BioCardia Completes Submission of CardiAMP Cell Therapy System in Heart Failure to Japan’s Pharmaceutical Medical Device Agency

SUNNYVALE, Calif. , July 05, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it completed its submission of the CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF). The formal consultation with PMDA to review the submission is anticipated in approximately three months and will be BioCardia’s third consultation with PMDA.

“We believe there is high potential for approval of the CardiAMP Cell Therapy for Heart Failure in Japan based on the existing safety and efficacy data, the CardiAMP cell processing platform’s existing approval in Japan for other therapeutic indications, the CardiAMP minimally invasive delivery system which does not require open chest surgical access to enable implantation of cells, and the Japanese leadership scientifically and clinically in cardiovascular regenerative medicine therapies. It may also help that our proprietary delivery system is approved in the European Union for the same indication and is expected to have utility for other therapies being advanced in Japan,” said Peter Altman, President and CEO. “While there is potential that PMDA will require additional data for approval, BioCardia has designed a post marketing study in collaboration with two globally recognized Japanese cardiology investigators who would lead the study as co-National Principal Investigators to enable the CardiAMP Cell Therapy to be advanced safely for the benefit of the patients in Japan who suffer from ischemic HFrEF.”

About the CardiAMP Cell Therapy Program

CardiAMP Cell Therapy – FDA designated as a Breakthrough 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 for Heart Failure Trial is the first known multicenter clinical trial of a cell therapy to prospectively screen for cell characteristics in order to improve patient outcomes. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis 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. The trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services.