BioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDA
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
SUNNYVALE, 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 with both FDA Center for Devices and Radiological Health (CDRH) and FDA Center for Biological Evaluation and Research (CBER) on this submission in recent weeks. CDRH is expected to lead the review in consultation with CBER. CDRH has acknowledged the CBER CardiAMP Cell Therapy Breakthrough Designation enabled by Helix. “FDA marketing clearance of the Helix would be meaningful for our business as the entire field of cardiac cell, gene, and protein therapeutics needs an FDA approved minimally invasive percutaneous intramyocardial delivery
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News
- BioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDA [Yahoo! Finance]Yahoo! Finance
- BioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT)GlobeNewswire
- BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the HeartGlobeNewswire
- BioCardia Announces Late Breaking Echocardiography Results from the CardiAMP HF Trial to be Presented at Technology and Heart Failure Therapeutics (THT)GlobeNewswire
BCDA
Sec Filings
- 3/17/26 - Form 8-K
- 3/3/26 - Form 8-K
- 2/10/26 - Form 8-K
- BCDA's page on the SEC website