NeuroSigma Receives FDA Breakthrough Device Designation for Monarch eTNS System®
LOS ANGELES, Feb. 22, 2022 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a bioelectronic medical device company, today announced FDA Breakthrough Device Designation for its Monarch eTNS System® for “adjunctive use for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to two or more antiepileptic medications.” The FDA’s Breakthrough Device Program is designed to give patients more timely access to novel technologies, like the Monarch eTNS System, that provide more effective treatments for life-threatening or irreversibly debilitating human diseases and conditions.
Drug-resistant epilepsy (DRE) occurs in approximately 30% of epilepsy patients, resulting in significant complications including increased risk of death, psychological disorders, and other severely debilitating conditions. It is widely recognized that alternatives to antiepileptic drugs (AEDs) and surgery are a significant unmet medical need, especially for patients with incomplete seizure control who may not be candidates for, or wish to avoid the risks of, surgery and implantable devices.
“We are delighted to achieve Breakthrough Device Designation for the Monarch eTNS System. Clinical trials of the device in patients with DRE have shown impressive results comparable to those achieved with adjunctive pharmaceutical and implantable device therapies,” commented Dr. Colin Kealey, President of NeuroSigma. “This Breakthrough Device Designation will expedite completion of a pivotal trial of external trigeminal nerve stimulation (eTNS) therapy for DRE. We are confident the Monarch eTNS System can become an important therapeutic option for the millions of patients worldwide who continue to suffer from seizures despite medication therapy.”
The Monarch eTNS System has demonstrated encouraging clinical trial results. Most recently, results from a clinical trial performed at the Hospital Clinic de Barcelona in Barcelona, Spain were published in the journal Brain Stimulation. Forty subjects with DRE were randomized to receive either eTNS with the Monarch eTNS System or their usual medical treatment. Subjects were followed for one year and evaluated for changes in seizure frequency, side effects and quality of life. At the 6 and 12-month timepoints, there was a 50% responder rate in subjects receiving eTNS versus a 0% responder rate among subjects randomized to the control group (p < 0.001). Similarly, after 12 months there was a median reduction in seizure frequency of 43.5% in the eTNS group versus 0% in the control group (p = 0.0013). There were no significant adverse events associated with use of eTNS, and the treatment was well tolerated for the duration of the trial.
“With an FDA clearance for pediatric ADHD and now Breakthrough Device Designation for DRE, NeuroSigma continues to demonstrate the Monarch eTNS System is a safe and effective alternative to drug-based or surgical treatments for an expanding number of serious diseases,” commented Tom Paschall, Director of NeuroSigma. “As a noninvasive, wearable therapy, the Monarch eTNS System is an exciting alternative to drugs, implantable devices, and brain surgery and avoids many of their negative side effects.”
NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients' lives. The company is developing therapies to treat a wide spectrum of neurological and neuropsychiatric disorders, including ADHD, drug-resistant epilepsy, and depression. The company is currently commercializing the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.