BioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDA

FDA Substantive Review and Meeting Scheduled for Early Q2SUNNYVALE, Calif., March 17, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for the approval of its Helix Transendocardial Delivery Catheter (“Helix”) intended for intramyocardial therapeutic and diagnostic agent delivery. BioCardia has had preliminary meetings wit ...