BioCardia^®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases reported submission to United States Food and Drug Administration (FDA) of the CardiAMP HF clinical study data and on its plans to meet with the FDA to discuss the accelerated approval pathway for the CardiAMP^® System for ischemic chronic heart failure with reduced ejection fraction (HFrEF).

This meeting request is in line with previous guidance and BioCardia expects to have the meeting during this quarter. The meeting will be held under BioCardia’s FDA Breakthrough Designation for the CardiAMP System.

The key objectives of the meeting are to obtain FDA feedback on the acceptability of BioCardia’s proposed submission for approval based on the safety seen in the CardiAMP HF Trial, the well-characterized clinical response data for the 125 ischemic HFrEF patients enrolled into the trial, and the low risk and high potential benefit profile in the subgroup with elevated biomarkers of heart stress participating in the trial.

For the CardiAMP HF trial subgroup with elevated biomarkers of heart stress, the cells delivered have shown meaningful benefit for these higher-risk patients already on stable American Heart Association and American College of Cardiology guideline directed medical therapy. Demonstrated benefits in the subgroup, in addition to benefits the patients received from guideline directed medical therapy over two years, include an additional 47% relative risk reduction in all cause cardiac death, 37% relative risk reduction in non-fatal major adverse cardiac events (stroke, myocardial infarction, and hospitalization), and meaningful improvements in quality of life (p=0.04).