The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for BioCardia’s CardiAMP Cell Therapy System for the treatment of heart failure.

CardiAMP Cell Therapy uses a patient’s bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. The therapy incorporates a pre-procedural screening assay to identify patients who may be likely responders, designed to enhance patient selection.

Eligible patients receive a high dose of cells using an intramyocardial delivery system that has been shown to present the lowest risk to patients for biotherapeutic delivery1 and to be three to six times more efficient at delivering cells to the heart muscle than other methods.2 This approach allows the patient to be discharged from the hospital the morning after the procedure.

CardiAMP Cell Therapy is designed to potentially stimulate the body’s natural healing response, provoking a beneficial paracrine reaction to repair the heart.

“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,” says Carl Pepine, MD, MACC, professor in the Division of Cardiovascular Medicine at the University of Florida. “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. I am enthusiastic about completing the U.S. pivotal trial of the CardiAMP Cell Therapy to build the body of evidence necessary to support this accelerated FDA path.”

The CardiAMP Cell Therapy Heart Failure Trial is currently enrolling patients to evaluate the effectiveness of the CardiAMP Cell Therapy System in improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for patients.

The CardiAMP Cell Therapy System has shown no incidence of mortality at one 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.

The Breakthrough Devices Program is designed to expedite FDA 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.


[1] Duckers HJ, Raval A, Pepine CJ, et al. Performance of Helix transendocardial biotherapeutic delivery system after 300 cases. Poster Presentation at TCT Conference 2018

[2] Mitsutake, Y. Pyun WB,  Rouy D, et al. Improvement of local cell delivery using Helix transendocardial delivery catheter in a porcine heart, Int. Heart J. 58 (2017) 435–440.