BioCardia announced positive primary endpoint results from the open-label roll-in cohort of its CardiAMP Cell Therapy trial for chronic myocardial ischemia, demonstrating significant improvements in patient outcomes at the six-month follow-up. The minimally invasive autologous cell therapy showed an average 82% reduction in angina episodes and increased exercise tolerance by an average of 80 seconds compared to pre-treatment measurements.
The trial enrolled patients with chronic myocardial ischemia and refractory angina who were already receiving guideline-directed medical therapy. All patients responded positively to the cell therapy, with 60% showing substantial improvements in both exercise tolerance and angina reduction measures. Notably, the treatment was well tolerated with no treatment-emergent major adverse cardiac events reported.
Superior Performance Against Current Standards
The CardiAMP results compare favorably to existing FDA-approved therapies for this condition. Current treatments include Ranolazine and Enhanced External Counter Pulsation (EECP), but the cell therapy demonstrated superior outcomes. Patients who were already receiving Ranolazine experienced dramatic additional reduction in angina episodes at the six-month follow-up when treated with CardiAMP.
"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," said Carl Pepine, MD, MACC, Professor of Medicine, Division of Cardiovascular Medicine, University of Florida at Gainesville.
Addressing Critical Unmet Medical Need
Chronic myocardial ischemia occurs when reduced blood flow to the heart causes angina, a type of chest pain. The condition becomes refractory angina when the pain cannot be controlled through optimal medical therapy, angioplasty, or bypass surgery. This debilitating condition affects an estimated 600,000 to 1.8 million patients in the United States.
Up to 15% of patients with ischemia or angina who undergo cardiac catheterization are suboptimal candidates for conventional revascularization. These patients experience significantly impaired quality of life and disproportionately high healthcare service utilization, highlighting the critical need for new therapeutic approaches.
Breakthrough Therapy Platform
CardiAMP Cell Therapy has received FDA Breakthrough Therapy designation for ischemic heart failure. The treatment uses a patient's own bone marrow cells delivered to the heart through a minimally invasive, catheter-based procedure designed to stimulate the body's natural healing response.
The therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system. This delivery system has demonstrated superior safety compared to other intramyocardial delivery systems and exponentially better cell retention rates.
Clinical Development and Next Steps
Peter Altman, President and CEO of BioCardia, stated, "We are working with our investigators to submit these results for peer reviewed scientific publication. The results from this roll-in cohort supports our continued development of this novel therapeutic approach for chronic myocardial ischemia with refractory angina and enhances the value of our CardiAMP cell therapy platform."
The CardiAMP cell therapy trials for both chronic myocardial ischemia and ischemic heart failure indications are covered by the Center for Medicare and Medicaid for both treatment and control procedures. The therapy remains limited by United States law to investigational use.
BioCardia's results align with previous compelling investigational trial results utilizing autologous bone marrow-derived cell therapy, though those approaches were cost prohibitive. The company's platform includes both CardiAMP autologous and CardiALLO allogeneic cell therapies, with three cardiac clinical-stage product candidates currently in development.
