BioCardia Announces Positive Preliminary Clinical Consultation with Japan Pharmaceutical and Medical Device Agency on Cell Therapy for Ischemic Heart Failure
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
SUNNYVALE, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has had a positive preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on the CardiAMP Heart Failure Trial results previously provided to the agency. The meeting was held in preparation for the formal clinical consultation on acceptability of the clinical data for submission of an application for approval. PMDA requested additional details including clarification on positioning of the prespecified composite endpoints, background on statistical power, clinical rationale for the NTproBNP subgroup and their risk-benefit profile, anticipated target number of patients in Japan, and clinical development status in the United States. BioCardia is completing responses to their questions and anticipates formal clinical consultation near
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BCDA
Analyst Actions
- 9/22/25 - HC Wainwright
BCDA
Sec Filings
- 12/3/25 - Form 8-K
- 11/24/25 - Form 8-K
- 11/12/25 - Form 8-K
- BCDA's page on the SEC website