Immediate Report – Interim Results of a Clinical Trial in Schizophrenic Patients with Auditory Hallucinations
Be'er Ya'akov Mental Health Center and the Medical Research Fund of the Assaf Harofeh Hospital
2 November, 2009
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To:
The Israel Securities Authority
22 Kanfei Nesharim St.
Jerusalem 95464
Via Magna
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To:
The Tel Aviv Stock Exchange
54 Ahad Ha`am St.
Tel Aviv 65202
Via Magna
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Dear Sir/Madam,
Re: Immediate Report - Interim Results of a Clinical Trial in Schizophrenic Patients with Auditory Hallucinations
Further to section 6.12.2.4.2 of Brainsway Ltd.'s (the "Company's") prospectus dated 26 February, 2009, and further to the Company's immediate report dated 22 October, 2008 (ref. 2008-01-288627), the Company is pleased to announce its interim results from a clinical trial of the Company's Deep TMS device for the treatment of auditory hallucinations in schizophrenic patients. The trial was performed at the Be'er Ya'akov Mental Health Center in the framework of a collaboration between the Company, the Be'er Ya'akov Mental Health Center and the Medical Research Fund of the Assaf Harofeh Hospital.
The interim results are based on an interim report by the Principal Investigator in respect of 7 patients (out of 20 patients included in the trial), two of whom received the treatment twice (i.e., a total of nine cases were assessed) (the "interim report").
The extent of the beneficial effect of the Company's Deep TMS device on patients was assessed using three different scales, as follows:
- 1. Hoffman's Auditory Hallucinations Rating Scale (AHRS), which assesses the frequency and number of voices heard, how "real" they seem, their intensity, the extent to which they affect the patient's behavior, their duration, and the level of distress they cause the patient. This is the primary scale whereby the treatment's efficacy was evaluated.
- 2. The Scale for the Assessment of Positive Symptoms (SAPS) in schizophrenia, which measures auditory hallucinations, among other symptoms.
- 3. The Scale for the Assessment of Negative Symptoms (SANS) in schizophrenia.
Treatment Efficacy
A greater than 50% improvement in Hoffman's AHRS scores was observed; on the SAPS, which includes assessment of auditory hallucinations, an improvement of approximately 28% in scores was noted; no significant improvement was observed on the SANS.
Summary
The trial results demonstrate significant improvement on Hoffman's Auditory Hallucinations Rating Scale (which measures the above dimensions of auditory hallucinations), as well as a significant improvement on the Scale for the Assessment of Positive Symptoms in schizophrenia.
The significant improvement on the AHRS and SAPS scales leads our researchers to believe that the Company's Deep TMS therapy represents a breakthrough for the treatment of auditory hallucinations in schizophrenic patients, for which an effective treatment has yet to be found.
Sincerely,
Brainsway Ltd.
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