BioCardia gets FDA confirmation of Helix catheter meeting minutes; De Novo submission planned this quarter

BioCardia, Inc.

FDA confirmed final meeting minutes from May 2026 Pre-Submission Meeting on Helix Transendocardial Delivery Catheter System.
BioCardia intends to submit follow-on pre-submission for Helix this quarter, incorporating agency advice.
Successful De Novo clearance could enable independent Helix market clearance and enhance partnering for cell/gene/protein therapeutics.
CEO Peter Altman stated the submission could enable Helix approval via De Novo pathway.

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