BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA Approval for CardiAMP® Cell Therapy for Heart Failure and Helix™ Transendocardial Delivery Catheter

Core Insights - BioCardia, Inc. is seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix Transendocardial Delivery Catheter, with anticipated submissions in Q3 and Q4 2025 respectively [1][2][3]. Regulatory Activities - The Helix Transendocardial Delivery System will be submitted to the FDA as a DeNovo 510(k) application, supported by data from twelve clinical studies demonstrating high safety standards with over 4,000 intramyocardial deliveries [2]. - A submission to the FDA for CardiAMP Cell Therapy for ischemic heart failure is expected, along with a meeting request to discuss its approvability based on existing clinical data [3]. - An in-person clinical consultation with Japan PMDA is anticipated in mid Q4 2025, which could facilitate market entry for CardiAMP in Japan if aligned [4]. Competitive Landscape - The approval discussions may be influenced by other sponsors' applications for allogeneic cell therapies that require chronic immunosuppression, which may receive early conditional approval under Japan's adaptive framework [5]. Clinical Development - The CardiAMP Cell Therapy system has received FDA Breakthrough Designation due to significant unmet needs, with previous clinical trials showing promising results in reducing all-cause death and improving quality of life [8][9]. - The ongoing CardiAMP HF II trial is actively enrolling patients in the USA, with key centers including Baycare Hospital and Cleveland Clinic [8]. Product Platforms - BioCardia's CardiAMP and CardiALLO™ cell therapies are part of its biotherapeutic platforms, with the Helix delivery system enhancing the therapeutic agent retention in the heart compared to other methods [11].