BioCardia provides Q3/Q4 2025 timelines for FDA and PMDA submissions for CardiAMP and Helix

BioCardia, Inc.

Helix DeNovo 510(k) submission to FDA planned for Q3 2025; based on >4,000 intramyocardial deliveries.
CardiAMP Cell Therapy FDA meeting request in Q4 2025 to discuss approval pathway using clinical data from three trials.
Japan PMDA clinical consultation for CardiAMP Cell Therapy expected mid Q4 2025; point-of-care platform already approved in Japan.
CardiAMP HF II trial actively enrolling at five US centers including Cleveland Clinic and Emory University.

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