Benzinga | Sep 23, 2020 06:01AM EDT

Athersys Announces FDA Has Granted RMAT Designation To MultiStem Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome

ARDS program well-positioned for an expedited path to commercialization with RMAT and Fast Track designation

Athersys, Inc., a leading regenerative medicine company in late-stage clinical development, announced today that MultiStem(r) cell therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the acute respiratory distress syndrome (ARDS) program. The RMAT designation enables sponsors to work closely with the FDA and receive their guidance on expediting development of their products, including providing advice on generating the evidence needed to support approval in an efficient manner. RMAT designation invites the Company to schedule a Type B meeting with the FDA to discuss multidisciplinary strategic development plans, including expediting manufacturing development for commercialization to support priority review and/or accelerated approval.