BioCardia Completes Third Clinical Consultation with Japan's PMDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 16 2025
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BioCardia announces it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency, PMDA, on 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.
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Analyst Views on BCDA
Wall Street analysts forecast BCDA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BCDA is 15.50 USD with a low forecast of 6.00 USD and a high forecast of 25.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.300
Low
6.00
Averages
15.50
High
25.00
Current: 1.300
Low
6.00
Averages
15.50
High
25.00
No data
About BCDA
BioCardia, Inc. is a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. It is advancing two cell therapy platforms derived from bone marrow, such as CardiAMP autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia. Its immunomodulatory allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as a cell therapy for two clinical indications: the treatment of ischemic HFrEF (CardiALLO), which is actively enrolling, and acute respiratory distress syndrome. Its CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph vascular navigation product platforms.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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BioCardia Completes Third Clinical Consultation with Japan's PMDA for CardiAMP Therapy
- Clinical Consultation Progress: BioCardia has completed its third preliminary clinical consultation with Japan's PMDA, preparing for formal discussions on the CardiAMP therapy for heart failure, which could pave the way for new treatment options in the Japanese market.
- Efficacy Data Support: Data from three clinical trials indicate that CardiAMP therapy shows positive outcomes in improving survival rates and reducing major adverse cardiovascular events, highlighting its potential value in treating heart failure patients.
- Innovative Treatment Mechanism: The CardiAMP cell therapy utilizes the patient's own bone marrow cells delivered via a minimally invasive catheter procedure to repair microvascular dysfunction, offering a new therapeutic option for ischemic heart failure patients.
- Clear Regulatory Pathway: The PMDA has indicated that BioCardia can advance to formal clinical consultation, and if the data sufficiently supports safety and efficacy, it will facilitate the company's application for regulatory approval in Japan, further driving its expansion in the Asia-Pacific market.
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