BioCardia gets positive PMDA preliminary consultation on CardiAMP HF trial for Japan approval

BioCardia, Inc.

Positive preliminary PMDA consultation on CardiAMP Heart Failure Trial data; formal clinical consultation expected by year-end 2025.
PMDA requested clarifications on composite endpoints, statistical power, NTproBNP subgroup risk-benefit, Japan target patient count, and US development status.
BioCardia completing responses to PMDA questions; 178 ischemic HF patients across three trials under review.
Focus on autologous cell therapy for patients with few therapeutic options, per CEO Peter Altman.

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