Hey there, it's Emma Cooksey here and I'm your host.
Before I get to anything else, I want to just mention to everybody that there's this survey that the University of Ottawa and the University of Calgary are working on some research all about the Phillips recall.
So I know so many of you have been affected by the Phillips CPAP recall.
So if you were affected and they're looking for people, it's only people that are in the United States and Canada.
So sorry about all the people because I know there's a ton of you in Europe and Australia and everywhere else.
And so if you're in the United States or Canada and you were affected by that recall and go to the link, I'm going to put in the show notes and you can complete the survey and help with their research.
And so pretty busy week for me All in all.
But I managed to get my workbook out and ready to order on Amazon's that's really exciting.
So if you are and you are struggling CPAP user and you would like to order a copy of my workbook, the Six Week CPAP Solutions Workbook, and you can go to the Lincoln and the show notes.
And I also have a link on sleepapneastories.com.
So if that's easier, you can go there too.
So I super appreciate everybody who's ordered it.
It's really exciting and I hope it will help a lot of people was really why I wrote it.
So on to today's guest.
I'm joined today by Olivier Lazarel and he is the General Manager of Somnix Health and they're the company that make the device called the INAP.
And I don't think we've done anything.
I think we've talked briefly to one patient who had used the INAP briefly, but we haven't really talked all about that device and what it is and what it does.
So we're going to dig all into that today.
And so Olivier with Sonic's Health, he brought the United States, this Taiwanese based product called the INAP and it was launched in 2021 with a direct to consumer subscription and out of pocket model leveraging telemedicine and online retail store with the goal to make OSA treatment comfortable and easy to access for patients yet being effective for all severities of OSA.
So I'm really glad that I had Olivier on to to really explain all about it and and how to access it.
So here is our conversation all about the INAP.
So thank you so much for joining me.
Oh well, thank you for having me and for having me.
I'm a big fan of yours, you know.
I love what you do and thank you for doing that for the community because you're bringing a lot of different perspective and solution and I and ideas to the to the patient.
Well, I sure I'm trying.
You're you're doing well.
You're doing good.
So I want to hear, we're going to talk all about INAP, but I want to hear a little bit about you and your background and how you came into the sleep apnea space.
Oh my God.
I'm going to try to make it short.
I think I'm kind of an odd background, So I grew up in France.
Yeah, hear the accent here and study that.
We've already covered that.
I grew up in Scotland, so.
Yes, I know that.
So everybody has an accent, right?
So I graduated with a Master in Aerospace Engineering, believe it or not.
And the first part of my career was in France building satellites for Alcatel Space.
And actually one of my project was XM Radio.
So if you're using it, I was involved in that.
That's kind of my baby that's actually over there in in orbit then I'm yeah, I know you know and then I'm keep up here right now move to the US to get another masters and NBA here in California and then join the startup scene, the tech startup scenes in Silicon Valley which.
This where that which has been my home for the past 22 years went to semiconductor, big data sensors, a lot of like very engineering, heavy engineering, very deep tech and hardware based.
And my wife used to be a jazz.
She's an MDPHD and Jazz pharmaceuticals.
I was like she used to play jazz or?
She has many, many kids.
Used to be a jazz pharma and then we had a conversation when.
When I saw the conversions between, you know, data and good sensors, especially wearables and some lifting of a regulation hurdle that will allow those new technology to come into play in the in the world of Med tech and just was investing in a startup for at home PSG.
With a real EEG because obviously that's important for the Moses of narcolepsy and I kind of helped that company that was in based out of the Netherlands and I'm sure you know the name Onera Health.
I mean, I know the name.
That's about it.
I know I was interested in them because there's spinoff of.
One of the top semiconductor research lab in the world and I spent ten years in semiconductor and I know that lab really well.
It's called iMac in in Belgium.
And so the technology was really good and I helped them, but they were not at the cleared.
But that was my first gig, I would say in the world of medical device and in sleep.
Learned a lot.
And then I learned also that there was more things to be done, I would say in the treatment than in the diagnosis.
Yes, because we see a lot of HST devices that are really patient friendly home sleep testing for anybody listening.
Yes, a lot of home sleep testing devices with the introduction of those advanced sensors coming into the market, but then.
The patients get like a nice patient friendly, accurate diagnosis, but then they talk to their physician and then Okay, we're going to put you on a CPAP and a CPAP works really well.
But in terms of the patient experience, I could see a disruption here.
You know there was not continuity, A continuum of of the patient journey and experience in terms of being a patient friendly, comfortable device.
Which they are entitled to.
And my big thing is OSA, obstructive sleep apnea is a chronic condition.
By definition, the patient needs to be treated every single night.
If they have to drive their feet because they don't like the treatment, they'll find any reason not to use it.
Oh, I have a sinus infection or I'm this or I'm that or whatever.
And I said.
We have to find something that the patient will tolerate is not enough will like or even love in terms of treatment.
Not only the patient but also the bad partner.
And this is when I was having all those thoughts and realization that I came in to know about Sonics and I met with the founder and CEO, Doctor Chung to Chan, who's Taiwanese, Chinese, Taiwanese.
He used to be a visiting scholar at Stanford University and he got the ID from Dr. Gimino and brought it back to Taiwan.
He's a patient himself and then developed.
I think that was back in 2012, ten or 12, and he developed the technology, so he took him.
Quite some time to perfect the design and to start launching the clinical trial and things like that, but also they launch in a number of country before the US, Taiwan of course.
So this device is the INAP, right?
The device is the INAP OKAY and INAP stands for Intermittent Negative Air Pressure.
There's a reason for INAP so he so I'm going to see if I can explain it and then you can correct me if I get it wrong.
So I think my understanding of it is instead of all of these positive airway pressure devices like CPAP and BI PAP that are pushing air to keep your air splinted open, this is a negative pressure device which is almost sucking air out of your oral cavity.
Do you wanna explain exactly how it works?
I mean it's so far so good.
I would say the main difference is think about PAP as a flow device.
Yes, in the sense that it constantly pushing air into the patient's lung.
So that's why the device has to be plugged in all the time.
The pump is running all the time and it's continuous it.
Doesn't, and it's continuous with the sea of CPAP.
It's continuing continuous positive air pressure.
INAB is a static pressure device, so I'm going to get a little bit technical here, but what it does, it will suck the air of the old cavity.
So we have like an old interface, very comfortable that create the seal in the front of the old heavy and then the seal in the back is created by the tongue, the palate and the soft palate that kind of closes.
So here you've got a pocket of air in your mouth and we're going to be sucking that out until we reach a target pressure.
And So what happened when you set the air out, you know?
Well, you create a kind of a vacuum that's replaced by all the soft tissues taking those tissues.
So your tongue and your soft tissue is being drawn forward in your mind.
So all those tissues that are not attached to a bone, I know a lot of alternative therapy are focusing on the tongue and definitely that's a big, big part of.
The big corporate, I would say for or say, but not enough, you know, for a lot of people, but but not As for everybody, right.
But so that's what makes it so maddening, because I feel like there's so, there's so many people trying to get to the root of their own issues and there's just so much variance between different people.
And yeah, it's a lot.
Yeah, yeah, yeah, it's it's.
But anyways, so it's interesting because as you.
Turn on the pump.
You can feel that pressure, that suction, all around your mouth, not only the tongue but also the different soft tissues, and there get gently pulled forward and upward.
So the tongue eventually sits against the palate, where it's supposed to be, where it's supposed to.
Be And then the good news is, once you reach that target pressure, there's a sensor that just stops.
The pump, you don't need to keep pumping at that point because okay static, there's no movement.
It's like a suction pump, so you're almost like pulls your tongue into the correct position and then just stops cuz it's done its job.
And then at that point, the back of the airway or the back of the upper airway is open, so the patient can actually breathe.
Naturally through their nose.
And they had.
So one of the things about your device is you have to breathe through your nose, right, which is how you're supposed to breathe, as we know from James Nasser and all the best friends.
And so your mice is going to be closed around the device and then you're going to be breathing through your nose.
So but we'll we'll get to to to that a bit later.
So what happened when the patient kind of open the mouth or move around or the the tongue falls back?
Obviously it's detected by the sensor in the device as a leakage and the pump kicks in again and reposition the tongue properly, everything while the patient is asleep.
So that's why it's intermittent because it's not always on.
So and we have a parameter here that we work with a patient which is what we call the seal time.
So what percentage of the overall usage time did they have a good seal.
So we're trying to target something above 80% for instance.
But what it means is that 20% of the time the pump is on 80%.
Being off means it's idle.
Everything doesn't create any noise and it is doesn't draw any any energy or very little energy just to keep that that pressure, negative pressure.
And that's the beauty of the of the design of the technology is you don't need to plug it in the back.
So explain to people what it looks like as well.
So it's kind of a small little.
So how would you describe that?
I mean I have it here but if you you know it's about it's a size of footprint of an iPhone of an iPhone those like gigantic and it's about twice as thick as a.
So the bottom part imagine kind of a this this iPhone and it's it has like a cut in half.
The bottom part is what we call the console.
This is where we have.
The battery lithium ion that is rechargeable by a USB port, the pump, the suction pump, the electronics, the sensor.
So it's rechargeable, but it doesn't need to be connected to power all night, You can just have it charged up.
And I'm a user myself.
I can go for six nights in a row without having to recharge OK.
So the top part is what we call a saliva container because as you're going to be pulling air from the old cavity, you will also be pulling some saliva and then patient don't like to have to deal with saliva.
It's kind of so in that container we put little bags with highly absorbent material.
You use that once per night.
Okay and all the saliva will be collected in these little bags and then like every morning you just toss them in a bin and the rest is clean.
So very easy for as well.
Then we have a cube which is about the diameter of a pencil.
A little bit smaller and it's a 3 foot long tube.
That much smaller than a CPAP pose by the look of it.
That's why, yeah, much smaller than a CPAP hose or yeah, call it holes instead of tube.
This is really a tube that's a smaller one.
And then we have a old interface, and the old interface is made of very, very soft plastic material.
And I would I describe it as an hybrid between a snorkel and a pacifier.
And the snorkel, because that's the way you wear it.
There's a kind of a flange that sits in front of the teeth and beyond, behind the lip.
And like a snorkel, it's here to create a seal.
If you're underwater, you don't want the water to.
So you're breathing through your nose, not through your mask.
Because it's sealed, you're.
Breathing through your nose and we have a stem here that's kind of a a.
The extension of the tube.
This is where the negative pressure is sucking from and that is sitting on top of the tongue.
It's funny because when I use it I always try to figure out why do we call the pacifier.
Pacifier in French is a different word and then pacifiers because.
It soothes the baby, it calms it down and for some reason when I try that and have that in my mouth, I fall asleep like in a minute.
It's almost, it's almost like I think it's to do with stimulating something on the top of the roof of your mat.
I don't know.
I think it's the same.
With wise, people suck their thumbs as well.
Like their Toms or I mean smokers, it's not only about the nicotine, it's also a sucking effect, calming down and soothing.
So anyways, so, so it's very, very quiet and comfortable and it's, it's good also for the bad partner because again it's quiet.
We're going to be pumping only a few milliliters.
That's a pocket that's in the Orient cavity, so you don't need a big noisy pump for that.
You have just like a very small white pump compared to the noisier pump for CPAP because it has to push a lot more volume per minute.
And so here's the bit that I really want to ask you about, cuz I was super confused.
So you got FDA approval from the device a while back, but then recently there was something where you were talking about mild, moderate and severe having different sets.
Know what I'm asking?
No, no, no.
Yeah, I know exactly.
I read about it, but I still didn't really understand, so I thought I just asked you.
So we we we receive our initial FDA clearance Class 2 device in May of 2020 for all severities of sleep apnea mile moderate and Sydney.
But that was with a fixed pressure setting and we filed an extension that was that was actually that we got in June like last month for the ability to titrate the negative pressure.
So the device has the ability to be remotely titrated by the physician not by the patient by the way by the physician.
And then we do have a protocol for that because you know, think about those patient with high BMI heavy tongue, they will need more force to be applied to their soft tissue to just pull them forward and keep them in that position.
And the initial pressure setting was not sufficient for some of those patients.
So now it is heavy clear to be able to remotely titrate by going deeper in the negative pressure and that means creating more force in all those tissues in the mouth.
OK, thanks for explaining that cuz I ran about it and I was like how would you titrate that?
I don't understand, but OK, so different pressure size that makes sense.
It's a very different titration compared to a CPAP of course.
But so the way it works, we have an app, so the patient needs to download the app and pair their device and then the provider has an access to a platform where they can see their patient progress, you know the and the treatment time.
And then if they feel that the patient needs a adjustment in a negative pressure, they just order it online and the next time the patient is actually opening the app, turning on their in app, there will be a pop up window saying hey your doctor increase your pressure by then.
Do you accept it?
They click yes and it's automatically synchronized with the pump, and the pump goes to the next setting.
So do you want to explain to people like if people are listening to this and?
The IMAP is not a device that their sleep specialist is familiar with.
Can they come direct to your website or what's the best way for patients to find out more you know and like yes, yeah, I mean we're we're working hard in spreading the word and making more and more physician and provider aware of IMAP.
But as you know it's a it's we're out there in the trenches and working out for that.
But we have a website with a lot of details, a lot of information.
We do have also a list of provider who are in all 50 states being in telemedicine as well and license in all 50 states.
So they can book a consultation with them.
And in order to get a prescription because we need a prescription as a Class 2 device, they will find a lot of resources as well to share with their physicians.
And really if they want us to contact the physician and share some clinical data, answer the question, do a demo online, we do that all the time and we'll be very happy to do it for them.
And so this is something, are people able to you have insurance coverage, right?
Like can people claim under their insurance or how does that work?
So it's a new device.
So we do not, we don't have positive coverage.
Now we are working on it.
We have a number of codes that have been granted to us already.
We applied for another code.
It's quite the system in America.
I don't know what it's like in France.
Well, you're talking to single payer so much, much easier.
It's a single payer system like most of Western Europe.
So it's a very, very different system.
But it's interesting you have to learn the rules of the game here in the US and of course try to play the best you can.
I mean not play it, but to comply to all the system and.
So you're still working on that part.
We're working on that and hopefully by 2024.
So we'll start having positive coverage.
But we do have because we're not covered yet.
So we we introduced it from the very beginning with two different models.
So see it's it's not just a new device that's kind of a small portable quite, but it's also I wanted to push the envelope.
So the patient experience to adopt the device is also different from what they had with CPAP.
So we introduced with two models, we have a out of pocket model so they can buy it up front on our website or they can have what we call membership which is a subscription model.
Pay a certain amount every month.
They pay a certain amount every month, but they can start the treatment right away.
If the treatment for some reason doesn't work for them, of course we help them.
There's a lot of coaching that's involved here, but after three months we say okay, send it back and then we stop your subscription like you would be stopping your cell phone subscription.
I want to make it really easy and not threatening to those patient and then included in that what we call membership, they are the supplies.
So the supplies Every three months the patient receive at home, a box with a new mouthpiece, a new tube and three months worth of those, you know what we call.
Pockets, yeah, yeah, the absorbent.
So that was going to be my next thing is like what does the maintenance and the cleaning look like?
So very easy.
So the maintenance is so every morning first thing you do you just toss the, the dry pad you want to rinse off if you want, but it's usually to dry the saliva container and you run tap water through the different component that's seen some saliva so that the cap, the cube and the oil interface and that's about it.
And once in a week, we suggest that you use one of those effervescent tablets that people use to clean their denture.
Yes, and then you suck the content of that glass of effervescent solution with a pump by dunking the OR interface into it, and the whole system will be soaked with this cleaning solution and you let it sit for like 15 minutes, then rinse it off and you kill most of the bacteria built up.
But it's very easy to in terms of maintenance as well.
And so just because I have listeners in all sorts of places, where is the INAP, So I'm assuming it's available in Taiwan and then the the US and then do you know the other countries where people can get access to it.
So, so we are seeing marks.
So that's in Europe, it's distributed in in the UK, in Germany, Switzerland, Austria, in Asia.
And there's a lot of country Korea, Korea, of course, South Korea, Thailand, Vietnam, Hong Kong, Australia.
So, so pretty good coverage.
And again, is it just a case of starting with the website and then kind of working back from that?
Like I I just feel like a lot of patients will go to their doctors and ask and a lot of times it just feels like it's tricky for like just anybody.
I've I've interviewed about newer devices.
It just seems to take so long for doctors to kind of catch up with.
What patients are asking for.
So yes, yes.
So that's why we're improving, we're increasing our presence in those conferences.
Yes, we're creating webinar for doctors.
We're trying to educate the doctors community here in the US specifically in the US Yeah.
And our approach was in terms of outreach was really A2 prong approach.
We have the direct to consumer.
We actually explain what it is on Facebook and Instagram and Google.
So we do almost like a tech approach of outreach and then we also have the outreach to the physicians giving them more information, clinical information and educational content.
And then we're trying to make sure the two population just talk to each other.
So our goal is really you create the need by the patient and the patient talk to their doctor and say, hey, yeah, seeing that I don't like my CPAP.
Or I think there's a huge element of that.
I feel like people in, I don't know, just that I've met at conferences and things kind of underestimate the power of patients.
Because I know, like, I mean, maybe I'm not your standard patient, right?
I'm a a lot to deal with.
But like, you know, when I go to my doctor, I'm like, hey, what about this?
What about that?
And, you know, and and you can see if they're kind of uncomfortable because they don't really know what you're talking about, they're going to go and Google it, right?
And try and figure out like, what is this person talking about?
So I feel like patients by demanding things can actually help change the system.
And and I think it's it's even more important for chronic condition.
You know if it's an acute condition and then going to be treated for a week or two or months that's okay.
You as a patient, you bite the bullet and you know that's going to be sold after a month and then you get whatever treatment the doctor is, is telling you to to to take or to use chronic condition again.
And the chronic condition is the main reason of a lot of issues.
I mean if not treated all the comorbidities are developed that are coming as well.
So it's so important that the patient is part of the conversation, is part of the decision and that the patient likes or loves the treatment.
And you know, I my one of my dream is also we all know those those statistics, you know, 80% of people suffering from obstructive sleep apnea are not which.
Is not acceptable, right?
I feel like we talk about all the time and it's like we've got to change that.
Because, you know, they associate the OSA treatment with the sleep app, with the stigma of a mask.
But you know, you're like a 30 something, you know, guy or girl, and then you've been diagnosed by sleep apnea and all of a sudden the doctor tells you, okay, here's a CPAP, go use it.
I mean, you, you realize that, Oh my God, no, I cannot.
It's not possible.
So so many of those people were sitting on the fence.
Hopefully we'll start a treatment with a device like an INAP.
And that's not the only one.
There's other new devices that are also patient friendly, but that's not as intrusive, that's not as disruptive for their lifestyle as a CPAP..
And as they start the treatment, they prevent their condition from getting worse and worse and they prevent comorbidities from from developing.
You know and that's actually that's super important you know if we can find a way for this huge population of patient who be 30 something or more and get them to start their treatment as early as possible because yeah change the image of a always say diagnosis is a non event.
It is not going to be changing your lifestyle is not going to be preventing you from, yeah from the OR all that you like to do in.
Life, I think.
Also, there's this whole thing of.
When you look at those numbers, they're so stark, like 80% of people aren't diagnosed and aren't being treated currently.
So to me, there's enough.
Market share for every possible, you know, solution to.
I just think that patients need to be offered everything that could help them and then people are so diverse and they're, you know, what they think sounds like a good plan.
I mean, I've just had so many people on my podcast at this point and some people are just like, give me whatever surgery there is because, you know, like they don't want to wear anything at night or other people think.
You know a Cpap's preferable to an oral appliance or you know like it.
Just the the vast array of people.
Like there's enough people on Diagnosed for all of these treatment options to have their audience, I think.
And as you mentioned earlier, there's so much diversity in people's body and shape and condition and perception and things like that that I'm not saying that Inapp is working for everyone.
There's a lot of contradiction and same thing for every treatment.
So I do believe that the physician should have a like a toolbox and show the different option that they have on their toolbox to their patient, discuss with them, advise them on what might be working better for them, but allow them to try different things as well.
You know the good news with INAP is like a CPAP you can get results from the very first night on, yes, you know the tongue stimulating devices or the inspire the hypoglossal nerve stimulator.
Of course that's moving involved and you will not know whether it's working for you right away.
So this is actually something that is very easy to use and you can see in a matter of a couple of nights, Oh yeah, that things work.
Actually, I like it.
So for people whose noses work, it could be a really good option.
So what about big Thing?
One of my big thing and I listened to a couple of your recent podcasts.
You know, with that's Doctor from Australia.
Dentist from Australia, yeah.
Doctor Shereen Lim, Trim Lim talking about posture and how it opens the nose and the Myofunctional therapy and things like that.
We do also encourage that we have actually a few tools in our toolbox to help patient become nose breather because I know we talked about that in SO.
Important Conversation, the great book from James Nester Breathe.
And that was completely eye opening for me And he said, Oh my God, yes it's it's incredible you know how we should all breathe through our nose.
But unfortunately society and lifestyles make that a lot of us are mouse breather.
We hear that a lot without patient.
Oh, I cannot use it.
I'm a mouse breather.
But I said, well let's work together.
So we we have some tips and plan where they become nose breeder only in a couple of weeks, you know, and the more they use it, the better they feel, the better the patency of their prior ways improves.
So cool, yeah.
So I'm gonna put some links in the show notes so that people can go find out more.
About, you know, your company and the INAP and where to get it and all those kind of things.
Was there anything else I didn't cover that you want to say?
Well, the only thing is also I didn't mention is we have very, very few side effects because again we're using natural breathing, so there's no dryness of air or got it thing like that.
And it's the only side effect that we have at the beginning for the first few night is over salivation because it's a foreign body effect in object in the mouth and that usually disappears after a few a few nights.
But that's, that's what make it, you know, a cool, a cool treatment that actually works well for a number of our patients, so.
Well, thank you so much for joining me.
I really appreciate it.
Thank you for having me.
It's been really fun.