BioCardia reports ‘positive’ outcome in consult with Japan’s PMDA for CardiAMP

BioCardia (BCDA) reported a positive outcome in its formal clinical consultation with Japan’s Pharmaceutical and Medical Device Agency, PMDA. PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Good alignment was achieved in the meeting on the acceptability of the foreign clinical data that has been developed in the United States, the indications for use in patients, the approach for introduction of the therapy in Japan, and the need for continued post marketing studies in Japan. The Company will await the minutes from PMDA to provide detailed feedback and timeline for potential filing.