The FDA Accepts Biocardia's Pre-submission Package For The Approval Of Its Helix Transendocardial Delivery Catheter Intended For Intramyocardial Therapeutic And Diagnostic Agent Delivery

BioCardia's pre-submission package for its Helix Transendocardial Delivery Catheter has been accepted by the FDA, following preliminary meetings with the FDA's CDRH and CBER. The CDRH will lead the review, which is significant for BioCardia's business as it seeks FDA approval for a minimally invasive delivery system essential for cardiac therapies. The approval process for BioCardia's CardiAMP Cell Therapy for ischemic heart failure is also expected to be enhanced by these discussions.