00:00:05:11 - 00:00:08:22 Unknown Welcome to the podcast. 00:00:09:00 - 00:00:32:01 Unknown welcome everyone to the hard tech podcast. You've got me, Grant Chapman, and today I've got Drew Westbrook co-hosting today. So CTO is back in the seat. Yeah it's been a little while. Hi, everybody. Yep. And we've got Kelly Roman in house from New York to all the way here to visit us. So he's working on an awesome new medical device in the space of brain stimulation between depression, anxiety, insomnia and some other cool things possibly coming down the line. 00:00:32:02 - 00:00:52:08 Unknown Kelly, thanks for coming in. Oh, yeah. Great to be here. Easy trip. Easy trip. Easy. Well, I'd love to start off this podcast with some of your, you know, story of, hey, how do you get to Fisher Wallace? What does Fisher Wallace been doing? And kind of jump into the deep end? Yeah, I had a very unexpected path to tech. 00:00:52:10 - 00:01:19:15 Unknown So I, you know, my my brother is actually a research scientist. So my brother is a professor at Downstate Medical School and teaches cell biology. So, you know, growing up, he's 12 years older. I was, you know, exposed to all of his research. You know, he would take me to his lab. So I was comfortable, you know, speaking with scientists, reading journal articles. 00:01:19:19 - 00:01:51:05 Unknown As I was older, I was reading what he was publishing. But I took very much of a humanities path. I went to Harvard English major, you know, worked at a couple, you know, tech digital media startups. One that was unions were ventured back. At the time, it was a little company called Odd Caste, where we were actually one of the first offices to use Twitter because, you know, we're ventures was one of the early adopters of Twitter. 00:01:51:07 - 00:02:15:18 Unknown So I worked in early social media, so I brought Bebo to Billboard platform and we will acquire bang! Well, probably never heard of them, but at the time they were big social media. So that was kind of my beginnings in social and digital media, and then wrote a book for Harpercollins. And graphic novel was a really a passion project. 00:02:15:20 - 00:02:37:22 Unknown I actually turned down a pretty senior role. They were poached me out of the word side and turned it down to do this book. And then Art of War, I adopted the Art of War, which was actually pretty relevant prep process for business. We were talking we were we were joking at lunch about this. I was like, are you sure you were writing? 00:02:38:04 - 00:03:12:12 Unknown You're writing nonfiction or fiction, right? Very much nonfiction. And and then I met my co-founder who had acquired this technology from the engineers who had actually passed away. Brothers and I had taken a presence in my 20s had, you know, rapidly unpleasant side effects stopped taking them. He handed me this device, which was pretty, pretty crude and prototyping. 00:03:12:16 - 00:03:36:21 Unknown But boy, it works with me. And, you know, this was in 2009. So, you know, Fitbit was just getting going. The whole word wearable was very new. And I was I just felt like this is one of those things where if we can really prove out the science. 00:03:36:23 - 00:03:59:02 Unknown It's like it's like one once in a lifetime opportunity just to be able to actually own that technology. Because I'm not a, you know, a researcher. So I went all in first six months, I was a little bit arm's length. And then after six months I was on. Yeah that's great. And so that was yeah, almost was 17 years ago. 00:03:59:02 - 00:04:26:05 Unknown So we spent the vast majority of the time running clinical trials and product development. But because of a whole called a loophole, but because of our FDA pathway that we're the only brain stimulation device to take advantage of, we were able to market this research device. From the moment that I started in 2009, all the way to 2023. 00:04:26:05 - 00:05:06:06 Unknown And so we were running research with a research device while serving it. And and then what we're doing now is taking all of that data and learnings. We've perfected the device, filed new patents and ran it. We ran the two through five trials, and we're now could be months away from FDA clearance for anxiety. And then the running, we may be about a year away from depression and then insomnia. 00:05:06:06 - 00:05:10:02 Unknown So we've we've already done. 00:05:10:04 - 00:05:35:02 Unknown Significant amount of research on all on all three of those things. The anxiety study that we've done is enough to get through the FDA process. You know, we we certainly think so. We've already been through it with the previous version. FDA knows this very well. And we had a home run in that study. We had 165 first responders running eight weeks through the society study without sounding results. 00:05:35:02 - 00:06:14:01 Unknown And so now, you know, we've we're pivoting both in terms of technology. It's perfected technology also the form factor of one from this kind of very basic, minimally viable product type of design, which is still we're still using tags and so has a lot of utility but has external wires. It looks very hospital like and we've moved into a very consumer any form factor, although it's going to be a prescription device reimbursed, etc. but we worked with the designers of beads and Rest. 00:06:14:03 - 00:06:38:11 Unknown Did you say like highly effective but you know, certainly has some usability issues. Is that what you guys are mainly pivoting towards now? It was it was more about I mean, the only usability issue was having wires hanging down from like a handheld pulse generator to electrodes, neither side of the head. You have these wires and so they can get in the way of doing things like if you're cooking dinner. 00:06:38:12 - 00:06:49:03 Unknown Yeah. So a new form factor is completely on the head. And but it's more about approachability. 00:06:49:05 - 00:07:09:21 Unknown Creating desire and very much taking a page out of beats headphones. Sure, we want to give people an object that they will naturally feel proud wearing and build awareness for sort of meshing like a lifestyle product, almost like with a with a clinical or like a med device. Is that how you would characterize it? Yeah, to the highest extent. 00:07:09:22 - 00:07:34:20 Unknown I mean, the depression indication that we're going after next is class three. So three device. Yeah. Highest level PMA anxieties. Class two insomnia is class two but very much the hard core needed clinical trial prescription device. But this could vary for the listeners. What what makes that so hard. Like why is that a class three device in your mind? 00:07:34:22 - 00:07:56:09 Unknown So class three is typically reserved for devices that are addressing something life threatening that Erin planted that pose serious risk. Yeah. Because it seems like for a wearable that's I mean, I, I know this so I'm trying to lead the, you know, the listeners a little bit here. Like to your point exactly that. Right. It seems kind of severe. 00:07:56:09 - 00:08:21:10 Unknown But is it mainly because the danger of not being effective is so high? Like you have to really prove that you're solving that particular problem. Is that it? There's two levels to it. One is when the FDA modernized the regulation, there wasn't enough depression research in this category for them to be able to put it into class two. 00:08:21:11 - 00:08:38:14 Unknown So if there had been more research done in depression that was convincing, they probably would have put it in the class two. But because there wasn't enough, this is how they stated it in the ranks. Like in the final order, they didn't have enough data to put it in the last two, so they had to put it in the class three is what their rationale was. 00:08:38:14 - 00:08:57:14 Unknown Now, because of our study that we published in 2024, you could argue that there is enough data to put it in a quest. Two and if we wanted to pick a fight, I would say and we could file a reclassification petition with the FDA and say, actually, this should be in class two now because there is enough data for you to create special controls. 00:08:57:16 - 00:09:20:05 Unknown Yeah, but why do that if you can get through the PMA? Well, that makes sense. You're you're digging around mode now, but by not feeling it, not getting shallower for everyone else, you already had to dig them out. You might as well, you know, live inside of it. Well, it's not even for the self-interest, that's certainly true. But it's also, I want it to be, say, FDA approved, that if it cleared and you can only see FDA approved for medical device. 00:09:20:05 - 00:09:47:03 Unknown It's class three. Yeah. Yeah, that's a good point. We'll say approved when it's not like TMS transcranial magnetic stimulation. You go into the clinic to get it. That's that's FDA cleared. Some people referred to as approved, but it's cleared. And I think having that approval and also the data requirements for class three or higher. So you have to have like a sham controlled, you know, they want to see at least a ten week study that sham controlled sham for everyone listening. 00:09:47:05 - 00:10:17:23 Unknown Because this you and I talked about this in our last call. That's like, yeah, but the the because you're studying person a mental health issue which is anxiety or depression, your personal experience by being in a study might change your anxiety and your depression because you're receiving some amount of care that it is a placebo effect, that it's not the thing they're testing that makes you feel happier or less depressed or less anxious during that time, is that you're seeing a clinician and meeting with them and talking with them, and that might be enough to move the score in false positives or false negatives, right? 00:10:18:00 - 00:10:34:21 Unknown It could also be that like, oh, I'm being monitored. I'm being a little more like self-reflective. Like maybe, you know, maybe I, I like maybe I feel more anxious just because I'm focusing on whether or not I feel anxious. Right. Like that. That also could possibly be a side effect of participating in a study. No, it certainly possible. 00:10:34:23 - 00:11:00:16 Unknown I think you but you typically see it the first way described. Yeah, there is a treatment effect from being in a study. And then you there's like a force multiplier of creating a self-care routine with our device. So or you know, if you're cutting out, if you're carving out 20 minutes a day or 20 minutes or more in an evening, and you've never created a self-care routine before. 00:11:00:16 - 00:11:25:18 Unknown So not only you're in a trial, but you're creating a self-care routine that may not provide a placebo effect three, six, nine, 12 months later, but it certainly will in the first four weeks. Sure, usually in the first 12 they start to see wash out. But because these trials are so expensive, you know, and people want to get approved, they don't want to run a trial for a year. 00:11:25:20 - 00:11:52:08 Unknown It prohibitively expensive. Sure. So you do have to strategically bake in a very high placebo effect in any mental health trial. Now you actually see that placebo effect is much higher in a home based study, in a remote study than a in clinic study. We've seen this. So we published a bipolar depression study device that was done out at Beth Israel, not Sinai. 00:11:52:10 - 00:12:21:06 Unknown And the placebo effect was actually quite small. We beat a placebo. It was, I think, if I remember correctly, it was we had it was a nine and a half point difference on the back. And then you got 13 points reduction in active. So it was like it's like a 13 to a four. Right. And so four points improvement versus 13 points improvement in Wow at home study. 00:12:21:08 - 00:12:44:18 Unknown The separation that we had in our published study in 2024 was only five points. So almost half of what it was in a in a in an on site. And there's a when you're going into the dentist, it's like it's different than when you're you're at home creating a self care routine. Right. So so there's so doing it at home is even a bigger challenge. 00:12:44:20 - 00:13:09:16 Unknown On site costs more on site is not really the use case to begin with. So the use case that we're building for is personal home use. Now five points is still twice what the necessary is. So maybe some people know this, but the difference between placebo and active a drug trial is incredibly razor thin. What is it typically like? 00:13:09:17 - 00:13:36:22 Unknown An extra points is what the average SSRI separation is between I mean, it's a which is why these drug studies have like thousands of subjects because you need to if that's how small your separation is to get to school significance, you need lots of people, right. So again, with a startup med device company, you can't afford thousands of subjects because you're talking minimum 5 or $6000 per subject. 00:13:37:00 - 00:13:58:18 Unknown Max. You know, for a you could spend 10,000 in a easily in a, in a on site study. Right. Well so you know, you have these limiting factors that just make it even harder to be challenged. Well, and let's let's open this up because I think the thing I'd love to talk about, the podcast for all the listeners is like, how do you design a good study for a device that needs a sham? 00:13:58:18 - 00:14:18:06 Unknown That can't just be a sugar pill, right? When you're doing a sham with pharmaceuticals? Easy. There's two pills. They both look white, one is sugar, one is the actual drug. There's no difference for your hardware device. A, you have to have a device. It has to light up and turn on. Right. The user has to be not just plausibly convinced, absolutely convinced that they are not in the sham study. 00:14:18:06 - 00:14:35:01 Unknown They test for it. Right? They have to believe they're getting that this is the real device. They ask them. Yeah. And so I think, you know, generating these studies is such a hard part of the design of a product experience as a med device. And for you, it has even harder because your device you feel it, you're getting stimulation. 00:14:35:02 - 00:15:05:12 Unknown How do you how do you guys design the sham versus the real? And what was the I? Maybe we can't even say this out loud, but what is the control behind the scenes? What's different? Well you actually don't feel it. And that is what's extremely hard to do with neuro Stem. So one of our our carrier waveform, what separates our device from every other one is we use a carrier waveform that is orders of magnitude. 00:15:05:14 - 00:15:40:03 Unknown Two orders of magnitude more than typical. And so that that's in frequency. Yeah, yeah. Two orders magnitudes faster. So you know it's not a radio signal, but it's kind of the same concept of radio where you get through, you can get through concrete wall. Right. And so so we've been able to kind of get less to get to get electricity without having to use a lot of what you can get it through the skull and in a way that you don't feel. 00:15:40:04 - 00:16:05:04 Unknown And so that that allowed us to have a successful blinding assessment, which is what you're talking about. We use something called the Genes Blinding Index. And more people in the 2024 depression study, more people who were on sham thought they had active. That's wild. It was not not. It was still like not a we beat. We were fine. 00:16:05:06 - 00:16:28:04 Unknown Overall, it was about equal. It's like a handful more people thought that they had active were in champ. It's just a great example of how what that basically proves is that our active device is as comfortable as one that does not emit electricity. And you had better outcomes. So so this is the the outcomes were better and the sensation was the same. 00:16:28:05 - 00:16:47:15 Unknown And that's what's so cool is you have a device that's indistinguishable from the sham from like a wearable perspective, like it's comfortable to wear. This is easily easily everyone's in the same boat. Yeah, but you got the data from the same study that it works. And again, from anyone else that's been looking at studies in Stem or other these I'll call hard to classify studies. 00:16:47:15 - 00:17:22:16 Unknown You hit both categories which had you only hit one of them. Believability gets hard. Yeah. And it's to the point when that the FDA there's only we have one competitor that's gotten through FDA and they actually let them through even though they failed the blinding assessment, which is more like an act of compassion. I mean, I think it as long as you don't have serious side effects, there's certainly an argument to be made that even if you're questioning the outcomes because the blinding didn't work, then people knew they had sham rapid. 00:17:22:18 - 00:17:38:06 Unknown The benefits can still outweigh the risk. And that's what the FDA basically said is like, basically, you're saying we know how hard it is to blind nearest, and as long as the benefit outweighs the risk, but they still had to supply them with a ten week. 00:17:38:08 - 00:18:16:05 Unknown Fairly high subject with sham control. And we did have a successful blinding. So and we did have much higher response rates than the competitor competitor. But so, you know, we feel very confident going into the question, does the FDA look easier or harder at efficacy based on the severity of what you're treating? So to give you an example, it's like and again, I'm maybe talking to my depth here, but it's like, you know, anxiety generally, you know, isn't necessarily as say, life threatening is say like severe depression. 00:18:16:05 - 00:18:47:18 Unknown Right? So when it comes to that, what you're treating, does that also have like an impact on like how much efficacy you really have to show? Right. Because I would think that your device would have to show really high levels of efficacy. You say for like depression, because the alternative is like if you prescribe this device as a treatment for depression, but it fails really bad outcome there versus if you, you know, prescribe a device to treat anxiety, it's like, okay, well, you're sort of just about as anxious as you were before being treated. 00:18:47:19 - 00:19:03:05 Unknown Do they do they look at those two things differently, like do they look at like severity of the outcomes or non treatment versus treatment. Like how do they take that into account. Is that is that by class. Is that by how the studies are actually set up. Is that by how much efficacy you have to approve to get approval? 00:19:03:06 - 00:19:08:23 Unknown How does that play in some of us a little so. 00:19:09:01 - 00:19:36:12 Unknown So the other reason I didn't really get into the other side, I talked about the lack of data, which is why we have to put it in class three for depression. But the other reason is that with depression there fear is if you don't have great effect of this data to your point and something actually doesn't work, then you actually in patients with severe depression, you have a risk of suicide because a existential risk here for the patient, not in all patients. 00:19:36:13 - 00:19:57:19 Unknown I mean, not all patients are are there's a big difference between suicidal ideation, like someone thinking about it versus someone who's planned it for someone who's acted right, right. Most people, like a lot of us, will. Idiot. Right? But, I mean, I hate to laugh about it, but man, no is common. But like, planning and acting is much less common. 00:19:57:20 - 00:20:31:23 Unknown But yeah, so. But where it gets intuitive, if someone is a really serious condition, you don't. The FDA is if you're not exposing them to a lot of risk, just a little bit of improvement is is important. Yeah. So so fascinating. So you know, I think like for instance, with there's a kind of brain stimulation that is approved for treating tumors and brain tumors, and the person wears the unit 24 hours a day. 00:20:32:00 - 00:20:53:22 Unknown And you said approved, not cleared. Yeah. Yeah. Just to make sure this there's a class three. Yeah. Okay. Forget the name of the device, but you wear it 24 hours a day. It uses super high frequency, stimulation. And it has been shown to reduce the mortality rate of brain cancer by a tiny little bit. But it's approved for that. 00:20:53:23 - 00:21:14:10 Unknown But it's approved. Tiny little bit. A tiny little bit matters when it's mortality. Right. So with it so interestingly, like if you get into the wellness space, one thing that the FDA has said is like, look, if you're a healthy person, then any risk is greater than any potential benefit, because if someone is healthy, then there is no benefit really that you have to give, right? 00:21:14:14 - 00:21:40:05 Unknown If someone's already healthy, then what could the benefit be? And therefore, if you're not really providing benefit that any risk is greater than benefit. So so that that's where it gets like, oh wait a minute, I see. And so now it's actually quite challenging in Europe and the US to get a wellness, you know, unless you're like like in Europe they've made it a higher class. 00:21:40:05 - 00:22:13:19 Unknown So depression is class two A or B in Europe a wellness devices class three. So Europe has made it class three. FDA hasn't done that yet. There are some wellness indications that that we can get that don't have that level of rigor. Like for engaging in tasks that require focus and concentration. We can, if we've established the risk, is very low and like the job that's being performed, for instance, flying a plane is you need focus and concentration. 00:22:13:19 - 00:22:35:22 Unknown It almost gets into that category of disease state where it's like, okay, it is existential if your performance is not at the top. So there are these variations where you have to it's interesting, these gray areas and it doesn't matter, but it's not always intuitive. Yeah. Kind of walk us through just maybe a little bit of of the company like journey. 00:22:35:22 - 00:22:57:05 Unknown I know you touched on like some of it so far in terms of like the devices and stuff like that being in the field. I mean, I think you touched on early, I mean, is fairly unique that you guys are still going for FDA clearance, yet you actually kind of have like quite a few devices that have like, you know, been in the field, which I think is a really kind of interesting, unique opportunity that doesn't always kind of happen in this space, right? 00:22:57:09 - 00:23:31:03 Unknown Yeah. It's never going to happen again in our space. So we, we, we we came into this when it was the strange the category was being regulated. In the same way, in 2009, it was being regulated in the same way it was in 1976. Wow. When the FDA first started regulating what's called cranial therapy stimulation, I have in my office a wooden box with these brass, you know, kind of bulbs that you put on either side of the head from, like turn of the century. 00:23:31:05 - 00:23:57:11 Unknown There were these electronic stem devices that people were marketing for sleep and mood. Some of them probably worked, but they didn't have trials. They didn't know why. But if I hold these two light bulbs up to my head, you know, fairly close, like I feel better in the morning. So they grandfathered this strange category in. When we got to the scene, there were no brain simulators in the category. 00:23:57:11 - 00:24:22:14 Unknown It was vagal nerve. So people that were having lectures on the ears, every cranial therapy stimulation device except ours. And there I think in 2018 there were something like 15 or 16 devices that had this. All of them were big American stuff for us. So anyway, we were able to kind of tack ourselves on to this category and market herself. 00:24:22:14 - 00:25:03:01 Unknown And then, you know, the FDA tried to modernize that. In 2011, two years after I got started, they called for a for depression, anxiety and insomnia. And I spent the next, from 2001 to 2018, engaged in the FDA, kind of back and forth. We had the equivalent of like congressional hearings through reclassification panel. We had to fight very hard to convince them that really anxiety and insomnia should be, at the very least in class two, because this device was so low risk. 00:25:03:01 - 00:25:19:00 Unknown And we're responsible for the fact that there's a class two path today. They wanted in 2011, they proposed class three for all indications. And and that's where I got my education. And. 00:25:19:02 - 00:25:37:02 Unknown So they weren't going to just close the door on this category. It was like they were going to lock it. And like you were going to have to definitely like get out the pick set to get back through the user fee for PMA is $400,000. Yeah, that's just the application fee. So like what startup. Right. It's a sorry. 00:25:37:04 - 00:25:59:07 Unknown It's all good. You're good, you're good. You can still hear me. Oh yeah. Yeah, yeah, we can hear you. Yeah. The application. So it that would have been a very, very hard bar. And they at that time were going to require, you know, the very highest level for all three. And, you know, I think having it for one makes, I think having for, for depression I'm cool with that I think. 00:25:59:11 - 00:26:19:03 Unknown Yeah. Kind of previous conversation. Right. I mean the, the, the risk of having a device, let's even just say side effects aside, know danger to the patient. Obviously that's always like first and foremost. But the risk of the device not having enough of attendant effect is is high, right. Particularly in a certain subset of of that user group. 00:26:19:04 - 00:26:49:13 Unknown Right? I mean, you can also be double advocate and say, well, you know, the recidivism rate or the relapse rate for antidepressants is something. Yeah, 8,588%. Yeah. I mean, if your standard of care has an overwhelming failure rate in terms of relapse. Yeah, I it's there are arguments to be made on both sides. Yeah. Ultimately I like because there's such a credibility gap with this category. 00:26:49:13 - 00:27:09:08 Unknown I like that it's in the class three for those reasons. Yeah. What even speaking I think if I think selfishly for your guys's company again, it's kind of back to this piece as if, if you can manage to climb that very high wall and get to the other side of it and prove the efficacy piece. Right. I mean, it's obviously very good for your company. 00:27:09:08 - 00:27:40:05 Unknown And it may, you know, again, kind of, open up just this whole new treatment pathway, right? That is non-drug based therapy. Right. Which is pretty amazing, right? It will happen regardless in that as long as Republic depression data, which we have now twice bipolar depression at the is written on Sinai. And then this recent major depressive disorder study. 00:27:40:07 - 00:28:03:08 Unknown You're going to get prescribers prescribing it for depression off label because they know the data is out there. So yeah, having the anxiety clearance. Oh, that's an interesting take. I didn't think about that. That's that's really that's really, really big. It's so cool. Yes, yes. Between the anxiety and depression is super high. So yeah it's the overlapping von diagrams are basically a circle probably. 00:28:03:09 - 00:28:36:21 Unknown Right. So I think what what getting the depression approval does is a the credibility of that be you can actually get reimbursed for depression not just anxiety. And so it is your ability to get reimbursement, which is by the way, that's the other reason to do a large scale trial is, I think a lot of entrepreneurs in this space per learning to think, oh, if I just get through the FDA, I get reimbursement. 00:28:36:21 - 00:29:01:05 Unknown That is absolutely not how it works. You just because you prove it safer use doesn't mean that the insurance carriers are going to cover it, right? Yeah. Companies like oh, you proved it's effective for 12 weeks. Well, you know, I don't want to pay for this forever for 12 weeks of benefit. Well, yeah. And it's like we want like the whole point of us insuring something is so that it reduces our costs and we don't. 00:29:01:06 - 00:29:25:05 Unknown If you can't show us that using your device reduces our costs, then we're not going to pay for it. And the only way you could do that is having quite long, like 1 to 2 year studies where you're not just tracking symptoms, you're tracking health care utilization, and you partner with a company like an Iqvia that literally has all of our health care utilization data. 00:29:25:06 - 00:29:51:20 Unknown Yeah, that's very expensive. And so you have when you're recruiting these real world studies after you're on the market, if you can figure out how to get your device purchased without reimbursement, and then you have you start collecting this real world data over a year, you have to enroll enough subjects where you can actually, the IKEA's can take your data set and then only a percentage of them, they're going to have all of this health utilization data. 00:29:51:20 - 00:30:02:03 Unknown So you have to go through that and you have to have a credible enough clinical trial. So we'll have that credible clinical trial. 00:30:02:05 - 00:30:32:19 Unknown For insurance with our upcoming mass general study for for depression. So, you know, and I think by the time we're done collecting real world evidence, we're going to have that for multiple. We'll have it for all of our approved conditions. So, you know, anxiety, depression, insomnia. So but yeah, you want really robust data for the insurance because that's the whole business model. 00:30:32:19 - 00:30:53:03 Unknown And are you guys going to probably be a durable medical good. Is that the categorization? Probably. We're there's kind of two options that I see on that. One is you have just an upfront fee. The other is you can try to build monthly, so a CPAp device, for instance, that used for sleep apnea, they, they bill every month. 00:30:53:04 - 00:31:30:06 Unknown You have to show adherence. You know, we're we're moving more towards the upfront fee for DME not doing the monthly. And I think we're not charging so much that like at $1,500, that's a very rationalized upfront fee, especially when you compare it to ongoing depression drugs that that kind of thing. Right? I mean, that's that's literally I mean, if you take a very crass look at it from an insurance companies perspective, I mean, that is like every single month now until whenever, right? 00:31:30:07 - 00:31:49:15 Unknown Whereas again, theoretically, this is a device that could last years, right? Yeah. We have a five year shelf life. And I think we don't have like I think the real world evidence burden for us is not that high to show, like real economic reason to cover it. And if you wanted to be super greedy, I'll just use the word greedy. 00:31:49:15 - 00:32:14:09 Unknown Have that greedy but like capitalistic, if we're going to be capitalistic and be like, hey, you know, the value that we're really is more like, you know, $6,000 a year, then we could charge $500 a month. If you want to go down that path for 500 bucks a month, you have to show them that level of data is a much higher bar than trying to get the 1500 bucks and its efficacy, and people will actually adopt and use it. 00:32:14:09 - 00:32:36:00 Unknown The adoption. This is where the IoT and med device comes in for you to passively collect the adherence data. Yeah, they're not going to they're likely not going to say to us, we'll only give you money if you show us like a year of adherence, right. And and the real world. And we know this from our version one device, the utility of the device. 00:32:36:03 - 00:33:02:12 Unknown Some people use it every day for years. Other people will use it. There's a lot of use in the first few weeks, first week especially, but once symptoms are in remission. And for a lot of people, that's after the first week they go down to a maintenance level. Some people for symptom free for, you know, a couple of years they will stop using it if their symptoms come back to use it again. 00:33:02:14 - 00:33:28:05 Unknown So, you know, there's there's actually quite a few different long term use cases, long term usage patterns that are still clinically relevant. But we wouldn't want to have to be so dependent on only one of those for reimbursement. So I think the the recurring revenue piece will come from the software side, the app side, not an app that controls the device, but that we can, you know, curate services. 00:33:28:05 - 00:33:33:16 Unknown We can have some predictive. 00:33:33:18 - 00:34:05:04 Unknown You know, data, as we talked about when we start actually collecting brain data in future future iterations. So but yeah, we're very happy with the, you know, 90 plus percent margin on the. Yeah sure. Well does good as it does being DME. Do you think kind of have any like like access concerns? I know that obviously like in the United States like DME is typically kind of treated separately like there's like some like sometimes separate pharmacies in different ways of distributing that. 00:34:05:04 - 00:34:20:01 Unknown Then, you know, going into my local Walgreens and getting an SSI that's sitting on the shelf, for instance, like, is there any concerns there? Or again, do you kind of view it as like, well, maybe a little bit harder to get up front, but then obviously then you're not having to constantly like renew prescriptions and do that kind of stuff. 00:34:20:02 - 00:34:45:12 Unknown Is there a like an initial barrier that you feel like, like patients are going to have to overcome there that sometimes associated with DME. So with with Medicaid in certain states, you have to distribute through a medical equipment distributor that takes, you know, a third of your revenue. Yeah. With the the VA, you tend to go through a sales and marketing distribution partner. 00:34:45:12 - 00:35:15:20 Unknown That and then the VA. One of the things we're learning, we're in the VA now in a pilot study. And because this kind of technology is so new. The as of right now, there is a we're going through the department that would handle prosthetics. Oh, interesting. Now, that will probably evolve as we scale into other medical centers. 00:35:15:20 - 00:35:48:21 Unknown But so each channel has their own challenges for direct to patient, which I differ, which is a telemedicine based e-commerce, which will be is how we sold a lot of version one. Interesting too. And can you just drop ship that drop shipping? Amazing. Yeah. Sounds good to ask that. Yep. Reimbursement. Now for commercial reimbursement. This is going to be made me through employers, sort of employers that have adopted this as something that they cover. 00:35:48:21 - 00:36:20:01 Unknown So it's not like all of a sudden as long as you have Blue Cross, you can get this. It'll be like through these, it'll start with a handful of employers and then more and more. So if they already support this telehealth channel. So it's actually a lot like our PEO drew. So here at class where we have a who provides our insurance and trying that our people actually provides a mental health care plus up to our insurance that is not covered under Anthem or United or any of our other carriers. 00:36:20:02 - 00:36:39:21 Unknown Try not carry. Is it so? We have a mental health hotline. There's a couple of services I see, I see. So he could partner with something like this and then sort of provide it via telehealth, a direct to consumer pathway. Is that the idea here? It's still prescription. Yeah yeah yeah yeah. This subsidy additional medical mental health coverage rather than your core health care. 00:36:40:03 - 00:36:59:19 Unknown And we're going to start with employers that 100% manage the financial risk. Certainly use a Blue Cross to administer. Yeah. Yeah. But don't self-pay. Yeah. The employer wants to take on the financial risk. That's it. 00:36:59:21 - 00:37:30:19 Unknown Doesn't care as much. And so you have to convince the employer of the value. And I think we're going to be convincing them of the value of they long because it's like if all we do is improve sleep in half of the employees. And right. Probably be like in our clinical trial for depression, 88% of the subjects is severely depressed women, 88% had a clinically meaningful reduction of symptoms in four weeks. 00:37:30:20 - 00:37:55:01 Unknown Wow. So again, we're pushing up against the ceiling. You're never going to get to 100%. And so I think the employers are you know, and if you get rid of depression symptoms you miss less work. Your productivity is higher. You consume people with depression as a group in the US, consume more than twice the health care services as those who don't hospitalizations, etc.. 00:37:55:01 - 00:38:22:19 Unknown So in a fairly short order, by short order, I mean like a year, we'll be able to show significant economic advantage, and I think we'll have to prove it out on a pilot study basis with employers at first, but then then it'll start to catch fire and the snowball. There's plenty of precedents like amateur health, Livongo. There's others that started with this model of doing these large employer pilots. 00:38:22:19 - 00:38:48:04 Unknown And then other employers are like, oh yeah, I want that. And then there's a snowball effect. Yeah, that's super cool. Yeah. The last topic I've got, because it's so rare we actually get to talk about prescription and hardware. And you guys in your IP moat are actually in this space. So one of the most exciting things, Kelly, you and I talked about is that part of your intellectual property, your US patents is the prescriptive dose of waveform electrons, etc.. 00:38:48:04 - 00:39:07:17 Unknown That is what you guys are claiming. That is actually how you model this. This is all about what you guys did with your electric field modeling to target the right areas of the brain and hit those areas that you would need to get over. We'll call the activation hump right to your treatments effective. Combining that research with that intellectual property turns it into the prescription. 00:39:07:17 - 00:39:29:13 Unknown So this is not only the IP mode. So no one else can just copy your waveform. This is the thing that people will prescribe to this intellectual property that you have ran these clinicals on. And it ties the, we'll call it all aspects of the legal together in a very nice package with a bow on it that this is what you have and that your company can hold sacred, and this should help protect you from competitors coming along. 00:39:29:14 - 00:39:54:02 Unknown They'd have to come up with a different waveform that has the same efficacy that honestly, I think that you have enough data that it took you long enough to figure the one that worked. This is probably not an easy nut to crack twice. Yeah. And I think I think what we're, we're expecting from what we're seeing is that of the handful of devices that. 00:39:54:04 - 00:40:27:00 Unknown You could say are tangentially competitive by tangentially mean they may have insomnia or anxiety or depression, but there's no device out there yet that I've seen except ours. That is, using the exact same usage protocol and the stimulation parameters for the same for all of these conditions. And that is very rare to be able to do that. Typically, there's one device out there that has has one device for insomnia, one device for they're very different. 00:40:27:00 - 00:40:50:00 Unknown It's not a brain stimulator device, it's a nerve device. But there are different devices. So if you happen to have anxiety and insomnia, as many people who have those do, you would need two devices just as little. That doesn't make sense. And so we're trying to compress the choice for the three most common conditions into one device. That takes a lot of time to be able to prove that. 00:40:50:02 - 00:41:09:21 Unknown Amazing. Well, as we wrap up time here on the podcast, Kelly, thank you so much for coming in and flying all the way to be here. Yeah, super insightful. I really blown away by the visit here today. You have an incredible team. So it's the people and the facilities. It's amazing. It's a lightning in a bottle. No thanks. 00:41:09:22 - 00:41:21:16 Unknown We just have to hire all of our friends right off all of our toys and make money. We're still working on number three. And, Kelly, I'm going to take notes for you later when you. You take this thing to the moon. But one and two worked out pretty okay. Oh, awesome. Yeah, yeah. Thanks so much for coming on, Kelly. 00:41:21:16 - 00:41:26:04 Unknown I really appreciate it. Thank you. We'll catch you guys all next time on on the next episode of the Heart Tech podcast. See you