BioCardia Inc. (NASDAQ: BCDA) experienced a sharp move in premarket trading Friday, with shares rising 26.2% after the company disclosed that the U.S. Food and Drug Administration had confirmed the regulatory pathway for its ongoing CardiAMP Heart Failure II Trial.
The FDA's Center for Biologics Evaluation and Research provided meeting minutes that indicate the CardiAMP Cell Therapy System - designed to treat ischemic heart failure of reduced ejection fraction - may be considered as supporting evidence for a Premarket Approval, or PMA, submission. PMA is the agency's most rigorous device marketing application and is used to establish the safety and effectiveness of higher-risk medical devices before they are cleared for general clinical use.
Company disclosures note that for large clinical indications such as heart failure with reduced ejection fraction - which the company estimates could encompass more than one million potential patients in the United States - the FDA typically expects two well-designed clinical trials to support approval. The meeting minutes from CBER reflect that the ongoing CardiAMP HF II Trial may serve as one of those trials.
The agency has previously determined that the CardiAMP Cell Therapy System is safe, a determination the company says enabled the Centers for Medicare and Medicaid to provide reimbursement in the CardiAMP HF trials. That prior safety finding remains a regulatory milestone on the path toward establishing effectiveness required for PMA.
Commenting on the development, Peter Altman, the company’s chief executive officer, said: "Patients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options. 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." The company develops cellular and cell-derived therapeutics aimed at cardiovascular and pulmonary diseases.
The FDA confirmation of the trial pathway represents a procedural advance for BioCardia as it continues the CardiAMP HF II Trial. While the minutes indicate the trial could be used to support a PMA, final regulatory decisions will depend on the totality of clinical evidence and any additional requirements the agency may outline.
Investors reacted quickly to the news in premarket trading, reflecting market sensitivity to regulatory clarifications that can influence a device developer's path to market and potential reimbursement. BioCardia's business focuses on cellular therapeutic approaches for serious cardiovascular and pulmonary conditions.
Context and next steps
The FDA confirmation applies specifically to the CardiAMP Cell Therapy System in the context of ischemic heart failure with reduced ejection fraction and relates to the role the ongoing trial may play in a PMA filing. The company will need to complete its trial activities and satisfy the agency's requirements for effectiveness, in addition to the safety determinations already in place, before a PMA could be granted.