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 Inspire V, coding and reimbursement, clinical data, competitive market dynamics, and the outlook. We're going to start with a short slide presentation by Tim, then we're going to jump into Q&A. As always, if anybody has a question they want me to ask on their behalf, please email 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 enjoy this call series, I think it is the one that can really highlight on innovation and the R&D spotlight. 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. We put together a couple 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 coding. Let's get that out of the way right up front. We have a couple slides on that. We can get into the Inspire V and the progress we have with SleepSync.
Really, the key of this call in innovation is really the advancement of the clinical evidence, specifically around cardiovascular health. We're going to really spend a lot of our time focusing on that's really going to be the long-term benefits of this treatment. Jumping right into the coding and reimbursement. Really, the process in 2026 has been develop, define, and educate centers on the coding process for Inspire V. That was kind of handed to us the beginning of the year, that the code that we used for 10,000 cases in 2025 was just no longer available to us. We worked with CMS, we worked with the payers to really lock down where we are with coding. We do have clear coding for Medicare Fee-for-Service, clear coding for commercial, for Medicare Advantage, but we know these policies can change.
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. We're in a good position now to be able to handle that. The benefit or the positive of this whole exercise is coverage hasn't changed. We still have the clinical evidence to support Inspire as a viable therapy for patients, the coverage remains strong with all the MACs of Medicare and with all the major payers. That's really good. 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 CPT Code 64582 with or without a modifier, but really, the range of modification is not that significant.
Even with a modifier today, it can align with what the payment was for CPT Code 64568 in the prior year. 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 their professional or the surgeons. We want to make a key note. Inspire IV reimbursement hasn't changed. That remains clear. Using CPT Code 64582 as 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 to centers if they want to continue in that process. We're letting the slide slowly update. As it transitions in, it's just a timing thing. It'll pop in.
The Medicare headwinds are a small portion of our overall market, that's kind of what we want to highlight as the slide kind of comes up here. There we go.
Maybe you lost it. You may want to just, Tim, 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, they are available for everybody. You'll be able to look at that.
All right. What's going on here?
I'm trying. There we go.
Okay. That looks good. We got it. Oh.
How's that for interesting?
There we go
how this all works. Inspire has coverage with Medicare and all major payers, 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 CPT Codes are provided on the prior authorization, and that really clarifies the coding and really de-risks coverage and any payment, right? I think an example being if a commercial payer would seek a clawback. They have a prior authorization, say, we discussed this before we did the case. There's no clawback there in that we are just billing to what we previously agreed to.
If there's any changes in commercial policies to coding down the road, we're able to just incorporate those into the prior authorizations. The Medicare Fee-for-Service is defined by seven MACs, a MAC, 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. Finally, the WISeR program is active in six states. The key here is that requires a predetermination, and so that it's pretty clear on what coding will be used and what the reimbursement will be with those. I'm going to try and change this again. Here we go. I think we're on task.
It's looking good. Yep.
Medicare billing to policy, here are the seven MACs. This is the summary of their policy as it stands today. The top two, WPS and Noridian, you can see they represent 13%, 17% share in the U.S. They have laid out the CPT Code 64582, which is for professionals or surgeons, or the C8007 is the C code for facilities. Both of those require a -52 modifier in that we don't implant the distal respiratory sensor. We provide information for the surgeon, so they're educated on when they submit their billing, there's added documentation to justify the reduction in work, and we expect that reduction to be in the order of 10%-20% reduction, or that would relate to about a $70-$140 off their Medicare cases.
We continue to work toward, we ideally would like to see it closer to 10%, but we want to make sure that we continue to provide that range. There are five other MACs, as you can see on the bottom of the page. They do not require a modifier today. In fact, Palmetto and NGS just specify CPT Code 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 they don't update to require a modifier, we'll just continue to bill CPT Code 64582. Really got in a position now to be clear. You can see the dates of when their last update was and what the effective date of their last change is.
You can see on the bottom, Novitas and First Coast, they really haven't updated their policies since 2022. If they do update, we'll be able to adjust and educate the centers in those areas. Really added a lot of clarity to the overall coding. When we look at longer term, we certainly want to develop a new CPT Code. 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's in the same cycle as the previous meeting in April, and it would become effective January 1st, 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.
Here's four of the key issues. There is some sub-coding in the application that caused confusion at the table, and we think that had 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 sent in June 10th is a cross-industry. It's not just Inspire. It has the other player in the space. There was a request for more clinical evidence. Obviously we have more with Inspire V that we're going to show in a couple minutes here, but we also used evidence from cross-industry too, so it's a much more robust package. Finally, it was around society support.
The good news is the society has really been active in reviewing the materials and providing input to get the key stakeholders aware and reviewed prior to the submission, which did go in June 10. More to come on this, but the meeting will be in September. This again is the long-term solution, but we have in place clarity around implementation of the short-term. We want to quick jump into technology a little bit and really kind of highlight where we are at the Inspire V. We're just in the process of really launching this in the middle of last year, but with the coding, really kind of had a little challenge kind of getting this out. Now we're in the position now we can really show the benefits of Inspire V, right?
We have utilized the proprietary closed-loop sensing algorithm that really helps with therapy delivery. You can see we no longer have the pressure sensing lead because sensing is now accomplished with an accelerometer that's inside the neural stimulator. What's the most important part of Inspire therapy or treatment of obstructive sleep apnea with hypoglossal nerve stimulation 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 airflow, 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 bi-level pressure, BiPAP, the BiPAP provides pressure at a higher pressure when the patient inhales and a lower pressure when they exhale. We do the exact same thing.
We use the accelerometer to detect when a patient inhales, 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, just like CPAP prevents the collapse of the airway during sleep. 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 talked, we showed that same curve talking about the inspiratory overlap, and we compared that to Inspire IV. Inspire IV was good. Inspire IV synchronized on 79.4% of the respiratory breaths, meaning 79.4% of the time when the patient inhales, there's a synchronous stimulation of the hypoglossal nerve taking care of the patient.
With Inspire V and with the accelerometer, we can improve sensing. Now we can synchronize at 87.1% of the breaths, we have a synchronized stimulation. That's really important. That's statistically significant and shows Inspire V is superior to the previous version of Inspire IV. You can see down here the reduction of Apnea-Hypopnea Index. I want to highlight, these are all-night sleep studies. These are not what you would call titration sleep studies or partial nights. These are full night studies, and you have equal reduction in Epworth 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 V and 100% success with the implants.
What's really important to note is the acceptance of Inspire V as it no longer has the respiratory sensor, which was a safe procedure, but one that is outside the normal operating range for an ENT. Really an advantage with Inspire V moving forward. We've made great progress with SleepSync as it's waiting to update the slide. SleepSync is really the key changes on the lower right. As you remember last year when we launched Inspire V, we took such a diligent effort to educate and bring all the centers in the U.S. up and active on the SleepSync system. Now as we have a new platform here, we can actually start to leverage that and add features to SleepSync. One key example is in the lower right corner that you can see underlined.
We can now do prior authorization requests from centers via SleepSync, they can digitally transfer the information for preparation of prior authorization forms. The previous method that's still active today is using eFax. It really streamlines the process, it really helps coach centers to have complete and accurate prior authorization submissions. This is just one example how you're going to see continuous evolvement of the SleepSync 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. 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 evidence. Before we get into cardiac updates, I want to just give a quick update on. 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, it's a lot of information, but being that it's a public slide, we left all that information in here. This is the final results of a 5,000 patient longitudinal study of Inspire. It has both Inspire II and Inspire IV patients, you can see they're followed for a significant period of time. You can just see the Apnea-Hypopnea Index reductions. These are medians going from an average of 32 down to 10. Right? You can see the classification of the demographics of the patient, I'll highlight the BMI being 29.3 kg/sq m, with the standard deviation at 3.6 kg/ sq m, I'm going to use that data point on the next slide. Right? This was the data set that was used to increase the BMI indication with the FDA up to 40 kg/ sq m.
This is the data that was used to expand our AHI indication from 15 to now 100 events per hour. After the final visit, we asked the patient satisfaction, you can see 5,000 patients over this period of time were 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, our ability to provide strong safety, safe and efficacious therapy, a therapy that patients use, the utilization remains very high. We talk about therapy adherence, hence we named this 5,000-patient registry the ADHERE registry because we talk about therapy adherence. You can see this is patients between 5.8 and 6.4 hours per night, that's over seven nights. This is not measuring at four nights, four hours a night, or five of seven nights.
We want patients use therapy all night, every night. When we start talking about our pipeline with Inspire VI, 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. Really exciting to be able to put out that data on ADHERE. Finally, we kind of come back. We look at the PREDICTOR study we've been talking about for a period of time, but this is now published. This is available, here's the algorithm that we look at patients who have a BMI less than 28 kg/ sq m. 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 kg/sq m and 32 kg/sq m, they also have to measure their neck circumference.
If it's less than 17.7 in as you see there, they can move on directly to surgery, they don't need a sleep endoscopy. Those patients that have a BMI higher than 32 kg/sq m or those patients that have a larger neck circumference because 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 concentric collapse. This ties in with high BMI and our ability to make sure that we are prescriptive of which patients get Inspire and which patients need to be addressed with weight management. What I'm talking about is the use of a GLP-1. We treat different mechanisms of action. GLP-1s will help the lateral wall collapse, which is indicative of a large neck circumference. Inspire and hypoglossal nerve stimulation treats tongue-based obstructions.
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 of 29.3 kg/sq m, you can see how this fits in to this algorithm. Most patients, therefore, may be measured with this algorithm and not necessarily with a sleep endoscopy. We'll continue to develop this as we move forward. Finally, I want to focus on the big change. The big change is the new data that's been put out on Inspire therapy and cardiovascular health. It starts with definition of hypoxic burden. I'm bouncing around. I got to slow down.
What we did is with the definition of hypoxic burden, we went back and we rescored the STAR trial and put that in terms of hypoxic burden, now we can relate that hypoxic burden to cardiovascular health. There have been numerous independent research studies on cardiovascular health with long-term Inspire as well. I'm being patient. I'm moving too quickly, let's get stable. Okay. What is hypoxic burden? Instead of using AHI, Apnea-Hypopnea Index, which just measures the number of events per hour, hypoxic burden takes it a step further. 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. With that, it's measuring the area under the curve, hypoxic burden is measured as percent, O2 percent reduction per minute per hour.
It's measured in five quintiles. You can see quintile down here in the table. Quintile 1 is the lowest baseline, low risk of any cardiovascular events, and that's used as a reference. You can see the reference, 1.0. As you step up from quintiles, Q2, Q3, Q4, Q5 being the highest, you have a 2.73 relative risk compared to Q1, which is a severe risk elevation over baseline. This measurement 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 health. Now, let's show some data on this.
What we did is we went back and looked at 108 STAR trials, and we rescored every one of those sleep studies because on the sleep studies, you look at the oxygen desaturations, and you calculate the area under the curve. Larry, you know that would be your triple algorithm or your triple integral that you'd use to do that. You can see the hypoxic burden at baseline went from 63.4%-minutes per hour down to 14.3%-minutes per hour. We broke our patients in that STAR trial into those that had a baseline in the high hypoxic burden range, meant about a 95.5%-minutes per hour hypoxic burden. A year later, at 12 months, that's down to a 21.2%-minutes per hour. If we go back, think about a 95%-minutes per hour is going from a Quintile 4 or a material risk down to 25%-minutes per hour, or 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 of 54 participants with a high baseline hypoxic burden transitioned to low, and that's a two-step reduction from Quintile 4 to Quintile 2. That's significant reduction in cardiovascular health. One last point I want to make on this. On 50% of the patients who were non-responders to AHI still had a significant reduction in hypoxic burden. Even though the AHI didn't get to a level of being a share responder, they did have a benefit and a reduction in their hypoxic burden. We did reduce their. Oh, here it is, I'm sorry. Here on this slide. We did reduce their cardiovascular risk, right?
That is statistically significant. On the right-hand side, when we look at daytime sleepiness, and that's measured using the Epworth Sleepiness Scale, and that is associated with quality of life and your ability to function during the day, and that's how it measures it. As the ESS goes up, you can see the patient function worsens, they feel not as well, and they perform worse in daily life. Changes in AHI, arousal index, T90, and O2 were not associated with ESS improvements in this subgroup of the non-responders, but hypoxic burden reduction was statistically significant in changing the ESS in this group. Remember, these are the 50% of the non-responders from STAR. Hypoxic burden does have a significant play. We've had real-world evidence, and now we did our own study of 30,000 patients using Definitive Healthcare claims analyses.
This is a comparison of Inspire versus untreated patients, CPAP versus untreated patient, and Inspire versus CPAP. You can see that Inspire versus untreated patients showed a statistical outcome in eight of nine measures, and you can see the reference down below, and this was presented last week at the sleep meeting, and that data is available. CPAP showed a benefit of six of nine, but Inspire showed a benefit in four of nine important measures. The conclusion is, you see Inspire is associated with lower risk than CPAP in four key outcomes: heart failure, coronary artery disease, cardiovascular disease, and cardiomyopathy. Really important outcome measures that we are going to be able to really help educate the market going forward, right? Cardiovascular disease drives significant healthcare costs.
Effective sleep apnea treatment may reduce the long-term burden, Inspire therapy delivers benefits beyond just symptomatic measures like ESS, AHI. Now we can track that to hypoxic burden, and we can now track that to cardiovascular health. There were independent studies done not by Inspire, but this is Virginia Commonwealth, VCU. They just published this paper about a month ago or a couple of weeks ago, and you can see the two-year odds ratio of adverse outcomes compared to CPAP. On the left, you can see the table, you can read down all the different variables that they looked at, and the dashed line is the odds ratio of one. Everything to the left shows a benefit to Inspire versus CPAP, and when you see the error bars all outside the dotted line, that shows statistical significance.
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, we also had a direct comparison to non-treatment as well. This is significant. This is a comparison of matched group of over 3,500 patients. Finally, there are two other additional studies, one from Thomas Jefferson University, one from University of Texas Medical Branch. This data you can see 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. Again, here is that reference line of 1.0. You can see the significant improvements in all the cardiovascular events, including cardiac arrest at one, five years. Here's Inspire versus no treatment.
Both TJ and UTMB determine Inspire's associated with significant reduction in multiple cardiometabolic markers. That's really pronounced. In UTMB's case, they even showed all-cause reduction in mortality when compared to CPAP. This is a game changer. This is going to allow us to really start reaching in and bringing in a new group, educated cardiovascular surgeons. In summary, to close our presentation, I know Larry's got a list of questions that you want to ask, let's get to just really the summary. We continue to develop what we project as 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.
They continue to drive the increased diagnosis of sleep apnea. We continue to develop our technology to drive better and better outcomes and better experiences for our patients and for physicians. Coding challenges presented themselves at the start of the year. As you know, Larry, we worked so hard to address these. We can provide a clear coding pathway for all payers, centers and professionals, be it Medicare, commercial, Medicare Advantage. We have the tools in place. We are working to educate centers one by one to make sure that they can have confidence that they will be reimbursed. To continue to drive and take care of their patients, fifth- generation Inspire V system has had a significant positive impact on the market with improved physician and patient experience. As we just showed you, with improved patient outcomes.
Our technology pipeline remains prominent, both in implant products. We already talked about the ongoing development with Inspire VI. The ever-evolving SleepSync and our ability to add features to SleepSync moving forward and the new clinical evidence, just to show the 5,000 patient 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 to have a DISE procedure. Now we've really demonstrated the long-term health benefits and reductions in hypoxic burden. Multiple independent research is showing how this Inspire outcomes is improving cardiovascular and other key health factors over CPAP and certainly over no treatment. A lot happening at Inspire right now. We're working through the coding aspects of it, but you can see we have a lot of energy behind that.
With that, Larry, we'll take a break. I guess we can probably stop sharing. 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.
Yeah. Thanks, Tim. Thanks for that comprehensive overview. That was super helpful. 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.
Sure.
I think everybody on this call knows that's been obviously the area of focus this year. Let me start with one on the commercial side. The slides mention Medicare Fee-for-Service is only 20%-25% of Inspire procedures. Which code are commercial payers using? 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?
Back in the first quarter, it's a systemic issue with the coding. 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? We have identified that pathway, and we've recognized 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. Now that we can provide that education, the coding is clear. They prior authorize commercial cases, as we mentioned on the Q1 call, we started to see trends of improvements there, but we knew Q2 would be impacted by that.
That makes sense. The slide states that two of the seven MACs, one of the slides you presented, which was helpful.
Yeah
On the MACs, two of the seven are using a -52 modifier. The reduction is expected to be 10%-20% for the physician B. Tim, what's the likelihood the other MACs start to require a -52 modifier?
I think the key is, number one, the benefit in there is the experience that we've seen right now is it does range between a 10% and 20% reduction. We want to make sure we provide the tools, so when the surgeons dictate their op notes, that they talk about the reduction in work associated with Inspire V, and to be able to be clear about what percent of the procedure or work is actually reduced. And again, will tend to be close to the 10%. That's what we want surgeons to talk about. If it goes to 20%, even that, I think is an acceptable number for surgeons going forward because it's coming off CPT Code 64582, which is a higher physician reimbursement than the old code CPT Code 64568. To answer your questions, I do think the MACs want to drive consistency.
It could be that some of the MACs will incorporate the - 52, but we have the tools in place to be able to educate surgeons right now. If they would do so, we'll be able to pivot around that. In the meantime, if the policy specifically states CPT Code 64582 without a modifier, we'll continue to recommend that that code is used because that's what the policy states. You got to recognize, going to a modifier, that triggers a manual review at the MAC. It is a cost impact for the MACs to administer those cases, too. I think we'll continue to monitor it very well, but now there's not a lot of surprises. If they make a change, that's fine. We'll adapt.
Tim, regarding the WISeR headwinds, just walk us through what's happening and when you expect that to be resolved, please.
WISeR is really kind of a big change, right? That is implemented in six states, but those are very large states. 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? How it adapts and changes in that review process. Combine that with code changes in the coding structure from the beginning of the year to the implementation of the C-codes, that has had impact. The good news is we're coming up that learning curve. We did mention on the Q1 call that it 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 two 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. Are you seeing any of that?
Simply answer the question, no, we're not. I'm not sure where that chatter really all originates from. Understand, commercial payers have a predetermination, have a prior authorization, right? Centers and physicians get the authorization from United, Blue Cross Blue Shield of Texas, Florida, wherever location you may be, to show that, yes, this is the indicated patient. These are the CPT codes that will be used for this specific case. 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 saying, look, we had this discussion. We have a letter that shows that this was authorized. It's unlikely that you're going to see commercial payers clawback.
They may make a change to coding going forward, if the commercial payers change their coding, well, then we adjust that and change the prior authorizations to put the proper coding that's in their policy. Prior authorization is the tool that people agree to upfront. WISeR has its faults, what WISeR does bring is WISeR does bring authorization for centers to do those Medicare cases in those six states, it really kind of de-risks the payment or reimbursement of said case.
That's helpful. 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-$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? Qualitatively, Tim, how are things going relative to your expectations? It's a super complicated topic, right? It's hard for us to track all of these things.
Well, I think that's number one, bring it back saying, I think what we wanted to do today is simplify it. Larry, you're a doctor in Boston. If you're doing procedures at Scripps or Mass Eye and Ear or Beth Israel or wherever you are doing your procedures, if you're Medicare, it's very clear for how you bill that Medicare case in Boston. If you're a commercial case with Blue Cross Blue Shield, Massachusetts, or whoever, it's very clear in their policy, whether you're commercial or Medicare Advantage, on how to bill that procedure. Really trying to simplify that going forward, and that really has been the education process. Again, we talked about on the Q1 call that we are seeing trends in prior authorization going forward.
We know, as we just mentioned, that we're coming up the learning curve on WISeR, and that's improving and will continue to improve throughout the year. 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 maybe a little bit differently. Any surprises, Tim, since the Q1 call in this area?
Well, the surprise was January 1 , with the coding surprise. I think that since the Q1 call, we've been working diligently to get this coding structure in place. I think we're running our playbook, and we're running the course. 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 SleepSync remote adjustments. You've been excited about that, Tim, for a while. You said that's coming on the slide. What's the timeline on that?
Well, that's still in development. We're focusing on Inspire VI as the next one. You'll see other areas or other features added to SleepSync first to improve that process. I think the remote programming, although you can highlight the benefits that that can be for patients to not have to drive into a center to 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. It is going to be a key feature in the future, no question about it.
Tim, on the predictor data, talk about how you're going to leverage that and timelines.
I think there's some payers have already removed the specific requirement for a sleep endoscopy and leave it up to the physician to determine if the patient has the proper anatomy to support an Inspire implant. We'll start with some of those payers and some of those physicians to use the algorithm in the prior authorization process to see if we can gain approval with that will help to gain experience and get the snowball moving down the hill to get a broader adoption of it. With the publication, we can start moving forward with select centers now.
Removing the DISE has what benefit to patients and Inspire?
I'm going to go back to the patient. In this case, Larry, you're not the surgeon, you're the patient. Patient Larry goes to the website, might see an outreach program, goes to the website, gets educated, may call our ACP Advisory Care program, goes to your first appointment to determine that you are a good candidate and your BMI is low, you have a small neck circumference, then you can go straight to procedure. You don't need that interim procedure of having a sleep endoscopy. 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 sleep endoscopy, wait for the results, and then submit the prior authorization.
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. That reduction in time, I think, really is going to help minimize what we call a leaky bucket of patients falling out of the funnel.
That's helpful. 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. Our ability to go to the PSG and really look at reductions of the hypoxic burden. Actually look at the area under the curve when you see that on a PSG or a polysomnography, 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. Not just minimize the 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 sleep apnea. Then improved, we showed the chart on the, both with Inspire V and especially with ADHERE registry.
Utilization or adherence to therapy is paramount in reducing hypoxic burden. When we go to Inspire VI as an example, which has sleep detection, which is going to drive therapy adherence higher, because when you fall asleep, the device will turn itself on. When you wake up, the device will turn itself off. The intent of Inspire VI is to take adherence to the next step. The intent of Inspire V was to improve inspiratory overlap. 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. Remember, we have to go through a whole FDA review cycle with that. I will say this one 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 should put everybody's mind at ease.
Okay, that's good to hear. I have to ask on this cardiovascular data you presented, the Virginia Commonwealth data, daytime drowsiness was the one 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. We specifically measure daytime sleepiness as well. That's measured with the ESS, that Epworth Sleepiness Scale. Any score below 10 is normalized, and you can see in all of our studies going back from STAR to ADHERE to Singapore, we're down in the six to seven range. We do show statistically significant reductions in daytime sleepiness. I'm not too worried about that because I do know our scores are very consistent over time and at a very therapeutic level.
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 at these, Larry, are retrospective in nature. It takes large numbers. As you look at our study, it involves 30,000 patients. VCU, 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 here in Minneapolis, they have their Optum system, which is a large database that the actuarials can use to leverage that information going forward. 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. Really to leverage the data that we have.
What's interesting between our 30,000 patient and using the TriNetX, and again, I referenced Optum in Minneapolis here, they're different databases that are used to prospectively validate each of the outcomes, and the outcomes are showing consistency.
That's helpful. 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.
Sure.
Tim, what are you seeing right now with a hypoglossal nerve stimulation company in the market? How are you guys responding? Just maybe, LivaNova's obviously going to come next year. What are the implications of having two new competitors in the market?
Number one, the value of competition is giving credibility to the therapy as a whole. It's not just those two. 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. 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, 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 is set high for what to be expected from a safety and efficacy standpoint. 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 if they want to go that way, but centers have really predominantly adopted to Inspire V because they see the benefits with it, and they know what to expect going forward. When you move to LivaNova, the key with LivaNova, again, back to the existing company, they're both using open-loop stimulation. I think what we've really highlighted today in our slides is the necessity to do closed-loop stimulation. You 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 hypoxic burden, and to maximize the reductions in cardiovascular risk. Both these companies are just open-loop. There's chatter right 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 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 titration or advanced programming. We're doing the exact same thing and have been for over 135,000 patients. The STAR trial showed 80% responder rate with those initial patients. In no way does that mean we give up on the other 20%. We showed the STAR trial that 50% of the non-responders 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.
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. Competition brings technology enhancements. It keeps everybody active, and it really drives credibility to the overall market. We welcome that part of it, and we expect to continue to evolve and develop and continue to set the bar really high.
All right, Tim, it wouldn't be an Inspire call without a GLP-1 question.
Okay.
I think there's a two-part. What are you seeing today? We just basically have tirzepatide out there.
I think people are now starting to focus on these next generation GLP-1s. Retatrutide had some OSA data out that's a more powerful triple agonist. Then we have Foundayo, the oral coming with OSA data. That, the entry criteria, Tim, I believe is 27 kg/sq m and above for BMI.
You expect GLP-1s to be a tailwind over time, and we conceptually understand that, but right now it's a headwind. How should we think about the impact of GLP-1s going forward?
Two different things in it. We talked a little bit on the slides earlier on with the PREDICTOR study. High BMI 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 address lateral wall collapse. As we've always stated, hypoglossal nerve stimulation does not address lateral wall collapse. We need to partner with the GLP-1s to help patients lose weight. The initial trial, the average BMI was 40 kg/sq m, the average AHI was 50. We need lots of population we don't treat today. In our ADHERE registry, we show today our average BMI is 29 kg/sq m versus 40 kg/sq m. We need those patients to lose weight to be able to qualify for Inspire.
If they lose weight and resolves the lateral wall collapse and it resolves their sleep apnea, they never had tongue-based obstructions or were never in our market anyways. With the new GLP-1s, that's wonderful because it's an easier way for patients to lose weight. If they lower it down to 27 kg/sq m, I think that's great. But again, recognizing that addresses lateral wall collapse, not tongue-based collapse. It is more specific or prescriptive medicine, and it's another tool to actively address the sleep apnea market. All these tools together are going to continue to grow the awareness of sleep. I think evolving of the GLP-1s, I think will help, but again, they're not addressing the tongue-based obstruction that we address. GLP-1s are addressing lateral wall collapse that we are not able to address today.
Well, Tim, just one follow-up before I give you an opportunity to close. The SEC filing suggests that they're a headwind to you today, not the top headwind. Do you still feel they're going to become a tailwind and any predictions of when?
Yeah, 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? Make sure that we get our coding structure in place. Our markets 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 care of patients with tongue-based obstructions, and we continue to evolve our technology and evolve the diagnosis, one example being the PREDICTOR. We do know that the diagnostic rates of sleep apnea has increased with GLP-1s. When you have Shaq out there talking about the need to address sleep apnea, that has a positive impact for everybody.
If we can increase the awareness and increase the diagnostic rates of sleep, that's going to definitely identify patients that have tongue-based obstructions that can benefit from Inspire. 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 coding, we can keep moving 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, number one, 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 Inspire IV to V to VI. What's the impetus of SleepSync? Why are we doing cardiovascular measurements? Why are we doing PREDICTOR? 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. Knowing that we are just at the early stages of a very large market in front of us. Again, appreciate you having us on a call like this 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.
All right, Larry.
Bye.
Thanks. Have a great weekend. Happy