BioCardia announced late-breaking echocardiography results from its Phase III clinical trial for ischemic heart failure of reduced ejection fraction (HFrEF). Patients treated with autologous CardiAMP cell therapy demonstrated decreased pathological left ventricular remodeling over time compared to control patients. These findings correlated with previously reported primary and key secondary endpoints, including reduced major adverse cardiovascular events and improved quality of life. In a prespecified subgroup of patients with elevated biomarkers of heart stress (NTproBNP), the differences in left ventricular end diastolic volume (p = 0.02) and left ventricular end systolic volume (p = 0.01) were both clinically meaningful (>20ml/m2 and 15 ml/m2, respectively) and statistically significant. The CardiAMP Cell Therapy has received FDA Breakthrough designation and is supported by the Maryland Stem Cell Research Fund, with reimbursement by Centers for Medicare and Medicaid Services (CMS).