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These statements are based on current expectations of future events.

If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Join PR Newswire for Journalists to access all of the free services designated to make your job easier. Submit a free Prof Net request and find the sources you need.

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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 near the surface of the forehead.

Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions. Food and Drug Administration has given Neuro Sigma approval to proceed with a pivotal Phase III clinical trial of e TNS in drug-resistant epilepsy.

We look forward to confirming these results in this Phase II clinical trial under double-blind controlled conditions.

A neuromodulation treatment option for ADHD could avoid concerns about the exposure of children to the psychostimulant medications that are the current first-line treatments." Background – The Monarch e TNS System from Neuro Sigma In , Neuro Sigma received CE Mark approval to market Neuro Sigma's first trigeminal nerve stimulation (TNS) product, the Monarch™ e TNS™ System, in the European Union, for the adjunctive treatment of epilepsy and major depressive disorder (MDD) for adults and children nine years and older.


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