episode#183

183: Kate Willis, Speaker & VP of Commercialization at Neurovalens: The New Prescription FDA-Cleared Sleep Aid Device That Aims To Transform Insomnia & Jet Lag!

Biography

Kate Willis is an esteemed leader in Healthcare and MedTech, known for her strategic prowess and innovative approaches. Currently, she serves as the Vice President of Commercialization at Neurovalens, responsible for leading all global and US commercial functions, including the US launch. Her career highlights include serving as the Director of Government Affairs and Advocacy, where she has been a powerful force in shaping industry standards and policies.

Kate's robust track record of leadership extends through premier companies such as Nevro, Medtronic, Nuvasive, and Zimmer Biomet, where her initiatives have not only spurred organizational growth but have also earned her multiple accolades. These honors include prestigious recognitions such as multiple President's Club awards, Sales Rep of the Year, and Rookie of the Year.

Beyond her healthcare expertise, Kate is a recognized figure in the arts as a producer and investor, with successful ventures in Broadway, West End, and film productions. Her unique flair for bridging the realms of business and entertainment underlines her diverse capabilities and visionary outlook.

In this episode, we discuss:

😴  How is Modius Sleep giving chronic insomnia sufferers a life-changing chance at restful nights?

😴  What’s the secret behind this non-invasive device that restores your natural circadian rhythms?

😴  What did the clinical trial reveal that makes this device a true game-changer?

😴  Beyond Gadgets: Why is this prescription-required, FDA-cleared device unlike anything else on the market?

😴  Who Can Benefit from Modius Sleep?

😴  Travel Sleep Hack: What’s Kate’s surprising strategy for long flights and jet lag?

😴  How did Modius Sleep win the National Sleep Foundation’s New Tech Award?

😴  Learn More:

  • Visit Neurovalens.com to learn about Modius Sleep and see if you're a candidate.
  • Take the quick quiz to connect with an online provider or use your personal physician to issue a prescription.

😴  And many more!

SPONSORS:

​💤 Upgrade your sleep with COOP Sleep Goods adjustable cooling pillow—customizable comfort and temperature regulation for the perfect night’s rest. Code: SLEEPISASKILL

‍🪟Ublockout— Can you still see your hand in front of your face when you are in bed? Well, you NEED to know about this company that will get on a Zoom call with you and help you measure your windows for a custom AND affordable blackout solution! Enjoy 10% OFF. Code: SLEEPISASKILL​

🛌🏻 Transform your sleep with Eight Sleep’s cooling mattress—personalized temperature control for deep, restorative rest every night. Code: sleepisaskill


‍😴 Recharge your sleep with BEAM Minerals —essential, bioavailable nutrients for deep, restorative rest. ​Code: SLEEPISASKILL​ ​


GUEST LINKS:

Website: https://neurovalens.com

Instagram: @neurovalens

X: https://x.com/Neurovalens

Facebook: https://www.facebook.com/Neurovalens

Linkedin: https://www.linkedin.com/company/nora-tech-co/?viewAsMember=true



DISCLAIMER:

The information contained in this podcast, our website, newsletter, and the resources available for download are not intended to be medical or health advice and shall not be understood or construed as such. The information contained on these platforms is not a substitute for medical or health advice from a professional who is aware of the facts and circumstances of your individual situation.

Mentioned Resources

Guest contacts

Transcription

Welcome to the sleep as a skill podcast. My name is Mollie Eastman. I am the founder of sleep as a skill, a company that optimizes sleep through technology, accountability and behavioral change. As an ex sleep sufferer turned sleep course creator, I am on a mission to transform the way the world thinks about sleep.


Each week I'll be interviewing world class experts ranging from researchers, doctors, innovators, and thought leaders to give actionable tips and strategies that you can implement to become a more skillful sleeper. Ultimately, I believe that living a circadian aligned lifestyle is going to be one of the biggest trends in wellness.


And I'm committed to keeping you up to date on all the things that you can do today to transform your circadian health. And by extension, allowing you to sleep and live better than ever before.


Welcome to today's episode of the sleep is a skill podcast. I'm your host, Molly Eastman, and I'm thrilled to introduce our guest, Kate Willis, vice president of commercialization at NeuroValence. Kate is here to share insights about the revolutionary FDA cleared modia sleep vestibular neurostimulation device explicitly designed to help those with chronic insomnia.

A quick note, this device does require a prescription, no affiliation, but I'm pretty excited to see an option that is available by prescription that is not a sleeping pill. So With a stellar career in med tech and healthcare leadership, Kate has spearheaded innovations that improve lives, including her work at Nuvro Medtronic and Neurovalance.


Her expertise in bringing groundbreaking health solutions to market has made her a leader in the field. And today she'll walk us through the science and potential of this exciting new sleep aid. So get ready for a deep dive into how technology is reshaping sleep health. Let's jump in. But first, a few words from our sponsors.

We all know that temperature regulation is key to getting those deep restorative stages of sleep, but how many times have you woken up in the middle of the night tossing and turning because you're too hot?

Thanks to your subpar bedding materials. I know I've certainly been there. And now this is where coop sleep goods comes in. They've designed a line of cooling products, including sheets and pillows that are specifically crafted to help you stay cool all night long. Coop sleep goods products are made with breathable moisture wicking materials that ensure you maintain an optimal sleep temperature so you can rest easy.

Literally what I love most about Coop sleep goods is their attention to detail. Their cooling pillows, for example, aren't just about the fabric. They're They also feature adjustable fills, allowing you to customize the firmness and loft to your liking. Remember side sleeping tends to be the position of choice from a sleep optimization perspective with back sleeping, potentially putting you at risk for blocked airway, increased mouth breathing, et cetera.

Additionally, coop sleep goods has award winning cooling sheets that are silky smooth, incredibly soft and designed to keep you cool without sacrificing comfort. Take care. Even my husband likes them and he is a complete picky baby when it comes to fabrics and usually thinks everything is uncomfortable.

So whether you're a hot sleeper or just someone who wants to optimize every aspect of your sleep environment, Koop Sleeps Goods has you covered. I personally use their products myself and because they are durable and easy to care for, which means. There'll be a staple in your sleep routine for years to come.

So if you're ready to upgrade your sleep experience, head on over to coop sleep goods. com forward slash sleep is a skill. So it's spelled C O O P S L E E P G O O D S dot com forward slash sleep is a skill and check out their range of cooling products.  Important question. Can you see the hand in front of your face in your bedroom?

If so, you need to hear about our next sponsor who is revolutionizing the blackout shade space and finally making it easy and affordable to get a truly blacked out bedroom. So challenging in the past, right? So introducing you block out the ultimate solution for creating the perfect sleep environment, ensuring total darkness, comfort, and control.

So why you block out in particular? Well, a hundred percent blackout guarantee comes with this product provides temperature comfort all year round. So you keep your room warmer in the winter and cooler in the summer. You block out helps in enhancing your sleep quality by maintaining a comfortable temperature, regardless of the season.

Acoustic noise reduction. Enjoy a quieter sleeping environment with uBlockout Shades designed to minimize external sounds that can disrupt your peace. Ideal for urban dwellers or anyone looking to reduce noise pollution. Customizable and easy to install. Tailored to fit your space with a simple 30 minute installation process, uBlockout makes it hassle free to achieve the perfect sound.

Sleep setting, ensuring your bedroom is a sanctuary for sleep. And for listeners of the sleep as a skill podcast, use the code. Sleep is a skill for exclusive 10 percent off and embark on the journey to unparalleled sleep quality. Remember light is the number one external factor affecting our sleep with you block out.

You're not just investing in a blackout shade. You're investing in your health, wellbeing, and quality of life. So again, go to U Blockout, spelled the letter U Blockout, and use code sleep as a skill for a discount. And welcome to the Sleep is a Skill Podcast. On this podcast, we are talking about lots of different topics that can help support people's sleep, but this one I'm really, really excited about.

I know I'm often saying I'm excited about each guest or what have you, but this is really what. feels like could be on the precipice of some real new exciting advancements and optionality for people that are struggling with their sleep. You know, I know I was there years ago with my struggles with my sleep and I was looking for anything and everything that could really move the needle.

And this is something totally outside of the bounds of what we've seen to market to date. So our guest is going to share all about that and more. So, Kate, thank you so much for taking the time to be here. First, Molly, thank you so much for having me. I'm so excited to share this with your audience because I think it's going to have a huge impact here in the U.S. now that it is finally available.


Yes, absolutely. Okay, and we might as well start right there. You know, what is this thing that's finally available? And granted, I want everyone to know, I mean, I have no affiliation with this company. It's a medical piece of equipment, but I think people might know. I've shared a little bit about, you know, I have.

personal family members as well as clients that have gone down the path of different pharmaceuticals for their sleep. And often we see some concerning things that arise for with long term use of some of these pharmaceuticals. And yet this is something new and could really be just a huge support for people.

So what is this? Tell us everything.  Yeah. So, you know, as you mentioned, what's great is this is a non drug option. So we're not talking about pharmaceuticals. We're not talking about crazy stories of ambient and people getting up in the middle of the night. And I've heard somebody told me about they got up and their spouse was grilling their shoes outside.

Let's go. I've heard that. I was just, I've heard some crazy things too, but the shoe story is pretty, that's pretty good.  Pretty, pretty wild thing. So I'm really excited to be here to talk to you about Modius Sleep and what is, it's a wearable neurostimulation device and what patients, it's a headband.

Actually, I have one right here. I can kind of hold it up. Yes, I have mine too. Amazing. And I'm new to it. So this will be exciting. Yeah. Yeah. So it's a headset that you wear, A patient wears it, and there's electrodes, uh, in the back. And what we're doing is we are stimulating, there's a vestibular nerve.

It's right behind you feel that bony part right behind your earlobe. Yes. And vestibular nerve is right there behind that mastoid bone. Mm-hmm. So it's  really low level electrical signals right there that stimulates the vest, the vestibular nerve, and that.  basically influences the neural pathways to your brainstem, to your hypothalamus,  and those are the areas that regulate your circadian rhythm.

So what it means is you're, you're going to wear this device for about 30 minutes and you wear it not while you're sleeping. It's pre bedtime. So typically we tell patients an hour, two hours before you plan to go to sleep. You put the headset on and what you're able to do is you can control the strength of it.

You turn it up.  To you get to that comfortable sensation level and most patients will describe. It's actually kind of strange. Um, but it feels very soothing and it's very relaxing and it's, it's kind of this gentle swaying sensation. And if you think about the concept when you're rocking a baby to sleep.

Yeah. sensation. So it's very gentle. It's subtle. Um, we tell patients to kind of start off at a low amplitude and then if you want to increase it, you certainly can over time. But typically we say start slow, at least in the beginning. And so you wear it 30 minutes, it shuts off on its own, you take it off and then you just, you know, Go on to bed.

So, um, it is FDA clear device. So it's gone through a lot of clinical rigor to get the FDA approval. It was approved last October of 2023. And it's non invasive, which is nice because our CEO and founder was looking for ways to basically stimulate portions of the brain without doing something invasive, like deep brain stimulation.

Obviously, that's a huge stretch. surgery, and then also looking at options that weren't vagus nerve stimulation because the vagus nerve can be difficult to locate, difficult to stimulate, and that's where they really got into pinpointing the vestibular nerve back here behind the ear. Yes, and as you pointed to, FDA cleared the And requires a prescription and these things I think could be signals to people to people listening that might point to Oh, wow, this sounds like this could have some real impact that can come along with this product, as opposed to because certainly for people in the sleep arena might have seen a lot of gadgets and gizmos that claim to support sleep.

And so often, you know, as I've been in this sleep arena for quite some time, and commonly, you know, the things can be helpful, maybe calming a bit or what have you. But certainly this is distinct to have something that is prescription required and FDA cleared. So maybe a little bit more about how did it achieve those or pass that process in order to achieve those markers.

Yeah, no, that's a great question. And you're absolutely right. There's a lot of gadgets out there. There's a lot of brain trackers, all kinds of things on the in the wellness space. You can go on Amazon, you can find all kinds of stuff. And, you know, as far as having clinical evidence. So in order to get FDA clearance, we had to do a randomized controlled trial.

We enrolled 147 patients in the trial. So it was a large scale multi center trial. and we had a sham group. So it was really cool because our engineers were able to create a sham device, a headset where patients had no idea if they were getting an active therapy or the sham. We followed the patients, uh, use the device for four weeks, five days a week for the 30 minute sessions.

And then we followed them out an additional 12 weeks. And what we saw was in the active group, we were able to reduce. those insomnia scores. So it's all measured through the insomnia severity index. And we were able to reduce those and basically eliminate what you would consider to be chronic insomnia.

And then we were able to follow that out to the full 16 weeks. So it was really incredible just to see, you know, the significant changes in the levels of chronic insomnia from, from the active group versus the sham group. And I mean, it just made a huge impact when we looked at just sleep quality, sleep latency, being able to sleep longer.

And then it was really interesting to see some of the other factors that were noticed in the study, just like mental clarity overall, just feeling better, things like that that was picked up at the end of the, at the end of the trial. So there was a lot of rigor that was done. It wasn't some small scale study.

I mean, we're talking about almost 50 patients that were enrolled in the study. And, um, you know, that's really the difference between going through that to get FDA approval versus throwing a wellness device, you know, on the market with no evidence behind it. Sure, and you pointed to improvements in both falling asleep and staying asleep.

So for people listening, if they're dealing with, they get into bed and they're just laying there and can't fall asleep. If they're the people does also apply for wake ups throughout the course of the night. So the 3 a. m. wake up or whatever. Uh, and then people that are having too short of sleep in total.

So all, all of those aspects. All of those aspects we saw improvement with the active group versus the sham group 100%. Yes. Wow, so interesting. And were there any like concerns that um, emerged out of the, you know, as I pointed to with benzos and Z drugs, certainly we know there's a whole slew of concerns and side effects that come about with the use of those over the long term.

Are there any concerns over long term use and maybe you can also there's like two multiple questions in this in this question, but any concerns and then expectation around the length of time that people might be utilizing this product. Yeah, I mean, as far as adverse events, there were very few that were reported.

I think in very rare cases where somebody was running it very high. Um,  few had headaches maybe the next day, but it was very minimal as far as the, you know, um, percentage of those. I think, you know, contraindication as far as somebody that wouldn't be able to use the device would just be somebody that had some sort of skin irritation or something that would cause those electrode pads to not be able to stay in place.

But it's a very safe, safe device. I mean, the nice thing is unlike taking, you know,  whether it's a medication or some people just use wine or alcohol to try to get themselves. sleep. You never know how you're going to feel the next day. So with it, just don't get any of those, those negative side effects that, you know, are, are possibilities, which is, makes it really nice.

Absolutely. And even the, the morning headaches immediately, just from my bias of knowing what I know about sleep, it makes me wonder if they've been tested for sleep apnea or other issues that could be at play for their sleep that we commonly see with morning headaches. But yeah, really interesting. And then.

So someone's utilizing this, so maybe they're dealing with something acute, and so some more acute insomnia or chronic insomnia. Is there an expectation that then, or is it case by case, of how long they would be using the device for over a stretch of time, or is it just to deal with like the media issue, or what do we see there?

Yeah, great question. I think it really depends on the patient. So we really looked at people that were suffering from chronic insomnia. That was part of the study. Fine. And that's what our labeling is from the FDA were indicated for chronic insomnia. That being said, um, what we see is our patients typically they'll see results within the first couple of weeks, sometimes sooner, sometimes longer, but where we really saw that steady level reduction of chronic insomnia was at week four.

And then that was what was sustained. But we do have patients all the time that will say, you know, Life happens, something stressful happens, and sleep pattern, it's a disaster, that's what they want to go back, that's what they want to use the headset for when life gets crazy, something happens, they're not sleeping, and that's where people will kind of use it as a maintenance therapy, so they like to have it on hand, or if they're traveling, um, but it really depends on the patient, but then there's others that honestly, they like the sensation of it.

and kind of get a little bit, I'm gonna say addicted, but they get addicted to that relaxation.  Feeling because it's kind of you designate that 30 minutes every night to just kind of wind down, calm down, and they would rather kind of feel that  little sensation or relaxation versus instead of like going for a glass of wine to kind of relax.

Yes, which as we know with sleep, wine, while it might, we do see that it often can support people falling asleep, interestingly, like shortening sleep latency, but that's kind of where all the positive aspects end with alcohol as we quickly see it and all kinds of slew of problems. So love that there's these kind of new options available for people.

And I know before we hit record, you're sharing that there can be a couple different steps that people could take to get the prescription is. All these things can be hurdles for people when they are sleep deprived and just want to sleep like tonight that sometimes things can occur as like a bigger process or when am I ever going to get into my doctor but it sounds like there's different ways that you can get that prescription and we can share about that.

Yeah so that's absolutely right and so when I joined NeuroValence I said we have to figure out a way to eliminate any pain point for a patient to get this product. So what we did we we You know, looked at the market and said, how can we make it as easy as possible? And so it's very simple. Patients go to neurobalance.

com right there. They fill out, you press, get started. There's a quick quiz questionnaire to see if they qualify. And then they have two options. They can either go through our online channel to connect them to a provider. that will evaluate their chart and determine if they are a good candidate to be issued the prescription for modia sleep.

They are more than welcome to also go to their own provider. Uh, if they have a great relationship or they can get in pretty easily and they feel more comfortable with their own family provider, go to them. They can issue the prescription and send it directly to NeuroValence and we are happy to take it and process it and have the, have the device shipped right to the patient's home.

Amazing. So great. And I mean, I'm really excited. I know I shared with you that I have a long haul trip over to Paris coming up. So I'm excited to be able to utilize that there. So, you know, it's, I think it has multiple use cases and you did share about travel being one of those potential use cases. And we have certainly clients that maybe they're not using Well, certainly once we're working with them, we're usually not seeing this, but, you know, in the lead up with their struggles with their sleep, they might not be day in, day out using sleeping aids, but then they have, you know, some big flight or something, and that's where they start utilizing some of these drugs.

Now, it sounds like this could be an option on these long haul flights. Is that what you see a lot too? Yes, and I honestly I'm a user for these long hauls because it, this has become my secret travel weapon and I thought when I joined the company, the company is based in Belfast, Northern Ireland. I am based in Ohio, which means long haul flights typically, um,  sometimes four different flights to get over there, you know, depending on if I have a direct from Cincinnati to London.

So for me, what I did, you know, I tried it the first time and as we were boarding, I put on the device, it runs for 30 minutes. That's usually the time when everyone's kind of getting settled and there's a lot of commotion. That's when I run it. And then I take the device off and I'm able to fall asleep and stay asleep for six, seven hours straight on the plane.

And I've never, ever been able to do that ever in my life. But the craziest thing is I wake up and I actually feel well rested, like I got good quality of sleep. And then I'm, I have to just go, I've got meetings, I've got to meet with the board. I have all kinds of things. So I don't have time to be jet lagged.

And it's so funny. Because everyone will say, Kate, are you jetlagged? Kate, are you doing okay? And I'm like, I'm good. I'm fine. So now it's been four trips of me doing this. And every time I'm able to sleep and then just function normally. So for me, it's a secret weapon. And I'll tell you one other way that I use it is oftentimes I have a really early flight light is a 5 a.m. flight.



And I  Well,  I could go to bed at eight, but how am I going to get myself to go to bed at eight o'clock? So lately I've been using this, throwing it on early around 7. 30, 7, um, put it on for 30 minutes and it kind of like forces my body into sleep so I can  sleep  when I'm sleeping in order to be Well, to, you know, get up early or do something like that.


So for me, it's really been, um, this secret weapon as somebody that has a really demanding job, stressful job and has to work all the time. It's, it's been, a great tool to have in my little pocket. So  for people to have this, because you know, if there's things that you can do to reduce, you know, one, get great quality sleep, but then two, in some ways, reduce that anxiety of falling asleep or stress and just feel better.

To me, it's, it's all worth it. Oh, a hundred percent. If you've tuned into the show or followed any of our content here at Sleep is a Skill, you may have heard that everyone that we work with wears the Oura Ring. And as a result, we have amassed a very large database of Oura Ring users and get to see what really moves the needle for people when it comes to their sleep measurably.

Now, because we have so much data around sleep optimization, many ask what they can do to improve their sleep quality. And for years, my answer has been that one of the few things I've seen makes such an Overnight difference is the use of a quality cooling mattress topper, not just any ordinary topper that claims to be cooling with like gels or what have you, but an actual cooling topper that uses water and can be dynamically adjusted to suit your unique needs and preferences.

Now, this is why I am so excited to announce that 8 Sleep is now an official sponsor of the podcast. I have tested various cooling mattress toppers and fan systems over the years, and none of them have come close to the innovative and customizable, seamless nature of the Eight Sleep system. Not only does it have an autopilot feature to intelligently adjust the temperature of the topper to work in alignment with your body's needs, but it also has additional features that truly set it apart.

So, with Eight Sleep, you can enjoy advanced sleep tracking, allowing you to monitor key metrics like heart rate, heart rate variability, and sleep stages, all integrated seamlessly into the app. It also has a dual zone temperature control, which means that you and your partner can each set your own ideal sleep temperature.

Plus the gentle rise wake up technology uses temperature and vibration to wake you up gently and naturally avoiding the jarring sound of an alarm, but it doesn't stop there. There's more, more, more. So the system even includes a smart alarm feature that wakes you up during your lightest moments. sleep phase.

I know a lot of people have asked me about this and this is included in here within a customizable time window, ensuring you wake up feeling refreshed and ready to start your day. And for those of you who struggle with snoring, eight sleep has an anti snore feature that adjusts your sleep environment in real time to help reduce snoring and improve overall sleep quality.

So this is truly a game changer for anyone serious about optimizing their sleep. So if you're ready to take your sleep to the next level, Head on over to eight sleep and use the code sleep as a skill. All one word at checkout for a discount  today. I want to talk to you about something that often flies under the radar, but is absolutely crucial for great sleep minerals.

Now you've heard me talk about circadian rhythms, light exposure, temperature control, and more, but let's dive into the foundational elements that fuel our body's ability to sleep deeply and restoratively. Specifically, minerals are modern lifestyle with its processed foods and environmental stressors can leave us depleted of essential minerals.

This depletion can mess with our sleep quality, leading to issues like restless legs, poor sleep initiation, and waking up in the middle of the night. Enter beam minerals. Beam minerals are designed to replenish your body's essential mineral levels, providing the building blocks your body needs for optimal health.

And this includes better sleep. What I love about beam is that they use a hundred percent bioavailable liquid minerals, which means your body can actually absorb and utilize them instantly without any fillers or additives. Magnesium, for example, is known as nature's relaxant, helping to calm the nervous system, support muscle relaxation, and some argue by extension can promote deep, restful sleep.

Beam's magnesium is sourced in a way that ensures maximum absorption and effectiveness, making it a key part of my sleep routine. But beam doesn't stop there. They've created a comprehensive blend that includes other vital minerals like potassium, calcium, and trace minerals that work synergistically to support your overall health.

And of course your sleep, the result, you wake up feeling more refreshed, more balanced, and ready to take on the day. So if you've been struggling with sleep, sleep and feel like you've tried everything. It might be time to look at what's happening on a cellular level. Beam minerals can help fill in those gaps and give your body the support it needs for truly restorative sleep.

So head on over to beam minerals spelled B E a M today and use the code sleep as a skill, all one word at checkout to get a special discount on your order, your body and your sleep. Well, thank you.  Are you seeing, is the company seeing application towards or in the domain of shift workers or maybe those high stress environments or just variable schedules and that sort of thing?

Is that a direction that you see people going as well as chronic insomnia? Absolutely. I think anybody that has to work crazy hours, um, there's certainly a strong interest in the device. There's, um, We've had a lot of success too with women that are, you know, around my age, pre peri menopause, where you've got that 3 a.m. wake up, so that is, is something where we're seeing a lot of, um, a lot of use there. And then I would say the third is, um, elite athletes. So I was in Belfast, I interviewed a former rugby player. Now rugby's big there, not so much here, but the amount of contact that they have, you know, and unlike the NFL, they don't wear pads.

They're just like barbarians out there. Exactly.  So he used the device because, um, you know, being a company over there, we were able to get it to him and everything like that. So he used the device as a player and he said it was absolute, you know, game changer to help for his recovery, um, coming down off of that anxiety or that all that adrenaline after playing.

In the evening, just being able to calm all that down and then, you know,  just, just getting quality sleep. And of course, they're traveling, you know, any professional athlete that has to travel the NFL now is going over, you know, across the pond. So we've had some good conversations too with elite athletes that are looking for, you know, anything to improve, right?

And if you improve your sleep, you're going to improve your performance. Oh, definitely. I'm excited to have this as an option for some of our, I have a niche in high stakes poker, so I work with a lot of high stakes poker players and yeah, and they're certainly on wild schedules, but also deal with, once they leave the poker table, if they're talking about live play but might be whatever, two in the morning and maybe they just lost a million, won a million, however you cut it, there's excitement or stress or, so there's high emotions, uh, on either side.

and to then be expected to fall right asleep right when you get back to your hotel or what have you and then sleep enough to then be cognitively intact to do it all over again the very next day and like you know a chess player or something and to have that kind of a cognitive athlete to be able to be making quick important decisions for hours and hours at a time that sleep is really crucial so to have some of these sort of options is  Very exciting.

Yeah, totally. Okay, so those different use cases, is there an understanding a bit more, uh, the why that this is working? Like, what exactly is happening? I know you touched on a bit of that around the placement and the distinction between that it's not around the vagus nerve. Is there any more kind of call outs around, like, what exactly is happening for anyone that's, like, Concerned or has fears around the long term safety of this or, you know, what are we seeing there?

Yeah, I mean, our clinical trials started almost 10 years ago. And what's interesting, it was we were looking originally at the CEO and founder was a appointed scholar at UC San Diego to work at the clinic. there and they started looking at metabolic diseases. And so they were evaluating, you know, obesity, diabetes, things like that.

But as they started stimulating that vestibular nerve, they noticed that the patients were falling asleep or they were reporting better sleep. And that was kind of what led to the initial studies around chronic insomnia and, and anxiety. So, um, which teaser more to come on additional indication. So this is just our first first launch with Modi asleep.

Our first, um, our first approval. We also have an approval for generalized anxiety, but we'll be launching that later this year. So we're building out an entire platform to treat, you know, various disease states. And so, um, it's been around and it's been studied for, for quite a while, but it's that it's the pathway of that vestibular nerve and getting to the brainstem.

and onto the hypothalamus, which is what basically you're just putting your body to back to its natural state, the way that it was supposed to be restoring your circadian rhythm, you know, more like as you were baby as you were, you know, the human body is supposed to function. And it's like over time, all these pathways get disrupted and stress and things and your body gets out of whack.

So it's a really, if you think about it, you're just putting your body back to the way it's supposed to be back to its natural, natural state. And That's where you see the improvement in sleep. So interesting. Okay. And any other thoughts around Jews? Uh, I know before we hit record, we're pointing to some kind of attention that the company has been receiving and sort of accolades as kind of being this new standout pizza tech.

If you can share. a little bit about that. Yeah, so we were really excited to be honored by the National Sleep Foundation. We, um, were the winner of their new tech award. So there were hundreds of applicants, five finalists, and NeuroValence, uh, Modia Sleep was the winner. So we're going to be at CES with the National Sleep Foundation and we'll be able to show the product off and, um, hopefully, you know, with, with the backing National Sleep Foundation is a great, great organization.

We're doing also, um, some other things, partnerships with them, looking at, um, you know, sleep products, coverage, reimbursement, wearable space, um, things like that. So we're really excited about our partnership with National Sleep Foundation. Amazing, very cool, very exciting. Correct me if I'm wrong, it doesn't appear that there's anything else that fits the bill that's out there right now that's like this.

Is that right? That requires a prescription, FDA cleared, and that's a kind of digital therapeutic for sleep. That's right. Yeah, we are the first and only FDA cleared, the stimular stimulation device for chronic insomnia. So this is it. It's, it's new. It's groundbreaking. And now it's finally available in the U.S. Yay! Yeah. Amazing. And how about price point for something like this? Is there any concern there? Is it because it's so new, very pricey, or what do we see there? Yeah. So it is listed at 11. 85. It does accept, we can accept FSA funds if you want to use your EtchIt. JSA account, but it's, We can do that. Um, we also offer split payments.

Financing is available. You know, we looked at how much people are spending per month when they look sleep aids and over the counter and the research that we did, it was over 120 a month alone. So, um, you know, although it may be pricey on the front end, um, investment in your sleep and something you're going to have and be able to use, you know, for years and years and get the benefits from.

So,  more to come on that. Um, we are working through reimbursement channels, so we will, anytime there's new technology that comes out, unfortunately it always takes a little bit of time to get reimbursement, to get coverage policies updated, and to get commercial payers to pay for it. But we are certainly working really hard and on.

NeuroValence website, we have a reimbursement toolkit. So if there are patients that want to see if their insurance company will pay for it or if they can get some reimbursement through Medicare, we're going to give them all the tools to take to the insurance company and, uh, see if they can get some, some reimbursement.

Amazing. Okay. And I like how you also pointed out that while on the front end, it might occur as, you know, an investment or what have you, if we look at what people are spending and finding themselves  truly often feels stuck in this cycle of now. taking these particular pills that as we pointed to a lot of concerning side effects for the long term use of these because we know they're approved for short term use, but they're really not designed for long term use.

Like many people are taking whole slew of side effects and then difficulty getting off of these. And maybe we can touch on that too, with the use of this device, because that's something that's very concerning when people are taking these medications is kind of rebound insomnia or that anxiety that they were struggling with, that insomnia they were just struggling with when they stop taking those medications.

Not only does that come back, but sometimes with a vengeance and even more than they were, uh, experiencing before. So any call outs about like withdrawals or anything with this product? Yeah, I mean, we really see this as being a first line, and what we would like to do is avoid people going down that pathway event.

Those are ambient. So it's try this instead of going down that cycle. So  as far as, but if you are already using one of those medications, you can certainly add this on as an adjunct therapy and then with your physician to titrate off. So they're not mutually exclusive. exclusive. It's just, um, it's just that I think it's better if you could just start this first before even ever walking down that pathway of, yes, seems like a better option.

Um, one other thing I did want to call out is we are approved at Veterans Health Facilities and DOD. So,  you are somebody that is a veteran and you get your Um, your health care at a veteran's facility or one of their community care facilities. You can absolutely get, you can get a prescription for MOTI asleep and it is covered on veterans health.

Oh, that's huge. Okay. I'm so happy to hear that. We definitely need to support our veterans and support with this real problem that seems that is plaguing so many of them, which is their sleep and subsequent wellbeing. So very important. Um, Thank you for that call out and before we shift gears to hearing about your own sleep and how you're managing your sleep any other call outs or anything else to share on this big and exciting new topic of kind of a new player in the game of supporting people with their sleep.

I would just say, you know, go to neural balance dot com. Um, you get more information there. There's all kinds of information about our founder, our CEO, who was a medical doctor. So he invented this technology. Um, so there's a lot of knowledge, a lot of expertise behind the product and the company. You can learn all about that.

And then also find out if you're a good candidate for Modi asleep. Amazing. Okay, fantastic. And we'll be sure to add all that in the show notes as well. And we have found that people are always interested in everyone we bring on that's really immersed in this conversation around sleep, how they're managing their own sleep.

So we ask everyone four questions. And the first one is what does your nightly sleep routine look like right now? And you can also share, I know you travel a lot and have different ways that you're helping to support your travel. So nightly sleep routine, whether traveling or at home. Yeah. So if I'm at home, I have a pretty, pretty solid, pretty consistent sleep routine.

Yes. Typically in bed by 10. Um, not so fam, I, I'm, I'm pretty good about TV, um, watching. I don't do, but I do like to have music on. I'll let that kind of wind me down and then turn that off. And so I've  always been a good sleeper to be honest, which is ironic that I'm  sleep device. Um, love it. Oh, that's a whole nother story because  weird space and everything like that.

I try to be as consistent as possible. But for me, it's really about waking up the same time every day. I'm huge. Yeah. So for me, I just try to be up at 6am every day and get my workout in. I like doing the grief fitness. I do that. So for me, it's like the morning routine. And then usually by that the evening.

I'm exhausted. So it kind of  serves itself. It is wild just how important exactly what you just pointed to that actually bleeds into our second question which is what is your sleep quote unquote morning sleep routine with the idea that how we start our day can impact our sleep but what you said about the consistent wake up time we find that to be so important.

So cute. So huge for people. And while it can be a struggle in the beginning if people aren't used to doing that seven days a week, over time it can be your best friend in this journey of normalizing your sleep and normalizing and intensifying that sleep drive by the time you get to the 10 PM, when you're starting to get sleepy.

It really, really can help support. Okay, so we're assuming so we're probably waking up around 6 a. m. What else might we see earlier? Sometimes it's five if I take a 6 a. m. class, but you know, right now I'm battling the time zones where I've got a team that's five hours ahead in the UK and, you know, on East Coast time.

And at one point our CEO was based out in California, so it was this eight hour time span. So I was up at 4 a. m., you know, dealing with.  The UK is staying up until nine, dealing with, you know, Jason out on the West Coast, but, um, no, I mean, for me, it's just that consistency of, and I try to do it on the weekends, maybe it's not that early, but I'm still up by, you know, six, seven on, on Saturday and Sunday too, just to keep it.

Keep it consistent. Sure. Absolutely. Okay. And then what might we see on your nightstand or in your environment? In my environment? Well, I'm not a clutter person. I like everything pretty, like, clean. Yes. Same. I mean, I've got a lamp. I've got a book. You have a lot of arrangement and that's, that's about it. I love it.

Yes. We found that to be a very, a through line for a lot of the people that their sleep is just working is minimalism and not relying on too many external things to support their sleep. But as you pointed to when travel comes about, are there any call outs of things that you have? We know that you might then utilize this product when you're traveling.

Any other things that you come to rely on or to help support sleep? I would just say, you know, I just, I try to get the room as dark as possible. I do use a sleep mask when I travel, which I don't at home. Again, just keeping that consistency as best as I possibly can. I try to adjust, um, as, as well as I can because I'm already asleep.

It makes it a lot easier to do that, but I try to stay, you know, consistent with that early wake up and try to just assimilate as soon as possible when I'm, when I'm traveling. Not always easy, but yeah, totally.  Either, but we try. How often are you having to travel to Ireland then? Typically, I'll go over about once a month.

Once a month. Okay, so you're, this is really like a regular routine, so you're actually using this quite a bit. Oh yeah. Very cool. Yeah, thank God for it. I don't know how I'd be surviving. That's amazing. I love it. Okay, and then the last question is, To date, what would you say has made the biggest change to your sleep game or set another way?

biggest aha moment in managing your own sleep. Yeah, I mean, I have to just say that getting up, I always thought it was, you know, growing up as a kid, it was like, you need to go to bed at this, you know, right time every night. And that's kind of like, I think as a mom and as a parent, you're kind of, you force on your kids because you want to feel like that's the right thing to do.

Your bedtime is this. Yeah. So actually I was I was talking to a sleep psychologist and she was the one that really made the the focus on that. It's the consistent wake up. And so once I started doing that, I started sleeping even better, but  I would say that. Yeah, 100%. Uh, amazing. Okay. And then I know you already pointed a bit to how people could check out this product, but maybe just to reiterate best ways to do that prescription, all the things.

Yeah. So you just want to go to neurobalance. com and you'll click on Modi asleep. There's a get started button will take you right through the questionnaire. It's very simple. It's not long. Um, and you can either go forward from there on to our online provider site and be connected with a physician to issue the prescription or you're happy to, you know, go see your own doctor and talk about Modi asleep and they can send the prescription directly to us at neuro balance.

Amazing. So awesome. I'm so grateful to hear that there are new options for people that are finding themselves in this challenging situation of chronic insomnia and or, as you point to do, some of these other use cases that very well might expand and different ways that we can help support people with their sleep that isn't leaving them in a lurch with all these different effects and issues along the way.

So really, really important. Thank you so much for taking the time. And thank you so much for sending one over for me to be able to experiment with. I'll be sharing if you're not already following me on Instagram, Molly dot Eastman on lots of different platforms, and I'll be sharing my own journey. And I'll also be putting this in my newsletter as well.

So excited to have this in my pocket for these long haul trips and what have you. So really, really great. And thanks again. Thank you, Molly. It was great to be here. Thank you.  You've been listening to the sleep as a skill podcast, the top podcast for people who want to take their sleep skills to the next level.

Every Monday, I send out the sleep obsessions newsletter, which aims to be one of the most obsessive newsletters on the planet. Fun fact, I've never missed a Monday for over five years and counting. And it contains everything that you need to know in the fascinating world of sleep. Head on over to sleep as a skill.com forward slash  newsletter to sign up.

THE SLEEP ASSESSMENT

Complete a short assessment to test the quality of your sleep

Free & Customized Actionable Strategies for Changing How You Sleep
Start the assessment