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BioCardia®, Inc. Announces FDA Acceptance of Phase III Clinical Trial Protocol Studying Bone Marrow-Derived Cell Therapy for Heart Failure Patients: Company’s CardiAMP™ Therapy is First Cell Therapy for Heart Failure to be regulated by FDA PMA Pathway and First Cell Therapy/Companion Diagnostic to be Studied Together in a Phase III U.S. Trial

November 11, 2014

SAN CARLOS, CA –BioCardia®, Inc., a leader in cardiovascular regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s application to begin a Phase III clinical trial of its bone marrow-derived CardiAMP Therapy for heart failure. The clinical trial is a randomized, controlled, multi-center study of 250 patients evaluating CardiAMP Therapy at up to 40 clinical sites.

The CardiAMP Therapy for heart failure integrates a proprietary biomarker panel to identify candidates likely to respond to therapy, a cell processing system consisting of a proprietary, high-dosage formulation of autologous bone marrow-derived cells and a unique transendocardial delivery system that ensures efficient and consistent targeted delivery. This therapy will be reviewed under the PMA regulations by the FDA’s Center for Biologics Evaluation and Research (CBER) division.

The CardiAMP trial efficacy endpoints include improvements in functional capacity as measured by the Six Minute Walk Test, quality of life as measured by the Minnesota Living with Heart Failure Questionnaire, and survival. Safety endpoints include non-inferiority with respect to survival and freedom from major adverse cardiac events.

Co-principal investigators for the trial are Carl Pepine, M.D., and Amish Raval, M.D., who were involved in the trial design. Dr. Pepine is Professor of Medicine, Division of Cardiovascular Medicine, at the University of Florida (UF) and principal investigator for the UF Center for the Cardiovascular Cell Therapy Research Network (CCTRN). He is also past president of the American College of Cardiology (ACC). Dr. Raval is Associate Professor of Medicine, Division of Cardiovascular Medicine, at the University of Wisconsin, where he practices as an interventional cardiologist conducting cardiovascular clinical trials for cell and biologic therapy. He is also Director of Cardiovascular Clinical Research and Director of the Regional ST Elevation Myocardial Infarction Program.

“CardiAMP has the potential to bring an effective therapy forward that will provide meaningful clinical benefit to patients with ischemic heart failure,” said Dr. Raval. “There is an enormous unmet need here, and CardiAMP is a worthy endeavor that has a high probability of meeting both the safety and the efficacy required to become a therapeutic option for heart failure patients.”

“CardiAMP builds on – and benefits from - what has been done in previous CCTRN trials in that it provides the highest effective dosage that has been studied in a rigorous trial to date, and the companion diagnostic selects patients that have potent autologous bone marrow,” said Dr. Pepine. “This trial pulls together everything we have learned in the field of autologous bone marrow cell therapy to treat heart failure. There are very promising signals in the Phase II data that we hope to see confirmed in the Phase III trial.”

“CardiAMP Therapy is based on the role bone marrow cells have in the normal cardiac repair process after an injury to the heart,” said Dr. Peter Altman, PhD, CEO of BioCardia. “The CardiAMP program presents a solution to issues with autologous cell variability. We believe CardiAMP provides a more potent and consistent dosage than any other autologous bone marrow cell therapy trial for heart failure studied to date. This is noteworthy, as previous clinical trials have supported the benefits of autologous cell therapy for heart function and overall survival in a setting of heart failure.”

Studies supporting the CardiAMP Therapy – including the Phase I Transendocardial Autologous Bone Marrow in Myocardial Infarction Study, which was published in Eurointervention, and the Phase I/II Transendocardial Autologous Cells in Heart Failure Trial, which was published in the Journal of the American Medical Association (JAMA) - showed statistically and clinically significant results. Trial results have demonstrated an excellent safety profile, as well as functional and quality of life improvements.



About BioCardia®
BioCardia, Inc., headquartered in San Carlos, CA is a privately held company developing regenerative biologic therapies to treat cardiovascular disease. The Company's current products include the Helix™ Transendocardial Delivery System and the Morph® steerable guide and sheath catheter portfolio. BioCardia partners with other biotherapeutic companies to provide its Helix Systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.


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