Biocardia Inc Stock Price, News & Analysis

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 announced the enrollment of the first patient in its Phase III CardiAMP HF II clinical trial at BayCare Morton Plant Hospital in Florida. The trial evaluates the company's lead autologous cell therapy for heart failure treatment. The CardiAMP cell therapy is unique as it personalizes treatment using the patient's own cells, avoiding immune suppression needs. The procedure utilizes the Helix minimally invasive delivery platform and new Morph DNA steerable navigation catheter for targeted cell delivery into heart muscle. Dr. Leslie Miller, Chief of the Congestive Heart Failure and Heart Function Clinic, serves as Principal Investigator. BioCardia is preparing regulatory submissions in Japan and the USA for approvals of both the cell therapy and delivery platform based on existing clinical data.

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.

BioCardia (NASDAQ: BCDA) has reported its financial results for 2024, showing a reduced net loss of $7.9 million compared to $11.6 million in 2023. The company's net cash used in operations decreased to $8.0 million from $10.0 million in 2023.

Key financial metrics include:

• Cash and cash equivalents: $2.4 million at year-end
• Revenues: $58,000 (down from $477,000 in 2023)
• R&D expenses: $4.4 million (decreased from $7.7 million)
• SG&A expenses: $3.7 million (reduced from $4.4 million)

Notable developments include completion of the CardiAMP HF Trial's last protocol-specified follow-up visit, with results to be presented at the ACC Scientific Sessions. The company has also completed treatment of the low-dose cohort in the CardiALLO Cell Therapy trial and launched commercial Morph DNA steerable introducer devices. Japan's PMDA has shown openness to considering existing trial results for potential product registration.

BioCardia (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has scheduled key events for March 2025. The company will release its 2024 financial results on March 26, 2025, followed by a corporate update conference call on March 31, 2025.

Additionally, BioCardia will present the principal results of the CardiAMP-HF Trial at the American College of Cardiology 2025 Scientific Sessions in Chicago on March 30, 2025. The presentation will focus on 'A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF'.

BioCardia (BCDA) has been granted Japanese Patent No. 7641330 for its Helix™ Biotherapeutic Delivery System, extending protection until at least September 30, 2034. The patent covers minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart.

The Helix System, featuring helical needle-tipped catheter technology, is currently the only catheter-based intramyocardial delivery system in active clinical use. The technology enables targeted treatment while minimizing off-target toxicities and avoiding surgical heart access.

Japan represents a strategic market for these therapies due to its national commitment to supporting novel cell therapy solutions for its aging population while developing its stem cell industry.