BioCardia Announces Positive Preliminary Clinical Consultation with Japan Pharmaceutical and Medical Device Agency on Cell Therapy for Ischemic Heart Failure
Rhea-AI Summary
BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary therapeutics developer, has completed a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding their CardiAMP Heart Failure Trial results.
The PMDA has requested additional information about the trial's prespecified composite endpoints, statistical power, and the NTproBNP subgroup's risk-benefit profile. The company plans to submit responses and anticipates a formal clinical consultation by year-end.
The consultation covers three completed clinical trials involving 178 ischemic heart failure patients, focusing on those with limited therapeutic options who showed significant benefits from BioCardia's autologous minimally invasive cell therapy.
Positive
- Positive preliminary consultation with Japanese regulatory authority PMDA
- Comprehensive clinical data from three trials with 178 patients
- Significant benefits observed in high-need patient group
- Progress toward potential market entry in Japan
Negative
- Additional data and clarifications required by PMDA before formal consultation
- Timeline for final approval remains uncertain
News Market Reaction – BCDA
On the day this news was published, BCDA declined 4.31%, reflecting a moderate negative market reaction. Argus tracked a peak move of +24.2% during that session. Argus tracked a trough of -12.2% from its starting point during tracking. Our momentum scanner triggered 33 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $686K from the company's valuation, bringing the market cap to $15M at that time. Trading volume was elevated at 2.9x the daily average, suggesting increased selling activity.
Data tracked by StockTitan Argus on the day of publication.
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 the end of the year.
“We look forward to working with the PMDA supporting their reviews of the three completed clinical trials with 178 ischemic heart failure patients,” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “Our focus is to enable access for patients with the greatest needs who have few if any therapeutic options. These are the patients who showed the most significant benefits in the recently completed CardiAMP HF study of our autologous minimally invasive cell therapy.”
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com.
Forward Looking Statements
This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, future regulatory submissions, future regulatory meetings, and outcomes of these regulatory discussions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
MEDIA CONTACT: Miranda Peto, Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT: David McClung, Chief Financial Officer investors@biocardia.com (650) 226-0120
FAQ
What was the outcome of BioCardia's (BCDA) PMDA consultation for their heart failure treatment?
How many patients were involved in BioCardia's (BCDA) clinical trials for heart failure treatment?
What additional information did PMDA request from BioCardia (BCDA)?
When does BioCardia (BCDA) expect formal clinical consultation with PMDA?
What type of therapy is BioCardia (BCDA) developing for heart failure?
