Revolution of Brain Disorder

Revolution of Brain Disorder

2016 has been a good year for Brainsway company: Its Deep TMS device is being sold more and more; its revenue jumped by 93% in 2016's first half; and the company is enhancing its penetration of the US market. Dr. David Zacut, CEO: “Brainsway has all the ingredients for a substantial sales increase and growth in upcoming years"

מאת: Charlie Shitrit
MedTech בריאות ורפואה טכנולוגיה והייטק

Last week, Brainsway Ltd., the leader in the field of Brain stimulation, announced its new regulatory approval from the Mexican government for marketing and distribution of Deep TMS, its medical device developed for prevalent brain disorder treatment. The distributor is obligated to increasing minimum commitments over the next seven years, with 10 devices in 2017 alone.

When considering that the 2nd quarter of 2016 showed an increase of 90% in the company’s revenue (compared to the parallel quarter last year), reaching $2.8 million, the outlook seems promising: An Israeli company which consistently succeeds in penetrating more and more markets around the world. Deep TMS is marketed around the world – including Brazil, France, Sweden and Italy – and over the past two years it invested major efforts in the US market.

The Deep TMS Revolution

Brainsway is responsible for the research, development, and marketing of its medical devices which treat brain disorders. This is performed through Deep TMS (Transcranial Magnetic Stimulation), a unique breakthrough technology developed by the company’s scientists, leading to a revolution in the treatment of psychiatric and neurological disorders.

Deep TMS System (picture: Baruch Greenberg). Click to enlarge

This technology is based on an electromagnetic coil featuring a unique structure, connected to a stimulator producing an electrical field which can impact various areas deep within the brain. This achieves stimulation of a wider region of neurons than was previously feasible with other non-invasive devices. The company’s device was cleared by the FDA for the treatment of major depressive disorder, and was also cleared by the European CE and the Israeli Health Ministry for the treatment of 11 additional indications.

In a special interview with Bio magazine, Brainsway CEO, Dr. David Zacut, states that “Brainsway has the technological ability to generate a positive response, and even remission, in many patients. Eleven additional indications were achieved utilizing other coils, each of which was designed to stimulate a different area in the brain.

In the many studies held in cooperation with leading hospitals and universities, we continue to discover the potential of our technology. In feasibility studies, we had excellent results in treating OCD, PTSD patients and more. There were also promising results in treating neurological conditions such as chronic pain and motor recovery from a stroke”.

Last May, Brain Research and Development Services, a Brainsway research-oriented subsidiary, received a grant totaling NIS10.9M from the Israeli Chief Scientist’s office for further development of Deep TMS.

According to Zacut, “Deep TMS is a highly effective treatment, which is also non-invasive, with no anesthesia or systemic side effects – and its clinical results speak for themselves. The system can help millions of patients who gave up on other treatments available to them, due to failure of the treatment or intolerable side effects”.

What conditions can potentially treated by Brainsway Deep TMS?

"Because Deep TMS has practical applications for numerous pathological brain disorders, Brainsway is currently conducting numerous investigative studies around the world, including several multicenter trials in the U.S. which are at different stages of completion".

According to the World Health Organization (WHO), approximately 120 million people in the developed world suffer from depression. In the US alone there are 15 million people suffering from severe depression, and half of them are considered resistant to first line medication or develop severe side effects. From this stems the high potential of the company.

Deep TMS: The treatment process

"The treatment process varies according to the condition. Generally there is a series of treatments. With MDD, treatment sessions last 20 minutes, taking place several times a week. The treatment is performed without sedation, and without hospitalization. Patients can resume their routine immediately after the treatment, as well as arrive and leave the session independently".

What is the most recent approval received?

"This year, Brainsway was approved by the Israeli Ministry of Health for the treatment of OCD. We continue our efforts to demonstrate efficacy and safety in this important condition- which has virtually no other satisfactory approved solution- in other jurisdictions, including in our multicenter trial in the US, where 70 of 98 patients have already been recruited.

"Following our approval in Israel and France in the areas of smoking addiction, PTSD and bipolar depression, we are also conducting additional multicenter trials in these fields. The trials meet very high standards, held in a double blind format simultaneously in numerous sites, so that their reliability is unquestionable".

What are your target markets today?

Brainsway aims to capture market segments all over the world, especially in the United States, and focus on the commercialization of this market. The company is preparing and improving its sales platform in all target areas, including Europe and Central America.

"As we identified a business opportunity supporting penetration of the US market, over the past two years we began working directly in the US, without a distributor. We appointed a Sales VP, Chief Medical Officer, and established customer support and sales representatives".

Simultaneously, the company is also pursuing penetration of major clinics and hospitals in the United States. There are also efforts for expanding medical coverage with insurance companies. As of now, more than 85% of US citizens are covered by insurance for the treatment. All the while, the company continues to collect clinical information to better understand response and remission rates in the real life settings, which can sometimes be even better than in clinical trial settings.

6 years ago, Brainsway, which is traded in the Tel Aviv Stock Exchange since 2007, expressed interest in issuing stock on the US Stock Exchange, and listing them on the NASDAQ to raise capital. It even submitted a draft of confidential prospectus to the US FCC, but finally decided to delay the move due to the terms and stock price offered by the underwriters.

You previously planned to issue the company’s stock in the US. Was the plan cancelled?

"Raising capital in the US is one way to realize the company’s long-term goals. However, at present, issuing stocks in the US isn’t relevant. Our current focus is on commercialization of depression treatment, but this option is definitely viable in our long term vision".

The last year was a good one for Brainsway. Where do you see the company in a decade?

"Through Deep TMS, Brainsway helps more and more patients around the world to dramatically improve their lives. The company has all the ingredients for a substantial increase of sales and growth over the next few years: An enormous market of hundreds of thousands doctors and psychiatrists, revolutionary technology with a competitive advantage over the existing technology in the market, intellectual property, wide insurance coverage, key opinion leaders adopting the technology, an experienced management and sales team in the US, and available funds for financing the activity. I am confident that Brainsway will continue to grow".