NeuroSigma starts trial for Monarch eTNS System for Epilepsy
NeuroSigma, Inc., announced conditional approval by the FDA of its Investigational Device Exemption (IDE) application to commence a Phase III pivotal trial of the Monarch eTNS System for treatment of drug resistant Epilepsy.
The Company plans 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 Pre-Market Approval (PMA) application to the FDA.
In Phase 1 and Phase II clinical trials of external Trigeminal Nerve Stimulation (eTNS), over 40% of patients treated showed a 50% or greater reduction in seizures.
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.
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