BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
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 delivery. The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen well-controlled clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications. The Helix Pre Submission has been made under the CardiAMP Cell Therapy System FDA Breakthrough Designation, which the Helix underlies. BioCardia seeks to align with FDA on the regulatory pathway and timing for approval in the next 45 days. An application for market clearance could soon follow. “This Pre
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- BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard Krasno [Yahoo! Finance]Yahoo! Finance
- BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard KrasnoGlobeNewswire
- BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure CongressGlobeNewswire
BCDA
Sec Filings
- 2/10/26 - Form 8-K
- 2/4/26 - Form 4
- 2/3/26 - Form 8-K
- BCDA's page on the SEC website