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Brainsway Announces Final Results in Clinical Trial for Smoking Cessation in Chronic Obstructive Pulmonary Disease Patients

JERUSALEM, Jan. 24, 2013 (GLOBE NEWSWIRE) -- Brainsway Ltd. (TASE:BRIN) ("Brainsway" or the "Company) is pleased to announce that it has received final results with respect to a clinical trial that was conducted at the Be'er Ya'akov Mental Health Center to assess the efficacy of the Company's Deep TMS device in inducing smoking cessation in chronic obstructive pulmonary disease ("COPD") patients using a specialized coil developed for this purpose.

A total of 115 patients participated in the study. The trial subjects were divided into three groups: a sham treatment group, a low-frequency real stimulation treatment group and a high-frequency real stimulation treatment group.  Half of the subjects in each group were exposed to cigarette cues designed to induce temporary cigarette craving prior to the start of each treatment session. Of these patients, 78 completed the treatment period (including 32 patients who received high-frequency treatment, 14 subjects who received low-frequency treatment and 32 subjects who received sham treatment).  The Company noted that, following an interim analysis, follow-up in the low-frequency group was discontinued as no improvement was observed in this group compared with the sham control group.

The primary outcome measure for therapeutic efficacy was the change in patients' cigarette consumption levels, as measured both by self-report and by urinary cotinine (a metabolite of nicotine) levels at the end of the treatment period, and again six months after the end of treatment using only self-report.

The results reveal a significant response (greater than 50% reduction in cigarette consumption) to treatment among approximately 81% of the high-frequency stimulation group subjects who were exposed to cigarette cues prior to treatment, compared to 12-29% of subjects in the other groups.  Approximately 44% of the subjects in the high-frequency stimulation group that were exposed to cigarette cues before each treatment session achieved total smoking cessation.  Approximately 84% of these subjects who achieved total smoking cessation at the end of the trial persisted in their abstinence six months after the end of the trial (as determined by self-report).  A similar trend was revealed in subjects' cigarette dependence levels, as measured by the Fagerström Test for Nicotine Dependence (FTND).

The principal investigator of the trial, Prof. Pinhas Danon, commented, "High-frequency TMS treatment was shown to be effective both by self-report of consumption levels and by measurement of urinary cotinine.   Further, these results indicate that high-frequency Deep TMS therapy using a specialized addiction coil is safe and effective for inducing smoking cessation, especially when administered in conjunction with exposure to cigarette cues."

Prof. Abraham Zangen, one of the key inventors of the Company's Deep TMS technology and the director of this trial, commented, "This study provides further evidence for the involvement of the insular and prefrontal cortices in addiction and shows the potential of repeated stimulation of these areas for smoking cessation. A large multi-center study is recommended in order to establish this novel treatment and bring it to the public."

Ronen Segal, CTO of Brainsway, commented, "Following the U.S. FDA's recent clearance of the Company's Deep TMS device for the treatment of depression, these results further demonstrate the potential of our groundbreaking technology to become a 'game changer' in the non-invasive treatment of not just one, but multiple brain-related conditions, presenting Brainsway with a number of large new market opportunities."

About Brainsway Inc.

Brainsway develops a medical device for the noninvasive treatment of common brain disorders. The device is based on a uniquely shaped electromagnetic coil connected to a rapidly changing current supply, which produces magnetic fields capable of affecting different areas of the brain. Deep brain areas can be either excited or inhibited, depending on the frequency of the magnetic field.   In January 2013, Brainsway's Deep TMS device was cleared by the U.S. Food and Drug Administration and by Health Canada for the treatment of depression in patients who have failed to respond to antidepressant medications in their current episode of depression.

Forward-Looking Statements

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.

CONTACT: Stephen Kilmer President Kilmer Lucas Inc. (212) 618-6347 stephen@kilmerlucas.com
 

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