BioCardia Establishes Canadian Site for Heart Failure Trial

BioCardia Inc. has activated Ottawa Heart Institute, the first Canadian clinical investigational site for the CardiAMP Cell Therapy Heart Failure Trial.  
 
“The Ottawa Heart Institute is the first of four planned world-class Canadian clinical sites able to enroll patients in the CardiAMP Cell Therapy Heart Failure Trial,” said Dr. Peter Altman, BioCardia CEO. “Our expectation is that each site will contribute six patients per year to the ongoing pivotal trial enrollment in the U.S. and facilitate completion of this important pivotal trial. We are honored to be working with the team at Ottawa Heart.”
 
The Canadian national principal investigator is Duncan Stewart, M.D., a globally recognized physician leader in developing cell and gene-based therapies for cardiovascular and lung disease, who leads the prestigious Ottawa Heart Institute. The lead study site investigators at Ottawa Heart Institute are principal investigator Darryl Davis, M.D., a clinician-scientist and cardiac electrophysiologist who directs the cardiac translational research laboratory, and Lisa Marie Mielniczuk, M.D., director of the Heart Failure Program at University of Ottawa. 
 
CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. The CardiAMP Cell Therapy Heart Failure Trial is the first multicenter clinical trial of an autologous cell therapy to prospectively screen for cell therapeutic potency in order to improve patient outcomes. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy, which the company believes improves the probability of success of the treatment: a pre-procedural diagnostic for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and more successful for enhancing cell retention. 
 
BioCardia Inc. is headquartered in Sunnyvale, Calif., and develops cellular and cell-derived therapeutics for treating cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the company’s biotherapeutic platforms that enable four product candidates in development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS Reimbursement. The company’s current products include the Helix Transendocardial Biotherapeutic Delivery System, which it partners selectively with other biotherapeutic companies requiring local delivery to the heart.