BioCardia files FDA Pre-Submission for Helix transendocardial catheter approval

BioCardia, Inc.

Completed Pre-Submission (Q-Submission) to FDA for Helix catheter for intramyocardial delivery.
Data from 15 well-controlled clinical trials supports safety and effectiveness.
Pre-Submission under CardiAMP Cell Therapy System FDA Breakthrough Designation.
Goal to align with FDA on regulatory pathway and timing within next 45 days.
CEO states Helix aims to be first approved transendocardial delivery catheter in US.

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