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News 2010

Chief Scientist Office Approves Grant

22 December, 2010

Brainsway Ltd. is pleased to announce that Moach R&D Services Ltd., a wholly owned subsidiary of the Company, has received approval for a grant award from the Office of the Chief Scientist in the Israeli Ministry of Industry, Trade and Labor, for a project related to the Deep TMS System for depression therapy.


Interim Results – Clinical Trial for Smoking Cessation in Chronic Obstructive Pulmonary Disease Patients

30 November, 2010

Further to Brainsway’s report dated 16 September 2009 and its periodic report for 2009 regarding the clinical trial being conducted by the Company 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 patients, the Company is pleased to announce that interim results from the trial have been obtained.


AMA Issues CPT Code I for TMS Treatments

30 November, 2010

Brainsway is pleased to announce that the American Medical Association, a professional association of physicians and medical students in the US, has issued a type I CPT code for health insurance coverage of TMS treatments, which will come into effect starting January 2011.


Final Results – Clinical Trial in Blepharospasm Patients

24 October, 2010

Further to that stated in Brainsway’s periodic report for 2009, the Company is pleased to announce that analysis of the results of the clinical trial of the Company's Deep TMS device for the treatment of the symptoms of blepharospasm (a disorder that affects the eye muscles and causes uncontrolled blinking), reveals that low-frequency Deep TMS treatment using the specialized H-BL TMS coil developed by the Company or using a C-coil (a coil employed in TMS studies), is safe and it leads to immediate alleviation of blepharospasm symptoms. The trial followed a double-blind design with a control group, and was performed by researchers from the National Institute of Neurological Disorders and Stroke (NINDS) research division of the NIH, headed by Dr. Mark Hallett.


Interim Results – Clinical Trial in Parkinson’s Disease Patients at the “Sheba” Medical Center

19 October, 2010

Further to Brainsway’s report dated 1 September 2009 and its periodic report for 2009, the Company is pleased to announce that analysis of interim results, which were obtained from a trial of the Company’s Deep TMS device for the treatment of Parkinson’s disease that was performed at the Chaim Sheba Medical Center at Tel Hashomer by Dr. Oren Cohen and colleagues, has revealed that Deep rTMS treatment using the H-Coil developed by the Company over the prefrontal and motor cortices is safe, and that it leads to significant improvement in the motor function of Parkinson’s disease patients.


Results of an Animal Study of Blood-Brain Barrier Permeability

14 October, 2010

Brainsway is pleased to announce that a study performed by researchers from the Ben-Gurion University, headed by Dr Alon Friedman, to assess the effects of magnetic stimulation on Blood-Brain Barrier (BBB) permeability in laboratory rats, has revealed an increase in cerebral vascular permeability within 30 minutes of stimulation, which is likely dependent on the frequency of the magnetic stimulation. The study was carried out using a magnetic coil provided by the Company, designed to mimic the effects of the Company’s Deep TMS device. The prospect of opening the BBB represents an additional and significant direction for clinical applications of the Company’s device, such as accelerating and focusing anti-cancer drug delivery to brain tumors.


Brainsway Announces Signing of Agreements to Perform Clinical Trials in Depression and Schizophrenia Patients in Canada

7 September, 2010

Brainsway is pleased to announce that it has entered into two separate agreements with the Douglas Mental Health University Institute, a research center that works in collaboration with McGill University in Montreal, Canada, to perform clinical trials to evaluate the efficacy of the Company’s Deep TMS device in the treatment of major depression and in the treatment of the symptoms of schizophrenia, with the use of functional magnetic resonance imaging (fMRI).


Distribution Agreement Signed in Brazil

29 August, 2010

Brainsway is pleased to announce that on August 26th, 2010, it entered into an exclusive agreement for the distribution of the Deep TMS devices with a company that markets and distributes medical devices in Brazil.


FDA Grants IDE Approval for a Clinical Trial in Cocaine Addicts

22 August, 2010

Further to that said in the Brainsway’s periodic report for 2009, regarding the signing of an agreement with the National Institute on Drug Abuse (NIDA) to perform a clinical trial in cocaine addicts and the receipt of the IRB (Institutional Review Board – the equivalent of a Helsinki Committee at the institute where the trial is taking place) approval for said trial, the Company is pleased to announce that it has received an Investigational Device Exemption (IDE) approval from the FDA, allowing it to begin the clinical trial, whose purpose it is to evaluate the efficacy of the Deep TMS device in the treatment of cocaine addiction. The IDE approval has been granted for 30 patients.


Final Results of a Clinical Trial of the Deep TMS Device for Maintenance Treatment of Drug-Resistant Depression

28 June, 2010

Further to Brainsway's periodic report for 2009 regarding the maintenance treatment clinical trial performed by the Company on patients who responded to the previous clinical trial of the Deep TMS device for acute treatment of drug-resistant major depression, the Company is pleased to announce that final results in respect of 30 patients have been obtained.


Brainsway to Open Deep TMS Treatment Center

23 June, 2010

Brainsway is pleased to announce that Advanced Technologies Innovation Distribution SRL (ATID), the distributor of Brainsway's products in Italy, has entered into an agreement with a leading medical center in the Milan area to set up a specialized clinic – the Deep TMS Center. The Center will have several of Brainsway's Deep TMS devices for the treatment of various neurological and psychological disorders (some treatments to be administered within the framework of clinical trials). The Deep TMS Center will open in July, and will be the first of its kind.


Brainsway Receives Ministry of Health Approval for Its Multiway Stimulator

11 May, 2010

Further to Brainsway’s report dated 6 July 2009, concerning completion of development of a prototype of the Multiway neurostimulator that will be used with Brainsway's Deep TMS device, the Company is pleased to announce that it has received approval from the Israeli Ministry of Health's department of Medical Devices ("Amar") to perform a clinical trial designed to evaluate the effects of said neurostimulator on various characteristics of motor cortex stimulation, compared to the widely used single-channel neurostimulator manufactured by the Magstim Company Ltd. The approval has been granted initially for 5 patients.


Brainsway Announces Receipt of Ministry of Health Approval for Continued Clinical Testing in Alzheimer's Patients

11 April, 2010

Further to Brainsway’s report dated 7 April 2009, regarding receipt of the Ministry of Health's approval for the performance of a trial of the Company's Deep TMS device in Alzheimer's disease patients in the Ichilov Hospital, and the Company's report dated 24 January 2010 regarding interim results for the first 10 patients treated, the Company is pleased to announce that it has received approval from the Israeli Ministry of Health's department of Medical Devices ("Amar") to continue the clinical trial.


Interim Results of a Clinical Trial for the Treatment of Pain

24 March, 2010

Brainsway is pleased to announce that it has received interim results from a double-blind for the treatment of diabetic chronic neuropathic pain that was performed by Advanced Technologies Innovation Distribution SRL (“Atid”), the distributor of Brainsway’s products in Italy.


Brainsway to Investigate Effects of Deep TMS on Motivation in Healthy Subjects using fMRI

23 February, 2010

Brainsway is pleased to announce that it has received the approval of the Helsinki Committee (i.e., the ethics board) of the Hadassah Medical Center to perform a clinical study to explore the behavioral effects of localized changes in brain activity. The principal investigator of the study is Dr Moshe Isserles.


Brainsway Announces Receipt of Approval to Market Deep TMS for the Treatment of Schizophrenia

16 February, 2010

Further to Brainsway’s report dated 7 October 2008, regarding receipt of the European Union’s CE Mark, which permits the marketing and sale of the Company’s Deep TMS device in Europe for the treatment of major depression, and its report dated 3 September 2009, regarding receipt of the CE Mark for Deep TMS for the treatment of bipolar disorder, the Company is pleased to announce that now that the Technical File for the Deep TMS device has been updated with all the details of the schizophrenia clinical trial, the Company may market its device in the European Union for the treatment of schizophrenia as well.


Interim Results of a Clinical Trial in Alzheimer’s Disease Patients

24 January, 2010

Brainsway is pleased to announce interim in respect of the first 10 patients treated in a clinical trial of the Company’s Deep TMS device for the treatment of Alzheimer’s disease currently being performed at the Ichilov Medical Center. The results were reported to the Ministry of Health’s Medical Devices Department in a safety and efficacy report submitted by the trial’s principal investigator, Dr. Eliyahu Simon.


Final Results of a Clinical Trial in Schizophrenic Patients with Auditory Hallucinations

3 January, 2010

Brainsway is pleased to announce its final 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 Brainsway, the Be'er Ya'akov Mental Health Center and the Medical Research Fund of the Assaf Harofeh Hospital.


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