Transcript
Kate Willis
Hi everyone. Welcome. We are so glad that you could join us this evening to talk about sleep reimagined. So I wanted to give you a little bit of an overview. My name is Kate. I’m the Vice President of Commercialization here at Neurovalens and for tonight’s webinar, I just wanna make sure that everyone knows this is for educational purposes only and it does not constitute a doctor patient relationship. This is gonna be very conversational. We’re so fortunate to have Dr. Audrey Wells and Dr. Jason McKeown here this evening. And,we’re gonna get a nice little demo of the device. You’re gonna get to see exactly how Modius Sleep works and, get a real sense of, of how, how the technology can really impact and, and hopefully improve your sleep.
Dr. Audrey Wells
Well, I’ll go ahead and introduce myself. I am Dr. Audrey Wells, I’m the founder and CEO of Super Sleep MD, which is an online platform for people who have sleep apnea and insomnia, and sometimes the combination of the two. I was quite frankly, frustrated with the medical delivery system and that was my motivation for starting something completely different. I’m super happy to be here tonight, to talk about Modius Sleep. I am gonna do a demo for you because this is technology that I have tried, which is really important, so that I can make sure to tell you exactly what my own experience has been. And I am thrilled to kick it off with Dr. Jason McKeown, who is the CEO of Neurovalens.
Dr. Jason McKeown
Hi everyone. Thanks Dr. Wells. So, just a little bit about my background. I almost have like two distinct parts to my background. One is the academic medical side. So I’m an MD from the UK. I also have a visiting professor position here at one of the universities in the School of Medicine. And then in the US I have visiting positions at the Department of Psychiatry in UCSD in San Diego, and then also in Stanford, department of Neurosurgery.
So my background in that sense is very academic medical, so hopefully I’ll be able to answer some of the background science questions to this. But then the other part of that is I’m also CEO of Neurovalens. Neurovalens was set up as a UK medical device company. It really stemmed from my research at those institutions that I mentioned, but also my desire to stop prescribing more and more sedatives and sleeping pills and drugs for my patients. And I didn’t want to prescribe them, I don’t think my patients actually wanted to take them, but we all felt that there was no other choice. So that really prompted me to look at noninvasive and non-drug ways that we can maybe influence parts of the brain that control sleep, and then after a long period of RD and research, and I’m sure we’ll talk about some of this in during the chat, but after a long period of that, then we got our FDA clearance for Modius Sleep device, and we can now prescribe that in the US to, to help people with their insomnia.
Dr. Audrey Wells
You know, that so resonates with me,feeling like you needed something else besides pills to give people who have trouble sleeping. And I know that a lot of the audience on this webinar today is interested in how this device works and what the science backing is. I wanna start out though with who is the ideal patient or ideal person that Modius Sleep is meant to help?
Dr. Jason McKeown
Yeah, I, there are almost different ways you can look at this. So I, I would say generally the device is, you know, it’s, it’s very safe. It’s a drug-free product, and that can actually just be used by a wide range of people who have sleep issues. So in a general sense, if you’re struggling with your sleep potentially for, you know, as I say, a range of issues, Modius Sleep can be considered as, perhaps something that you can add in or you can use instead, that might provide benefit. But if you dive into that and be a little more specific and you look at, say, the clinical trials and what the FDA allows us to do, strictly speaking that definition is adults who have chronic insomnia. and for those who don’t know what chronic insomnia is, it’s almost like that, sometimes I call it the normal type of insomnia. So it’s not caused by something external. It is just a normal person who goes to bed at the right time and does all the right things, but no matter what, they cannot sleep. And that might be that they can’t fall asleep. It might be that they have multiple wakenings during the night, or it might be that they waken really early in the morning and they can’t get back over. So if that sounds like you, and you’ve had that for quite a long time, probably more than three months, then actually that’s, that’s the definition of, of what the FDA clearance is about. And that’s typically who we’ve studied in the clinical trials that we’ve carried out.
Dr. Audrey Wells
Yeah, it makes sense. And insomnia is one of the most common sleep disorders. So you have sleep onset insomnia, middle insomnia, and terminal insomnia. A lot of times what I hear from people is, I don’t sleep well and I don’t care if it has a name, but I want help and I wanna feel better. It’s not uncommon for somebody to have more than one sleep disorder, sleep apnea and insomnia, restless legs and insomnia, et cetera. So I’m wondering, does the Modius Sleep device, sort of layer with other treatments, is that one way it can be used?
Dr. Jason McKeown
Yes, we’ve had a lot of success with exactly that. So for example, yes, you know, sleep apnea is very common.and yes, there might be a mechanical issue and you need the positive airway pressure to, to really help with that. But, but a lot of those patients actually, even if they can, work through that, they still don’t get super great sleep or they feel tired or they feel that their sleep could improve. So we’ve actually had quite a lot of patients who then add this in on on top of their treatment,and have had really good results actually. And then overall with time, the whole, their, their quality of sleep actually starts to really improve. so, anyone, anyone who’s considering that actually Yeah, I think there’s a good chance that you would see a nice benefit there.
Dr. Audrey Wells
Yeah, I, and I think that’s an important point for anybody who has a diagnosis of sleep apnea and is using something like pap therapy. PAP may take care of your breathing during sleep, but it doesn’t necessarily improve your sleep quality. And for a lot of people, their sleep quality gets worse, at least transiently as they’re acclimating. So, it makes sense that you would have something that boosts sleep quality or helps.and that kind of brings me to, one of the things that you and I were talking about earlier, which is when to use the Modius Sleep device. Now, as a sleep medicine physician,if I see a sleep treatment, it seems to me that it would be used in the time before sleep or during sleep. So when I got the sample of this device, I was inclined to put it on as I was going to bed in order to try it. But then I learned later from you that it was actually intended to be used during the day.
Dr. Jason McKeown
Yeah, I think that’s a really common, sort of mindset whenever you come to look at sleep products. And if you look, and I know there’s a range of, of almost sleep technology,that you can look at.there’s, there are medical devices, and I’m sure, again, we’ll dive into this a bit later, obviously we’re in that category. And then there are kinda like wellness lifestyle type devices. And the trend that we noticed with a lot of the lifestyle devices where there were maybe some sort of cap or some sort of wearable that you put on and then you tried to sleep and it would maybe measure some activity or, or there, you know, plays audio or it tries to synchronize with, with your, your sleep architecture. Mm-hmm.but I always find that almost counterintuitive because the last thing I’d want to do if I was going to bed at night is have something that’s on my head and I’d be thinking about it, and every time I’d roll over it would, it would maybe like disrupt my sleep. Yeah, so that was actually one of the key motivators as to why we created the technology in the way we did. And diving into the science a little bit, what we find is that, you know, your brain has almost like a wake state and a sleep state. and that has to transition. and actually what we are doing is activating that part of the brain. So, if you activate that before you go to bed,then that’s actually where the benefit comes from. So, we’re almost prompting your brain to, to be in a state where it can sleep and have good quality sleep. and then the other part of the brain, or, or it’s a similar part really, but the other element of this is then the circadian regulation. So,that’s why we recommend using this again before bed, but at the same time, approximately every day. So you’re really training that circadian rhythm, so that comes your bedtime that your brain knows to be in the state where it’s allowed to sleep or, or it’s, it’s ready to sleep. So, to your point about, yes, you might naturally think this is worn in your head, when you sleep. Absolutely not. It is the complete opposite. Take this off before you go to bed and it won’t disrupt hopefully a good night’s sleep.
Dr. Audrey Wells
Yeah. Yeah. And you know, it occurs to me that if you’re using it in the evening, it’s a nice way to initiate a period of wind down some time to get calm, get quiet, and prepare your body as well for sleep.
Dr. Jason McKeown
Absolutely. I think that’s a secondary benefit actually of how we’ve, you know, created the device. So when, when it’s worn on the head, for those who don’t know, we would recommend that you stay seated. So the device actually puts a tiny little bit of electricity, just a small little, stimulation into the vestibular system, which is sometimes called the inner ear. So whenever you activate that part of the brain, it actually gives you a nice, and, and I’m sure you’ll describe, your, your experience with it, but it actually gives you a nice kind of relaxed, almost like you’re on a hammock or you’ve had a glass of wine sort of floating. It is very relaxing. Yeah.so it’s, yeah, it’s, it’s, the, sorry, I’m just, I’m, my, my mind has been off now on all these kinda like, various, elements of sleep.
Dr. Audrey Wells
It seems like it’s a good time to show the device right now. I mean, I want to really make this tangible for people as they imagine what it would be like to use. So, I’ve got the device right here. This is called the Modius Sleep Device. so a headband, and this is the controller with a couple of buttons on top and an on off switch on the side. Now, to wear this, you actually have to apply snap electrodes first. So I’m gonna show that. These are the little electrodes. They have a sticky back and then sort of a metal snap. And I’ve already come prepared. I put the electrodes on the back of my ear, and if you can feel just behind your ear, there is a bony protuberance there, that is where the electrodes go, and there’s one on each side. so you put the electrodes on after doing some skin prep with alcohol. And then I will dawn my little crown here. I like to think of myself as Passia, the Greek goddess of sleep hypnosis, if you’re a man, I guess. And then I just attach these little electrodes to the sticky pads and here is a little satisfying snap. So this is what it looks like with the device on. And I was, as I said, laying in bed, and I had to put it a little forward because I was laying on my back, but I think it’s a much better fit, when I’m upright. And then I just turn on the device on the side, and you hear a little beep. Now there’s 10 settings, right? there’s 10 settings. And what I understand is that,you wanna go slow. You wanna go slow to increase the electrical current that’s being delivered, and with each beep it goes a notch up. And this is part of the customization of the device. Maybe you can speak to this a little bit, Dr. McKeown, because for me, I’m, I pump it up to 10 and I just like maxing it out and getting the full effect. I have tried this on a couple of people that I know, and it’s really interesting to see the variability of when you start feeling the effect. And I would describe it, it’s not painful. It reminds me a little bit of a TENS unit. and for those who aren’t familiar with a tens unit, I would say it, it feels like maybe pulling one single hair from my head on either side, just a little tiny, uh, prick maybe to the skin. And then as it comes up, and I’m just going up slowly, I have that sensation of just being a little bit woozy, a little bit, like in a hammock, as you said. Yeah. Last wine, maybe after one or two glasses of wine. That’s right. And it’s interesting to make that analogy because,you know, a lot of people when they can’t sleep, they will use alcohol as sort of a self medication. Unfortunately, even though it can get you to sleep quickly, there are a lot of detriments to using alcohol. So it’s, it’s, it’s really interesting to sort of have that effect without the actual ingestion of alcohol. So I’m pretty high right now, and I am feeling it. Normally I’m sitting down, so this is a little bit interesting, but it’s just like, like if I, if I were to just show how I feel, it’s like a little bit of spin.and there’s again, just a prick kind of, in the place where the electrode is contacting my skin. So what is the mechanism? How does this work?
Dr. Jason McKeown
So, the little tingling that you feel going into the skin is, as, as said earlier, just a very, very small electrical pulse. And what we are trying to do is activate the nerves that are just below the surface in, in the ear.and those nerves, almost like a USB cable, they, they actually carry information or signal down, down a wire, almost into the center of the brain, and it’s the center of the brain that controls many, many of the automatic processes that your, your body regulates without you having to think about it. Mm-hmm. And, and, and one element of that is, is sleep. You know, from, as I said, the transition from sleep to wake, but also the circadian regulation and, and even your, your sleep architecture. So we know that from the surface, we can actually turn on that part of the brain by just putting a little tiny bit of electricity into it. And actually, to your previous question, you know, the reason that we would say, you know, don’t be walking around and stay seated, is whenever you activate that part of your inner ear, that’s what’s actually giving you that sensation of, of movement. Your brain can detect the electricity going down the nerve, and it gives them this almost illusion that you’re sort of rocking a little bit. So we recommend that patients stay seated. Yeah. But, what typically happens is that most patients line this up with an episode of something on television, so it’s a th it’s a 30 minute session with a 30 minute, TV show, and then night after they’re night at the same time, they make their way through.so, and, and what I’m highlighting, what I’m trying to highlight there is it’s, it fits into your lifestyle really, really nicely. It’s not that you have to go off and do something or visit a clinic or, or, you know, sit in a doctor’s chair doing something. This just fits into your lifestyle. You watch television after 30 minutes, it turns off, and then you can finish your evening routine and go to bed.
Dr. Audrey Wells
Yeah. Yeah. I like that. And,you know, that feeling, I was also thinking, it’s like when you first step onto a boat and you kind of have to get your sea legs a little bit, but you don’t really acclimate to it, do you?
Dr. Jason McKeown
so, so actually the, you mentioned going up in the steps and like some, you know, sometimes you can go right up to level 10. So what we typically find is that the tingling, just because it’s a new sensation, the first few nights of using the device, you might, you know, feel it a little more. So we recommend staying at a low level, mm-hmm. Maybe like level two or three, or maybe even level four.and just staying at that level for a few nights. And there’s two reasons. One is that tingling, you, you, you get more used to it, so eventually you can keep increasing. but, but the other is actually, you don’t want to overstimulate and just like crank it up, you know? So it’s, it’s the con this concept of more is better that does not apply here, more can actually be too much. Mm-hmm. so, we recommend starting, starting low and going slow.so, so maybe level 2, 3, 4 at the start, and then over the period of a couple of weeks, you might eventually get that up a bit. And, we typically find that patients end up around level seven at nine, eventually after a couple of weeks.
Dr. Audrey Wells
Got it. And,I, I wonder what your experience has been with people reporting back what their outcome is. Are they looking for faster sleep, higher sleep quality, daytime alertness, all of the above? What is, what is the outcome?
Dr. Jason McKeown
I think no matter what the problem is, what people want to experience, or whenever I’m chatting to our patients, what people wanna experience is that they feel great the next day. Mm-hmm. Uh, now it could be for different reasons that you don’t feel great, and that, that as we were talking about earlier there, there’s almost like three kind of common reports. One is that you just take a long time to fall asleep. Mm-hmm. Some people, they wake up multiple times during the night, and then other people, they wake up really early in the morning and, and, and they can’t get over.and we’ve actually found that all three of those categories actually respond very well. So if, if that’s, if you have one or one or more than one of those problems, actually, there’s a really good chance that you’re gonna see a nice result. But ultimately, no matter what we do, the goal is that you feel great the next day, which is really the best indicator that your sleep quality is good, and you wake up and you feel refreshed and you know, you’re, you’re ready to take on the day.
Dr. Audrey Wells
Yeah. And, and I wanna underscore that there is no sort of panacea sleep treatment. All sleep treatments are sort of,meant to, to be implemented on a backdrop of good sleep hygiene techniques, regular bedtimes and wake times, comfortable sleep environment, all of that. So this is really,for people who have established those good sleep habits who are now ready to take the next step. Now, as a consumer of things, I’m always kind of,thinking about like, you know, questions of how do I know that this is gonna work for me? How long is it gonna take? And how will I know if, who it’s not for, like people who have dizziness conditions, as you mentioned. I wonder if you can talk about like, what are some realistic expectations for someone with sleep problems who’s considering a device like this?
Dr. Jason McKeown
Yeah, I, you know, I, I think there’s so many things out there that kind of claim that this is just going to revolutionize your sleep or, or like, you know, it’s gonna work for everyone. And actually we, we are very upfront and open and say, look, this is a medical treatment. So yes, this has been validated by the FDA, it is, see if it is effective, a doctor prescribes this to you, but this is still a medical treatment. And medical treatments do not work for everyone. Now whenever you look at our clinical trials, actually our results were better than we expected. So, 95% of our patients reported some improvement by four weeks, which is really high actually. But if you look at those who hit a really nice target, it was around two thirds of people. So at four weeks, it wasn’t just a small improvement. They had actually hit a really meaningful improvement in their sleep. so, so what we would say to people is this is, this is something that we’ve shown, again, with all the science, it’s really robust, all the medical data we have the FDA, stamp on there as well, but the only way for you to really know if this is going to impact your sleep is to, to try it, and a big part of what we do, and, and we’ll maybe talk about this again, but the, you know, we have a, a money back guarantee, and I know lots of companies have money back guarantees, but, but ours is not just a marketing gimmick as such, it is to allow you that trial period. So it’s not to catch you out, you know, it’s to give you, I think it’s 30 days where you can actually try the device. And if you feel that it hasn’t helped, we’ll refund you. As I say, we’re not looking for ways to try and catch you out. It, it is to allow you to have a trial. So I would strongly recommend that anyone who is, is thinking about this and they’re like, not sure if it’s gonna work for me, or is it, or isn’t it, the only way to do it is try it. If it works, great. Most of our patients absolutely love it, but if it doesn’t, you know, no, no problem. Let us know and, and we’ll, we’ll dig into maybe the reasons why, but we’ll certainly refund you,to allow you confidence in that trial period.
Dr. Audrey Wells
Yeah. Yeah. I think that’s great and really reassuring to people who have been looking for a meaningful and significant treatment over time. So a lot of the folks who struggle with insomnia are really sensitized to this idea that what they try may not work. So I really like that. Yeah. Reassurance that they could have an out.it seems like when I looked at the clinical trials,the outcome measure that you were looking for was, their score on the insomnia severity index. Is that right?
Dr. Jason McKeown
Yeah. yeah. Insomnia about index, that’s, yeah, there are, there are a few, you know, I’m, I’m sure for your own patients, there, there are different maybe scores that you look at. So we want one that really applies just to, you know, the, a wide population, And not only one, one that gives us an indication of both how severe your insomnia is, but also if it’s actually improving over time. So if, if you go on our website, we’ve actually made a really simple version of the ISI and you can go through and answer it’s seven questions there, there are some background questions, but the insomnia severity index or, or ISI, there’s seven questions, and we can actually score the severity of your insomnia.and some people think, yeah, I don’t, I don’t sleep super well. And actually when they score it, it’s, it’s really, you know, these people have really severe insomnia and they should absolutely be treating it. So again, I would recommend that people go and, and do that little assessment. It takes five minutes. Yeah. but the basis of our clinical trials and all our, you know, all the FDA processes and, and eventual clearance was all based on us showing conclusively that we can improve the insomnia severity score over a period of four weeks.
Dr. Audrey Wells
And I wanna repeat that back to you because I think the results were really impressive. So 95% of people in the clinical trials reported benefit, and for two thirds that benefit was significant.
Dr. Jason McKeown
Yes. Yeah. Really, we would call it clinically meaningful benefit. Yeah. So it’s not just better, it’s actually really treating the, these, these individuals there in their insomnia. Yeah.so I, I, I say I was even curious, I was gonna ask, you know, what, what was your own experience? Because everyone has a slightly different experience when it comes to, you know, as I say, what, what’s the, the concerns that they have during sleep, and then even how long does it take before they feel a benefit? And, you know, I know you, you’ve had a good experience with it, so I’m sure the people watching would be interested just to get your take on that.
Dr. Audrey Wells
Yeah. and you know, this is something I’ve, I’m always really transparent about, because as a sleep medicine physician, you know, I’m an expert in my field, but I wanna be really clear that I am still a human being. And I have had issues with insomnia. I have obstructive sleep apnea. And so this has made me not only book smart with, sleep disorders, but also street smart with sleep disorders.for me, when I have periods of insomnia, it’s mostly, get trouble getting to sleep and trouble staying asleep.when I first started using this device,I noticed the effect of that, you know, little bit of disequilibrium immediately. And I remember telling you that was so reassuring to me because when you get that result, you feel like something’s happening. And I, I thought, you know, that was really, reassuring. And then,what I noticed as I was using it at the same time every day was that I felt really relaxed after it was over. And for me,that pause to like sit down, you know, take a few minutes at the end of my day and kind of, wind down is not something I always do. So I think there’s an additive effect there, as we were mentioning earlier.so getting to sleep definitely, is a big change for me. So I think this reduces the time for me to get to sleep. And I think, staying asleep is, you know, always a challenge, especially at, you know, my stage in life. But I think my nighttime awakenings are a bit shorter actually, especially if I’m really consistent with using it.
Dr. Jason McKeown
Yeah, yeah, I know. So, so many patients experience that, and I say that that’s my sleep problem. I travel a lot. Yeah, as you know, when we were chatting about,and whenever I have periods of say, disruptive sleep, the, the biggest impact that I personally have is wakening during the night. So even if I get and get over to sleep, I’ll, I’ll waken up at like, you know, 1:00 AM 2:00 AM and you’re, you’re almost, it feels like you’re fully awake.but what I found was with regular use, that that period actually started to really shorten down, and then eventually, almost without realizing you’d slept the whole night through. And then, and that actually then is maintained for quite a long time, or was, for me anyway, and in the clinical trials that was maintained for quite a long time. Until then, maybe you go traveling again or you know, international flights. But actually one of the benefits of the device, and, and I I know for sure Key actually does this quite a bit when she travels, internationally, is, you know, putting the device on before, before you get on a plane so that actually you have good quality sleep, and then you’ll wake up feeling much more refreshed.
Dr. Audrey Wells
Oh, that’s so interesting. Yeah. Yeah. And this wouldn’t be something I think would get a lot of attention if you either work to wear it up in public. I remember taking my son to a school event with my little electrodes in the back of my ears, like I was Frankenstein. But you know, it, it’s, it’s actually very subtle.
Kate Willis
It is subtle. I put, like, like you mentioned, I put it on when we’re boarding and there’s a lot of commotion. Most people don’t even notice that I have it on, but I run the session while everyone’s settling in 30 minutes, and I sleep the whole duration of the plane ride. So it works great.
Dr. Audrey Wells
Now, we’ve talked a little bit about the anti-anxiety effect that this can have. I wonder if you can speak more about that.
Dr. Jason McKeown
So obviously, you know, anxiety and insomnia go hand in hand. Mm-hmm.and, and actually we, we were very conscious of this and we, whenever we were designing our clinical trials, we actually designed two clinical trials.one was to look at insomniacs with who, who didn’t have much anxiety. And then the other was really to look at people who have insomnia or, or sorry, anxiety,and, and a modest degree of insomnia. And we wanted to compare those two groups.so one trial, if I was to put it into lay terms, one trial was designed at just looking at insomnia. And the other trial was designed to look at anxiety. And, we weren’t surprised at this, but it, but it is quite interesting. Both of those trials came back very, very positive.and, and not to derail the discussion, but,we actually got two FDA approvals. So, the device is approved for insomnia, which we’ve been talking about, but that other trial also got our anxiety device approved as well. And that is something that we’ll probably bring to the market, you know, later this year.but a question we get asked quite often is, well, I have insomnia and anxiety. Which one should I, which one should I use? And actually we would, we would always recommend the insomnia device on, on this. It’s really severe anxiety.and the reason we recommend the insomnia device is if you can actually improve your insomnia. In many, many cases, just that de-stressing you feel better, it actually pulls anxiety down as well. So we see this complimentary effect almost for those, and it’s super common who have insomnia, but also have, you know, let’s say moderate to severe anxiety, kind of in parallel.
Dr. Audrey Wells
Yeah, I could agree more. That really resonates with me because I’ve seen it so many times where there the insomnia and the anxiety sort of exacerbate, each other. And sleep is so powerful that once you have a handle on your sleep, quality and the reliability of your sleep, that establishment of trust with your sleep, actually a lot of things improve.anxiety is just one, but, sleep is, is that powerful? And of course I am.
Dr. Jason McKeown
Oh, I think so, yeah.
Dr. Audrey Wells
I’m always on my soapbox about that.
Dr. Jason McKeown
I was just gonna say really quickly, yeah. My, my clinical practice has changed over the years and, you know, I got a lot of people coming and asking about, say, general health and wellness. So, you know, maybe they, they wanna feel better, they wanna lose some weight there, you know, there’s maybe quite non-specific. And what’s almost presented is like, Hey, how could I improve my, you know, gym and exercise and how could I improve my diet? And previously I would’ve said, yep, let’s, let’s, let’s look at your, you know, your exercise, your activity levels, let’s look at your diet, and then also let’s look at your sleep. but actually I’ve totally flipped that over now, and I, and I actively recommend fixing any sleep issues before you start those other things, because the impact that that has on your physical and mental health and your ability to actually maintain consistent exercise and maintain a healthy diet, if you don’t have your sleep in place, the chances of those other two failing are so high that it’s not, it’s almost not worth it.so, so just the importance of just highlight again, the importance of, of sleep coming first and making sure that that is absolutely, you’re, you know, you’re absolutely on point with your sleep, and then you can layer in these other things.
Dr. Audrey Wells
Agree. We’re like this when it comes to prioritizing sleep.you mentioned that there’s a prescription necessary for getting Modius Sleep, so I wanna talk about that process.I understand that people need to start at the Neurovalens, website. can you explain what happens at that point?
Dr. Jason McKeown
Yeah, I, I suppose this is more, you know, validation on the medical device side, you know, so, so yes, we have the FDA, but actually this is prescribed by a doctor.and, anyone whose, whose own doctor wants to prescribe it, no problem. They can actually just use that prescription and they can come to our website and upload it or send it to us, and then, you know, we can arrange them for the device to be purchased. That is totally fine, but, you know, people are busy and it’s sometimes difficult getting in front of their doctor, and sometimes the doctor won’t even know what the device is, so you’re mm-hmm. You’re, you’re educating them.so, so we realize that was a pinpoint for our patients. so what we’ve spent the last almost six months I think doing, is building a virtual prescribing service on our website. So you as an individual can go on, you fill out, you know, as I say the, that severity questionnaire, you give us a little bit of background info just to make sure the device is right for you. And then that actually goes to one of the providers who, who we partner with, but essentially it’s, it’s a doctor who’s licensed in your state.and then they will do, they will assess all of the information if they need anything more from you, they can send you a, a text message to get, maybe just answer a few questions.and that whole process is only $30. And once that prescription then is issued by that doctor, then we get the instruction essentially to ship you the device. So it is, it is very seamless. A patient won’t even know that they’ve, they’re going through it, it just looks like a kind of, you know, Modius sleep step by step by step right through the purchase. But in the background, a doctor in your state has reviewed all your information and has signed a prescription for you.
Dr. Audrey Wells
Got it. Yeah. And I’m wondering, are they like screening out people that it’s not for, and, and I wonder if you can, tell me who is not a good candidate to use this type of device?
Dr. Jason McKeown
Yeah, the, there would be a few specific things that we would say, you know, don’t, don’t use the device. And probably the two most common ones are if you have an implanted neurostimulator. So, and that could be anywhere. So like a deep brain implant, a vagus nerve stimulator, even like a cochlear implant.there are now some OSA, you know, devices that kind of get implanted in here.and then even cardiac, you know, PS mers, so, so if, if you have that, unfortunately, we’re, we’re not allowed to prescribe a device for you.and then the other one sometimes is, we get asked about is pregnancy. So if obviously you’re pregnant, we can’t prescribe a device, it can be used immediately postpartum. So, so once you’ve had a baby, I’m sure your sleep’s not great, but at that point you can add in,the, the Modius sleep device, no problem. and the reason I’m highlighting that is, you know, if you were to take sleeping pills, but you were breastfeeding, you don’t want to transfer, any of the medication, whereas you can put this on day one post postpartum. and then the other, you know, maybe kind of common things we, if anyone had any like psoriasis or maybe skin breakdown with the little pads on, we probably wouldn’t recommend it.and I think probably those, those are the main ones, actually. So if, if, if you don’t have those issues, you’d probably be quite a good candidate for the device.
Dr. Audrey Wells
Yeah. And I, I had some questions, from people in my, groups about, you know, I, I have ye’s, disease or vestibular issues, and I would think that, you know, a great deal of caution, would be needed in those situations as well.
Dr. Jason McKeown
Yeah. So those are not automatic exclusions or contraindications, but just as, as you’ve say, we would, we would definitely recommend caution. So, you know, for people to experience from time to time, maybe vertigo on and off, if, if that’s pretty mild, I’m, I’m not super concerned, but what we would say is start, you know, level one, level two, and just really, really assess for a period of maybe days and weeks before you slowly increase. And, and so far, thankfully, we’ve, that, that process has worked really well for us.if you are seeing a specialist for something like that, so maybe like vertigo or mini errors or whatever, then feel free to discuss with that specialist and just get their take on it. and, and we, we’ve had patients who, who have used it and have been totally fine. And we’ve had patients who said, look, I’m, I’m a little concerned I’m not, I’m not going to use it in this case. And, and that is also totally fine.
Dr. Audrey Wells
Yeah. Yeah. And adults, so 18 and above, is that right?
Dr. Jason McKeown
22 actually, the FDA are quite, quite strict on this. So a lower clinical trials were based, on, on adults, 18 and above adults. Mm-hmm. the, the definition or the, the indication that the FDA allow us to prescribe is adults 22 and up.
Dr. Audrey Wells
Got it. Got it. Okay. Well, I think the next question would be, does insurance cover this HSA, FSA? What kind of out-of-pocket expense can people expect?
Dr. Jason McKeown
Yeah, so it, it, the HSA and FSA absolutely, you know, that that can be utilized right now. When it comes to insurance, we actually do have eligible codes that we can use.but it would be on a case by case basis at this stage. So,typically we would have a patient would buy the device and then we can provide them with almost like a pack of information of, you know, medical necessity and why the device is being prescribed that is submitted to their insurance company, and then that claim is reviewed and, and they potentially could, could then get reimbursed. But as I say, that’s a case by case basis that we don’t really have any control over. And then the other quite interesting area is just recently we have been put, it’s called on contract with the va. So, so nationwide in in any VA center, our device modestly can be prescribed,and the VA will, you know, they, they reimburse that basically, and we just ship direct to the patient. So, for any, any veterans out there, this is absolutely an opportunity to go and speak to your, your VA clinician and, and ask them about Modius Sleep.
Dr. Audrey Wells
Yeah, that’s so great because,sleep problems are huge among veterans and just a really nice, opportunity to get some real treatment for that.for those who, end up paying out of pocket, is there any sort of, payment plan or arrangement that they can look for?
Dr. Jason McKeown
Yeah, so, currently the device, out of pocket cost is $1185. plus if people use the prescription service, then it’s $30 that, that doesn’t go to us, it actually goes to the provider. Mm-hmm.so you do have the option of just, you know, paying upfront, but also, you know, we have like, like split kind of payments there, there’s a payment provider and it can be over a period of months if interested. and then what we are actually doing, or hopefully rolling out eventually is maybe more like a, a rental type model that that’s not available just yet, but hopefully that’ll be coming as well.
Dr. Audrey Wells
Yeah. And all of these,things are meant to, you know, be an investment in your sleep. To your point, this is a foundational biological need Of course, yeah. That you engage with night after night after night. So I think that, you know, there’s, there’s a certain amount of longevity, that you can expect from a device like this. And so it’s a real investment in your brain health, your heart health, your metabolic health, and your mental health.
Dr. Jason McKeown
Yeah. Yeah. And, and actually the, the $1185 for the device that, that’s your device forever, it, it, it doesn’t, you know, turn off or we, we, we don’t, it’s not like a certain amount of sessions that, that is yours.the little electro pads, I mean, they’re, they’re not very expensive, but they, they’re replaced their single use pads. So maybe every couple of months patients would buy more. but what’s interesting, because you have the device, what, what we see is patients often wear the device for a period of, let’s say, you know, three or four weeks, and then they, they reach a target insomnia level or sleep quality that they are happy with. Mm-hmm.and quite often at that point, patients will start to use the device less and less and, and some people stop entirely and they still have this maintain benefit, but then if something happens, like they go, they go traveling or there’s a stressful event or whatever, they have the device that’s there in, in their wardrobe or in their drawer or whatever, and then they can just start using it again and they can really nip the oncoming insomnia, they can really nip that in the bud. Yeah. you know, be because they have the device. And then the other thing I would say, actually, just when people are considering this is that money back guarantee period. If, if this were medication, you don’t get your money back if it doesn’t work, you know, you could be trying expensive medication or expensive other like therapies or treatments or going to clinic visits, you don’t get an opportunity to get that money back actually if it doesn’t work. So, so we wanna do something really different and we, we really wanna put the patient first, so, so that is why actually, even if you’ve used this for a month, if you feel it hasn’t worked, we will refund you.
Dr. Audrey Wells
Yeah. And again, this, this is a really nice adjunct to treatments that may already be in place. And then if you feel a benefit, you might be able to peel back other things that have side effects or, not as much benefit, not as much,return on the investment. I would always encourage people, you know, do work with prescribing doctors. If you’re taking medication for insomnia, you might need a taper, you might need some sort of exit plan. And that’s a really safe way to sort of, come off of prescription medication or supplements which are not regulated. That’s another area of expense that a lot of it, people with insomnia, turn to.
Well, I just noticed that we’re about quarter till the hour, and I do wanna leave some time for questions. Kate, how are we looking in the Q&A box?
Kate Willis
Well, the q and a box is full. We are getting a ton of questions in. So great, great crowd this evening.we are having a lot of questions about sleep medications and the, the idea of if you’re taking medications for sleep and maybe they’re working well for you, but that’s not something you wanna be doing long-term, what are your thoughts on using the device versus using sleep medications? From a long-term standpoint?
Dr. Jason McKeown
My thoughts would be exactly as Dr. Wells has, has just said, so, you know, Somnia has prescribed that if, if that’s a, you know, prescription drug.so I would speak with them,and say, and explain, you know, this is what you’re doing and if you’re seeing additional benefit, then take their advice. but if they’re okay that you start to taper that down, then that is fine. And actually that is a very, very common scenario. We see people who are in long-term tablets or sleeping pills, they sort of help with the terrible side effects. So they want to get off them and they don’t wanna use them long term, but they have no other choice. So what you can do is layer in the device on top, and then if you’re prescribing doctor is happy, then you can actually start to take that right down.and in, in many cases, actually, it’s really exciting. We’ve, we, we have got people who have been on long-term medication entirely drug free after, you know, a period of several weeks.
Dr. Audrey Wells
Mm. Gosh, what a relief. Yeah. That, that’s incredible. And just to at score, again, like, all sleep is dependent on good, healthy habits, what you eat, what the light you have, the exercise that you engage in. So there is sort of that fundamental common sense approach to getting healthy sleep. But if you’ve got sleep aids on top of it, don’t just stop them. yes. Work with your prescribing physician to peel back, to taper off, to do it very safely, not just,for the long term health, but also in the short term you don’t wanna have rebound insomnia.
Kate Willis
Absolutely. Yeah. you have, you have some questions coming in,about the device itself as far as,battery charging, just a little bit more specifics on maintenance of the device and, and how it, how it functions.
Dr. Audrey Wells
Yeah, I’ll show you that.there’s a little, micro USB charger on the device and, in my hands there, it actually lasts for many charges.maybe Ja, Dr. McKeon, you can be more specific. and then there’s an auto shutoff after 30 minutes. so the session is automatically timed and I like that because once I get going, doing something, I forget and I can be probably stay there for a while, but it automatically shuts off with a little pleasant tone after the 30 minute mark, and then, you know, the session is done.
Dr. Jason McKeown
Yeah. Yeah, I just add to that, yeah, probably about,you know, five to seven days, of simulation can be used on a, on a single charge. Yeah. So it’s, yeah, because I, interestingly, I’ve, I’ve seen medical devices, neurostimulation devices that actually just have a limit on how often they can be used. And once, once it’s done, you, you, you’re actually meant to go and bin that device and then get a prescription for a new device. And I mean, there’s just so many things wrong with that. but what we wanted to do is allow you just to be able to recharge it and use it on and on and on at, at no additional cause to you.
Dr. Audrey Wells
Any comments on the durability of the device? Like how long its lifespan would be expected to be?
Dr. Jason McKeown
So the approval process actually specifies that the device must be durable for at least a period of three years. So, so the absolute minimum, lifespan is three years, but in practice, we’ve actually had people using right back when we first started, we’ve had people using the device almost daily for five or six years. and, and they’re still going. So yeah, we, we expect a, for your purchase of the device, we expect a really long, you know, lifespan of that technology.
Dr. Audrey Wells
Yeah. And then the consumable parts are just these snap electrodes and the alcohol swabs?
Dr. Jason McKeown
Yeah. And, and I would, I’d strongly reiterate, using the alcohol kind of skin swabs. Yes. just the, there’s a little layer of oil in the skin and actually it, you might think it’s, oh, it’s just a skin wipe. I can skip that step. That is one of the most important steps actually, to really take the oil out of the skin and allow the electrode part to send in the electricity without any additional resistance.
Dr. Audrey Wells
Agree. Yeah. Don’t skip the step
Kate Willis
One of the other questions that’s come in,pretty frequently is what time of day do you recommend using this? Now I know we talked about it’s not used while you’re sleeping, but people are asking an hour before bed, two hours before bed, right before bed. Does it matter? So we’ve had a lot of questions and a lot of, you know, chatter on that topic.
Dr. Jason McKeown
I’d be curious I to hear, what Dr. Wells naturally did, because every, everyone kind of finds their own rhythm, but,what we, what we would start by saying is probably in the, in the r before you go to bed.so if you go to bed at say 10 o’clock, you know, around nine o’clock, maybe a little earlier, I would start this, you do your 30 minute session and then it gives you another like 30 minutes or so to, to almost unwind and, you know, brush your teeth and get everything ready before you, you go to bed. It doesn’t have to be a case of you put this on and when the timer goes off at 30 minutes, you’re like jumping into bed.it just, just in the hour or so before you go to bed is totally fine.
Dr. Audrey Wells
Perfect. Yeah, I, I agree with that and I think it’s really conducive to that rat wind down routine. So you may get an augmentative re effect there, but,I’ll say that I’ve actually picked it up in the middle of the night to have like a middle of the night session because the sensation of that rocking is pleasant. And it kind of taps into,maybe that infant part of your brain, you know, being rocked and reassured. at one point I was thinking that doing,a body wrap or like an adult swaddle would also be complimentary, but it’s just a nice pleasant feeling. And if you’re looking for that in the middle of the night, then I say, go for it.
Dr. Jason McKeown
Yeah. It’s, it is interesting you mentioned the rocking, feel and being similar to, you know, like an, an infant.that is not a coincidence actually. So whenever you rock a baby to help it sleep, you’re, you’re actually manually activating the receptors in the inner ear. So as you can rock back and forth, it’s a very slow frequency.I love that the, the, the inner ear actually activates in a certain way and for a long time, like, you know, years, like 50, 60 years,it was assumed that rocking had a pleasant effect just because of the kind mechanical rocking. Mm-hmm. but actually there were experiments done in the early two thousands that showed it’s a very specific receptor that you must activate. And if you don’t activate that receptor, the rocking does not actually help with sleep. Mm-hmm.so what we have done then is, is isolate that that receptor, and that is the one that we turn on repeatedly with the electricity. So, so it is, is actually very, very similar to the, the neurological experience of being rocked to sleep.
Dr. Audrey Wells
I love that I could geek out on that all day. I mean, that’s, that’s really interesting tech. And this is completely different than anything I’ve ever seen for sleep.but that effect is real and I enjoy it. Awesome.
Dr. Jason McKeown
Yeah, that’s every, everyone enjoys it. The other kind of rocking feeling. It’s, it’s lovely actually. Yeah.
Kate Willis
One Of the things that came up, which is there’s kind of two interesting questions. One is, is it normal to have weird dreams if you’re using Modius Sleep? So this sounds like maybe a current user that’s maybe experiencing weird or vivid dreams, is that something that we see?
Dr. Jason McKeown
I can answer from my personal experience. Absolutely. so, so that is, I suppose, you know, I, you would almost have to call this a side effect, but it is, it’s, it doesn’t feel like a side effect. It’s just I have extremely vivid dreams.so whenever I wear the device compared to not wearing the device, it is, it is really, I actually quite enjoy it. But yes, that is a very common, well, not very common. It’s a, it’s a common enough, effect.and some people when you describe it, they have no idea what you’re talking about. ’cause they do not get any of this. But then if you do get it, you, you know exactly what you’re talking about. So whoever asked that question, I know exactly what you’re talking about because I get that myself. It’s Very exactly.
Dr. Audrey Wells
Oh, that’s so interesting. I, I don’t get that at all. But I will say that one of the functions of dreaming is, you know, emotional regulation and processing, playing out the experiences of the day on the virtual reality of your mind. And I think that if this is at all giving a safety signal for that, it could be incorporated into dream imagery.so that’s a really interesting side effect. Fascinating.
Kate Willis
Yeah. And then what about naps? We had a question about is it advised to avoid using the device for a planned nap because it can confuse the circadian rhythm. So is that, what are the thoughts on using this with, with naps?
Dr. Audrey Wells
I’m gonna ask Dr. Wells her opinion on naps in general. before, before I say something, I, I love naps, but, but they need to be kept short and especially if you’re somebody who, suffers from insomnia. So 30 minutes really is a limitation and it’s also better to put your nap earlier than in the day, assuming you sleep overnight before 3:00 PM is the general recommendation, for napping. But I’m, I’m team nap all the way.
Dr. Jason McKeown
Oh, yeah, no, that, that, that aligns actually exactly with my own thoughts. Yeah. My, my concern with, some people say napping, but actually they’re, they mean deep sleep during the day and then you actually can sort of mess everything up. So as, as you’re describing, you know, short naps kind of early in the day, short to, to totally fine. When it comes to the device, what I would say is do not use the device at that time of the day to induce napping. So if, if you want to do the napping, that that is, that is fine. but then in the evening, regardless is when you want to use the device to actually almost, as I say, induce that better quality sleep during the night. and, and if, if your napping schedule then changes, maybe you need it less because you’ve improved your sleep quality, that that is totally fine.
Dr. Audrey Wells
Yeah, I would hope that’s the case too.
Kate Willis
Well, I think we are almost out of time, so we’ve got time for maybe one more question.and that is about the safety profile and long-term effects of using the stimulation. What the safety profile of Modius Sleep and is there any downside or harm with using this? You know, long-term.
Dr. Jason McKeown
What I would often say in, whenever I’m asked about this is,you should remember that the implanted neurostimulators have been around for like 30 years. You know, so these things like deep brain implants or sometimes they’re put in the neck and they send signal into the base of the brain. Those devices are implanted and they are on 24 7. Like so, so ev every minute of every day those devices are delivering neurostimulation. And from those studies, actually we know that they’re extremely safe. There, there, there are almost no, you know, negative effects with that ongoing stimulation. I mean, they’re surgically implanted, that has risks and everything, but the actual electrical stimulation there, there are almost, you know, no long-term negative effect. So, so based on that our stimulation is only 30 minutes and it’s non-invasive and it’s a much lower dose than any of these implanted devices. We’re extremely confident in the safety. But on top of that, we actually then carried out, I mentioned patients were using this for up to five years. We actually carried out a long-term safety study on those original patients who, who were using this, as I say, you know, literally for five years. and we did not find any long-term side effects. so in short, extremely safe technology, much, much safer than drugs. We’ve done all the kind of background research, but anyone looking at this now should have confidence that the FDA have also said, this device is safe and this device is effective. Perfect. Great.
Kate Willis
One final question. And that’s about the electrode pads. Where do they get them and can other vendors, other suppliers of the electrode pads be used with the mods device? Headset?
Dr. Jason McKeown
Currently, you can order a refill packs on Amazon. So I, I think we have it on the prime system. So people are getting, you know, free delivery like next day delivery.those are not expensive. so I, I would strongly recommend not using another pad. And the reason for that is the stimulation is so precise. It’s, it is a tiny little targeted stimulation that although you could maybe get another pad to fit onto the device and to stick onto your head that the consistency of that pad, that the hydrogel, which actually carries the electricity, if that is different, then we have no way of actually knowing that the stimulation that we want to deliver is being delivered.so as I say, our, our electro pads are cheap for the reason that we, we want people to use them and not feel they have to look somewhere else.but, but even if you could find cheaper pads somewhere else, I would, I definitely would not recommend using them. ’cause we really don’t know if it’s gonna work or not.
Dr. Audrey Wells
You know, before we close, I, I also wanna say that there was a lot, there were many questions from people in my group, not in the United States, wanting to know more about when it, it would be available elsewhere.
Dr. Jason McKeown
Currently it’s only available in the United States. Any sort of trajectory for, expanding that in the future? Ideally? Yeah, we, we we’re trying to work our way through,so, you know, Europe or the EU and thewe’re under review, so it’s kinda like approval pending. Mm-hmm.and then there is a collection of approvals that you can actually almost get at the one time. And, and Canada would, would be one of those.also I think Australian, maybe New Zealand are part of that.so, so we’re, we are slowly expanding.but if you subscribe to our, you know, mailing list as, as these approvals come through, we will be sure to, to let people know.
Dr. Audrey Wells
Good tip, good tip.
Kate Willis
And if anyone has questions that we, we didn’t get to everyone’s questions, so I, I apologize there were so many great questions that came in. You can certainly go to our website, neurovalens.com and from there you can submit our questions, submit questions to us. We have a clinical care team that monitors the inbox, and we will definitely get back to you and answer all the questions that you have since we did.
Kate Willis
Unfortunately we’re out of time and we’ve gotta make sure we get to the, the code, right? So, Oh, yes. Yay. Yeah. So as a, as a thank you for everyone. All right, Dr. Wells, we’ll let you, you wanna give the code? We gonna put it up?
Dr. Audrey Wells
Oh, yeah, I would love to. so the code is SUPERSLEEPMD yay for Super Sleep. so SUPERSLEEPMD is the code for getting a discount. remind me how much it is, What The discount Is with the discount.
Kate Willis
Well, the, it’s normally $1185, but with the discount, it will bring the device down to $795.
Dr. Audrey Wells
Love it. Yeah. Yes. And how long will that be active for Kate?
Kate Willis
That will be active for 72 hours. So,awesome. 72 hour window to use the code.
Dr. Audrey Wells
So go to the website, neurovalens.com. You’re gonna look for a button that says, “Do I Qualify: in black? It’s right there, at the top. And that will take you through a survey, that’s meant to screen your candidacy. And then you can go into the system for, prescribing and you’re on your way to getting your device.
Dr. Audrey Wells
Listen, everybody, I really appreciate you showing up.you’re showing up for your sleep, you’re showing up for your health, and you’re showing up to get good, credible information about a completely new insomnia treatment, which is, I hope we’ve demonstrated effective, safe, and accessible to you.I don’t bring a lot of things to, folks unless I can endorse them. And I really like this device. I’m so thankful to Dr. McKeown and to Kate Willis, Craig McConnell, and the whole Neurovalens team for hosting and letting people decide for themselves whether this is gonna be an option for them. Any parting words, guys?
Dr. Jason McKeown
Well, I’d, I’d like to thank everyone and, and thanks for having me on and, and chatting. and I would just really strongly recommend reach out to us if you have any questions. We, we, we are, the, the cornerstone of why we founded Neurovalens was to make the lives of our patients better. you know, I I said that earlier, so that has not changed. We, we wanna do that. So reach out to us and we will absolutely try and help you through this. And as I say, the, the trial period is there for a reason. If, if you wanna try it, and I would hope you have a great result, but if not, you just let us know and, and we’ll take care of all that.
Kate Willis
And we did record this session tonight, so we will send it out as well. You feel free to pass it along, share it with your friends, and,again, thank you everyone for, for giving up your time this evening to learn about Modius Sleep.