Brainsway Announces Breakthrough Results in Clinical Trials in Parkinson's, Migraine and More

JERUSALEM, Nov. 13, 2012 (GLOBE NEWSWIRE) -- Further to Brainsway's (BRIN.TA) announcement regarding the association between Brainsway and Advanced Technologies Innovation Distribution SRL ("ATID") for the marketing and sales promotion of Brainsway's Deep TMS devices in Italy, in the context of which ATID has been conducting - among its other activities - clinical trials in the San Raffaele medical center in Milan, Italy, the Company is pleased to announce the following clinical trial results:

1. Clinical trial to evaluate the safety and efficacy of a specialized Deep TMS therapy for Parkinson's disease patients.

The trial was carried out in two phases. The first was a double-blind placebo-controlled phase. The data from this phase are still being analyzed. The following are the final results of the second, open-label phase of the trial, in which all patients received REAL Deep TMS treatment.

The trial included 27 Parkinsonian patients who received 12 high-frequency Deep TMS treatment sessions over the course of 30 days.

Analysis of patients' scores on the motor section of the Unified Parkinson's Disease Rating Scale (a commonly used scale for rating the severity of Parkinson's disease symptoms) revealed a significant improvement in severity of motor symptoms compared to the patients' pre-treatment (baseline) levels. Furthermore, significant improvement in tremor and rigidity subscores was already evident after the first treatment. The foot-tapping and hand-tapping subscores, which are commonly used to assess motor function, also improved following treatment.

No side effects were reported. These results demonstrate that magnetic stimulation of prefrontal and motor areas using Brainsway's Deep TMS device, with stimulation parameters as in the trial, is safe and effective for the treatment of Parkinsonian patients.

2. Clinical trial to evaluate the safety and efficacy of a specialized Deep TMS therapy for chronic migraine patients.

22 chronic migraineurs received 18 high-frequency Deep TMS treatment sessions over the course of six weeks. Treatment effects were assessed on weeks 4, 8, 12 and 24 after the beginning of treatment. The interim results demonstrate that 10 patients experienced a greater than 50% improvement in clinical scores in the following domains: migraine attack frequency, migraine intensity, level of medication use, and daily function. 7 patients exhibited partial improvement, i.e. between 20% and 40% improvement in scores in the abovementioned domains. No improvement was noted in the remaining 5 patients. No side effects were reported by any of the patients.

These results indicate that magnetic stimulation of prefrontal areas using Brainsway's Deep TMS device is safe and effective for the treatment of drug-resistant chronic migraineurs.

3. Clinical trial to evaluate the safety and efficacy of a specialized Deep TMS therapy for patients with chronic lower-limb motor deficits following a stroke.

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Brainsway Announces Breakthrough Results in Clinical Trials in Parkinson's, Migraine and More