Post by icemandios on Dec 18, 2023 13:56:26 GMT
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 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: TABMMI 1 , TAC-HFT 2 , and CardiAMP HF 3 . 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.
About BioCardia ®
BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also acts as a biotherapeutic delivery partner supporting therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. For more information visit: www.BioCardia.com .
Anticipated 2023 Q4 Milestones:
BCDA-03: NK1R+ MSC Allogeneic Cell Therapy in Ischemic HFrEF Phase I/II Trial Enrollment
Helix Biotherapeutic Delivery System Update on Licensing / Partnerships
1 Transendocardial Autologous Bone Marrow Myocardial Infarction Trial, NCT00507468
2 Transendocardial Autologous Cells in Heart Failure Trial, NCT NCT00768066
3 CardiAMP Heart Failure Trial, NCT 02438306