SanBio Granted Regenerative Medicine Advanced Therapy Designation from the U.S. FDA for SB623 for the ...
(World News USA)

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Sep 19, 2019-- The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(TOKYO:4592), a scientific leader in regenerative medicine for neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation for SB623 cell therapy for the treatment of chronic neurological motor deficits secondary to traumatic brain injury (TBI). The designation is based on clinical results of SB623 including the Phase 2 Study of Modified Stem Cells in Traumatic Brain Injury (STEMTRA) trial. Created under the 21st Century Cures Act, the RMAT designation is reserved for a regenerative...