BioCardia Plans FDA, Japan PMDA Meetings for CardiAMP Heart Failure Therapy

BioCardia, Inc. announced plans to request a meeting with the FDA in the fourth quarter of 2025 to discuss the approval pathway for its CardiAMP® Cell Therapy System, an investigational treatment for ischemic heart failure. Despite the pivotal phase 3 CardiAMP HF clinical trial not meeting primary endpoints, BioCardia points to its FDA Breakthrough Therapy designation, longer-term follow-up data, and ongoing phase 3b trial as factors potentially supporting approval. The company also intends to submit a DeNovo 510(k) application for its Helix Transendocardial Delivery System to the FDA in the third quarter of 2025, highlighting its safety and performance from multiple clinical studies. In addition to U.S. regulatory activities, BioCardia expects a clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in the fourth quarter of 2025, which could lead to market approval in Japan. The Helix system has demonstrated high safety standards in over 4,000 intramyocardial deliveries and improved therapeutic retention compared to other approaches. These regulatory developments are significant for BioCardia's market positioning and potential stakeholder value.