NEW YORK--(BUSINESS WIRE)--Soterix Medical, Inc. announced today the receipt of CE Mark approval for its 1x1 tDCS ™ Therapy System for the treatment of Major Depressive Disorder (MDD). The decision is based on data from four studies, collectively that 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 a majority of patients, with only twelve percent 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.
“There is a significant need to extend non-drug treatment options to patients with depression, as not all patients respond to drug therapy,” said Shani San Solo, VP Europe Business for Soterix Medical, Inc. “The CE Mark for 1x1 tDCS Therapy System is an important milestone as it signifies that we have met 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. This announcement also allows commercialization of the 1x1 tDCS System in countries in Asia and Latin America that recognize the CE Mark.”
Soterix Medical 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. 1x1 tDCS is a highly-promising therapy for adults living with MDD without the systemic side effects commonly associated with oral antidepressant medications.
Dr. Abhishek Datta, Soterix Medical CTO explains, “The 1x1 tDCS Therapy system is the first device for transcranial Direct Current Stimulation that provides clinical grade quality, controls, and features. The CE Mark approval for the 1x1 tDCS certifies that the 1x1 tDCS Therapy system can be used immediately for many adults in EU with depression supporting Soterix Medical’s mission to provide relief to patients around the world.”
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.
Depression is a common illness worldwide, with an estimated 350 million people affected, according to the World Health Organization. People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiety, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems.
About Soterix Medical 1x1 tDCS Therapy™
1x1 tDCS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation. It modulates nerve cells in an area of the brain that has been linked to depression by delivering low-intensity current fields. The treatment is typically administered daily for 3 weeks with additional continuation sessions administered weekly for a total of around 20 sessions. 1x1 tDCS is available by prescription only in approved markets. Typical side effects are mild including itching and skin redness that resolve shortly after treatment. For more information, visit SoterixMedical.com.