Olivier Taelman: So thank you, Adam, for the question. So as I mentioned, and we will communicate latest beginning of April, the data that will be in a press release followed also by a call. We will be focused on top-line results, AHI reduction, responder rate, ODI reduction. And then we are planning and moving forward to reveal all the data in detail during the ISSS conference in September, where we will have PI talking to the data and the details. So what you can expect is top-line data being released in a press release, followed also by call where there can be more questions and we will be focusing on, in fact, responder rate, AHI reduction, ODI reduction, we will also talk high-level on the safety data that we are having. And then of course, in parallel, we are preparing everything for a publication in a Tier 1 journal.
Adam Maeder: That’s perfect. Thank you for the color, Olivier. And then for the follow-up, I wanted to ask about the ACCESS study. I think it was mentioned in the prepared remarks, but was hoping just to get a little bit more granular in terms of enrollment progress in that study. How should we think about potential timelines for enrollment completion and ultimately potential FDA commercial approval for CCC patients? Thanks for taking the questions.
Olivier Taelman: Okay. So, we continue to make progress with the study. We will not disclose the number of patients implanted already, but that being said, we still continue to plan to close all implants by the end of 2024. Then there is a 12-month patient follow-up. So that brings us to the end of 2025. And then the aim is to submit the CCC data as a PMA supplement that should take maximum six to nine-month review period. So we plan to have the label expansion assuming all data are positive mid-2026.
Operator: Thank you. One moment for our next question, please. And it’s from the line of Laura Roba with Degroof Petercam. Please proceed.
Laura Roba: Hi, thank you for taking my questions. We see that gross margin was lower in Q4. Could you elaborate a bit on that and on what we could expect for 2024?
Olivier Taelman: Definitely, and this is definitely a question for our CFO.
Loïc Moreau: Thank you. Thank you, Laura. Yes, indeed. We were at 60% in Q4 versus 62% for the rest of the year. Actually, this is explained by our scale and specifically the fact that we have a newly opened manufacturing site in Belgium that is not yet at full capacity. So we see some modest variability quarter-over-quarter. That said, we anticipate the gross margin to increase over the coming quarters as we scale up volumes. Over time, we expect our gross margin to eventually approximate the level of other neural stimulation companies and to be above 80%.
Operator: Thank you so much. And one moment for our next question, please. All right. And our last question will be from Suraj Kalia with Oppenheimer. Please go ahead.
Suraj Kalia: Olivier and Loïc, can you hear me all right?
Olivier Taelman: Yes, we can.
LoïcMoreau: Yes.
Olivier Taelman: Hello.
Suraj Kalia: Pardon the background noise, and congrats on the progress. So Olivier, a few questions from my side as we look forward to DREAM, Olivier, what would you say in your position say the results are — how do you characterize the delta between bilateral versus unilateral. What would make you say these results are better than unilateral? What would make you say these are somewhat less than unilateral?
Olivier Taelman: So if I understand the question correct Suraj, because there is a little bit background. So you’re asking the results, comparison between bilateral result and unilateral result that we are seeing; is this correct?
Suraj Kalia: Yes. I guess what I’m trying to understand, Olivier is, you can rest assured the numbers are going to be sliced and diced 10 different ways to make different arguments, right? I guess what I’m trying to understand is hypothetically; if you have 50% responder rate in the complete cohort inspire had a certain responder rate. We can slice and dice different metrics. What would make you say, you know what the totality of these results show bilateral is better than unilateral? What would make you somewhat cautious and say, you know what, we missed somewhere versus unilateral?
Olivier Taelman: Yes. So first of all, I have to point out that the study was not designed to show superiority and it was even not a head-to-head trial. But on the other hand, you are look at those patients phenotyping. We look at the inclusion criteria; we look at the BMI criteria. So the studies are really similar or comparable. Now, what would we expect? So if we can show, and that’s what we already communicated. First of all, of course, reaching the primary endpoint. Second, showing equivalent compared to the unilateral stimulation for non-CCC patients. I think that would be already a first accomplishment. When you look at what the respond rate would mean. In our case, we are forward and we have to show responder rate of 62.6%.
So I would like to see numbers, of course, above. That is one thing. And then second, there will also be a lot of analysis that will be done on AHI reduction. What is the AHI reduction for patients with a higher BMI for patients with a BMI that is, for example, 25 and then going lower. So I think this is really important. Let’s also not forget the ODI reduction because there is also direct oxygen desaturation and the mortality risk. So I think this is important. And of course, all reductions have to meet the clinically, have to be clinically relevant. So that’s what we are looking at. So equivalent that’s what we would like to claim. We would further slice and dice the data and looking on AHI reductions. There is also the supine position that we are seeing and how the reduction is this because during a night patients, they tend not to stay only in one position, but to toss and turn a little bit.
