BioCardia Japan PMDA supports CardiAMP cell therapy submission for HFrEF; submission planned Q4 2026

BioCardia, Inc.

PMDA Consultation Record confirms alignment on remaining questions; positive outcomes credible.
Estimated 20,000 of 300,000 Japanese HFrEF patients initially eligible for CardiAMP therapy.
BioCardia plans PMDA submission in Q4 2026 with a Designated Marketing Authorization Holder.
Clinical data showed 179 sec average exercise tolerance improvement and 82% angina reduction.
PMDA requested additional details on GDMT compliance, revascularization ineligibility, and adverse events.

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