Xoran Technologies LLC SBIR Phase II Award, June 2022

Abstract Point of Care Lung CT for patients with Acute Respiratory Failure Two million patients develop acute respiratory failure requiring hospitalization in the US each year, with half requiring mechanical ventilation and more than 20% dying before discharge. Identifying underlying pulmonary pathologies in these patients is essential to ensuring they receive the right treatment, but standard chest imaging, a portable chest X-ray exam, poorly discriminates important pulmonary pathology in patients receiving invasive mechanical ventilation. Computed Tomography (CT) can identify pneumonia, pleural effusion, and/or pulmonary embolism (with contrast load) that may otherwise go undetected. Yet the risks and burden of moving critically ill patients to a conventional CT scanner is a significant barrier to safely performing CT in this population. A “point-of-care” CT scanner in the intensive care unit (ICU) would transform how care is provided to these patients. However, a portable device that is compact and low radiation yet capable of thoracic CT imaging does not currently exist. In this SBIR Phase II project, Xoran intends to develop and clinically validate a compact, mobile yet highly functional system to provide point of care thoracic CT images suitable for use in hospital ICUs and also deployable to field hospitals or other frontline settings. This effort builds on a previously commercialized compact and portable flat-panel CT technology for cranial applications, and leverages significant progress made in imaging capabilities for soft tissue structures in the brain and a prototype portable and compact open gantry mechanism intended for spine imaging. The project includes expansion of imaging capabilities using larger format detectors operating at fast frame rates in order to capture the larger volume of the lungs within the constraints of a patients breathing cycle. Self-shielding and self-disinfecting features will be incorporated to maximize safety and optimize workflows. Clinical evaluation will take place at the University of Michigan. Partnering with a team of Pulmonary and Critical Care physicians, thoracic radiology, and ICU nursing leadership, it will then establish the safety and clinical utility of point-of-care Thoracic CT system in support of FDA 510k submission leading to an approved indication for use and commercially viable product.