All right, great. Let's go ahead and get started. My name is Ross Osborne, the MedTech, Life Science Tools, and Diagnostics Analyst at Cantor. Today we have Nyxoah, including the company's CEO, Olivier Taelman. Maybe just provide a brief background on yourself.
Yes. So my name is Olivier Taelman. I'm now six years leading Nyxoah as CEO. I'm Belgian by background. Recently, something really drastic happened in my private life. I moved to the U.S., so I'm now here for the last five weeks with my family. My son is going to high school. Before Nyxoah, I worked and I started my career with Eli Lilly in pharma. Then, I spent there roughly nine years, moved to Medtronic, where I spent another ten years. Got to know the country by doing a Wharton MBA, so spent some time here as well. And after that, I built my further experience in start-up companies with a company called Nevro. At that time, it was still a start-up. I think today it's a well-known company in spinal cord stimulation, and the last six years were extremely exciting, leading Nyxoah.
Great. Maybe for those who are less familiar with Nyxoah, maybe just walk through how the company was started and what exactly you guys do.
Yes. So in fact, it all began in two thousand and nine with a Belgian serial entrepreneur, Robert Taub, who is today still our chairman, and he was also the founder of the company, who started getting to know about the space of obstructive sleep apnea. He also knew at that time that there was a very successful U.S. company called Inspire Medical, that introduced a pacemaker platform technology to treat obstructive sleep apnea. And he worked together with a group of researchers, also trying to position an alternative to a pacemaker platform technology, listening very carefully to physicians, but also to patients, and built a technology that would be, in fact, showing minimum as good efficacy as the pacemaker technology, but would be much more patient-centered. And that's how it all started with Nyxoah.
From two thousand and nine to nineteen, in fact, we did what every med tech company has to do. You start with feasibility studies. You have your animal studies. You go in human. And in two thousand and nineteen was the first big milestone where we hit CE Mark in Europe. Based on the CE Mark, we were able to get reimbursement in Germany a couple of years later. But in parallel, we also decided, and we started interacting with FDA to set up an FDA pivotal study, the DREAM study, where we showed our data this
year in March, and they were looking extremely strong, and I will be telling more about this data. And we also made a decision to move away from private into a public company. We did two IPOs in nine months. We raised $200 million. Last IPO was the Nasdaq IPO, July second, 2021, and with that financial raise, in fact, it gave us oxygen to focus on further developing innovative products, to run a clinical trial, and to successfully introduce our product in Europe.
Great. Maybe starting at a high level and to level set the room, just walk through what exactly is sleep apnea?
Mm-hmm.
How have patients historically been treated, and how does your device improve upon this?
Yeah. It's unfortunate that our chief medical officer is not on stage. Dr. Boon, he would be able to explain this much better than I do, but I will give it a shot, like a non-physician explaining obstructive sleep apnea. In a nutshell, when you go to bed, and you start sleeping, you see that due to muscle relaxation and also due to pressure on your upper airway, the airway tends to collapse. When it collapses completely, it's called an apnea. When it collapses partially, it's called a hypopnea. Now, that being said, what happens when your airway is collapsing? You get a lack of oxygen that goes through the airway and that will reach your vital organs. Now, if you happen...
If this happens twenty, thirty, forty, fifty times during one, two, three, four, five seconds every hour when you sleep, you can be sure that there are a couple of things. First, you will not feel well rested when you wake up. This has an impact on your social life. It can even result in the fact that there is an absenteeism from work, that you simply, you know, don't find the energy anymore to go to work. That is one aspect, but I think more important of untreated sleep apnea is, because of this constant lack of oxygen, you also increase the risk for stroke. It doubles, and your cardiovascular risk goes up by five. So the mortality risk significantly increase, and that's why, in fact, people should be treated.
Now, maybe as an anecdotal, what you also have is the moment you have an airway collapse, you also start making a noise. The noise is referred to as snoring. It's very hindering for your bed partner. So also this, when you have a well-treated obstructive sleep apnea, you will - this will also go away. So you will not only feel better, but also your bed partner will feel better.
Definitely. And then regarding treatment options on the market-
Yes.
How, historically, how did patients or how were patients treated?
Yeah. So the golden standard today still is a CPAP mask, so positive oxygen pressure mask. And I have to tell you, those masks, they work fine, but there is only one issue: You need to use them, and that's where the issue is. So we see that compliance ratio with patients wearing a CPAP mask is relatively low. And when we look at literature and data that are published, they are clearly indicated that up to 50% of all patients wearing a CPAP mask, they simply quit wearing or quit the technology after two years' time. Now, if we put some numbers behind, last numbers is that in the U.S., you have approximately 1.3 to 1.4 million new CPAP users every year.
So you can understand how many of those will drop out by quitting their therapy, but are still in need for a technology because they have moderate and severe OSA, and that is where we focus on. So if we then further drill down, and you look at the market opportunity for hypoglossal nerve stim, it's clear that we end up in the USA alone with roughly 500,000 patients that are in need for treatment because of the severity of OSA, and that would be eligible for hypoglossal nerve stim. Today, 30,000 of 500,000 are really offered treatment. Because there is the Inspire that has the monopoly, that is doing a phenomenal job in helping patients, but it's still like only, if I can say this, 30,000 out of the 500,000.
And that's where we believe that we will make a difference in this market by having a second company coming in. You will increase awareness, you will give physicians an option to choose, you will give patients an option to choose, and that's why it's so exciting, for us at this moment, because we're getting really close. We expect FDA approval, this year still, and we are also preparing our U.S. launch.
Yep. So I guess while we're talking about patient numbers, are GLP-1s taking away your target market?
So it's the most asked question that I received in the last four months, and I try to answer really fact-based. So if you look at the Eli Lilly trial, so there you see that the average BMI of patients before they were put on a GLP-1 was 40. And you look at the obstructive sleep apnea, so the AHI index, that was 50. Now, what we see with GLP-1s, so they will reduce, of course, the BMI. So they are claiming it will be roughly 25%, 25%-30%. So a 40 will become 30 from a BMI perspective, and then the question is: What is the effect on obstructive sleep apnea, on AHI? And you also see that AHI is directly related with the body weight of a patient, so also the AHI goes down.
The 50 was reduced by 50% and becomes 25. If you have a BMI of 30 and you have an AHI of 25, you are spot on the criteria where hypoglossal nerve stimulation or where Genio can be the perfect solution with proven clinical evidence. To answer your question, net-net, we think there will be more patients that will become eligible for successful treatment than patients that we might lose because of the BMI goes down from 28 or from 30 to 21 or something like this, and there would be no need for an active treatment because patients would no longer suffer from moderate OSA.
Got it. And then switching to DREAM, which is obviously very, very exciting. Would you walk through the trial for us, for those less familiar?
Yes. So what we did when we talked with FDA was: How would we compose our clinical trial? And in fact, after quite some discussion, it became very clear that although FDA was not looking for a head-to-head comparison trial with Inspire, with their STAR trial, they wanted to have a trial that was showing comparable endpoints, but that was also showing comparable patient phenotyping. So the DREAM trial, compared to the Inspire trial, it's like 95% identical. We are aiming on the same patient phenotype, and we have to show the same primary endpoints. There are some nuances, and I will come back to this. One of the nuances is the fact that within the DREAM study, we started by having a broader range of AHIs.
It starts at 15, and it goes all the way to 65, where in STAR it was 20-50. It was more narrowed down, more concentrated. But from a primary endpoint perspective, for example, we have the same, meaning that we have to show a 50% reduction in AHI, and you need to bring the AHI below 20. Now, as you can imagine, if you have a patient with an AHI of 60 or 62, let's say that you are successful in reducing the AHI with 50%. Patient, you bring him to 25 or 22, his life or her life would be totally changed. But according to the study, it would be a non-responder because it's not below 20. So if you only go up to 50, there is a difference. So that is one aspect.
The other aspect that we also saw is that with the DREAM study, we had to have patients sleeping minimum 60 minutes or longer on their back, so in a supine position. Now, why is this important? Once you sleep on your back, you see that your increase of obstructions goes up. It almost doubles, and I think all of us, and especially the male population amongst us, I think after a heavy meal and some good glasses of wine, and you go to bed and you sleep on your back, you feel yourself that you start snoring more heavy than when you would would sleep on your side. Sometimes my wife, at least, she push me a little bit, saying, "You know, turn, because you're making too much noise," so that's what you're seeing in supine position.
Now, in our study, we were mimicking what is called, what I call a natural sleep night. In a natural sleep night, all of us, like this evening, we will sleep between 35%-40% of the time on our back. Now, in our study, we are showing data that are comparable to the Inspire STAR trial data, but with the key differences that for Genio, everyone was sleeping one hour or more, the average was close to two hours, on their back. In the Inspire trial, this was not the case. What is the key takeaway for a physician? Regardless of the sleep position, the main... the airway maintained opened, showing the same results as a STAR trial, where you only have results published where patients are not on their back. And then I do think this will be, like, a key differentiating factor also when they have to choose for a therapeutic option.
That's a good point. Okay, and then what are the next steps with DREAM?
So the next steps are, we will. Next week, in fact, you have the AAO-HNS Congress in Miami. We will reveal all our clinical data. We have the PI on stage, we have a podium presentation, a lunch symposium, and we even do a dinner after, where we are inviting all physicians that were participating in the study and all sleep physicians that are present at the Congress to make them more familiar with our data. So that will happen next week, important. There is the publication submission that will take place.
We aim to go for the JAMA, a Tier 1 medical publication that will be next, and then it will be close to Christmas. And this year, Christmas can be beautiful for Nyxoah because it could bring us FDA approval. In the meantime, we hired already quite some salespeople, sales, marketing, market access. Also, the gentleman over there is our Chief Commercial Officer, who is on board, and we will be ready with a full trained team to go out and start selling our product as of new year, in fact.
Great. And, I imagine Inspire did a lot of the heavy lifting for you guys in terms of developing the market. You know, how do you think about your size of your sales force?
Yeah. So first of all, we are extremely recognizing all the hard work Inspire did. I am extremely humble when I see how many patients they are treating, how they did have a lifting on reimbursement and everything, so credit goes to them for doing this. Now, that being said, I think it's also time that we give patients and physicians an option to choose. Now, if you look at the market in the U.S. currently, so Inspire, they have roughly opened 1,400 sites spread all over the U.S. 1,400. It stays a very concentrated business because 300 to 350 sites of them are generating 85% of their revenue.
If I do some mathematics behind real fast, you will see that those Tier One sites, those top 300-400 sites, they do roughly 85-100 implants annually. And then you have 1,000 sites that are doing, let's say, 5-10 implants annually. So there is still a huge margin to improve, to increase therapy penetration with open sites. Now, coming back to our strategy, we will focus on the Tier One. And why? Because they have the patients, they have an established referral network, and we will position and give those physicians an option to choose. Now, to your question with how many and how big will our sales force be?
You know, I do not wanna start creating expectations that could become difficult to live up to in the future, but I do think we have to stay realistic on what is the training capacity we have to train surgeons in a high-quality way. And then the next thing is: How can we scale up? So how can we, every quarter, add new sites, add new salespeople? So to give you a number, because I know also you would like to have a number, I think we will be around 50 people to do the U.S. launch. In those 50 people, you will have half of them pure sales guys, and the other half will be a combination with engineers that will make sure that patients get the correct outcome of therapy. We will have market access people helping the hospitals, preparing the pre-authorizations, and some marketing that goes around.
Got it.
And then we scale every quarter by adding salespeople.
How do you foresee the market developing in terms of will there be Inspire sites in the U.S., Nyxoah centers, or will there be centers using both Nyxoah and Inspire?
Yeah. It's, again, difficult to predict. I can only look a little bit at Germany because that is a major market for Inspire outside of the U.S., what happens there. So I do think that the majority of sites will be splitting, will be of both Nyxoah and Inspire. That's what I think. I also think there will always be some Inspire sites. You have those people who love the technology, who would like to do something else. I also think that there will be some exclusive Nyxoah sites, but the majority will be split sites.
Got it. And then what does the reimbursement dynamic look like?
You're asking all the difficult questions today. So, you know, I try to answer also as fact-based as I can, and I think three weeks ago I was listening to Inspire when they were interviewed on stage with another bank, and they were asked the same question: "So what do you think that Nyxoah will do from a CPT perspective?" And the answer, and I quote, was, "We do think that Nyxoah will be able to piggyback on the work that we have done." Now, if you would ask the question six months ago, the answer would have been, "We don't think Nyxoah will have a CPT code when they launch, and they will have to wait four years, just like we had to wait-
Right
... four years before we came. So it already changed. Now, what I know and where my team is working hard on, is the fact that, first of all, we do wanna have a coverage in place the moment we have FDA approval. And I also learned that you can have a coding, but you will not have your coding before you have FDA approval. You will have to work with pre-authorizations. There will be healthcare providers who will say, "I refuse to pay at this moment," and there will be others who say, "I will pay." So this is a process
we also will be going through. We have a code that is very specific, that would cover our technology, so from a CPT perspective, that is well known by payers and that is covered already for HGNS. That is also, I cannot use the word endorsed, but supported is maybe a better word, by the American Academy of Otolaryngology-Head and Neck Surgery. We are comfortable that we will have a coding in place and that we will get paid, and that we can launch right after FDA approval.
Got it, and then longer term, does it make sense for you to go after your own code?
Yes. That's the short answer. Yes. I don't think it will take two years. We plan to have our own code beginning 2026, because also this work is ongoing in parallel. But once again, first things first, FDA approval, then we work with pre-authorization. We use a kind of bridging code, and in parallel, we go for our own coding. And what is playing in our favor is that also Inspire, with their Inspire V, they can no longer use their existing code because they refused one, or they have no longer this respiratory lead. So also they are doing some work, and maybe this is helping for both of us, ending up with correct coding pretty fast.
Great. And then lastly, would you walk through the Complete Concentric Collapse market opportunity, and how you guys are able to benefit patients there?
Yeah. So what we see when it comes to complete concentric collapse, and for those who are not so familiar, it means that your upper airway, you have both walls collapsing and even really, really closing up. So it's a market that is quantified as being 25%-30% of the total OSA market. Competitor Inspire, they do have a contraindication because they tried to show data, and they failed. They shown that they were not capable with unilateral stimulation, in fact, to help those patients, and so show successful efficacy
outcomes. So that is one thing we did. So we have a study. It is published. We have already our label expansion in Europe. When it comes to the U.S., we have a separate study ongoing, ACCESS, only focused on CCC patients, and we are planning to close the enrollment by year-end. Then there will be a twelve-month follow-up, and we do a supplemental PMA submission, so we expect to be having the label expansion mid-2026.
Great. A lot of exciting catalysts. Any questions from our audience? All right, if not, Olivier, I'll leave the floor with you for any closing remarks.
No, I can only say that we worked hard to get where we are today. I think before Christmas, we will can have a nice present, FDA approval, and then we are getting fully ready to launch in the US.
Yep, looking forward to it. Thank you for being here.
Thank you. Thank you.