BioCardia Announces Completion Of Process With Japan's Pharmaceuticals And Medical Devices Agency Seeking Regulator Nod For Its CardiAMP Cell Therapy system To Treat Ischemic Heart Failure

BioCardia®, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has completed the process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) concerning the application materials required to obtain regulatory approval in Japan for its CardiAMP Cell Therapy System ("CardiAMP") for the treatment of ischemic heart failure.

This milestone represents significant progress toward regulatory approval and commercialization of CardiAMP in Japan, one of the world's largest and most sophisticated cardiovascular medical device markets and a country at the forefront of regenerative medicine, including induced pluripotent stem (iPS) cell therapies.