Soterix Medical meets EU requirements for 1x1 tDCS Depression Therapy.
M2 PHARMA-December 30, 2015-Soterix Medical meets EU requirements for 1x1 tDCS Depression Therapy
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Soterix Medical Inc, a provider of non-drug treatment options for patients with depression, announced on Tuesday that it has received CE Mark approval for its 1x1 tDCS Therapy System, used to treat Major Depressive Disorder (MDD), which meets the requirements of the European Union (EU) authorities with extensive clinical efficacy and safety evidence to support the role of 1x1 tDCS in treating depression.
According to the company, CE Mark approval for the x1 tDCS Therapy System is based on data from four studies that collectively demonstrate the safety and efficacy of 1x1 tDCS Therapy in depressed patients across a broad range of antidepressant treatment resistance. Two of the studies showed sustained benefit through one month of follow-up in most patients, with only 12% of patients experiencing a relapse of illness. One study which tested continuation tDCS in a prolonged 6 month follow-up phase noted mean response duration of 11.7 weeks.
The company stated that 1x1 tDCS Therapy is a non-invasive, non-systemic therapeutic device that delivers low-intensity direct current to a region of the cerebral cortex, the part of the brain that controls mood. It added that 1x1 tDCS is said to be a highly-promising therapy for adults living with MDD without the systemic side effects commonly associated with oral antidepressant medications. The treatment is only available by prescription only in approved markets.
Soterix Medical added that 1x1 tDCS is typically administered daily for three weeks with additional continuation sessions administered weekly for a total of around 20 sessions.
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|Date:||Dec 30, 2015|
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