BioCardia Collaborates with Japan PMDA on CardiAMP Clinical Data for Ischemic Heart Failure Approval
BioCardia, Inc. reports a positive consultation with Japan’s PMDA regarding their CardiAMP Cell Therapy for ischemic heart failure, indicating that clinical data is likely sufficient for market clearance. The meeting emphasized the acceptability of foreign clinical data and discussed the therapy’s introduction in Japan, alongside the necessity for post-marketing studies.
SUNNYVALE, Calif., April 20, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today 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.