NeuroSigma receives FDA approval to begin Phase III trial of Monarch eTNS System for epilepsy

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 the Monarch™ eTNS™ System 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 Pre‐Market 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.