(K. Moxon, M. Sperling, and A. Sharan)

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Abstract: Epilepsy affects between 0.5 to 1.0% of the U. S. population, well over 3 million people. Approximately 20% of these patients do not respond to the best available treatments and continue to have intractable seizures. The economic effect of these numbers and the overall burden to the U.S. health care system is approximately $17.6 billion. Our product is a closed-loop seizure control device that will record neuronal data, predict that a seizure is imminent and stimulate the neural tissue to disrupt the onset of the seizure. While the idea of a closed-loop neuromodulation system is not new, all previous attempts used electroencephalography (EEG) signals. Our approach, using the activity of multiple single neurons, is unique and we were the first to demonstrate this possibility in a rat model and currently the only research group with the technology to test this approach in humans. While our preliminary data in rats is impressive, the goal of this proposal is to provide confirmation of our algorithm to detect seizures and the ability of our sensor to record neural activity in human subjects. Successful completion of our project will deliver compelling human proof-of-concept data in 7-10 patients. This data with the associated IP would be presented to investors (e.g. for a de-novo start-up) and/or to strategic partners (e.g. device companies) for funding in return for an option to license. This approach would provide a timely return on the initial investment from this program. Alternatively, there are two additional licensing opportunities that arise at logical points along the path to commercialization. Successful completion of each phase of commercialization represents a significant decrease in the risk to investors and increase in the value of the IP and, therefore, a greater return on investment to the program. Based on other neurostimulation devices (e.g. for Parkinsons disease) we expect full reimbursement of cost to the patient for this device and adoption by physicians and patients. As an example using today’s numbers, if this device could capture 1% of the market (currently 574.6 thousand patients with intractable epilepsy) and was sold for $10,000, revenue of $57.6 M could be generated. The Team consists of the inventor Dr. Moxon, a world leader in research and clinical care for epilepsy Dr. Michael Sperling and well-established neurosurgeon Dr. Ashwini Sharon, with expertise in surgeries for epilepsy.