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NeuroPace RNS® System Will Play a Key Role in DARPA's Groundbreaking Restoring Active Memory (RAM) ProgramMOUNTAIN VIEW, Calif. --(Business Wire)-- NeuroPace, Inc. today announced its partnership with the Defense Advanced Research Projects Agency (DARPA) Restoring Active Memory (RAM (News - Alert)) teams at the University of Pennsylvania and the University of California, Los Angeles (UCLA) to develop new treatments for memory deficits using neurostimulation. The RNS® System is the world's only commercially available implantable closed-loop responsive neurostimulator system. NeuroPace received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the RNS System in November 2013. It is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs. Through the DARPA RAM research, NeuroPace and other collaborators will gain fundamental knowledge regarding the restoration of memory. The company believes this research may expand the clinical applications of the RNS System beyond the treatment of epilepsy, as well as provide the understanding necessary to inform the development of future devices that expand the capabilities of responsive neurostimulation. This collaborative effort will advance the field of brain research and closed-loop neurostimulation applications. A portion of the DARPA project will involve epilepsy patients implanted with the RNS System at seven Comprehensive Epilepsy Centers and will be led by Dr. Barbara Jobst, Professor of Neurology at Dartmouth, and Dr. Martha Morrell, Chief Medical Officer at NeuroPace and Clinical Professor of Neurology at Stanford University. A separate part of the project will begin with epilepsy patients implanted with the RNS System at UCLA with Itzhak Frid, MD, PhD, serving as the principal investigator. "Using the RNS System, we will be able to immediately explore ways in which brain stimulation can restore memory function in patients with epilepsy. Insights derived from these early studies will help to guide future research in patients with other neurological disorders that result in memory loss," said Michael Kahana, PhD, principal investigator at the University of Pennsylvania. As a closed-loop system, the RNS System monitors the brain's own signals, interprets those signals, provides stimulation when needed, and then assesses the brain's response. The breakthrough aspect of the RNS System is its advanced detection and stimulation capabilities. This is unlike all other existing neurostimulation therapies, which continuously or intermittently stimulate the brain without determining the need for treatment or monitoring the response. "The RNS System is the only commercially available product that continuously monitors the brain's electrical signals, delivers stimulation only when needed and then monitors the response," said Frank Fischer, CEO at NeuroPace. "This capability is critical to the research phase of projects like the DARPA RAM program. Restoring active memory could improve the lives of so many. We are thrilled to be a part of this program and hope to be part of similar brain research and product development projects in the future." About the RNS® System The RNS System is the first closed-loop responsive brain stimulation system. The system is designed to treat partial onset seizures by detecting specific types of electrical activity in the brain through leads containing electrodes that are placed near the patient's seizure focus or foci. When detection thresholds are met, the device delivers small bursts of electrical stimulation intended to reduce the frequency of seizures. Physicians can program the detection and stimulation parameters of the implanted RNS Neurostimulator non-invasively to customize therapy for each individual. Indication for Use: The RNS® System is an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than two epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and / or secondarily generalized seizures). The RNS® System has demonstrated safety and effectiveness in patients who average three or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures. About NeuroPace NeuroPace designs, develops, manufactures and markets implantable devices for the treatment of neurological disorders. The company's initial focus is the treatment of epilepsy, a debilitating neurological disorder affecting approximately one percent of the population worldwide. An estimated 30-40 percent of the 65 million people worldwide (including nearly three million Americans) with epilepsy experience uncontrolled seizures. In addition to treating epilepsy, responsive neurostimulation holds the promise of treating several other disabling neurological disorders that negatively impact quality of life for millions of patients throughout the world. Located in Mountain View, California, NeuroPace is a privately held company.
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