NeuroSigma wins an FDA green light for Phase III clinical trials

July 29, 2013 by Sony Salzman

California medical device maker NeuroSigma lands FDA investigational device exemption to launch Phase III studies of its epilepsy treatment in support of U.S. approval.

NeuroSigma

NeuroSigma is one step closer to bringing its epilepsy treatment to U.S. markets with FDA approval to begin its Phase III clinical studies.

Currently only available for investigational use in the U.S., NeuroSigma's Monarch eTNS system is already on the shelves in Europe and Canada. Earlier studies have shown a 50% reduction in seizures for 2/5 of epilepsy patients treated, NeuroSigma said.

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The Los Angeles, Calif.-based company plans to launch new trials at medical centers in the U.S., Canada and Europe to support its pre-market application with the FDA.

The Monarch eTNS device generates an electrical pulse which is transmitted to the patient through the skin via a patch attached to the forehead. The pulse targets the largest cranial nerve and PET scans show that this stimulus targets regions affected by epilepsy.

"We are eager to take this next key step in the regulatory approval process of eTNS in the United States," CEO Leon Ekchian in prepared remarks. "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."

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