BioCardia announced the allowance of a Japanese patent titled “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation” to protect its Heart3D Fusion Imaging software, intended for treatment planning and real-time navigation during CardiAMP Cell Therapy procedures.
The patent’s claims cover transposing preoperative three-dimensional CT or MRI heart images onto two orthogonal two-dimensional images to generate a combined three-dimensional model displayed within or adjacent to a sterile field for navigating delivery systems and recording procedural locations.
Heart3D is designed to support CardiAMP autologous cell therapy and the Helix intramyocardial delivery system and is being developed with partner CART-Tech.
BioCardia said it is working toward regulatory submissions in Japan after a positive consultation with the Japan Pharmaceutical and Medical Device Agency and is discussing approval pathways in the United States. Heart3D remains for investigational preclinical use, and BioCardia is inviting partnering inquiries for preclinical research, the company added.
