Good morning. Thank you for attending the Nyxoah Investor Day presentation. My name is Alyssa, and I'll be your moderator for today's call. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers throughout the presentation. If you would like to ask a question, please be at text, excuse me. You may do so by pressing the Q&A button at the bottom of your screen. I would now like to pass the conference over to our host, Olivier Taelman, Chief Executive Officer of Nyxoah. You may proceed.
Nyxoah. As you most likely all have seen, we yesterday published our Q1 preliminary numbers. I can tell you there is a lot of excitement inside of the company. We'll walk you through all of the details during the day. If we go through the agenda, as you can see, it's quite a busy agenda. We also hope that we will be able to provide you with a lot of insights on where we stand, but also, most important, on where we are going and what you can expect. We will start by having some of our leading physicians talking about their experience. Afterwards, we will address the hot potato in hypoglossal nerve stimulation reimbursement. Also there, we were able to have an expert panel in the U.S., reimbursement experts, the JD Lymon Group.
We will focus a little bit more about Nyxoah and where we stand, how do we see the market dynamics, because there is also a lot of activity recently going on impacting HGNS. We will provide you with a clinical update, more specific around CCC. Of course, we will also share our thoughts on how we see becoming a profitable and leading company in the U.S. We have our chairman with us today as well, who will talk a little bit about value creation. At the end I will wrap it up by talking about our mission and our vision and the innovation and how we are and will be leading in going forward. That's, in a nutshell, the coming two hours. After every session, there will be a Q&A.
I think it's better to be a little bit interactive and not having to wait for two hours to ask your questions. With this, I will not take it any longer. I will invite already our Chief Medical Officer, Dr. Maurits Boon, together with Dr. Huang and Dr. Jain to share their physician experience. Maybe let us start by a quick introduction. I think it may be best that everyone introduces himself. Dr. Jain, can I ask you for a quick introduction?
Thanks for having me. I'm Dr. Vikas Jain. I'm the Owner and Founder of Dream Sleep Medicine in Frisco, Texas. A large part of what we do is we manage a wide spectrum of sleep disorders, but particularly manage a lot of patients with obstructive sleep apnea and help them manage and navigate through all of the different treatment options that exist. We have a very large panel of HGNS patients under management. I appreciate you having me here.
Thanks for making time for us, Dr. Huang.
Hi. I'm Andrew Huang. I'm the Former Director of Sleep Surgery in the Positive Airway Pressure Alternatives Clinic at Baylor College of Medicine in Houston, Texas. As of this week, I transitioned to the largest sleep medicine practice in Houston to direct their hypoglossal nerve stimulation program.
Dr. Boon?
I'm Maurits Boon. I'm an Otolaryngologist and Sleep Medicine Physician by background. I joined Nyxoah in 2024 as Chief Medical Officer after an extended career in Academic Medicine at Thomas Jefferson University Hospital in Philadelphia, specifically focusing primarily on treating obstructive sleep apnea and using alternative treatments to help those patients. Just as a little additional background, both Dr. Jain and Dr. Huang have extensive experience in actually using hypoglossal nerve stimulation. Dr. Jain was the first physician in the country to commercially activate a patient, and Dr. Huang has the most extensive surgical experience, having implanted 22 patients with Genio since we had our FDA approval last year. It's an honor to be with you here both. Thank you for being here.
Thanks.
I'll pose the first question to you, Dr. Jain. When you look at all the treatment options that are available, why actually use hypoglossal nerve stimulation therapy at all?
Absolutely. For me, I think, you know, why add this therapy to our repertoire? I think in the past, largely, treating sleep apnea has been a binary decision. You either got a CPAP or you didn't, and those were the only two options that you had. By adding this as an option for patients, we've been able to really personalize treatments. For patients, we've seen an increasing number of consultations that come in week over week, month over month, because patients are now understanding that they have more than one option to treat this condition.
Dr. Huang, given all the experience you've had thus far, what has really been your experience with the therapy and the platform?
I mean, this therapy is the most different hypoglossal nerve stimulation procedure that we have available right now, especially comparatively to Inspire, which we have the most experience with. We started our program in Inspire in 2019, obviously just this past year with Genio. The approach is completely different, the bilateral stimulation equally different. I think having a new approach, having the ability to target both hypoglossal nerves, has made the platform, for me, very differentiated so that our patients have better options, hopefully better therapy. It takes a lot of kind of support from the company, which has been great, to help develop this program for us.
You have served as both a surgeon and a proctor. What's been your experience with the surgical learning curve? As a proctor, what's been your experience in actually how quickly physicians can actually incorporate this and become proficient?
Yeah. That's a great question. I mean, as a surgeon, I mean, I've been in practice for 11 years. It's pretty rare to come across a new procedure. I think some surgeons gravitate to that, some surgeons are averse to that. This is a new procedure. You know, it is hypoglossal nerve stimulation like Inspire, but it's bilateral. The approach is completely different. The way the stimulation is delivered is different. For me, I gravitate to new procedures. I always kind of compare it to how it was, obviously, to Inspire. I have to say that it was a good learning curve for me. It was nice to have Mau there as my proctor to help me get through the procedure.
When I looked at it in terms of timing, my first procedure for Genio actually was pretty similar to my first procedure for Inspire back in 2019. As a proctor, I've been pretty surprised and impressed with the community of ENTs that I've helped, all having good timing with the surgery. You know, obviously having to go through that comprehension of this new approach, but I think as ENTs, we're all, or at least the ones going through this, are up to the challenge.
I would certainly echo that. As a proctor, I've certainly seen that people have been able to adopt this and really incorporate this and become proficient very quickly. To both of you, I'm going to pose the question now. What clinical outcomes have you observed, both objectively and subjectively? Would you be willing to share a patient story that you've experienced?
I'll go first, or?
No, you can go first.
Okay. Yeah. I mean, I think for us, I think, you know, our practice is largely focused both on objective and subjective outcomes. I think in terms of objective outcomes, obviously we're looking at, is there improvements in the AHI, is there improvements in hypoxic burden? I've also, you know, largely been interested in, is this going to fit your lifestyle and the way that you live? For me, the patient that really stands out with Genio is sort of the one that I would say might be you might consider atypical. She was a compliant CPAP user, she was recently divorced. She travels the world as a, you know, as an executive.
She was like, you know, "CPAP works for me, but it just doesn't fit with the lifestyle that I want to live." After we discussed options, she chose Genio. What was great was that she not only just, you know, we saw a robust reduction in AHI and an improvement in her sleep apnea, but it was just the comments that, like, she was able to be more confident when she traveled, she was more confident in relationships, she felt more refreshed daily. Those are the outcomes we're really after, you know, not just does the therapy work, but does the therapy align with the lifestyle that the patient wants to live?
hmm.
Yeah. I'll look at it more globally. You know, we've implanted 22 patients right now. I would say all of them are candidates for both Inspire or Genio. Really it's how that differentiated approach is and why patients choose it. For me, the patients that ultimately choose Genio over something like Inspire are because of not requiring a second chest incision, you know, better MRI conditionality. My most recent patient we implanted is a United flight attendant, and he didn't want to have to go through having the IPG, through the imaging every time, which can be a little bit more of a hassle. There's different reasons, but they're doing it. Ultimately, the outcomes we've been getting are equal or better to Inspire, I've been very happy with that as a total platform.
To both of you, I'll also pose the question. As your experience has grown with the therapy, are there specific patients you consider particularly suited for Genio? You know, how has the actual process of selection evolved in your practices?
I think for us, I think twofold. I mean, one is we certainly look at patients who are having trouble using CPAP. I always find that the best alternative therapy patient is someone who uses their CPAP every night but can only use it for three and a half hours. They're clearly compliant with therapy. They're just not able to use that therapy well. I think we've moved a bit away from obviously we want to make sure that patients meet the eligibility criteria, but really we're looking more at, you know, do you understand what this treatment is, how to use it, will it align with your daily life? You know, we offer all of these options to every patient at consultation so they're aware of Genio as an option. I'm a surgeon. Everybody gets surgery. Not everybody gets surgery.
When it comes to how I discuss this with patients, it's all about giving them the options. You know, we have data on both devices, present the data very objectively. You have to also then describe the other factors objectively. It's not all just about AHI. It's about usability. It's about lifestyle. When it comes to Genio, at least what, like I said, differentiates us and our patients that have chosen it has to do with just, you know, not requiring that incision, the MRI conditionality. Those are two big things that cause people to really gravitate towards it.
Great. Again, to both of you, how do you actually see Genio evolving in your practice in terms of, you know, the future, et cetera, and how you'll incorporate it and how you'll?
You know, again, I think for us, you know, for me, there's 80 million people who are still undiagnosed with sleep apnea. In my experience, most patients don't come to my office because they're worried that they're going to get a CPAP machine. Where we've seen this really evolve is by having treatment options for patients, they're more willing to come in. We're seeing as the treatment landscape continues to evolve, more patients are coming in, you know, it doesn't matter for which treatment. It's just more patients are entering the pipeline. They're getting diagnosed with obstructive sleep apnea, they're looking for solutions for it. This is great to add, you know, to our toolbox.
I think it's an evolving cadence, you know, in how this gets adopted in different people's practice.
I can think from my personal opinion, the cadence has really been, how do I discuss this with patients? How do I make it efficient for me? You know, I was spending 15 minutes per patient talking about hypoglossal nerve stimulation when there was one option. Now I'm spending 30 minutes per patient. It's well worth it. As we incorporate that, for me, as of this point, about 40% of people who undergo hypoglossal nerve stimulation in my practice are getting Genio. That can continue to evolve as more treatment data comes out, as I get more comfortable discussing this with people. This is new technology, new conversations, everything keeps evolving.
Maybe a question for my side as well. When interacting specially with the investor community or even the analyst community, one of the questions that we're always getting is, what about the GLP-1s? You know, they're introduced. There is a lot of debate around, will they enlarge the market, will they increase awareness, will they shrink the market? I also would like to hear a physician perspective in the sense that, what are you seeing in your daily practice? Are you seeing more patients since GLP-1s are there pushing and helping awareness? How do you position this? Do you see a positive impact for HGNS, more of an impact where you see, oh, it could slow down? Just curious to hear about your thoughts on this.
I mean, I love GLP-1s. I prescribe a lot of Zepbound. I think it helps with a lot of other things, not just obstructive sleep apnea. Obviously, diabetes, depression, addiction. There's lots of things that are great about it. I think when I look at it objectively as a treating physician, I look at the SURMOUNT trial data, obviously from Lilly. You look at the average patient that came in. You look at, obviously, a BMI over 35, 20% total body weight loss after 12 months of therapy, all great outcomes. AHI reduction, 50%, great outcome. Average incoming AHI of 50. That means on average dropping to 25, which by AHI standards is still moderate obstructive sleep apnea. I look at it as a way of patients who are coming in who are not good candidates for hypoglossal nerve stimulation. This is a great option.
It brings more people in. They're coming in for it. Ultimately, the majority of them are going to get better, but still be candidates for hypoglossal nerve stimulation. In that case, I'm more than happy to do it. I'm more than happy to see them back, especially if they can't tolerate it or stop using it after a year in their recidivism rate, and then offer them other therapies like hypoglossal.
Thank you. Yeah. I think for us, very similar. You know, again, I think if you look at SURMOUNT trial, a few things I could tell patients. Again, 50% of patients saw improvement, but we also have 50% of patients that don't. They're, you know, if you still have residual sleep apnea, this may still be a treatment option. We've seen that it's been a motivating factor for patients to want to go get a sleep study because they want to see if they can qualify for a GLP-1s. Once they actually identify that they have this condition, we've seen patients more motivated to address their sleep apnea in the kind of, I guess you'd say, in the short term, because again, a GLP is more of a long-term treatment plan.
We can summarize that you see this as a kind of tailwind in moving forward to have more patients also becoming eligible and successfully treated with Genio, to be very precise. Mau, I don't know if you have the last question.
I do.
I'm also a little bit timekeeper.
Sure. I have one final question, which is really, what gives you confidence in Nyxoah as a company and Genio as a device that will be successful in the market, you know, clinically and obviously commercially?
I mean, for me, there's a couple of factors. One, bilateral stimulation I think is important. Having bilateral stimulation of the tongue to open the airway is important for me from a treatment practice perspective. The other is the launch. I feel like there's been a lot more support for us as surgeons to get through and really understand the procedure and do it, which I was not accustomed to or was not exposed to with Inspire, at least in terms of talking with other surgeons. I think that's very important for us as surgeons, not just for adoption, but for comfort and for understanding how this incorporates into our practice.
Yeah. For me, I think there are a lot of innovations in the sleep medicine space. It really depends on I think what matters more to me is implementation. That's largely where I saw a huge difference with Nyxoah. You guys have invested in working with surgeons and educating the surgeons. You've invested in working with sleep medicine physicians. Sometimes we're usually the last ones everyone comes to, but you guys made sure to involve the sleep medicine community from the very beginning. You've been very focused on the patient journey from beginning, middle, and end, and ongoing. What I really appreciate is that sort of the company vision motto is to keep sleep simple. That's been great because I think the more we can simplify this for providers and patients, it makes the whole journey better for everyone.
Maybe building a little bit further on that one, specifically for you, Dr. Jain, also post-implant, you know, like in patient management. What are the expectations that patients are having coming back? Do they want to be, you know, that you call them back every three months? Do they want to say, "Okay, as long as therapy is fine, just leave us out there and we're doing great"? How do you see the role of a sleep physician in this post-implant follow-up? Because I do think it's important knowing what you do with CPAP patients. How would you position an implanted Genio patient in your post-implant follow-up?
Generally, fairly similarly. Even with my CPAP patients, we see them fairly regularly over the first three months, once they're compliant, we generally will see them once a year. With Genio, we give them similar expectations. Once you get implanted, they'll be activated about two months later. Usually, within the first month or two, we're finding a therapeutic amplitude for them. What's been impressive for us is we've been doing awake endoscopies earlier on for our Genio patients, and we're seeing very robust opening of the upper airway. That's great as a provider, and it's very reassuring to the patient as well. Generally, we'll either do a follow-up sleep study, also depending on how the patient's tolerating therapy, we'll start this phase out.
Usually, we see them about once every 6 - 12 months.
Really the last question on this one, because with Genio, we also have already strong results on complete concentric collapse patients. CCC in Europe we're already on label. In the U.S., we are, I will not steal the tongue of our clinical officer. He will talk about the ACCCESS trial. How important is this for you when you have a technology where it can treat successfully both CCC and non-CCC patients? How important is this in going forward?
It's important for us. Our population is generally about 20%-30% of patients with CCC. Of those that are surgical candidates, obviously, they've been kind of at a loss up to this point. This is a great option with that. The second is it could make keeping things simple. If there is nothing off-label for it, the process of drug-induced sleep endoscopy may not be necessary overall, depending on the provider that's administering care.
I think it helps broaden who has access to therapy. Rather than saying, "I'm only going to go look for CCC or not CCC," now we can offer this therapy to a wider range of patients and say, "Look, we see that this works whether you have CCC or not, whether you have positional OSA or not." We know that we can keep this option on the table in terms of a treatment that could work for you.
With this, let's open it up for questions in the room. Q&A session. The online questions might come in, but let's start first with the people that you have in the room. I'm sure you have some questions.
David Rescott with Baird. Thanks for hosting this. I wanted to ask about, you know, patient selection, right? When we typically, from our side, think about, you know, new products, we think about the patients that are out there that you can go out and capture. It feels like, at least based on some of the comments here, you know, as opposed to going from that top-down approach to who you can capture, it's looking at smaller subsets of patient populations from a bottoms-up approach, whether it's the flight attendant, right, who travels a lot, or some other, you know, patients that are out there.
I'm curious to hear about how you think about the difference of, you know, going after or going after, you know, subsets of patients as opposed to, you know, saying, "Hey, this is something that more broadly, you know, is addressable to everyone that's out there." I know that 40% at least, you know, was that mix that you're seeing today. I mean, how do you expect this, you know, mix to shift over time? Is 40% pretty much this bottoms-up number, or do you think that the technology itself is more broadly applicable to all comers that are out there?
I guess I wouldn't look at it like we're targeting subsets of patients. At least the way I try to run my practice is everybody gets all alternative options to PAP therapy. For example, if a patient comes in and they're not tolerating PAP therapy, not complying with PAP therapy, we do a drug-induced sleep endoscopy. We see what they're a candidate for, which if it's hypoglossal nerve stimulation, I present both options. Everybody gets the same options to start out. What ends up happening is there's a differentiating factor when it comes to what people then are told about the objective factors involved, which the main ones for me being in Houston, I guess in Texas in general, where people generally care about their appearance, is do they really want this second incision? Do they want the IPG here, which can be seen to a degree?
Do they want to have to deal with that MRI conditionality, like I said, with the lithium-ion battery? If they don't, then they're automatically differentiating themselves to something like Genio. In the subset type of conversation, then we talk about post-drug-induced sleep endoscopy, right? Then we're talking about, okay, now we see you have CCC. You're not even a candidate for Inspire. Genio is really your only option if you really want to do hypoglossal nerve stimulation. It's more like it's capturing more people into the total population of people looking at alternative options to PAP therapy. At least that's the way I envision it.
Yeah. I think, okay, I don't think that we're looking at subsets. I think, you know, anyone that comes to my office, we're talking about all the treatment options from the get-go because I want you to understand that if you can't tolerate CPAP, that there are other options for you. We know, like, pretty much nationally, doesn't matter which center you go to, at a year, 50% of patients are still using CPAP and 50% are not.
What we've seen is largely once you have the discussion with the patient, they generally will kind of help self-select to if they're a better candidate for one or the other, whereas, you know, we're not always having to be the ones to make that decision because sometimes it is, sometimes it's a question of, like, for example, if it's age, I let patients know, like, if you pick the alternative, you're going to have to go in for a revision surgery every 7-10 years. Do you have a sense of what your health status is going to be 10 years from now? Like, oh, well, if you're worried about that, then maybe we want to consider Genio as compared to the alternative.
Yeah. Maybe on, you know, the reimbursement landscape today, right? It's less, you know, clear than it was a couple of years ago, right? I'm not as much interested in, you know, how those dynamics have played out for you know, in 2026, but more interested to hear about how that backdrop sets up, you know, adopting or being interested in a new type of technology like Genio, if there is, again, you know, improvement in what reimbursement clarity looks like at a certain point in time. Does that maybe open the floodgates more just toward being able to be interested in adopting some type of new technology versus what, you know, you had sort of been using a couple of years ago?
I think the reimbursement thing to me is funny, mainly because I'm not a financial guy. I just cut people. I think when I think about the reimbursement landscape, I think about when we started doing Inspire, when I started doing it in 2019, and insurances were still rolling out and authorizing it, and people still adopted it. So we adopted it kept going up. Insurances started to follow through and more started, you know, having, authorizing it. Ultimately this whole thing, and this is just my outsider looking in, because again, I know nothing about finances and insurance and blah, blah. All I hear is, you know, Medicare was going to increase reimbursement. Everybody just went totally crazy. Like, totally crazy.
I was just like, I don't quite understand because it's not like we were doing poorly before this. Now, like, this number is getting thrown around, the facilities are talking about it, they're all going ecstatic. It's like we were already doing it. Nobody was not doing it. Now we're, like, back to the original, and it's like, I don't understand. We're just the way we were. I don't know why people are unhappy. I'm still doing it. It's still the same.
Yeah. I mean, I'm a sleep medicine guy, I probably don't, I'm not the one billing for these procedures. I think what I've seen in my area is that there are a lot of ENTs that offer HGNS therapy. When you consider how many were treating sleep apnea prior, not a lot because the success rates were not so you could get reimbursed for a procedure that had a very low success rate. Generally, you know, most providers don't necessarily want to utilize those therapies, but now you have, you know, interventions that have higher success rates and are reimbursable. You're seeing a lot of ENTs that have now said, "Hey, I, you know, I want to come back to treating sleep apnea again because now I have confidence that I have options for my patients.
It's also a nice bridge to the next panel that are specialized in reimbursement, and they will definitely go a little bit more in depth. Maybe some other questions from the other side of the room for both physicians? If not, you have been extremely clear, I think. Thank you again for joining us, and thank you for the questions.
Thank you.
Thank you. Let's now make the switch to the reimbursement expert panel. The team from JD Lymon, they will be coming in in a second. I think I'm hearing them coming. Yes, here they are. Joe, Carla, please have a seat. Let me also invite Scott Holstine, our Chief Commercial Officer. Maybe we can start again like we did with the physicians with a brief introduction of yourself, and then Scott has prepared some very interesting questions for you.
Good morning, everybody. Nice to see you all here. My name is Jolayne Devers. I'm a Partner at JD Lymon Group. We are a market access firm based out of Minneapolis and the Washington, D.C. area. My background is that I've been in reimbursement about 35 years. I know that makes me older than most of you in this room. That I've had the pleasure of working for, on the provider side for a while, and then at a very large payer, UnitedHealthcare, for a number of years in reimbursement policy, fraud and abuse technology assessments. Got recruited to Medtronic, and I have spent the last 25 years with my business partner Carla here doing consulting. I am the certified coder in the group. It's a pleasure to be here today.
Good morning. My name is Carla Monacelli, as Jolayne just said, I am her partner. I often say, other than my husband, she is my longest relationship. We've worked together for 25 years. Prior to working with Jolayne, I spent my first 10 years doing government affairs and public policy work primarily in healthcare. Along the way, I think a few things of interest is Jolayne was a gracious partner. I spent 10 years in the medical device industry doing an 80/20 role where I was the vice president global of many startups. What was interesting about that was seeing the inner workings of an executive committee and the trade-offs and interactions between market access, clinical, regulatory. Combined, yes, we bring a number of years of experience. It's a pleasure to be here today. Thank you.
Good morning. I'm Scott Holstine. I only have 28 years of experience in the medical device space, primarily in Class III implantables, mostly in neuromodulation. Most notably with Guidant, which is now part of Boston Scientific, and then St. Jude, which is now part of Abbott, and a couple other small companies in between. I've spent my entire career introducing new technologies to the landscape. The last two years I've spent building out the U.S. commercial team across the U.S., and happy to report where we're at today after our first nine months of launch in the U.S. To kick off this panel, and we just started asking the questions in the last panel, why is reimbursement such a hot topic? How did we get here?
I think it's important that we start with a little bit of history as to how we did arrive here. Many of you may remember that when Inspire entered the market, they used an existing CPT code, 64568. They got an additional Category III code to report that additional lead. They reported those two together. When they converted to the Category I code, the 64582 code, that is when they just had to, they converted to the category II code and converted, quit using the 64568, and then had their dedicated code, right? Now we face this interesting challenge in the market where there's been a form factor change. We've removed that one lead, and now there's questions from providers, questions from the market, questions from industry about how are we reporting this procedure today.
Many believe that 64568, reverting back to that, made a lot of sense. The questions continue, it is beholden to the American Medical Association and the CPT editorial panel's authority with CPT to answer those questions. That's what has been circulating today. What's important to note is that enter in a number of other things. 64582 has been historically also used for other technologies with different indications. What has evolved over time is a differentiation or a bifurcation of costs. The other technologies cost a great deal more than what the hypoglossal space has been in the past. CMS took a look at that, and they said, you know, we don't want to be underpaying or overpaying. Rightly so, they've created these HCPCS C codes for facility reporting. C codes were created.
They became effective in January for the hypoglossal procedures, your insertions, revisions, removals, those kinds of things. They've been priced accordingly, importantly, as parity with the existing Category I CPT codes. Other than the numbers and letters, nothing has really changed. The payers have responded appropriately. They have not opened up coverage policies, but they've added the codes appropriately to the policies so that when claims are submitted, they're adjudicated appropriately. Would you add anything to that, Carla?
I would just add that it's really important to understand that the C codes are for payment for the hospital outpatient and ambulatory surgery center for Medicare, and it does not impact coverage. We get that question a lot, and there's been no change in coverage. It's just a reporting for the hospital and parity. The proposed rule that everybody probably saw with some happiness last week also restated that the C codes are here to stay, and it's not an unusual or an anomaly. I'd add that.
I think that we would expect the C codes to hang on a long time. There has been a lot of history of other technologies. Looking at UroLift, for example, has had C codes for hospital reporting under the Medicare program for a very long time. We could go on and on, but we don't anticipate that to be changing anytime soon.
During the previous panel, one of the physicians or both the physicians were asked how all of this change in reimbursement or the unclarity influenced them, and the general response was, it's been business as usual. They don't understand what this noise is about because they're treating the same patients that they've always been treating at the same rate. Can you speak to why at the physician level everything is business as usual, but at the payer level or analyst level or financial level, there's a perceived unclarity in the marketplace?
Sure. I think that in general, really from a CPT perspective, nothing has changed as of yet. There has been a meeting at the CPT editorial panel where they're trying to clarify that, give more direction in writing within the manual itself to point providers in an appropriate direction of hypoglossal stimulation. That will come out in January, and that will provide a little bit more clarity that providers and coders can point to in the manual because that's one of the first questions we get asked is, well, how do you know that? Well, here's where it says type of thing. They're wanting that. I think that creates a little stir. The shift from the facility reporting that CMS has pulled in, I think, you know, people aren't really sure what that always means. It's not uncommon, certainly at all, but it's new to this space.
There's always questions about what does that mean when you change coding? What does it mean for payment? The answer is there's no difference. They have crosswalked the payment, so there's parity there. The natural next question is, well, what does that mean for coverage? What we have seen there is that, again, payers aren't really very excited about reopening coverage policies. Hypoglossal nerve stimulation is a well-known mechanism of action. They've had coverage policies for many years, but in order to adjudicate claims correctly, they've got to add those to the policies. Again, people can point to something in writing that says, oh, here's where it goes. Now we know how to do that. Payers are able to program their systems to adjudicate claims correctly.
I'm in agreement with you to say, I'm not quite sure why there's so much, you know, uncertainty. The mechanisms are there. They've just changed a little bit, but they're being adjudicated appropriately, and we're just seeing some things being clarified within policies to update current coding situations.
I agree. I don't really have a lot to add other than I think change is sometimes hard for people. Just the nature of change being what it is, it can create a little uncertainty, but we feel really good about the coverage landscape, which ultimately is where the payment, you have a payment established without coverage, that's where things go a little awry. That's not what's happening. The payers spent a lot of time evaluating hypoglossal nerve stimulation, and it's well covered, well documented. While you might see a name brand in a commercial policy, that is also not uncommon as the first to market also leads it, but we're not seeing, as Joe said, revisit. It's a poor example. Just so everybody knows, if they were to make a change, those are long drawn out policies that would not be a surprise.
We don't expect that because they don't like to pick winners and losers in a hypoglossal nerve stimulation. They believe it works, and they're going to cover everybody, we believe.
I thank you for this clarity. We focused mainly now on Medicare. I think it's very clear with the C code for Genio, we have the C8011, as you well explained, and also with the proposed CMS facility payment increase. I think we are even set up to have more motivation also for facilities to continue doing HGNS with the specific coding also for Genio. That's one aspect. We are a young business, you know, just launching in the U.S., Medicare patients are still a minority of the patients we treat. We are talking about less than 10% of patients that are covered under Medicare, and the other 90% are covered under commercial payers. Maybe can we elaborate a little bit on the commercial payers, like how you see this and what was the impact so far?
From our perspective, you all have been listening to me during the earnings calls. We are in a great position. We have the 100% prioritization. Scott and the team did fantastic on this, maybe also nice to hear your perspective, like commercial payers, how do you see this evolving?
With commercial plans, our experience has been that they tend to contract higher than Medicare rates in the implantable space. Those contracts are set based on the CPT codes. With, you know, shifting of chairs, they don't tend to recontract because it's administratively, you know, just a hassle, if nothing else. What we see in those instances is that they will ask or require providers to use existing contracted codes. For example, if they were contracted under 64568, and then there's change to a different code, whatever that may be, a C code or a new CPT code, they may keep 64568 in their contracts and agreements until and unless they open the whole contract to renegotiate. That doesn't typically happen mid-year. Usually during an open enrollment period is what we see.
It is not uncommon for payers to have requirements of specific codes because they're linked to negotiated contracts. We see, really, I think we've experienced, Scott, we've heard some really very favorable commercial payments coming out for Genio. I think it's really optimistic, actually.
I would add a couple of things. I would say, first, the codes changing isn't going to change the contract rate. Just in that simple term, whether it's a renewal or that it could be a one-year, two-year, the rates will be based off of Medicare or the percentage of Medicare they pay above. Then on the coverage side, I would say we conducted a payer ad board about 18 months ago now. Just to put an exclamation point on what I said earlier is they all agreed that the mechanism of action, they saw no reason if payment is parity with a facility setting that they would pick a winner over a loser. That's, they're like, the rising tides and the float the boats. We believe it works. We had six commercial payer medical directors that we talked to.
It's very public information that Inspire is pursuing their own CPT code. What's the timing of something like this?
The next opportunity for them to do that will be for the September CPT editorial panel meeting held in Minneapolis. You're all welcome to come, visit us at home if you like. That would be their next opportunity. If that is positively received, if the panel votes that through, those would become effective in 2028. That is because they have to go through under regulatory process, the RUC, and all of those kinds of things. For Genio, we have been talking, we talked with Nyxoah, we talked with the AAO-HNS, specialty societies play a really important role in the CPT editorial panel. They are advisors. The panel relies on them very heavily for their expert areas because those that sit on the panel are probably a dermatologist, an orthopedic surgeon. They're not experts in this field. They do rely on the societies for that.
In talking with AAO-HNS, the panel had given them prescriptive instruction to address the CPT code set, make sure that there's clarity, and make any changes that they see fit. AAO was clear with us and other industry stakeholders that they intend to start that process themselves. They want to take it forward. They want to be the ones to take a step back and really evaluate the code set from a holistic perspective, not just a single company perspective. They were very clear about that. We have honored that process and respected that. It remains to be seen that agenda, Scott, will come out on Friday. We'll be able to see exactly what's on the agenda and who has submitted. We'll know that a little bit more on Friday, but that's what that means.
Maybe, maybe.
I think I'll make one more quick scenario that I didn't hear. Even if, let's say, that application would go through, remember that the code still exists today. It doesn't orphan Genio in any way. It provides perhaps more granularity, again, introducing another code, but it doesn't orphan the Genio procedure. We still have, you know, 64568, 64582, whatever the clarity will be that will come out for January, but it doesn't change anything here. The panel's very, very prescriptive about not orphaning anything that already exists in the code set.
I would say AAO-HNS is also very strongly in support of that. They are looking for a holistic approach and not to leave anybody behind. We feel really strongly about where we're headed with them.
Yeah. Maybe to elaborate a little bit on that topic, from a company perspective, of course, we also are thinking strategically. It is clear that we want to be very supportive and collaborative with the association, the AAO, at the next surgery department. That's one aspect. On the other hand, we also have strong clinical evidence that could help us in a meta-analysis if there would be a path going for a dedicated code. I just saw out of clarity and also following the advice of experts, we do believe that collaboration is better than, you know, trying to do your own thing. Why am I saying this? If I remember correct, also the previous submission for Nyxoah for a dedicated code for Nyxoah , it was rejected during the editorial panel. Now they are resubmitting this.
Everyone does what he or she thinks that they have to do. Genio. From our perspective, we want to be collaborative. We are well prepared for every scenario, but as the way it's going, there is no risk that we would fall without reimbursement. I think there is absolute clarity from CMS with our C code and even some potential upside. The commercial payers you also addressed. I have one question, and I know that this is also a burning question. What about the physician fee? There's also specific guidance in how to calculate and how to come up with a physician fee. How do you see this and how do you see Genio positioning in this? We have a totally differentiated technology from a surgical perspective.
The CPT codes, again, exist to report procedures, not necessarily technology and devices. Those procedure codes exist today. We will get further clarity, I think, from the CPT editorial panel. The discussion was not to use one code to direct to another. There's always going to be the direction that we leave coding up to the providers. It's their NPI on the claim, and their documentation needs to support use of the appropriate CPT code.
I'm not sure, Olivier, if you were also alluding to. Let's assume the code application is successful, right, for the new form factor in September. It will go through the RUC process, and they will look at similar procedures. Going back to where Joe started in the beginning of 64568 plus the T code was how they billed at launch. I think it's reasonable to expect that the new payment for the new form factor will be in alignment with 64568 on the physician side. A little bit less than where it's at today.
Just for clarity, this is not referring to Genio. It's referring to competition, just for clarity. Okay. Thank you, Scott. I know that maybe you have some further questions.
I would like to have questions from the group.
Perfect.
Be kind.
Yeah, I'll ask a couple. Maybe first, you know, there was an initial submission by your right for coding in the editorial panel. I guess it got rejected, right? Based on your understanding, why could that have happened? Why would that have happened? Two, when you think about, you know, the potential now for September, you know, what would CMS consider when they are deciding whether or not to now decide to accept this new coding? Three, when you think about, we getting to the RUC panel and, you know, what those rates potentially could be versus what we have today, you know, there's, of course, the absence of an IPG, the inclusion of an IPG. Why or why not should those physician reimbursement rates be similar if there's different components to it?
Do you want to answer the panel rejection question?
Sure. A lot of questions there. The panel, I mean, they evaluated, there's five criteria for Category I codes, right? I think this group's probably very familiar with it. Two, at least two peer-reviewed publications with no overlapping authors, no overlapping patients. There was a lot of debate about the new form factor. FDA said it was a PMA supplement, but this is a new procedure. Let's not forget that CPT is about the procedure. There really wasn't a peer-reviewed publication at that time on the new procedure, and there was a lot of questions about that. That is what I believe was a large part of the discussion and the data. If I pull that thread through, if there's a new publication, will it have a better or different outcome in September? Possibly.
Again, we don't know where the society will weigh in, or there's a number of moving parts, but there was a lot of discussion on the data. I think LivaNova also might have a publication out, so that may bolster that, if you will. Then the other part on the RUC, I will say, is that when they go to do the RUC, it will be the AAO-HNS that will do the survey. They develop a list of reference services to look at. Are you more like this, less like that, and the surveys go out. There's no manufacturer involvement in those surveys, right? You need to have enough widespread use in that procedure to do that. Based on what they've said, in some of their earnings calls, they say they've had a number of procedures. I don't see that being an issue.
I would see that being very similar. What was your question about CMS?
Yeah.
Sorry.
When you think about the September panel, right, there's these different criteria that they'll consider to establish a code, you know, why, I guess, do you think that maybe this time, if you do think this is the case, that we'll have enough now data to get that through, meaning that if there was to be a reason why it gets kicked again, now this 2028 potential is a 2029 potential, you know, what would that look like and how would that process play out?
CMS does not have a vote in that process. They have a seat, and Dr. Edith Hambrick has that seat. She's very astute and will definitely be reviewing the literature as well as the other criteria. To be honest, every CPT meeting is its own meeting. If the panel wants to pass it, they'll pass it. If they don't, they'll find a reason not to. It's hard to know. Presumably, if they can meet literature criteria, I wouldn't imagine that it would be difficult to get over the line because I certainly think that their utilization is probably decent.
Yep. Again, I mean, I want to link it to Genio. Regardless of what is happening on that front, there is no risk for Genio that we will fall out of coding, coverage, payment. I think you also made it very clear on that front.
Very clear. Even if there's a new code for, let's say, the new form factor, again, they don't delete others and orphan existing technologies under existing CPT codes. That is a precedence that's been set with drug-eluting balloons and stents and all sorts of things over the course of time. I wouldn't foresee that that would ever be an issue. It would just be adding granularity to the code set.
In summary, we are 2026. For 2027, we don't foresee any changes. 2028, potentially. If not, it would already move into 2029. When we listen to the physician association, the AAO, at the next surgery department, they are more in favor in a more comprehensive solution that will cover everyone instead of having companies playing solo, is this what you say in the U.S., and going by themselves. Is this a correct summary?
That is a great summary.
Thank you.
A few questions from the live feed. Can you talk about the pathway to obtaining a new Category I CPT code for Genio, which I understand you are pursuing? Do you plan to make an application at the upcoming AMA CPT editorial panel meeting in September? What's the level of confidence you will be successful? It doesn't sound like you think the lack of a Category I code is a headwind to adoption. Is that correct?
To all the easy questions. I mean, like.
Yeah.
Okay.
I think I mentioned that we have been working with and talking with quite closely the AAO-HNS, they've made it very clear that their strong preference is that they are the drivers of this. It's very common for societies to take the lead in putting applications forward, particularly when it's Category I. They like to be able to have a little bit of that less biased approach and take control of questions on procedures and technology, literature, those types of things. They've made it very clear to us, loud and clear, very specific. We have honored that. We have not submitted an application for the September meeting. You will not see that for Genio. Again, we'll still have our Category I codes anyway.
One more question from the live chat. Why would Nyxoah push for an approach going for their own dedicated code that goes against the request of AAO-HNS?
I think we are in the wrong room to answer that question. Honestly, I don't know.
I would say we can't speak to.
My crystal ball is a little fuzzy. Don't know.
Everybody has their own reasons inside, I think that is a question for them.
More questions?
Back here, Joe.
Joe, please.
Okay, Joe from Stifel. Just to clarify, if the current submission is accepted in September, would the plan then be, you know, for Nyxoah and Genio to submit a separate submission with the expectation that that would be effective in 2029?
An interesting question, Joe. First of all, we have never chosen the path to be a follower. You know, like, we do believe in our own strength. As we were just learning also, to do a submission for coding, it starts with having the literature behind, having the clinical evidence behind. I can tell you, we do have this. We have the evidence, we have the clinical data. We also will come, and this is also a nice bridge to Jey when he will be presenting our publication structure. We will show you this. In fact, we are in a position of strength in the sense that we can choose. Do we want to submit? We can. We have everything that is needed. Will we submit? We are thinking strategically, as I was saying.
We also want to be supportive, collaborative, and we do respect the opinion of the AAO at the next surgery. Here we are sitting a little bit in a position where we want to collaborate, and we want to have the best intention for the patient, whether it is having a comprehensive coding or a dedicated code. That is the answer. Will we do this? At this moment, I cannot answer this question. Can we do this? Yes, we are prepared in both scenarios. We will make, I think, the best strategic choice at that time. Maybe we can wait until it's rejected again. No, no, I cannot make jokes. No, maybe we should wait to the outcome, what will happen after the first rejection. One never knows.
I want to provide a clarification here because a part of the question was, let's assume that Nyxoah is successful at the September panel. They're going to have their own CPT I code for January of 2028. How does that impact Genio?
It doesn't.
Thank you.
Exactly.
I will just put an exclamation on what you said, Olivier. We are well positioned to make a choice.
Exactly.
We have the criteria in place to do that if it strategically makes sense.
When will the earliest fee that the company would submit for a panel, if we find out it before the code has been accepted in the September panel?
What I would say is that whether Nyxoah's code is accepted or not is not part of our strategy because we have reimbursement in place that's going to stay in place. Our decision to submit a code is going to be in conjunction with the AAO. I believe we would submit that in November for the February meeting.
That's been their strong preference.
Yeah. They've actually advised all the companies, wait until we can all do this together to submit in November for the February meeting, which would then come into play in 2029.
That is correct.
The February meeting is the first meeting. There are three each year for the cycle. February, May, and September would be all of 2029.
The AMA RUC committee would therefore be in?
The September CPT meeting will have a February RUC.
Right. If you submit in November for the February meeting, it's now the.
May RUC.
Of 2027 or 2028?
2027 for a 2029 implementation.
It has to be RUC because prior to rulemaking, because federal statute requires that new codes go through rulemaking. They first RUC, and then it goes to CMS.
Right. The RUC would be in 2027 and not 2028?
Correct.
Yes.
Every CPT meeting has a correlating RUC meeting that follows. If you actually go to the AMA website, there's a calendar that tells you when it's all happening.
Three months after the CPT meeting.
One clarification there, for me at least, is if Inspire is successful, it's Inspire V that's getting RUC'd. It's not Genio.
Correct.
It's just that product. It doesn't impact.
It will be based on the description of procedure that they put in the CPT application.
Okay.
Correct.
Thank you.
I think we answered all the questions on reimbursement. I hope it has provided you with more clarity. Joe and Carla, thank you again for making time to be with us.
Our pleasure.
Thank you.
Thank you. Scott, you stay a little bit for me. Our next topic, we will be digging in a little bit further into the U.S. launch update. I started the presentation by saying you all have seen our press release where we released our global data. For Q2, again, it was a very successful quarter. Globally, we were over the 20% quarter-over-quarter growth with EUR 7.7 million. Since we are in the U.S., I like also to talk dollars. $9 million, another milestone for the company. When we dig into the U.S., because that is where our focus lies with Scott and the entire team. We will start with the leading indicators. We will end up with revenue. We will also be a little bit more forward-looking, what you can expect.
Scott, I think you are presenting these numbers with pleasure.
Thank you. What I call this is predicting the future. I think the last panel reimbursement, we were talking about 2028, 2029, 2030. Let's just start now with Q3, the next three months. You can see on the slide some of the leading indicators that give us confidence that as we go into Q3 or our first full year of launch, that we have a strong confidence in growing at a higher rate in future months, starting with the number of surgeons we've trained. We've trained 262 as of last week, which is 27% over the first quarter. Probably more importantly, we have increased demand for surgeon training for the rest of 2026. Every other weekend, we do cadaver labs across the U.S.
What we've had to do recently is traditionally, we bring in the surgeons on a Friday and we train on a Saturday morning. The demand is so high now that we have to do two sessions on Saturdays. Starting with our cadaver lab next week, we'll do a morning session and an afternoon session. Last year, how we managed the demand was we had one surgeon training on Friday and the other one on Saturday. It was very difficult for surgeons to take the time out of the labs where they work every day. That's why we're doubling up now on Saturdays to meet that demand. We have plenty of surgeons that are already trained to continue to drive the growth into Q3. I think what's more important is that we've doubled the number of VAC approvals in the last three months.
We exited Q1 with 90 approvals across the U.S. Now we have 120 VACs that are approved where we can sell. I think the 123 ordering customers is important because then you can see this leading edge indicator. We already have 180 approved. We have 123 of those 180 that have ordered, which is 60% more than we had in Q1. As we look to Q3, we have a much different momentum than we had in any quarter so far. This is what I like to remind everybody. It's new and it's early. We're encouraged because these numbers demonstrate progress in adoption. If you look at the patient side, we've had almost 1,200 unique patients that have been identified by physicians. Physicians like Dr. Huang and Dr. Jain. They've brought the patients forward as candidates for hypoglossal nerve stimulation.
So fat failure patients. Of those 1,200 patients, we've had 900 consented into our Genio navigation system. This is important to our company because the Genio navigation system is unique to Nyxoah. When a patient consents into our navigation system, they are allowing us to manage their patient pathway. The physician offices like Dr. Jain's that we work with love this because instead of their staff having to work through navigating the patient, the navigation center does that. You can see that's a 62% increase over the first quarter. Finally, and maybe most importantly, since we just came out of the reimbursement conversation, we have 427 patients in prior authorization, which is a 77% increase quarter-over-quarter. When we look at predicting the future of Q3, we're in a much stronger and larger foundation than we did coming into Q2.
Finally, at the bottom, we did a backwards analysis over the first six months. This doesn't include Q2. This is just in Q1. After Q1, the first six months, we had already accomplished a 15% market share in accounts where we had launched Genio since 2025. These are objective measures. If we go to some subjective measures.
I will let you breathe for a second. Yes? No, no, because these are a lot of numbers. You see the excitement. Maybe in digesting this, let me also go back to how we started launching. We started launching with a focused approach. We wanted to be in the high-volume hypoglossal sites. We identified 400 in the U.S. At this moment, you see we're already at 180 where we can do actual treating patients or doing business. Scott started with 25 sales reps. We added 15 in Q4. They were fully trained in Q1. In Q2, we entered with 40 sales reps in the territory. If you then see also all these numbers, I mean, it's impressive.
At least we are impressed what we are seeing and also the feedback we are getting from patients, from physicians, but also from the nursing staff, also incorporating a new technology into their daily business. It's truly impressive and it gives us a lot of confidence. I don't know before we go to the next slide if you have any questions on this because I do think it's important that the numbers are well read and interpreted. If there are questions on this one, maybe it's a good time. David, I'm sure you have a question.
I believe there's a difference between we have the net revenue where there's a difference in gross and net. When we back into what the number of procedures were in Q2 relative to the number of patients that were in or had been submitted for prior auth exiting Q1, it implied that you captured like 80%-85% of those patients that exited Q1. If we have the number for what the exit rate is in Q2, and if you take that same 85% number, it puts you at a revenue dollar in Q2 that's higher than what the consensus models today.
Trying to get an understanding around maybe what the difference could be on the math, if it's because of net or gross, and whether or not it's fair to assume that that capture rate of the exit prior auth submissions is a fair number to assume on a go-forward basis, or just as you scale it should work its way down.
Can I take this?
Yeah, yeah.
It's a great question. The reason why it's hard for you to model and us is because since we're early in the launch and we're getting new VACs and new accounts approved each month, when we have 55% more patients identified by physicians just over Q1, it's hard to model it because we're getting traction and momentum. I appreciate, and you're right when you talk about 80% - 85% capture because prior authorization sometimes takes maybe it takes one or two weeks for approval, but then you have to go through the whole scheduling process. We'll have patients that have approval in Q1 but don't get scheduled until Q3. There's always going to be some carry-through. The 427 numbers are really conservative number, right? Because that doesn't include patients that we might be carrying over.
It's hard for you to model because we're just gaining our momentum. The additional 15 reps that Olivier just referenced, they're just now opening new accounts. We're seeing a broader influx of patients. It's hard to model that. To the physician's point, we have accounts coming on now that have never worked with us, but are high volume, and they're starting at a high volume. I think you're thinking about it the right way. It's just hard to give you the direct number because of the adoption of the therapy. Was there a question from the?
There is a question from the live chat, you may have touched on this in your response, Scott. On average, what is the percentage of prior authorizations resulting in an effective implant? What is the average number of days between prior auth and effective implant?
Yeah. That's hard to model. What I will say is that we to this point, and the numbers are still small relative to Nyxoah, we have a 100% approval rate on all of our prior authorizations. If it does get rejected, it gets through on appeal. Now, the amount of time it takes to get scheduled is variable right now. I can't speak to an average time because it's that broad. To give you an average would not be indicative of what the market's demonstrating.
Also in building a little bit further on this, what we have learned is that there is a direct correlation. Also, we're having feed on the street. Yes. Also accelerating the opening of new accounts. I think the 98% growth is demonstrating this. You also are aware that we recently also financed the company further. I was always saying one of the key priorities in doing this is we would like to add more feed on the street. We would like to invest in U.S. commercialization. With this, and maybe this is a primeur, as we like to say, Scott is already hiring the next cohort of salespeople that are directly the result of our recent financing. We are accelerating this. We will be adding another 15 sales reps. The hiring is ongoing.
We do think that they will also show us an impact already in the last two or three months of this year, and definitely setting us up in a stronger position also for entering 2027. I think we covered the questions on this slide. Scott, maybe also go a little bit more into the patient experience, physician experience that you are hearing from all the physicians you are interacting with.
Yeah. Moving from objective measures to subjective measures, if you will, we've outlined how this procedure and therapy is being responded to by physicians, healthcare providers, and patients. On the surgery side, you heard it this morning from both of the physicians. Physicians want to offer options to their patients. In the early days, there's a lot of physicians that have come to us and they've walked towards us wanting Genio because they want to be the experts in their marketplace. This 88% of providers' commentary came from an external survey that was done where physician decision makers said that they prefer options for their patients. That's nearly 90%. The DREAM study, and Jey's going to talk about our data, but the DREAM study allowed for patients with positional OSA. Those patients are very difficult to treat.
Positional OSA patients were completely excluded from the STAR Trial by Nyxoah, they were excluded from the OSPREY Trial by LivaNova. 70% of the patients in DREAM had positional OSA. They were difficult to treat, but we still achieved great results. That matters to surgeons, and it matters to sleep providers. Finally, this is probably the most important bullet of my time here with you today, is the real-life experience. When these patients are activated and physicians perform an awake endoscopy, they see an airway opening they've never seen before. This isn't coming from me. This is coming from physicians. They ask us, why is the airway opening so much higher and so much broader than what we've witnessed over the last 10 years? It comes back to how bilateral stimulation works.
We're actually spending a lot of time trying to help people understand the mechanism of action on why bilateral stimulation works the way it does. Because seeing is believing. When physicians see this airway opening, they're blown away by how effective the therapy is, regardless of the position that the patient sleeps. On the patient side, it's relatively intuitive, but aesthetically and cosmetically, we have seen younger patients and women in particular who do not want to have a pacemaker, and they don't want to have a lead tunneled up to their chin. Also, think about the technology itself. It's smart app-based. The MRI conditions for Genio are minimal, and they're unrivaled by any technology, not only in hypoglossal nerve stimulation, but in most implantable products, our conditions are minimal.
There's also this desire for patients for an implant for life. That's because our activation chip is the brains to the operation. The average age of patients in all of these clinical studies was mid-50s. These are young patients. They're going to have to think, how do I want to plan the rest of my life? When we can take our activation chip and put it in its charger and have it update just like your phone, they don't have to have a replacement surgery to get the most current device available to them. These are subjective measures that give us confidence for Q3 in particular, but Q4 and beyond. To restate something I said on the last slide, we have surgeon training every other week. We have sleep program.
We have a high demand for sleep training programs, and we're oversubscribed for the rest of the year. The challenge that we have is meeting the demand of new surgeons and new sleep providers who want to work with us.
If there are no further questions for Scott on this one, I would propose a five-minute break, and we are back with clinical data and looking forward on the market dynamics. Would that be okay? Can I just ask five minutes, not make it 10, but please limit it to five, and I see you back shortly. Thank you.
Thank you, Scott, for calling. There's two chairs over here.
Yes. Okay. Thank you. We will continue with part two. Part two, we will cover the clinical update. We have our Chief Science Officer, Jey Subbaroyan, with us. We will talk about market dynamics with our Chief Strategy Officer, Ashlea Mittelstaedt. We will talk about our financial update with our CFO, John Landry. Maybe can I call all three? Jey, Ashlea, John. Jey, let's start with you. We already talked a little bit about the results. We listened to the physician experience, and also the complete concentric collapse patients were coming up. Okay. Switch microphone. Yes. Okay. Jey, from a clinical perspective, what can we expect? Is everything okay? Okay. From a clinical perspective, Jey, what can we expect?
Thank you. Thank you, Olivier, for the question, and good morning. It's a pleasure to meet everyone here. In terms of the clinical update, the best thing we can give at this point is a quick update on the progress that we are making on the CCC indication. Just as you can see, Genio is not currently approved. We have a warning, not a contraindication. Just to give you a little bit of background, why CCC has been challenging endeavor. We have ENT surgeons, sleep medicine physicians here. It's the inward collapse of the circumferential inward collapse of the whole upper airway, right, at the soft palate level that makes it really, really difficult to treat this condition. Currently, there is no good evidence in long-term clinical, high-quality clinical studies.
Having said that, we are finishing the last of the patient follow-up for the ACCCESS trial, which focuses on hypoglossal nerve stimulation, this case Genio therapy for OSA patients. That's next week. We will have data readout before the International Surgical Sleep Society meeting in October. I am pretty confident, based on some of the early data that we have seen in the BETTER SLEEP Study, which was done in Australia about five years ago, and also the early data that we are getting from the EU commercial uptake in the CCC patients, that the data will be strong. We do not have any official data readout, but if we can see these numbers, these are some clinically significant improvement in these patients.
Of course, if you look at the European commercial data, it is small numbers, but about 67% improvement in a small patient group. Our plan remains the same. We will write this up and submit the PMA supplement, as Olivier alluded to in the past, by Q4. We are positive that this will result in some meaningful acceptance of the data from FDA.
Any questions on CCC and where we stand? David? No question on this one? No, because I think it is very important. We have been talking from the beginning when we look at our bilateral stimulation effect, how we completely differentiate it. I think also in our vision, make sleep simple. This is what we mean also with making sleep simple. That when you are a patient and when you are a physician, you do not need to think, is this patient a CCC patient? Is it a non-CCC? Is it sleeping on its side, on the back? All these things. It is supporting also this mission. Jey, I mean, already extremely strong work with you and the team. Sorry that you cannot disclose more, but I think everyone understands why on ACCCESS. From a timing perspective, timelines unchanged. They remain the same.
We submit Q4, we expect also a positive reply. By Q1, we could be adding this to the label in the U.S. to be very specific. Next step, Jey, publications.
Yeah. The data is one thing, then the scientific dissemination of the data is equally important. What you see, there are two main themes if you look at this, right? One of them is there's a heavy focus on generating evidence for actually three main themes on CCC, whether it is through clinical studies or real-world outcomes. That is one. More real-world outcomes. You just see one publicaton from Single Center at Marburg, but there are a couple more that are in works right now. Lastly, we have started trying to understand the mechanism of action better. Let me walk you through real quick. On the left, we have all the publications that are currently being written up, or it is an active review in a journal. The BETTER SLEEP study that has data for both CCC and non-CCC.
You saw real-world data that about 30 patients from Marburg in Germany by Professor Richard Berg, that is currently in review. We just got feedback from the reviewers last week, we will have that addressed, get it published soon, accepted soon, rather. The last one is on the left, it is the paddle design, right? We have developed a finite element model to understand what is the difference between paddle and other modalities of stimulation, what happens electrically within the nerve, and why we are seeing the kind of outcomes that we are observing. Those things have all been written up. They are either, like I said, it is in active review or in the process of submission. To the right, we did talk about the ACCCESS trial. We will write that up.
At the same time, we will finish the CSR and the PMA supplement, and that will go to a high-quality journal. More importantly, now we are actively collecting around 30 patients right now, by my count, real-world data on CCC patients. The idea here is these real-world patients would have been followed up a lot longer than what we have in ACCCESS. In case there is a question or a pushback comes from FDA, we will have data beyond 12 months showing really good outcomes in these patients. The dissemination of this scientific evidence is just as important as generating them.
ISSS for us in L.A. will be very important. We will have a lot of new numbers to disclose specifically on CCC patients. Also looking forward to seeing you there as well and updating you on this. Jey, thank you.
Thanks, Olivier.
For this update. Stay with us. We will move now to Ashlea. Maybe Ashlea, a quick introduction on yourself as well before we jump into the market dynamics that we are currently facing in the U.S.
Sure. I'm Ashlea Mittelstaedt. I'm the Chief Strategy Officer for Nyxoah. I've been working in med device for over 20 years now. Launched quite a few products in the ENT space and other indications as well. I've been with Nyxoah since 2023.
Thank you. Tell us, Ashlea, what is happening in the market?
I would say I love this question. Even under the most conservative numbers, I would say we're still looking at a very large market, huge unmet needs overall, and underserved and underpenetrated. All of those factors obviously play well. With the cloud parting on the coding situation, I think there are some other drivers that we're really seeing play out well in the marketplace, especially for Genio. When we look at what's happening right now, obviously one of the bigger things within OSA is the expanding prevalence. Slow, but sure. In the U.S. in particular, with the rising BMIs and then also the aging population, we're seeing quite a few women come into OSA. This goes really well for Genio because there's high appeal among women, female patients, based on the design of the device and where it sits.
What we're also seeing now with GLP-1s, because of our timing in the U.S. market, we didn't really see the major disruption that some others experienced. For us right now, we're seeing it as a net diagnostic catalyst. It's been great for driving momentum, bringing people into the office, and then obviously with that, exploring new treatment options. For us, obviously we haven't been chasing BMI. We're looking for more interesting and complicated airway options. That's, I think, been an interesting one for us and seeing that definitely as a tailwind. The other thing that we are looking forward to and have already been enjoying is HST reliability. I say this from two perspectives. One is the sophistication of the devices, but also the coding clarity that's come alongside those as well.
When we look at what's happening with HST, this is something that works well with the Genio pathway. We've leveraged that, working with physicians and patients in working in HST as well as PSGs. We are expecting that to continue to open the funnel for patients coming in, both for OSA diagnostics and for HGNS assessment. That's been a wonderful driver, and again, expecting that to continue in early 2027 with the coding there. The last one, which is the one I'm also so excited about from a patient-facing perspective, is wearables adoption. So again, even with the most conservative estimates, we see a very large undiagnosed population in the U.S. Wearables can really unlock that for us. For Genio, obviously we have a wearable as part of our solution, and these patients are predisposed to wearables.
For them, it's a much easier conversation, and it's something that, again, we see as a major tailwind, excuse me, major tailwind for Genio and for the market as a whole.
Before we move to the next slide, I would like to come back to one aspect, the GLP-1s. Why? I was facing, again, 100 questions myself on GLP-1s, but I want to link it actually to more of strategic choice. Also, Jey, you can also share your thoughts on this. It says Genio focus on complex airway openings. We have our cutoff BMI 32. Strategically, Nyxoah always has chosen not to build evidence in going with BMIs 35 and above to 40. Can you elaborate a little bit on why? And then also, of course, what is the impact on GLP-1s and why for Genio this is really a kind of tailwind, where sometimes for others it can be perceived as a headwind? Please.
This is purely my clinical perspective based on this. There are a couple of reasons, right? When we're trying to power a system externally with the higher BMI, it becomes much more of an energy requirement. We can definitely reach, if you really crank up the amplitude, we can. We do have anecdotal evidence we can probably go up to a BMI of 35 and have an impact. We wanted to get into the market before we explore all of these opportunities. The biggest advantage or driver that I have seen based on some of the conversations with the ENTs is, despite the GLP-1s and weight loss and improvement in OSA, these patients still have significant residual disease, one, and now they are within the BMI range of our implant system. It's actually a net positive that we have seen.
The other thing that we hear, and some of the physicians here will agree to this, it's not a one-solution for these OSA patients. It's probably going to be a combination therapy for these patients. Use GLP-1s, bring their weight down, and probably get them on Genio therapy, right? That's something that we have seen that, and again, all the conversations seem to lead to the fact that it'll bring more patients within the treatment pool of Genio therapy that's currently indicated, even without going to the BMI of 35.
Well, that's something.
Sorry. There's one more aspect that we have to think about, right? GLP-1s, the OSA, it's a mechanical problem, right? The GLP-1s can reduce some weight for these patients. Maybe they lose some visceral fat and whatnot, and they get overall healthy, and their OSA symptoms may reduce. The mechanical construct of the airway is not going to change significantly. That's one of the main reasons the residual disease burden for these patients will remain significant that warrants an additional treatment, in this case, a hypoglossal nerve stimulation. Sorry, Olivier.
Correct. Just summarizing this, if you look at the overall therapy penetration, still below 10%. We do think that it's so important that we can treat patients with successful clinical outcomes and that we can make sleep simple by also offering solutions when there are complex airway obstructions. I think that's where we differentiate. Just wanted to point this out. Ashlea, I will let you continue.
Just really briefly, in addition to what we hear from physicians every day, we did some double-blinded research, and we found, again, surgeons value the option of Genio as well as the Genio design. We are seeing very strong adoption intent, and we've been very specific with our targeting, and we've been very successful with that targeting to date. We've seen a strong adoption ramp overall within the space, and we're also seeing evidence that our sleep strategy is absolutely on point. I think one of the things that I'm also excited to see as we hear from physicians and especially patients is you've talked before about the 20% - 25% of patients that refuse other HGNS solutions because they don't want an implanted battery.
What I really like is how we're seeing that play out right now, what we're actually seeing from patients and physicians. I would say, at a really high level, these are some categories where we're seeing patients come into the pipeline that had turned down the therapy before or are now considering it. Number one is patients with aesthetic concerns. This is especially true within the female population, but also with men as well. A lot of patients decline surgery because they don't want to have the visible neck or chest scars, or they don't want a palpable IPG in the chest. We've seen a surprising surge of patients that have come forward that have aesthetic concerns. Obviously, Genio is a great fit for those, single incision in a discrete location. We're also seeing patients come forward from a work environment compatibility perspective.
If somebody is working in a setting where there's potentially interference with active electronics, this is a serious consideration for their career. We have seen patients come forward, example, nuclear facilities workers that are looking at Genio in particular because it's a passive implant. The other one is replacement procedure concerns. From a patient perspective, those very young or very old patients are looking at this as something that they'll have for their life. As they look at what choices they have, Genio was designed as an implant for life. Looking at those potential replacement procedures down the line has become a factor, especially for the much younger and much older populations. I think from the patient perspective, those are the three that are front and center.
When we say patients have declined for the battery design and other solutions, this is how they're coming forward. From the physician perspective, you talked about complete concentric collapse, and obviously there's a lot of interest there. Obviously, expecting to hear more at ISSS. The other one we hear a lot about is MR conditionality. Obviously any patient needing a lot of MRI-dependent care. We've got three torso MRI conditional, three Tesla—excuse me. Thank you—in the torso. Lastly, obviously, position-dependent OSA. Obviously, not a factor with every patient, but it can compound the issues that patients are experiencing with their OSA and definitely a critical factor in the decision-making for their care.
Thank you. Maybe on this one, because before we go into the financial section, any questions so far on the way we look at the market dynamics, the positive view that we are having or we see the market continue growing, even double-digit, but also Genio's unique profile, like Ashlea was highlighting, because sometimes we tend to go only in how can we expound in a CCC population. If you look at the aesthetic concerns, for example, all these things that are really impacting and influencing patients' choices. Any questions from the group on this one before we continue?
Yeah. Maybe one. When you think about, I don't know, five years from now, when you think about the CCC versus the non-CCC patient population, would you expect if there's 100 implants that you have, that there would be a higher percentage of those total implants that are coming from the CCC patient population, meaning that market expansion is more of the piece behind longer-term Genio adoption? Or if CCC is 30% of the addressable patients out there, would it be fair to assume that it's a 70-30 split of non-CCC versus CCC?
Jey, feel free to fill in. First of all, today, CCC is simply contraindicated for HGNS unilateral stimulation. Just by offering these patients also an HGNS solution, it is already a large win and will also have a positive impact in increasing the patient pool because today, 25%-30% of those CCC patients cannot be treated. That is a question. I maybe answer one. Second thing to your question, we also have seen that there is a direct correlation between a BMI and CCC. We see the more that patients are being heavier, also you see the more complex the airway openings are becoming. To that one, we are coming back to what we explained previously. On one hand, bilateral stimulation clearly differentiates itself from unilateral in being effective in opening a more complex or a complete concentric airway obstruction.
On the other hand, there is also the GLP-1s impact that is bringing down patients from a BMI 35 or higher into a segment, let us say, a BMI around 30. Yes, that is the short answer. First of all, by treating something that cannot be treated today by unilateral stim, and yes, by also offering a treatment option with patients where you have a higher BMI. That is our answer. Jey, if I am forgetting something, please.
No, actually, I would definitely, Mau, and I want a surgeon's perspective. Mau, do you?
Well, I would say, number one, generally speaking, physicians and payers do not love drug-induced sleep endoscopy. If some of these things work out positively, the CCC was no longer a warning, but actually indicated, I think it would be a big boost because it would be for physicians not to have to worry about actually choosing this therapy to actually offer to their patients. I will defer, obviously, to Dr. Huang, who also does this, just his thoughts as well.
With CCC patients, I mean, obviously, I think we touched on it before. Obviously, it is, I guess, market expansion is the term you all use. I don't know. It is market expansion in terms of these people were not offered anything before other than maxillomandibular advancement surgically. Adding this is something that is definitely less invasive, less recovery time, and good outcomes. Yeah, to second what Mau said, it does have to do with the population of surgeons who do not want to do drug-induced sleep endoscopy just because it does not fit the efficiency of their practice pattern or the reimbursement that they would like to have from these outpatient endoscopic procedures. That would open up the market, or at least open up more surgeons' probably perspective on wanting to adopt something like this in a practice.
Thank you. I hope this is answering the question. Any questions from the online audience? No? Okay. We can continue, and we will now turn into more of the financial aspect. John, thank you also for joining us on this one and also sharing your view on the path to profitability and, of course, starting with the recent raise that we did.
That's right. Thank you very much, Olivier. For those of you who don't know me and haven't had the pleasure of meeting, my name is John Landry. I'm the Chief Financial Officer here at Nyxoah. I joined in the fourth quarter of 2024. This is my third medical device company. I started my career in public accounting and probably at the risk of dating myself, I started with Coopers & Lybrand before the PricewaterhouseCoopers merger. At that point, I audited mostly hospitals and manufacturing companies. When I moved away from public accounting, medical device was a very nice marriage of the combination of hospital healthcare and manufacturing. It's a nice transition into the medical device space. I've been here for over 20 years now. Again, third medical device company.
The first two medical device companies I joined were in a very similar stage to Nyxoah when I joined the company. We had about $5 million in revenue in both of those companies, and we were fortunate enough to grow both of them up over S100 million, still going strong today. When I joined Nyxoah, I saw a lot of the hallmarks of those two companies in Nyxoah, very specifically, great technology and outstanding patient outcomes. I think the combination of those factors will allow us as well to get to $100 million in an accelerated fashion. One of the things, turning now to the slides, as we talk about the path to profitability, it's one of the things that Olivier and I talked an awful lot about is how do we get there and how do we get there quickly?
When you look at the path to profitability for us, the annualized revenue break-even point for us is EUR 150 million in revenue to get to break-even. What does that represent in terms of total market share? When you look at the total market share from an HGNS perspective in the U.S., it's about 15%. As you think about the 15% level, recall from a slide or so ago from Scott, when we looked at the initial six months' experience that we had in the U.S., we've seen about 15% in those accounts that we've seen to date already. If you look at some of the commercial pilot experience that we had in Germany going back a couple of years, within 18-24 months, we were also at 20%-25% market share within an 18-24 month period of time.
When you look at that gives us confidence that we can achieve that revenue break-even point within a relatively short period of time. Another key to this path to profitability is gross margin. We need to get our gross margin to scale at 80+%, and we have a very defined pathway to get there with two key drivers. One is our Genio 2.1 device. That Genio 2.1 device will have a new activation chip as well as a new disposable patch. Both of these are redesigned for patient comfort first, and then also to reduce the cost of the device dramatically.
We're going to take about 90% of the total cost of that disposable out of the cost of the product overall, which will allow us to step function our gross margins from the low 60s to low 70s when we roll that out in the first half of 2027. Additionally, another key driver is around our volume discounting. We have a contract manufacturing agreement with a manufacturing firm here in the U.S., and we have predefined volume-based price points in that contract. As we drive volume through the contract manufacturing firm, we'll see another step up in gross margin to get into the low 80% range. Those are two very key drivers that will get us there. They're very defined, they're very tangible, and we have pathways to go out and execute upon both of those within this timeframe.
Another item on the bottom left-hand of the screen is our annualized cash operating expenses. We want to maintain tight financial OpEx discipline throughout the organization. What we've done, a couple of things. One is we've taken a look at our operational expenses and then redeployed operating expenses from parts of the business that we needed to grow and scale in order to get to commercial launch. Now that those projects are done and behind us, we've redeployed that capital to our U.S. commercial organization to help grow the business faster. We're going to continue to do that and redeploy capital from parts of the business where we can leverage what's been built and then go drive that into faster growth.
That will allow us to grow our operating expenses at a modest rate, kind of mid-single-digit rate on an annual basis, while allowing us to go out and expand the U.S. sales force and drive additional top-line growth. Again, tight cash OpEx management will be a key to getting to that path to profitability. The last, as Olivier mentioned, the financing. Very glad to have that behind us and get that done. A special thanks to our board member investors who participated in the financing, the existing investors who invested in the round, and we welcome new investors who came into the capital structure. It's a great show of support for our organization, for our technology and our opportunity that we have out that's laid out in front of us. Very happy to have that behind us.
That gives us the cash to get to profitability and to get to cash flow positive. That's very important because that allows us to go out and focus on the business, focus on executing our strategy, and building a very strong business here that's profitable and can continue to scale. That's path to profitability. The next slide that you see up here is just a graphical depiction of what that looks like. It compares and contrasts two things. One, it compares and contrasts our 2026 guidance as laid out from a revenue, gross margin, cash OpEx perspective, and the operating result. What you see in the pale-colored bar graph side of the chart, then you have the teal colors, which represent what this path to profitability looks like at EUR 150 million of revenue with an 80% gross margin and OpEx of EUR 105 million.
You can see that we go from a negative operating result to a positive operating result at that level. Excuse me, one of the keys there is, again, gross margin and the OpEx and managing our OpEx to be able to drive continued growth and knock that operating result in the opposite direction. A key element that you'll start to see in our financial statements as we publish on a quarterly basis is our cash burn will start to come down. For the first quarter of 2026, we had cash burn of approximately EUR 22 million. With the cash balance that we presented here in the release, if you adjust for the cash that we raised, our cash burn was about EUR 19 million.
I would expect to see that continue to decrease quarter after quarter by roughly EUR 2 million-EUR 3 million per quarter until we get to break-even and then positive thereafter. This is really something near and dear to our heart. We want to get there because we want to be a self-sustaining business, and we want to make sure that we can use the capital efficiently to drive top-line growth and maximize the value of the organization, especially since we'll be based on multiples of revenue here until we reach that profitability stage. Those are the metrics that we have here on the path to profitability pathway. Now turning to the next slide, you can see, I think we touched upon some of these.
I'm not pushing. I want to pause for a second.
You want to pause too.
I know this one and with some of you, we had also some interaction, some discussion on this. I want to ask questions on this part because we can explain this, but on the other hand, you also need to believe what we are explaining and to feel trust behind this plan. I think it's a good moment to have this conversation since we're here together. Any questions on this part to profitability?
I guess I'll ask one.
Yes, please.
I feel like when we look at other similar stage medical device companies in the past several years where that profitability or break-even level hits at EUR 3 million-EUR 4 million, EUR 500 million in sales, right? EUR 150 million, of course, is a lot sooner than at least what we have seen in the past. I guess what gives you the confidence that the level of spend that you expect at the year in which you get to EUR 150 million relative to that number will still be able to support growth on a go-forward basis and EUR 150 million is kind of the right number?
Sure. A couple of things, David. One, I think as we take a look at the strategy that we deployed in targeting the top 400 accounts in the U.S., that allows us to be capital efficient with our sales organization. Going into those accounts where the top 400 accounts represent 70%-75% of the total HGNS opportunity. By being concentrated in those accounts, that again allows us to be capital efficient in that regard. Then the second area we'll be capital efficient is in regard to DTC spending. When we look at our competitor, they spent a significant amount of capital in terms of drawing people and patients to the top end of the funnel. They did an outstanding job of making HGNS awareness grow over time, which we'll now be able to capitalize upon.
Based upon some of the early lessons that we've learned in Germany and in Europe in terms of how to manage that DTC channel and how to make every EUR count and be optimal and efficient in that regard, that will allow us to drive the patients in the top end of the funnel, allow us to generate that growth, and do so in a way that's economically efficient to allow us to get to that break-even point faster than our competitor did. That's how we're thinking about that.
I think maybe in addition to this as well, sometimes it's nice to be second to the market. What I'm trying to do this is that you can accelerate. You can go much faster. Take, for example, the reimbursement aspect that we covered. We just launched a technology. We have reimbursement in place. We got a good payment. It took Inspire five years to get to a point where they had coverage from a decent amount of payers in the U.S. to start generating revenue. I do think if you follow the calculation, that the calculation as such makes perfect sense. In the modeling, it's more about the timeframe. How fast can we get there? We touched on the 15% and seems to be a kind of magical market share number. Why is this 15 so important?
If you look 2026, the projections or the revenue expectations for HGNS are between EUR 850 million-EUR 875 million. In going forward next year, I do think we will be touching EUR 1 billion. If you are touching EUR 1 billion and you want to have EUR 150 million to get break-even, it corresponds with the market share percentage where we today are feeling confident listening to Scott, seeing how we are ramping up and seeing also the excitement with physicians and with patients that we are capturing. Again, how do you say this? The proof is in the eating of the pudding or in the pudding? It's something with the pudding. I just think by showing continued execution, delivering quarter after quarter and ramping up, that will be the best way also in moving forward to convince everyone that we can reach this point pretty fast.
There is one question coming from.
Yeah, it's one from the chat. Some analysts note that to reach break-even, Nyxoah would need to capture 40% of the incremental HGNS market. Do you agree with this?
I will let John answer, but I will say no. I don't agree with this. Please say no, you will understand in a second.
Sure. I think there's a couple of different ways of looking at it. One way to look at it would be to say, okay, there's a current market now, then you need to capture an additional growth, which would be the 40% calculation. How we think about it is we're going into existing accounts, we're going into existing books of business across the U.S., again, very focused on the top 400 accounts. As we think about gaining market share, we're going to gain market share in those accounts very specifically. We're not going to be looking at the growth in the market overall. For us, that's how we're calculating the 15% market share opportunity as the baseline for our revenue target here of EUR 150 million of revenue.
Yeah. That's exactly what we are seeing today. The patients we are capturing, the ones that Dr. Huang and Dr. Jain were referring to, those are patients that normally would get the Inspire implant. Today they're getting the Genio implant. Our success will not be defined from the new incremental patients and how strong we are there. It will be defined from the total patient population that gets an HGNS implant. That's why I was saying no.
A second question. Footprint expands rapidly. Do you expect future revenue growth over the next several quarters to be driven primarily by opening new accounts or by increasing implant volumes within your existing mature accounts?
Yeah. I will take this one. I know that Scott is also having an opinion on that one. It will be a combination. Yes, it will be a combination. Scott, maybe you want to elaborate a little bit more on where you think will be the acceleration short term and how this will.
This is on. It's clear it's going to be from the initial hires because there's a 6-12 month startup time that's not going to change. We still have to get into new VACs. We still have to train new surgeons. The growth is going to accelerate from the accounts that we've already penetrated because we've built a referral pathway in those accounts. We've built comfort with the surgeons in those accounts. They're seeing great results with their patients. The referral rates are accelerating for Genio from the referral in existing accounts. Our initial cohort of hires have really, what I call, walked through the desert of getting us to this point of proving the concept to U.S. physicians and they're adopting it at a high rate.
We still need to scale soon because we have to get those reps deployed so they can start the VAC process and start the surgeon training in the new accounts. It's a great question. The bulk of our growth and acceleration is going to come from the people who've been here the longest.
Perfect. Last one from the chat. You reported 180 active high-volume U.S. accounts and 427 patients in the prior auth process. Beyond these encouraging leading indicators, which operational KPI should investors monitor to assess whether these accounts are successfully ramping toward mature productivity?
I like the leading indicators that we presented. There was a question earlier about how can you map forward the prior ops in particular? What percentage of those can you map forward? I think that's the primary indicator for us is who's in prior authorization and how quickly can they be scheduled. Because it is still very early for us, that is a moving target. What I'll be focusing on moving forward is exactly what I presented today.
Okay. Thank you. Joe.
We have a question here.
Sorry. Sorry, Joe.
I just wanted to follow up again quickly on the EUR 150 million. It's kind of two questions. I think on the prior slide, it said that it was predicated on an assumption for 15% market share. I know in Germany where it's obviously a duopoly, I think Genio has hovered around 15%-20% market share. I think earlier today you said that in totality U.S. centers where Genio is being implanted, it's been 15% share. There's another competitor supposed to come to market in the coming, call it, six months plus. Is your assumption for 15% share that when they come in, their share of the market would be entirely out of Inspire's pie and you'd be able to maintain the 15%? How do you see those dynamics working out as it relates to this pathway?
Yeah, it's a good question. I think from our perspective, we expect to gain market share and still be at the 15% level in these accounts and continue to growing. Another factor that, as we look back at the Germany experience, the Germany experience before we entered into the market when it was just a monopoly, the business was growing roughly low double digits in terms of growth % on an annual basis. Then when we entered the market, the growth rate in the overall HGNS market moved to like the 25%-30% range. With more players in the market, we'd expect to see growth increase as well. We expect, based upon the results that we're seeing and the patient outcomes, we would expect to see that market share for us continue to be there and continue to grow over time.
Yeah. Maybe in addition to this as well, we also showed that the current HGNS penetration is not even reaching 10%. It's a huge pie. We do think, to John's point, when you have no monopoly, you go to duopoly, there's a third company coming, that this will only help drive more and a faster market growth for HGNS. That's one aspect. Second, we have the tailwinds from the GLP-1s where we also see that the awareness increase, more OSA patients. No, maybe just focusing a little bit on HGNS and on LivaNova. Since this is touched as well, from a technology perspective, this is another pacemaker solution where Genio is totally differentiated and that's also how we position.
We do think that within the pacemaker solution, there will be a competition between both companies where we see Genio as more the unique, totally differentiated approach. To answer your question, we want to capture 15% market share of HGNS as a total.
Okay. Great. If I can just sneak in one follow-up. I believe you said, John, that I will give this question to John. I am not sure if you can affirm, obviously, timeline on this EUR 150 million bogey. Based on what you said, EUR 2 million-EUR 3 million reduction in OPEX per quarter, I think if I am just doing back of the envelope math, to get to the break-even point would be seven or eight quarters, call it, at the midpoint of that range. Does that sound reasonable for your expectations?
Yeah, just a quick clarification. The EUR 2 million-EUR 3 million is a reduction in cash burn, not cash OPEX. Yeah. Cash burn. We would see that. That is in the near term. We are talking like 2026 type of timeframe. As we see 2027, they will probably grow. That reduction in cash burn as our revenue growth grows. We will see that reduce. In terms of that timeframe, certainly not going to provide guidance as to when we are going to be at the EUR 150 million today. From in terms of timing, it is not too unrealistic from a calculation perspective as we have discussed.
Yes.
Yeah. I have a question related to the market growth side of things, I want to come at it in a little bit different way. Not to put words in your mouth, it seems like at least for the next couple of years while you are a little more capital constrained, you are really focused on taking share rather than investing in the way that the market leader may be in growing the overall pie. I am curious if that calculation changes at all, not only once you cross over into being cash flow neutral until you are a little bit less capital constrained, but also if Inspire reimbursement does become decoupled from yours, is there a concern at some point that the differences in procedure and differences in reimbursement become so stark that you have to start doing market building of your own?
Also once LivaNova comes into the market, just how you think about all those different dynamics and how much you as a company need to invest in growing the top of the funnel versus the more targeted approach.
Yeah. I think from my perspective, what we want to do is we want to get to profitability because at that point, we have control of our own destiny. While we're managing our operating expenses tightly, we're also investing for continuous growth. The investments that we're making today are going to allow us to have continuous cycles of growth beyond the point of profitability through new technology introductions, through clinical differentiation. Those will allow us to separate ourselves in the marketplace and allow us to have those next legs of growth and provide that engine to continue to grow at a larger than typical rate going forward. That's how we're thinking about it. The investments that we're making today, we're not cutting those out. We're planting the seeds for future growth and we'll continue to do so and drive going forward.
That's how we're thinking about it. In terms of some of the items that we're looking at, wearables is something that is a key item, incorporating artificial intelligence as well, having smart technology built into the device to help improve the patient outcomes even further and differentiate even further. That will allow us to continue to gain market share, allow us to continue to grow our business, and continue to have those continuous cycles of growth once we get to that break-even point. At that point, I think our philosophy is we don't want to take the cash and take the profits and just build buildings or invest in non-revenue growth generating opportunities. We want to continue to invest in innovation in clinical and in people to go drive the business further and drive further adoption of our technology.
I think we have a nice pathway to do so.
Yeah. Practical applications of this that we discussed today as well. If you look at you ask about traditional market development or market growth drivers, we haven't presented the ACCCESS data. If you look at the percentage of patients that have CCC, that alone has the potential of growing the market more than our competitor can grow it through advertising, number one. Number two, through what Dr. Jain offered earlier today, these options and it's not just Genio. There's options across the sleep space are naturally bringing more patients into sleep physicians already. I would argue that with the technology that we already have and the clinical data that we already have, we have the potential to grow the market higher and faster than our competitor. The fact that there's an explosion in the sleep space of interest in options, the patients are already coming in.
Yeah. Since we all want to say something on this and we're all saying more or less the same thing, also from a business rule perspective, we are giving a guidance for 2026 reaching EUR 36 million-EUR 40 million. If you look at competition, they are at EUR 850 million. I think it is obvious also that they play their role and invest more than we are doing, just entering. That is one aspect. Second thing, we broke a monopoly. Please let us not forget this. We broke a monopoly and we provided optionality. We trust the physician will make the correct choice what patient will benefit best from what therapy.
In a market that is so underpenetrated where there are so many patients, I mean, only this will already give us a lot of tailwind in growing before we are even thinking in investing in a specific type of patient that we would only own. That's the second aspect. Then to Scott's point, with our technology differentiation, take CCC, I do think that is a huge expansion of all the pooling going forward. If you combine all those things, we are the challenger. We are entering the market. We are completely differentiated. We also see that we can unlock the patient pool already in the CCC indication. I think and I hope this is answering your question. There seems to be one more question.
One more question from the live chat. Could you explain the slight difference between the 22% sequential growth achieved in quarter two and the 25%-30% sequential growth you had guided for?
Yes. Yes, we can. It's a little bit, how do you say this? A silly explanation that I have to give. I had the question yesterday even before as well. I will give you an honest answer. What happened? We are still a scaling company. We received our last order, I'm looking at Scott, on June 30. Unfortunately, there are not 31 days in June. It were 30 days. As a small company, there is a person who needs to pick the product. There is a person who needs to ship the product before we can recognize the revenue. We were not able to do this last order in a timely manner. I mean, it sounds like a BS reason if I can say this, but this is what actually happened.
If we would have converted that order, we would be at 27% growth. Today, we are at 22%. Yes. That's what it is. Will it happen again? No. It happened. That's where we are. I hope also when you look at the leading indicators and how healthy the business is, that this will not be the argument that will be the key takeaway of this investor day. At least that's the honest answer. John.
Okay. We just touched upon the preliminary results for the second quarter. You can see our revenue for the second quarter at EUR 7.7 million, EUR 5.2 of which came from the U.S. The 22% mentioned quarter-over-quarter growth. We had EUR 2.5 million in our international business. Our international business continues to grow nicely, as does our U.S. revenue on a sequential quarter-over-quarter basis. When we look at this year-over-year for the first half of 2026, we booked about EUR 14.1 million of revenue. That compares to about EUR 2.4 million in the first half of 2025. We almost have fivefold increase in terms of what we've been able to do in terms of growing the business on a year-over-year basis. That's an outstanding outcome and testament to both our U.S. international sales representative trying growth on a worldwide basis.
As we look at full year 2026, we are continuing to reiterate our guidance for the full year of EUR 36 million-EUR 40 million for the full year. With the delta, the 22%-25%, as Olivier explained, we have orders in hand, product out the door. We're confident in that number. Now, well, as some people have pointed out, that provides us with a little more we need to deliver more growth in the back half of the year because of the second quarter result. We're very confident that we have the orders, we have the pipeline, we have the backlog to be able to do that. Very specifically, when I speak of backlog, I'm thinking about those number of patients that are in the pre-authorization process, the 427 patients that are in pre-authorization.
That grew 77% in the second quarter versus the first quarter. From my perspective, I feel very comfortable that we have a good play in place. We have the patients in the funnel in the pre-authorization phase that will allow us to generate that revenue growth in the back half of the year that we've outlined with this guidance here. Again, our preliminary cash balance was EUR 98 million. Again, thank you to our existing investors, new investors, and our board members who participated in the round. I think that brings us to a conclusion on the financial slides. I'll turn it back over to Olivier.
Yes. No, no, it does. John, you also set it up for a nice bridging in going forward because we're almost reaching the end of the investor day. There are two more topics that are coming. It's the value creation aspect. Today, we have the pleasure of having the founder of the company, but also the current chairman of the company, but also the single largest investor of the company. That's 15% investment or ownership in our company with us today. It's a pleasure to have Robert also. He will explain his vision and also in how he sees value creation. The last slides will be for me and also talking about the vision and the mission going forward. Robert.
The microphone working?
Yeah.
Does it work here? Yeah. I'm Robert Taub, indeed the Founder and the Chairman of this company. I can say for sure that I'm the most senior person in this room. I'm a serial entrepreneur. I'm Belgian. I've lived in New York for a while also. I have, yeah, more than half a century of experience in healthcare. We have managed it wasn't so easy, but we managed to put together this capital increase. We've reduced the OPEX together with John and Olivier. We worked a lot on that in order to achieve or to reach all the figures that you have seen. I'm not going to repeat all of that. Yes, the whole thing is about value creation. Right now, our focus is on the U.S. commercial execution and that we want to be the leader in HGNS in the United States.
Well, actually also in Europe. Clearly, there is a huge challenge for the company in general to recreate the trust that we have lost with the Street. That's clear. This is not going to be done easily, but we will execute quarter by quarter our 25% growth or more. It will take many quarters in order to recreate this trust, but we will be there. At the same time, we will continue to look very carefully at our OPEX in order to manage, if you want, the cash that we have and that we will never have to raise money again because this was a painful, obviously, very, very painful exercise last time. However, by managing this cash, we also have to remain innovative because, yeah, the focus is, of course, for Scott to deliver his quarters one quarter after the other.
On the other hand, we also have to maintain our leadership in innovation. Now, I have to say that there's a lot of technology that is available in the company which has not been exploited yet and even in the activation chip. Because all of this can be developed and is even available in the activation chip but not used at this stage. These are some of the things that we will be able to develop without too much money in the wearables. We're also looking at, of course, other technologies. We will be very, very tight on the cash. Focus for the next 18 months is the launch. To quote a bank that has shown us some statistics, we have Nyxoah is in a perfect situation. I mean, the total addressable market remains huge, as you know.
Only in the U.S., you have 500,000 new patients eligible for HGNS every year. The total addressable market continues to grow. We have gross margin, as John has explained, at the moment, we do not have yet this 80%, but we will get there. We know how to get to 80%. The growth in general will be 25% quarter by quarter. If we compare this to the 150-odd MedTech listed companies, there's only about a handful of them, maybe a little more than a handful, that will meet all of these three criteria: gross margin above 80%, a total addressable market. I'm talking about MedTech company, but also some hybrid companies that are. Of course, the growth, the annual growth, which we will be exceeding at least in the first three to four years.
If you want, that is the way I see value creation. Now, I will not avoid, of course, speaking about the CEO transition because that has been, of course, a question that has been asked, etc., etc. Yeah. I mean, the growth of the company and the success of this company will be in the U.S. We made the decision together with Olivier that we will have a U.S. CEO and a U.S.-based CEO, but also an American CEO. We started the search only, what is it, five weeks ago or four weeks ago. It's going to take still some time, but everything is set up that by, let's say, latest the end of the year, we will have a new CEO, possibly earlier. We're using, of course, a headhunter. That's in a nutshell what I wanted to tell you.
I'm open to questions. I invested quite a bit in the company from the very beginning. I continue to believe that we will get there. Any questions? Okay, Olivier, go back to you.
No questions. Thank you, Robert. Please stay with us because I will now do my closing slide. We will open it up last time for the entire management also for questions if there should be any. I think you heard today a lot of interesting presentations, different perspectives from physicians all the way to reimbursement experts, also to the company view. When I talked about tailwinds, we're talking about structural tailwinds for the obstructive sleep apnea business in general. I mean, it's a quick recapitulation. The addressable market underpenetrated. Robert was just mentioning 500,000 eligible to treat patients in the U.S. alone. I mean, today, more or less 40,000 are getting treatment. If you look at the GLP-1s, a lot of words have been discussed on GLP-1s. I think by now you understand our view.
We see this as a catalyst. We also know that it will drive more patients. It will increase awareness. Reimbursement, Joe and Carla, thank you for providing further clarity. I hope that the dust has been settled, as they say in the U.S., on this reimbursement. There is reimbursement. There is a coding. Yes, there is an evolution, but there is no reason to be thinking or considering that we would be out of reimbursement. On the contrary, with the latest CMS proposal, I think it's even more beneficial. Optionality, also to Ashlea's market research that was done, 88% of providers, and that's physicians, both sleep as ENT surgeons, they want to have an option to choose. There is not such a thing as one technology that fits everything and everyone. We broke this monopoly.
Also, we are seeing in the commercial results in the U.S. that this is all the right way. We are really well embraced by physicians as we are by patients. Now, in going forward of vision, one OSA ecosystem. I like to use the buzzword of ecosystem because I do think today OSA is part of chronic disease management. It's not something that you do, and then six months later, I'm cured. You're not cured. You have to stay disciplined. You have to stay compliant with your technology in going forward. When it comes to compliance, we're always talking about patients. You can have the best technology ever. If a patient is not using the technology, it's useless. As simple as this. We do believe with Genio that we are the best positioned company. We have a smart wearable.
We will be investing short-term in making everything cloud-based. When you do cloud-based, you also do telemonitoring. You will have physicians that can see how are my patients doing that can also act upon this. But you also have patients that will get live feedback on their sleep quality. I am wearing a WHOOP. I think some people are wearing an Oura Ring. Also, in going forward, we see how important it is today. People want to control their health. They want to know, "How did I sleep? How is this impacting my life?" So with Genio, I do think, and I hope you agree with me, we are the best placed company today that can make this difference. When it comes to the implantable stimulator, also there, we touched about the single incision MRI compatibility, the design for forward compatibility. Also there, we are unique.
Nobody else can offer the same thing. Sometimes it is nice to say this, but that is exactly what it is. What can you expect from Genio? As we are growing, we are capturing data. I mean, today, there is something called AI, ChatGPT, Claude, whatever, all the names. These things, if they are well used, they will help us accelerating, getting even better in providing feedback, in developing cost-economic effectiveness data. Also this, we are integrating. There was a question. I think it must have been from David since he is asking 90% of the questions. No, David, sorry for the joke. What do you expect in five years from now? You know what we expect in five years is that when you are suffering from OSA, you don't feel like a patient.
You go to sleep, the system will detect that you are sleeping and activate itself. The system will automatically adjust stimulation just in what you need to have a good night rest with your airway remaining open. It will be a self-learning system. When you wake up in the morning, you get all the feedback that you are waiting for on quality, on oxygen desaturation, on hypoxic burden. We will also measure and make sure that all these data are incorporated and show the payers how much profit, if I can use this, or how much less they will be spending by an optimal management of an obstructive sleep apnea patient. That is what we stand for. Those are the last words of this investor meeting. Thank you again for being here.
Looking forward to continue interacting more in going forward and looking forward to show you not only 25% because next quarter, I think we will be showing 35%-45%. I do think we will have to accelerate even further. Also there, we think you are in a good position. Thank you. Let me invite you also for a light lunch because you know there is a relation between BMI and OSA. A light lunch. Thank you.
That concludes the Nyxoah investor day presentation. Thank you for your participation. You may now disconnect your line.