42% Response Rate in Patients Who Did Not Respond to Other Treatments in a Double Blind Placebo Controlled Study
JERUSALEM, Sept. 30, 2014 -- Brainsway® Ltd. (TASE:BRIN) is pleased to report substantial improvement in OCD (Obsessive-Compulsive Disorder) patients following Brainsway Deep TMS therapy in a clinical study held in Sheba Medical center, Tel Ha'Shomer, Israel.
The study, whose principal investigator was Prof. Joseph Zohar, who was the chairperson of the anxiety and OCD section of the World Psychiatric Association (WPA), included 41 OCD patients who did not respond adequately to medication or psychotherapy treatment. In this double-blind placebo-controlled study, participants were divided into three groups - a high frequency group (20Hz), low-frequency group (1Hz), and control group. The study utilized the YBOCS questionnaire, which is the gold standard for evaluating OCD symptom severity.
In the final study results, the high frequency group patients (20Hz) showed a 27% improvement in symptom severity, on average, as measured by the YBOCS questionnaire. This improvement was found to be statistically significant when compared with the control group patients (p=0.0002).
The percentage of patients who responded to the treatment was 42% in the high frequency group, compared to 7% in the control group, with the response to the treatment defined as a decrease of at least 30% in the symptom severity.
Since the participants had previously experienced psychological and pharmacological treatments, the results of the study indicate a significant response in patients who did not sufficiently respond to a common treatment. Brainsway is currently conducting a multi-center study across the United States, which thoroughly examines the impact of Brainsway Deep TMS on OCD patients.
The information in this report includes a description of the results of a clinical trial covering a limited number of subjects. The results do not necessarily indicate the effectiveness of the company's device for treating OCD and there is no certainty of this effectiveness, and the effectiveness is subject to successful completion of additional clinical studies which could continue for a long period of time, and there is no certainty of the duration of time that would be required for completing the licensing procedure for the treatment of OCD using Brainsway's device, and regarding the success of this procedure and the costs involved.
Brainsway Ltd. is dedicated to the development and marketing of dTMS (deep Transcranial Magnetic Stimulation) systems, for treatment of brain disorders. The unique technology of Brainsway is based on patents filed by the National Institute of Health (NIH), and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Brainsway's technology was cleared by the FDA for treatment of depression patients who did not respond to any number of medication treatments in the current depressive episode. Brainsway's dTMS was enthusiastically received by the international academic community, with 60 clinical trials held in major institutions worldwide.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.