LOS ANGELES, July 29, 2013 /PRNewswire/ --NeuroSigma, Inc., today announced conditional approval by the U.S. Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) application to commence a Phase III pivotal trial of theMonarch eTNSSystem for treatment of drug resistant epilepsy. The Company is planning to conduct a multi-center trial at leading medical institutions in the U.S., Europe and Canada. The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a PreMarket Approval (PMA) application to the FDA.
In earlier Phase 1 and Phase 2 clinical trials of external Trigeminal Nerve Stimulation (eTNS), over 40% of patients treated showed a 50% or greater reduction in seizures. "We are eager to take this next key step in the regulatory approval process of eTNS in the United States," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "We believe a safe, non-invasive and affordable alternative to pharmaceuticals and invasive treatments is urgently needed by the 50-million people with epilepsy worldwide."
The Monarch eTNS System is currently available with a physician's prescription in the European Union and Canada as adjunctive treatment of epilepsy and depression, for adults and children 9 years and older.
About TNS and The Monarch eTNS System
The Monarch eTNS System is composed of an external electric pulse generator and an electric patch, which is attached to a patient's forehead to safely stimulate branches of the trigeminal nerve through the skin. The electric patch needs to be replaced daily for effective therapy and can be worn primarily in the evening while asleep. In clinical trials, eTNS has been well tolerated and found to substantially reduce seizures in patients with epilepsy and reduce symptom severity in patients with depression, PTSD and ADHD. For more information on the Monarch eTNS System, please visit the Monarch website.
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.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located very close to the surface of the face. The low-energy stimulus is confined to the soft tissues of the face without direct penetration into the brain. PET imaging studies in humans confirm that eTNS alters the activity in key regions implicated in these disorders and the changes were observed within minutes of therapy.
NeuroSigma is the exclusive worldwide licensee ofUCLA's entire TNS intellectual property portfolio and continues to develop additional technologies and target additional indications.
CAUTION:IntheUnited States, both eTNS and sTNS are investigational devices and are limited by Federal (orUnited States) law to investigational use.
eTNS,sTNS,Monarch,andMonarch eTNSare trademarks of NeuroSigma, Inc.
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NeuroSigma Announces FDA Approval to Commence Phase III Trial