BioCardia's CardiAMP HF Phase 3 study results will be presented at the American College of Cardiology 2025 Scientific Sessions.
Quiver AI Summary
BioCardia, Inc. announced that its double-blind, randomized, placebo-controlled CardiAMP HF Phase 3 study results will be presented in a late-breaking symposium at the American College of Cardiology 2025 Scientific Sessions in Chicago from March 29-31, 2025. The presentation, titled "A Double Blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF," will be delivered by Dr. Amish N. Raval on March 30, 2025. The CardiAMP Cell Therapy utilizes a patient's own marrow cells to potentially stimulate healing in the heart, targeting microvascular dysfunction through a minimally invasive procedure. The company, based in Sunnyvale, California, specializes in cellular therapies for cardiovascular and pulmonary diseases and is supported by the Maryland Stem Cell Research Fund and CMS reimbursement for its clinical developments.
Potential Positives
- Results of the CardiAMP HF Phase 3 study accepted for presentation at a prestigious medical conference, highlighting the company's commitment to advancing cardiovascular treatments.
- Presentation in a late-breaking symposium indicates significant developments in the study, attracting attention from leading experts in the field.
- CardiAMP therapy has received FDA Breakthrough designation, underscoring its potential impact in treating heart failure and distinguishing BioCardia from competitors.
Potential Negatives
- The press release extensively uses forward-looking statements and includes a cautionary note about the uncertainty of future performances, which may indicate potential risks and implications for investors.
- Despite acceptance for presentation at a major conference, the mention of the CardiAMP therapy being limited to investigational use under U.S. law may raise concerns about its commercial viability and regulatory approval.
- The inclusion of a disclaimer stating that actual results may differ materially from the forward-looking statements suggests a lack of confidence in the outcomes of ongoing studies or trials.
FAQ
What is the CardiAMP HF Phase 3 study?
The CardiAMP HF Phase 3 study is a double-blind randomized placebo-controlled trial evaluating an autologous cell therapy for heart failure.
When will the results be presented?
The results will be presented on March 30, 2025, at the American College of Cardiology Scientific Sessions.
Who is presenting the CardiAMP study results?
Dr. Amish N. Raval from the University of Wisconsin at Madison will present the study results.
What is CardiAMP autologous cell therapy?
CardiAMP is a breakthrough cell therapy using a patient’s own marrow cells aimed at treating microvascular dysfunction in heart failure.
What is the significance of the ACC Scientific Sessions?
The ACC Scientific Sessions is a premier event showcasing advancements in the treatment of cardiovascular diseases among medical professionals.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
SUNNYVALE, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [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: www.BioCardia.com.
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:
[email protected]
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email:
[email protected]
Phone: 650-226-0120