BioCardia’s CardiAMP Cell Therapy System for Heart Failure Receives FDA Breakthrough Device Designation

February 3, 2022—BioCardia, Inc., which develops cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced that the FDA has granted Breakthrough Device designation for the company’s CardiAMP cell therapy system for the treatment of heart failure.

According to the company, CardiAMP is designed to potentially stimulate the body’s natural healing response, provoking a beneficial paracrine reaction to repair the heart. CardiAMP cell therapy’s indication is heart failure with reduced ejection fraction secondary to an ischemic event such as a heart attack.

The FDA’s Breakthrough Devices Program is intended to expedite approval of certain novel devices or device-led combination products (products that combine drugs, devices, or biological products) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, noted the company.

CardiAMP cell therapy uses autologous bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. The therapy incorporates a preprocedural screening assay to identify patients who may be likely responders, a first for a cardiac cell therapy and designed to enhance patient selection.

BioCardia explained that eligible patients receive a high dose of cells using an intramyocardial delivery system that has been shown in published literature to present the lowest risk to patients for biotherapeutic delivery and to be three- to six-times more efficient at delivering cells to the heart muscle than other methods. This approach allows the patient to be discharged from the hospital the morning after the procedure.

“It is exciting for the field of cardiology that the FDA has recognized the potential of a cell therapy to improve the lives of patients struggling with heart failure,” commented Carl Pepine, MD, in the company’s press release. “Getting this therapy fast-tracked and to patients more quickly than traditional methods would give us new options and a greater armamentarium to assist our patients in need.”

Dr. Pepine, who is Professor in the Division of Cardiovascular Medicine at the University of Florida in Gainesville, Florida, continued, “I am enthusiastic about completing the United States pivotal trial of the CardiAMP cell therapy to build the body of evidence necessary to support this accelerated FDA path.”

As summarized by BioCardia, the CardiAMP Cell Therapy Heart Failure Trial is a United States pivotal trial currently enrolling patients to evaluate the effectiveness of the CardiAMP system in improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for patients.

The trial is scheduled to have a prespecified formal Data Safety Monitoring Board Review which will assess both safety and futility of the trial on February 8, 2022. BioCardia advised that results from this review should be available in the days following the review.

The CardiAMP system has shown no incidence of mortality at 1 year in its phase II trial or in the 10-patient roll-in cohort from the phase III trial that is currently enrolling. Earlier studies of the therapy have shown statistically significant improvement in exercise tolerance and quality of life, report the company in the press release.