BioCardia’s CardiAMP-HF trial primary endpoint did not reach significance

BioCardia (BCDA) announced two-year outcomes from the double-blind randomized placebo-controlled Phase 3 CardiAMP-HF study of its CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction, HFrEF. The study showed increased survival and reduced major adverse cardiac and cerebrovascular events observed study-wide, despite primary composite efficacy endpoint not reaching statistical significance. Two-year results from the trial demonstrated: In patients with elevated NTproBNP biomarkers compared to patients on optimized heart failure medication regimens alone: 13% fewer heart death equivalents; 47% relative risk reduction in heart death equivalents; 2% fewer non-fatal major adverse cardiac and cerebrovascular events MACCE; 16% relative risk reduction in MACCE; Clinically meaningful 10.5-point improvement in quality-of-life score, as measured by Minnesota Living with Heart Failure Questionnaire; 13.9-meter improvement in Six Minute Walk Distance. In all treated patients compared to patients on optimized heart failure medication regimen alone: 3.6% fewer heart death equivalents; 20.9% relative risk reduction in heart death equivalents; 8.7% fewer non-fatal MACCE; 44.6% relative risk reduction in non-fatal MACCE; Clinically meaningful 5.5-point improvement in quality of life score, as measured by MLHFQ; 14% fewer non-sustained ventricular tachyarrythmias and 5.5% fewer sustained ventricular tachyarrhythmias; Although both treated and controlled patients saw modest improvements in left ventricular ejection fraction, treated patients also showed evidence of reduced left ventricular end diastolic and end systolic volumes