1. BioCardia completed a third consultation with Japan's PMDA regarding CardiAMP therapy. 2. PMDA may allow submission for regulatory approval in Japan pending formal discussions. 3. CardiAMP shows improved outcomes in heart failure patients from prior clinical trials. 4. Therapy uses autologous cell treatment to enhance heart function and quality of life. 5. Ongoing regulatory discussions in Japan and the U.S. support CardiAMP's development.
FAQ
Why Bullish?
The approval process in Japan can positively impact BCDA’s stock, similar to past FDA approvals for breakthrough therapies. Successful consultations indicate strong regulatory alignment and potential market expansion.
How important is it?
The progress in regulatory discussions for CardiAMP could significantly influence BCDA's market perception and investor confidence.
Why Long Term?
Regulatory approvals can take time, but establish a foundation for future revenues. Evidence from successful trials will take time to translate to market performance.
BioCardia Advances CardiAMP Cell Therapy for Heart Failure to Formal Clinical Consultation with Japan PMDA
Published on: December 16, 2025
Source: GlobeNewsWire
Key Developments Surrounding BCDA's CardiAMP Cell Therapy
BioCardia®, Inc. [NASDAQ: BCDA], a leading innovator in cellular therapeutics for cardiovascular and pulmonary ailments, has made significant strides in the potential approval of its CardiAMP Cell Therapy for Heart Failure with Reduced Ejection Fraction (HFrEF). The company has completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA), positioning itself for a formal consultation on the acceptability of its clinical data for regulatory submission.
Progression to Formal Clinical Consultation
The latest discussions with PMDA have granted BioCardia the opportunity to advance to a formal clinical consultation. This pivotal step could lead to the company seeking regulatory approval in Japan, contingent upon the PMDA's agreement regarding the safety and efficacy data of the CardiAMP Cell Therapy.
CEO Peter Altman's Insights
“Our autologous minimally invasive cell therapy presents a new mechanism of action of microvascular repair for ischemic heart failure patients evidencing active heart failure while on guideline directed medical therapy who have few additional therapeutic options,” states Dr. Peter Altman, BioCardia’s CEO.
Dr. Altman emphasized that the outcomes from completed Phase I, II, and III trials indicate substantial clinical efficacy, highlighting improved survival rates and reduced major adverse cardiovascular events alongside enhancements in heart function and quality of life metrics as compared to control patients.
Clinical Evidence of CardiAMP Cell Therapy
The support for the CardiAMP Cell Therapy currently rests on robust clinical data encompassing three major trials demonstrating a favorable benefit-risk profile:
- Phase 1: TABMMI Heart Failure Trial (n=20) - 90% patient survival at three years; LVEF improved by 7%.
- Phase 2: TACHFT Trial (n=33) - 100% survival at one year; MACE reduced by 20% and quality of life significantly improved.
- Phase 3: CardiAMP HF Trial (n=125) - Indications of improved heart function and quality of life on top of standard medical therapy.
About CardiAMP Autologous Cell Therapy
CardiAMP Cell Therapy employs a patient's own bone marrow cells delivered to the heart through a minimally invasive catheter-based approach, aimed at increasing capillary density and reducing myocardial tissue fibrosis to rectify microvascular dysfunction. This therapy has received FDA Breakthrough designation and has garnered support from the Maryland Stem Cell Research Fund, with reimbursement from Centers for Medicare and Medicaid Services (CMS).
Company Overview and Future Directions
Headquartered in Sunnyvale, California, BioCardia, Inc. is recognized as a pioneer in cellular and cell-derived therapeutics targeting cardiovascular and pulmonary diseases. The company's biotherapeutic platforms, including CardiAMP for autologous treatments and CardiALLO for allogeneic applications, underscore its commitment to advancing care for heart failure patients.
For more information, visit www.biocardia.com.
Forward-Looking Statements
This article contains forward-looking statements that are subject to risks and uncertainties, particularly in regard to BioCardia's investigational product candidates and regulatory interactions. Readers are cautioned that actual results may differ materially from those anticipated in these statements. Further details can be reviewed in BioCardia’s Form 10-K filed with the Securities and Exchange Commission.