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News 2008

News 2008

Brainsway Announces a Capital Raising Agreement for up to $15 Million

21 December, 2008

Brainsway Ltd. (the “Company”) is pleased to announce that today, December 18th 2008, it has entered into a SEDA (Standby Equity Distribution Agreement) capital-raising agreement (the “Agreement”) with YA Global Investments L.P. (the “Investor”), which is an “institutional investor”, as such term is defined in the Securities Law Regulations (Offer of Securities to the public) 2007 (“Public Offering Regulations”).
The Investor is a fund managed by Yorkville Advisors, LLC, which specializes in structured financing solutions for companies


Clinical Trial Agreement Signed with the National Institute of Neurological Disorders and Stroke

National Institute of Health (NIH) ,Bethesda, Meryland, USA

20 December, 2008

On December 28th 2008, Brainsway Ltd. (the “Company”) signed an agreement to perform a clinical research trial in human subjects with the National Institute of Neurological Disorders and Stroke (NINDS), which is one of the research divisions of the National Institute of Health (NIH).


Brainsway announces of receipt of FDA Approval of IDE

26 October, 2008

Brainsway Ltd. (the “Company”) announces that on October 23, 2008, the FDA approved the Company’s IDE submission in respect of the performance of a multi-centre clinical trial utilizing the Company’s Deep TMS device


Clinical Trial: Bi-Polar Disorder - Double Blind Placebo Control

Shalvata Hospital, Hod Hasharon, Israel

22 October, 2008

Further to the final results of the clinical trial in human subjects suffering from Bipolar Depression (Manic Depression) reported on October 2, 2008, Brainsway Ltd. (the "Company") announces that further to the approval of the Helsinki Committee of the Shalvata Hospital, the Company received the Ministry of Health's approval for the performance of an additional trial of a broader scope, that will be double blinded, utilizing the Company's Deep TMS device with respect to 50 subjects suffering from Bipolar Depression


Clinical Trial: Schizophrenia - Auditory Hallucinations

Be'er Ya'acov Mental Health Centre

22 October, 2008

Brainsway Ltd. (the "Company") announces that further to the approval of the Helsinki Committee of the Be'er Ya'acov Mental Health Centre, the Company received the Ministry of Health's approval for the performance of a trial utilizing the Company's Deep TMS device with respect to 20 subjects suffering from schizophrenia and experiencing auditory hallucinations.


Brainsway Announces Receipt of Ministry of Health Approval for a Clinical Trial in Schizophrenia Patients

Be'er Ya'akov Mental Health Center

22 October, 2008

Brainsway Ltd. (the "Company") announces that further to the approval of the Helsinki Committee of the Be'er Ya'akov Mental Health Center, the Company has received the Ministry of Health's approval for the performance of a trial of the Company's deep TMS device in 20 schizophrenia patients with auditory hallucinations.


Neuronetics Inc. announced of recieving of FDA approval for using NeuroStarTMS for the treatment of Depression

8 October, 2008

Neuronetics, Inc., a privately-held medical device company and a leader in the field of neuromodulation, announced that the U.S. Food and Drug Administration (FDA) has cleared its NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system for the treatment of depression


Brainsway announces of Receipt of CE Approval

7 October, 2008

Brainsway Ltd. (the “Company”) announces that yesterday, October 6, 2008, the Company received the European Union’s CE Mark, which permits the marketing and sale of the Company’s Deep TMS device in the European Union.


Brainsway announces Receipt of CE Approval

7 October, 2008

Brainsway Ltd. (the “Company”) announces that yesterday, October 6th, 2008, the Company received the European Union’s CE Mark, which permits the marketing and sale of the Company’s Deep TMS device in the European Union.


Clinical Trial for Treatment of Bipolar Disorder (Manic Depression) in Human Patients – Final Results

Shalvata Hospital, Hod Hasharon, Israel

2 October, 2008

Brainsway Ltd. (the “Company”) announces the final results of a clinical trial of the Company's Deep TMS device for the treatment of bipolar disorder (manic depression) in subjects that did not respond to medication


Report Regarding the Final Results of a Clinical Trial in Subjects with Bipolar Depression (Manic Depression)

2 October, 2008

A clinical trial of studying the feasibility of using the Deep TMS H System for treating bi-polar
disorder episodes, took place at the Shalvata Mental Health Center, Hod-Hasharon, Israel.


Clinical Trial: Depression Maintenance Treatment

Shalvata Hospital, Hod Hasharon, Israel

5 June, 2008

Brainsway Ltd. (the "Company") is pleased to announce that further to the approval of the Helsinki Committee of the Shalvata Hospital, the Company has received the Ministry of Health's approval for a maintenance treatment trial of the Company's deep TMS device in 20 medication-resistant major depression patients who previously participated in a trial for the treatment of major depression at the Shalvata Hospital whose results were reported in the Company's immediate report dated 14 February 2008 (the "Primary Trial").


Immediate Report on the Results of a Clinical Trial for the Treatment of Schizophrenia

10 March, 2008

Brainsway Inc. (hereinafter the “Company”) is pleased to announce the results of its clinical trial for the evaluation of the safety and efficacy of the Company’s Deep TMS device for the treatment of schizophrenia, which the Company intends to present at the Annual Meeting of the Israeli Society of Biological Psychiatry, which will be held on the 11-13 March in Kfar Giladi.


Clinical Trial: Post-Traumatic Stress Disorder (PTSD)

Hadassah Ein-Kerem, Medical Center, Jerusalem, Israel.

25 February, 2008

A new clinical study has begun in Hadassah Ein-Kerem Medical Center, Israel, using Deep TMS , for the treatment of post-traumatic stress disorder (PTSD).


Immediate Report on the Final Results of a Clinical Trial of the Company’s Deep TMS Device for the Treatment of Major Depression

14 February, 2008

Brainsway Inc. (hereinafter the “Company”) is pleased the final results of its clinical trial to evaluate the safety and efficacy of the Company’s Deep TMS device for treating medication-resistant major depressive disorder (in patients who failed to respond, or responded only partially, to at least two antidepressant medications), as reported to the Helsinki Committee of the Shalvata Mental Health Center on 14 February 2008.


Immediate Report of Interim Results of a Clinical Trial of the Deep TMS Device for the Treatment of Blepharospasm (Uncontrolled Blinking) Conducted in

17 January, 2008


Immediate Report on the Interim Results of a Clinical Trial Exploring the Effects of Using the Company’s Deep TMS Device in Conjunction with Medicatio

2 January, 2008


The Company is pleased to announce its interim results in a clinical trial for treating depression using the Company’s Deep TMS device as an addition to antidepressant medication therapy. The trial was conducted at the Hadassah Ein Kerem Medical Center as part of a contractual association between Hadassit Medical Research and Development Services Ltd. and the Company, and was designed to evaluate the treatment of depression using the Company’s Deep TMS device as an addition to antidepressant medication therapy.

This is the first trial conducted to evaluate the efficacy of treatment using the Company’s device in which the subjects continued to take medication.


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