BioCardia provides update on plan seeking approval for CardiAMP and Helix

BioCardia (BCDA) provides the anticipated timing of regulatory activities seeking FDA and Japan PMDA approvals of its CardiAMP Cell Therapy System and Helix Transendocardial Delivery Catheter. The Company intends to submit for approval of the Helix Transendocardial Delivery System to FDA as a DeNovo 510 application based on its safety and performance in twelve cell and gene therapy clinical studies. The clinical performance of the Helix system sets a high safety standard with more than 4,000 intramyocardial deliveries including studies under CE-mark in Europe. Therapeutic agent retention in the heart has also been shown to be superior using Helix compared to other catheter and surgical delivery approaches. BioCardia expects to complete a submission to FDA and meeting request to discuss the approvability of CardiAMP Cell Therapy for treatment of ischemic heart failure based on the available clinical data. The FDA has previously approved a number of important high-risk cardiovascular therapeutic medical devices where safety and benefit were demonstrated but which did not meet pivotal study primary endpoints. It is expected that the in-person meeting on the clinical consultation with PMDA requested in July 2025 will take place mid Q4. If the parties are aligned, this could enable BioCardia to submit for approval of the CardiAMP system for market entry in Japan. This discussion may be influenced by other sponsor’s applications to PMDA for allogeneic cell therapies to treat the same clinical indication expected to require chronic immunosuppression and open chest surgical delivery of cells.