JERUSALEM, June 5, 2014 - Brainsway® Ltd. (TASE: BRIN) is pleased to announce the final results for a study examining the safety and effectiveness of Brainsway's technology for treating major depressive disorder patients (the "Study") who did not respond to medication treatments, held at the Douglas Mental Health Institute of McGill University in Canada.
According to the study results, Brainsway's dTMS treatment is efficacious and safe for treating major depressive disorder patients who did not respond to medication treatments.
The Study results were obtained for 15 subjects (the Study initially included 17 subjects), who did not respond to various types of antidepressants in the current episode (failure of long-term treatments including at least three types of antidepressants). Each patient underwent a series of 5 treatments a week at a high frequency, with double the amount of pulses used in previous studies. The treatment was administered over 4 weeks, and the main clinical outcomes (using the standard measures as detailed below) were evaluated a week after the end of the treatments.
Depression was examined using the Hamilton Depression Rating Scale (HAM-D) and the Quick Inventory of Depressive Symptomatology (QIDS-SR). Anxiety symptoms were examined using the Hamilton Anxiety Rating Scale (HAM-A) and the Beck Anxiety Inventory (BAI).
The Study results show that 12 patients (70.62%) had a significant response to the treatment, with a significant response defined as a decrease of at least 50% in the standard HAM-D depression score. Moreover, 7 patients (41.2%) achieved remission. A significant improvement was evident in both HAM-A and HAM-D scores (p<0.0001), in QID-SR (p<0.003), BAI (p<0.004), as well as in the Clinical Global Impression - Severity (CGI-S ) score (p<0.0001).
No severe side effects were observed during the Study.
The researchers stated that according to the Study results, Brainsway's device is safe and efficacious for treating severe major depression patients who did not respond to at least 3 antidepressant medications in the current episode. They also stated that brain imaging research would enable a systematic examination of the treatment mechanism and effects.
The information in this report includes a description of the results of a clinical trial covering a limited number of subjects, as appears in the head researcher report. The results do not necessarily indicate the effectiveness of the device for treating severe major depression and anxiety symptoms in patients suffering from severe major depression. The results do not indicate the certainty of this effectiveness, and the effectiveness is subject to completion of the Study, and to additional clinical studies based on Brainsway's device. Furthermore, there is no certainty regarding the timeframe required for completion of the licensing procedure for the treatment of the above-mentioned conditions 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.
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