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.
Cellusion Announces First Patient Transplanted iPSC-Derived Corneal Endothelial Cell Substitute (CLS001)
Cellusion, a Japanese regenerative medicine startup, and Minaris Regenerative Medicine, a global CDMO, announced Letter of Intent (LOI) for the manufacturing of CLS001 for a Corneal Endothelial Cell Regenerative therapy in the U.S.
ALLENDALE, NJ, USA and YOKOHAMA, Japan, October 04, 2022 / B3C newswire / -- Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., “Cellusion”), a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells (CECSi Cells) for bullous keratopathy novel treatment (PJ code: CLS001), and Minaris Regenerative Medicine, LLC (CEO: Hiroto Bando, Ph.D. MBA, “Minaris”), a leading global contract and development manufacturing organization (“CDMO”) and a member of Showa Denko Materials Co., Ltd. (CEO: Hidehito Takahashi, “Showa Denko Materials”), today announced Letter of Intent (“LOI”) of the Manufacturing of CLS001 for a Corneal Endothelial Cell Regenerative therapy in the United States.