BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes

SUNNYVALE, Calif., Dec. 18, 2023 (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 Japan Pharmaceutical and Medical Device Agency (PMDA) minutes support the Company’s understanding that CardiAMP autologous cell therapy may be approved for the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) based on follow-up data from the patients currently enrolled in the CardiAMP Heart Failure Trial (CardiAMP HF) that will be available in Q4 2024.

BioCardia has previously reported that although the primary endpoint of CardiAMP HF would most likely not have been met at one year; there was both reduced mortality and reduced major adverse cardiovascular events in treated patients compared to controls at two years follow-up. PMDA and its medical advisors have seen these and additional results that will be presented and published in the appropriate peer reviewed scientific forums. The FDA reviewed this data and recently approved the CardiAMP Heart Failure II Study protocol.

BioCardia will follow PMDA’s process to confirm the regulatory pathway ahead. This is expected to include a clinical consultation with PMDA in the second or third quarter of 2024 on clinical data from its three sponsored trials: TABMMI¹, TAC-HFT², and CardiAMP HF³. These studies include almost two hundred patients followed-up for an average of 1.9 years and each has shown benefit to patients with no treatment emergent safety concerns. With PMDA confirmation, BioCardia expects to submit for approval in Japan based on the data available in late Q4 2024.

“As CardiAMP cells are autologous and delivered in a minimally invasive manner with our proprietary catheter system, the therapy has no requirements for immunosuppression, antiarrhythmic drugs, or open chest surgery,” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer. “We aim to partner with Japanese heart failure cardiologists and their interventional cardiology colleagues to be able to offer this therapeutic option for heart failure patients.”

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. 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 CardiAMP HF trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services. CAUTION - Limited by United States law to investigational use.