BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this QuarterGlobeNewsWire · 5 days ago
BioCardia Presents CardiAMP HF II Trial Design at Heart Failure Society of America Annual Scientific MeetingGlobeNewsWire · Oct 7, 2026
BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ CatheterGlobeNewsWire · Oct 1, 2026
BioCardia Confirms Timing and Provides Update on FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin SubmissionGlobeNewsWire · Sep 23, 2026
BioCardia to Present CardiAMP Regulatory and Corporate Progress at H.C. Wainwright 28th Annual Global Investment ConferenceGlobeNewsWire · Sep 10, 2026
BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for ApprovalGlobeNewsWire · Aug 24, 2026BioCardia, Inc. is a pioneering clinical-stage company dedicated to regenerative medicine, focusing on the development of advanced cellular and cell-derived therapies for a range of cardiac and respiratory ailments. Central to its pipeline is the CardiAMP Cell Therapy System, designed to address heart failure and chronic myocardial ischemia. Additionally, BioCardia is advancing an allogeneic cell therapy program, also targeting cardiac and pulmonary conditions.
| Date | Est. | Actual | |
|---|---|---|---|
| Aug 12, 2026 | -$0.18 | -$0.13 | Beat |
| May 15, 2026 | -$0.17 | -$0.21 | Miss |
| Mar 24, 2026 | -$0.20 | -$0.06 | Beat |
| Nov 12, 2025 | -$0.25 | -$0.24 | Beat |
| Aug 11, 2025 | -$0.25 | -$0.40 | Miss |
| May 14, 2025 | -$0.39 | -$0.59 | Miss |