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.
Epilepsy and depression are major health concerns in the EU, with approximately 4 million people suffering epilepsy and 20 million experiencing clinical depression.
"We are proud to successfully complete the CE marking process. It is a major milestone for NeuroSigma and will enhance our efforts to transform the way epilepsy and depression are managed. I would like to thank all of our employees, suppliers, clinical trial sites and consultants for their hard work and all our investors for their support," said Lodwrick Cook, Chairman of NeuroSigma.
"As a company, we are committed to making eTNS affordable and widely available in the EU," added Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "We are excited to begin the rollout of our commercialization strategy for patients suffering from epilepsy and depression. Simultaneously, we will seek to obtain approvals in other parts of the world. In the United States, we will be submitting a request to the FDA for an Investigational Device Exemption (IDE) to commence a multi-center eTNS pivotal trial in epilepsy. Over thirty major centers in the US and Europe have expressed interest in being part of this pivotal trial."
Trigeminal nerve stimulation was invented at UCLA and is exclusively licensed to NeuroSigma.