Gali Weinreb Brainsway Ltd. (TASE:BRIN Nasdaq: BWAY) announced today that its H7-coil deep transcranial magnetic stimulation (dTMS) system had failed to demonstrate effectiveness in treatment of adults with post-traumatic stress disorder (PTSD) in comparison with the control group, according to interim results of a trial currently being conducted by the company. Results were obtained for 87 patients in the study.
BrainsWay announced that it would not continue the current trial, but that it may conduct later trials of the product for treatment of PTSD with a slightly different definition of the endpoints. BrainsWay's share price on the Tel Aviv Stock Exchange actually closed 0.38% higher today, while on Nasdaq its price I sup nearly 2%. The company has a NIS 414 million market cap.
BrainsWay has already achieved success in a multi-center trial of its dTMS system for treatment of depression, obsessive-compulsive disorder (OCD), and addiction to smoking. The first two products already have marketing approval from the US Food and Drug Administration, and are being marketed in the US and other countries. The new trial results indicate that BrainsWay has not produced a single invention that solves all of the world's mental and brain disorders, but the potential of the three markets in which the company already operates is in the billions of dollars. BrainsWay's treatment method is also in initial trials for treatment of other disorders, among them anorexia, Alzheimer's Disease, epilepsy, nerve pain, and stroke recovery. This may be the reason that the company's share price did not plunge in response to the latest trial results.
BrainsWay's device works through magnetic stimulation of the brain, which can affect electrical activity of nerves in the brain. Treatment of depression through intervention in electrical brain activity is the basis of electroconvulsive therapy (ECT), which has been used for decades in the treatment of depression that is resistant to drugs and other forms of treatment. Magnetic treatment is an alternative to ECT used by a number of companies. BrainsWay is the first company to extend magnetic-based treatment to areas in which ECT was never used: OCD and addiction. The company has demonstrated the potential of electrical intervention in such cases. There are also companies that use implanted electrodes to stimulate the brain directly for treatment of epilepsy and Parkinson's Disease.
BrainsWay was dual-listed on Nasdaq last April, raising $30 million. Its share price has gone up and down since its offering, but is currently near the offering price. The company's revenue in the last quarter totaled $5.9 million, 38% more than in the corresponding quarter in the preceding year, after it increased the number of its systems installed in doctors' clinics and added a kit for treatment of depression. $3.4 million of this was repeat revenue. 488 BrainsWay systems are now installed in the US. The company posted a $2.2 million operating loss and a $2.6 million net loss, due to high marketing costs, despite its high gross profit margins.
A few months ago, BrainsWay appointed Dr. Christopher von Jako as president and CEO. "We remain focused on executing our growth strategy through our current FDA-cleared indications of Major Depressive Disorder and OCD, which represents an addressable market of approximately $9 billion," he said today. "In addition, we continue to maintain a robust pipeline of additional applications with our proprietary dTMS platform targeted at other large-market psychiatric, neurological, and addiction conditions."
Published by Globes, Israel business news - en.globes.co.il - on February 6, 2020
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