BioCardia receives FDA confirmation for CardiAMP trial pathway

BioCardia Inc. (NASDAQ: BCDA) announced that the FDA confirmed its ongoing CardiAMP Heart Failure II Trial may support Premarket Approval for the CardiAMP Cell Therapy System to treat ischemic heart failure with reduced ejection fraction.

The confirmation came through FDA meeting minutes from a Q-Sub Meeting with the FDA Center for Biologics Evaluation and Research. Premarket Approval represents the most rigorous type of device marketing application required by the FDA and is used to establish safety and effectiveness of high-risk medical devices before public approval.

The FDA previously indicated it typically requires two well-designed trials for approval in large clinical indications such as heart failure with reduced ejection fraction, where over one million patients in the United States could potentially benefit from CardiAMP Cell Therapy. The agency has previously determined the CardiAMP Cell Therapy System to be safe, which enabled Centers for Medicare and Medicaid Services reimbursement in the CardiAMP HF trials.

"Patients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options," said Peter Altman, BioCardia's Chief Executive Officer. "FDA recognizes this need and the strengths in our completed CardiAMP HF clinical data to be the first of two trials to support Premarket Approval."

CardiAMP Cell Therapy has received FDA Breakthrough designation and uses a patient's bone marrow cells delivered to the heart through a catheter-based procedure. The therapy is intended to increase capillary density and reduce tissue fibrosis to address microvascular dysfunction.

Japan's Pharmaceutical and Medical Device Agency has indicated that clinical results from three completed trials for ischemic heart failure treatment likely provide sufficient evidence for a successful approval submission.

BioCardia plans to submit CardiAMP HF to Japan's PMDA in the fourth quarter of 2026.

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