BioCardia(US:BCDA) Globenewswire·2026-02-10 14:15Core Insights - BioCardia, Inc. has completed its Pre-Submission to the FDA for the Helix Transendocardial Delivery Catheter, aiming for approval for intramyocardial therapeutic and diagnostic agent delivery [1][2] - The Helix catheter is positioned to be the first approved transendocardial delivery system in the U.S., which could streamline future approvals for BioCardia's cell therapies [3] Regulatory and Clinical Development - The data supporting the Helix Pre-Submission comes from fifteen well-controlled clinical trials focusing on cell and gene therapy delivery to the heart, covering three primary cardiac clinical indications [2] - BioCardia plans to align with the FDA on the regulatory pathway and timing for approval within the next 45 days, with a market clearance application potentially following soon [2] Product Features and Advantages - The Helix catheter allows for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart, providing superior retention compared to other delivery methods [4] - It features a specialized small distal helical needle that engages heart tissue from within the chamber, ensuring stability during agent delivery [4] - Clinical reviews indicate that Helix has shown superior procedural safety and a three-fold increase in effective dosing compared to open surgical access, and an eighteen-fold increase compared to intracoronary artery infusion [5] Company Overview - BioCardia, Inc. is focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO cell therapy platforms in clinical development [6] - The Helix delivery system is part of BioCardia's biotherapeutic delivery and navigation platforms, enhancing the efficacy of their therapies [6]