Active Signal Technologies, Inc. (AST) proposes to advance, during Phase II, the development of its non-invasive Brain Assessment Monitor (BAM) that was successfully tested on 30 patients during Phase I. AST's partner, the R. Adams Shock Trauma Center (STC) at the University of Maryland, will conduct an expanded clinical study designed to demonstrate correlations of the BAM indications with traditional measures of intracranial pathology. Specifically, AST will refine the sensor and electronics to be more universal in application, and add signal processing to increase accuracy and automate decision making. Active Signal will test the upgraded system on healthy volunteers until satisfied it produces zero false positive, and then will produce and deliver two units to STC for the clinical study. The STC will evaluate approx. 300 head-injured patients using the BAM upon admission and track approx. 100 receiving invasive monitors throughout their treatment. Correlations will be made between BAM indications and clinical evaluation on admission needs for subsequent interventions and outcome. Upon Phase II's conclusion this new non-invasive technology will achieve a statistically-demonstrated operational accuracy, currently available only with invasive techniques or CAT/MRI scans, thereby significantly increasing accessibility and reducing costs of brain-injury assessment.
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