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BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix™ Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter

SUNNYVALE, Calif., Oct. 19, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for marketing clearance of its Helix catheter (“Helix”) intended for therapeutic and diagnostic agent delivery.

GlobeNewsWire • Oct 19, 2026
BioCardia Presents CardiAMP HF II Trial Design at Heart Failure Society of America Annual Scientific Meeting

SUNNYVALE, Calif., Oct. 07, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the upcoming presentation of a scientific poster entitled “Cardiac Delivery of Autologous Minimally Processed Cell Therapy in HFrEF: Multicenter, Double Blind RCT (CardiAMP HF II)” at the Heart…

GlobeNewsWire • Oct 7, 2026
BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter

SUNNYVALE, Calif., Oct. 01, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has completed its revised Pre-Submission to FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program for the approval of its Helix Catheter (“Helix”) for therapeutic and…

GlobeNewsWire • Oct 1, 2026
BioCardia to Present CardiAMP Regulatory and Corporate Progress at H.C. Wainwright 28th Annual Global Investment Conference

SUNNYVALE, Calif., Sept. 10, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that Peter Altman, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 28th Annual Global Investment Conference. The conference will be held at the Lotte New York Palace…

GlobeNewsWire • Sep 10, 2026

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