BrainsWay Ltd. products

In 2018, BrainsWay’s Deep TMS technology was cleared by the FDA (De Novo) for the treatment of Obsessive-Compulsive Disorder. In 11 medical centers worldwide, patients who had not responded to SSRIs and/or psychotherapy and received treatment for six consecutive weeks experienced a significant reduction in their OCD symptoms. BrainsWay’s H7 Coil, specifically designed to treat the anterior cingulate cortex, is the only TMS technology platform cleared by the FDA for this purpose.

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.