BioCardia submits CardiAMP cell therapy for PMDA clinical consultation in Japan

BioCardia, Inc.

Submitted clinical data package including full CardiAMP HF trial results and STED to Japan's PMDA on July 24, 2025.
Consultation seeks PMDA alignment on efficacy, safety, target patient population, and positioning in heart failure care.
Positive PMDA feedback could enable BioCardia to submit for market approval in Japan.
CEO expects potential post-marketing study in Japan next year if regulatory pathway is cleared.

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