BioCardia reports positive results from CardiAMP Cell Therapy trial.

• BioCardia announces CardiAMP Cell Therapy results • Procedure well-tolerated with no major adverse cardiac events • Patients on GDMT showed positive response to autologous cell therapy • Average increase in exercise tolerance of 80 seconds • Average reduction in angina episodes of 82% at 6-month primary endpoint • 60% of patients showed substantial improvement

BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has announced encouraging results from the open-label roll-in cohort of its CardiAMP® Cell Therapy trial in patients with chronic myocardial ischemia and refractory angina. The trial, designed to evaluate the efficacy and safety of the therapy, demonstrated significant improvements in exercise tolerance and angina episodes.

The primary endpoint results, released on September 18, 2025, showed that the minimally-invasive CardiAMP Cell Therapy procedure was well-tolerated with no treatment-emergent major adverse cardiac events. Patients on guideline-directed medical therapy (GDMT) responded positively to the autologous cell therapy, experiencing an average increase in exercise tolerance of 80 seconds and an average reduction in angina episodes of 82% at the six-month primary endpoint.

Sixty percent of the patients exhibited substantial improvements in both measures, indicating a consistent therapeutic benefit across multiple parameters. These early results compare favorably to current FDA-approved therapies such as Ranolazine and Enhanced External Counter Pulsation (EECP), which have more modest efficacy profiles BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Top Line Data of Roll-in Cohort Show Improved Exercise Tolerance and Reduced Angina Episodes at Six-Month Primary Follow-up^[1].

The absence of major adverse cardiac events is an important safety signal, particularly considering that these patients were already on GDMT. The fact that patients already on Ranolazine experienced dramatic reductions in angina episodes suggests potential synergistic effects with existing treatments .

Dr. Carl Pepine, MD, MACC, Professor of Medicine at the University of Florida at Gainesville, commented on the results, stating, “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.” Peter Altman, President and CEO of BioCardia, added, “We are working with our investigators to submit these results for peer reviewed scientific publication. The results from this roll-in cohort support our continued development of this novel therapeutic approach for chronic myocardial ischemia with refractory angina and enhance the value of our CardiAMP cell therapy platform.”

The trial is part of BioCardia's broader effort to develop cellular and cell-derived therapies for cardiovascular and pulmonary diseases. The company's CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are in development, with three cardiac clinical stage product candidates .