In 2003, our focus shifted to identifying and building out commercial applications for the robust technologies we developed in prior years. Our development approach is centered around the concept that iMRI must be intuitive, easy-to-use, cost-effective and, most importantly, provide significant benefit to the patient. To achieve these objectives, we found that all components of an iMRI platform must be tightly integrated: disposable and reusable devices; imaging coils; procedural software and more; all designed from the ground-up as a complete system, a full clinical solution.
We have two core product platforms, the ClearPointTM system and the ClearTraceTM system, both of which are designed to enable minimally invasive surgical procedures to be performed in a hospital’s existing MRI suite. We developed our ClearPoint system to perform interventional applications in the brain. We are developing the ClearTrace system to perform interventional applications in the heart. Both platforms harness the power of MRI to guide surgical interventions with continuous, high resolution visualization capabilities.
We have received 510(k) clearance from the FDA to market our ClearPoint system in the United States for general neurological interventional procedures. We are marketing our ClearPoint system to provide guidance for the placement and operation of instruments or devices during the planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. Our ClearPoint system is intended to be used as an integral part of procedures, such as biopsies and catheter and electrode insertion, which have traditionally been performed using other methods.
The ClearTrace system is a product candidate under development that is designed to allow catheter-based minimally invasive procedures in the heart to be performed using continuous, intra-procedural MRI guidance. Some catheter-based cardiac interventions, such as stent placement, do not require detailed visualization of the cardiac tissue. However, we believe that other procedures, such as cardiac ablation to treat arrhythmias, would significantly benefit from continuous high resolution imaging of cardiac tissue and the surgical instruments. We expect that the ClearTrace system’s initial application will be for catheter-based cardiac ablation to treat cardiac arrhythmias, such as atrial fibrillation. In May 2009, we entered into an exclusive co-development agreement with Siemens, the global market leader in MRI scanners, for the development and commercialization of the hardware and MRI software necessary for the ClearTrace system.