BioCardia, Inc. announced on July 24, 2025, that it submitted its CardiAMP autologous cell therapy investigational heart failure treatment for clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This marks a significant regulatory milestone.
The submission is a direct step towards discussing the approval pathway for CardiAMP Cell Therapy in ischemic heart failure in Japan. This engagement follows previous positive consultations with the PMDA.
The company anticipates an in-person meeting with PMDA in mid-Q4 2025 to discuss the clinical consultation. Alignment during this meeting could enable BioCardia to submit for approval of the CardiAMP system for market entry in Japan.
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