Nyxoah at Morgan Stanley Conference: Breaking the AGNS Monopoly

On Tuesday, 09 September 2025, Nyxoah (NASDAQ:NYXH) presented at the Morgan Stanley 23rd Annual Global Healthcare Conference, unveiling its strategic initiatives and innovations. The company highlighted its hypoglossal nerve stimulation technology, GeniO, aimed at treating obstructive sleep apnea (OSA). While Nyxoah’s recent FDA approval marks a positive step, challenges remain in capturing market share and educating physicians.

Key Takeaways

• Nyxoah’s GeniO technology offers bilateral stimulation and MRI compatibility, distinguishing it from competitors.
• Recent FDA approval in the U.S. on August 8th sets the stage for a strategic commercial launch.
• The company targets 400 high-volume implanting sites in the U.S., representing 80% of the market.
• Future plans include the ACCESS trial to expand the patient label and next-generation device innovations.
• Nyxoah aims to disrupt the existing AGNS market monopoly by offering an alternative without an implantable battery.

Operational Updates

• U.S. FDA Approval: Nyxoah’s GeniO system received FDA approval on August 8th, enabling its U.S. market entry.
• Commercial Team: The company employs 50-55 personnel, including 25 territory managers focused on high-volume accounts.
• Launch Strategy: Targeting approximately 400 high-volume AGNS implanting sites across the U.S.
• Physician Training: Weekly training sessions are conducted, with 24-36 surgeons trained each weekend.
• Pre-Authorizations: Nyxoah has submitted nearly 20 pre-authorizations within 10 days of launch.

Future Outlook

• Label Expansion: The ACCESS trial aims to include patients with Complete Concentric Collapse, with results expected in early 2027.
• Product Innovation: Next-generation wearable components with enhanced sensors and apps are anticipated in 18 months.
• R&D Focus: Exploring technologies like independent stimulation and pillow charging to enhance patient experience.
• Commercial Scaling: Plans to expand the commercial organization each quarter to support growth.

Q&A Highlights

• Target Accounts: Success is measured by market share gain in 400 high-volume sites.
• Reimbursement: Utilizing CPT code 64568 for AGNS; several MACs have accepted coding with covered lives.
• GLP-1 Impact: The BMI limit of 32 allows Nyxoah to target a patient segment still in need of treatment.
• Ideal Patient Profile: Typically, a 53-54-year-old, health-conscious individual with a BMI under 35.
• U.S. Manufacturing: Decision made three years ago to produce in the U.S. for the local market.

Readers are invited to refer to the full transcript for a comprehensive understanding of Nyxoah’s strategic plans and market positioning.

Full transcript - Morgan Stanley 23rd Annual Global Healthcare Conference:

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Excellent. Thank you, everyone, for joining us. Before we begin, I’ll give the standard disclosure. For important disclosures, please see the Morgan Stanley Research Disclosure website at morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, thanks, everyone, for joining us. We are here with the CEO of Nyxoah. Thanks for being with us here, Olivier.

Olivier, CEO, Nyxoah: First of all, thank you for having us and giving us the opportunity. I think it’s great to meet with you and have you appreciate it.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yeah, absolutely. Maybe to kick it off, for those in the audience unfamiliar with Nyxoah, could you please provide a brief overview of how Nyxoah is changing the obstructive sleep apnea landscape?

Olivier, CEO, Nyxoah: No, no, definitely. With Nyxoah, we are offering an innovative next-generation neuromodulation solution, more specifically hypoglossal nerve stimulation to treat moderate to severe OSA patients. I do think we can say we have a totally differentiated technology driven by bilateral stimulation, single-incision implants. Next to the bilateral stimulation and single incision, it’s also clear that we go with full body MRI compatibility from the beginning for the simple reason that we do not have an implantable battery. When we look at the wearable component, the piece that the patient will wear when he or she is sleeping, the wearable component is containing the battery, but also the software of the system. One of the big advantages when you do not have an implantable battery is that there is no need for re-surgery when the battery is depleted.

There is also no need for re-surgery when, for example, we have an upgrade in software that we want to push through. That’s like with your iPhone. We can do this even without seeing the patient in the hospital. If you combine all of these things, I do think we can conclude that we are very differentiated to what is currently out there, which is a pacemaker platform technology that we are looking forward to launch in the U.S. as it’s happening today.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Absolutely. We’ll definitely hit on that. Before we touch on the launch, maybe could you talk a little bit about your DREAM pivotal study? You showed some pretty differentiated data. Could you give us the highlights and why they matter so much to patients and physicians?

Olivier, CEO, Nyxoah: Yeah. I think it’s truly important that you have robust clinical evidence. When we look at the study protocol of DREAM, we had as primary endpoint a reduction of apnea-hypopnea index. We had to reduce the number of events or obstructions with at least 50%, and we had to bring the overall number of events below 20. Those are the so-called shared criteria. Next, there is also the oxygen desaturation expressed in an oxygen desaturation index, but we also had to show a significant relief in an oxygen desaturation index. Please, first of all, that we map all primary and secondary endpoints. I think that’s an important one.

Next, if you drill a little bit deeper and you look also at what is important for a patient, but also for the physician in the selection coming from clinical evidence, I think, and this is also supporting our vision in making sleep simple, a physician, he wants to have a safe product. From a severe obstructive event percentage, we had 8.7%. If you compare and put it a little bit in perspective, also towards competition, it was close to 20%. I do think we have a safe product, and it’s also driven by the single incision compared to multiple incisions.

If you go a little bit further in the efficacy perspective, I think it’s important to see that first, you can reduce, of course, the number of events, but also looking at the median reduction, important for a physician knowing what to expect regardless of what the stage is of events. Like if you have someone with extreme severe OSA, 15 events every hour, or someone with more moderate OSA, 20 events an hour, what can you expect from a median reduction? There we showed 70%. More important, we even showed 82% of people that we were able to bring back an AHI below 15. Fifteen is a little bit of a magic number because below 15, you’re officially not in need for treatment. Once you go above 15, you become eligible for treatment. So 82% of all our participants, we were able to bring down to below 15.

I think that is great. Another one in being ease of use for a physician is positional OSA. Very short, when you go in a supine position or sleeping on your back, the number of AHI can double, and it can also, and it will definitely significantly increase. We are currently the only company with proven clinical evidence that we maintain the same airway opening as when you are in a non-supine position. That is also reflected in our label. I do think for a physician and for a patient, it’s important in their decision-making of what therapy they would like to have. Those are more or less the big things that are coming out of the study: space, positional OSA, reduction of 80% below 15, and we hope that this is resonating well with the clinical audience.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yeah, absolutely. I think you mentioned your label. That obviously came fairly recently. You just got approval in the U.S. Can you maybe talk about the specifics of the approval and what it means for a patient wanting an alternative OSA treatment?

Olivier, CEO, Nyxoah: Yeah. No, no, definitely. We got approval August 8th. We will never forget the Friday. We have been working quite long in order to get the PMA approved, and I’m extremely pleased that the team and the team is great in achieving this. Now, when we look at our label, we see the positional OSA reflected in the label, but there is also another specific patient population with extreme difficult airway openings to treat, and those are the patients suffering from complete concentric collapse. It’s contraindicated for current AGNS technology, but we already were able to show positive data in our Australian study. In Europe, we already had the notified body accepting this and adding to our label, and we see in the U.S. that we did not receive a contraindication. That’s already, I think, an important sign from FDA that they are trusting the data that we showed.

We are specifically also doing a clinical study related on CCC patients in the U.S., where we hope then to be able to further expand our label in the near future. Those are, I think, two major differentiation points when you compare the GeniO label compared to the compact PEP labels. Next, what do we expect? I think nobody likes a monopoly, to be very straightforward. When you talk to physicians, they like to be given an alternative. Patients like to have an option to choose, and we are the ones who are breaking the current monopoly in AGNS. I think that’s very positively perceived because we have patients, and it’s measured up to 15%, saying, "I do not want to have a battery in my body. I refuse simply to have this." So far, there was no alternative. Now there is. I think that’s a good thing.

We learned, and I think we can maybe talk a little bit more about this later, but also in our German experience, that once you break a monopoly, you have two companies stopping and positioning their technology in AGNS, that you also see the overall therapy penetration increasing. I think also that is very important.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Absolutely. I think you hear a lot of super interesting points. Access, we’ll definitely want to talk a bit about that later. We’ll definitely ask you about some of the German experience. Maybe, now that you have the approval in hand, how are you planning on prosecuting the U.S. launch to make it as impactful as possible?

Olivier, CEO, Nyxoah: Yeah. We obtained, on a Friday, the approval, and on Monday morning, the sales team was launching. I think we took a little bit of a gamble by hiring already last year, December, our commercial team. We currently have 50, 55 people, to be precise, in the commercial team. We have 25 different territory managers. We focus on high-volume AGNS implanting accounts, and the people are doing great. We are now more or less three weeks after the FDA approval. We already have strong results in our leading indicators, number of surgeons trained, for example. We also went to the value analysis committees already with a high number of sites. We see the first approvals coming in. Next, we are working with preauthorizations for commercial payers. Also there, we have close to 20 already after our 10 days of launch of preauthorizations that are submitted.

We see the positive reactions with surgeons. There is a lot of positive energy, and people are excited.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Great. I think one of the things that we’ve heard in the way that you’ve set up your commercial strategy is that you’re targeting primarily sleep physicians as opposed to, you know, ENT surgeons, which maybe some people would say that should be the target. Why do you think that’s the right strategy? Why target the sleep physicians?

Olivier, CEO, Nyxoah: First of all, I would like to highlight we have a two-pronged launch strategy where the ENT surgeons are playing an important role. On the other hand, we believe that a sleep provider or a sleep physician is really central in the management of the obstructive sleep apnea patients. Very simple. They are the ones identifying in PSGs like how severe is the condition. They are the ones also working with CPAP as a gold standard. They’re also the ones that are seeing CPAP patients coming back saying, "You know, I’m looking for an alternative. I don’t tolerate my CPAP. I’m about to quit. I want something else." Therefore, I do think it’s our role in educating those physicians, one, on how to position and what is the correct phenotyping for successful GeniO treatments.

Also, second, and I think this is so crucial, what is their role in patient management post-surgery? Because today, sometimes you see that they’re a little bit confused, not knowing exactly what to accept and what to expect, and how to contribute. By educating and training them in how to stimulate patients, how to adapt stimulation, also how to gather data by working, for example, with home sleep tests, seeing and evaluating the technology and how well their patients are doing, will give them the option, first of all, to see themselves what it can do, to help also getting better in defining what is the correct and the best patient phenotype, but also to provide us with data that we can learn from and that we can also develop all the time health economic data.

For us, the sleep doctor has a crucial role and a central role in the patient management. The ENT doctor has more of a technical role in doing high-quality implants and making sure that he can do a lot of implants and doesn’t need to worry in post-surgery management of patients. This is done by a lot of experts. That’s how we see the future of AGNS significantly increasing.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yeah, fair enough. I think you said you’ve had the approval for a couple of weeks now. Pre-approval, we had heard that there’s a lot of pent-up enthusiasm for, you know, for the Genio. As you look forward over the coming months, what are some of the key leading indicators you’re focused on to sort of measure the enthusiasm translating into commercial success?

Olivier, CEO, Nyxoah: Excellent question. First of all, we focused on the high-volume sites. If you look in the U.S., you have roughly 400 implanting sites that are representing around 80% of the total volume. We want to reach those 400 as soon as possible. With our current sales force, we can already reach 125. We will be scaling up every quarter. We will be adding more sales reps. We will be opening more territories. From a leading indicator perspective, it starts with surgeons trained. Then we have the value analysis committees approving and accepting our technology. There are the preauthorizations. Of course, as we call it, a full active site where the surgeon is trained, where the V.A.C.s have approved, that we have patients identified. Those are the leading indicators before we will start generating revenue and also start communicating on and giving projections on revenue and on implant is done.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: All right. I guess you mentioned the 400 at high-volume accounts. Yes, how are you identifying those, and what would success look like at one of those accounts once you’re in?

Olivier, CEO, Nyxoah: How do we identify them? Allow me to make a little joke, but sometimes it’s nice to be second. I mean, we have our competitors done a great product in developing and introducing AGNS in getting it covered. Sometimes when you come in as a fellow or as a smart follower, they have paved the way, and it’s relatively straightforward to identify those accounts. There we took an advantage. On the other hand, how will success look like? I think success in those accounts will be expressed in market share and market share gain. We started in Germany. We did a commercial proof of concept. We were able to capture 25% market share in two years’ time. Not saying we’ll do the same thing in the U.S., but I do think it is an illustration that there is an acceptance of GeniO, that there is a need for an alternative.

Now we hope to see that also in the U.S. We will be having high-volume accounts and measure our success in revenue and in market share gain.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yeah, fair enough. Maybe pivoting a bit to reimbursement. We know that it can be for many med techs a hurdle early in their commercial lifecycle. How are you managing your reimbursement progress, and sort of how do you make sure that patients get the treatment they need?

Olivier, CEO, Nyxoah: Yeah. What we did is we looked at both the scientific and the medical organization. In our case, the American Association of Otolaryngologists, AAO. We worked very closely with them in also educating them on what our technology is doing, listening to them where they are seeing the place, they are interacting with AMA. That was one aspect. The second aspect, during the FDA process, we were also part of the early payers program that gave us the opportunity to present GeniO in front of all the major commercial payers in the U.S. There was also quite an educational work done. We know that there initially was a CPT code, 64568, that was used by, I will call them by name, AGNS. They moved out of this code, but now they are coming back to the same coding because they’re the latest high-technology innovation.

We just received the news from Medicare that this code is now also officially accepted as an AGNS code. You do the same mechanism of action. You have the same stimulation parameters. Next to their reimbursement, we at GeniO will tap out to the same coding. That would be step one. With commercial payers, we will work with preauthorizations. With the government payers, if I can say Medicare, we know that we already have several MACs that have accepted this coding, and we already covered one person. We have both covered lives, so that’s, I think, a good start. The rest, however, we will see when the preauthorizations are coming back.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: All right. As we look forward, how will you measure success with payers? Is there a certain cadence of covered lives you’re looking for? Are there certain milestones that we should be looking out for in terms of reimbursement?

Olivier, CEO, Nyxoah: First of all, every time that we have a preauthorization submitted and that is approved by a payer, that will help us scaling up, and we can then also start talking about covered lives. I think we can benefit a little bit from being the second mover because there was a lot of work done, and today it is hypoglossal nerve stimulation that has a code, and it’s not a specific technology that has one. That’s why we think we will be able to scale up fast.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yeah. Fair enough. Maybe, you know, you mentioned Germany as a proof of concept market for commercialization. Maybe can you talk a bit about that experience and how you would think that translates to the U.S. and maybe what parts you don’t think are going to translate?

Olivier, CEO, Nyxoah: Yeah. First of all, outside of the U.S., Germany is one of the largest markets for hypoglossal nerve stimulation, but it stays underpenetrated and is an extremely small market compared to the U.S. It was also not so intensively commercialized by competition. That being said, there are similarities, and it started by reimbursement. The first thing we wanted to prove is, can we obtain a similar reimbursement to our competitor? The answer was yes. We had exactly the same criteria. The second thing we wanted to show is, if we go to high-volume centers, are we able to break the monopoly, to break the relationship, and to gain significant market share? The answer was 25% in two years’ time. The next thing is, how can we drive it forward? Also there, we looked at sleep physicians.

We saw that we were struggling a little bit because the sleep physician in Germany is totally not well-educated when it comes to AGNS, and they were seeing us as the novel therapy. That’s how the lack of awareness was. We struggled a little bit, and we had to do some more focused DTC, reaching out direct to patient organizations. The learning was education of sleep physicians. It is crucial. Last, what we also were seeing in Germany is that the importance of also patient testimonials, people speaking on forums, being positive about your technology, and also there you have positive interactions. That was the German proof of concept. Next thing, since this year, we entered the UK market where both competition and GeniO entered at the same time.

I can tell you, there you see that we are so identified who will be the number one, and I think we have a little bit of the lead after six months. Last, we also wanted to explore the distribution model, and there we are unique by entering in the Middle East countries. We did our first implants in Dubai, in Abu Dhabi, and in Kuwait. There also, we are learning what it means if we would go indirect. Those are the three eye-learning concepts. Germany, closest to the U.S. with differentiation. The UK, you start at the same time. You show that we can take leadership. In the Middle East, we are the only provider going indirect, and also there we have our partners.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Fair enough. As we look at your experience in those three markets, is there any specific type of patient where you’re more successful, or what is the ideal patient profile that you’re looking for that’s really successful with GeniO?

Olivier, CEO, Nyxoah: It’s a very interesting question because when you look at obstructive sleep apnea, the average age is roughly 53, 54 years old. I hope those people will live 30, 40, even longer than that. It’s becoming almost like a lifestyle implant that we would like to promote in the sense that we have an implant for life, 25 years longevity. We have a passive implant that is totally powered, but also the brain is external, so there is no need for resurgery anymore. We want to also have people that are conscious about their health. I mean, if you have a BMI of 40 and you refuse to lose weight, to be very straightforward, and you want to not change your lifestyle, I don’t think an implant or a drug will change your life. There needs to be some kind of motivation, especially in sleep.

We want to stay away from those extreme BMIs above 35. We want to position ourselves for people who are conscious that a healthy lifestyle will also give them, I mean, not only more functionality, but also the aspect of not dying of comorbidities. I think that is very important. When you look at the perfect GeniO patient, it’s a female or a male, 53, 54 years old, who are conscious about this, and who also want to make an effort to stay healthy for the coming 20, 30, 40 years.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: In the vein of health, there’s obviously a lot more optionality now for people above a certain BMI, with therapeutics that might take them below a certain BMI threshold. How are you thinking about the evolving landscape in therapeutics, either expanding your funnel or not expanding your funnel, or does it change the Nyxoah opportunity?

Olivier, CEO, Nyxoah: Could you repeat one question?

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yes.

Olivier, CEO, Nyxoah: What is the impact on this? Like I was saying, almost all clinical evidence is done with the BMI limitation of 32. That is where we know we can be very efficient and offer safe technology. Now, if you look at the GLP-1s, in the Surmont trial of Ivanili, the average BMI was 37, and we saw clearly that the AHI was also very high. It was 50. There is a correlation between the weight of a person and obstructive sleep apnea. Goes without saying. These results were showing that when you use the GLP-1 and you are a GLP-1 respondent, you can lose up to 25% of your BMI. The 37 becomes somewhere like a back of 28, 29. The correlation with AHI was patients were losing, in fact, 40% to 60% of events. So 50 becomes somewhere in the 22 all the way to 28.

This is the spot where we have strong clinical evidence where patients are still in need for treatment, and where they have demonstrated also their motivation to lose weight. This segment, we were unable to tap on if there would not have been GLP-1s because we are limiting ourselves at 32, and we do not want to take the risk to increase our BMI because I do think it would be a strategic mistake already with a young novel technology going to so extreme high BMIs that you could have a failure rate that would be higher and that is not helping nobody. We see this as very positive. Will we lose some patients? Definitely.

I call it more the cosmetic use of GLP-1, but if you see that, there will be more patients coming in from the extreme obese and high BMIs than patients who are going out because of more of the cosmetic use of GLP-1.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yeah. Fair enough. I think one, maybe going back to a bit of the commercial side of the equation, I think, if I’m remembering correctly, you mentioned over 100 trained physicians in your last earnings call. Can you talk a little bit about sort of the cadence of physician training and, you know, what the period was to train those 100 physicians and if we should expect, you know, 1,000 physicians in the next call if you trained over two weeks, or how should we think about physician training?

Olivier, CEO, Nyxoah: First of all, I would like to compliment my training and educational team. I thought they’re doing a phenomenal job. Just to highlight how we do this, we fly physicians in most of the time on a Thursday late afternoon. We start with a dinner where we also have discussions on what is the patient’s phenotype, how should the perfect patient look like. We bring also sleep physicians in these trainings. There is already this relationship building between the ENT surgeon and the sleep physician. We start very early, 6:30 A.M., with a theoretical session. After the theoretical session, the surgeons go into the cadaver lab, and they start to learn how to implant. The sleep physicians go with our technical people learning how to program, how to stimulate, how to interact with patients, what to expect from a technology.

We are all coming together for a light lunch, and people are moving or flying back. The next group is coming in in the afternoon on Friday. The next group is coming in on the afternoon on Saturday. Each time we have a physician group of roughly 12 physicians because with the cadaver that we are doing, we want to make sure we can guarantee the correct quality. Twelve surgeons at a time is perfect, and we have weekends between 24 to 36 surgeons that are trained.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: How many of those trainings do you have to do to feel comfortable that you’ll be able to successfully implant a Genio?

Olivier, CEO, Nyxoah: After the training, the surgeon is flying back to his or her hospital. Before the training, we have identified a number of patients so that they can start also actively implanting. We will send over a proctor to make sure that the first two cases are going to spot this. What we see in the learning curve is that four implants is more or less the magical number that surgeons are feeling really comfortable, and then they’re off for a great start.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Great. Are the 100 physicians, are they across centers? Is it multiple from a specific center? I know you mentioned there was a target of 25 in the near term. How should we think about, you know, either geographically, is there any specific place that you’re starting?

Olivier, CEO, Nyxoah: Yes, we have a focused launch. My marketing colleagues taught me the word heat maps. Heat maps, where you have the hotspots with the large implant sites and also where the referral network is coming from, and you have mapped all this out. To my surprise, you’re seeing that the East Coast is showing much more hotspots, to use this word, compared to the West Coast. Don’t ask me why. We see that we have specific regions, like, for example, the Texas region, and also the Midwest. What we are doing is with our focused launch, we have identified several of those hotspots, and that’s where we start rolling out our technology.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Great. How should we think about in those hotspots? Are the value analysis committees, how’s that progress going? How should we think about it?

Olivier, CEO, Nyxoah: I feel like rebuilding my entire business model. First, we have the heat maps, we have the hotspots. We look at the value analysis committee because there is also a huge difference in getting an approval from a value analysis committee, and it varies from one week to sometimes up to eight months. We put a second layer, like in these hotspots, which are the ones with the fastest value analysis committees. That’s where we were Monday, August 11, 12, 13, 14. That’s the first one resulting in the ones that are already having ID approval granted to us, and that’s also further expanded.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Great. Maybe moving it a little bit further down the P&L. You mentioned you had hired the commercial presence back in December, so we should probably have seen some of that already rolling through the P&L. What should we expect going forward in terms of OpEx, R&D, etc.? Should we expect OpEx to ramp? How should we think about the cadence of OpEx?

Olivier, CEO, Nyxoah: As I mentioned, we will be scaling up our organization, our commercial organization, significantly every quarter. That will definitely have an impact. I’m looking at our CFO, but I will not be sharing complete numbers. I don’t think this can be wide at this point, but there will definitely be a scaling up when it comes to further building the organization. Let me touch on something that we did not speak about, and it’s innovation. Although we are a small company, we put innovation as one of the top priorities in going forward in the vision and making sleep simple. I think we can further make progression in our implantable part. For me, what is so important will be also the patient aspect. That starts, I name something very simple.

I would like to have every patient getting live feedback in the morning when they wake up in how their sleep quality was. We already have a patient app, but we can do much more on this. We can provide information about the ODI. We can provide information about the number of events. I do think that this will also increase compliance. It will also make patients like owning their technology. That’s where we are investing in. In our wearable component, we are wearing sensors, for example, because over time, I would love to have an implant for life that is intelligent, that knows automatically when you are sleeping, that can also adapt stimulation.

On the other hand, I want to have a wearable component that is providing data to patients, but also providing data to healthcare providers and to us to continue self-learning, to increase, in fact, the quality of our device. That’s where we are going. That’s where we are investing in. Over time, if I look a little bit further, and I’m looking and thinking five years down the road, I want to have a technology without a wearable component that you don’t even see that the patient is implanted. There we are thinking about pillow charging concept. You would have your coil in the pillow. You would have a battery on the nightstand and a closed loop system. This isn’t existing. We just need to roll it out. Here I’m getting totally carried away on enthusiastics.

No, but that is what makes our platform so unique. By having a passive implant, we never have to reoperate this patient. We can operate all of this without making another incision in any human body. This pacemaker platform technology will never enable or be able to do this. That is why I think we are in the next generation hypoglossal nerve stimulation, and this will resonate well with patients and with physicians.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Absolutely. I did have a question. Actually, my next question was going to be about R&D and about the pipeline opportunities. You mentioned the pillow. You mentioned the intelligent design. How should we think about the cadence? You obviously have a ton of near-term opportunities with the commercial, but as we look further away, further out, you know, 18 months from now, 24, five years from now, what’s the future hold in terms of next-generation devices?

Olivier, CEO, Nyxoah: With our current technology, I’m convinced we are extremely well positioned to compete with what is existing. We will further expand in the CCC patients, representing 30% of the total population from an indication perspective. If we go to a product innovation perspective, the implantable component, we are exploring how to stimulate independently. Now, we do bilateral, but we can also do this independently. That will help us also treat more complex airways and give the patient more leverage. The next thing that we will be is in the wearable component. We have next generation is ready. It has a different shape. It follows more of the shape of the chin. It contains its sensor. It will further develop the app and provide already and capture more data, as you can expect in roughly 18 months from now. It will be regulatory approved.

The next step will be that we are going all the way to this pillow charging. We will be in the 2030s, something like that.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Yeah. One of the things that you mentioned that I don’t want to shortchange is you recently announced the access trial has reached a number of patients where you feel comfortable you’re going to get good data out of it or a powered study, right? Can you maybe talk about what the access study will provide, what sort of clinical validation it will provide, and what time it opens up for you?

Olivier, CEO, Nyxoah: Yeah. Sorry. Today, the physicians need to do a specific examination called DIS, Drug-Induced Sleep Endoscopy, to rather identify if a patient has a complete concentric collapse or not. If they do, they are no longer eligible for what is existing on the market. This examination is something that is cumbersome for physicians but also for patients. You feel a little bit, as we say in Europe, like flagella. You prepare the endoscopy, shaft in your throat while you’re still awake, and you’re a little bit hungry, but you are still awake, and then they don’t see what happens with your airway. This is something nobody likes. When we designed the access trial, we were also very straightforward.

If you want to have an own label for CCC, you also need to make sure that a physician, and here we go again, make sleep simple, that a physician can expect the same outcome for a CCC patient as for a non-CCC patient. The primary endpoints are identical as we are doing. That is one aspect. We had to implant 106 subjects in this study. I will not disclose the precise number, but we have a sustainable number where we believe that we have strong power, analytic power to convince that this also should be on label in the U.S. We have the data from Better Sleep. We have a lot of experience in Europe. We do feel comfortable.

We also are seeing that FDA currently with other companies that are in a clinical stage are accepting like up to 30% patients being CCC in a study quote of roughly 100. We have significantly more patients than 60, to name a number, in our access study. We want to bring also CCC patients as a solution ASAP in the U.S. We close the enrollment. There is a 12-month follow-up that will bring us next year around this time. We will do a PMA supplement submission, normally four to six months. I hope that by the first quarter of 2027, we can also have the label expansion in the U.S.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Wonderful. I think we have about a minute left, so last question. What do you think is the most underappreciated part of the Nyxoah story that you would want everyone to know?

Olivier, CEO, Nyxoah: I think that people are not fully realizing how differentiated our technology is and how bilateral stimulation will make a difference to maintain also more complex airways open. That is one aspect. There is one thing I would like to say, and it’s maybe a funny anecdote in the last minute, but three years ago, we made the decision to manufacture in the U.S. for the U.S. Today, with all the kind of discussions, it seems to be also a good decision. I think that’s also important. We were earlier also having a manufacturing site in Europe for the international market. In the last 30 seconds, the scalability of our platform, as I was already explaining a couple of times, I think this could benefit patients so much. I think that is crucial in managing obstructive sleep apnea going forward.

Unidentified speaker, Morgan Stanley Sales Representative, Morgan Stanley: Wonderful. We look forward to seeing how you change the landscape of OSA. Thank you. Thank you very much for being here.

Olivier, CEO, Nyxoah: Thank you for having us.

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