Shares of BioCardia rallied 26.2% after the FDA’s Center for Biologics Evaluation and Research confirmed that data from the ongoing CardiAMP Heart Failure II Trial could support a Premarket Approval application. The trial targets ischemic heart failure with reduced ejection fraction in over one million potential U.S. patients.
BioCardia received official minutes from the FDA’s Center for Biologics Evaluation and Research confirming that data from the ongoing CardiAMP Heart Failure II Trial may support a Premarket Approval (PMA) application for its cell therapy system.
The CardiAMP Heart Failure II Trial is evaluating a treatment for ischemic heart failure with reduced ejection fraction in patients; management estimates more than one million U.S. patients could potentially benefit if the therapy is approved.
PMA is the FDA’s most stringent review process, generally requiring two well-designed clinical studies for high-risk devices; BioCardia expects the current trial to serve as one of the studies needed for submission and will engage further with regulators.
CEO Peter Altman emphasized the unmet medical need for therapies in ischemic heart failure and highlighted the strengths of completed clinical data, while BioCardia continues focusing on developing regenerative cell-based and cell-derived therapies for cardiovascular diseases.
