In this phase I, Koronis Biomedical Technology Corporation (KBT) proposes to develop and evaluate a prototype device that provides non-invasive, real-time intracranial pressure (ICP) monitoring. The proposed device will measure ICP with the simplicity of a hearing testing using Otoacoustic Emissions (OAE). Monitoring of intracranial pressure is critically important in many neurosurgical patients. There is a clear need for ongoing real time assessment of ICP in the management of acutely ill patients. The existing methodologies for assessing intracranial pressure are all invasive and carry with them some inherent risks. A non-invasive, accurate, and re-producible method of following the intracranial pressure has great value in this patient population. The initial market is aimed at an assessment tool to track ICP changes for mild and moderate Traumatic Brain Injury (TBI) patients. Currently there are no assessment tools for these patients other than subjective observational tests. The proposed device provides an optional assessment tool where current invasive tools are not available or are prohibitive due to cost or risk to the patient.
There is significant need for an assessment tool for patients suffering from mild or moderate Traumatic Brain Injury. An estimated 1.75 million TBI's occur annually in the US with related health care costs estimated to be $10 billion.
