BioCardia submitted clinical study data for the CardiAMP System to the FDA. The company is seeking a meeting with the FDA this quarter to discuss an accelerated approval pathway for ischemic chronic heart failure with reduced ejection fraction (HFrEF). The CardiAMP System holds FDA Breakthrough Designation. Clinical data highlights a 47% relative risk reduction in all-cause cardiac death and a 37% relative risk reduction in non-fatal major adverse cardiac events for a specific patient subgroup with elevated biomarkers of heart stress.