BioCardia Inc. (NASDAQ:BCDA) shares surged 26.2% in premarket trading on Friday after the company announced that the U.S. Food and Drug Administration had confirmed a regulatory pathway that could support future market approval of its CardiAMP Cell Therapy System.
The update relates to the company’s ongoing CardiAMP Heart Failure II Trial, which is evaluating a treatment for patients suffering from ischemic heart failure with reduced ejection fraction (HFrEF).
FDA Confirms Potential Route to Premarket Approval
According to BioCardia, the FDA’s Center for Biologics Evaluation and Research provided official meeting minutes indicating that data from the ongoing study may contribute to a future Premarket Approval (PMA) application.
PMA is the FDA’s most stringent regulatory review process for medical devices and is generally required for products considered to carry higher levels of risk.
The process is intended to demonstrate both safety and effectiveness before a device can be commercially marketed in the United States.
CardiAMP Trial Seen as Key Step Toward Commercialization
The CardiAMP Cell Therapy System is designed to treat patients with ischemic heart failure and reduced ejection fraction, a serious cardiovascular condition that affects a large patient population.
BioCardia noted that the FDA generally expects two well-designed clinical studies when reviewing therapies intended for major medical indications such as HFrEF.
The company believes the current CardiAMP Heart Failure II Trial could serve as one of the studies needed to support a future PMA submission.
Large Potential Patient Population
Management estimates that more than one million patients in the United States could potentially benefit from the CardiAMP therapy if approved.
The company also highlighted that the FDA has previously determined the treatment system to be safe, an assessment that helped support reimbursement for participants enrolled in CardiAMP HF clinical trials through the Centers for Medicare and Medicaid Services.
CEO Highlights Unmet Medical Need
Chief Executive Officer Peter Altman said patients with ischemic heart failure continue to face limited treatment options.
“Patients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options,” Altman stated.
He added, “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.”
Company Focused on Regenerative Therapies
BioCardia develops cell-based and cell-derived therapies targeting cardiovascular and pulmonary diseases.
The company’s platform is focused on regenerative medicine approaches designed to improve outcomes for patients suffering from chronic and severe conditions.
Investors responded positively to the FDA update, viewing the agency’s confirmation as an important milestone in the regulatory process and a potential step toward eventual commercialization of the CardiAMP Cell Therapy System.