Key Developments: Brainsway Ltd (BRIN.TA)
5,647.00
19 Jun 2013
49.00₪ (+0.88%)
5,598.00₪
5,900.00₪
5,996.00₪
5,645.00₪
225,592
85,076
7,440.00₪
2,140.00₪
Latest Key Developments (Source: Significant Developments)
Brainsway Ltd Gets FDA Approval For Anti-depression Device-Reuters
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
Brainsway Ltd Secures New Contract In Japan
Brainsway Ltd announced that it has secured a new contract in Japan for the lease of one of the Company's devices. The device will be leased for a period of two years and supplied during the month of November, 2012. Further details were not disclosed. Full Article
Brainsway Ltd Reports Positive Preliminary Results Of Study Using Deep TMS To Treat OCD
Brainsway Ltd announced that it has received interim results with respect to a clinical trial being conducted at the Sheba Medical Center at Tel Hashome to assess the efficacy of the Company's Deep TMS device in treating obsessive-compulsive disorder (OCD) using a specialized coil developed for this purpose. In a double-blind, placebo-controlled study, a total of nine patients have undergone the trial to-date (out of 45 patients expected to be recruited). The trial subjects were divided into two groups a real 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 repeated electroencephalography, or EEG, testing, a reliable and objective tool for measuring the effect of magnetic treatment. The results showed that 40% of patients in the group receiving active therapy experienced improvement in their condition based on Y-BOCS. In addition, EEG testing showed a reduction in pathological activity that correlated with treatment effect. In contrast, there were no patients in the sham treatment group that experienced improvement. Both real and sham treatments were well tolerated by patients and there were no side effects observed in either group. Full Article
Brainsway Ltd Receives CE Mark Approval For Deep TMS System To Treat Neuropathic Chronic Pain
Brainsway Ltd announced that it has received CE Mark enabling commercialization of its Deep TMS system to treat neuropathic chronic pain (neuropathic pain) in the European Union and the countries in Asia and Latin America that recognize the CE Mark. Full Article
Brainsway Ltd Reports Positive Final Results Of Study Using Deep TMS To Open Blood-Brain Barrier In Patients With Brain Tumors
Brainsway Ltd announced that it has received the final results of a clinical trial performed by Advanced Technologies Innovation Distribution SRL (ATID) in Italy to explore the efficacy of Deep TMS in the opening of the blood-brain barrier (BBB) in patients with brain tumors. The study was conducted in the framework of collaboration between Ben-Gurion University (Principal Investigator – Dr. Alon Friedman) and the University of Rome (Principal Investigator – Dr. Maurizio Inghilleri). A total of 19 patients with glioblastoma multiforme (GBM) tumors were recruited for the study. All of these patients had undergone surgery more than a year before the trial. The data from three patients were excluded due to technical problems, while in four other subjects the limited size of post-resection tumor prevented analysis. In addition four subjects with no tumors were also recruited to serve as a control group. The final results indicated that high-intensity Deep TMS treatment protocols induced a temporary but significant degree of BBB opening in 10 of the remaining 12 patients (83%), following the REAL stimulation in comparison to SHAM stimulation, in an area within and around the tumor zone. This clinical trial confirms and extends the findings of a previous animal study conducted at Ben-Gurion University. Full Article
Brainsway Ltd Signs Agreement For Distribution And Sale Of Deep TMS Device In Chile
Brainsway Ltd announced that, on January 1, 2012, it entered into an exclusive agreement for the distribution of the Deep TMS devices with a Chilean company specially formed for the purpose and owned by a business group in the pharmaceutical industry. The distribution company has been granted exclusive rights to market and promote sales of the Deep TMS device in Chile for 10 years. The retention of these exclusive distribution rights for the duration of the contractual period (except during the first three years) is contingent upon the distribution company's renting out the contractually specified minimum number of Deep TMS devices each year. The distribution company will promote, market and distribute the Deep TMS device in Chile for the treatment of major depression, schizophrenia, bipolar depression, Parkinson's disease, post-traumatic stress disorder, and any other indication approved by the Chilean authorities. Brainsway will provide the distribution company with the devices it orders, and the distribution company, in turn, will be responsible for renting out these devices and installing them at the clients' facilities. Clients will pay the distribution company a fixed fee for each device, or alternatively, a pay-per-use fee based on the number of treatments administered using each device. At all times, the Deep TMS devices will remain the property of Brainsway. The distribution company will pay Brainsway a fixed monthly fee for each Deep TMS device provided. Full Article
Brainsway Ltd Announces New Exclusive Distribution Agreement In Chile
Brainsway Ltd announced that it has signed a new exclusive distribution agreement with a Chilean company for the sale and distribution of its "Deep TMS" device in Chile. The agreement will be valid for a period of ten years. The agreement will be binding as long as the Chilean company purchases at least 455 "Deep TMS" devices from the Company each year following the first three years of the agreement. Full Article
Brainsway Ltd Announces Interim Results In Multiple Sclerosis Clinical Trial
Brainsway Ltd announced that it has received interim results with respect to 26 patients from a double-blinded clinical trial being conducted at the Charité Hospital in Berlin and at the University Medical Center Hamburg-Eppendorf in Hamburg to assess the safety and efficacy of the Company's Deep TMS device for the treatment of multiple sclerosis (MS) patients. The trial subjects were divided into three groups: a sham-stimulation control group, a treatment group that received high-frequency (18 Hz) left prefrontal stimulation, and an additional treatment group that received low-frequency (5 Hz) motor cortex stimulation. Each subject received a series of treatments three times per week over a period of six weeks. The effects of the treatment were evaluated over the course of the subsequent six-week period. The effects of the treatment on subjects' fatigue levels were assessed using standard fatigue rating scales such as the Fatigue Severity Scale (FSS), the Modified Fatigue Impact Scale (MFIS) and the Visual Analogue Scale (VAS); and its effects on subjects' depression levels were assessed using the Hamilton Rating Scale for Depression, the Beck Depression Inventory (BDI) and the Positive and Negative Affect Scale (PANAS). As for the treatment's effect on depression, a improvement on the BDI and the PANAS was observed in the motor cortex stimulation group, while the other groups' scores on these depression rating scales did not change significantly. Full Article
Brainsway Ltd Announces Interim Results Of An Animal Study Of The Effects Of Deep TMS On Macular Degeneration
Brainsway Ltd announced that it has received interim results from an animal study being conducted at the Sheba Medical Center to explore the effects of the Company's device on macular degeneration. In the first stage of the study, the effects of electromagnetic stimulation in an animal model for retinal degeneration were explored in 15 rats, of which eight received active stimulation treatment and seven received sham treatment, over the course of two weeks. A short-lasting improvement in the retina's response to light was observed following this stage of the study, with the real treatment group displaying significantly improved retinal function relative to control animals, as measured by an electroretinogram – a standard measure of the electrical response of the retina to light (the improvement was apparent in the late negative deflection of the electroretinogram). The second stage of the study was conducted with 16 rats, of which half received real treatment and half received sham stimulation, and was essentially the same as the first, except that stimulation was prolonged to four weeks. Extending the treatment period produced a greater and longer-lasting improvement in retinal function. In addition, the longer treatment period also brought about an improvement in the b-wave of the electroretinogram (which indicates improved photoreceptor function). This latter improvement wasn't observed in the first stage of the study. Full Article
Brainsway Ltd Announces CE Marketing Approval For "Deep TMS" Device
Brainsway Ltd announced that it has received marketing approval from the European Community (CE) in order to market and sell its "Deep TMS" device in Europe. The marketing approval pertains to the treatment of major and bi-polar depression and schizophrenia patients who suffer from very negative symptoms and cognitive damage. Full Article
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