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BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart

SUNNYVALE, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has completed its Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter (“Helix”) for intramyocardial therapeutic and diagnostic agent…

GlobeNewsWire • Feb 10, 2026
BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

SUNNYVALE, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced…

GlobeNewsWire • Dec 16, 2025

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