Welcome to our dedicated page for Biocardia news (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on Biocardia stock.
BioCardia, Inc. (NASDAQ: BCDA) generates news centered on its development of cellular and cell-derived therapeutics for cardiovascular and pulmonary disease. As a clinical-stage company headquartered in Sunnyvale, California, its updates often relate to progress in late-stage trials, regulatory interactions, and advances in its enabling delivery and imaging technologies.
Investors and clinicians following BCDA news can expect regular coverage of the CardiAMP autologous cell therapy platform in ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia with refractory angina, as well as the CardiALLO allogeneic mesenchymal stem cell platform in ischemic heart failure. Recent announcements have highlighted Phase 3 CardiAMP HF II trial enrollment at leading centers, subgroup efficacy signals from prior trials, and discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the potential approvability of CardiAMP Cell Therapy for HFrEF.
News items also address BioCardia’s Helix transendocardial biotherapeutic delivery system, Morph vascular navigation platform, and Heart3D fusion imaging platform, including updates on planned regulatory submissions and performance in preclinical and clinical settings. Corporate developments such as leadership appointments, board changes, financing activities, and Nasdaq listing compliance updates are disclosed through press releases and corresponding SEC filings.
This BCDA news page brings together these announcements so readers can follow clinical milestones, regulatory consultations, device platform progress, and governance developments in one place. For those tracking investigational therapies in heart failure, refractory angina, and related conditions, the BioCardia news feed provides an ongoing view into how the company’s programs and platforms are evolving over time.
BioCardia (NASDAQ: BCDA) has been granted US Patent No. 12,311,127 for its Helix biotherapeutic delivery system, a minimally invasive catheter technology for delivering biological therapies to specific sites in the heart. The patent, titled "Radial and Trans-endocardial Delivery Catheter", protects the company's helical needle-tipped catheter technology platform.
According to scientific literature, this technology represents the safest and most efficient approach for biotherapeutic delivery to the heart. The system is crucial for BioCardia's CardiAMP Cell Therapy development program, targeting patients with ischemic cardiomyopathies of heart failure and refractory angina.
BioCardia (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, announced its CEO Peter Altman's participation in a fireside chat at the A.G.P. Virtual Healthcare Company Showcase on May 21, 2025. The presentation, scheduled for 3:40 p.m. EDT, will focus on recent business developments and the company's therapeutic pipeline, particularly highlighting their lead product CardiAMP, an autologous cell therapy for treating ischemic heart failure. The session will be moderated by Jim Molloy, AGP's Managing Director of Equity Research Biotechnology & Specialty Pharmaceuticals.
BioCardia (NASDAQ:BCDA), a company specializing in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has scheduled its Q1 2025 corporate update and financial results conference call for May 14, 2025, at 4:30 PM EDT. The call will include management's formal remarks followed by a Q&A session.
Participants can pre-register online or join by phone: U.S. callers should dial 1-833-316-0559, while international callers should use 1-412-317-5730. A live webcast will be available, and replay options will be accessible until May 28, 2025, through both web and telephone platforms.
BioCardia (NASDAQ: BCDA) has announced the initiation of patient enrollment at the University of Wisconsin at Madison for its pivotal Phase 3 CardiAMP HF II trial. The study is evaluating the CardiAMP™ Cell Therapy Product for treating patients with ischemic heart failure of reduced ejection fraction (HFrEF) and elevated markers of cardiac stress.
Dr. Amish Raval, Professor of Medicine at the University of Wisconsin School of Medicine and Public Health, will serve as Site Principal Investigator and Co-National Principal Investigator. The minimally invasive autologous approach has shown promising results, avoiding the need for immune suppression while preserving therapeutic options including heart transplant for patients.
BioCardia (NASDAQ: BCDA) has received positive safety review from the independent Data Safety Monitoring Board (DSMB) for its CardiALLO-HF allogeneic cell therapy trial for heart failure. The DSMB recommended proceeding with the study as designed, following assessment of 30-day safety data from the initial 20 million cell dosing cohort.
The trial showed no treatment emergent major adverse cardiac events or clinical evidence of immune reactions to the allogeneic cells. The company plans to expand enrollment to 39 participants across the United States.
The CardiALLO HF trial at high dosage is expected to deliver at least double the effective dosage compared to previous studies and will uniquely target patients with active inflammation. Earlier clinical results from the TRIDENT trial demonstrated that higher MSC cell dosages reduced myocardial scar and increased left ventricular ejection fraction.
BioCardia (NASDAQ: BCDA) announces the initiation of patient enrollment at Emory University School of Medicine for its pivotal Phase III CardiAMP HF II trial. The study evaluates the CardiAMP™ Cell Therapy product for treating ischemic heart failure patients with reduced ejection fraction and elevated cardiac stress markers.
Dr. Arshed Quyyumi, Professor of Medicine at Emory's Division of Cardiology and Co-Director of the Emory Clinical Cardiovascular Research Institute, will serve as Principal Investigator. The trial compares CardiAMP Therapy, which involves harvesting and delivering autologous mononuclear cells to enhance microvascular density and reduce fibrosis, against a placebo procedure.
The study, which includes multiple clinical sites across the United States, aims for completion in 2027. Recent trial results presented at the American College of Cardiology Scientific Sessions showed compelling benefits for treated patients.
BioCardia (NASDAQ: BCDA), a leader in cardiovascular and pulmonary disease therapeutics, has announced a correction to their conference call timing for discussing two-year CardiAMP-HF results. The call is scheduled for March 31, 2025, at 4:30 PM EDT, not PDT as previously stated.
U.S. participants can call 1-833-316-0559, while international callers should dial 1-412-317-5730. Pre-registration is available at dpregister.com/sreg/10194429/fdf5f0e427. A live webcast will be accessible through event.choruscall.com, with replay options available approximately one hour after the call concludes.
BioCardia (NASDAQ: BCDA) announced two-year outcomes from its Phase 3 CardiAMP-HF study, evaluating CardiAMP autologous cell therapy for ischemic heart failure patients with reduced ejection fraction. The trial, involving 115 patients across 18 centers in the US and Canada, showed promising results.
In patients with elevated NTproBNP biomarkers (50% of enrolled patients), the therapy demonstrated:
- 13% fewer heart death equivalents with 47% relative risk reduction
- 2% fewer non-fatal major adverse cardiac events with 16% risk reduction
- 10.5-point improvement in quality-of-life scores
Overall results showed 3.6% fewer heart death equivalents, 8.7% fewer non-fatal adverse events, and meaningful quality of life improvements. The FDA-designated Breakthrough Therapy incorporates three proprietary elements: pre-procedural cell analysis, high target cell dosage, and a minimally-invasive delivery system.
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