BioCardia announced the allowance of a Japanese patent protecting its Heart3D Fusion Imaging software for treatment planning and real-time navigation in CardiAMP Cell Therapy procedures.
Key takeaways
Japanese Patent allowed for 'Target Site Selection, Entry, and Update with Automatic Remote Image Annotation'.
Patent protects Heart3D software used in CardiAMP Cell Therapy and Helix delivery system.
Heart3D fuses preoperative CT/MRI 3D heart images onto 2D X-ray for procedural navigation.
Recent positive PMDA consultation; preparing submissions for CardiAMP and Helix approval in Japan.
Upcoming May 2026 catalysts include FDA meetings on approval pathways and EuroPCR presentation.