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Henry Ford Health Initiates Patient Enrollment for BioCardia’s CardiAMP HF II Pivotal Study for Ischemic Heart Failure of Reduced Ejection Fraction

SUNNYVALE, Calif., July 16, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the

articleBiocardia, Inc.July 16, 20253/company/biocardia-inc/news/henry-ford-health-initiates-patient-enrollment-for-biocardias-cardiamp-hf-ii-pivotal-study-for-ischemic-heart-failure-of-reduced-ejection-fraction
Henry Ford Health Initiates Patient Enrollment for BioCardia’s CardiAMP HF II Pivotal Study for Ischemic Heart Failure of Reduced Ejection Fraction

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[{"type":"text","content":"SUNNYVALE, Calif., July 16, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that Henry Ford Health in Detroit, Michigan is now enrolling patients with ischemic HFrEF in the Company’s ongoing pivotal CardiAMP HF II trial. “The CardiAMP HF cell therapy trials are important for patients with ischemic heart failure in need of new therapies,” said Gerald Koenig, MD, Director of the Cardiac Catheterization Laboratory, Henry Ford West Bloomfield Hospital, and Principal Investigator of CardiAMP HF II for Henry Ford Health System. “Together with the other investigators in this trial, we hope to confirm the promising results in the CardiAMP HF trial and enable our patients early access to this novel investigational autologous cell therapy.” The CardiAMP HF II trial is a confirmatory trial of autologous bone marrow derived mononuclear cell therapy for patients suffering from ischemic heart failure. The investigational therapy is intended to promote microvascular repair, reduce fibrosis, and increase capillary density. Patients who qualify for the study have cells harvested the day of the procedure, processed at their bedside, and delivered in the same procedure using minimally invasive catheter delivery systems. At the end of the procedure, nothing is left behind other than high doses of the patients’ own cells adjacent to damaged zones in their hearts. “We are delighted to continue our partnership with Dr. Koenig and the world class cardiovascular clinical research team at Henry Ford Health in CardiAMP HF II,” said Peter Altman, PhD, BioCardia’s CEO. “We share the common mission of enhancing therapies to treat cardiovascular disease. The results from our completed TABMMI, TACHFT, and CardiAMP HF trials underlie the potential to improve the lives of patients with heart failure and the families who care for them.” About the CardiAMP Heart Failure II Study CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic HFrEF on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the C...

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