This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay D is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
JERUSALEM – Brainsway® Ltd (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced the final results of a study testing the efficacy of Brainsway Deep TMS for senior patients suffering from geriatric major depression. The results show that Brainsway Deep TMS is safe for treating these patients, and has significant beneficial effects on depressive symptoms. No significant side effects were reported.
The experiment was held in Shalvata Medical Center in Hod Hasharon, Israel, headed by Dafna Shefet, M.D. The study included 14 patients aged 64 or older, who received 20 Deep TMS treatments over 4 weeks.
The results showed a significant average improvement of 5.07 points in the HDRS (Hamilton Rating Scale for Depression) rating, which measures the depressive level, and a significant improvement of 5.29 points in the HARS scale (Hamilton Anxiety Rating Scale), measuring the anxiety level, after 4 weeks of treatment.
Furthermore, statistical results from several U.S. clinics that treat depression patients using Brainsway Deep TMS show that out of 27 patients suffering from geriatric depression, 12 patients (44%) reached remission, and 17 patients (63%) reached a significant response after 20 treatments. The impact of the treatment was measured using the PHQ-9 questionnaire, a standard depression rating scale.
The information in this report is a description of final results of a clinical experiment which included a small number of patients, as appeared in the chief researcher’s report, and in the results of commercial treatments performed with the company’s device. The results do not necessarily testify to the device’s efficacy for treating geriatric depression, and there is no certainty of this, and it is subject to further clinical studies to be held using the device. Additionally, there is no certainty of the length of time required for completing the procedure of expanding the license of the company’s device for treating depression in geriatric patients, and of the success of this procedure and the costs involved in it.
Brainsway is dedicated to research, development and marketing of medical systems for non-invasive treatment of common brain disorders. Brainsway’s medical system is based on a unique revolutionary technology called Deep TMS, which enables reaching deep brain areas and generating neural stimulation or inhibition. The company’s systems are sold around the world, and are backed by CE and FDA clearances, as well as medical insurance coverage, held by 70% of US population. The main focus of the company at present is commercializing and deepening penetration of the US market, especially relating to severe depression.