Cellusion Receives U.S. FDA Orphan Drug Designation for CLS001

TOKYO--(BUSINESS WIRE)--Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., “Cellusion”), a deep tech start-up developing a novel cell therapy, announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to our regenerative medicine product “iPS cell-derived corneal endothelial cell substitute” (“CLS001”) for the treatment of bullous keratopathy. FDA grants ODD if the drug meets specific criteria, the treatment, diagnosis, or prevention of rare diseases tha