This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
BrainsWay’s Deep TMS technology is based on the H-Coil, which features a novel patented structure that maximizes electrical stimulation of deep brain regions and includes the following unique features:
BrainsWay’s technology is based on a patent registered by the U.S. National Institutes of Health (NIH). BrainsWay has an exclusive license from the NIH for both the patent and the technology.
BrainsWay’s Deep TMS technology includes a double-blind system that enables researchers to easily conduct randomized studies. The system includes smart cards that are randomized between the patients. At the beginning of each treatment, the patient’s individual smart card is inserted into the card reader, automatically activating either the real or the sham coil, which are both located in the patient’s head set. Both coils produce similar scalp sensations and acoustic artifact, so that neither the patient nor the caregiver knows whether the treatment taking place is real or sham.
BrainsWay’s Deep TMS technology can be used to stimulate a wide variety of brain regions and networks. It can easily be applied to diverse clinical applications by designing coils that target different locations, depths, directionalities & morphologies relevant to target neuronal structures, and usage of different protocols during treatment.
The following is a list of brain regions that have been stimulated in various studies using BrainsWay’s technology: lateral and medial prefrontal cortex (PFC), including ventral PFC, Orbitofrontal cortex, right & left Insular cortex and entorhinal cortex, anterior cingulate cortex, posterior cingulate cortex, lateral and medial motor cortex, including deeper leg motor cortex, premotor cortex, supplementary motor area, precuneus, right and left temporal cortex structures, including fusiform face area (FFA) & superior temporal sulcus (STS), parietal cortex regions, occipital cortex regions, auditory cortex, visual cortex and cerebellum.
BrainsWay’s treatment has been cleared by the FDA** for patients who tried any number of antidepressants with no improvement (in the current depressive episode). The FDA indication is based on a unique long-term 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 4 weeks of acute treatment. In the study, BrainsWay’s treatment was proved to be safe, and the treatment was well tolerated by the majority of the study subjects.
BrainsWay’s treatment has CE marks* for the following brain disorders: