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.

In May 2026, the Company and FDA met and reviewed our initial De Novo pre-submission package. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns regarding the product’s safety data, performance, or compatibility with general classes of agents. In August 2026, FDA confirmed and accepted the meeting minutes. In September 2026, the De Novo pre-submission was revised, incorporating the advice from FDA CDRH as detailed in the meeting minutes, re-submitted and has now been accepted by FDA. BioCardia expects FDA substantive review with written feedback, followed by a meeting with BioCardia to discuss approval via the De Novo pathway, this quarter.