BioCardia, Inc., a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, and CART-Tech, B.V., a provider of vendor independent platform technology for augmented fluoroscopy during cardiac interventions, have announced an exclusive development and commercialization agreement for Heart3D Fusion Imaging technology.
Technology Overview
The Heart3D system is designed to enhance two-dimensional x-ray images used for cardiac biotherapeutic delivery and biopsy procedures by fusing these images with annotated pre-procedure three-dimensional anatomical heart models created from gold standard MRI and CT images. This fusion imaging approach aims to provide interventional cardiologists with enhanced visualization during cardiac procedures.
Partnership Structure and Distribution Rights
Under the development and commercialization partnership, both companies are advancing Heart3D Fusion Imaging specifically for biotherapeutic interventions and cardiac biopsy applications. The system is expected to be sold initially as a research tool with support services for partners in preclinical studies, with subsequent approval sought for standard clinical practice.
The partnership leverages both companies' clinical experience in positioning electrodes and drug delivery systems in the heart, as well as their complementary intellectual property portfolios for cardiac fusion imaging. BioCardia will have exclusive distribution rights for biotherapeutic delivery worldwide and for cardiac biopsy in the United States, while all other distribution rights remain with CART-Tech.
Market Potential and Revenue Projections
"Heart3D Fusion Imaging has potential to enhance the procedural experience for interventional cardiologists, improve therapeutic strategies for sponsors and most importantly, benefit patients," said Peter Altman, BioCardia CEO. He emphasized the significant commercial opportunity, noting that "management estimates that a single approved biologic therapy for a large market cardiology indication could potentially generate $100 million of revenue annually from Heart3D automated cloud-based image post-processing and live procedural guidance services if it becomes standard of care."
Clinical Applications and Benefits
Johan Maas, CART-Tech CEO, highlighted the technology's potential impact on biotherapeutic delivery: "Together, we present the ultimate biotherapeutic delivery solution for partners developing cell, gene, and protein-based therapies to the heart. The Heart3D Fusion Imaging product offering has potential to significantly enhance procedural planning and real time image precision for the delivery of biologic agents."
Intellectual Property Exchange
As part of the partnership agreement, BioCardia has licensed global exclusive rights to CART-Tech intellectual property for the fields of biotherapeutic intervention. Conversely, CART-Tech has licensed global exclusive rights to BioCardia intellectual property for cardiac resynchronization therapy.
Current Regulatory Status
The Heart3D Fusion Imaging system is currently for investigational use only and is not CE-marked or FDA approved. The companies plan to initially market the system as a research tool before pursuing regulatory approval for standard clinical practice.
CART-Tech has been developing vendor independent platform technology for augmented fluoroscopy during cardiac interventions for over ten years, with approved products for Cardiac Resynchronization Therapy and developing products for Ventricular Tachycardia-ablation, biotherapeutic delivery and biopsy.
