Devices & Diagnostics

Israeli medtech firm aims to tackle depression, opioid use with noninvasive brain stimulation

An Israeli public company hopes to free patients of multiple drugs that don’t relieve major depression by offering a device approach to manage their condition.

 

The Brainsway Deep TMS system

Brainsway’s CEO, Yaacov Michlin, is quick to point out that his company is not a startup. And that he didn’t come to the Mecca of all life science companies — the annual J.P. Morgan Healthcare Conference in San Francisco — to raise money.

After all, the public noninvasive brain stimulation company based in Jerusalem and founded in 2003 just raised $8.7 million in December from Israeli investors.

But sitting at the Sir Francis Drake Hotel, taking meeting after meeting after meeting, Michlin is motivated by something not so different from what drives a  startup CEO: collaboration with a larger strategic (drug or device company) that will be the wind beneath its sails. Specifically, a large drug or device company with sales and marketing muscle that can bring exposure to the company’s deep transcranial magnetic stimulation (TMS) technology.

Brainsway already has the nod from the FDA to market its Deep TMS product to address major depressive disorder. Patients who are not responding to the usual regimen of Prozac, Zoloft and other depression drugs or find the side effects too debilitating have the option of trying a device approach to treat their condition.

The coil contained within the helmet that provides magnetic pulses to the targeted area of the brain to relieve severe depression.

Through this, patients suffering from major depression visit their psychiatrist at the clinic and wear a helmet like device that contains the h1 coil approved to send magnetic pulses to one specific area of the brain – the prefrontal cortex. A mere 20 minutes later, they are done.

The treatment regimen is as follows: five days a week for the first 4 weeks involving 20-minutes of treatment per visit. This is followed by twice a week sessions for the next 8 weeks.

“It’s a relatively user-friendly device,” Michlin said in an interview in San Francisco during J.P. Morgan week. “You work in an investment bank in the middle of Manhattan. You walk in on your lunch break to get the Deep TMS treatment therapy. It takes 20 minutes. You sit. You get the therapy and you go back to work.”

Michlin declined to say how many systems are installed in the U.S. only preferring to say that installation rate is increasing at a nice clip. More than 20,000 patients have been treated.

The addressable market is many times larger.

About 4.5 million people in the U.S. fall in the category of people with treatment-resistant depression and TMS is considered an effective therapy for them. But Brainsway is not the only player. Danish firm MagVenture and Malvern, Pennsylvania-based NeuroStar also have approved devices to treat severe depression in the U.S.

Michlin says that patient testimonials and physician testimonials captured in the company’s YouTube videos show how the treatment is truly effective.

“It changed my whole life,” says Michelle, a patient at the Milford Clinic, Massachusetts in a video about Brainsway’s therapy adding that depression felt like carrying around a heavy weight 24/7. “I hope that people see me and know there’s an answer, there’s a solution. What medication and therapy couldn’t do for me alone, Deep TMS did.”

But that video was published in September 2014, and Brainsway hasn’t done any follow-on studies with users to see how permanent the results of wellbeing are. A video published seven months ago, which included a portion of the above sentiment from Michelle, also featured psychiatrists.

“This has absolutely exceeded my expectations,” said Dr. Sachin Mehta, a psychiatrist at the Belmont Behavioral Health in Philadelphia.

“It’s not only that they have a high degree of expertise in this type of interventions [sic], they are dedicated to improving people’s lives,” said Dr. Oscar Morales, medical director of McLean Hospital, an affiliate of Harvard Medical School referring to Brainsway, in the same video.

Michlin said the company has no financial relationship with the patients or the doctors featured in the video.

As Brainsway attempts to strike a partnership that would help to scale the device in psychiatric offices around the country, Michlin is already looking to develop a pipeline of TMS products that go beyond depression. A de novo application using a second coil to treat obsessive-compulsive disorder (OCD) by targeting a different area in the brain is already filed with the FDA. Brainsway is also planning to develop applications in neurology that Michlin believes will be a game-changer for the company.

But there is another area that he is excited about: addiction. Currently, the company is conducting a multicenter study on smoking cessation using Deep TMS therapy. Many patients have already enrolled and Michlin expects the study will be completed in the third quarter.

“We believe that if we can show [that] we can manage addiction in smoking, the same basic concept is applicable to opioid addiction, alcohol addiction, cocaine addiction,” he declared.

And that would add another tool in the toolbox for managing the opioid addiction crisis that has ravaged communities across the country.