BioCardia announces FDA alignment on Helix catheter clearance pathways; no safety concerns

BioCardia, Inc.

FDA agreed two pathways for Helix marketing clearance: simultaneous with CardiAMP cell therapy approval or DeNovo via follow-on pre-submission.
FDA raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents.
FDA's preferred route is simultaneous approval with CardiAMP cell therapy for heart failure.
BioCardia aims to pursue both pathways to enhance development and commercial partnering.

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