BioCardia, Inc. (NASDAQ: BCDA) announced that the results of its double-blind, randomized, placebo-controlled CardiAMP HF Phase 3 study have been accepted for presentation at the American College of Cardiology (ACC) 2025 Scientific Sessions in Chicago, taking place March 29-31, 2025.
The presentation, titled "A Double Blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial," will be given by 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, on March 30, 2025.
CardiAMP Cell Therapy
CardiAMP Cell Therapy, which has been granted FDA Breakthrough designation, utilizes a patient’s own bone marrow cells delivered to the heart via a minimally invasive, catheter-based procedure. This approach aims to stimulate the body’s natural healing response, increasing capillary density, reducing tissue fibrosis, and treating microvascular dysfunction. The therapy targets mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, largely through the production of growth factors, cytokines, chemokines, and other factors.
CardiAMP HF II Trial
The CardiAMP HF II trial is designed to enroll approximately 250 participants across up to 40 clinical centers. The randomized, controlled study will evaluate the efficacy of CardiAMP treatment in patients with ischemic heart failure and reduced ejection fraction. The primary endpoint is a composite score based on all-cause death, non-fatal major adverse cardiac and cerebrovascular events (MACCE), and quality of life improvements measured by the Minnesota Living with Heart Failure Questionnaire (MLwHFQ).
In August 2024, the FDA approved a protocol amendment for the CardiAMP cell population analysis, allowing for the inclusion of more patients by adjusting dosing for those with lower concentrations of specified bone marrow cells.
CMS Reimbursement
In March 2024, BioCardia received a boost when the Centers for Medicare & Medicaid Services (CMS) approved reimbursement for study procedures, related products and services, and routine items for the CardiAMP HF II trial. This financial support is expected to mitigate study costs and aid in the program's development.
Market Position
BioCardia's focus on autologous cell therapy for heart failure positions the company in a competitive market. Initial results from the previous Phase 3 trial were encouraging, with patients showing significant risk reductions in heart death equivalents and non-fatal MACCE events after receiving CardiAMP treatment.
Financial Outlook
BioCardia holds more cash than debt on its balance sheet but is quickly burning through available funds. Analysts anticipate that positive trial results could lead to increased investor interest and potentially pave the way for commercialization of the CardiAMP therapy system. Enrollment in the CardiAMP HF II trial may be completed by 2025.
