BioCardia completed its clinical consultation process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) regarding application materials for the CardiAMP Cell Therapy System. This milestone advances the company toward submitting a marketing approval application for treating ischemic heart failure in Japan, one of the world's largest cardiovascular markets. The firm targets initiating treatment for the first patients and realizing commercial revenues in 2028. BioCardia develops cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases.
