Inspire Medical Systems, Inc. (INSP) Earnings Call Transcript & Summary

All right. Good morning. I'm Larry Biegelsen, the medical device analyst at Wells Fargo. Welcome to the final call in our 2026 Medtech Innovation spotlight series. I'm pleased to be joined by Inspire Medical's management team. We have Chairman and CEO, Tim Herbert; CFO, Matt Osberg. and the Vice President of Investor Relations, Ezgi Yagci. On today's call, we'll focus on Inspire5, coding and reimbursement, clinical data, competitive market dynamics and the outlook -- we're going to start with a short slide presentation by Tim and then we're going to jump into Q&A. And as always, if anybody has a question, they want me to ask on behalf, please e-mail it to me. Tim, Matt and Ezgi. Thanks so much for joining us -- you guys have been very strong supporters of this call series. So thank you very much.

Thank you, Larry. We really enjoyed is call series, and I think it is the 1 that can really highlight on innovation and the R&D spot. And I think that we value that because we spent so much time on the development of the Inspire system and driving outcomes and positive experiences. And so we put together a couple of slides to really kind of walk through several of the key areas I know it's an innovation call. I know it's R&D spotlight, but I think everybody really wants to hear an update on the coating. So we want to -- let's get that out of the way right up front. We have a couple of slides in that. Then we can get into the Inspire V and the progress we have with Sleep Sync. But really, the key of this call in innovation is really the advancement of the clinical evidence and specifically around cardiovascular health. So we're going to really spend a lot of our time focusing on that, and that's really going to be the long-term benefits of this treatment. So getting jumping right into the coating and reimbursement, really, the process in '26 has been developed to find and educate centers on the quoting process for Inspire V. That was kind of handed towards the beginning of the year and that the code that we used for 10,000 cases in 2025 was just no longer available to us. So we worked with CMS. We worked with the payers to really lock down where we are with coating. So we do have clear coating for Medicare fee-for-service, clear quoting for commercial, for Medicare Advantage -- so we know these policies can change. And when they change, we have the tools in place to be able to pivot and support those changes, whether it be with an added change from a Mac or a change from a commercial payer. So we're in a good position now to be able to handle that. The benefit or the positive of this whole exercise is convergent changed. We still have the clinical evidence to support Inspire is a viable therapy for patients, and the coverage remains strong with all the MAX on Medicare and with all the major payers. So that's really good. And really, the payment hasn't changed either. The payment levels that our facilities and physicians have experienced in 2025 remain consistent here in 2026. Medicare physician payment may vary a little bit whether they were using 6582 with or without a modifier, but really the range of modification is not that significant. And even with the modifier today, it can align with what the payment was for 6568 in the prior year. So really what our work is it's about educating individual centers and physicians on the reimbursement reviews, educating them on the coding structure. And this training is both for facilities and for the professional or the surgeons. We want to make a key note. Inspire 4 reimbursement hasn't changed. That remains clear. Using 64582 is the code, the reimbursement levels are consistent with previously. And if centers want to stay with InSpire IV, we do have that product available, and we do offer that 2 centers if they want to continue in that process. We're letting the slide slowly updating. But as it transitions in -- it's just a timing thing. It will pop in. The Medac headwinds are a small portion of our overall market. And that's kind of what we want to highlight as the slide kind of comes up here. There we go...

Maybe you lost and you may want to just remind people that they can pull up these slides from the SEC filing this morning. just in case if people want to follow along, you guys did issue the slides this morning.

Yes. They are issued and they are available for everybody and be able to look at that. .

What's going on here? That looks good. We got it.

That's interesting, how this all works. So Inspire has covered with Medicare and all major peers as we already mentioned, right? The commercial and Medicare cases have a distinct advantage that we use a prior authorization. And so that payer policy is used as the baseline. That policy lists which CPT code should be used and the patient information or the indication statement, along with the CPD codes are provided on the prior authorization, and that really clarifies the coating and really derisks coverage and any payment, right? I think an example being if a commercial payer would seek a clawback. Well, they have a prior authorization that we discussed this before we did the case. No, there's no clawback there again that we are just building to what we previously agreed to. If there's any changes in commercial policies to coating down the road, we're able to just incorporate those into the prior authorizations. And then the Medicare fee-for-service, it's defined by 7 MAX at a Medicare area contractor, and they have their own policies. They're called LCDs or local coverage determinations and they account for about 20%, 25% of our Inspire procedures. And then finally, the Wiser program is active in 6 states. Now the key here is that it requires a predetermination -- and so that it's pretty clear on what coating will be used and what the reimbursement will be with those try and change this, again, Okay. Here we go. I think Ron.

Yes, it's looking good.

So Medicare building to policy. Here are the 7 MAX. This is the summary of their policy as it stands today. The top 2, WPS and Noridian, you can see they represent 13%, 17% share in the United States. They have laid out the Code-64582, which is for professionals or surgeons or the C8007 is the C code for facilities, but both of those require a DAS 52 modifier in that we don't implant the respiratory sensor -- and we provide information for the surgeon. So they're educated on when they submit their building, there's added documentation to justify the reduction in work, and we expect that reduction to be in the order of 10% to 20% reduction or that would relate to about $70 to $140 of their Medicare cases. So we continue to work for it. We ideally would like to see a close attempt, but we want to make sure that we continue to provide that range. There are 5 other MACs as you can see on the bottom of the page, they do not require a modifier today. In fact, Ometto and NGS just specified 64582, if they make an adjustment in the future to add a modifier, we have the tools in place working with WPS and Noridian that we can educate the physicians on those areas. If we don't -- if they don't update to record or modify, we'll just continue to build 64582. So really got in a position now to be clear. You can see the dates when their last update was and what the effective date of their last change is. And you can see on the bottom, Novitas first cost, they really haven't updated their policies since 2022. So if they do update, we'll be able to adjust and educate the centers in those areas. So we really added a lot of clarity to the overall coating. When we look at longer term, we certainly want to develop a new CPT code. And so this is the long-term solution. We have submitted a new application to the AMA CPT panel. We expect that it will be reviewed at the September 2026 AMA CPT meeting -- if approved, it would be -- it's in the same cycle as the previous meeting in April, and it would become effective January 1, 2028. We did present at the April meeting, it was denied -- and we had the opportunity to sit down with the AMA and understand what were the issues associated with that. And here's 4 of the key issues. There is some sub coating in the application that caused confusion at the table -- and we think that, that has a negative impact. We have clarified all that, and that's been resolved in the new application. There was lack of cross industry support. This submission that was just set in June 10, is across industries. It's not just Inspire, it has the other player in the space. And there is a request for more clinical evidence. Well, obviously, we have more with InSpire5 that we're going to show in a couple of minutes here. But we also used evidence from across industry, too. So it's a much more robust package. And then finally, it was around society support. And the good news is that society has really been active in reviewing the materials and providing input to give the key stakeholders aware and reviewed prior to the submission, which did go in June 10. So more to come on this, but the meeting will be in September. But this, again, is the long-term solution, but we have in place a clarity around implementation of the short term. I want to quick jump into technology a little bit and really kind of highlight where we are at the Inspire5 -- and we're just in the process of really launching this in the middle of last year. But with the coating really kind of had a little challenge kind of getting this up. But -- now we're in a position now we can really show the benefits of Inspire 5, right? We have utilizes the proprietary closed-loop sensing algorithm that really helps to therapy delivery. And you can see we no longer have the pressure sensing lead beta setting is now accomplished with an accelerometer that is inside the neural stimulator. What's the most important part of Inspire therapy or treatment of obstructed sleep apnea with hypoglossal neurostimulation is closed loop stimulation. What you see on the right is a curve that we add in -- and it's very important that when we detect air flow, we provide stimulation that is synchronous with the inspiratory phase of respiration. When you inhale, that's when the airway is most susceptible to collapse. If you put it in terms of CPAP, when CPAP went to by level pressure, BiFab the bypath provides pressure at a higher pressure when the patient inhales in a lower pressure when they excel. We do the exact same thing. We use the Acceleron to detect when a patient inhales and then we provide stimulation as you see here, synchronous with when a patient inhales. Therefore, the therapy is preventative. We want to prevent the collapse of the airway Cheste CPAP prevents the collapse of the airway during sleep. And it's important to be able to optimize that synchronization during sleep. When we did the Singapore study, here's the data. And here we talk, we showed that same curve talking about the inspiratory overlap, and we compared that to Inspire 4. Inspire 4 was good. Inspire 4 synchronized on 79.4% of the respiratory breast, meaning 79.4% of the time when the patient in-house, there's a synchronous stimulation of the hypoglossal nerve taking care of the patient. With Inspire 5 and with the accelerometer, we can improve sensing and now we can synchronize at 87.1% of the breadths, we have the synchronized stimulation. That's really important. That's statistically significant and shows at Inspire 4 or 5 is superior to the previous version of InSpir4. And you can see down here the reduction of apnea index I want to highlight these are all night sleep studies. These are now what you would call titration sleep studies or partial nights. These are full mine studies and you have equal reduction in effort sleepiness. On the left-hand side, very important to note out of the treatment that share responder rate is up to 80% in this patient population shows the value of the Inspire 5 and 100% success with the implants. And what's really important to note is the acceptance of Inspire 5 is it no matter has the respiratory sensor, which was a same procedure, but 1 that is outside the normal operating range for an ENT. So really an advantage with Inspire 5 moving forward. We've made great progress with sleep sync, as its way and to update the slide. And sleep sync is really the key changes on the lower right. As you remember, last year, when we last 5, we took such a diligent effort to educate and bring all the centers in the U.S. up and active on the sleep sync system. But now as we have a new platform here, we can actually start to leverage that and add features to sleep sync. One key example is in the lower right corner that you can see underlined. We can now do prior authorization requests from centers via sleep sense Sleep sync so they can digitally transition or transfer the information for preparation of prior authorization forms. The previous method that's still active today is using eFax -- so it really kind of streamlines the process, and it really kind of helps coach centers to have complete and accurate prior authorization submissions. So this is just 1 example. Now you're going to see continuous evolving involvement of the sleep sync system to add additional features that are going to just continually improve the ability to manage patients and improve the experience of both patients and physicians and it's going to eventually just keep driving more and better patient outcomes. Okay. I want to take another break here. Let's go into clinical abates. Before we get into a cardiac updates, I want to just kind of give a quick update. This is the update of our adhere registry. This is a poster. This was just presented at the American Academy of Sleep Medicine meeting last week in Baltimore. And it's a lot of information. But being that it's a public side, we left all that information in here. This is the final result of a 5,000-patient longitudinal study of Inspire. It has both Inspire 2 and Inspire 4 patients, and you can see they're followed for a significant period of time. You can just see the Avnehopopic index reductions. These are medians going from an average of 32 down to 10%, right? And you can see that the classification of the demographics of the patient, and I'll highlight the BMI being 29.3 with the standard deviation at 3.6, I'm going to use that data point on the next slide, right? And this was the data set that was used to increase the BMI indication with the FDA up to 40. This is the data that was used to expand our AHI indication from 15 to now 100 events per hour. And after the final visit, we asked the patient satisfaction. And you can see 5,000 patients over this period of time, we're still at a 90% satisfaction rate. This is real material. This gives us the confidence in the market that we're in, our ability to expand our technology to grow outcomes and our ability to provide strong safety -- safe and efficacious therapy and a therapy that patients use and the utilization remains very high. We talk about therapy adherence as we named this 5,000 patient registry, the ADHERE registry because we talk about therapy adherence and you can see -- this is patients between 5.8 and 6.4 hours per night. That's over 7 nights. This is not measuring at 4 to nights 4 hours at night or 5 or 7 nights. We want patients use therapy all night every night. And when we start talking about our pipeline with its 5 or 6, we are now going to start focusing on therapy adherence where we have auto activation and sleep detection when we go to the next platform. So really exciting to be able to put out that data at here. Finally, we kind of come back and we look at the predictor study we've been talking about for a period of time, but this is now published. This is available. And here's the algorithm that we look at patients who have a BMI less than 28, the data shows they don't need to have a sleep endoscopy. They can move directly forward to implant. Those patients that have a BMI between 28 and 32 but they also have to measure their Nexerconference. If it's less than 17.7 inches as you see there, they can move on directly to surgery, and they don't need a sleep endoscopy. But those patients that have a BMI higher than 32 are those patients that have a larger net circumference they carry their weight in a different part of the body, they should continue to have a sleep endoscopy study to determine whether they have complete concept or collapse. This ties in with high BMI and our ability to make sure that we are prescriptive on which patients get inspired and which patients need to be addressed with weight management. And what I'm talking about is the use of a we treat different mechanisms of action. GOP 1 will help the lateral wall class, which is indicative of a large Nexerconference Inspire and hypergene stimulation treats tongue-based obstructions. So if you kind of look at the data, what it suggests is about 65% of the patients in our studies really wouldn't require to have a sleep endoscopy procedure. When I talked about the BMI on the previous page of average at 29.3%, -- you can see how this fits in to this algorithm and most patients, therefore may be measured with this algorithm and not necessarily with sleep endoscopy. So we'll continue to develop this as we move forward. Finally, I want to focus on the big change. Then the big change is the new data that's put out on Inspire therapy and cardiovascular health. And it starts with definition of hypoxic burden bundled -- and then what we did is with the definition of hypoxic burden, we went back and we rescored the STAR trial, you put that in terms of hypoxic burden and now we can relate that hypoxic burden to cardiovascular health, and there have been numerous independent research studies on cardiovascular health with long-term Inspire as well. I'm being pacive, I'm moving too quickly, and let's get stable. Okay. One is hypoxic burden. Instead of using AHI and a hepatic index, which just measures the number of events per hour. hypoxic burden takes it a step further. And what it does is you can see under the second bullet there, it quantifies how often, how deep and how long the oxygen levels fall in the body during sleep. And with that is measuring the area under the curve and hypoxic burn is measured as percent, or 2% reduction per minute per hour and is measured in 5 quintiles, You can see Quintile down here in the table. Quintile 1 is the lowest baseline no risk of any cardiovascular events. And that's used as a reference, you can see the reference 1. And as you step up from Quintiles Q2, 3, 4, 5 being the highest, you have a 2.73 relative risk compared to Q1, which is a severe risk elevation over baseline. This management provides a clearer method for physicians to communicate with their patients before and post treatment, really showing them we need to manage that hypoxic burden because this directly relates to cardiovascular help. Now we show some data on this. So what we did is we went back and looked at 108 Star trials, we rescored every 1 of those sleep studies because on the sleep studies, you look at the oxygen desaturations and you calculate the area under the curve. And Larry, you know that would be your triple algorithm that or your triple integral that you'd use to do that. And you can see the hypatic burden that based on went from 63.4% down to $14.3 million -- but we broke patients in the START trial into those that had a baseline in the high hypoxic burden range meant about a 95.5 epoxic burden and a year later at 12 months, that's down to 21.2%. If we go back, think about 95% is going from a quintile 4 or a material risk down to '25, we're down to a minimal increase in risk. That's a significant reduction in cardiovascular risk. And that's going to play out on a few slides as we start looking at some other measures that have shown long-term benefits of Inspire. You can see that last bullet on the lower right. 44 or 54 participants with the high base hypoxic burden transitioned to low and that's a 2-step reduction from Quintile 4 to Quintile 2, that significant reduction in covardiovascular health. One last point I want to make on this 50% of the patients who were nonresponders to AHI still had a significant reduction in hypoxic burden. So even though the AHI didn't get to a level of being a share responder, they did have a benefit in a reduction in their hypoxic burden. So we did reduce their -- here it is, I'm sorry, I hear it on this slide, we did reduce their cardiovascular risk, right? And that is statistically significant. And on the right-hand side, when we look at daytime sleepiness, and that's measured using the app were sleeping at scale, and that is associated with quality of life and your ability to function during the day, and that's how it measures it. So as the ESS goals up, you can see that patient function worse as they feel that as well, and they performed worse in daily life. So changes in AHI, RELS, GFT90 and 02 were not associated with ESS improvements in this subgroup of the nonresponders, but heptoxic burden reduction was statistically significant in changing the ESS in this group. Remember, these are the 50% of the nonresponders from STAR. So hypoxic burden does have a significant play. So we've had real world evidence. And now we did our own study of 30,000 patients using definitive health care claims analysis. And this is a comparison of inspired versus untreated patients CPAP versus untreated patient and Inspire versus CPAP. And you can see that Inspire versus untreated patients showed a statistical outcome in 8 of 9 measures and you can see the reference down below, and this was presented last week at the sleep meeting and we can -- that data is available. CPAP showed a benefit of 6 of 9, but Inspire showed a benefit in 4 of 9 important measures. So the conclusion is you see, Inspire is associated with lower risk of CPAP, lower risk -- than CPAP and 4 key outcomes, heart failure, coronary artery disease, cardiovascular disease and cardiomyography. So -- we are sorry, cardiomyopathy. So really important outcome measures that we are going to be able to really help educate the market going forward, right? Cardiovascular disease drives significant health care costs, effective sleep apnea treatment may reduce the long-term burden and Inspire therapy delivers benefits beyond just symptomatic measures like ESS AHI, but now we can track that to hypoxic burden, and we can attract that to cardiovascular health. Now there are independent studies done not by Inspire, but this is a Virginia Common world, VCU. They just published this paper so about a month ago or a couple of weeks ago. And you can see the 2-year odds ratio of adverse outcomes compared to CPAP. And on the left, you can see the table, you can read on all the different variables that they looked at and the dash line is the odds ratio of 1. Everything to the left shows a benefit to Inspire versus CPAP. And when you see the air bars all outside the dotted line, that shows statistical significance. So in all of those features, it's a benefit for patients to be treated with Inspire to help reduce their cardiovascular risks as a direct comparison to CPAP, but we also have a direct comparison to nontreatment as well. And this is significant. This is a comparison of a matched group of over 3 -- over 3,500 patients. Finally, there are 2 other additional studies 1 from Thomas Jefferson University, 1 from University of Texas Medical brands. This data E&C was presented last year, the table that you see is comparison from TJ from Thomas Jefferson -- on the left is a comparison of Inspire versus CPAP. And again, here's that reference line of 1.0. And then you can see the significant improvements in all the cardiovascular events, including cardiac arrest at 15 years and then here's Inspire versus no treatment. So both TJ and UTMB both determine Inspire's associated with significant reduction in multiple cariometabolic markers. That's really pronounced. And in UTM Best case, they even showed all-cause reduction in mortality when compared to CPAP. This is a game changer, and this is going to allow us to really start reaching in and bringing in a new group educated cardiovascular surgeons. So in summary and to close our presentation, I know Larry has got a list of questions that you want to ask. So that's kind of get just really the summary. We continue to develop what we project is a very large and growing obstructive sleep apnea market, right? GLP-1s are there, they treat a different mechanism, but they continue to build awareness of the necessity to treat sleep apnea to continue to drive the increased diagnosis of sleep apnea, and we continue to develop our technology to drive better and better outcomes and better experiences for patients and for physicians. Coating challenges presented themselves at the start of the year. And as you know, Larry, we worked so hard to address these, and we can provide a clear coated pathway for all payers, centers and professionals be it Medicare, commercial, Medicare Advantage. We have the tools in place, and we are working to educate centers 1 by 1 to make sure that they can have confidence that they will be reimbursed and to continue to drive and take care of their patients. Fit generation and SPF system has had a significant positive impact on the market with improved physician and patient experience. And as we just showed you, with improved patient outcomes. Our technology pipeline remains prominent, both with our planet products. So we already talked about the ongoing development with Inspire 6, but the ever-evolving sleep sync and our ability to add features to sleeving forward and the new clinical evidence just to show the 5,000 patients Adhere Registry and the confidence of the therapy and the confidence of the adherence to therapy and predictor can help the patient experience by not requiring them to go have a dice procedure and now we've really demonstrated the long-term health benefits and reductions in hypoxic burden and multiple independent research is showing how this Inspire outcomes is improving cardiovascular and other key both health factors over CPAP and certainly over no treatment. So a lot happening at Inspire right now, and we're working through the coating aspects of it, but you can see we have a lot of energy behind that. So with that, Larry, we'll take a break, and I guess we can probably stop sharing or we'll leave it up if we want to go back and reference any chart and hand it off to you if you have any questions for us.

Yes. Thanks, Tim. Thanks for that comprehensive overview. That was super helpful. I appreciate you putting the slides out this morning. Before we get to kind of the clinical data and the technology questions, let me ask a few follow-ups on the coding and reimbursement. I think everybody on this call knows that's been obviously, the area of focus this year. So let me start with 1 on the commercial side. The slides mentioned Medicare fee-for-service is only 20% to 25% of Inspire procedures, which code or commercial payers using -- and if Medicare fee-for-service is the main issue. Why did you guide down in Q2 for prior authorizations, what's causing the delay in these prior authorizations?

Well, back in the first quarter, it's a systemic issue with the coating. And it was just the uncertainty of the physicians of the payers of if the code exists and are they going to be paid? Is coverage still there? How do we address this moving forward? And we have identified that pathway, and we recognize the reduction in prior authorizations in Q1 as we talked about on the early call it's the uncertainty of the centers and the physicians. Well, now that we can provide that education. The coating is clear. They prior authorized commercial cases. And as we mentioned on the Q1 call, we started to see trends of improvements there, but Q2 would be impacted by that.

That makes sense. And the slide states that 2 of the 7 merits, 1 of the slides you presented, which was helpful on the MAX, 2 of the 7 are using a 52 modifier and the reduction is expected to be 10% to 20% for the physician be. What's the likelihood of the other MAX start to require a 52 modifier?

I think the key is #1. The benefit in there is the experience that we've seen right now is it does range in a 10% and 20% reduction. We want to make sure we provide the tools. So when the surgeons dictate their op nodes that they talk about the reduction and work as sole to with Inspire 5 and to be able to be clear about what percent of the procedure or work is actually reduced. I think it will tend to be close to 10%. That's where we want surgeons to talk about. But if it goes to 20%, even that I think, is an acceptable number for surgeons going forward because it's coming up 64582, which is a higher physician reimbursement than the old code 64568. To answer your questions, I do think the MAX want to drive consistency. It could be that some of the MAX will incorporate the DAS-52, but we have the tools in place to be able to educate surgeons right now -- and if they would do so, we'll be able to pivot around that. But in the meantime, if the policy specifically stayed 64582 without a modifier, we'll continue to recommend that, that code is used because that's what the policy states. And you've got to recognize going to a modifier that triggers a manual review at the max. So it is a cost impact from the MAX to administer there's cases, too. So I think we'll continue to monitor it very well. But now we -- there's not a lot of surprises they make a change, it's bind well adapt.

And Tim, regarding the Wiser headwinds, just walk us through what's happening and when you expect that to be resolved, please.

Well, Wizer is really kind of a big change, right? That that is implemented in 6 states, but those are very large states. And it took a little bit of a learning curve, both for ourselves, for the surgeons, for the facilities to understand how the process works to understand how the Wiser AI system reviews cases, how it adapts because it's learning, right? And how it adapts and changes in that review process? Combine that with cold changes in the coding structure from the beginning of the year to the implementation of the C codes that has had impacted -- good news is -- we're coming up that learning curve. We did mention on the Q1 call that did have an impact in the first quarter. It continues to impact going forward, but to a lesser extent, as we get up the learning curve and we believe that, that will continue to improve throughout the year.

That's helpful. Just 2 more on coding and reimbursement. One -- there's just been some chatter in the market about commercial payers seeking clawbacks, retroactive to the start of the year related to the confusion over the wrong CPT code being used -- is -- are you seeing any of that?

Simply answer the question. No, we're not. But let's -- I'm not sure where that chat really all originates from. But understand commercial payers are -- have a predetermination of a prior authorization, right? Centers and physicians get the authorization from United, Blue Cross Blue Shield of Texas, Florida, wherever location year may be to show that, yes, this is the indicated patient. These are the CPT codes that will be used for this specific case. And then when the procedure is performed, the hospital or the professional, the surgeons submit to those CPT codes. If any payer comes back and wants a clawback, you just show the prior auth letter said, look, we had this discussion. We have a letter that shows that this was authorized. So it's unlikely that you're going to see commercial payers clawback. They may make a change to coding going forward. And if the commercial payers change their coding, well, then we adjust that and change the prior authorization to put the proper coding that's in their policy and prior authorization is the tool that people agree to upfront. Weizer has it's false. But Weiser does bring is Wiser does bring authorization for centers to do those Medicare cases in those 6 states. And so it really kind of derisks the payment or reimbursement outside case.

That's helpful. And Tim, just to put a bow on this, on the Q1 call, you lowered the 2026 revenue guidance by $125 million, I believe, at the midpoint. That assumes coding reimbursement and wiser headwind of $40 million to $50 million in Q2. And $35 million, I think, in Q3 and Q4 in each quarter. My question is, what key leading indicators are you monitoring to gain confidence in this new outlook? And qualitatively, Tim, how are things going relative to your expectations? It's a super complicated topic, right? It's hard for us to kind of track all of these things.

Well, I think that's number one, bring it back, say, I think what we wanted to do today is simplified. So Larry, you're a doctor in Boston, if you're doing procedures at scripts or mass in ear or Beth Israel or wherever you are doing your procedures if you're Medicare, it's very clear for how you build that Medicare case in Boston. If you're a commercial case with Blue Crest Shield, Massachusetts or whoever, -- it's very clear in their policy, whether you're commercial or Medicare Advantage on how to build that procedure. So really trying to simplify that going forward. And that really has been the education process -- and again, we talked about in the Q1 call that we were seeing trends and prior authorization going forward. We know, as we just mentioned, that we're learning -- coming up the learning curve on Wiser and that's improving and will continue to improve throughout the year. And those are really the metrics that we use to track our progress. And to get the confidence of the centers back that they know Coverage is consistent. Reimbursement is consistent to where it's been and that the coding structure that's in place now can help them take care of their patients knowing that they will be properly reimbursed.

Well, let me ask it maybe a little bit differently. Any surprises, Tim, since the Q1 call in this area?

Well, the surprise was Jan 1 with the coating surprise, but I think that since the Q1 call, we've been working diligently to get this coating structure in place. And I think we're running our playbook and we're running the course and both short and long term, I think we're learning a lot of things and improving the process.

Okay. Well, I'll wait for questions to come in on that, but we'll move on from coding and reimbursement to the new clinical data and the technology you shared with us. I was curious on the Sleep Sync remote adjustments. You've been excited about that, Tim, for a while. You said that's coming on the slide. Where -- what's the time line on that?

Well, that's still in development. We're focusing on Inspire 6 as the next one. You'll see other areas or other features added to Sleep Sync first to improve that process. And I think the remote program in -- although you can highlight the benefits that can be for patients to not have to drive into a center to be have a device programming, you can do real-time changes. That's still in the works right now. So we don't have a release date on that. But it is going to be a key feature in the future. No question about it.

And Tim, on the predictor data, like talk about how you're going to leverage that and time lines?

Yes. I think there are some payers have already we've moved a specific requirement for a sleep endoscopy and leave it up to the physician to determine if the patient has the proper natomedisiforti in Inspire of the implant. And we'll start with some of those peers and some of those physicians to use the algorithm in the prior authorization process to see if we can gain approval with that, and then that will help to gain experience and get the snowball over down the hill, they'll get a broader adoption of it. So with the publication, we can start with forward with select centers now.

And removing the dice as what benefit to patients and Inspire.

Well, I'm going to go back to the patient. And in this case, Larry you're the surge in you're the patient. And so patient Larry goes to the website, might see outreach program goes, the website gets educated, may call our ACP Advisor Care program goes to your first deployment to determine that you are a good candidate and your BMI is low. You have a small next conference, then you can go straight to procedure. You don't need that interim procedure of having a sleep endoscopy. And that just really streamlines your process as a patient, but it also helps streamline the process for the surgeon. They don't need to do the stipendospy or wait for the results and then submit the prior authorization. So it really is going to help the patient experience and reduce the time for you to get from the website to call the call center to your first appointment to finally receiving implant. And that reduction in time, I think, really it's going to help minimize what we call a leaky bucket of patients following out of the funnel.

That's helpful. And obviously, you're excited about the cardiovascular outcomes data, what might be driving better cardiovascular outcomes for hypoglossal nerve stimulation versus CPAP?

Adherence I think adherence is a key part of it. And our ability to go to the PSG and really look at reductions of the hypoxic burn actually look at the area under the curve when you see that on a PSG or polysomnography and to be able to show distinct outcomes, I think, is really the advantage. I think synchronization is really important to make sure that we synchronize stimulation with inspiration to be able to minimize the number of events, but not just been buys a number of events, minimize the length, depth and duration of those events, and that's what makes the difference of hypoxic burden and the reduced oxygenation of the blood is what's driving the negative cardiovascular risks in snip apnea and then improved we showed the chart of the -- both with Inspire V and especially with the her registry, utilization or adherence to therapy is paramount in reducing hypoxic burden. And when we go to Inspire V as an example, which has sleep detection, which is going to drive therapy adherence higher because when you follow sleep with the device to turn it up by, when you wake up the device will turn itself off, the intent of sit is to take adherence to the next step. The intent of V was to improve inspiratory overlap. So each of these features has a unique outcome that we're trying to drive. And by driving adherence, we can reduce hypoxic burden even further.

Tim, have you said how far away the Inspire VI is?

I said we are in the development phase right now, and we'll keep pushing that. But remember, we have to go through a whole FDA review cycle with that. I will say this 1 point, though. The Inspire VI is the Inspire V platform with a firmware upgrade -- software upgrade only. It does not affect the CPT coding I think that's what everybody's mind their needs.

Okay. That's good to hear. And I have to ask on this cardiovascular data you presented, the Virginia Common Wealth, the data daytime drowsiness was the 1 area that looked, I think it was better for CPAP versus Inspire -- Tim, if I was reading the slide correctly. Why would that be?

Well, I think we'll look at that data and just see how statistical it is, but we specifically measure daytime sleepiness as well. That's measured with the ESS that effort sleepiness scale. And any score below 10 is normalized. And you can see in all of our studies going back from start adhere to Singapore, we're down in the 6% to 7% range -- so we do show statistically significant reductions in daytime sleepiness. So I'm not too worried about that because I do know our scores are very, very consistent over time and at a very therapeutic level.

And Tim, the cardiovascular data looks interesting and compelling, but it is retrospective -- is there any plan or consideration to do a prospective study? Or is that just takes too long, too expensive, too many patients?

I think most of these studies when you look this, Larry, are retrospective in nature. It takes large numbers. As you look at our study, it involves 30,000 patients. DCU, I think, is over 3,500 patients. I think TJ has over 3,000 patients. These are large databases that provide the opportunity to look back. And our good friends, UnitedHealthcare, we have Minneapolis, they have their Optum system, which is a large database that the actuarials can use to leverage that information going forward. So a retrospective review of large databases is common practice and very acceptable. And it's very difficult to do prospective studies of 30,000 patients, obviously, but really to leverage the data that we have. And what's interesting between our 30,000 patients and using the trinetics and again, I referenced Optum in Minneapohere. -- they're different databases that are used to prospectively validate each of the outcomes and the outcomes are showing consistency.

That's helpful. Well, we can spend a lot of time on all these different areas, but there are a few other areas I wanted to get to competition -- what are you seeing right now with a hypoglossal nerve stimulation company in the market? How are you guys responding? And then just maybe LivaNova is obviously going to come next year, what are the implications of having 2 new competitors in the market?

Well, #1, the value of competition is giving credibility to the therapy as a whole. It's not just those 2. There are many other companies developing a stimulation for sleep apnea. It's a real market. It's a large market that we are just at the beginning of tapping into that market. and having competition really gives credibility that this is real, and this is a need that is important. As far as the company on the market today, a different form factor really completely a little young they need to continue to develop clinical evidence. We know our sites are going to trial their device, but they also know that the bar was set high for what to be expected from a safety and efficacy standpoint. And all of our physicians and centers know what to expect with Inspire, especially with the evolution of Inspire V we make Inspire IV available to centers that they want to go that way, but centers are really predominantly adopted to V because they see the benefits with it, and they know what to expect going forward. When they move to levanova the key with -- again, back to the existing company, they're both using older lobe stimulation. I think what we've really highlighted today in our slides is the necessity to do closed loop stimulation, it got to synchronize with the inspiratory waveform because that's how you can target stimulation with inspiration to minimize the oxygen desaturation to minimize the hypoxy turn and to maximize the reductions in cardiovascular risk. And both these companies are just open loop -- there's chatter and now with LivaNova, they're partnered with us on the coding, but they have an algorithm to help titrate patients. What they're highlighting there is the benefit that neural stimulation brings to the market. all of our devices are programmable. We've been doing what they've described since 2014 when we were approved. You heard us talk about the green yellow pathway. That's being able to recognize how many patients can get a fast response and how many patients may need advanced penetration or advanced programming. We're doing the exact same thing and have been for over 135,000 patients. And the STAR trial showed 80% responder rate with those initial patients. But in no way does that mean we give up on the other 20%. We show the START trial that 50% of the nonresponders had a reduction in hypoxic burden. We made their lives better. We made them healthier. We want to continue on with those patients going forward. So even that 20% -- we will put them through what we call our green yellow pathway to make sure that we can optimize that therapy as best as possible so they can have the best possible experience with it. So competition brings technology enhancements that keeps everybody active. And it really drives credibility to the overall market, and that's we welcome that part of it and we expect to continue to evolve and develop and continue to set the bar really high.

Right. It wouldn't be inspired call without a GLP-1 question. I think there's a kind of -- well, 2 part, what are you seeing today? We just basically have tirzepatide out there? And I think people are now starting to focus on these next-generation GLP-1 redatrutide, had some OSA data out. That's a more powerful GGG. And then we have found AO, the oral coming with OSA data and that -- the entry criteria, Tim, I believe, is 27% and above for BMI. But you expect GLP-1s to be a tailwind over time, and we conceptually understand that. But right now, it's a headwind. So how should we think about the impact of GLP-1s going forward?

Two different things, and we talked a little bit on the slides earlier on with the predictor study. High DMI is associated with a different anatomy in the airway. GLP-1s don't treat sleep apnea -- they help patients lose weight and with reduction of weight. That has a resultant effect on reducing the severity of sleep apnea. Specifically stated, they addressed lateral collapse. As we've always stated, hypogotomlerd stimulation does not address lateral wall claps. We need to partner with the GLP-1s to help patients lose weight. The initial trial, the average BMI was 40 -- the average age was 50. We need lots of population. We don't treat today. In our adherent registry, we show today, our average BMI is 29 versus 40. We need those patients to lose weight to be able to qualify for Inspire. If they lose way resolves the letter wallcaps and it resolves their sleep atna.they never had tone-based obstructions or were never in our market anyways. And with the new GLP-1s, that's wonderful because it's an easier way for patients to lose weight. And if they lower it down to 27%, I think that's great. But again, recognizing that addresses that walk up, not tone-based collect. It is more specific or prescriptive medicine, and it's another tool to actively address the sleep apnia market. And all these tools together are going to continue to grow the awareness of sleep. So I think evolving on the GLP-1s the think will help. But again, they're not addressing the time-based obstruction that we address, but GLP-is or addressing glatiralwalk class that we are not able to address today.

Tim, just 1 follow-up if I give you an opportunity to close. I mean it's -- the SEC filings suggest that they are a headwind to you today, not top headwind. I mean do you still feel they're going to become a tailwind and any predictions of when?

Yes, I do think they're going to be a tailwind, but we've been -- can I say distracted this year, working on our coding issues, right, and make sure that we get our coating structure in place, our market is still there. We still educate patients. We still have patients in with our physician groups, they understand the necessity to continue to grow and take our patients with time-based obstructions. And we continue to evolve our technology and evolve the diagnosis of 1 example being the predictor. So we do know that the diagnostic grades of sleep apnea has increased with GLP-1s. When you have Shack out there talking about the need to address the apnea, that has a positive impact for everybody. And if we can increase the awareness and increase the diagnostic rates of sleep that's going to definitely identify patients that have time-based obstructions that can benefit from Inspire. So yes, we do believe that it will be a tailwind in the future. And I think that let's continue to address this as we go forward. Now that we have better definition and structure around our coating, we can keep looking through the year and continue to monitor.

That's helpful. Tim, obviously, a minute, maybe even less than that left. Appreciate your time. I'll just thank everyone for listening now, but I want to give you the last word. Any key messages, Tim, you want to leave us with before we end the call and head into the weekend.

Well, we're #1, Larry. Thanks for hosting these calls to not just focus on business, but to really let people kind of dig in on innovation and why we do what we do and what is the impetus between going from spot 4 to 5 to 6. What's the impetus of sleep sync? Why are we doing cardiovascular measurement? Why are we doing predictor. And it's all about driving improved outcomes, driving improved patient flow and gaining the best possible safety and efficacy and welcoming competition, but they're going to have the same level of commitment to outcomes and patient experience and knowing that we are just at the early stages of a very large market in front of us. And so again, I appreciate you having us on I'll call it just to really highlight the technical and the innovation side of our business.

All right. We'll leave it there. Thank you so much, guys. Have a good weekend.

Thanks. Have a great weekend. Happy for it.