NeuroSigma Receives CE Certification

NeuroSigma Receives CE Certification PR Newswire LOS ANGELES, September 5, 2012 - Prepares for Fourth Quarter 2012 European launch of eTNS, its non- invasive treatment for epilepsy and depression LOS ANGELES, September 5, 2012 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that it received CE Certification for its external Trigeminal Nerve Stimulation (eTNS™) system, called the Monarch™, for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older. NeuroSigma's approval was supported by years of safety and compelling efficacy data generated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California (USC). The eTNS system will be sold under prescription from a physician in the European Union (EU). It is composed of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily. The patches can be worn primarily in the evening while asleep. In clinical studies, eTNS was well tolerated and has been shown to substantially reduce seizures in patients with epilepsy and improve mood in patients with depression. Planning is underway for the introduction of this treatment at major EU epilepsy and depression centers. NeuroSigma is establishing a marketing, sales, and distribution infrastructure for a fourth quarter 2012 product launch in the EU.