BioCardia Begins Enrolling Patients at Emory for CardiAMP HF II Study

BioCardia, Inc., a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has announced the enrollment of patients at Emory University School of Medicine for its Phase III CardiAMP HF II trial. This trial targets individuals suffering from ischemic heart failure with reduced ejection fraction and elevated cardiac stress markers. CardiAMP HF II is focused on assessing the efficacy of the CardiAMP™ Cell Therapy, a treatment designed to harvest, process, and deliver autologous mononuclear cells directly to the heart. The therapy's objective is to boost microvascular density and diminish fibrosis, thereby improving heart function.

Dr. Arshed Quyyumi, a prominent figure in cardiology from Emory University, serves as the principal investigator for the study. He expressed confidence in the trial, noting the promising outcomes from recent presentations at the American College of Cardiology Scientific Sessions. The therapy utilizes screening for CD34+ cell composition and administers a high dosage in an interventional setting, aligning with prior research and enhancing expectations for successful patient outcomes. Emory's team is eager to offer this therapeutic opportunity to patients with heart failure.

Peter Altman, President and CEO of BioCardia, highlighted Dr. Quyyumi's expertise and Emory University's renowned capabilities in interventional cardiology as valuable contributions to the CardiAMP HF II trial. This collaboration is expected to accelerate patient enrollment, aiding the trial's progression towards its anticipated completion in 2027.

Heart failure with reduced ejection fraction (HFrEF) is a condition where the heart's blood output does not meet the body's metabolic needs. According to a 2022 report by the American Heart Association, roughly 3 million American adults have HFrEF, a figure projected to exceed 4 million by 2030. As the disease progresses, the heart's capacity to handle metabolic demands diminishes, leading to severe symptoms and limited daily activity. Despite various pharmacologic, device, and surgical interventions, many patients advance to severe stages that current treatments fail to manage effectively.

CardiAMP Cell Therapy has received the FDA's Breakthrough Designation. It involves using a patient's own bone marrow cells delivered to the heart via a minimally invasive procedure aimed at triggering the body's natural healing processes. The therapy includes unique elements like pre-procedural cell analysis for selecting suitable patients, administering a high target dosage, and utilizing a proprietary delivery system. This system has demonstrated greater safety and cell retention success compared to other intramyocardial delivery methods. Clinical trials have suggested improved patient survival, a reduction in major adverse cardiac events, and enhanced quality of life for recipients. The development of CardiAMP therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by the Centers for Medicare and Medicaid Services for both the treatment and control groups.

The CardiAMP Heart Failure Study, involving 125 subjects, demonstrated increased survival rates and reduced major adverse cardiac and cerebrovascular events when results were presented at the American College of Cardiology in March 2025. A significant improvement was noted in patients with elevated cardiac stress biomarkers treated with CardiAMP Cell Therapy. BioCardia is working with regulatory agencies in the United States and Japan to seek approval for the therapy, particularly for patients with elevated NTproBNP levels who have limited treatment options. The approval of the Helix transendocardial biotherapeutic delivery system is also anticipated to benefit numerous biotherapeutic delivery partners.

BioCardia, based in Sunnyvale, California, continues to lead in the development of cellular therapies, with its CardiAMP® and CardiALLO™ platforms at the forefront. These therapies are supported by its Helix™ biotherapeutic delivery and Morph® vascular navigation systems, offering innovative solutions for cardiovascular and pulmonary conditions.