NeuroSigma's Monarch eTNS System to be Unveiled in London

Posted: Published on September 25th, 2012

This post was added by Dr Simmons

LOS ANGELES, Sept. 25, 2012 /PRNewswire/ --NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that its Monarch eTNS system for the adjunctive treatment of epilepsy and depression will make its debut at the 10th European Congress on Epileptology, which takes place in London, England from September 30 to October 4, 2012.

"This conference represents an outstanding opportunity to put the Monarch in the hands of many healthcare professionals who will be future advocates of the system in the European Union. Our team looks forward to forming alliances and introducing a new paradigm for the management of epilepsy," said Leon Ekchian, Ph.D., NeuroSigma's President & CEO.

NeuroSigma was invited by the conference organizers to lead a Satellite Symposium on September 30th, focused on trigeminal nerve stimulation (TNS) for the treatment of epilepsy and neuropsychiatric disorders. The presentations on eTNS will cover the following topics:

The presenters will be Christopher DeGiorgio, M.D., NeuroSigma's Vice-President, Neurology, and Professor of Neurology at UCLA, Ian Cook, M.D., NeuroSigma Senior Medical Advisor and Professor of Psychiatry at UCLA and Colin Kealey, M.D., NeuroSigma's Manager of Business Development. The symposium will include the first public presentation of long-term data on the efficacy of eTNS for the treatment of epilepsy. Dr. DeGiorgio will also participate in an additional panel discussion, Devices and Epilepsy: the Future, on Wednesday, October 3rd.

NeuroSigma is preparing for a fourth quarter 2012 commercial launch of the Monarch in the European Union.

Background The Monarch System

The Monarch eTNS system, which is CE-marked in the European Union, will be sold under prescription from a physician. It is composed of an external pulse generator and electric patches placed on the forehead, which are replaced daily. The patches can be worn primarily in the evening while asleep. In clinical trials, eTNS has been both well-tolerated and shown to substantially reduce seizures in patients with epilepsy and improve mood in patients with depression.

Background - TNS

There are two embodiments of trigeminal nerve stimulation: eTNS (the Monarch system) and sTNS (subcutaneous electrodes and implantable pulse generator, currently being developed). TNS stimulates branches of the trigeminal nerve, which are located very close to the surface of the skin in the forehead. The low-energy stimulus is confined to the soft tissues of the forehead without direct penetration into the brain.

The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain. The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD and other disorders. PET imaging studies in humans confirm that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy. Many patients may elect to be treated with the external eTNS system, but once approved by regulatory agencies, patients who respond well to eTNS may opt for the implantable sTNS system.

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NeuroSigma's Monarch eTNS System to be Unveiled in London

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