BioCardia FDA accepts pre-submission package for Helix catheter; review meeting early Q2

BioCardia, Inc.

FDA accepted pre-submission package for Helix Transendocardial Delivery Catheter; substantive review and meeting scheduled early Q2 2026.
CDRH to lead review in consultation with CBER; Helix enables minimally invasive intramyocardial delivery of therapeutics/diagnostics.
CEO states FDA marketing clearance would be meaningful for business; Helix is platform for cardiac cell, gene, and protein therapeutics.
CardiAMP Cell Therapy Breakthrough Designation (enabled by Helix) acknowledged by FDA in this submission.

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