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BioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDA
FDA Substantive Review and Meeting Scheduled for Early Q2 SUNNYVALE, Calif., March 17, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a developer
About this update from Biocardia, Inc.
[{"type":"text","content":"FDA Substantive Review and Meeting Scheduled for Early Q2\nSUNNYVALE, Calif., March 17, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the FDA has accepted its pre-submission package for the approval of its Helix Transendocardial Delivery Catheter (“Helix”) intended for intramyocardial therapeutic and diagnostic agent delivery. BioCardia has had preliminary meetings with both FDA Center for Devices and Radiological Health (CDRH) and FDA Center for Biological Evaluation and Research (CBER) on this submission in recent weeks. CDRH is expected to lead the review in consultation with CBER. CDRH has acknowledged the CBER CardiAMP Cell Therapy Breakthrough Designation enabled by Helix. “FDA marketing clearance of the Helix would be meaningful for our business as the entire field of cardiac cell, gene, and protein therapeutics needs an FDA approved minimally invasive percutaneous intramyocardial delivery system,” said Peter Altman, PhD, BioCardia Chief Executive Officer. “These meetings with FDA on Helix are also expected to enhance the approval process for our CardiAMP Cell Therapy for the treatment of ischemic heart failure.” About the Helix Transendocardial Delivery Catheter The Helix transendocardial delivery catheter is an enabling platform for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart intramyocardially. It enables agents to be delivered precisely within the heart with superior retention over other therapeutic delivery modalities, and to many regions of the heart that other delivery methods cannot reach. The Helix includes a specialized small distal helical needle which engages the heart tissue from within the chamber of the heart and provides stability within the dynamic beating heart to safely enable agent delivery. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also acts as a biotherapeutic delivery partner supporting therapies for the treatment of heart failure...