At launch, we anticipate being reimbursed through prior authorizations and we would expect to be included in coverage policies within 12 months afterwards. Now very complete from a market access perspective, we have the team in place that is working to secure reimbursement from both CMS and the commercial payers. That team will also work with customers through the prior authorization process when we launched in the U.S.
Operator: Our next question comes from Suraj Kalia from Oppenheimer & Company.
Shaymus Contorno: This is Shaymus on for Suraj. So I believe earlier you said that you had submitted the third module to the FDA. Have you received any questions on the submission so far? Any feedback yet that you can share with us?
Olivier Taelman: So the short answer is yes. We did receive some deficiency questions on module one and two. We answered them, and they will also be submitted shortly. So just to summarize, and as a reminder, there are four modules in total, the first module was more quality overview on preclinical data. We submitted. We got some questions, nothing that is worrying us in the sense that we do feel extremely confident, and we also have answered all these questions. Second module, same thing, remaining preclinical data. Also there, we got, I think, I can say the normal or the expected questions that we are answering and then now with third module, it’s more on manufacturing and the manufacturing validation. So it was submitted a week ago.
Now the last one, and that’s why it got really exciting. So module 4, it will be the final module and that is the one we can submit with, including clinical data review and IFU labeling, and we expect to do this somewhere end of March, beginning April after we had the time to analyze the data that we will have in the first week of March of the DREAM study.
Shaymus Contorno: Got it. Looking at Germany and kind of the competition there, there’s some overlap, I know you’ve discussed it before between you and a competitor. So in those sites, what’s the driving factor for those accounts saying I’m going to implant a patient with Genio versus one of your competitors’ systems.
Olivier Taelman: So first, I would like to point out that in quarter 3, we are still estimating that our market share stays in the range of 20% market share during the quarter. I think this is first really important point, because as you know, since we entered the German market two years ago, with having also CPT codes, we were able to immediately capture 20% to 25% market share, and this has been continuing always being in this range with a strong Q4, where we were slightly above 30%. So that is already the first part to your question. So if you look at implant sites, that we are going after as a fast follower in sites where Inspire already was several years active. We see that in those sites or in all sites, we are able to take market share in a significant way.
That’s number one. Point two, what we are seeing is when you go to higher volume side, we also saw that in the top 5, we were able to take more market share than the 20%. So there was even stronger uptake in some top implanting sites in Germany. Now I think when you have competition entering and there is a monopolistic market, you also can increase overall HGNS penetration. And I’m really pleased to see that we are driving this because that is something that we are hearing back from surgeons as well. First, we are extremely pleased that there is not an option to choose between two therapies. Second, by having this option, they’re also seeing that more patients are being treated with one of those two [indiscernible] an increased therapy penetration.
And I keep repeating, and I have to come back to the uniqueness of our system that a single incision, a CCC indication, a full body MRI compatibility and also a real patient-centric approach is really something that is speaking very positively to physicians and patients. [indiscernible] to the next quarter, we are looking forward to beginning 2024 also in Europe commercially to see the impact of the investment, and of course, to also further expand into new and other countries. And to that point, I’m sorry that I keep going. But to that point, we also have some good news coming from the U.K., where we are now officially allowed to participate in an NHS standard. So that will also definitely help us accelerating revenue in Europe coming from more countries than mainly Germany.
Shaymus Contorno: Got it. I appreciate all the color there. And if I can sneak one more in. Just kind of looking when you do the U.S. launch. I know it’s a little ways away, but I know you said about 100 to 150 reps. How many sites are you looking to initially launch at, how many centers? Just trying to tie the color of centers to reps, so to speak.
Olivier Taelman: So although I would really love to answer your question, I think you can understand that I do not want to be going too concrete to that question for the simple reason that ’24 will be the year where based on successful DREAM data, we will have FDA approval later at the end of the year and hopefully also start commercializing. Currently, we are looking at a couple of scenarios. One scenario is where we would go, of course, with a kind of focused launch and try to go immediately after, let’s say, roughly half of the Inspire side that we have today. On the other hand, it’s also not a secret when you look at productivity for a sales rep, whether it now is with Nyxoah or with another new modulation company, we would be aiming to have €1 million of sales by sales up.
Operator: Our next question comes from David Rescott with Baird.
David Rescott: I wanted to start off on the partnership that you announced a couple weeks ago, I’m curious. I know it’s — I mean it seems like it’s something that could be pretty exciting. I know it’s a couple of weeks or so into it since the announcement. I’m just curious if you’re at a point yet where things are kind of established and maybe you’re starting to see some patients start to either roll in specifically to Nyxoah, maybe through the partnership at all? Or if there’s anything you anecdotally — that you can provide just around how that maybe already is starting to impact the business? Or maybe if it’s a couple of more quarters still before the potential benefits from that partnership could be realized.
Olivier Taelman: Yes. So first, since it’s really [indiscernible], I think it’s difficult to exactly predict when we will see what kind of impact. But what I would like to come back to, and I think this is something where I also would like to give a lot of credit to the ResMed colleagues in Germany. It is really putting a patient at the centers. Really further looking beyond CPAP, hypoglossal nerve stimulation, mandibular device treatment. Now what is exactly and precisely the best solution for patients suffering from OSA. And therefore, I keep repeating, CPAP is the golden standard. It was excellent, but the issue is that a lot of patients simply quit their CPAP after a period of time. Now if these patients are suffering from moderate-to-severe OSA, it is so important to offer them a treatment.
We all know the cardiovascular risk that is associated, the risk of strokes, the cost for healthcare systems, if you do not treat patients suffering from moderate-to-severe OSA. So I’m really proud, on one hand that we can say that, together with ResMed in Germany, we are really looking at what is best for the patient. Now that being said, it’s also clear that we need to, first of all, stores then get used to each other a little bit. that is ongoing. Sales teams are talking with each other, marketing teams of talking with each other. We are looking at DTC initiatives. We have the first major congress coming up in Berlin, where we both will be present and interacting with several KOLs. And I think a realistic approach would be that you would see the first impact in overall patient penetration increase and Genio specific increase as of Q1 next year.
David Rescott: Okay. Great. That’s helpful. And just on ACCESS in the U.S. I’m wondering the level of visibility maybe you have into that trial, I know that with kind of complete concentric collapse patient population there, maybe a higher concern around those patients having higher BMIs and maybe there being a bigger impact from GLP-1s. So just wondering what level of visibility you have into that and whether or not you have a better informed view maybe on what the potential impact could be either into that specific patient population or just broadly across all nerve stimulators?
