Key Developments: Brainsway Ltd (BRIN.TA)

BRIN.TA on Tel Aviv Stock Exchange

18 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Brainsway Ltd receives IDE approval from FDA for Launching Pivotal PTSD Multi-Center Trial
Monday, 15 Dec 2014 08:01am EST 

Brainsway Ltd:Receives an IDE approval from the FDA for launching a Multi-Center trial which will examine the effectiveness of Brainsway's Deep TMS (Deep Transcranial Magnetic Stimulation) for treating PTSD (Post Traumatic Stress Disorder) patients.Approval was given for 166 patients and 15 medical centers.  Full Article

Brainsway receives CE approvals for Treating Multiple Sclerosis, Stroke and Obsessive Compulsive Disorder
Thursday, 4 Dec 2014 08:00am EST 

Brainsway Ltd:Receives CE Marketing Approval, enabling it to immediately market and sell Brainsway Deep TMS (Deep Transcranial Magnetic Stimulation) in Europe, for treatment of Multiple Sclerosis (MS), Stroke and Obsessive Compulsive Disorder (OCD).These new indications join Brainsway's numerous CE approvals for treating brain disorders, including autism, Alzheimer's disease, bipolar disorder, chronic pain, major depressive disorder, Parkinson's disease, post-traumatic stress disorder, schizophrenia (negative symptoms(, and smoking cessation.  Full Article

Brainsway Ltd receives FDA approval of IDE for obsessive-compulsive disorder study
Thursday, 19 Dec 2013 08:32am EST 

Brainsway Ltd:Says the U.S. Food and Drug Administration has approved an Investigational Device Exemption that allows the company to begin implementing a double-blind, multi-center study to assess the efficacy of the its Deep TMS device in treating patients suffering from obsessive-compulsive disorder.  Full Article

Brainsway Ltd Raises ILS 23,733,320 In Ordinary Shares Tender
Thursday, 3 Oct 2013 03:25pm EDT 

Brainsway Ltd announced the results of tender for the Company's ordinary shares, October 1, 2013, as of the shelf prospectus of February 28, 2012. Brainsway Ltd accepted 49 bids for 45,496 units of shares issued at the price higher than the minimal fixed price, and 7 bids for 145 units of shares issued at the minimal fixed price. The minimal fixed price for Brainsway Ltd ordinary shares was ILS 520. The Company raised ILS 23,733,320 in the tender.  Full Article

Brainsway Ltd Reports Positive Final Results Of Study Using Deep TMS To Treat OCD
Wednesday, 4 Sep 2013 07:48am EDT 

Brainsway Ltd. announced that the final results of a clinical trial conducted at the Sheba Medical Center at Tel Hashomer to assess the efficacy of the Company's Deep TMS device in treating obsessive-compulsive disorder ("OCD") using a coil developed for this purpose. The double-blind, placebo-controlled study involved a total of 25 OCD patients that had previously failed to respond to both pharmacological and psychological therapy. The trial subjects were divided into three groups: a low-frequency treatment group, a high-frequency treatment group and a sham treatment group. The primary outcome measure for therapeutic efficacy was the change in patients' Yale-Brown Obsessive Compulsive Scale, or Y-BOCS, a standard test to rate the severity of OCD symptoms. In parallel, treated subjects underwent electroencephalography (EEG) measures in order to test objectively alterations in pathological neural activations that are associated with OCD. The clinical results showed an average improvement of 27% in symptoms of patients in the high-frequency treatment group, which was relative to the sham-control treated group (p=0.0003).  Full Article

Brainsway Ltd Gets FDA Approval For Anti-depression Device-Reuters
Wednesday, 9 Jan 2013 08:32am EST 

Reuters reported that Brainsway Ltd received U.S. Food and Drug Administration approval for use of its Deep TMS device for the treatment of depression in patients who fail to respond to medication.  Full Article

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