BioCardia Shares Data From CardiAMP-CMI Trial Roll-in Cohort

September 30, 2025—BioCardia, Inc. announced the primary endpoint results of the open-label, roll-in cohort of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia (CardiaAMP-CMI) trial.

The company stated that CardiAMP cell therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. It has been recognized by the FDA as a breakthrough therapy for ischemic heart failure. In the United States, it is limited by law to investigational use.

According to the company, the results showed that in patients with chronic myocardial ischemia with refractory angina, the minimally invasive CardiAMP cell therapy procedure was well tolerated with no treatment-emergent major adverse cardiac events.

As summarized in the BioCardia press release, all patients were on guideline-directed medical therapy and responded positively to the autologous cell therapy.

At the 6-month primary endpoint, patients experienced an average of 80 seconds of increased exercise tolerance and an average of 82% reduction in angina episodes when compared to measurements before cell therapy treatment. Additionally, 60% of the patients showed substantial improvements in both measures, reported BioCardia.

“With these final roll-in results, this novel investigational therapy shows promise in addressing debilitating refractory angina, a significant unmet need for patients with chronic myocardial ischemia,” commented Carl Pepine, MD, in the company’s press release. Dr. Pepine is Professor of Medicine, Division of Cardiovascular Medicine, at University of Florida at Gainesville in Gainesville, Florida.

The company advised that these early, open-label results compare favorably to those demonstrated by current FDA-approved therapies such as ranolazine and enhanced, external counter pulsation. Patients already on ranolazine experienced a dramatic reduction in angina episodes at 6-month follow-up. Additionally, the results are in line with previous compelling investigational trial results utilizing cost prohibitive cell therapy, stated BioCardia.