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Date
Monday, Aug. 18, 2025 at 4:30 p.m. ET
Call participants
Chief Executive Officer — Olivier Taelman
Chief Financial Officer — John Landry
Head of Investor Relations — Pearson Dennis
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Takeaways
FDA PMA approval-- GENEO system received premarket approval for commercial sale in the United States, authorizing the first and only bilateral AGNS (autoglossal nerve stimulation) therapy for obstructive sleep apnea (OSA) in the US.
Revenue-- $1.4 million in 2025, a 73.8% increase over 2024.
Gross margin-- 63.4% in 2025, unchanged from 2024.
Operating loss-- $21.2 million in 2025, compared to $14.2 million in 2024, attributed to accelerated commercial investments in the US market.
Cash position-- $45.9 million as of June 30, 2025, down from $67.3 million at March 31, 2025, with $29.3 million of term debt capacity remaining, available in two tranches.
US commercial launch-- Commercial activities have begun, with a 50-person commercial team targeting 350-400 high-volume AGNS implanting accounts, accounting for 75%-80% of total US AGNS market revenue.
Physician training-- Over 100 US physicians trained at launch, with regular weekly sessions ongoing to build clinical adoption.
Patient compliance and satisfaction-- Published DREAM study data show device compliance of 85.9% and patient satisfaction of 90%.
Regulatory label differentiation-- The GENEO system is not contraindicated for patients with complete concentric collapse (CCC), although the US label includes a warning since US-specific CCC effectiveness is not yet established.
Reimbursement pathway-- GENEO uses CPT code 64568, the same as its main competitor, recognized by both commercial and government payers for OSA indication; initial pre-authorization approvals have been secured.
Patent litigation-- Nyxoah reported that Inspire Medical has initiated a patent lawsuit prior to GDUFA approval, but stated this "will not impact our US commercial launch."
Access study enrollment-- Enrollment in the US access study for CCC indication was purposefully stopped, as management determined the cohort offers adequate statistical power for PMA supplement submission.
Commercial expansion plans-- The US field team starts with 25 territory managers, each with responsibility for 4-6 accounts, with approximately 15 additional managers to be added each quarter, scaling coverage toward all high-volume implanting sites.
Differentiated label-- Management claimed FDA approval included a label reflecting both positional OSA efficacy and absence of CCC contraindication, emphasizing "bilateral stimulation is making a difference compared to unilateral stimulation."
US pricing-- Tied to the shared CPT code structure.
GLP-1 market dynamics-- Management expects the GENEO patient pool "will grow, not shrink," as GLP-1 drugs could move higher-BMI patients into the device's efficacy range (BMI <32), according to commentary during the Q2 2025 earnings call.
Post-launch metrics-- Leading indicators being tracked include number of physicians trained, value analysis committee (VAC) submissions, and pre-authorization approvals.
Physician engagement model-- Before physician training, candidates must present five eligible patient cases, supporting immediate post-training implant procedures.
Future CCC label expansion-- Management expects to submit a PMA supplement after the twelve-month follow-up of access study patients, as stated on the Q2 2025 earnings call, with possible FDA label addition for CCC at the end of 2026 or early 2027.
Summary
The transcript revealedNyxoah(NYXH 5.63%)’s entry into the US OSA market after obtaining FDA PMA approval for its GENEO system, which is now commercially available. Gross margin in 2025 was 63.4%, unchanged from 2024, and a significant operating loss for 2025, attributed to US commercialization investments. The company’s unique regulatory label allows bilateral AGNS therapy and avoids a CCC contraindication, underscoring a pivotal competitive positioning. Management articulated a focused commercial and reimbursement strategy, highlighted positive clinical adoption and compliance rates, and outlined near-term expansion through increased sales force and VAC processes, all while addressing patent litigation risks and anticipating label updates for CCC indications.
John Landry stated, "we could expect to see potentially the SG and A spend nearly double in 2026 over the levels seen in 2025."
CEO Olivier Taelman explained GENEO’s immediate commercial rollout concentrated on high-volume implanting sites, with a sequential ramp in both targeted accounts and territory managers.
The company confirmed initial rapid VAC and pre-authorization approvals, despite variable timelines for full account onboarding, some of which can extend up to nine months.
Management specified that CCC patients remain an off-label use for GENEO in the US, with promotion expressly limited to on-label indications until further regulatory approval.
Demand for the device is driven, in part, by the absence of an implanted battery, distinguishing GENEO from competitors in patient and physician outreach.
Industry glossary
AGNS (Autoglossal nerve stimulation): A device therapy delivering electrical stimulation to the hypoglossal nerve to treat obstructive sleep apnea.
OSA (Obstructive sleep apnea): A sleep disorder marked by repetitive airway obstruction and disrupted breathing during sleep.
CCC (Complete concentric collapse): A specific upper airway collapse pattern relevant for device therapy eligibility and regulatory labeling.
VAC (Value analysis committee): Multi-disciplinary hospital group evaluating new medical devices for clinical and economic benefit prior to purchase or adoption.
DREAM study: Nyxoah's pivotal trial evaluating GENEO device safety, efficacy, compliance, and patient-reported outcomes in OSA treatment.
PMA (Premarket approval): The FDA’s regulatory process for authorizing new medical device commercialization in the US.
CPT code 64568: Billing code used in the US for hypoglossal nerve stimulation device implantation.
Full Conference Call Transcript
Pearson Dennis: Thank you. Good afternoon, everyone, and I welcome you to our second quarter 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our second quarter 2025 financial results released after U.S. market closing today. After which, we will host a question and answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section on the Investor Relations tab of our website.
We begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results, or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements.
For a list and description of our risks and uncertainties associated with our business, please refer to the risk factors section of our form 20-F filed with the Securities and Exchange Commission on 03/20/2025. With that, I will now turn the call over to Olivier.
Olivier Taelman: Thank you, Pearson. Good day, everyone, and thank you for joining us for our second quarter 2025 earnings call. I'm extremely proud to announce that we received FDA PMA approval for our GENEO system in the United States. This result was the culmination of persistence, strong regulatory, and clinical execution supported by the entire passionate and committed Nyxoah S.A. team. For US patients suffering from obstructive sleep apnea or OSA, the GENEO system provides them with a significant advance from currently available treatment options. For physicians, they now have a choice to select the optimal AGNS therapy for their patients. For Nyxoah S.A., it marks the beginning of an exciting journey in the US.
This PMA approval confirms the safety and effectiveness of our innovative technology and authorized commercial distribution in the US, which now has actively begun. The GENEO system becomes the first and only bilateral AGNS therapy approved in the US for treatment of OSA. It's also important to note that the GENEO system is not contraindicated for patients suffering from complete concentric collapse or CCC. And all of these key differentiators represent off-label highlights of the ability to treat patients with positional OSA. This is important as according to published data, a patient's AHI score can double when a patient sleeps in a supine position on their back.
Adding this another label serves as a validation of the clinical outcomes for more pivotal dream study which met its primary endpoints regardless of a patient's sleep position. Also note, that complete concentric collapse of CCC is not contraindicated but is included as a warning in the company's label as the safety and effectiveness of patients suffering from CCC has not yet been established for the GENEO system based on US specific clinical data. Our goal is, however, to monitor to make GENEO available for US patients suffering from CCC as soon as possible. Therefore, we strategically elected to stop enrollment in the access study.
We believe that the number of patients enrolled in access will have enough statistical power to draw meaningful conclusions on our effectiveness complete concentric collapsed patients. In addition, we see great results in real life data from patients in Europe where our CE Mark already includes an indication for CCC patients. I'm also pleased to report that our dream study was published by the Journal of Clinical Sleep Medicine, which is a leading journal for the sleep community. I'd like to highlight a couple of data points that were published for the first time which demonstrate a high level of patient satisfaction. The device demonstrated compliance of 85.9% and the patient satisfaction was scored at 90%.
This data confirms our early experience in Europe and we believe the publication of the DREAM study will strengthen our US launch and will also give us access to new international markets. Immediately, upon receiving FDA approval, we started our focused US launch with a commercial organization with over 50 highly talented and experienced professionals. This team is now executing on our two-pronged launch strategy. They will target high volume hypoglossal nerve stimulation implanting centers, where they will position GENEO as a differentiated option for patients suffering from OSA. And they will focus on developing strong referral networks with physicians managing large populations of moderate to severe OSA patients who quit CPAP but are in need of treatment.
Our US sales team is already actively engaging with these targeted sites, working through the value analysis committee and pre-authorization approval processes. From a launch execution perspective, I am very pleased to report that already in the first week, we received several VAC and pre-authorization approvals. It's also very exciting to see multiple physicians with patients lined up who are running quickly to become the first to implant the GENEO commercially in the US. Regarding reimbursement, we have identified the use of CPT code 64568, which has been recognized by commercial and government payers for the OSA indication.
This is the same CPT code used by our competitor, and we feel confident that we will be able to differentiate ourselves via our unique technology benefits and patient focus. As a result of our ongoing work with the American Academy of Otolaryngology and participation in the FDA's early payer feedback program, educating CMS and major commercial payers on the clinical impact GENEO can have on their OSA patients, positions us well for acceptance of pre-authorization submissions in the near term and favorable coverage decisions in the long term. With over 100 physicians in the US already trained and additional weekly training sessions scheduled, there is strong momentum building in the medical community.
Organizational traction in the marketplace is demonstrated by the many physicians lining up patients for a GENEO implant in just our first week of commercialization. This early interest gives us confidence in the success of our US launch. We have also identified demand from patients who are hesitant about receiving an implanted battery which requires the need for subsequent surgery to replace this battery. The GENEO system addresses this need with its unique and less invasive design. There has recently been a lot of discussion on the potential impact of GLP-1 on the AGNS market.
Contrary to our competitor, we have strategically limited our patient population to those with a BMI below 32, since that is where the efficacy for GENEO is proven. As a result, we believe that the eligible GENEO patient population will grow, not shrink. This belief is based on third-month study data showing GLP-1's ability to bring patients with high BMIs of 37 and above down to a BMI level where clinical data demonstrate that GENEO is effective. Without GLP-1s, we would never be able to treat this high BMI patient population. While there might be patients with lower BMIs dropping out of the potential AGNS patient population, this will be outweighed by a significant number who become eligible for AGNS.
On another topic, prior to GDUFA approval, Inspire Medical initiated a patent lawsuit against Nyxoah S.A. Since Nyxoah S.A. was founded, we have invested significantly in our IP portfolio and we will vigorously defend ourselves in this matter and have the means to do so. This patent lawsuit will not impact our US commercial launch, which is already underway and generating a lot of enthusiasm in the marketplace. To conclude my opening remarks, I want to emphasize that the FDA approval marks a pivotal moment for Nyxoah S.A. Our bilateral stimulation technology offers a truly differentiated solution that makes us unique for patients.
We believe GENEO can fundamentally improve the quality of life of OSA patients by giving them a good night's sleep. With the current ongoing momentum, and physicians already lining up patients for GENEO, we are confident in our ability to execute a successful US launch. With that, I'll turn the call over to our CFO, John Landry, for a financial update.
John Landry: Thank you, Olivier. We recorded revenue of €1,300,000 in 2025 compared to €800,000 in 2024 for an increase of 73.8%. Gross margin in 2025 was 63.4%, or essentially flat to 2024. Total operating loss for 2025 was €19,900,000 versus €13,300,000 in 2024. This was driven by the acceleration in the company's commercial investments in the US in preparation for post-FDA commercial launch. Our cash position, including cash, cash equivalents, and financial assets, was €43,000,000 at 06/30/2025, compared to €63,000,000 at 03/31/2025. We also have €27,500,000 available to us under our term debt facility, which can be drawn down in two equal tranches of €13,750,000 each, subject to certain milestones.
With that, I'd now like to hand the call back to Olivier to discuss his thoughts on the remainder of 2025.
Olivier Taelman: Thank you, John. Before we conclude, I want to emphasize that this FDA approval represents a truly historic moment for Nyxoah S.A. I would like to thank all Nyxoah S.A. employees for their persistence and effort in making this happen. We have now officially entered the US OSA market with our innovative GENEO solution, and the launch is actively ongoing. The enthusiastic response from physicians and their patients reinforces our confidence in the success of this US launch. We believe the remainder of 2025 will be a transformative period as we establish GENEO in the US market and advance our mission of making sleep simple for patients worldwide.
We look forward to updating you on our progress on our next earnings calls. With that, I would now like to open the line for questions.
Operator: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press 11 on your telephone, and then wait for your name to be announced. To withdraw your question, please press 11 again.
Jon Block: Our first question comes from the line of Jon Block with Stifel. Your line is open.
Jon Block: Obviously, big congratulations to you and the team. I'll start off just any year-end '25 metrics you know, any indicators to focus on. Trade positions. I don't know. I'll throw that one out there even though I know you said you already have, I think, it was over 100. Can we be getting a glimpse to that? The number of certified centers, the number of implants? I know it's early days, but just as we think about over the next three or four months, you know, where our eyes or where our focus should be as we think about exiting '25 in regards to the GENEO launch? Thank you.
John Landry: Yeah. Thanks for the question, Jon. In terms of some of the leading indicators that we're tracking, obviously we mentioned today the number of physicians trained. That's going to be something that we keep a close eye on as that's obviously a leading indicator. We'll also be looking at the number of value analysis committee applications that we submit to the various institutions over time as that's also another leading indicator. Think over time we'll be looking at some other metrics vis a vis maybe number of accounts opened or pre-authorization approvals received. However, at this point in time, we're still working through that and we'll share more on our next quarterly call with all of you.
Jon Block: Fair enough. Thanks for that. And then I'll sort of pivot. Olivier, this one might be for you, but just you know, obviously, was the approval, but then there was also I don't know. I mean, in call it, like, the favorable label that went along with the approval. So you talk about how you expect to leverage the differentiated label, you know, such as no triple C contraindication, the sleep positional data. You know, I know if it's more of a commercial question, if you would, but how do you expect to capitalize on that in the go-to-market we think about over the next handful of quarters. Thank you.
Olivier Taelman: Thank you, Jon, for this question as well. Yeah, clearly it was for us. But an important win to also see this differentiation reflected in the label. As our mission is always to make sleep simple, and that starts also by being certain that we can protect patients throughout the entire night regardless of what position they are in. And that is why positional OSA is so important that also there we can continue showing a highly effective technology and therapy. And so forth, GENEO is the only technology that is offering this. So that comes to the supine data and the positional OSA.
When it comes to CCC, of course, there is extremely encouraging to see that also FDA is recognizing this. By not giving us a contraindication. Contrary to competition. And as you know, with access, there we also did great work. We had our PIs implanting a significant number so now we can closely we can stop the enrollment earlier because also there, we would like to advance on bringing this and making it available for CCC patients in the US. So both are reflected in the label. I know that you and many of your colleagues had questions on this in the past.
And, again, it is confirming what we were telling you that bilateral stimulation is making a difference compared to unilateral stimulation. And that this definitely will also help convince physicians when they have to choose between the two available AGNS technologies.
Jon Block: Alright. Great color. Thanks. I'll hang up more, but I'll hop back in the queue for now. Thanks, guys.
Olivier Taelman: Thank you, Jon. Please stand by for our next question.
Operator: Our next question comes from the line of Adam Maeder with Piper Sandler. Your line is open.
Kyle: This is Kyle on for Adam. Thanks for taking the questions, and extend our congrats on FDA approval as well. Maybe just first to double click a little bit on the commercial strategy, that you discussed in your prepared remarks. Was somebody to get an idea of which accounts you're kind of aiming to target first. Are they, you know, kind of centers from the dream study? Some of the high volume implanters? Can you just give us kind of any color around the accounts and the strategy there?
Olivier Taelman: Yes. No, no, definitely. As I mentioned in the script, we have a two-pronged approach. So first of all, we go and our sales team will focus on high volume, but also stimulation implanting accounts. Maybe as a quick reminder to this, you know that in the US, there are roughly 1,400 implanting accounts offering AGNS, but it stays a very concentrated market, meaning that 350 to 400 of these are high volume accounts and are representing 75 to 80% of the total revenue. So those are the accounts the team will be focused on. We start with a team of 50 commercial people. Of which 25 are territory managers.
They will all have four to six of these accounts, and we have built what we call a scalable technology. So every quarter, we will add a number of territory managers and increase the number of accounts so that we can cover as soon as possible all 400 of those high volume implanting accounts. So that is what we call, you know, focused launch. Next, and I think as important, is also strengthening the referral parts. And the way we are doing this in that technique, so it's totally different compared to the way it's done in the past in the sense that we will focus on patients that have moderate to severe OSA and are quitting CPAP.
And also there, focusing on those specific patient groups will definitely strengthen the trust and confidence of physicians, and will also further make sure that patients in need for treatment will get a sleep surgeon that can help them with the solution. So that's all we plan to go forward with our launch strategy.
Kyle: That's super helpful. Thanks for the color there. Maybe just for my second question, to shift over to reimbursement a little bit, is there just how do you plan to go about that process here looking forward? Is there any logistical considerations you know, around, like, the work that you're doing with the different payers? And then maybe more specifically, when can we expect to see some onboarding of some of the larger payers? Would it be fair by the end of this year, or it kind of more of a 2026 story? Thanks again, guys.
John Landry: Yes. Thanks, Kyle. I can take this question. So, in terms of our reimbursement strategy, we have a comprehensive reimbursement strategy. So, we're using, as you may be aware, an established CPT code. At launch, we're using the 64568 code. We've worked closely with the AAO on that particular code. We've participated in the FDA's early payer feedback program. And we're also been working with engaging CMS in major commercial payers in the US around this particular code. So as we work through this multifaceted approach and strategy, we expect these decisions will start coming in first for the pre-authorizations. We'd expect some of those to come in this year.
Clearly, I think we mentioned we had our first one now, but we expect more of those to come in over the balance of the year. And then as we start moving into more of coverage decisions, if you will, that'll be probably more of a 2026 item, Kyle.
Kyle: Perfect. Thank you.
Olivier Taelman: Welcome. Please stand by for our next question.
Operator: Our next question comes from the line of Suraj Kalia with Oppenheimer. Your line is open.
Suraj Kalia: Hey, Olivier. John, can you hear me all right?
Olivier Taelman: Yes. We can. Hello, Suraj.
Suraj Kalia: Perfect. Gentlemen, congrats on the approval. I know it's been a long time coming. And on the label. So, Olivier, quick one. Let me start out. You mentioned system enrollment has been stopped. I presume that the SME chimed in and helped you all reach that decision.
Olivier Taelman: Yeah. So when it comes to the access study, in fact, we reach a significant number of patients that are already implanted that gives us the confidence that if we have to draw statistically conclusions that are statistically forward enough, right, to use this terminology that we have more than enough patients. Maybe to give you some background Suraj on this, and I'm looking also what is going what is happening in the OSFIRE study. We know that the number of patients that we are having, we have already more than doubled the number of patients that have an where they're also looking at CCC patients.
So that's just a side comment but I think important information for you to know as well. And then the next thing on this why we make this decision is we wanna help patients with CCC in the US as well. Like we are doing in Europe in a very successful way, like we demonstrated in Australia, the better sleep study. And therefore, here, we cannot wait. And when you have enough patients implanted, we do think it is so well calculated decision to stop earlier and that we can activate the twelve-month follow-up time frame.
So by same time, same period next year, will be able to publish those data then we submit a PMA supplement, and we should already be able to '26 beginning latest beginning '27 also to add this to our label in the US and be able to help CCC patients. That are currently contraindicated for AGNS.
Suraj Kalia: Got it. Will it be a I'll question, please? So just the second one for me. This how are you thinking about patient outreach and packaging of the products specifically Supine, CCC, lack of a battery, what's the How are you thinking about packaging this? Do you think you're making it back even it's the same inspired Yes. Makes sense. So you'll intend launching a targeted approach for bilateral.
Olivier Taelman: So first of all, Suraj, we will further leverage on our clinical data. I think this is this is really important. So that we look at patient phenotypes when we know we are extremely efficient. You know, the adult patient population, then when it comes to AHI, and I would like to point this out in dream of AHI range, it's 15 to 65. Which is already different compared to competition where it's 20 to 50. So there, we're already able to install to demonstrate a strong number 15 to 65. So that is one aspect.
Another aspect is what we learned in market research is that for physicians is extremely important to know that their patients will be protected through o gen iodide. So this is something that is not only resonating well with ENT surgeons, but it's very well resonating with sick physicians who have to refer patients. Because they see this effect when they stop studying polysomnography sleep exams They see exactly when a patient is in what position So it's a great benefit being able to show protection throughout the night for a sleep physician providing them confidence when they refer a specific patient all the way to an ENT surgeon for the genome.
And then last, when it comes to the outreach, yes, we have a focused launch. We start with 25 territory managers. They hook up four to six centers. I think I already explained concentrated the business still is in the in the US, and we will scale quarter after quarter by adding roughly 15 new territory managers and each time adding up to 75 new implant sites. And that, to John's point, will only also become one of our key metrics in measuring our success going forward. And it gives us the ability in short term also to reach all 350 to 400 high volume sites. Hope this is answering your question.
Suraj Kalia: Thank you.
Operator: Please stand by for our next question. Our next question comes from the line of Ross Osborn with Cantor Fitzgerald. Your line is open.
Matthew Park: This is Matthew Park on for Ross today. Thanks for taking the questions, and congrats again on FDA approval. So starting off with Olivier on back approvals, how should we think about a reasonable pace for account openings through the remainder of '25 and into '26? And then are there any headwinds here that we should be mindful of?
Olivier Taelman: Yes. No, it's an excellent question in the sense that what the team did really successfully is to augmenting also the VAC committees by time they need in order to reach a decision. What we learned is you have some that go extremely fast. As I already mentioned, we have the first time we have several of those fast track committees where we already passed the VAC committee. But you also have number of VAC committee that will really take their time, and time can go up to nine months in some in some advantage and so in some cases.
So here, will focus and follow the segmentation The fastest, of course, there we are currently immediately, and that's how we further scale up. And I do not want to set expectations on saying this is the precise number that we will achieve by the end of this year. It is clear that, you know, targeted approach all the hospitals that we are targeting, they also will go to the VAC and we expect all of them to gain us an approval in the coming six months.
Matthew Park: Got it. That's super helpful. And then, that one for John here. You know, as we're thinking about spending the back half of the year and into '26 as you guys filled out commercial infrastructure in the US, can you kind of walk us through some of the puts and takes around operating leverage that we should be mindful of?
John Landry: Sure, absolutely. From an OpEx perspective, we don't provide specific guidance, but maybe you can provide some color in terms of how we're thinking about the investment levels. So for so the back half of this year, in terms of OpEx spend, we'd expect to see R and D continue at pretty consistent rate and then maybe be a little bit up year over year. Considering some of the investments we're making in the IP litigation front. From an SG and A perspective, that will be considering the investments that we made in our sales and commercial efforts in the US with the 50 highly talented professionals we have in that organization.
And then as we look at 2026 from an overall investment level perspective, we'd expect the majority of the increase next year to be in the way of SG and A as we increase the size of commercial organization, again, by expanding it by those scalable units 15 territory managers over the course of the year. So you know, we could expect to see potentially the SG and A spend nearly double in 2026 over the levels seen in 2025.
Matthew Park: Got it. Thanks for the color. Congrats again, guys.
Olivier Taelman: Thank you.
Operator: Please stand by for our next question. Our next question comes from the line of David Rescott with Baird. Your line is open.
David Rescott: Great. Thanks for taking the questions, and congrats on the approval here. Wanted to ask first on reimbursement, the VAC, the prior auth processes that you've called out. In the prepared remarks. I guess, you just help us understand what considerations go into those, VAC and prior auth, you know, conversations? Are you definitively kinda locked in to reimbursement there? Did Is that fully ironed out? Just how do we think about what the prior auth and back processes are, relative to kind of what the underlying CPT code and commercial coverage cost?
John Landry: Sure. Yes. Thanks for the question, David. Yes. So early on, it's clearly early on in the process. But in terms of the approvals that we received, vis a vis the VAC and or the pre-authorizations that answer is yes. So we've gone through the process. I think really what we're looking to do there is demonstrate the clinical efficacy and the effectiveness of the technology. Certainly, utilizing the HTNS code, the 64568 code on the CPT side, And we've been able to have success in demonstrating that at least in this early stage to those hospitals and accounts and centers where we've completed the VAC.
And as Olivier mentioned, there are various lengths of process for these VACs as well as the pre-authorization process. The VAC approvals can range anywhere from very short periods of time up to nine months. And you know, on the pre-authorization process, it's, you know, extended as well. So that's where we're at this point in time, and forward to continuing to build this body of approvals.
Olivier Taelman: And maybe in addition to this, if you allow me to add, AGNS is no there is no longer one company that is offering an AGNS solution. I mean, with GENEO, we enter the market. There is no option to choose. And that's why today, as of today, there is an AGNS treatment solution there are different companies offering this. And I think that's also important. So the previous work done in the past it was also linked to AGNS. So all the faculties, they recognize this. And they know what it is and what it can do.
And as of today, there are two companies who can offer solution, and it's up to their physicians that will decide together with the patient solution they will choose.
David Rescott: Okay. Great. And then maybe on the, you know, DCC patient, population, you know, you've got the no contraindication. You know, there's the warning that it wasn't tested, but you have access, that is coming. One, I guess I don't know if you if you called out a timeline. I might have missed it on the access side for when that data should read out. But I guess how do we think about the patients that are on the CCC side that can get treated you know, today versus those that you can kinda go after and target once you have access kinda fully in hand.
Olivier Taelman: So when it comes to the access trial, now we stop the enrollment. So the time clock for twelve months can start. So twelve months from now, we will have the data of all access patients, and then based on this study data, we will submit the PMA supplement. Normally, this takes roughly another six months before FDA grants you a supplement. So if you do the math, earliest end of Q4 2026 beginning Q1 2027, we could have CCC patients added to the label. Today, having no contraindications, I will vary I thought that FDA is recognizing already that CCC, it's something where they would like to see US specific data before adding the label.
But where they also recognize the fact that CCC should not be a contraindication. And I think that's an important first step in the direction in opening it up in the US market for patients also OSA patients suffering from CCC.
David Rescott: Okay. So would it be fair to assume that you know, can start treating NCCD patients, say, since there is no contraindication, maybe pump the gas, on that once you have access out and the PMA supplement in? Or, in the near term, are you really kinda just waiting for the access results?
Olivier Taelman: Thank you. So in the near so we are waiting for the excess results and let me be very clear on this one. We would not promote an off-label indication. And today's CCC, It's Also For GENEO Off Label In The US. So we would never ever promote this. But on the other hand, it is clear that it's on a contraindication and it is in the warning section of our labeling. So physicians, they know what this needs.
David Rescott: Okay. Perfect. Thank you.
Operator: Please stand by for our next question. Our next question comes from the line of Michael Polark with Wolfe Research. Your line is open.
Michael Polark: I have two First one, pricing. Can you confirm as you launch now in the US, intent to price at Inspire's level $25,000 Or has the thought process on pricing changed?
Olivier Taelman: No. Indeed. So we use the same CPT code. And we are following also the class strategy that it comes with the CPT code. To your point.
Michael Polark: What I figured. Just thought it worth clarifying as we go into launch. And then my second question is if you look to open accounts, is there an ask you're making of these surgeons You invest in them, you train them, you're gonna be, you know, targeting and competing for patients, on their behalf. That's an investment that you make. What kind of return do you ask of these initial centers, if anything? And I'm just thinking, like, look. They're they're all in the business of hypoglossal nerve stem. They have large wallets.
What is a share of wallet that you're you're wanting kind of a maybe not as a firm commitment, but a soft commitment from these surgeons as you get going this initial cohort? Is it is it 10%, 20%? Is it more? I'd love a feel for how you go about those initial conversations and signing up this initial group of their planters. Thank you.
Olivier Taelman: Thank you, Mike, for this And it's also a question, of course, as you can imagine, that we internally discussed as well because we have a lot of demand from positions for HMO to be trained on the on the technology. And we can unfortunately not train all of them at the same time. So what we are asking is before a physician is eligible, like, to join the training or invited for a training, they need to come with five patients. Clearly defined patients, and we use the criteria as the same criteria as in the dream study. So we ask them to come with five patient cases, then they get the training.
We can already discuss those five patients so they can be implanted right after they go back after being trained. That's what we do. When it comes to much share, because you are removing also the last 10 of 20% market share, Honestly, we don't at this stage.
We do think that if they are well trained, high quality training, they do their five cases meaning that they will all go through their surgical learning curve, then we are convinced that they will make the right decision when patients are coming and that also patients will know if they can choose a bilateral stimulation with a single incision You know, all the different differentiated factors, full body MRI compatibility, that we will be able to capture a lot of patients with our GENEO.
Michael Polark: Thank you for the color.
Operator: Thank you. Ladies and gentlemen, that concludes our question and answer session. I will now turn the call back over to Olivier Taelman for closing remarks.
Olivier Taelman: Thank you again for your time today. And your continued support of Nyxoah S.A. As I mentioned in the beginning, this is the most exciting time in our in our company history. We are so excited to be able to launch in the in the US. I will also not forget on international markets where we're also making good progress but it's clear that the market is in the US. And finally, after so many months, years of orthographic I'm pleased that we can answer this and then the entire team is extremely exciting. So you will and I will look forward also updating you on our progress in the coming months.
So thank you all again, and have a nice day.
Operator: Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.