BioCardia announces PMDA acceptance of CardiAMP data for ischemic heart failure clearance in Japan

BioCardia, Inc.

PMDA determined CardiAMP safety/efficacy data likely sufficient for market clearance in ischemic heart failure.
Alignment reached on acceptability of US foreign clinical data, indications for use, and introduction approach.
Company will await formal minutes from PMDA for detailed feedback and filing timeline.
CEO Dr. Peter Altman states company on track for first minimally invasive biologic therapy approved in Japan.

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