BioCardia Says FDA Raised No Safety Concerns, Outlines Two Clearance Pathways For Helix Catheter System

BioCardia, Inc.

BioCardia, Inc.

BCDA

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BioCardia®, Inc. (NASDAQ:BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the outcome of its Pre-Submission Meeting with FDA on the Helix Transendocardial Delivery Catheter System (Helix).  

FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents. FDA's preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the DeNovo pathway.  

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