About BrainsWay

A global medical technology company, BrainsWay focuses on developing cutting-edge medical devices that help advance the level of treatment offered to patients. To do so, BrainsWay’s advanced flagship technology of Deep Transcranial Magnetic Stimulation (Deep TMS™) is expanding the treatment of mental health beyond what was thought possible.

BrainsWay’s noninvasive Deep TMS treatment has been proven to offer significant results by directly stimulating deeper and broader areas of the brain, effectively treating conditions such as depression, obsessive-compulsive disorder, and smoking addiction.

With numerous studies and a growing number of patients and healthcare providers attesting to its success, BrainsWay’s cutting-edge technology is boldly advancing the treatment of mental health disorders.

About Christopher R. von Jako, PhD

Dr. Christopher von Jako has served as BrainWay's President and Chief Executive Officer (CEO) since January 2020.

Chris is a technology-driven executive with 30 years of leadership and experience in the global medical device market. He is specifically passionate about the development and commercialization of minimally invasive techniques to improve health and transform lives. During his career, Chris led organizations to improve profitability, performance, and value in early-stage, expansion, turnaround, and Fortune 500 environments with five entities resulting in a merger or acquisition.

Most recently, Chris served as CEO of Dynatronics, a publicly traded medical device company that designs, manufactures, and sells high-quality restorative products. Prior to Dynatronics, he served as President and CEO of NinePoint Medical, a privately held medical device company that designs, manufactures, and sells an Optical Coherence Tomography (OCT) imaging platform for clinical use in gastroenterology. Chris served as President and CEO of NeuroTherm, a privately held, minimally invasive interventional pain management company. In 2014, he successfully executed the divesture of NeuroTherm with his team to St. Jude Medical. He has also held leadership roles with other leading medical device companies, including Integra LifeSciences, Covidien, Medtronic, and Radionics.

Chris holds a PhD in Biomedical Sciences from the University of Pécs Medical School (Pécs, Hungary), an MS degree in Radiological Sciences and Technology from the Department of Nuclear Engineering at the Massachusetts Institute of Technology (Cambridge, Massachusetts), and a double BS degree in Physics and Mathematics from Bates College (Lewiston, Maine). Additionally, he has served on several boards throughout his career and currently serves as an independent director on the board of nView medical, Inc.

Steve Martorano 
The Behavioral Corner is produced in partnership with Retreat Behavioral Health -- where healing happens.

The Behavioral Corner 
Hi, and welcome. I'm Steve Martorano. And this is the Behavioral Corner; you're invited to hang with us, as we've discussed the ways we live today, the choices we make, the things we do, and how they affect our health and wellbeing. So you're on the corner, the Behavioral Corner, please hang around a while. 

Steve Martorano 
Hi, everybody, welcome to the Behavioral Corner to be again, Steve Martorano, I hang here in the hopes -- and I'm never disappointed -- and that we will run into some interesting people. The Behavioral Corner is underwritten by our partners Retreat Behavioral Health, you'll hear about them a little bit down the road. What we're about is the business of talking about behavioral health. And that's a gigantic field. And that's why we like to refer to the podcast "as a podcast about everything." I got a good one for you today. This is something that interests me for a very long time when I became aware of it. We're going to be talking to the CEO of a company called BrainsWay. They are a global technology company. What they do is develop cutting-edge medical devices -- there is a wide range of those. We're going to talk about one that's very exciting specifically, and that is the transcranial magnetic stimulation -- TMS is what we're going to talk about. There are some very exciting things going on with this device and its treatment for certain mental health disorders. To tell us all about that. We go to the top, you know how we work here on the corner. We have their CEO, Chris von Jako, he is... Janko. Did I get that right, Chris?

Chris von Jako 
Von Jako. Close enough.

Steve Martorano 
Von Jako.

Chris von Jako 
Yeah, yeah, yeah.

Steve Martorano 
And I rehearsed that earlier. Chris has been in this sector field for over 30 years and he's the holder of multiple degrees. He Ph.D. in Biomedical Sciences, he got an MS in radiological sciences, as well as an MS in physics, and mathematics. I'm humbled by this man's time spent in school. Chris, thanks for joining us here on The Behavioral Corner.

Chris von Jako 
Well, thank you for having me. It's a real pleasure to be here to talk to you about this technology. So fire away.

Steve Martorano 
Well, let's do it, then let's begin with what it isn't. And then we'll get into what it is. I think in the popular imagination when you talk about stimulating somebody's cranium. In a mental health context, what comes to mind is the Academy Award-winning motion picture, One Flew Over the Cuckoo's Nest, based on the famous book. And in that, of course, the McMurphy character, Jack Nicholson is subjected to electric shock therapy. In a punitive sense, it was used to punish him and subdue him. So it's...it's a very horrific thing and I think in the popular imagination, people go away thinking when they plug these things in that's what it's like. TMS is not that is it?

Chris von Jako 
Correct, it's not that. It's actually completely different.

Steve Martorano 
So if it's not that, what is it?

Chris von Jako 
So in fairness, let's just start with electric shock therapy would now known as ECT. Today, that's been around for over 100 years. That was a very dramatic scene was shown there, where you're shocking the patient's brain with electricity, and you're trying to create a seizure within the brain. It's very much like taking your computer and rebooting it. So that's what you're trying to do with the brain. So electric shock therapy is used in the United States and around the world. It's probably actually one of the most effective things for depression today, but people are very afraid of it because of that scene. And also, because of the side effects they have with it, which is, could be, you know, short-term and long-term memory loss, and people, in general, are afraid of it. But in reality today, electric shock therapy is also done under anesthesia and can be quite effective. But what we're talking about today is transcranial magnetic stimulation. This technology was actually originally invented back in 1985 in England. And the original kind of thought around it was like, "Can we put an electrical signal into the brain, non-invasively?" And that's what they did back then. And the way they did it was, they used a coil, and in that coil, they put in an alternating current. And when they put an alternating current into the coil, what it created was a magnetic field, and it was you can stimulate a magnetic field into the brain. And how they knew it was working is the brain on both sides --some people may know this -- but you have what's called the motor cortex. So it's the surface of the brain. And you have the motor area on the surface of the brain is kind of on the side of each or your head. And is some people know and they learned this, you know, growing up, you know, the left side of your brain controls the right side and the right side rows left side. So what they did was they invoked this sort of this magnetic field into the brain from the outside non-invasively. And it moved somebody's hand and they're like, "Wow."So diagnostically they thought to themselves this is could do something, you know, non-invasively they can, you know, move the motor cortex do other things.

Steve Martorano 
Was that the impetus for trying this technology out to...

Chris von Jako 
Absolutely.

Steve Martorano 
 ...lesson evasive?

Chris von Jako 
Yep, that's exactly what it was. So then some smart people, you know, in around like, you know, the mid-90s, it took another 10 years. They started saying, could we actually do something and this whole field kind of blew up. I would say, since 1985, people have been trying to do many different things with this noninvasive magnetic stimulation. Right? So that's what he called transcranial -- so it goes across the skull -- magnetic, and then using magnets to stimulate the brain. And sort of in the mid-90s, they started looking at there was a Dr. Mark, George, down in South Carolina started looking at, you know, demonstrating the effects of this technology, and using it repetitively over time to help people with depression. So that's how the whole thing started. And then it kept evolving. So TMS, as I said, transcranial magnetic stimulation, you know, was invented in 1985, and then started being used for these different things. Well, from our perspective, we had a researcher that happened to be originally from Israel, and he was over in the United States. He's a neuroscientist, and he was in the United States doing a post-doctorate at the NIH, National Institute of Health. And he was specifically focused on looking at magnetic stimulation for addictions. And what he found out was, he said, your addiction area is a little bit deeper than potentially where your depression areas. So he developed the technology, which is the BrainsWay technology today, which we call it not TMS, but we call it "Deep TMS." So it goes deeper and broader into the brain. And this was gentleman, he's a professor, now he went back to Israel, he actually licensed the technology from the NIH. And then they started studying it for addictions and all different sorts of things. And then, you know, lo and behold, you know, they started a company, they raised some money. And then back in about 2013, the company got its first FDA clearance for depression treatments. The original technology, what we call a traditional TMS got the clearance back in 2008, for depression. But the beauty around Deep DTMS is that it goes deeper and broader. So it's not just focused on depression. It's a platform technology.

Chris von Jako 
Why was it thought that this stimulation in the very beginning would be suited for sounds like it's suited specifically for depression, rather than some other mental health disorder? Why was that?

Chris von Jako 
In the late 80s, the first entity depressant became FDA approved, and they were looking at chemically if they could do something, they were also from a neuroscientist's view, there was a lot of medical imaging that was done to try to figure out what parts of the brain don't work. When you have depression is something happening. And sort of the thought was around that, basically, neurons which electrically fire in the brain, a certain location actually stopped firing. And they were like, can we get that to happen now, if we use mag... you know, this transcranial magnetic stimulation. Which is essentially what you're doing when you're doing an electric shock, you're trying to, you know, restart the brain,

Steve Martorano 
The more we learn about the working of the brain, obviously, the better we can become, in not manipulating it, but...but being very precise, about how to treat problems because you got to treat them where they occur, not where you think they occur. So it's fascinating for me. Okay, so now, we talked a little bit about depression -- Deep TMS, which is what you guys are doing...

Chris von Jako 
Yeah.

Steve Martorano 
...goes beyond that or tell me does it go just...does it bypass depression and go right to the addiction centers and treat that? How does it work?

Chris von Jako 
Great question. So we have three different coils today, or helmets in our case. And inside the helmets, we have three different coils and these three different coils are focused on different parts of the brain. So we have a helmet as a coil in it, which is our first FDA clearance, which treats depression, we just about nine months ago also had an additional expansion for that it's not only treating depression, but it's also helping treat patients with anxiety that also have depression. Those are very coincident with a lot of patients about 60 to 90% of patients that have depression also have moderate to severe anxiety. So that's one area and that treats sort of the front left part of the brain. Then we got clearance back in 2018. So the first clearance was depression 2013 We got this anxious depression just clearance about nine months ago. But then in 2018, we had another coil that's inside a different helmet that treats OCD. So obsessive-compulsive disorder is a very, very unique brain disorder. And then, late in 2020, we got clearance for our first addiction indication from the FDA. And that was for smoking addiction. And this is great because remember the original sort of founder and inventor of the technology, Professor Zangen, he really was a neuroscientist looking at addictions. And his key thing is he's been looking at like, smoking, addiction and alcohol, and a whole bunch of other addictions as well. So the thing that I love about Deep TMS is the fact that it's just not a one-trick pony, that allows you it's a platform, so we can do a number of different things

Steve Martorano 
That is interesting. So let's talk a little bit about the side effects. What are the side effects of this technology?

Chris von Jako 
Well, let's talk about depression specifically, right. So in depression, there are many, many medications. And unfortunately, you know, CDC numbers, you know, from 2019, prior to the pandemic, was about 21 million people get depression each year, okay? And about more than half of them, like say, close to 11 million of them, don't have any benefit from that first medication that they take. And a lot of people associate medications, also with side effects. And there are a number of different side effects with antidepressants, right, you're talking about, you know, whether it's weight gain, sexual side effects, you know, GI issues, there's just a tremendous amount of different side effects, because, and that's why there's a lot of these two medications is probably, you know, over 30, medications out there different antidepressants. And so the side effects can be very, you know, troublesome, and that's why people need to change out the medications. So when you look at Deep TMS and TMS in particular, there are really no side effects, main side effects with the technology. And it's been well studied. You know, for many, many years now, many, many patients have been done many, many publications on it, and really, essentially, no side effects of the safety profile is really good.

Steve Martorano 
That's amazing. So your FDA approval, which you've received, each time you advanced this technology, you undergo the same kind of trials that any like a pharmaceutical drug, or any other device would have to go through the process seems very fast. I mean, what, you know, it seems like you've been able to demonstrate we can do this, and oh, by the way, we think we can do that, then you get approval for that. So you've got all those FDA approvals, you're under pretty rigorous scrutiny here, right?

Chris von Jako 
Well, yeah, so it's a little bit different than the drugs, I will say that. When the FDA goes from a drug standpoint, when they're looking at drugs, it is a little bit more rigorous, because people are ingesting a drug, and they want to make sure that they're studying it really completely. And they actually call those approvals. And you could do a lot more patients when you're looking at drugs. In our case, it's an FDA clearance. What the...what the FDA is looking for is safety and efficacy, right. So we go through FDA clearance. Traditionally, there is potentially a prior company that's already cleared something in our case, the traditional TMS was cleared. So we ended up doing a process of showing that we were efficacious, as well as they were. And we also are safe as they were. So we got that clearance. When we did OCD, nobody had an OCD clearance before. So we had to do what was called the "de novo" -- the first time ever -- so it was a little bit more, you know, in-depth than say, you know, just doing an FDA clearance. But in general, I can say the technology is extremely safe. It is efficacious. And I have to say that, you know if we're taking any of the things that we're treating. We're actually always treating the most difficult patients because we're treating those patients that failed medication.

Steve Martorano 
Yes. 

Chris von Jako 
So it makes it even more difficult.

Steve Martorano 
Yeah. This is an interesting topic, we're talking with the CEO of BrainsWay of about a technology that they are at the leading edge of that is Deep TMS, transcranial magnetic stimulation. So Chris, let's get to the nitty-gritty here now, if ...if I am looking for this treatment, how do I prepare myself for it? Is there anything special I have to do to get ready to go gets stimulated?

Chris von Jako 
So absolutely not. The question that you know, I'm always asked about it is like awareness. So thank you very much for helping us get the awareness out there. The other side accesses. How do I get access to the technology? So from a depression standpoint, the technology is paid by all insurance companies -- most of them, I would say, throughout the United States, and that includes Medicare, right? A lot of people associate Medicare with a safety net for, I won't say the elderly, but I'll say for, you know, 65 and older, but what people don't know is that if you're if you have a disability, you also covered under Medicare as well. And so depression and OCD fall under that. So from a depression standpoint, you know, over 250 million covered lives, from an insurance standpoint, which is great. The difference, though, is that some insurance companies have more rigorous requirements in order for you to be covered. In the beginning, it also took like, you had to fill out medications, right. And that can be a little bit of a nightmare, because it can take, you know, three to six months for one medication to come up it, fail it come down off that, then you go up and try another one. And then he comes down that one. But you know, since the pandemic, and just maybe just prior to the pandemic, there has been a relaxation of some of those requirements by insurance companies. So a bunch of them have moved from four down to two, which is great. And in some cases, Medicare only has one failure, which is really nice. And then if you're thinking about OCD, obsessive-compulsive disorder, a year ago, we were talking, we had zero coverage, we're the first ones to get this clearance for OCD, there are only five medications out there for OCD. And again, it's about 50% of the time, you won't get any benefit from taking medications. So in our case, it's great. We're now started having coverage about a year and started to go. But now now we have about 60 million covered lives to date. So we're making more and more improvements with OCD, which is great,

Steve Martorano 
There are a couple of things about keeping your eye on what insurance companies will cover. One is certainly if you're a consumer, you got to worry about what's out of pocket. But the second thing I always think of is the insurance companies are covering something, they are not doing it from some humanitarian position, they have figured out that this is a cost-effective procedure that will ultimately make them -- lowers there, you know, the what they might have to pay out, this is an effective treatment, let's cover it. Down the road, we'll all be better off where it's always a key thing when the insurance companies want to get involved. Tell me, Chris, about who administers the treatment, once you're in the office? Does BrainsWay train people on how to do this?

Chris von Jako 
Yeah, so we sell our technology to psychiatrists, and they have it in their offices. The psychiatrist typically does the first treatment, but they're there throughout the whole treatment. But it's typically a technician that can administer the treatment, which is really nice. You know, we train up the psychiatrist and how to do the technology. And we also train up the technicians and we're there to support them, we want them to be successful, because obviously, the more and more people they can treat like I talked about 21 million people in the United States get depression, it's probably more than that on the pandemic. And about 78 million have no effective treatment from medication alone. So these are the patients that we end up treating. And you just mentioned that, by the way, you mentioned, like the insurance covering...the economic burden is over $300 billion per year for depression. So think about that. So that is what, whatever we can do. And by the way, a lot of people think about just the patient, but it also affects everybody around them as well. So, but yeah, we think we have a phenomenal group that does a great job of doing training to make sure that everybody understands how the technology works and that it's ministered correctly.

Steve Martorano 
Let's talk about it a little bit. I don't want to get too far in the weeds because we're not technicians here. How much energy is shot into your head or stimulated? What kind of juice are you giving people?

Chris von Jako 
Well, I don't know if you've ever been in an MRI. 

Steve Martorano 
Yes, I have.

Chris von Jako 
It's...it's...it's...it's similar to going into an MRI. You hear this sort of knocking, knocking noises, right?

Steve Martorano 
And you're not in an enclosed space. Are you in an enclosed space?

Chris von Jako 
You actually wear a helmet. In our technology wear a helmet, which is nice. With traditional TMS, they just put a magnet close to your head, but you're lying back in a dental chair and you can't move. With our device, we have a helmet on the patient's head so they can move their head around. They can watch TV, they can sometimes play Jenga with the technician.

Steve Martorano 
How can you know...it's interesting if you bring that ou...how can you know that the treatment is not being interfered with or altered if somebody is watching, you know, the news and getting upset about it or depressed? I mean, I don't just...how does that work?

Chris von Jako 
So traditionally, when from a depression standpoint, again, what we're doing was stimulating a certain part of the brain and we're trying to jumpstart that part of the brain means. Think about it, like, you know, you're trying to work out a muscle, right. And I always think about it in our case, our depression treatments can be anywhere, but it's short as three minutes and as long as 19 minutes. It really depends on the protocol that's used by the psychiatrists, and what's happening to that particular patient.

Steve Martorano 
So it begins with a psychiatrist doing a traditional psychiatric evaluation of the patient.

Chris von Jako 
Correct.

Steve Martorano 
The patient is exhibiting these...these symptoms, you then understand what centers of the brain are involved in that process and, accordingly, map where the pulses are gonna go. Is that the way this works? 

Chris von Jako 
Yeah.

Steve Martorano 
Okay. 

Chris von Jako 
100%. Yep. 

Steve Martorano 
Yeah, with regard to the helmet, which is interesting, so you're not placing anything on anyone's head in any particular place. You put a helmet on, there are lots of electrodes out there, and then you just alter where the energy is coming from in those individual places. You don't move them around.

Chris von Jako 
So what we do, that's a really great question, what we do is, patients actually put a cap on. The cap actually is helpful for cleanliness, right? Because you don't want you to know, many people are different, or you know, people are getting treatment. So you want cleanliness, so they have their own cap. And then the cap has a special grid on it. And that grid kind of gives you the coordinates, think about like a GPS, something like that, to when we do the mapping to figure out, "Okay, where is this?" you know, "Where can we move the right hand, okay? We can move the right hand now." So now we have to move the helmet in such a direction that on those coordinates to get to the right spot. And the beauty about Deep TMS is that it goes deeper, so we're treating more neurons and it goes broader, so we don't miss the target. And that's a big difference between us and traditional TMS. Because traditional TMS is a very focal and very shallow treatment, where we go deeper, we treat more neurons, and we don't miss the target. So that's a really key thing with our technology. You asked a little bit, sorry about the energy, and I just wanted to make sure that I described that. In general, it's the same kind of amount of energy as you're getting an MRI. But that knocking that you hear, right, that knocking is much closer because the coils are close to your head. And you know, you asked about side effects earlier, the most common side effects that people get are like a headache, right, because they feel this knocking on their head kind of like a woodpecker little bit. 

Steve Martorano 
The real attractive difference between an MRI and what you've described, what your machines do, is, at least in my experience, I've only had one and never thought in my wildest imagination, that I would be troubled by this. It would be uncomfortable, the claustrophobic thing. And I don't want to frighten anyone. If you need an MRI, you gotta go get one. But it was not pleasant. There's no other way because it was not pleasant. And it's long. And they can play all the reggae music and show tunes they like, it's not going to change the fact that you are entombed in this thing. Crazy noises are going off. And you can't move. Do not move. When every fiber in your body says let me out of here. So that TMS -- Deep TMS -- allows you all that, you know, openness, and space is spectacular. Chris, let me ask you this now with regard to the...to the people who are suffering from depression, or, or...

Chris von Jako 
OCD.

Steve Martorano 
Yeah. And they've, they're at their wit's end. Their psychiatrist who may not have this technology, do they...how do they find out about it? How do they send you...how do people who need it find out about it?

Chris von Jako 
Well, if people go to brainsway.com, right, upper right-hand corner, we have a provider list on there. And we have a growing number of providers, you know. We have roughly about 800 systems out there, definitely not enough. You know, if we were going to treat just all the depression patients that needed to be treated, we'd probably need close to 50,000 systems. So we're at the very beginning spot here. And we're trying to get out to as many psychiatrists as well, but we're also reaching out, to patients to make them aware of it so that they're demanding the technology from psychiatrists as well.

Steve Martorano 
I think if it came from the consumer or the patient side, it would be much more powerful. Yeah, our underwriter partners, you know, want to use this technology. And I know some personal friends who are in psychiatry they're very excited by this as well. Let me ask you finally this Chris, with regard to this treatment being beneficial to people, how often are the sessions necessary? And do they always take place in conjunction with other forms of treatment? You know, you...your typical talk therapy, or maintaining...how do you maintain TMS is what I'm trying to say. What do you do with drugs with therapy what goes on in addition to TMS?

Chris von Jako 
So everybody is a little bit different, right? We all have different brains. And we're all kind of just a little bit different. So I think in general, I've been doing medical devices for many, many years, as you mentioned, close to 30 years, and most of my life has been focused on cancer. Most of it has been focused in the brain with neurosurgery in the brain. And whenever you're trying to deal with cancer, you're always going to try to use as many different tools as you can, whether it's surgery, radiation, chemotherapy, there's a whole bunch of other new technologies. You know, we look here BrainsWay, as mental illness is a brain disorder. You may have a patient that may have a...they get clinical depression. It's episodic, something happens in their life, and they get depressed. A lot of people get confused and think, okay, depression, you're in a bad mood. I'm a...I'm a sports fan. I'm a big New England Patriots fan. We've had a lot of success. But they were by early years, you know, we had a lot of lost games, and I would be in a bad mood because of that, but I was never depressed or clinically depressed.

Steve Martorano 
That's because you're not a Philadelphia Eagle fan.

Chris von Jako 
Hey, we lost to the Eagles. Come on. 

Steve Martorano 
Yeah, yeah.

Chris von Jako 
So in general, you can get a patient that can get depression, can get on the medication can get better, get off the medication, and never have a depression again. Then you can get somebody that can go on medication, not feel relief from it. Look at another medication and other medication. I mean, I have so many stories, I've had so many interactions with patients over the last two and a half years since I've been at the company, it's been amazing to actually see what happens to these patients and how they get better. And sometimes they get angry, they get angry after they get better, because they're like, "How come I didn't know about this technology?" They had depression for over 30 years. 40 years.

Steve Martorano 
Well, what's exciting...what's exciting about this, and, you know, is that, as you mentioned with...with I'm not disparaging drugs for the treatment of psychiatric disorders. But it seems to me from talking to people, that the drug may be science, the creation of the drug may be science, but the application of it and the efficacy of it is sometimes more art and science. Let's try a little more of this. Maybe that didn't work. Let's try a little more of that. And maybe perhaps that's just the nature, of depression. But it seems like technologies, like BrainsWay, and other TMS technologies are more specific, that it's more targeted. It sounds smarter, is that fair?

Chris von Jako 
I think that's fair. But I think that to be fair, like, you know, those drug companies are working hard to come up with something to help people and they're trying to do it chemically. We're doing it electrically. And the point I was actually going to try to make was sometimes people can just have Deep TMS treatment or TMS. And they get better and all this good. And they get and get off their medication. But sometimes it's done in conjunction. That's the point I was trying to make from a cancer perspective. Because I think, you know, people don't want to be on drugs. And I think that's the nice thing about TMS. But sometimes they have to have the combination of the two together. 

Steve Martorano 
Sure. Well, good. I'm glad we made that clear. Chris von Jako, thanks for joining us. Chris, again, CEO of BrainsWay, he...give the website address again so people want to find out more about your company.

Chris von Jako 
It's quite easy. So it's BrainsWay, right like one-word dot com. That's easy. And then up in the right-hand corner, you can find the providers. We have providers throughout the country.

Steve Martorano 
Chris, thanks so much. It's a fascinating topic. And boy, we'd like to think we're at you know, at the beginning of the conversation, it sounds like we're we are so we appreciate your demystifying this thing for us. And we'd love to have you back. Anytime. You can talk a little more authoritatively about depression after Brady left New England. So tell me, don't tell me that didn't bum you out. But anyway, thanks so much for joining us on The Behavioral Corner. We appreciate it.

Chris von Jako 
Thank you so much. It was a pleasure to be here. I really appreciate it.

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