Good morning and welcome to the next session of Oppenheimer's 34th Annual Healthcare Conference. I'm Shaymus Contorno from the MedTech Research Team. Next up, we're pleased to have Loïc Moreau, CFO of Nyxoah, to do a presentation followed by a few minutes of Q&A. With that, I'll turn it over to you, Loïc, and I'll resurface at the end.
Thank you very much for the invitation. It's a pleasure to present Nyxoah and our product Genio today at the Oppenheimer Conference. So first of all, if we go to the next slide, Nyxoah is a company that was founded in 2009 by a serial entrepreneur called Robert Taub. The company went public on Euronext in 2020 and is public in the U.S. on Nasdaq since 2021. So, and I'm the CFO of the company, and you can see on the slide Olivier Taelman is our CEO. So if we look at what we call the roadmap to success or the Trinity to success, why we think there is a tremendous opportunity there is, first of all, the size of the market for obstructive sleep apnea.
So when we look today at the number of patients that are using CPAP, it's a massive number. Those that do no longer tolerate CPAP, it's really, really big. We are talking about 500,000 patients in the U.S. and 500,000 in Europe. So in total, the market potential is absolutely giant, and it's totally unpenetrated today because the overall penetration is about 5%. We are coming in this market with a very different technology, very different for many reasons.
First, on the features and the fact that there is no battery inside the body, but also in terms of the population we can address because we can access or we will be able in the future to address a specific part of the population called Complete Concentric Collapse patients, representing 30% of the total eligible population as per the literature, and that was confirmed when we did the ACCESS study. I will talk more about this later. The third is we received the CE Mark approval in 2019 in Europe, and we are already commercial in a number of European countries. The biggest one is Germany, where we are commercial since the beginning of 2022. And it gives us a lot of insights on the market dynamics, on the competitive landscape, and we call it the proof of concept before we enter in the U.S.
If we look at Germany, we managed to take 27% market share if I look in 2023. The last one is about the IDE study. We are very excited because we are a few weeks away from a major inflection point, which will be the release of the clinical data for our U.S. IDE study. And it's a risk in a number of ways. The most important one I would like to mention is the fact that in March last year, we released data on the first 34 patients for efficacy and on the whole cohort of patients for safety as well. But on top of this, we are gradually building our commercial pool of patients and history with them, and we see how the patients are reacting to those in the real world, in a commercial world. So this is really what we would like to go through today.
The next slide is about the commercial opportunity. Without going too much into detail, the product is positioned for patients that are refractory to CPAP. You will know that in the U.S., for instance, every year, there is between two million and 2.5 million CPAPs that are prescribed. A big part of them or a big part of the patients leave CPAP after two to three years. When we look at the total patient pool, we think of 500,000 in the U.S., and the number is relatively similar when we look at Europe and other countries like Japan. This is a market that is relatively large because there is a real unmet need in a large population. The stimulation of the hypoglossal nerve is a technology that is existing for six to seven years in the U.S.
It's growing very fast, but it's still largely underpenetrated. Today, we're talking about 6% of the market being penetrated, and the number of patients is actually almost doubling every year for the past three or four years. So in terms of penetration, it's increasing fast, but it's still very, very underpenetrated, and we expect with a second player like us on the market, the penetration will accelerate, and this is what we see in Germany as we speak. So if we look at the technology itself, what you will see is it's made of an implant, an implantable stimulator, as we call it, and completed with a wearable. So the whole battery is outside the body of the patient. There is no lead.
Actually, the implantable stimulator is keeping the airway open, and the patient, every night, removes the wearable, puts it on the nightstand, and recharges it, and also gets data on the quality of the sleep. So this is a very new technology, very novel technology, and very disruptive because this is not existing on the market today. So if we look at the evidence, at the clinical evidence, I will just mention a couple of those studies. One which is important was the BLAST OSA study, which gave us access to the European market, so that's a very important one. It was completed by a study on 42 patients called Better Sleep. And why this study is important?
Because this was the first time it was demonstrated in a study that if you're a patient with CCC, complete concentric collapse, or non-CCC, the technology, because it's bilateral stimulation, works for both sets of patients. And as a result of that, we are now the CCC patient is now in the label in Germany, for instance. So we had a label extension in Europe, and we received Breakthrough Device Designation in the U.S. for CCC patients because this is a part of the population that not only is big, but that does not have any alternative in terms of treatment. The next study that is extremely important for us, and we are very excited because we are close to the data readout, is a DREAM study.
The patient cohort is 115 patients, and what we are trying to demonstrate is that 62.6% of the patients that are treated have an AHI reduction of 50% and an AHI below 20. An AHI is the number of obstructions, the number of events a patient has every hour. If we are able to demonstrate this, it will pave the way for FDA approval, which we expect to be late 2024 or early 2025, and U.S. commercialization. So that's extremely important for us. As I was saying, we released the first data points on the first 34 patients, and we met the primary endpoint on those first 34 patients. We are also building experience with the patients commercially implanted in Germany, mainly. In parallel to the DREAM study, we have a study that is specific for CCC patients called ACCESS.
We are talking about 106 patients, and the study is currently enrolling. It's a U.S. study, and the study is currently enrolling. We expect to have the end of the enrollment by the end of this year. Patients will be followed for 12 months, and we expect to submit a supplement for the regulatory approval by mid-2026. As you can see, it's a special moment for us and a very exciting moment for us because we are a few weeks away from a major inflection point with the readout of the U.S. clinical study. If we go to the next slide, this is a zoom. This is providing a bit more information on the different results we saw. As I was mentioning, we want to reach 62.6 responder rates.
We achieved this result in the BETTER SLEEP study, and we saw this result achieved in the 434 patients of DREAM data. So this is why this data gives us comfort in terms of the final results for the study. You also have to know that when we look at commercial, we now have close to 500 patients implanted that we are following and monitoring the results based both in terms of efficacy but also in terms of safety. We also performed a number of surveys to see how our product from a commercial standpoint would be perceived by physicians. And the last one I'm showing there was done nine months ago with ENTs and sleep experts in the U.S.
And as you can see on the bottom of the slide, when we asked them what is a portion of the population that would receive Genio versus the competition, they pictured approximately a 50% market share for Genio versus the competition based on what? Based on the number of features for our product, actually. And that's what's mentioned on the left-hand side of the slide. One important element that is for the patients and for the ENT, the scalability of the platform, the fact that it's a bit like with your car, with your Tesla, you are always pushed with the latest upgrades in terms of software. So that's important. There is no battery, no implantable battery, so you don't need to go back for a surgery. Full body MRI compatibility, 1.5 and 3 Tesla.
We talked about CCC patients because it will expand the market, but also to rule out the CCC patients, there is an examination that is required called DISE. It's not a pleasant examination, obviously. So if CCC is in the label, then there is no longer a need for drug-induced sleep endoscopy examination. And the last point is a single incision under the chin. So that's what gives us confidence that when we enter in the U.S. market, we will be able to quickly gain commercial traction and have an important share of the business. So this is just an overview and reminding you of the timeline that we have in front of you. So the first one is the DREAM data readout, which we expect in the first half of April. On the back of this, we will submit the last module of our PMA submission.
There were three other modules that have already been submitted, and we expect to have the FDA approval by end of 2024, early 2025. In parallel to that, we are building the commercial team. At the moment, this is mainly market access and pre-commercial investments, but that is expected to ramp up and accelerate strongly on the back of the DREAM data. We want and we expect to have a full commercial team trained two months before FDA approval so we can directly promote, sell, and train sites on this new technology. If you look in parallel, you have the extension of indication for CCC, which we plan, as I mentioned, by mid-2026. Now if I turn into where we are in terms of cash first, as I mentioned, we did two IPOs, one in 2020, one in 2021. We raised close to $100 million of cash.
At the end of 2023, we still have $58 million, and we have cash runway until the last quarter of 2024. So obviously, we will make the most of inflection points to put money on the balance sheet in the coming months, whether it is the clinical data or whether it is the full FDA approval. If you look today at the shareholder base, we still have strong historical shareholders. They own 25% of the company. They are completed by two strategic shareholders, Cochlear and ear implants. They have 18% of the company, and they joined us right before the IPO in 2020. The second one is ResMed. ResMed owns now 5% of the company, and we have now a collaboration in Germany to accelerate the referral of patients and to create a continuum of care for patients with sleep apnea.
I'm happy to cover this in more detail during the Q&A. Historical shareholders and strategic, they account for approximately half of the shares. The other ones are U.S. institutions or Europe. You can see our key shareholders on the slide here, like BlackRock, like Pura Vida, or others. I will close the formal part of the presentation on this slide. I hope you understand the excitement we have at the moment in the company and our business agenda for the next months and the focus we are having at the moment.
Thank you for that presentation, Loïc, and much appreciated. I know there's a lot of interest in the company and this DREAM data that everyone's been watching for the last year, and especially now with the finalization, so to speak, coming up and the initial readout. So on that news, what can we expect? What data points will we see come April? What can you highlight or at least can say at this point that we'll see?
So we will topline the data in April. For us, toplining the data will be, of course, the response rate for AHI. There is a co-primary endpoint, so then there will be the response rate for ODI. We will probably also mention the average AHI reduction because it's important for the clinicians as well and the safety data as well. Those will be the four points we're going to cover early April. We will then have a more comprehensive presentation at ISSS in September, and we will also publish. We'll also do a publication in a tier one journal with much more detail and review of the data and much more claims as well on the data. But the beginning of April, you will know whether we met the primary endpoint and to what extent our therapy is efficient.
Understood. I know. It's a big key thing, a nice catalyst coming up that everyone's looking for. So definitely looking forward to that. Kind of on the backs of that commercialization in the U.S., I know you said 2 months out, you want to have a fully trained workforce. Any idea how many feet on the ground you're looking to target initially? I know you've said previously you're looking to just target, so to speak, high-volume implant centers. But will you maybe try some regionalization there as well so you can kind of train physicians and move throughout? Or is it just going to be primarily just large centers across the U.S.?
It will be primarily large volume centers across the U.S. What is important for us is to have centers that we can match with sleep centers. There, we are learning from what we see in Germany. I mean, the relationship between a sleep center and an ENT center is critical, and trust and how they work together is really, really important. With regards to how many feet on the ground, we are still reviewing strategically those. It will also depend on how the stock reacts to our catalyst and how much money we can put on the balance sheet. So it's difficult for me to give you a precise number now. But this is a number in terms of territory manager, but also in terms of patient care and sleep tech that will enable to cover the top three, minimum the top 300 centers in the U.S.
Okay, so the top 300. Got it.
One important point as well for us is to unlock the market, of course, the experience of the clinician. And for this, having a very strong story, a training and education team, and a pool of proctors that are convinced and know our product. So we're talking a lot about commercial and territory manager, but actually, this group of training and education and proctors will be instrumental for the first experience of the ENT surgeons.
Understood. Understood. So kind of parlaying from what you've learned in your EU commercialization and whatnot, what kind of feedback have you gotten on physicians? Why would they pick, I guess, the Genio system versus a legacy system? What's the key point in what they say, "Hey, this is the reason why we want to do one versus the other"?
Sure. So when we look at it, there is obviously, because it's in the label now, the CCC, complete concentric collapse patients, and the fact that they don't need to do a DISE. But there are also other features that are speaking to them. One is single incision. It's simpler, actually, to implant. And in terms of safety, it's always better to do one incision versus two or three. So that's a big point. The fact that the platform is scalable and there is no battery is a very, very strong argument. So that's what we learned. The implanting technique is actually very different from what they know. But when they are beyond this learning curve, this is what we hear from them. And they also very much like the ability to choose between at least two technologies. It's also something that they appreciate.
When we are in Germany, we see most of the sites we have and the competitor has, they do both. It's very rare that you're only using one technology. That makes sense from a patient preference standpoint.
Got it. And I think you just said there I want to touch on this, the learning curve. Any idea you can roughly give what you've seen from presumably some of the implanters in the DREAM trial and presumably some European implanters have used the legacy system? How long does it take them to switch over and learn Genio? I know it's a single incision. It's a little bit differently than legacy. So how long does that learning curve take, case time, that kind of stuff?
The way we do it is they accompany your proctor first. They see them implant. They also have the whole education and theory on this and they end up with a cadaver training. That's standard. Then we add to this two or three proctoring surgeries. We always ask that when we have a new center, they have lined up the first two or three patients just to have this learning curve and make sure they are doing this with a well-trained proctor. Then they go by themselves. They are past their learning curve. Of course, you always improve your time for surgery and the nitty-gritty. But we see after two or three implants, they are very at ease with the procedure, and it's a single incision. That's the feedback we get on the ground. With regards to duration of procedure, it's variable.
It can be just below the hour. It can be close to 90 minutes. But this is usually the type of time we see in an hour.
Okay. Good to know. And then I want to touch on this quick, the ResMed partnership, two things. One, what have you seen kind of so far? What takeaways has there been? I don't want to say any adjustments, but working out, I would say, the initial kinks as you kind of go through that. And then is there any potential for expansion within EU? Because I believe it is only in Germany at this point.
Yeah. No, you're absolutely correct. So because HGNS and our technology is positioned right after CPAP, it just makes sense if you think about the patient journey that has sleep apnea. They are diagnosed. They start on their CPAP. They are not compliant. Sometimes they go back to CPAP. And at some point, they say, "OK, I'm done. And I want an alternative." And that's where we can position Genio. So that really makes sense from a patient continuum. So one of the things we are promoting in Germany is to speak with one voice, with ResMed, about this, to the society when we are at symposiums and things like that. So it's relatively important. So that's one leg of what we do together. What else do we do? We both have a helpline. They have their helpline. We have ours.
So for them, when they see that the patient no longer wants CPAP, they refer these patients to us. On the other hand, when we have patients that have not yet tried CPAP, of course, ResMed is our partner of choice. We refer back those patients. So this is a natural good business practice. The selling team are working together to create ecosystems of ENTs and sleep hubs that are working together. For ResMed, it enables them to differentiate from the competition that is quite strong in Germany. For us, it is accelerating the treatment pathway and increasing the number of referred patients. So those are really the key points. It takes a bit of time to see this materialized in implants because we started in September, at the end of September.
We always know we need four to six months to see the first patients because they need a PCP. They need to go to the ENT. So it takes a bit of time materializing. But we will see at the end of Q1 the first patients and the acceleration due to this partnership. So that's one thing. We are not yet discussing expanding this partnership in other European countries. Also, it could make sense. One of the key reasons is, for us, we try to be very focused in terms of where we allocate our attention. And for us, Europe and Germany is really our proof of concept. And then our eyes are on the U.S., where we expect 90% of the sales in a couple of years from now.
So that's why we are not yet or we are not going to Switzerland, to Austria, to these countries where we are already reimbursed. We stick to Germany. We do the learnings, and we will apply to the U.S. Now, looking at the U.S. market, we have not discussed a collaboration with ResMed on this. I'm not saying it's totally outside the picture, but we primarily want to go alone. The market will be as well different from Europe in a number of cases. We also think we can, with what we learned, we can have a very strong relationship with the sleep centers in the U.S. as well. So at the moment, it's a partnership. We're learning a lot from it, but it's not expanded in other geographies.
Got it. Very much appreciate that. Sad to say that we are up in time. I really appreciate you taking the time to come and speak today. A lot of exciting data to come out very soon. I know we'll be eagerly watching. Thank you all for attending.
Thank you, very much.