OssDsign receives regulatory approval and prepares for launch in Japan

OssDsign AB (publ) today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval of OssDsign Cranial PSI for the Japanese market. OssDsign plans to launch OssDsign Cranial PSI in Japan together with a national distribution partner immediately following formal reimbursement approval which is expected within the next two quarters.As previously communicated, OssDsign has been pursuing a regulatory application in Japan since June 2019. The recent notice of regulatory approval from the PMDA is highly significant for OssDsign as the Japanese market for