BioCardia’s CardiAMP Trial Yields 179-Second Exercise Gain and 82% Angina Reduction
BioCardia’s open-label CardiAMP CMI trial showed exercise tolerance rose 179 seconds and angina episodes fell 82% at six months, sustained through two years with no major adverse cardiac events. This FDA-designated Breakthrough Therapy uses autologous marrow cells via a proprietary catheter to treat up to 1.8 million refractory angina patients.
1. Trial Presentation and Design
BioCardia presented preliminary results of its open-label CardiAMP CMI cohort at a leading interventional cardiology meeting. The study enrolled patients with refractory angina who had exhausted all percutaneous and surgical options while on guideline-directed medical therapy, evaluating autologous cell therapy delivered via catheter.
2. Efficacy Outcomes
Participants experienced an average increase of 179 seconds in exercise tolerance and an 82% reduction in angina episodes by six months. Those gains persisted through the two-year follow-up period, indicating durable clinical benefits in this high-need population.
3. Safety Profile
No treatment-emergent major adverse cardiac events were reported, underscoring the procedure’s tolerability. The proprietary delivery system and high target cell dosage are designed to optimize retention and minimize complications.
4. Therapy Platform and Market Potential
Designated an FDA Breakthrough Therapy for ischemic heart failure, CardiAMP leverages proprietary elements—pre-procedural cell analysis, high cell dose, and novel catheter delivery. Coverage by Medicare and Medicaid for both treatment and control arms could facilitate broader adoption among the estimated 600,000–1.8 million U.S. patients with refractory angina.