel‑T, an investigational product for the treatment of patients with advanced heart failure due to ischaemic dilated cardiomyopathy.
The RMAT designation is a new expedited program established under the 21st Century Cures Act to foster the development and approval of regenerative medicine products intended for the treatment of serious diseases and conditions.
