BioCardia Submits for FDA Approval of Morph® DNA™ Steerable Introducer Product Family

Core Insights - BioCardia, Inc. has submitted a 510(k) application for its Morph® DNA™ Steerable Introducer Sheath, aimed at enhancing the introduction of medical instruments into the vascular system [1][2] - The Morph DNA technology has already been utilized in previously approved products, including the Helix biotherapeutic delivery Morph DNA guide system and the Avance transseptal steerable introducer [2] - The potential market for the new product family encompasses millions of procedures annually, including various cardiac and peripheral vascular interventions [3] Company Overview - BioCardia, Inc. is focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its main product platforms being CardiAMP® and CardiALLO™ [4] - The company has three clinical stage product candidates in development, supported by its Helix biotherapeutic delivery and Morph vascular navigation platforms [4] Product Details - The Morph DNA design allows for improved catheter performance by enabling tensioning elements to rotate around the catheter shaft, which aids in navigation and reduces mechanical "whip" [2] - The new introducer sheath is designed to accommodate a wide range of sizes and lengths for various complex clinical procedures, aligning with the company's mission to advance therapeutic solutions [3]