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Results Reported for Phase Ib Open-Label Clinical Trial for the Treatment of Depression Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
Date:5/8/2012

This Phase Ib study was an open-label clinical trial of eTNS™ therapy in adults with non-psychotic unipolar MDD that had lasted more than 4 months and had not responded to at least one antidepressant, with a median of 4 medication failures.  Clinical improvements were consistently found across several different ways to measure symptom burden.  

The TNS technology, including eTNS™ for the treatment of depression, was invented and originally developed at UCLA.  NeuroSigma, Inc., a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice, is the exclusive worldwide licensee of UCLA's TNS intellectual property.  "We are extremely pleased to be working closely with Dr. Cook and his talented and dedicated team at UCLA," said Dr. Leon Ekchian, President and CEO of NeuroSigma.  "We look forward to helping make his vision of a safe, non-invasive, non-pharmacological therapy for depression available to patients worldwide."

NeuroSigma has completed development of its external TNS (eTNS™) system and is developing its implantable subcutaneous TNS (sTNS™) system.  Once approved by regulatory agencies, patients who respond well to eTNS™ can opt to switch to the implantable sTNS™ system.  Near term milestones include filing a CE Mark application in mid-2012 for approval to commence marketing the eTNS system for the treatment of epilepsy and depression in Europe, and in the second-half of 2012, NeuroSigma is planning to file an IDE with the FDA for a multi-center epilepsy Phase III pivotal trial in the United States. 

Background – TNS

NeuroSigma's eTNS™ system is a non-invasive therapy, which utilizes a self-adhesive conductive pad applied to the forehead to stimulate branches of the trigeminal nerve, which are located very close to the surface of the skin of th
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