US-based Soterix Medical has received CE Mark approval for its 1×1 tDCS therapy system to treat major depressive disorder (MDD), a mental disorder.
MDD is characterised by a pervasive and persistent low mood that is accompanied by low self-esteem and by a loss of interest or pleasure in normally enjoyable activities.
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The system is a non-invasive and non-systemic therapeutic device, which offers a low-intensity direct current to a region of the cerebral cortex, the part of the brain that controls mood.
It is designed to modulate nerve cells in an area of the brain that is linked to depression by delivering low-intensity current fields.
The company noted that 1×1 tDCS is a better therapy for adults living with MDD without systemic side effects commonly associated with oral antidepressant medications.
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Soterix Medical Europe business vice-president Shani San Solo said: "There is a significant need to extend non-drug treatment options to patients with depression, as not all patients respond to drug therapy.
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By GlobalData"The CE Mark for 1×1 tDCS therapy system is an important milestone as it signifies that we have met the requirements of the European Union authorities with extensive clinical efficacy and safety evidence to support the role of 1×1 tDCS in treating depression.
"This announcement also allows commercialisation of the 1×1 tDCS system in countries in Asia and Latin America that recognise the CE Mark."
Approval was based on data from four studies, which showed the safety and efficacy of 1×1 tDCS therapy in depressed patients across a wide range of antidepressant treatment resistance.
The company said that two of the studies showed sustained benefit through one month of follow-up in a majority of patients, with only 12% of patients experiencing a relapse of illness.
One study that tested continuation tDCS in a prolonged six month follow-up phase noted a mean response duration of 11.7 weeks.
