Good morning, everyone, and welcome to the 44th Annual JPMorgan Healthcare Conference. My name is Varun, and it is my pleasure to invite on stage today Nyxoah, represented by their CEO, Olivier Taelman. Please put your hands together for Olivier.
Thank you. Let me start by thanking JPMorgan for the invitation. My name is Olivier Taelman. I am the CEO of Nyxoah, a medtech company offering an innovative solution by neurostimulation to help patients suffering from obstructive sleep apnea. We are listed on both Nasdaq and Euronext under the ticker NYXH. Currently, we are going through the most exciting time in company history since we have obtained, in August last year, FDA approval, and we are actively launching our product to help patients in the U.S. suffering from obstructive sleep apnea. Our vision is to make sleep simple. Now, before I will walk you through the technology, the commercial updates, etc., I would like to start by sharing how we at Nyxoah, how we see sustained value creation. Everything starts with the addressable market, and if you look at obstructive sleep apnea, it is a huge market.
There are a lot of people, and we are talking up to 450,000-500,000 people that are eligible for the Genio technology in the U.S. only. That represents roughly a $10 billion market opportunity. If we would have been in pharma, we would have talked about blockbuster potential. Next to this, it's also a largely underpenetrated market. Today, not more than 8% of the total eligible-to-treat patient population will actually get therapy. It's a fast-growing market, and we at Nyxoah, as I was already saying, we are currently actively launching as a second player in the space in the U.S. With Genio, we have a completely differentiated patient-first technology with a unique bilateral mode of action. I will come back to this later in my presentation in more details. Of course, we do have robust, compelling clinical evidence coming from our clinical pivotal study called DREAM.
In the meantime, we already treated more than 1,000 patients outside of the U.S., across Europe, and in the international business. We are commercially available in both Germany and the U.K., and also recently in the Netherlands and in the UAE, as I start my presentation by saying, it is the most exciting time for our company because we are heavily, we are intensively launching in the U.S. In the U.S., we already can also say that we have a reimbursement code secured, and we have both received already coverage from private payers and also from CMS. Now, before we talk a little bit more about why do patients need treatment when they suffer from obstructive sleep apnea, it also starts by touching a little bit further on what is exactly sleep apnea? It is a chronic disease.
It, in fact, enables the patient during the night to breathe properly because they will have several collapses of the upper airway that can vary from 10, 15, 20, 30, all the way up to 60 obstructions of their upper airway every hour during the night. This all is categorized in mild sleep apnea. Then we talk five to 14 obstructions every hour. You become moderate once you have 15, all the way up to 30 obstructions, and you get to severe apnea once you have more than 30 obstructions every hour. As you can understand and imagine, this is also associated with a higher mortality risk. And linked to the higher mortality, there is also the increased risk of comorbidities. And that is the main reason why patients suffering from OSA, as we like to refer to when we talk about obstructive sleep apnea, need treatment.
The risk of stroke doubles, cardiovascular risk is going up by five, and the risk of heart failure simply triples. Next to this, there is also a high prevalence in other key chronic diseases. I always like to highlight one. I'm sure you can see there are more than one, but I like to highlight one, and that is type 2 diabetes because up to 72% of all type 2 diabetes patients are suffering from OSA. Also, there is a clear need to further invest and investigate clinically what the effect would be if we were able to stabilize the OSA of these patients during the night, give them back a good night's sleep with a good oxygen flow, also on the glucose levels in managing their diabetic disease. But more to come on this one later. Now, we know and understand now why patients need treatment.
Now, the next question is, what are the current existing treatment options? CPAP, and I'm sure you all know someone who is wearing a mask, a CPAP mask, still is the golden standard in the treatment. Next to CPAP, there are mandibular advancement devices. What we see with the mandibular advancement devices is that the predictability of the efficacy of the therapy is rather low, and we also see that it's associated with a high out-of-pocket cost for patients. When we talk about CPAP, I think that the biggest issue is compliance. There is a patient quitting percentage going all the way, in the literature, from 29% all the way up to 83%. On average, we see that up to 50% is quitting using their CPAP on an annual level. Next to the CPAP and the mandibular advancement devices, there is traditional surgery.
What we learned with traditional surgery is that it's highly invasive. It's an extremely painful surgery, or more specific, the recovery after the surgery. The success rate is rather low, 30%-60%, and we also are seeing that it's reoccurring. So once you have surgery, over time, you will be in need for again having surgery. And we're also seeing that with the younger generation of ENT surgeons, this is no longer applied so much. And then, of course, there is unilateral hypoglossal nerve stimulation. Unilateral hypoglossal nerve stimulation, today, it's associated with an implantable battery, a kind of pacemaker platform technology. And just by saying this, this is already one of the hindering factors that patients will get a battery implanted on the chest, and that goes hand in hand with MRI compatibility restrictions.
Now, these are the options, and as you can understand, there is a clear need for a totally differentiated patient-first technology, and that is the gap that we are filling with our Genio technology. A little bit more details on Genio. So first of all, the Genio technology contains two key components. You have the implantable stimulator, as we like to refer to, and then there is the smart wearable component. If we focus a little bit first on the implantable stimulator, and you can see it on the slide bottom right, you can see that it's a very elegant device. It offers bilateral stimulation, so we have two leads, a left and a right lead. There is no implanted battery. The technology of the implant is totally passive, and that brings immediately a huge advantage for the patient that it's offering them a full-body MRI compatibility.
Next, driven by the bilateral stimulation, we also learned that we are the only company with a clearly differentiated clinical evidence showing that we maintain our efficacy also with more difficult airway obstructions, but I will touch a little bit more on this once we are touching the clinical evidence in the upcoming slides. Single incision, minimally invasive. It takes less than 60 minutes for the surgeon to implant skin-to-skin. After the implant, that is done in a daily hospital visit. You come in in the morning, you leave the same day, less than 60 minutes, as I was already mentioned. The patient goes back home, the wound or the incision is healing, and roughly five to seven weeks later, the patient is coming back to get the technology activated. In order to activate the technology, we are talking about a smart sleep wearable.
Again, as you can see on the drawing, the patient is wearing his sleep wearable under the chin. It is attached to the body with an adhesive. In the morning, of course, the adhesive is removed, and the wearable component will be charged and will be good to go for the next evening. If you compare this with a CPAP mask, if you compare this with a pacemaker technology implant, I'm sure you all agree that this is the most elegant and also the least invasive solution that currently is available on the market. I was referring to a smart sleep wearable, and why is it smart? It is smart because it is containing the software or the intelligence of the system, which is providing control for the physician when they start programming, but it's also providing a further optionality for patients once they are implanted.
It's also capturing the data that patients are getting and also the impact on how they get their sleep quality back. Next, it's also containing the battery. So the implantable part, as I was referring to earlier, it's a total passive device that is activated once there is true induction, an energy transfer coming from the smart wearable, activating the device once patients are sleeping. Now, next to the wearable component, the patient also has access to what we refer to as an intuitive app, and what can they expect from the app? First of all, it's monitoring them during the sleep.
Next, that it's capturing data, data that can be sent back to the physician, data that can be sent back and used by the company to further innovate, and data that can even be used for healthcare economic figures to also see what it means when you start treating patients and you give them back a good night's sleep. And to give you one of the most obvious examples, also how patients are returning to work or no longer suffer from daily sleepiness. And then last, there is even the option for a patient to personalize his or her stimulation. And when I'm saying this, it is in predefined boundaries, of course, always controlled by the physician, but it gives them a little bit more option to find their optimal comfort. And by doing so, we are really empowering the patient, and definitely it helps driving compliance.
Just to give you some background on compliance, we already recorded more than 87% compliance data from patients and also 92% patient satisfaction. Last, and I think also not to be neglected, people suffering from obstructive sleep apnea, they move, they travel, they want to go out with friends and family. So if you look at the device that they are carrying with them, it is the wearable component weighing less than 12 g. And you also have the charging unit comparable, in fact, like sometimes when you put your phone in a charging unit. We have an implant for life concept, meaning that the implantable stimulator, who is ceramic encoded, guarantees already a longevity of 15 years. And that is only what we measure today, so it definitely doesn't mean that the device will stop working after 15 years, but that is what is reflected in the label.
So that is the implant for life concept we refer to. And then there is the scalable technology platform. I talked already about the smart wearable. Now, what is the key advantage of a smart wearable is that there is no longer need for resurgery when there is, for example, a software upgrade available. The patient can simply have this push-through to the smart wearable, a little bit comparable like what we do with smartphones when there is an upgrade available. All this, I hope you agree, is bringing back to a totally differentiated but patient-first technology. Now, once we describe the technology, I think the next thing for a med tech company, which is crucial, is building robust clinical evidence. So here we have our pivotal study that was conducted in the U.S. We call it, and we refer to this as the DREAM study.
It is published in the Journal of Clinical Sleep Medicine, and the two major outcomes that I would like to share already in the beginning is safety and efficacy. When we look at efficacy, it's clear that we touched our primary and secondary endpoints in both the responding rate for the AHI, apnea-hypopnea index, and also the oxygen desaturation index, so there we see results up to 64% and more than 71% for both, so the conclusion is Genio reached its primary and secondary endpoints in the clinical pivotal study. Now, from a safety perspective, which is also important, you see an overall serious adverse event ratio of 8.7%. Now, putting the 8.7% a little bit in perspective, comparing with other neuromodulation solutions, there we see that it's a very low severe adverse event rate because on average, we see SAEs between 15% all the way up to 22%.
With 8.7%, I think it's clearly linked also to the fact that we have a single incision procedure that is also associated with less adverse events. If we look at the most common AEs, they can be brought back to the fact that it stays a surgery with an incision of roughly four to five centimeters in the chin fold, but we also see that those side effects, that they are vanishing roughly two to four weeks post-surgery. Conclusion on this one is we have compelling evidence, and we reach both the safety and efficacy primary and secondary endpoints. Now, what is important for patients and what is important for physicians when they are offering or making, in fact, the choice for their technology? What is crucial is, of course, that you get rid of your obstructions, that you get back to a normal sleep.
And what we are seeing is that we have a median AHI reduction after 12 months of more than 70%. I was mentioning that with Genio, we are the only ones who can guarantee also an efficacy in more complex airway obstructions, and this is what you can see in this clinical study also. When patients are sleeping on their back or in a supine position, we can also guarantee a very high reduction of airway obstructions all the way up to 67%. And then lastly for a patient, it's crucial that you are protected from your comorbidities, your risk for stroke, your cardiovascular risk. And we see that 82% of all patients treated with Genio, we are able to bring their AHI back below 15. And why is this 15 such a magical number?
Once you are below 15, in fact, your morbidity is related or is exactly the same as people who are not suffering from obstructive sleep apnea. And that's what Genio can offer in 82% of all implanted patients after 12 months. That brings me to the next chapter in our company history, and that is commercialization. So when we look at commercialization, we did our commercial proof of concept in Germany in the international markets. And I will keep it also very high level, but what we did is everything starts by obtaining reimbursement for your technology. In Germany, we managed to get reimbursed, but not only reimbursed, we got exactly the same reimbursement as competition, which gives us immediately the big advantage that we can differentiate on technology and that we will also, through the reimbursement, align on pricing.
Now, the next commercial strategy that we applied was how can we enter the market as a smart follower, meaning we go where there is already a lot of experience with hypoglossal nerve stimulation, we position our technology, and we see how the uptake is and the embracement of Genio with surgeons and patients, and guess what? By doing so, in less than 24 months, we were able to capture 25% market share in high-volume competitive centers where we simply entered and positioned our technology. We did not invest at that moment in any DTC activities. It was mainly driven by giving surgeons, physicians, and patients optionality, an option to choose. It resulted already in 25% market share in high-volume competitive sites. Now, next, we are selectively expanding internationally. Next to Germany, you have the surrounding countries like Switzerland.
We also started in 2025 in the U.K., in the Netherlands, in UAE, but our aim stays focused on the U.S., and why? Because the U.S. today is simply representing the largest market opportunity with close to $1 billion of sales already coming from hypoglossal nerve stimulation, and that brings me to the next slide. How do we enter the U.S. market? So we took the learnings internationally under our belt. We kept going for a smart follower strategy with a focused launch where we are focused on two key pillars. One is the high-implanting ENT surgeon. We learned that in the U.S., you have approximately 400 sites that are generating 70% of the total AGNS revenue, so that's where we want to go and where we will, in fact, be present.
The next thing that we also saw was that patients are referred by sleep physicians or sleep pulmonologists, to be more precise, and what we did and differentiated also from competition is that when we train our ENT surgeon, we do this hand in hand with their key or their largest sleep physicians by bringing them together to a training, discussing patient phenotyping, and then making sure that also the sleep physician understands what his or her role is post-implant. We have a Nyxoah dedicated commercial team. Today, we are roughly 60 people. Of the 60 people, we have 40 territory managers, sales reps, whatever you would like to call them. We like to refer to them as territory managers, and with those 40, we can already cover 200 high-volume sites in the U.S. out of the 400 high-volume sites that are existing.
Our plan is to scale up on a quarterly basis and to each quarter add a cohort of new territory managers so that by the end of the year, we can cover all 400 high-volume sites in the U.S. Next to the territory managers, we have a dedicated market access team that is focused on helping also on the reimbursement preparation with the hospitals that also helps in the value analysis committees preparation. There is also a small marketing team. And of course, there is a field training and education team that is ensuring high-quality implants and also helping sleep physicians with the correct patient phenotyping. Reimbursement has been a hot topic the last days. There were a lot of questions around reimbursement. What we did at Genio is we started preparing our reimbursement already in 2024.
And I'm happy to say that we have established a CPT code, 64568, that is recognized by payers for AGNS. Today, when we look at the commercial payers, and just to quote a couple of the big names that already reimburse our technology, Blue Cross Blue Shield, United, Anthem, Cigna, so far, we have 100% acceptance of all the pre-authorization files that we have submitted. And if we look at CMS, also there we can say the same thing, that we have obtained reimbursement from the majority of the MACs already where we did our submissions. So I do think we can conclude by saying that we also de-risked the reimbursement. I'm coming and I'm getting closely to the end of my presentation, but I do think it's very important to share with you what you can expect from Genio and from Nyxoah in going forward.
I would like to start in the middle of the slide with FDA approval. Once again, we have obtained this in August last year, and we have just released our first full quarter of results in the U.S. And I can tell you they were extremely exciting. Extremely exciting. We see that we have trained close to 150 surgeons. We have happy patients. We see the patients that are activated already reaching out to their surgeons, saying how pleased they were and how happy they were that they have chosen for Genio. But in going forward, we also invested in a clinical study very much focused on a specific patient population called CCC, or complete concentric collapse patients. They represent roughly 30% of the entire U.S. patient population, and currently, they are contraindicated for AGNS.
With Genio, we already have them on label, so we are treating them outside of the U.S. In the U.S., we just closed the enrollment in a trial that we called ACCESS. We will be showing 12-month results in June this year, and that should also result in a label expansion for U.S. patients as well suffering from CCC. There is further geographic expansion, and then, of course, there is the innovative leadership. So today, we are actively investing in incorporating the learnings and in making sure that by enhancing and advancing our technology, we can even continue increasing the response rate with Genio. We are looking at the wearable component to make it even more patient ergonomic.
We are looking at how can we further stimulate different nerves, like the ansa cervicalis stimulation, for example, also to increase the current patients that are not yet responding to hypoglossal nerve stimulation. So a lot of excitement ahead of us. And my last slide, and I like to start, or I like to end with the same slide as I started with, how do we believe of Nyxoah's future success in creating sustained value? Now, obstructive sleep apnea, huge market, $10 billion market opportunity in the U.S. alone, under-penetrated, fast growing. Nyxoah entered as a second participant, and we are breaking a monopoly. A differentiated technology, so we are bringing optionality to patients, and we see the first very successful momentum built in the U.S. We have evolved as a company from a clinical stage all the way into a fully commercial global public company.
We are definitely not experimental because we already treated more than 1,000 patients in Europe. And then, of course, you have the FDA approval that is finally unlocking the Genio potential for U.S. patients. We shared our numbers on Monday, and as I was saying again, I think we have beaten all expectations in the first quarter, and we do realize that it's just a start. But as we like to say, it's better to start strong than to start weak, and we are extremely excited and looking forward to what 2026 will bring. Thank you for your attention, and it was a pleasure talking and doing this presentation.
Thank you, Olivier. I think we've got a few questions that have come in online, and I'll read them out. So the first question is asking more about the initial U.S. commercial outcomes.
Would you potentially want to make a comment on that, and are you pleased with what you've been seeing there?
Yeah, so the short answer is yes. And I think I already alluded to this, but the first full quarter, it was a pleasure to see all the excitement with surgeons. We have trained almost like 150 U.S. surgeons in all those high-volume implant sites. We have already sold in the U.S. in the first quarter $4.5 million. We see the first positive patient reactions after being activated. So the short answer is yes. There is a lot of momentum, and I'm extremely excited.
That's amazing to hear. The next question we have is, who are the typical patients who are getting Genio, and are there any specific patient demographics that stand out at this point?
Are the patients asking for the device, or is it more of the physicians steering the patients towards the device at the moment?
Yes. Oh, and it's an excellent question. So first, who are the patients that we are seeing? It's started by what we refer to as low-hanging fruit. We have a high number, and that goes from 15%-20% of patients that are simply saying, "I do not want to have an implanted battery on my chest. I don't like this at all." So they have now the option to go for Genio. So that's already a first group. A second group are the patients who are saying, "What about clinical evidence? What about the fact when I sleep on my back? What about the fact when I have a lateral wall collapse?
Can I be protected?" So that's the second group, driven by clinical superiority, if I can say it like this. And then the third group that we are seeing, it's more linked, in fact, to the elegance or the minimum invasiveness of our technology. And there we see women that are saying, "I don't, again, do not want to have a visible scar on my chest this summer when I go to the beach. I don't want to be looked at as someone who has a pacemaker." We also see younger patients who are saying, "I do realize what it means to get an upgradable platform. I don't want to go back to the hospital. I don't want to be explanted and implanted with something new in order to just benefit from software upgrades." So that's also what we are seeing.
And then, of course, last, and I think it's also part of the question, we see that when a physician is giving the patient the choice by showing actually the two available technologies, we also see that spontaneously Genio is winning this.
And one of the questions that I have personally as well is, based off of your presentation, when you mentioned type 2 diabetes being one of the comorbidities or the issues that do come up with it, so then the question then leads to, so GLP-1 weight reduction drugs, what role do you think that they play when it comes to sleep apnea? And how do you think about potential near-term and long-term impact of GLP-1s to the specific space? Yes.
So from day one at Nyxoah, we have been saying that we welcome GLP-1 to our space for the simple reason that it will further expand the eligible-to-treat number of patients. And why is this? If you look at clinical evidence for hypoglossal nerve stimulation, we see that we are extremely efficient or efficacious when the BMI is limited up to 32. That's where all the clinical evidence is taking place. Now, with GLP-1s, we are going to the extreme obese patients with BMIs 35 all the way up to 40. Those patients, we would never be able to treat until GLP-1s came in play. So what we are seeing is that by losing weight, there is also a direct correlation on the severity of OSA, but we are seeing that the new patients coming in with a BMI up to 32 are still in need for treatment.
And that's a complete new cohort that we would never be able to touch if there would not have been GLP-1s. So I think there is a short-term, mid-term, and long-term positive effect from GLP-1s.
Perfect. I'll just quickly check in the room if there are any questions in person? Otherwise, we can continue with the online questions. Perfect. So the next question that we have online is, regarding reimbursement, are you still tracking to 100% prior authorized approvals? And how quickly is the prior authorization process going?
Yeah. So I think it was one of the most heated topics during JPMorgan when it came to AGNS. I can confirm what we also were saying in the beginning. We started building our reimbursement strategy already in 2024. We followed the correct traditional path, working with the medical association, AAO. Then there was a recommendation made by AMA to CMS.
CMS accepted coverage. Today, we are in policy for this. And so far, we have seen both with private payers as with CMS, a 100% exception. So for us, the way we are doing this with private payers, we work with pre-authorizations. With CMS and with local MACs, we work with manual reviews, which is a little bit comparable to pre-authorizations. And we have seen no change, in fact, in how we ended the year in the months of October, November, December. So for us, so far, so good.
Next question is, when do you expect FDA approval for the complete concentric collapse indication?
Yeah. So first of all, we need to have 12-month data. These data we will have available in June.
Based on this, it will take a little time to analyze this and to put it in the correct format to submit to FDA for a supplement and for a label expansion. We do think that end of Q4, but most likely beginning Q1 in 2027, we will have this on label as well.
And how should investors look at the rest of the Nyxoah pipeline?
Yeah. So as I was mentioning, we have a scalable technology platform, and we do put the patient first. So in going forward, we are coming with our second generation of wearable component. What does it mean concretely? It means that we are adding features to the wearable, to the smart wearable component in order to even capture more live data.
Next, we are also investing in increasing our gross margins by having a new, how do you say this, a new adhesive where the disposable or where the smart wearable will be connected to that will have a direct positive impact on gross margins. So that's what investors can expect in 2026, also into 2027. And then more on the long run, of course, we are further exploring how we can make our system even more intelligent. How can we integrate AI, for example, in capturing data, eventually resulting in a complete smart system that knows when to activate, knows what waveforms to use when, and also maintaining, protecting patients really in function of their specific needs.
Got it. Okay. And do you have any update on the ansa cervicalis pipeline initiative, and where does the program stand today?
Yeah.
I mean, with the ansa cervicalis, and I do realize that we are an early stage company, but we already looked at the future from day one. So it's a collaboration that we have with the Vanderbilt University in the U.S. And in fact, what we try to do is we try to understand what would happen if you stimulate the hypoglossal nerve, and then you start adding on a second or a new nerve being the ansa in order how this could help patients, because there are still roughly 15% of patients that are non-responders today, how we could help them as well and further expand the total eligible-to-treat patient population. Got it.
I think this is the last question that we've got online is, with the majority focus, and this was the prior slide as well, on the U.S., what about your international business, and what are the key drivers for international growth that you see in the next one year?
Yeah. So I think you pointed out correctly, as a company of our stage, we need to make strategic choices. And of course, the focus is the U.S. for the simple reason that it's the huge market. 97% of currently AGNS treatment or revenue is generated in the U.S., and we want to have a piece of this. Next, internationally, besides Europe, we also enter the UAE. So we will be very selective. We will not go everywhere. But where we go, we need to fulfill a couple of criteria. First, it is obtaining reimbursement.
Second one, having enthusiastic surgeons that we can train and also having the correct patients identified so that we can guarantee high-quality implants, resulting also in high-quality patient outcomes.
Perfect. And with that, thank you so much, Olivier. Thank you for your time.
Thank you. Thank you for having me.