MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NeuroPace, Inc. today announced the company’s RNS System received the industry’s Most Promising New Product Award at the 2015 Phoenix Medical Device CEO Conference, the 22nd annual conference of medical device and diagnostic industry executives. The award, chosen by leaders in the industry, recognizes the RNS System as the most promising new product of the year.
“We are honored that our RNS System was recognized by industry leaders at the 2015 Phoenix Medical Device CEO Conference,” said Frank Fischer, CEO of NeuroPace. “The ability to deliver targeted brain stimulation when it’s needed has often been life-changing for people living with epilepsy, and it is humbling to see our peers recognize the impact of the therapy. Beyond the hundreds of thousands of people diagnosed with epilepsy in the U.S. who are unable to achieve seizure control with medications, we believe there is immense potential for the RNS System to be used in the treatment of other neurological disorders. As a closed-loop system, the RNS System continuously monitors the brain and has the ability to deliver stimulation when needed, then monitors the response. We’re learning so much about the brain and its response to stimulation that I’m as excited about the potential for future developments as I am about the current product.”
The RNS System includes the RNS Neurostimulator, a small implantable device, and leads (tiny wires) placed near up to two seizure onset areas. 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 aspects of the RNS System include 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 and monitoring the response.
The RNS System is the only epilepsy therapy that also provides physicians with clinically meaningful ongoing data about their patients’ seizure frequency and brain electrical activity. Each patient has an easy-to-use remote monitor at home to wirelessly collect and upload data from their neurostimulator. The data is made available to their doctor to review and analyze to help improve patient care. For many medically refractory partial-onset epilepsy patients who are not candidates for epilepsy surgery, the RNS System provides a clinically proven therapy option to reduce seizure frequency and improve quality of life.
Long-term benefits of the RNS System were recently published in Neurology, demonstrating that the RNS System significantly reduces seizure frequency among adults who have a common form of epilepsy that is difficult to treat with medication. The published interim study results include data on 230 people with medically intractable partial onset epilepsy enrolled at 33 Comprehensive Epilepsy Centers in the United States. The study confirmed the long term effectiveness of RNS System therapy. Median seizure frequency reductions compared to patients’ pre-implant seizure frequencies ranged from 60-66% in years 3 through 6 post-implant. At this time, some patients have been treated with the RNS System for more than 11 years, and more than 1,700 patient years of experience with responsive neurostimulation have been accumulated to date.
Findings from another study, recently published in Epilepsia, demonstrated that people treated with the RNS System showed no adverse effects on cognition. These results are clinically meaningful because it is common for people living with epilepsy to experience adverse effects in many cognitive areas, including memory function, mental processing and reasoning, verbal communication, and decision making.
The RNS System was FDA approved in November 2013 to treat adults with partial onset seizures that are not controlled by medication. Approximately 65 million people worldwide have epilepsy, including nearly 3 million Americans. Epilepsy is the fourth most common neurological disorder in the country, and an estimated 150,000 new cases of epilepsy are diagnosed every year. There are as many people with epilepsy as with autism spectrum disorders, Parkinson’s disease, and multiple sclerosis combined.
About the RNS® System
The RNS System is the first and only closed-loop brain-responsive neurostimulation system designed to prevent epileptic seizures at their source. When detection thresholds are met, the device delivers imperceptible levels 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.
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.