Promising clinical trial results announced Tuesday morning by Brainsway for its treatment of clinical depression saw the company's shares soar 21.8% on extraordinarily high turnover of NIS 16.6 million Tuesday before retreating by 2.0% yesterday.
The company, which posted a loss exceeding NIS 24 million in 2011, is now trading at a NIS 290 million market value as investors anticipate it winning new U.S. Food and Drug Administration approvals and increasing its sales.
Brainsway has developed a medical helmet-like device for noninvasive treatment of common brain disorders. The device uses deep TMS, transcranial magnetic stimulation, to affect various areas deep within the brain by nerve stimulation or repression through electromagnetic current.
The trial reported by Brainsway lasted five weeks and involved 233 patients suffering from deep clinical depression. Results revealed a significant drop in depression rates of patients treated by the company's device, both in absolute terms and in comparison with the control group.
Depression is the indication on which the company has made the most progress toward penetrating the U.S. market - the most highly prized market among biomed companies - among 10 indications it's addressing with the device. Having begun its first trials for the device in 2006, the company now expects to receive FDA approval for marketing it as treatment for depression sufferers as early as this summer.
The significance of its first FDA approval, though, is much greater and goes beyond the treatment of depression. According to U.S. regulatory rules, if one indication is approved for marketing, the company can then accept patients for treatment of other indications. Those interested in treatment by the device's magnetic coil could sign a form allowing them, in this case, to benefit from treatment by the device for other indications it addresses. This procedure is possible because the device has a uniform structure for all the various treated indications.
Emphasis in the reported results was placed on the safety factor, and the company stressed in its notice that the published figures are based only on initial analysis. The frequency of side effects among the various treatment groups has not yet been analyzed, and full results will be available after a full statistical analysis is completed, Brainsway noted.
Safety is a major factor since Brainsway's treatment would compete with existing antidepression drugs available on the market that can cause severe side effects. Doctors and patients, in such cases, need to weigh the benefits of treatment against the severity of side effects. The treatment of Alzheimer's disease using the Brainsway device, also in the trial stage, is therefore considered a golden opportunity since there is no other efficient treatment available on the market for this condition.
The company is now preparing to submit its request to the FDA for licensing by the end of June, according to Brainsway CEO Uzi Sofer. "This is a very happy day for Brainsway," he said. "We are very pleased to see the excellent results after hard and extensive efforts. We thank The Holy One, Blessed be He, and everyone involved, down to the very last company employee."
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