eClinical Technology and Industy News

BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada

Excerpt from the Press Release:

SUNNYVALE, Calif., March 01, 2022 (GLOBE NEWSWIRE) — 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.”

About the CardiAMP Cell Therapy Program

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 a stem cell therapy to prospectively screen for stem 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 Phase III Trial: 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 exponentially more successful in cell retention. CAUTION – Limited by United States law to investigational use.

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