BCDA BioCardia

BioCardia Announces Late Breaking Clinical Trial Presentation on CardiAMP Heart Failure Trial at the American College of Cardiology 2025 Scientific Sessions

BioCardia Announces Late Breaking Clinical Trial Presentation on CardiAMP Heart Failure Trial at the American College of Cardiology 2025 Scientific Sessions

SUNNYVALE, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) --  [NASDAQ: BCDA] today announced that the results of its double-blind randomized placebo-controlled CardiAMP HF Phase 3 study have been accepted for presentation in a late-breaking symposium at the American College of Cardiology 2025 Scientific Sessions, taking place in Chicago, March 29-31, 2025.

Title: A Double Blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial

Presenter: Amish N. Raval, M.D., Professor of Medicine and Biomedical Engineering, Chair of Cardiovascular Regenerative Medicine Focus Group, and Medical Director of UW Health ST Elevation Program, University of Wisconsin at Madison

Date: March 30, 2025

Session Title: Featured Clinical Research II

Session Type: Late-Breaking Clinical Trials

Session Time: 3:30:00 PM

Session Location: Main Tent

The American College of Cardiology Scientific Sessions meeting is one of the leading forums for the latest developments in clinical trials for cardiovascular disease. Attendees include experts from across the cardiovascular medical, pharmaceutical, biotechnology, and medical device communities who share a common goal of advancing treatment for cardiovascular disease.

About CardiAMP Autologous Cell Therapy

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms.

The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). 

CAUTION - Limited by United States law to investigational use. 

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 clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information, visit:

Forward Looking Statements 

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the presentation at the American College of Cardiology. 

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 27, 2024, 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

Email: 

Phone: 650-226-0120

Investor Contact:

David McClung, Chief Financial Officer

Email: 

Phone: 650-226-0120



EN
27/01/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on BioCardia

 PRESS RELEASE

BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell ...

BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial Independent Data Safety Monitoring Board (DSMB) recommends that the study proceeds as designed based on 30-day data safety assessment of participants treated in low dosage group. The company plans to progress the trial to enrollment of 39 participants in the United States. SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary dise...

 PRESS RELEASE

BioCardia Initiates Patient Enrollment at Emory University School of M...

BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve as Principal Investigator SUNNYVALE, Calif., April 11, 2025 (GLOBE NEWSWIRE...

 PRESS RELEASE

BioCardia’s Conference Call Today, Monday, March 31, 2025 to be Held a...

BioCardia’s Conference Call Today, Monday, March 31, 2025 to be Held at 4:30PM EDT Time Today SUNNYVALE, Calif., March 31, 2025 (GLOBE NEWSWIRE) --  [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today clarifies that two-year CardiAMP-HF results will be addressed in a conference call scheduled for today, Monday, March 31, 2025 at 4:30pm EDT. The press release earlier this morning incorrectly noted the call would be held at 4:30pm PDT. To access the call today:Participants can register for the conferenc...

 PRESS RELEASE

Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for ...

Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, and Improved Quality of Life at Two Years Increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide, despite primary composite efficacy endpoint not reaching statistical significanceStatistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) t...

 PRESS RELEASE

BioCardia Reports 2024 Business Highlights and Financial Results

BioCardia Reports 2024 Business Highlights and Financial Results SUNNYVALE, Calif., March 26, 2025 (GLOBE NEWSWIRE) --  [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the year ended December 31, 2024 and filed its annual report on Form 10-K with the Securities and Exchange Commission. The Company will host a corporate update conference call on Monday, March 31, 2025 at 4:30 PM ET following its presentation of results from the CardiAMP HF Trial at the Late-Breaking Clini...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch