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H1 Coil for Major Depression
"BrainsWay’s treatment was cleared by the FDA in 2013 for patients who tried any number of antidepressants with no improvement in the current depressive episode. The FDA indication is based on a unique 16-week double-blind, placebo-controlled, multi-center study which enrolled over 200 subjects, and reported a marked decline in HDRS-21 scores, as well as significant remission (32.6%) and response (38.4%) rates at the primary endpoint of the study after four weeks of acute treatment. In the study, treatment with BrainsWay’s H-1 coil helmet was proven to be safe, and the treatment was well tolerated by the majority of the study subjects. The H1 Coil is also in clinical trials at various stages for the treatment of Bipolar Disorder, Post-Traumatic Stress Disorder and Schizophrenia."