BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
SUNNYVALE, Calif., Dec. 16, 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 completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan. “Our autologous minimally invasive cell therapy presents a new mechan
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- BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure CongressGlobeNewswire
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- BioCardia, Inc. (BCDA) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
BCDA
Analyst Actions
- 9/22/25 - HC Wainwright
BCDA
Sec Filings
- 12/16/25 - Form 8-K
- 12/10/25 - Form 4
- 12/10/25 - Form 4
- BCDA's page on the SEC website