Morning, everyone, and welcome to the Jefferies Global Healthcare Conference. My name is Ashwin Seetharaman, and I'm with the Healthcare Investment Banking team, and I'd like to welcome Olivier Taelman from Nyxoah. Thank you.
Thank you. First, let me start by thanking Jefferies for having Nyxoah to share our story with you. The story of Nyxoah, it's a story of neuromodulation, more specific stimulation of the hypoglossal nerve to treat obstructive sleep apnea with patients suffering from moderate to severe obstructive sleep apnea. I promise it will not be a long presentation. I just would like to highlight and make sure that we have some time for Q&A, for questions afterwards. 7:30 in the morning, flying in from Europe yesterday evening, it stays very early, so I apologize if sometimes I'm looking a little bit for the right words.
Starting with Nyxoah's blueprint for success or the reason why we believe that we will be successful in entering this market, in fact, it starts by, first of all, looking at the market of obstructive sleep apnea patients. It's a huge market. We are talking from a prevalence perspective of more than 900 million people worldwide suffering from some kind of obstructive sleep apnea. If we drill down from prevalence all the way to incidence, and we also narrow down the geographic scope to the U.S., we see that roughly half a million or 500,000 patients are suffering in the U.S. from moderate to severe obstructive sleep apnea and would be eligible for hypoglossal nerve stimulation as a treatment solution. Today, in this field, or yesterday...
Not yesterday, but last year, in the field of OSA with hypoglossal nerve stimulation in the U.S., roughly 30,000 patients have received treatment. There is one company that is holding the monopoly. I think you're all aware of the company. It's Inspire Medical. They did a phenomenal job in introducing hypoglossal nerve stimulation into the space of ENT surgeons, and then they did also all the heavy lifting, convincing the commercial payers, but also the Medicare, to reimburse for this technology. So a lot of credit goes to them. And we at Nyxoah, we came in roughly five, six years after them, and when we start developing our technology, and sometimes it's nice to be second, we start first listening to surgeons interacting very closely with patients.
What we were hearing is that a lot of patients, in fact, were suffering from wearing the CPAP mask, which is still the gold standard. Some of the patients were giving feedback saying: "You know, when I sleep and I start tossing and turning in my sleep, I wake up in the morning with the mask everywhere, besides where it should be." Some other people are saying: "I don't tolerate it. I cannot sleep when I'm wearing a mask." And some others are simply saying: "From a cosmetic perspective, I don't wanna be seen wearing this mask for my bed partner or when I'm traveling with my friends." So there is a clear need for an alternative. Up to 50% of all CPAP mask patients are quitting using their CPAP mask after roughly two years. So that's where hypoglossal nerve stimulation comes in as a solution.
Today, as I was mentioning, there is one company holding the monopoly with a pacemaker platform technology, and when we came with Nyxoah, we were just further exploring what could be a less invasive solution, what could be showing minimum as good of clinical results as is existing. The solution we came up with is called Genio. We do a bilateral stimulation. We do not have an implantable battery, so there is no IPG. It's not a pacemaker platform. There are no leads. Also, knowing that leads can break over time, so we try to stay away from leads. We respect the nature of the hypoglossal nerve by stimulating both left and right, and this will be reflected also in clinical work with a more difficult patient population suffering from a Complete Concentric Collapse.
I think most important, we came with a real patient-centered solution, knowing that a patient would go in the hospital, day hospital, 60-minute skin-to-skin time surgery, only one incision, single incision. Once you have your implant, you don't need to worry about safety. I'm thinking, for example, about MRI, full body compatibility. We have this because there is no implanted battery, and as a patient, you also don't see the implant. The scar is minimum. It's just in the chin fold under your chin. And you also know that over time, you don't need to worry what will happen if your battery will deplete. There is no need for this. It's like an implant for life concept. So that is one aspect. Then, if we see how the technology is controlled, it's all controlled through a wearable component.
We call it an activation chip that will have the battery but also the software. Now, what is the advantage for a patient having a wearable component? First of all, access to the latest and greatest technology upgrades without going to the hospital. We do this cloud-based. Patient will connect to the computer, physician does the same thing, and we can push it through. The latest technology upgrades, a little bit like you do with your iPhones. Another big advantage of having a wearable component is that when you wake up in the morning, there is also direct feedback. There is a patient app. I don't know what is happening with the microphone, but... So there is a patient app. Patient will get immediately feedback, like how long did you sleep? What was your sleep quality? What were the number of events you had?
This is also not only motivating the patient, but also helping the compliance. Just for, we have a compliance ratio of 87% that we measure in this, in our studies, and compliance was measured as using our technology minimum five nights a week and minimum five hours every night. In our blueprint for success, there is a market, a huge market, an under-penetrated market. There is a technology called Genio. We believe it will be disruptive, it is innovative, it's completely patient-centered. We proved this in Germany. We have a commercial proof of concept. I will come back later on this one. And of course, ...
There is also the recent IDE study results of the DREAM study in the U.S., where we are extremely proud that we can say that we also passed all our primary endpoints and secondary endpoints, looking at the study with the most critical eyes being from an ITT, from an intent to treat perspective. So all patients that participated in the study that were implanted, if you look at results, we can say that we passed all our primary and secondary endpoints, including also safety endpoints. Last thing, especially in the U.S., but I would also say in Europe, same, same, same thing is, if you want to be successful with a medical technology, somebody needs to pay for it. And as I was mentioning, our competitor did already all the heavy lifting in the U.S. We have all the commercial payers reimbursing hypoglossal nerve stimulation to treat OSA.
That is one thing, and of course, there is the Medicare and the local MACs that are also reimbursing this. For Genio, we work together with the American Academy of Otolaryngology-Head and Neck Surgery. They came with a proposal that they endorsed, sent to the AMA, and also there, we are really confident that the moment we will obtain FDA approval, which by the way, is expected by the end of this year, that we will also immediately have coverage and can start commercializing in the U.S. and really generating revenue. I think I covered this slide more or less. It's again, on the prevalence and then the incidence. This is how the system is looking like. Also, there I was, I was talking about the implantable component. You see it under number one. It's...
You can see both the left and the right pedal that are put in contact with the hypoglossal nerve, and then you have the body of the device that is completely passive. It contains an antenna, and you will have an energy transfer through induction when patients are sleeping, coming from the wearable component and activating the passive device. That becomes then active, and under number 4, you see the charging unit. So every morning, the patient will remove the disposable patch, the adhesive, and will put the activation chip in the charging unit and will be good to go the next evening. Now, going a little bit through clinical strategy and also studies. As every med tech company, we also started with proof of concept, feasibility study. We went through all the stages we had to do. I just want to highlight a couple important ones.
The first one was the BLAST OSA study that resulted in CE mark that we obtained in 2019. There was another study called BETTER SLEEP. That's the first time that within hypoglossal nerve stimulation, we could demonstrate to be effective also for patients suffering from a complete concentric collapse, meaning both the lateral walls are collapsing. And also there, today, our competitor is contraindicated. We are demonstrating that we maintain the airway open in these difficult circumstances, and that resulted into a label expansion already in Europe and a breakthrough designation in the U.S. We also are doing a long-term data follow-up in Europe. We have now over 500 patients implanted, and we have more than 125 surgeons trained in Europe.
So I think also there, we are seeing that we gain a lot of experience, we get a lot of feedback, and the longest implanted patient is now close to 5 years. If you look at the results or the responder rates, because that's how efficacy is measured in hypoglossal nerve stim, you look at the apnea-hypopnea index or the reduction of number of events that a patient is having while they are sleeping. So when we started with the BLAST OSA study, after 6 months, we were able to show 50% reduction of AHI responder rates. When we went a little bit further, and we included also BETTER SLEEP, we, you see a significant increase from 50% to 64%. What is behind? I think as every very young technology, two major tech components.
1, surgical skills and also being and learning how to position the electrodes, and the second thing is also patient management, post-surgery, making sure they get the correct stimulation settings. If you then look at the DREAM study, now we are looking at 12 months. You also see that it stays in the 64%, 63% range, and that is very effective, and it's also comparable to what the competition has been showing. Digging a little bit further into the DREAM pivotal study in the U.S., the design or patient characteristics, very straightforward. We did 115 implants. It's a pivotal, multicenter, center prospective open-label study. Safety and performance were measured, adult patients, and I think important, AHI range was 15-65.
Crucial in this is that every patient had to sleep minimum 60 minutes or more on their back or in a supine position. Now, why is this so important? When you try to mimic a natural night of sleep, all of us, like most likely yesterday evening, we slept around 35%-40% of the time on our back. I think it's crucial in the selection for a physician when they go for a therapy, that they know that their patient will always maintain an airway opening, regardless in what sleep position they are. We, at Nyxoah, we are the only ones at this moment who have data that we maintain our airway also open with the same AHI reduction percentages, regardless of what position a patient is in. If you look at competition, they have no data on this.
Recently, they published something out of a survey, and there they are showing that the data or the airway opening or the AHI reduction in supine, it's really significantly less. It's 40%-45%. With the Genio, it's 70.8%. So I think that's really crucial also for physicians when offering a technology to their patients. What else can I say? Safety, maybe. A little bit more on safety. This we talked about. So safety and severe adverse events, we had 11, so it's 8.7 SAE ratio in neuromodulation. I think this is really at the low side. Just to give you some reference, if you look at competition, we have 8.7, they have 34%. So I also think this is directly linked to the fact that we have a single incision, not a multiple incision.
We don't need to tunnel under the skin from the chest to reach hypoglossal nerve, and the faster you can implant, the less invasive you are. Of course, the lower is the risk. So we are seeing this. We had the 3 device-related SAEs. Also there, it's more or less in line with what you see in neuromodulation, and we had 3 explants. And when it came to explants, I can be very detailed on this. It was with one physician had 2 explants, 2 x mispositioning of the electrode. First time we saw it immediately, second time it became visible after a month of stimulation that the effect was gone. And I did further examination, the pedals were not in contact with the hypoglossal nerve. So that's what we saw in those explants. And then there was one explant, a very specific case.
It was also after a dental procedure, a severe dental procedure in the back of the mouth, that there, due to the drilling, they touched the electrode and it moved. It was, very exceptional, but when you do a study, you have to report on everything and also this we saw. I can say in the other 500 implants, we have never heard about such a thing, but okay, here in all transparency, 3 explants and 8.7% adverse events. Jumping now from the clinical data, first inflection point to the next inflection point, and that would be FDA approval. We have a modular PMA. We already have submitted 3 out of 4 modules last year. We answered the deficiency questions on the first 3 modules, and now we are preparing or in the final stage.
In fact, it's a matter of days that we will submit our final module containing the safety and efficacy data, but also the label proposal that we would like to make, and we are also getting ready internally for potential FDA audits by doing mock audits already in the different sites. So, end of this year, it's still realistic. We don't control fully the FDA timelines. I know it's an election year, I was told, so if there would be maybe 1 month or 2-month delays, don't shoot me. But if we just respect the timelines, it should be this year, and we will be ready from a commercial perspective to launch also this year. Now, how will we be launching in the U.S.? Also there, as you can understand, I cannot go too much in details.
It's quite confidential, but I do think the highlight, and I can highlight the strategy. First, we are competing against a very huge and strong competitor in the U.S. I cannot highlight enough that we are working in an under-penetrated market, so with 30,000 implants out of 500,000, so we are talking about roughly 5% market penetration. So the pie is really large enough for multiple companies to enter in this space. How will we do this? We will have a really laser-focused approach. We will focus on the 75 to top 100 tier one implant accounts in the U.S. of competition or Inspire accounts.
What we know is that in the U.S. today, you have almost 1,300 implant sites spread over the U.S., of which 300-350 are generating 85% of the total revenue, so it's very concentrated. Out of those 350, we will focus on 75-100, that we pick and choose. We will have a sales team, of course, working with those surgeons. We will have the sales team also working with sleep physicians to streamline a referral path of CPAP-quitting patients and offering them HGNS if they are eligible, if they are the right candidates, of course. And next to the salespeople, we will have a team that will be working with the hospital purchase departments, helping preparing also the healthcare dossiers.
We will have engineers and sleep experts during the implant and also post-implant, following up our patients, because we do believe that that will be crucial, that you streamline a CPAP-quitting patient in need for treatment because he or she is suffering from moderate to severe OSA. We will not invest EUR 100 million in DTC. I can be very clear about this. I think that's something that was the work of the first mover of competition. It was very successful. I think you all have seen some of the commercials somewhere, but in our case, from a resource perspective, but also in our strategy, we don't think that that is what we should be doing.
We will benefit from this awareness, but we will focus on sleep physicians, streamlining referral paths for CPAP-quitting patients, and of course, trying to take market share with the high volume, implanting accounts and the ENT surgeons. We did some market research, independent, asking, "Is there a need for a second company in this space?" The answer was yes. Then we went and we dug a little bit deeper. If there would be a second company, how do you rate, for example, no implantable battery? What do you think about full-body MRI compatibility? What do you think about bilateral stimulation? And I do think that some of the physicians were, at that moment, already guessing what, what company or what technology the questions were asked about.
It's extremely motivational and also gives a lot of confidence in going forward, that the outcome of the survey done by Guidepoint was that physicians see this evolving to a 50/50% market over time, and I think, that is crucial. Now, if we look, and I pushed a little bit too fast, but if we compare this with our commercial proof of concept we did in Germany, we have to know Germany is the largest market outside of the U.S. There are a lot of differences, but there are also some similarities.
From a similarity perspective, we managed to obtain the same reimbursement, same price point, everything comparable, same patient phenotyping, and we are now 24 months after launching, and we saw that last year we had an annual market share of close to 30%, 27%, and we exited 2023 with 50% market share after 24 months. So again, I think this is confirming what the survey is also saying. Physicians are in need or looking for an alternative. They are looking to have an option to choose. There are a lot of patients, and what we also learned is in Germany, we have roughly 60 implant accounts. 51 out of the 60, we have a mixed market, and I think that is also what you will see in the U.S. It's not that you will see Inspire accounts, Genio accounts or Nyxoah accounts.
I do think it will be a mixed account based on the patient, patient characteristics, and then, of course, there will be a minority that will be more exclusive. Last slide. What can you expect from us this year? I think, the second most important inflection point will be FDA approval by the end of the year and a U.S. commercial launch. We are also building further and investing in therapy expansion through complete concentric collapse patients. It's a difficult patient population. It represents up to 25% of all OSA patients suffering from moderate to severe OSA, and there is nothing. I mean, there is nothing. Inspire is even contraindicated for those patients. So we already have the label expansion in Europe. We are working to obtain it in the U.S. I expect this somewhere mid-2026.
The study is ongoing, and we do believe that based on a PMA module extension, we will be able to have this somewhere mid-2026 as well. Commercially, I think we covered. Regulatory-wise, we covered definitely, and then the DREAM data, you saw them, and you also know that there are more data to come from Europe, where we now have more than 500 patients. So we are extremely excited at Nyxoah because getting access to the market in the US is crucial, because that is currently where the big volume is. And in order to do this, we are getting totally focused on the US. To give you an example, yesterday, after my arrival, I was looking for some homes in the US to bring my family over and to put my children in school in September.
Also, how we went through, we are in the last phase of hiring our chief commercial officer. We saw really strong candidates. We have one that is the preferred one. I hope to be able to close this. We have our marketing leader, we have a reimbursement expert, we have our clinical person, our regulatory person, all in the U.S. So it's clear that we want to evolve from a headquartered company in Belgium to a complete US-focused company. Thank you. I think there is no further slide. Cash, I always forget, the most important thing at an investor conference. So we have EUR 44 million cash on our balance sheet. That will bring us till the end of the year. Last week, we raised another EUR 50 million. Maybe you are aware, you saw the press release.
So that will pay for the U.S. commercialization and will extend our runway. We are also exploring some non-dilutive financing, where we will get back to the market also shortly. So with all this, I think we would be able to take away the financial overhang and have cash somewhere till mid-2026, and by then we should have reached our inflection points and already have several quarters of U.S. revenue under our belt. From a institutional investment base, I'm only proud to say that in the last round, we... Fidelity was anchoring. We have Cochlear and ResMed as strategics. We have strong historical shareholders. In Europe, we have the Schroders, the Swedbank. In the U.S., you see the names.
I think, we are well set up to be financed, to continue being financed, and then this will also, set us up for further success in our execution. Thank you.