Nyxoah SA

Ladies and gentlemen, thank you for standing by, and welcome to the Nick Sola First Half 2021 Earnings Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star then one on your telephone. If you require any further assistance, please press star then zero. I would now like to hand the conference over to your speaker for today, Vivian Cervante, Investor Relations at Gil Martin Group. You may begin.

Thank you, Tawanda. Good morning and good afternoon, everyone. Welcome to our earnings call for the first half of 2021. Participating from the company today are Olivier Talmad, Chief Executive Officer, and Fabian Suarez, Chief Financial Officer. During the call, we will offer commentary on our operating activities and review our first half financial results released after U.S. markets closed on August 31st, after which we will host a question and answer session. The press release can be found in the investor relations section of our website. This call is being recorded and will be archived in the investor relations section of our website. Before we begin, we'd like to remind you that any statements that relate to expectations or projections 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 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 information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our prospectus files with the SEC on July 6, 2021, in connection with our initial public offering on NASDAQ. With that, I will now turn the call over to Olivier.

Thank you, Viviane. So, good morning and good afternoon, everyone. Thank you for joining us on our first earning conference call as a publicly traded company. on both Nasdaq and Euronext Brussels to discuss our first half of 2021 operating results. Before I begin with my script, I'd like to thank our team at Nixoa for their dedication and focused execution, resulting in a Nasdaq listing during which we raised $97.8 million. Having completed two IPOs in less than 12 months puts the company in a strong financial position to achieve its vision to become a leading neuromodulation company in the field of obstructive sleep apnea. I also would like to welcome the new Nixoa shareholders and thank them for their participating in our journey. In the first half of 2021, we continued to execute on our programs, building further on key accomplishments made in 2020. This includes the first area of focus, the pivotal US IDE trial called DREAM, for which we can report steady progress, maintaining our target to complete enrollment in Q4 2021. The second key area of focus being the commercial proof of concept in Germany, where I'm pleased to report that Nixoa is now fully integrated into the German hospital system with a formal DRG reimbursement scheme, resulting in in a strong therapy adoption in the top accounts, but I will come back to this later. Further, market expansion activities in Europe resulted in a formal DRG coding in Switzerland. It's the second DRG reimbursement scheme that we have in place in Europe, and we generated our first revenue in Spain and in Belgium. Next area of focus is the therapy indication expansion for concentric collapse or complete concentric collapse, so-called triple C patients studied in the Better Sleep trial. Better Sleep top line results show that we reached primary safety and performance endpoints with a statistically significant mean reduction in AHI for both triple C and non-complete concentric collapse patients, leading to a submission with the European notified body to expand our label to include those complete concentric collapse patients. In the United States, Nixoa plans on pursuing the FDA breakthrough device designation for the Genio system in order to shorten the approval path to treat CCC patients as well. We will submit full Better Sleep study data to a medical journal for publication and announce results following further analysis. Next, Nixoa is strengthening its vision through our collaboration with the US Vanderbilt University, supported by US and German key opinion leaders, in order to integrate a new anthracervicalis stimulation technology into our scientific and technology department pipeline. Anthracervicalis is a different nerve compared to hypoglossal nerve stimulation, and it's also located in the neck of the patient. We also achieved further advancements in the tech transfer to our second manufacturing facility, the one in Belgium, by successfully completing the third phase. So far, the highlights. Let me now move to a more detailed review of our activities. Following our successful NASDAQ IPO, we strengthened our balance sheet, allowing us to continue to strategically deploy our resources to drive market penetration in Europe, steadily advance our clinical programs, scale up, and build upon our IP, product, and adjacent technologies with our focused R&D activities. Now let me walk you through our priorities, and starting with the first one being the U.S. DREAM Pivotal Study. The U.S. DREAM Study, or our Pivotal Study in the U.S., aims to, first, confirm the safety and effectiveness of the GenioSystems, and to support marketing authorization of the GENIUS system in the U.S. The study plans to enroll 134 moderate to severe OSA patients who failed first-line CPAP therapy, with 12-month effectiveness and safety primary endpoints. We continue to make progress on rolling patients into the trial. To date, we have identified 25 centers for the trial worldwide, of which 16 centers are currently active and enrolling patients in the United States. The other centers are in Australia, one in Germany, and one in Belgium. Based on the current enrollment rates, we continue to expect enrollment completion in the fourth quarter of 2021. We expect to obtain FDA approval and Genio's system to be commercially available by the end of 2023. Let me now discuss our commercial activities. We are committed to developing and then leveraging key centers of excellence as we go deep versus go wide in driving market penetration of our genius system. Our activities center on active engagement, education, and market development across patients, physicians, and hospitals, with focus on high-volume EMT surgeons and sleep doctors. who see, diagnose, and treat patients with OSA. We also tailor our programs to suit local and regional reimbursement needs, including the pursuit of a fast follower strategy in regions where there is already hypoglossal nerve stimulation therapy and establishing market leadership in new regions where we intend to develop coverage. In the first half of 2021, In Germany, we successfully transferred our existing NUB coding into a dedicated diagnosis-related group, or DRG, for hypoglossal nerve stimulation. This shift allowed us to ramp up our commercial activities with the German accounts. NYXOA commercial proof of concept consists of a two-step approach. Step 1, 12 months after DRG reimbursement, becoming German market leader in these top accounts, tier one accounts, or center of excellence. And 24 months after DOG reimbursement, becoming market leader all over Germany for hypoglossal nerve stimulation. In the first half of 2021, 20 genius systems were implanted in these top accounts or tier one accounts in Germany. During the first half of 2021, there was an increased commercial penetration with a six-time increase in accounts in Q2 versus Q1, resulting now in 12 active German accounts. In addition, Nixowa invested in building a German commercial organization by having eight full-time employees in Germany led by a German country director. All these employees were trained and were operational by the end of June. The recruitment of two additional sleep experts who will interact directly with sleep labs and patients, and on top of that, a dedicated German marketing manager is ongoing. Simply put, we are strategically hiring personnel as we build out both our organization and infrastructure to grow our business. We plan to drive further expansion by entering new markets. During the second quarter of 2021, we were able to generate revenue in Spain which is a complete new market for hypoglossal nerve stimulation, and in Belgium. In these two countries, several accounts were activated. And last but not least, Switzerland. Reimbursement under an OSA-specific DRG code obtained from the Federal Statistic Office was obtained. We also submitted a new reimbursement dossier for hypoglossal nerve stimulation in Belgium. Further, we are preparing market entry in the Nordic countries, Italy, and Israel by actively engaging centers of excellence. Turning to our clinical program for international markets, where the focus is clearly on the Better Sleep Study. Better Sleep, as a reminder, it's a multi-center, prospective, open-label, two-group clinical study to evaluate the safety and efficacy and performance of the Genio system for the treatment of OSA in adult patients with and without complete concentric collapse of the soft palate. This study is the first study of its kind to include those triple C patients. It was conducted in nine medical centers in Australia and New Zealand. In June 21, we announced that the Better Sleep trial reached its primary safety and performance six-month endpoints, in 42 implanted patients. Of these 42 implanted patients, 17 were complete concentric collapse patients. And the data showed us a statistically significant mean reduction in the AHI score from baseline to six months post-implantation in the full analysis patient population, meaning both triple C and non-triple C patients, the same statistically significant mean reduction in AHI in the triple C patient subgroup only, and a statistically significant mean reduction in AHI from baseline in the non-CCC patient subgroup. To quote our principal investigator, Dr. Richard Lewis, the most impressive aspect of the result is the response rate of the complete concentric collapse patient subgroup. In summary, we continue to build a body of clinical data in support of our bilateral hypoglossal nerve stimulation technology. We publish the full data set of our Better Sleep study and already have productively dialogued and interaction with the European notified body. In the United States, Nixoa plans on pursuing the FDA breakthrough device designation for the Genio system which we hope will have a positive impact on shortening the approval path to also offer a treatment solution for complete concentric collapse patients. Let me now turn to a discussion of our resurgent development activities. In the first half of 2021, we made important progress in our R&D programs. In January 2021, We received a CE mark for an MRI conditional labeling, ensuring that patients implanted with the Genio system can now undergo a full-body 1.5 Tesla and 3 Tesla MRI diagnostic scan within approved parameters. We note that MRI compatibility aids in OSA patients' quality of life with over 40 million MRI scans performed on OSA patients in 2020 alone, with 60% of MRI scans performed in the thorax or abdominal area, and 40% of MRI scans in 3-TESLA. To date, we are the only company with an MRI compatibility label for 3-TESLA. And in February 2021, we announced also or exclusive licensing agreement with the Vanderbilt University. This is allowing us to access to technologies and capabilities to build our pipeline. We have started development of this new technology in collaboration with US key opinion leaders, but also with the help of some German key opinion leaders. New treatment options will focus amongst others on stimulating the ansa cervicalis nerve. As previously noted, we developed our proprietary junior system with the obstructive sleep apnea patient in mind. Our R&D initiatives maintain that focus. Building on these accomplishments, we look forward to delivering on additional milestones ahead. For the second half of 2021, we expect to begin marketing in Switzerland Nordic countries and Italy, with an increase in revenue generated in countries where we are already present with the key focus on Germany. We also look forward to opening our manufacturing facility in Belgium to further scale up production capacity. And finally, in the US, we continue to expect to complete enrollment in the DREAM IDE trial by the fourth quarter of 2021. With this, let me now turn the call over to Fabian for our financial discussion.

Thank you, Olivier. Good day to everyone. Thank you for joining us on our call. I will provide some highlights from our P&L and our balance sheet. For further details, please refer to our earnings press release issue yesterday and our half-year report. Revenue was €355,000 for the six months ended June 30, 2021, compared to no revenue for the same period of 2020. The increase in revenue was attributable to the company's commercialization of the junior system, mainly in Germany and with some contribution from Spain and Belgium. Due to an administrative delay in one of our German hospital finance departments, €100,000 of revenue generated during the second quarter will be recognized in the third quarter. The total cost of goods sold was €150,000, with gross profit of €240,000 or gross margins of 67.6%. We realized a net loss of 12.6 million euros for the six months ended June 30, 2021, compared to a net loss of 4.3 million euros for the same period in 2020. General and administrative expenses increased by 2.4 million euros, or 99%, from €2.4 million for the six months ended June 30, 2020, to €4.8 million for the same period of 2021, due to an increase in consulting and contractor fees. Research and development expenses increased by 173% before capitalization of €0.6 million for the six months ended June 30, 2021, and the same amount for the same period of 2020. Research and development expenses increased by 1.1 million, sorry, from 0.7 million to 1.8 million due to an increase in staff and consulting costs to support our R&D activities. Clinical expenses increased by 96% before capitalization of 3.1 million euros for the six months ended June 30, 2021, and 1.4 million euros for the same period of 2020. Clinical expenses increased by 1.8 million from 1.9 million to 3.7 million euros. The increase in the expenses was mainly due to an increase in staff and consulting to support the completion of the Better Sleep trial implementations, continuous recruitment for the ELISA trial, and the ongoing Dream IDEA trial in the United States. On June 30, 2021, cash equivalents totaled 79.2 million euros, compared to 92.3 million euros on December 31, 2020. The decrease in cash and cash equivalent resulted mainly from net cash flows used in operating activities of 8.4 million euros and net cash used in investing activities of 4.5 million euros. In July 2021, we completed our initial public offering in the United States with 3,260,250 ordinary shares included over allotment at a price to the public of $30 per share for total gross proceeds of $97.8 million before deducting underwriting discount and commission and estimated offering expenses. Proforma Cash, assuming the US IPO was completed as of June 30, 2021, was 154.7 million euros. With that, I will turn the call back to Olivier.

Thank you, Fabien. We are now concluding the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session. Thank you.

Thank you. Ladies and gentlemen, as a reminder to ask the question, you need to press star then one on your telephone. We ask that you limit yourself to one question and one follow-up. To withdraw your question, press the pound key. Again, that's star one to ask the question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Adam Mader with Piper Sandler. Your line is open.

Hi, Olivier. Hi, Fabian. Congrats on all the progress over the past six to 12 months, and thanks for taking the questions here. I wanted to start with one on U.S. path forward, regulatory path forward. It sounds like the DREAM study is tracking according to plan, which is great, but was wondering if you could give us some incremental details on things like number of patients implanted and consented, You know, how are those metrics trending? And just talk a little bit more broadly about the level of confidence in delivering against that Q4 2021 enrollment completion guidepost that you've given us, and then add a follow-up.

Well, thank you, Adam. Thank you for the question. So there are several questions in this one question, so let me try to answer as complete as I can at this moment. So first of all, I started by saying what would the regulatory part look like in the U.S. in going forward. As we already explained in the past, there will be two different routes that we can become eligible for. One would be the more traditional PMA. The other one would be the de novo route. Now, in order to get more clarity on this from FDA, we will definitely need first preliminary dream study results around safety to get a further indication on FDA's thinking. So what we expect to do on this one is after we reach six-month endpoint, I know six-month point already, to look at the safety results, that's also how it was designed in the study, and then start interacting with FDA to get more clarity. So that is maybe an answer to the first part on the regulatory path, PMA, or the notice. Second part of the question, if I understood correctly, is where are we on the enrollment? And as mentioned already before, We are feeling very confident that we will close the enrollment by the end of this year, so by the end of Q4. To give you some more details on the enrollment, currently we have 172 patients enrolled into the DREAM study. You know that we have 16 sites active in the US. On top of that, we have our Australian, German, and Belgium sites. What we also learned is that by working with a professional recruitment agency, that this is really impacting in a very positive way also the enrollment on patients. So in conclusion, regulatory part will become more and more clear when we have six-month safety data coming from the dream patients. And when it comes to the enrollment, we stick with our previous commitment, ending this by Q4. And when it comes to speeding up and also to manage current challenging situations in the market, mainly driven by COVID, not to call this in as an excuse because I think in business life now, COVID has become part of this, but we also take some creative actions like working with recruitment agencies, like virtual proctoring, et cetera.

Got it. That's very helpful, Kalar. I appreciate that, Olivier. And maybe just for my follow-up, wanted to hear a little bit more about the commercial progress you're making in Europe and in Germany in particular. I think you added a nice chunk of accounts in Q2. Maybe just talk about how quickly you anticipate those accounts will ramp. You know, how do we think about the revenue contribution from these centers going forward? And then just would love to hear how physicians are, you know, embracing Genio or utilizing Genio in you know, in their systems. Is it outright switching away from the incumbent product? Is it trialing? Is it splitting? Just any color there would be much appreciated. Thanks again, guys.

Yeah. So first of all, I'm very happy that you noticed also the strong uptake in opening new accounts. So today we have 12 active accounts in Germany, and this is really exceeding our expectation, and let me explain why. And therefore, I would like to come back to our commercial proof of concept that we rolled out in Germany. As you maybe still remember, we are talking about a two-step approach. Step one would be to focus on the tier one or the center of excellence or the top account in Germany, roughly six accounts. Step two or phase two would be following by other Hippoglossal North experience accounts and also becoming the market leader in 24 months or by the end of 2022 in Germany. So what we see today is that the top one, or the tier one accounts, that we have opened up these accounts, that we are actively engaging with them, and that these are the ones that are driving our end plan. That's already part of our strategy, and also reaching our expectations in the first six months. On top of this, we were solicited by multiple, what we call tier two, or accounts where there is a colossal nodular activity ongoing, and they're reaching out strongly to us, so therefore we already are happy to communicate that we opened seven more accounts of these tier two accounts. So in total, 12 active accounts in Germany, they're all screening for patients, and we will expect in the second half to have all 12 of these accounts actively implanting. So that's the first step. So next to this, answering how physicians are responding and what their reaction is, also here, I can say that the reactions are extremely positive. First of all, for a surgeon, the implant time is so important, and we are now having skin-to-skin times of 61 minutes, 62 minutes, so we already communicated that we see skin-to-skin around 60 minutes. Also, this is confirmed by the German surgeons who are actively implanting the NYXOA technology. So that is already one positive sign. The next positive comment that we get is on the results when the technology is activated, and there EMT surgeons are mainly referring to the bilateral stimulation effect, that they really see very concentric pools on the upper airway, which they describe a link to bilateral stimulation, and that patients are also extremely happy when technology is activated and that they are using this in a very compliant way. So that's the second key observation that we have. Now, in going forward, and I already touched on this, you have the patient group of complete concentric collapse patients that are currently contraindicated for hipoglossal nerve stimulation. So also in this patient group, physicians are really waiting for us to get this therapy indication expansion to have the warning that we have currently in the IFU lifted so that they can also implant these patients as well. So overall, very, very positive reactions. and we also know are focusing on having patients talking to each other and sharing also their personal experience.

That's a helpful call. I appreciate that, Olivier, and thanks again for taking the questions.

Thank you.

With pleasure.

Our next question comes from the line of John Block with Stiefel. Your line is open.

Thanks, guys. Good morning, good afternoon. Olivia, maybe for you to start, can you just help us with maybe the timing or next updates for the pursuit of CCC in Europe, when you'll hear from the regulators, and then maybe also the next step or timing when you expect more color regarding the breakthrough designation in the U.S. for CCC as well, just any color around the timeline for both of those would be very helpful, and then I'll ask the follow-up.

Thank you for the question, Jonathan. The first one, the notified body regarding CMORG expansion to include CCC patients. We have submitted the file to the notified body and know there are two options based on the review criteria. If they would use the latest MDR criteria, we would have the answer before the end of the year. If they would still use the existing review criteria, And we think we make a good chance that that can happen because we have submitted the file and engaged the interaction already before the transfer was taking place under the new MDO criteria. We could already have an answer by the end of October. So it will definitely be before the end of this year. Best case, it can also be before the end of October.

Okay, great. Thanks for that. And then maybe just to pivot and go back to Adam's question on Dream, I think I got the number right. I think you said 172 enrolled. Is there a rough sort of enrolled to implant ratio that you can provide? Is it four to one? Is it five to one? You know, maybe if you're willing to help us out with that, or even better, just give us the outright number of implants to date for Dream. You know, either one of those would be very beneficial. Thank you.

Thank you. It's a little bit funny when you mention 4 to 1 or 5 to 1 because to be very precise, it's 4.5. That is the enrollment implant ratio that we are seeing today. So that is one thing. The next thing is at this moment we have 22 patients of which 10 are already implanted, 12 more have an award date and will be implanted in the coming days. I'm also very pleased to announce that we will have Dr. Lewis from Australia now flying in to the U.S., arriving on September 20, and stay there for two weeks, with the key objective in having four U.S. EMT surgeons fully trained and certified to start proctoring their colleagues. This is something that I would like to address of being creative based on the COVID restriction in travel that we are seeing. So I'm really pleased that we were able to overcome this and by having our PI present, our most experienced implanter, and so also we'll make sure that we have US proctors in place to then train and educate other US physicians, which definitely I will help and drive further the implant ratio. But from an enrollment perspective, it's going strong. we see that we are lining up patients, we are blocking over time, and we are doing already our implants. Okay, perfect. Thanks for the call, guys. I'll follow up offline. Thank you. Maybe I missed one question. I want to come back to Jonathan because there was also the question on the breakthrough designation timeline, not only on the notified body for CCC, but also breakthrough. This one I would like to be very precise. As you know, FDA, they have communicated strict timelines, so 30 days review time. This has happened. They came back with very positive news to us already with one more question, which we answered. So now we expect the final decision to be communicated in the middle of September, so second to third week of September. If they respect their 30-day timeline, we should be able to give you also the final answer on whether we have obtained the approval.

That's great. So a lot of news to come on the triple C side, I guess, both from U.S. and Europe over the next couple months. Thanks for following up on that, Olivier. I appreciate it.

With pleasure. Thank you.

Thank you. Our next question comes from the line of Laura Robo with DeGroff Petercare. Your line is open.

Yes, good afternoon. Thank you very much for the clear presentation. One question from my side. Could you provide some colors on the success rates that you get on approaching and convincing centers of excellence to adopt the genius system?

Yeah, so just that I understand the question precisely. So you're asking the success rate when approaching a center? Is this the question?

Yes, indeed.

So what we are seeing is because of our phased approach where we first focus on top centers or top experience centers with hypervascular nerve stimulation, we already see that there is a very strong pool of existing patients that is present. As you know, most of the patients, they are using CPAP. They need to be refractory to CPAP before they become eligible for hypervascular nerve stimulation. So this filtering... already is done or has mostly been done before the patients reach those specialized top implant sites. So then, at that moment when the physician is approaching and offering the technology options, meaning Nixoa versus the one competitor that we are having, what we are hearing back is that patients are really focused on the fact to have a surgery that is as minimal invasive as possible. I think that is one key success factor what you're hearing back from patients and from physicians. So the minimal invasive surgery. The next thing that we are hearing is that patients are also really interested in, once they are implanted, not have to come back too often to the hospital. With our technology, with the external software of the intelligence of the system, We can even push through software upgrades the moment the patient is just connecting the external component and the physician is also logging into a platform and the software upgrades can be pushed through. So that's the second thing that we are hearing. And last, we are also hearing that when patients, for example, are talking about recharging their device, about having no battery that can deplete Also, this is the third success factor that we are hearing. So in summary, minimum invasiveness of the surgery. Next, software upgrades that can be pushed through without going to the hospital. And last, having no implantable battery so that if they need to replace the battery or if the battery will be depleting, that they can simply charge it like they charge their phones currently. Those are the three success ratios, and that's what we are hearing back here.

Okay, very clear. Many thanks.

Thank you. As a reminder, ladies and gentlemen, that's star one to ask the question. Our next question comes from the line of Michael Pollack with Baird. Your line is open.

Hi. Good afternoon. I'm going to ask again on Dream Study. I just want to make sure I have the data straight. Okay. Twenty-two patients implanted so far, an additional 12 to be implanted in coming days or weeks, so that's 34 total. The 170, 170 number enrolled, what does that number mean? Because that's higher than your target, so I'm just trying to true up all these numbers.

Okay. No, no. And Mike, let me also share some more clarity because there are some things that I want to further clarify. So first of all, when you're mentioning on the implants and the patients that are pending an implant with an award date, so the number of implants that we have done is 10, and the number that is pending an implant with a fixed award date is 12. So in total, we're talking about 20. Okay. Just to clarify this. Now, when we talked about enrollment, the 172 patients, So what is this? So those are all patients that have been screened that are C-POP failures or refractory to C-POP, so they are eligible. Patients that are moderate to severe OSA, the only thing that still needs to happen is we still need to undergo a dice, because as you know, in the DREAM study, patients suffering from complete contemporary collapse needs to be excluded. So when we say 172, The only thing that is missing to make them eligible is the screening of dyes and not being complete concentric collapse. And that's also why the ratio is higher than, of course, your implant target. Now, another comment to this, to throw even a little bit more numbers at you, I mentioned the enrollment versus implant ratio being 4.5. So, in fact, if we have patients that are enrolled, For every four patients, we have one patient that currently is being implanted. And that's why we still need to enroll roughly 400 patients more before the end of the year in order to make sure that we will hit our implant ratio. I hope that makes something clarify things.

Yeah, so the 172, so all that needs to be done is dice, you know, the rough data and is a third of patients have triple C, so they get kicked out, leaving two-thirds. So is that what you're seeing in practice? So we take the 172, we multiply it by 0.67, and that's maybe a number that's closer to folks that you have enrolled that are going to be able to move to implant.

Okay. At this moment, the number in your calculation is a little bit lower. To be very precise and not going too much into the details, but what we are seeing is that we will need to have roughly 600 patients that qualify to be enrolled in order to get 134 implants. That's how we do the calculation.

Okay.

Okay. Yeah, no, I appreciate that, and I don't look at... I wanted to make sure we did as much clarification on this call as possible on that. So thank you. Maybe if I can ask on Better Sleep. So I appreciate all the data insights so far. My question is, the investigator in that press release commented that the most impressive data in Better Sleep was the responder rate for the triple C patients. You have not. and correct me if I'm wrong, you have not disclosed what that responder rate is. So can you give us a flavor for what that is or what you see in the data?

Unfortunately, I cannot at this moment because, as you know, there is always this tradeoff of making between a publication into a top medical journal, which we are still aiming for. So it would be wrong if I would comment on things like this because they are not public. And when it comes to the statement of our PI, As you can understand, we are extremely happy that he makes those statements, and those statements are also driven by his own experience when participating in the study and what he sees with his CCC. But I cannot comment more on this at this moment.

Okay. And what is updated timing for a potential publication or more data disclosure on Better Sleep?

Yeah, also on this one, Mike, unfortunately, so what we are currently doing is we are exploring the tradeoff to be made between submitting for a publication in a top medical journal versus disclosing study data in the most fast way. I know that everyone, including ourselves, we are really, really waiting to see the data and to show the data when it comes to NICSOA. Currently, the database is still being analyzed and the medical journal submission is being prepared. Unfortunately, we do not control whether it will be accepted and in which time frame. But as you can understand, and I keep coming back, we will have to take a strategic decision in order to make the tradeoff between the top medical journal versus disclosing as fast as possible. But we also are very well aware that the market and also physicians are waiting to see the analysis, and we do our utmost best to provide you with the full data set as soon as we can.

Yep, perfect. And if I can sneak one more in, on the Vanderbilt collaboration, the new target, the ANSYS cervicalis, look, I understand this is really early stage work, but at a high level, what are believed to be the potential benefits of stimulating that target for OSA versus hypoglossal?

No, no, this is an excellent question. And the The reaction and the feedback that we get from the researchers at Vanderbilt, but also from supported by top KOLs in the US and in Germany, as I mentioned, is the fact that today, hypoglossal nerve stimulation is really offering a strong solution for moderate to severe OSA patients. But there is still a percentage of non-responders. So the question will be, and that's where we will also be conducting further research, is how can antacervicalis provide an answer, those non-responders. That's already one thing. Second thing that we are looking at, as well as how will antacervicalis do as a standalone product, and how would antacervicalis do in combination with hypoglossal nerve stimulation. So all these parts are being examined, but it's clear that with what we can do today, hypoglossal nerve stim, we are focused on one dimension, the anterior-posterior dimension of the upper airway, with the antacervicalis, we will add a third dimension. And by having those three dimensions, we really believe and we are really proud that we can explore this and work with the researchers together because that is providing us a pipeline and we are convinced that that also will offer a neuromodulation solution for patients that currently have no solution. So we want to further expand, in fact, the market of the therapy access to patients that are currently cannot benefit from hypoglossal nerve stem.

Thank you. I'm sure no further questions in the queue. I would now like to turn the call back over to Olivier for closing remarks.

Well, thank you. Thank you. And in closing, I would like to close the call by reaffirming the large market opportunity for hypoglossal nerve stimulation. We really look forward to well addressing the unmet needs of this market with our patient-centric genius solution. So thank you for the questions. Thank you for calling in and listening. I'm happy to continue interacting with all of you. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.