Kelly Roman, Fisher Wallace Laboratories - Wearable Brain Stimulation Technologies | LSI USA '24

Kelly Roman  0:04  
Fishser Wallace Labs is a, we think of ourselves as a mental health company, not a brain simulation company. But that's what we're starting with as a mental health company. We've been actually round since 2009, my co founder and I commercialized a proof of concept device under a grandfathered. 510. K, and I don't know if you're familiar with, with the FDA 510 K process, and in how, you know, in the 70s categories of devices were, were grandfathered in and cranial electrotherapy stimulation was one of them. And so we were able to market a brain stimulation device for depression, anxiety and insomnia without having a pivotal trial without having kind of the typical things that you need today. That's now been changed. And we're going through a PMA process for depression, and a new 510 K process for anxiety. But during that period of time, where we were able to take advantage of that process, we sold $40 million worth of our version one device, which is really a proof of concept device, through 14,000 prescribers. And we were able to fund some pilot research, which kind of laid the groundwork for what we knew we would have to do in the future with with with larger trials. So over the last four years, we've been you know, really focused on on getting the data we need to get through a PMA and to commercialize our version two devices, what you're seeing on the on the left hand side here. So in 2022, and 2023, we ran two trials, one for depression 255 subjects, with a principal investigator who had done one of the early spravato trials, we just looked at four weeks of treatment, so an acute treatment. And we had statistical significance at weeks one, two, and four, where we were where we were measuring on the on the Beck Depression Inventory. And I think, most importantly, we had a really large effect in the first week, and there's very few things that work to treat depression in the first week, as ketamine is one of them AECT beta burst, you know, kind of a concentrated series of TMS treatments. And so, you know, I think the other end, we had no serious side effects. So like most non invasive brain stem, it's very safe. But we were able to demonstrate very rapid action and depression. And then with anxiety, we did a 200 subjects study with the Seattle Police Department. And also we had a week to endpoint there was four weeks of treatment, primary endpoint when week two p value under point 001, no serious side effects. So we believe that study may be enough to get through the 510 K process, we're going to find out we're going through a pre sub process there. And for the PMA, for depression. We're we partnered with Mass General and Dr. Mercia fava is, has been designing our pivotal over the last couple of months. He's the psychiatrist in chief at Mass General and Associate Dean of clinical research at Harvard Med School. And, you know, when he saw our four week data, you know, his reaction is you have a great signal here. And the most important thing that we can do in this field is increase access right is now this device or research device cost $36 to manufacture device you see on the left, probably going to cost we're we're about six months of engineering left on it about 65 $70. So and it's it's a it's a very easy device to use. And we ended up hiring the I ended up hiring the, the the industrial designer behind beats and Nast because I wanted a device that looks like a consumer wearable kind of look like something Apple might build. So that it's it kind of helps to break down the stigma and the and make brain stimulation approachable, right especially for you know, Gen Z Gen alpha, which has the highest prevalence of depression so, you know, we're we've also so we have kind of as far as a business model and we're we've been raising a Series A for the past month I say we I think we found our lead we have a number of investors that I think are going to come on board after the lead. And I you know, we're going to be using that money to fund this pivotal for for the PMA as well as get OIC into production. And we're going to build the best 7500 units for pilot testing. And we're going to we're focusing on the VA for our reimbursement channel. So Dr. David Shulkin joined us a couple of years a couple of months ago. I've known him for couple of years to really help guide our VA strategy. And, you know, in a nutshell, we can develop a number of pilot programs at the VA that can convert into contracts through something called the credo process. And just there's a huge acute need their for for mental health treatment. And again, access is the problem, you know, there's there's just a long waiting list to get care. And so I think we have you know, and Medicaid is another reimbursement channel, we're to get main Medicaid to cover our version one device under that grandfather 510 K periods. So we, we have confidence in those two channels, I think the other ones we'll get up to, it'll take some time to, to onboard them. And while we're doing that, I think there is a real self pay market here. You know, we've we've seen that with with spravato, and a number of other rapid depression treatments as well, as well as other kinds of things that have been slower to get, you know, mass reimbursement. So most of our version one customers were paying out of pocket. And so we have about 60,000 of them that are daily users at this point. So, you know, that's 10s of millions of potential revenue at launch, just just an upgrading our version one customers. I think, you know, the other kind of important point, I think is, you know, that I want to distinguish this is a very simple I, I think of it a little bit like the Google Cardboard, if you remember, I know, the VR market is very different than this market is much larger, much healthier. But, you know, I look at this kind of device as the simplest, lowest cost. But yet having, you know, all the all the benefits of really high quality, therapeutic, but you know, when I look out over the marketplace, we have in brain stimulation, there's a lot of focus on brand imagery, and using closed loop to, to customize brain stimulation to to you know, real time brain activity. And I think there's huge promise in that. And we're beginning to see that in the data. And I do I do look to to that with this device in the future. I think we're not we want to commercialize something that's, that's simpler. And that is a little bit easier to, to manage. And you don't even need a cell phone to to operate this. This can be used standalone. We are building Bluetooth into it. And there are things that we're developing on the software side. But this is about as simple as you can get. And I think it's hard to beat hard to beat the cost on that. Does anyone have a question? I can answer while I'm up here. Yeah.

Speaker 1  7:54  
Yep. Can you explain a little bit how it works? Yeah, sure. So so it's a transcranial alternating current stimulation device. T ACs. So it's, you know, it's very differentiated from others. Yes. Yeah, yeah. So yeah, sorry. Yes. Yeah, it's an electrode, no, no, right. It could be a bracelet. It there's an electrode on either side of the head. And patients worked for 20 minutes in the morning and 20 minutes before bed. We did do a pilot study on insomnia. And that was sham controlled. And we did increase total sleep time by 48 minutes per night, by the fourth week, a half an hour difference in the first week. And we are also we're kind of past the first phase of review at the Alzheimer's drug discovery Foundation. We submitted a letter of intent there with the lacuna route day at UPenn as a pi, so Alzheimer's is also a target of ours. And but, you know, my goal here is is to, you know, get the, you know, I want to sell 5 million units in the first year. And I think there's not a lot of brain stimulation products that you can actually say there's a realistic shot of doing that. I think in this case, we've we've built a model and an ability to do that. Everything from the look and the data to the to the manufacturing. That's it for me. Yeah, thank you.