BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to expand into Canada.
The Phase III pivotal trial is currently enrolling patients in the U.S.
Four world-class Canadian clinical sites are currently working through the activation process in order to be ready to begin enrolling patients in the near future. The Company expects to announce these sites in the coming months.
The CardiAMP Cell Therapy Heart Failure Trial is evaluating the effectiveness of the CardiAMP Cell Therapy System for improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for New York Heart Association (NYHA) Class II and III patients who have heart failure associated with ischemic cardiomyopathy.
“Expansion into respected centers in Canada is expected to strengthen the overall clinical trial and accelerate its completion,” said Peter Altman, Ph.D., President and Chief Executive Officer of BioCardia. “The Health Canada process has been longer than expected as the trial was required to be approved by both the devices and the biologics groups at Health Canada in a sequential process. We value the rigorous Health Canada reviews as each one has made us stronger. We are delighted to partner with the site leadership teams in Canada and the United States to further the development of this promising treatment option for their patients with ischemic heart failure. ”