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Phase I Clinical Studies Completed at USC

Based on promising internal research and development results, Guardian commenced a broader survey that was designed to evaluate and validate the applicability of Signature Mapping™ to the medical imaging applications. A series of broad pilot studies involving multiple modalities and multiple diseases were undertaken through a collaborative effort with the Image Processing and Informatics Laboratory (IPI) at the University of Southern California. IPI provided clinical cases including radiographs with confirmed diagnoses, as well as medical imaging informatics expertise. Clinical study areas and imaging modalities were chosen based upon their ability to provide Guardian broad and deep insight into the capabilities of its core technologies.

The initial pilot study chosen was multiple sclerosis (MS), a disease that has been diagnosed in over 400,000 Americans. Healthcare experts believe that over one million people currently live with multiple sclerosis today in the U.S. MS patients undergo multiple MRI scans that require the radiologist to quantify and report any changes to MS lesions over multiple studies and time. This evaluation process is a time-consuming and imprecise activity when performed without the benefits of an automated detection technology such as Signature Mapping™.

Results of the MS study found that Signature Mapping™ algorithms are capable of accurately detecting lesions and, more importantly, provide accurate measurements of size and overall lesion volumes. Compared to clinical observers, Signature Mapping™ proved to be a more sensitive tool for detecting lesions that were considered marginal or undetectable and provided extremely accurate measurements, while reducing the radiologist analysis time to just seconds.

Normal pressure hydrocephalus was also analyzed by IPI. In the normal course of aging the adult brain begins to shrink as a result the internal ventricles which contain cerebral spinal fluid begin to enlarge. Enlargement of the ventricles is also associated with numerous anomalies including obstructing tumors. The challenge faced by the radiologist is to determine whether the pressure changes in the ventricles are caused by the normal course of aging or as a result of an anomaly. Signature Mapping™ technologies detected and quantified the ventricles and cranial spinal fluid visualized from the MRI images. IPI reviewed the results of utilizing Signature Mapping™ and determined the effects to be impressive by demonstrating its ability to detect cerebral spinal fluid, provide a methodology for segmenting the ventricles and determining and quantifying ventricular size and volume.

Acute intra cranial hemorrhage was the third area of application in the brain for Signature Mapping™. This area is of clinical interest due to the large number of intra cranial bleeds occurring either due to disease, such as stroke, or from traumatic head injury. There are over 1.5 million traumatic brain injuries in the United States each year. The goal was to develop a Signature Mapping™ technology for accurately segmenting and detecting intra cranial bleeding using axial Computer Tomography (CT) slices. Cases were categorized into three groups; gross identifiable bleeding, subtle small subdural bleeds and extremely small subdural bleeds which could be confused with CT bone hardening artifacts. Signature Mapping™ demonstrated in all cases to be an accurate and sensitive tool for the detection of acute intra cranial bleeds. It also demonstrated an ability to differentiate between small intra cranial bleeds such as less than 5% subdural hematomas and difficult to discern bone hardening artifacts typical in most CT scans.

The use of Signature Mapping™ to monitor tuberculosis (TB) changes over treated time using radiographic chest x-rays was also studied. Tuberculosis is a serious world health problem; the World Health Organization estimates that over 2 billion people or one third of the world population has or will contract tuberculosis. Tuberculosis is an immune deficiency disease and is a complication of HIV disease. Tuberculosis is a leading cause of death outside the United States afflicting millions of people in Africa and Eastern Asia. A Signature Mapping™ technology was developed to detect lung volume area, quantifying normal lung volume from diseased lung volume and quantitatively report changes in lung volume through drug treatment progress. Signature Mapping™ proved to be successful in detecting lung area, quantifying normal lung volumes, and reporting lung volume changes over time during drug treatment therapies. It demonstrated itself to be an excellent tool to aid in quantification and tracking of TB therapy.

The last and most difficult area that was evaluated was breast imaging. Two specific challenges are in the areas of image clarification and the clinical interpretation of dense breast digital x-ray examinations. Clinicians at USC indicated that as high as 50% of their dense breast tumors could be palpated, but not clearly seen or detected on x-rays. Typically these dense breast areas obscure the visualization of anomalies and potential tumors. Signature Mapping™ technology was used to clarify difficult to visualize areas of the breast and to provide improved visualization and detection of tumor areas and edges. Preliminary results suggest a likely opportunity for early detection and mapping of tumors and tumor growth over time. Microcalcifications were easily visualized and demonstrated unique signature responses. Results were extremely encouraging and further clinical study is required.

Overall Guardian is extremely excited by its ability to add clinical value to difficult imaging problems in diagnostic radiology. Guardian was able to demonstrate its ability to easily transfer its Signature Mapping™ technologies to a new imaging industry application. The Signature Mapping™ technologies proved to be an effective tool for detection, segmentation, clarification, quantification and visualization for specifically targeted diseases or anatomical structures. The technology shows broad modality and clinical adaptation for deployment in a wide variety of clinical diagnostic and therapeutic applications.