Depression-treating neuromod developer Soterix Medical said yesterday it won CE Mark approval in the European Union for its 1×1 tDCS therapy system designed to treat major depressive disorder.
The 1×1 tDCS system is a non-invasive therapeutic device that uses low-intensity direct current to stimulate a region of the cerebral cortex that controls mood, according to the company.
“There is a significant need to extend non-drug treatment options to patients with depression, as not all patients respond to drug therapy. 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 commercialization of the 1×1 tDCS System in countries in Asia and Latin America that recognize the CE Mark,” Soterix europe business veep Shani San Solo said in a press release.
The approval was based on data from 4 studies of the device which reported safety and efficacy data in patients with antidepressant treatment resistant that were treated with the device, demonstrating appropriate safety and efficacy. In 2 studies, data suggested sustained benefit through 1 month of follow-up in the majority of patients, with only 12% relapsing.
“The 1×1 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 1×1 tDCS certifies that the 1×1 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,” CTO Dr. Abhishek Datta said in a prepared statement.
The 1×1 tDCS device has investigational device exemption clearance in the U.S., but is not cleared for use, the company said.