News 2009

Brainsway Announces Receipt of Italian Ministry of Health Approval for Marketing and Sale of Deep TMS Device in Italy

7 September, 2009

Further to the immediate report dated 7 October 2008 regarding receipt of the European Union’s CE Mark, which permits marketing and sale of Brainsway Ltd.’s (the “Company’s”) Deep TMS device in the European Union; and further to the immediate reports dated 30 April 2009 and 17 June 2009, regarding the Company’s association with ATID (Advanced Technologies Innovation Distribution SRL) for the purpose of marketing and sales promotion of the device in Italy, the Company is pleased to announce that now that the Italian Ministry of Health’s database (the Italian repertorio) has been updated with all the details of the Company’s Deep TMS device, the Company has received the Italian Ministry of Health’s approval for the marketing and sale of the device in Italy for the treatment of depression patients.

Brainsway Receives Approval for Marketing of Deep TMS Device for the Treatment of Manic Depression

3 September, 2009

Further to the immediate report dated 2 October 2008 regarding the final results of a clinical trial in bipolar disorder (manic depression) patients (the “Trial”); and further to the immediate report dated 7 October 2008 regarding receipt of the European Union’s CE Mark, which permits marketing and sale of Brainsway Ltd.’s (the “Company’s”) Deep TMS device in the European Union for the treatment of major depression, the Company is pleased to announce that now that the technical file for the Deep TMS device has been updated with the details of the Trial, the Company may market the device in the European Union for the treatment of bipolar disorder patients, as well as for the treatment of major depression, for which marketing approval of the device was previously granted to the Company.

Clinical Trial for the Treatment of Parkinson's Disease at the "Sheba" Medical Center – Interim Report

"Sheba" Medical Center at Tel Hashomer, Israel

1 September, 2009

Brainsway Ltd. (the "Company") announces that the Movement Disorders Clinic of the Chaim Sheba Medical Center at Tel Hashomer (the "Sheba Medical Center") has notified the Company that interim results have been obtained from a clinical trial which the clinic is performing to assess the safety and efficacy of the Company's H-PD H-Coil for the treatment of Parkinson's disease

Final Results of a Clinical Trial Exploring Deep TMS Device in Augmentation of Antidepressant Medication for Drug-Resistant Depression

Hadassah Medical Center and the Be'er Ya'akov Mental Health Center

6 August, 2009

Brainsway Ltd. (the “Company”) announces the final results of a clinical trial of the Company's Deep TMS device, which explored the effects of using the Deep TMS device in augmentation of antidepressant drugs, for the treatment of resistant depression. The trial found treatment using the Company's device in conjunction with antidepressant drug therapy to be safe and effective

Agreement to Perform a Clinical Trial in Adults with Attention Deficit Disorder (ADD) Signed with a Los Angeles Hospital

Los Angeles Hospital

2 August, 2009

Brainsway Ltd. (the “Company”) is pleased to announce that today, August 2nd 2009, it has entered into an agreement with the Veterans Administration Medical Center (VAMC) in Los Angeles, USA, to perform a clinical trial to explore the safety and efficacy of the Company’s Deep TMS device in the treatment of adults with attention deficit disorder (ADD).

Brainsway Completes Development of Prototype and Receives Standards Institution Approval for Check-Up

6 July, 2009

Brainsway Ltd. (the “Company”) is pleased to announce that today, July 6, 2009, the Company has completed development of the prototype multi-channel stimulator to be used with the Company’s Deep TMS device (the “Device”), and that said stimulator has successfully passed the electromagnetic compatibility (EMC) and safety (check-up) tests of the Standards Institution of Israel. This will enable the Company to proceed toward clinical trials of the Device with said stimulator

Multicenter Trial to Evaluate Safety and Efficacy of the H-Coil for the Treatment of Major Depression Registered on NIH Website

15 medical centers in the USA, Canada, Europe and Israel

1 July, 2009

Brainsway Ltd. (the "Company") is pleased to announce that further to the FDA’s approval of the Company's IDE submission for the multicenter trial to evaluate the safety and efficacy of the Company’s H-Coil for the treatment of major depression, reported by the Company on October 26, 2008 (the “Trial”), and described in the Company’s prospectus; and further to the IRB (Institutional Review Board) approvals to commence the Trial, reported by the Company on February 25, 2009, registration of the multicenter trial on the National Institute of Health’s (NIH’s) official website has been completed.

Receipt of Ministry of Health Approval for a Clinical Trial in Chronic Obstructive Pulmonary Disease Patients with an Addiction to Smoking

Be'er Ya'acov Mental Health Centre, Israel

29 June, 2009

Brainsway Ltd. (the "Company") announces that on this day, June 29th 2009, the Be’er Ya’akov Mental Health Center received the Ministry of Health's approval for the performance of a clinical trial designed to assess the efficacy of the Company's Deep TMS device in inducing smoking cessation in chronic obstructive pulmonary disease patients.

Agreement Signed to Market the Deep TMS Device in Italy

17 June, 2009

Brainsway Ltd. (the “Company”) is pleased to announce that yesterday, June 16th 2009, it signed a binding agreement with Advanced Technologies Innovation Distribution SRL (“ATID”) – based on the memorandum of understanding signed with ATID and reported on 30 April 2009 – whereby ATID is granted exclusive rights to market and promote sales of the Company’s Deep TMS device (the “Device”) in Italy for 10 years, under the terms of the agreement.

Brainsway Announces Signing of Memorandum of Understanding to Market the Deep TMS Device in Italy

30 April, 2009

Yesterday, April 29th 2009, Brainsway Ltd. (the "Company") signed a Memorandum of Understanding (MoU) with Advanced Technologies Innovation Distribution SRL ("ATID"). ATID is an Italian Company owned by psychiatrist Dr. Ruggero Raccah, businessman Eliyahu Tshuva and others.
According to the MoU signed, ATID will be granted exclusive rights to market and promote sales of the Deep TMS device developed by the Company (the "Device") in Italy.

Receipt of "Helsinki Committee" (IRB) Approval for the Performance of a Clinical Trial in Cocaine Addicts at the NIH

23 April, 2009

Brainsway Ltd. (the "Company") announces that on April 22nd, 2009, the Company received the approval of the ethics committee of the National Institute on Drug Abuse (a division of the American National Institute of Health) to perform a clinical trial to evaluate the efficacy of the Company's Deep TMS device in the treatment of cocaine addiction.

Brainsway Announces Receipt of "Helsinki Committee" Approval for the Performance of a Clinical Trial in Multiple Sclerosis Patients

Berlin Hospital, Germany

23 April, 2009

Brainsway Ltd. (the "Company") announces that it has received the approval of the ethics committee of the Charité Hospital – considered to be the leading university hospital in Berlin – to perform a clinical trial to evaluate the safety and efficacy of the Company's Deep TMS device in the treatment of multiple sclerosis patients.

Brainsway Announces Receipt of Ministry of Health Approval for a Clinical Trial in Alzheimer's Patients

Ichilov Hospital in Tel Aviv, Israel

7 April, 2009

Brainsway Ltd. (the "Company") announces that on April 7, 2009, the Company received the Ministry of Health's approval for the performance of a trial of the Company's Deep TMS device in Alzheimer's disease patients.

Agreement to Perform a Clinical Trial in Alzheimer’s Patients Signed with the “Ichilov” Medical Center

“Ichilov” Medical Center, ISrael

2 November, 2008

Brainsway Ltd. (the "Company") announces that today, November 2nd 2008, it has entered into an agreement with the Medical Research Fund at the Tel-Aviv Sourasky Medical Center (“Ichilov”) to perform a clinical trial in Alzheimer’s disease patients.

Agreement to Perform a Clinical Trial for the Treatment of Obesity

9 February, 2009

Brainsway Ltd. (the “Company”) is pleased to announce that today, February 9th 2009, it has entered into a clinical trial agreement with the United States Department of Veteran Affairs, as represented by the VA Pittsburgh Healthcare System (“VA”), which is a research institute of the US government

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

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.

Chief Scientist Office Approves Grant

7 December, 2009

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.

First Order for Deep TMS Device Received by Brainsway’s Italian Distributor

14 October, 2009

Brainsway is pleased to announce that it has received the first order for a Deep TMS device from a client in Italy, according to the terms of the agreement signed with Advanced Technologies Innovation Distribution SRL (“ATID”) (see Brainsway’s reports dated 30.04.09 and 17.06.09).

Brainsway Set to Begin Clinical Trial for Smoking Cessation in Chronic Obstructive Pulmonary Disease Patients

16 September, 2009

Further to that stated in Brainsway’s report dated June 29th 2009, regarding receipt of the Ministry of Health's approval for the performance of a clinical trial at the Be'er Ya'akov Mental Health Center designed to assess the efficacy of the Company's Deep TMS device in inducing smoking cessation in chronic obstructive pulmonary disease patients, Brainsway is pleased to announce that it has received approval for the trial from the Director of the Be’er Ya’akov Mental Health Center, as required by the Procedure for Clinical Investigations in Human Subjects (2005).