All right. Good afternoon. For those of you on the East Coast, good morning. For those of you in the Midwest and the West Coast, I'm Larry Biegelsen, the Medical Device Analyst at Wells Fargo. Welcome to the next call in our 2025 MedTech Innovation Spotlight call series. I'm pleased to have the management from Inspire, Tim Herbert, Chairman and CEO, Rick Buchholz, CFO, and Ezgi Yagci, Vice President of Investor Relations. On today's call, we'll talk about the launch of Inspire's latest innovation, Inspire V, and its future development, as well as the commercial and competitive dynamics in the OSA market. As always, if anyone has a question, let me. Okay, let me keep going
right now.
I got it.
Okay. Tim, Rick and Ezgi, thanks so much for joining us. You guys have been strong supporters of this call series for many years, so thank you.
Very good. Thanks for having us.
Of course. Before we jump into Q&A, I know Tim would like to share a few slides and video. Tim, over to you.
Very good. Did I do that correctly? And you can see the slides there, Larry?
Yes.
Fantastic. Thank you again. Thanks for. We've done this in years past. We really appreciate the R&D Spotlight call. I think it's a very special series that you conduct and really be able to focus on the technology behind the products and talk about how they're able to really help patients. We thought we want to get started today and just kind of show you some introductory slides because we are so excited about our Inspire V launch that, you know, we just launched and of course we have our own disclaimer slide there. First off, really just showing a slide on what Inspire V is, right. It's a 20% reduced implant time to improve the therapy performance.
We have incorporated the sensing inside the neural stimulator, whereas we used to have a separate pressure sensing lead to detect respiration, and now we've incorporated that inside the can. The key to it is talking about sensor performance, because if we're able to more accurately measure a patient's respiratory cycle, we're in a much better position to deliver stimulation synchronous with the inspiratory phase, which we all know is very critical in having the optimal outcomes with Inspire. Of course, in the process, we have our new remote control that we released that does have Bluetooth communication, so it can communicate with the patient's app on their cell phone and in turn communicate with SleepSync, which is our cloud based patient management system. The physician programmer is new to Inspire V.2 that also directly connects with SleepSync.
Physicians can just use their own laptop or their own tablet to be able to communicate with the device in a patient's body. All the performance parameters are saved to SleepSync automatically. Whereas with Inspire IV, you would have to manually upload those and connect the cable to be able to upload all the data into SleepSync. We are really in the process of streamlining patient management, streamlining the flow. I think it is important. We wanted. We had a training video that we show physicians to really talk about the necessity to do closed loop stimulation. I want to run that. I think instead of me talking through that, it is really a lot more effective if we can kind of just let you watch a video and it really kind of helps explain it.
On the back side, I'm going to show several posters that have been presented, some at the sleep meeting this week in Seattle to show the performance of Inspire V and the performance of the Inspire system. Let's run this.
With the release of Inspire V, one of the most exciting new features is the change in how Inspire's respiration sensing technology works. With Inspire IV, respiration was detected using our proprietary pressure sensor lead. Inspire V has incorporated all our collective knowledge and experience about how to measure a patient's breathing pattern directly inside the generator using an accelerometer. With this innovation, there is one less lead implanted in the body and the implant procedure is simplified. Sensing a patient's breathing pattern has always been critical to ensuring effective treatment with upper airway stimulation. You may be wondering, why is respiration sensing needed at all? Why not just leave stimulation on permanently? Unfortunately, leaving stimulation on for the whole night leads to tongue muscle fatigue. Imagine trying to hold a five pound weight in your hand indefinitely. You will be putting that weight down faster than you think.
The tongue muscle is no different. It needs time to rest. This is why Inspire is designed to turn on and off with the patient's breathing cycle. We have already established the tongue needs to rest after stimulation. Since we have to turn stimulation on and off to rest the tongue, does it then matter when stimulation is actually on? Why can't we just run stimulation in a pacemaker-like mode without needing to detect respiration? Obstructive sleep apnea is a difficult problem to solve. A patient's airway is dynamic and once it closes, it can be very difficult to reopen it. Indeed, the collapse cascade for obstructive sleep apnea begins during the late exhalation phase of breathing and continues through the inhalation phase. This is the most vulnerable time for the airway and is the time when it is most prone to collapse.
It stands to reason that we should target that period in the breathing cycle. In 1996, Dr. Alan Schwartz and his team at Johns Hopkins proved that rhythmic stimulation targeting the inhalation phase of breathing could stabilize OSA. Their research was verified by Inspire during the STAR trial, but we also learned that turning on stimulation during the late exhalation phase was critical for success. It is important to deliver stimulation before the collapse cascade of OSA begins. Inspire's sensing algorithm is designed to provide stimulation during this vulnerable period of breathing and relax the tongue during the beginning of the following exhalation cycle. As such, Inspire delivers stimulation during most of inhalation and some of exhalation for most breaths. This allows some flexibility for the algorithm to adapt to different sleep states, body positions and breathing patterns.
Here is a patient example from a sleep study who was having frequent obstructive events because stimulation was not well synchronized. After some simple programming adjustments to the sensing settings, this patient's obstructive events resolved. Fortunately, the default sensing settings work for the majority of patients and it is very rare that we need to change these settings from their defaults. Here is another example. Look how the inspiratory flow is limited because stimulation is not capturing inhalation. You can see how much the airflow is improved after stimulation is moved to the correct portion of the breathing cycle. There have also been several peer reviewed publications that have studied what happens when you do not have well timed sensing. In 2019, Dr. Steffen and colleagues examined the effects of poor stimulation timing in three separate patients.
By inverting the sensing signal and reducing the sensitivity to breathing cycle detection, they observed worsening in ODI, AHI, and especially supine AHI. These outcomes returned to their treatment levels when the settings were corrected. In future sleep studies, the authors concluded correct respiratory signaling supports controlling OSA. In summary, constant stimulation can cause muscle fatigue. Timing of stimulation is critical to target the most vulnerable portion of the breathing cycle to prevent airway collapse. Inspire V uses an accelerometer inside the generator to monitor the patient's breathing cycle. Inspire is committed to providing the most cutting edge technology for our providers and patients. Inspire V's new accelerometer-based sensing not only makes the implant easier, but it continues to deliver stimulation at the right time to ensure the best possible patient outcomes.
I think that training video really kind of summarizes why we do what we do, how the technology is advancing and being able to take the knowledge from the 100,000 patients who have received Inspire therapy and be able to apply it to our fifth generation. That really sets up the platform as we start moving forward. I want to show you just a couple other data points that we looked at and introduce a couple concepts that we talked a little bit about. The first one, this was presented back in 2024, but this talks about the clinical data that we used to show the FDA the efficiency and the effectiveness of the Inspire V neurostimulator. What we did is we had 56 patients who had either an Inspire II device or an Inspire IV device in their body.
We can attach an Inspire V device externally and use their patients as their own control. The key measure that we want to track is right here, the inspiratory phase overlap, or what we call inspiratory overlap. How much of that inspiratory cycle are we able to capture with our sensing? If we can capture that, therefore, we can now provide stimulation synchronous with the inspiration. That is the critical phase that we need to provide to the patient to prevent obstructive events. You can see we've been shown to be quite effective with the device. As an example, when we start looking at the commercial system, this is Inspire IV. When we went to an accelerometer, we can tune that up and actually see if we can't get better respiratory patterns and increase that respiratory overlap. Right.
When we look at the commercial systems, we were running at about 78% of the inspiratory cycle, we could detect and provide stimulation, but when we went to the accelerometer version, we were up to 83%. We need to demonstrate that a non inferiority at a lower 90% confidence bound that the Inspire V system is at least as effective. What we want to show is potentially that the effectiveness of the sensing is even better with the Inspire V device versus the Inspire IV, as shown in these pictures. That is the key as we go forward. If we can improve the detection of respiration, we can deliver the therapy most appropriately when we need it. That in turn further increases the performance of the Inspire system. Take that to the next step. This was just presented this week.
This is the first results from the Singapore data. Before we started our limited release in the United States, we actually went to Singapore and we did a study with 44 patients who prospectively received Inspire therapy. We did it at two centers. Pretty standard demographics that we experienced with an AHI of 37 at the beginning. Implant time was documented to be 20% less compared to implants of existing Inspire IV systems. Remember, the sites in Singapore are experienced Inspire sites and they have significant experience with the Inspire IV system. What's really nice that we measure is the nightly usage at 3 months post implant. You can see the total time, six hours per night on average with 6.2 at Singapore General. That is National University 5.6. Very, very impressive.
Now, we have several other key features that have been incorporated into Inspire V that we learned over the years. One of them is a smaller step size. What that means is the patients have the ability to titrate their own therapy with the remote. They used to be able to go up in amplitude in step sizes of a 0.1 V . Sometimes we found that that just was not specific enough. With Inspire V, we can now go up in 0.05 V increments. Very important to get more precision stimulation for the patient. We have ramp duration, is how long. Instead of the device just turning on, the device will now turn on.
It is more comfortable for the patient when they go to sleep to be able to have a therapy titrate at a lower level, allowing them to sleep and then be more comfortable before it gets up to the therapeutic levels. It is really important with the new features, we have been able to really demonstrate those and we are going to be able to show more data as we go forward because we are going to be collecting the AHI data at 6 months with additional feature usage. Finally, we wanted to come back. There is another unique poster there because there has been some discussion of supine AHI. This was a study conducted by St. Luke's Health in St. Louis on their own accord. We were able to go through and talk to them about their data. This is a large study. It is 59 patients.
They wanted to measure what happens with supine versus non-supine. Is there an impact with the Inspire system? What we know is that we titrate our patients when they're in the supine position. Of course, we all know gravity is a key part of sleep. On your back, your tongue can fall back into your airway. Their data suggests that hypoglossal nerve stimulation is effective regardless of sleep position. If you look through the percent of patients that were responders, again, this is the Sher criteria. The Sher criteria is defined as a reduction in AHI of 50% and a resultant AHI in this case less than 15. You can see the success rate in positional sleep apnea is over 80% and in the total sample size, over 72%-73%. This is an independent study by St. Luke's.
That's significantly improved versus the STAR trial. Because the STAR trial was conducted back in 2012, there's so much more information we know on how to select patients, how to design the technology, and then how to apply and manage patients to be able to improve our efficacy. This was nice to walk in and see St. Luke's Health actually have a study independent of Inspire to show not only the efficacy that we've come to expect with Inspire, but to also come back and really put to bed the whole argument of supine sleep. Saying that Inspire is designed for, has managed supine sleep for years since the beginning, and will continue to be effective as we move forward. We're very excited to have launched the full launch of Inspire V in May, and that's really just the slides that we wanted to cover, Larry.
I'm going to stop sharing and kind of hand it back to you and see if you have any questions in regards to the slides or anything else within Inspire.
I definitely have some questions on the slides and Inspire Tim, and maybe worth pointing out to people that those slides, which are a little hard to read on the screen, were included in your 8-K this morning. If people want to see the details, they have them.
Thank you. Yeah.
Definitely want to follow up on some of those things. Let me ask you one big picture question. You guys have reached important, important milestones over the past year. Inspire V approval and launch, sustainable profitability. Talk about your top priorities for the remainder of this year and key milestones for the company over the next couple of years.
Yeah, absolutely. I think that our priority is obviously the launch of Inspire V and how excited we are. We did announce 100,000 patients have been treated with or have received Inspire therapy. What a key milestone that is and to be able to learn so much from those patients and apply that learning to the Inspire V system for years in the development efforts and now to be in the full launch. That really has been our focus going forward. We've made significant progress, certainly having the inventory levels to be able to support it. We had confidence in the performance of the system, but we just weren't able to go to full launch until we had the inventory levels to really support the full launch. We've been doing a limited market release since late in 2024.
Going forward, we're going to continue to focus on growing the adoption of Inspire therapy and really we know that we're lightly penetrating our overall target market and so just really probably a small single-digit penetration. Really our focus going forward is continue to grow, to focus on growth and focus on growing the adoption. Now we have a new tool with Inspire V and that allows us to start the development on Inspire VI and to really keep focusing on the development along our SleepSync, which is our cloud-based patient management system. Very exciting times at Inspire and really look forward to the ongoing activities.
Perfect. Let's move into Inspire V. As you mentioned earlier, you announced the.
Official launch in May.
You just had the sleep meeting in Seattle this week, which I know you attended. Talk about any feedback and learnings from the launch and what did you hear? What was the buzz like in Seattle?
I think some of the abstracts that we just showed kind of talk a little bit more quantitatively about the performance of the system. What we're seeing with the inspiratory overlap, what we're seeing with the ability to improve the implant time, all the implants were successful. That's very key. Safety, performance. As you saw, were strong. I think when we get to Seattle we get to talk to physicians more so about the qualitative aspects of it. What do you think about the Inspire V device? What's your reaction today with your experience? And it's not only the limited market release sites, but now we have formally launched the product and so we have more of an expanded network to get feedback. Number one, I think the surgeons, ear, nose and throat. Right.
Ear, nose and throat, they really appreciate the ability to implant the Inspire device without placing a pressure sensing lead in the chest wall. That's always been a little bit of the part of the surgery where the ENTs do not go every day. It's a safe procedure. We performed that in over 100,000 procedures. That's the one part of the procedure that was not most comfortable for the ENT. First comment overwhelmingly is not putting in the pressure sensing lead is really a very good, very nice desired change. Number two is the reduced OR time is very noticeable. As they place the electrodes and tunnel, once they place the neural stimulator, they know they just do the final intraoperative testing and close and they do not have to deal with the pressure sensing needs. Quite an advantage going forward with reduced time.
That really makes a difference. I think what they're starting to learn too is the added features that we put in, especially more of a soft launch or the soft ramp of the amplitude so it's more comfortable for the patients during therapy. That's something that we've learned over the years. Until you get such experience with technology like that, you won't know that to be able to apply that into your devices. I think that's going to be one of the benefits that we have going forward. The feedback has been very positive to date and really look forward to doing more Inspire Vs.
You talked about the accelerometer or the video or you. I can't remember, talking about the accelerometer more accurately measuring respiration. Why would the accelerometer do that better than sensor lead?
Technology has been around for many years. Accelerometers have been standard technology in rate responsive pacemakers where if you go jogging, your pacemaker is faster because it's measuring your respiratory rate. It is a proven technology that we're able to apply into the Inspire V device to improve that. Secondly, the pressure sensing lead, while it was quite effective and you saw it was in the high 70% inspiratory overlap, provided a good respiratory signal. There is always some rotational ailment when you get between the intercostal muscles and some interface on how we're measuring it and if the patient's moving at body position. I think the accelerometer just provides a much stabler environment being inside the can and the can is always flat in the chest wall when the patient is and it's not as susceptible to patient movement.
We have already shown a little bit of improvement and I think as we progress further that will continue to document improved sensing.
Tim, you still expect to complete the transition to Inspire V by the end of the year. Just remind us of the timeline for that kind of full transition, please.
We do. We're making very good progress right now. We've trained the majority of the surgeons. Again, the surgeon's relatively simple. They do. It's a self-training on a tablet where they're able to go through the slides. The primary focus is saying you don't need to implant the pressure sensing lead anymore. How does that change interoperative testing? What are the new features of the device with step function and ramp? I think the training goes relatively quickly and then the surgeons sign that off and they're qualified. Step two is the contract phase where we have an addendum to the pricing agreements at the centers. All the contracts are out to the sites. It's a relatively simple change. You're just adding a model number.
As you know, we have not changed the system level pricing, so we do not need to go back through the value add committee. That is a very straightforward process. We are making very good progress with that. The third step, as mentioned in the slides, is that we have gone to a new physician programmer that directly interfaces with SleepSync, and therefore the sites need to be on the SleepSync system. The data changes that they make when programming a patient's device are automatically stored into SleepSync. The majority of the top centers have already been on SleepSync, and that new programmer was approved by the FDA last year. It has been in play for quite some time. We need to make sure all the centers adapting to Inspire V are on SleepSync.
That can take a little bit longer, up to 30 days or longer if you're a sophisticated site working with the IT departments. We're quite experienced incorporating that. We don't see that as a long term showstopper. Yes, we fully expect to be transitioned to Inspire V. That said, Inspire IV is still available. If sites wish to remain with Inspire IV, if a physician desires to stay with Inspire IV, it will continue to be available. We believe the majority of surgeons, once they start implanting V, will quickly transition over to the 5th- generation device.
Tim, sticking with the clinical data, you've got World Sleep in September and then I think you have the ISSS meeting in October. So you're going to show additional data sets September. I think it's going to be where data comparison for Inspire IV versus V. Why is that important?
That actually we showed a little bit of that in the first slide, and the data comparing IV to V, that's actually the data we use of the clinical study we conducted to give the data to the FDA. They had confidence in the sensing and the algorithm of Inspire V. With that data from the WEAR study, that is what the FDA used to give us approval. The Singapore studies is actually a post-approval study where we're conducting additional evidence to show, and with that we can collect AHI data as well. We're going to be showing some of that data when we get to World Sleep and when we get to the International Sleep Surgical Society meeting, which by the way is right in front of the big meeting, which is the American Academy of Otolaryngology, which is the ENT Society meeting.
Yes, we have ongoing data generation and ongoing data reporting, and so it'll be a big fall to be able to show some additional data.
You're going to show 6 month PSG or sleep study data on Inspire V at ISSS AAO?
We're going to try and get that data. Yeah, we're going to try and get that data done. It's going to be tight to be able to get that through. That's the intent, is to try and get most of that data available.
You talked about improved therapy performance. It was a heading on one of the lead slides. Is there anywhere besides the titration that you talked about that is more comfortable for the patient? Anywhere you think you might be able to show a clinical benefit for Inspire V over Inspire IV?
I think the real clinical benefits is going to be the reduction of the comorbidities. Of course those are the ones that take longer periods of time and larger numbers of patients to be able to monitor. But we are monitoring all those. When you look at the sleep parameters AHI, we're certainly going to be looking at that. We did show you the slide from St. Luke's Medical Center in St. Louis that showed significant improvement from the STAR trial in the Sher criteria with the AHI responder rates pushing high 70%. That's just phenomenal with the study of up to 60 patients and also showed, well, supine AHI has never been a concern of ours. We've been treating that since the beginning. I think that's one independent study that shows AHI. We expect that.
We look forward to monitoring that data with Singapore as well because it's not just Inspire V, it's what we've learned over all these years in STAR. Think about that. We conducted those implants in 2012. We're in the year 2025 now. That's years ago and 100,000 patients later. And the amount of learning we have with patient selection, with implanting of the device and our outcomes today far surpass what people are comparing to back in the STAR trial back then. The St. Luke's study is just one little piece of evidence to show our performance today is far significantly improved versus what we had at the STAR trial. Yeah, and we're going to continue to generate more evidence ourselves as well as our physician partners in our centers continue to generate it.
What was really exciting at the sleep meeting is when we walk to the poster sessions and all the fellows doing research. There is a whole row of people investigating different aspects of Inspire therapy. It is really a proud to be able to walk down the row to talk to the physician, talk to the fellows, let them understand the research that they did, why did they choose to do research on that and how they are going to continue that forward. We will partner with a lot of them to continue pushing that research because it is just learning across the board.
Tim, a couple other questions on Inspire V. One is you've talked about the procedure time being 20% faster, but the surgeon fee is also lower. You've talked about surgeons being able to do more cases to make up the difference. What are you seeing? What are you hearing on that front? The kind of time savings, but you know, objectively slightly lower surgeon physician fee.
Yeah, it all kind of works together. Let's kind of walk through it a little bit. We know that when surgeons do more procedures, they become proficient with the procedure and therefore they can do more cases because their OR time or their surgical time, skin to skin, is significantly reduced. Couple of examples. We have a surgeon in Hamburg, Germany. He's very well versed in the Inspire procedure, but they have done 12 cases in one day. That was with Inspire IV. Now, in their situation, they're very proficient. They do the procedures quickly and they had two different rooms. As they're cleaning one room, they go to a second room, do another case and go back and forth through the day. They're doing six cases in a single procedure room during a day.
With Inspire IV in the United States, we've had a couple instances where physicians have done nine cases in one day. With Inspire IV, we know our top physicians can do the procedure in about 30 minutes, we think, on average, we talked about Inspire V procedures being between 45 and 60 minutes. We know that with practice and becoming more proficient, we can really get that down to about 30 minutes. When you start talking about the reimbursement rates of $600, which is a national average Medicare payment, of course, commercial payers pay higher than that. That calculates for a national average Medicare procedure at 30 minutes of $20 a minute. That is as strong as any other procedure that they do. With Inspire IV, it is a little less than that, but that is still a very strong reimbursement rate on a per minute basis.
For the ENT surgeons, it's really about driving efficiencies, though, not just in the operating room. That's one example, what Inspire V does by driving that implant time down, yes, it's a reduced reimbursement, but there's reduced work. The work that's reduced is the work that the ENTs don't want to do, which is placing the pressure sensing lead. It really works together. We also have to build efficiencies outside the operating room so the ENT surgeons can spend a lot more time in the operating room. One example is we talk a lot about training APPs, advanced practice providers, which are nurse practitioners, which is physician assistants, to be able to communicate with patients, give them the education tools, make sure that help them through the process.
The ENTs don't spend their time in the office with education aspects, but they could spend their time in the operating room doing procedures where they can take advantage of the strong reimbursement that Inspire has at $20 a minute for an Inspire procedure. If they can do more cases in a day, they can generate appropriate revenue for their practice. It really works hand in hand, just building efficiencies outside, inside and improving technology to maximize the reimbursement that's there. For those physicians, if they really want to continue doing Inspire IV, Inspire IV is going to continue to be available for them for a period of time. I think once they get experience with Inspire V and improve their time to do the procedure and not have to implant the pressure sensing lead, you'll see them convert to Inspire V.
We won't really talk about this reduction in reimbursement.
Just remind us Medicare is what percent of U.S. implants? And do you have any idea like how much higher the physician fee is for commercial versus Medicare?
For a hospital and professional fee, we estimate commercials pay about 1.4 times that. Generally speaking, commercial cases make up 65-70% of our cases. Medicare can make up 30-35%. Then there's the VAs and military can make up 5%. If I did that right, it doesn't add up to 100%, but generally those are the numbers that we've always talked about.
All right, that's helpful. Tim, on the Q1 call, you talked about Q2 sales growth being slower because of patient warehousing in anticipation of Inspire V and work down of inventory of Inspire IV at hospitals. Talk about what you're seeing on these two fronts so far, please. Have things been in line with your expectations?
I think they have. When we got to the Q and earnings call, we had been on an extended limited market release and so we spent more time with the centers understanding the dynamics there and did see that we did have some patients who chose. They want to wait for the Inspire V device, and that's fine. Those are patients that really aren't in the queue yet. Right. Because the doctors aren't going to put them into the queue until they have a chance to get Inspire V contracted, trained and available at their sites, and then they'll come back and get them in the queue and get them taken care of. We also know many sites are working with a backlog of patients. So the patients already in the queue, they're going to be offered Inspire V as well.
We did see a little bit more of that. It is kind of in line with what we were envisioning beforehand. The warehousing of existing inventory and working that down, that is in process. As the sites come on board, they work through their Inspire IV inventory and then rebuild with Inspire V as they do their transition. That is consistent with what we reported at the Q1 call.
Okay, so no surprises from your perspective? Things are playing out as expected?
Yes.
Okay. Okay, that's helpful. Let me just scan my questions here. I mean, you think the bottom line is, though, Tim, on this position fee change, do you think it's kind of overblown? It sounds like. I mean, I know there's been a lot of investor focus on that. You think that the procedure time reduction is, you know, neutral to, you know, more than offsets that?
Yeah. The concerns are not unwarranted. We understand. I mean, everybody, you know, with a physician, follow the dollars. We've heard that before. The key to it is the reduction in the reimbursement is commensurate with the reduction of associated work. Now, if they were doing the same procedure to procedure and the reduction goes down, that's a concern. In our case, it's a reduction of work with a commensurate reduction in reimbursement, but a reduction in time allowing them to do more cases in a given day. It's not just the professional fee. With additional cases in a day, that adds a significant amount of revenue to the site of service, the hospital or the ambulatory surgical center. There's a greater benefit with the reduction of surgical time on the broader picture. No, the concerns are not unwarranted.
I think I, I do not want to say it is overstated, but I think once you, the physicians get comfortable with Inspire V with the reduced OR time with the benefit it brings their hospitals or if they are a part of ambulatory surgical centers and the benefits that it brings the overall ASC. I do not think this is going to be an ongoing discussion.
Okay. And just one more kind of guidance question. Maybe Rick will jump in here. You know, the 2025 guidance, I think investors are concerned about the back half ramp. What gives you the confidence that that's realistic? Remind us of what's baked into the guidance for competitive trialing, please.
Yeah, we did assume some competitive trialing in our guidance for, for 2025.
What's included in our guidance really.
For the second half of the year is continued increase in capacity by adding more centers and more surgeons also.
The improvement on productivity from a surgeon standpoint.
Okay, so as you sit here today, Tim, still confident in the second half ramp?
We are confident with Inspire V and what is so exciting is to be able to show data and to show feedback from the physicians that the excitement around V is real. We have the inventory to support the full launch with a stable production line. We are very excited about continuing the rollout of V and taking care of patients.
Okay. I know, Tim, you love talking about the pipeline. Sure, we love talking about it too. Inspire V, you've talked about as a platform for future upgrades. What share, you know, some of how you're thinking about these future upgrades.
Right. In the video, it did show kind of some pictures of the insides of the neural stimulator. It's state of the art. The technology that we put in there with our integrated circuits and microprocessors based system really allows us to take this to the next level. One example is we're already working on Inspire VI right now. The message that we had at the sleep meeting right now is we know to drive outcomes, we need to have the highest level of inspiratory overlap because then we can provide stimulation during the respiratory cycle and that helps us prevent apneas and that gets us the highest level of outcomes. The second part of that statement, and this applies to CPAP and everybody else, if the patients don't use the therapy, it's not going to be effective.
Therapy usage is so critical. What we showed from the Singapore data is we're showing patients using the therapy over six hours a night. That's really fantastic. We want to keep pushing that so that if we can maximize therapy usage or maximize the patient's adherence to therapy, that's something that's really going to be an advantage to patient outcomes. That's what we're all about when we go to Inspire VI. The concept of Inspire VI and what we're targeting to do is detect sleep. We'll know when the patient can fall asleep and when the patient wakes up.
The vision is that we are going to be able to turn the device on when the patient falls asleep, turn the device off when they wake up, that way taking therapy adherence to the highest level and along with the therapeutic stimulation because our closed loop system, we are going to have outcomes that are going to be even better than they are today. That is what we are really targeting. Very excited about VI. When we go to future generations, we know that we can detect with our internal sensing if patients are having apneic events or if they are having position, what position they are in.
We can start to detect the performance of our system internally to our device and then longer term apply that learning to be able to have a device that may be able to auto titrate and auto adjust during a night to optimize outcomes throughout the night. Similar to what you see with the auto titrating CPAP machine. An auto titrating CPAP machine senses when a patient breathes and knows that it needs pressure high enough when the patient breathes in to prevent apneas and lower pressure when they exhale. It optimizes that pressure to get outcomes. We're doing the same thing except we have our device inside the body and stimulating the hypoglossal nerve. A lot of excitement around that. Really, this data is going to be captured in our SleepSync.
All of our centers will be using SleepSync with the Inspire V, and we will be able to get a good view of outcomes across the board to be able to take those outcomes to the highest level. It is also a tool to help centers efficiently manage their patient flow because we know they are going to be seeing a lot more patients, and we need to make sure that the sleep physicians are also equally set up to be able to manage those patients.
By going back to Rick's comments earlier, basically Inspire V, it saves time and some centers are going to be able to do more procedures. It's an easier procedure because you're getting rid of the center lead, so you're going to get more new surgeons. That's part of, like, that's the formula for accelerated growth. It's that simple.
That's what we want to do. Take existing centers. Existing centers can do more cases in a day. Like we talked about, the centers are working on a backlog today and we still have strong patient demand. We need to go to those physicians, say we need to train your partners to build some capacity at these existing centers. Finally, we're going to continue to keep opening centers as we have since approval back in 2014. We'll keep adding new centers as well. It's really a three prong event and really taking advantage of what you just described with the benefits of Inspire V. Not only reduced OR time, comfort with the surgeons to do the procedure now that they don't have to go into the chest wall.
Some of the surgeons that are trained today, but they just don't do a significant number of procedures. The low productive accounts, now we get to go back to them saying, hey, remember that pressure sensing lead, that's gone. We don't do that anymore. Now you can come back and do it. Just the stimulation lead and a neurostimulator, that's kind of more in the wheelhouse of the ENT surgeons, and re-engage those previously trained surgeons. That is a big effort that we're putting in right now too. About four different groups that we're going after that can help us treat an additional, the new wave of patients coming through.
I mean, Tim, it's so early. You just had the full launch in May. Are you seeing any evidence of that? Where surgeons, some of these new groups of surgeons saying, hey, now that the sensor lead is gone, I want to do. I'm interested.
It is too early, as you say. But with the surgeons that have it, we know with the positive experience and we know a lot of the, even the surgeons in the limited market release, they had patients waiting for Inspire V or they had patients in their mind waiting for Inspire V. We already know with those centers that they want to be able to do more cases as well. Early on. But even with the LMR sites, we are seeing positive activity.
All right. All right, so 14 minutes left. You know, you've got this exciting Inspire V launch going on, but there's more kind of, I guess, noise in the market, if you will, with, you know, competition, drug therapy. Let's try to tackle that, GLP-1s. Someone sent me an article before this call from MedPage Today that talked about, you know, interest in GLP-1s among sleep apnea patients at the, that, that was discussed at the sleep meeting. What, what are you, what, what are you seeing? Is this, we know there's the puts and takes. Is this kind of net neutral? Is it too early? What, what are you seeing today?
Yes, it's too early. I mean, Lilly had presence right next to us at SLEEP meeting and they're still trying to figure out how the sleep physicians are going to manage patients on GLP-1. They're not set up to do the prescriptions and do the management. While they want to put the patients on CPAP, they can also refer them either to their weight management clinic or back to the family practice doctors to have the weight management clinic and the family practice doctors prescribe the GLP-1s and manage that long term. I think that's what's really happening today. When the patients come to the sleep physicians, they don't want to wait 6 to 8 to 9 months to see if it's going to work. They're putting them on CPAP right away. We're still trying to track how that all plays out in the end.
We know there are a lot of patients with a high BMI that we're just unable to treat because of the lateral wall collapse. Hypoglossal nerve stimulation does not treat complete concentric collapse period. We all stimulate the tongue to move the tongue forward. We do not stiffen the lateral walls. That is a different mechanism, a different nerve bundle that needs to be stimulated. We are continuing on with our own research to do that as well. I think that the GLP-1, the concerns are not as great. We are tracking it really closely to see how patients are responding to that. What we hear is, and what we see is, patients actively on GLP-1s in our range coming in to receive therapy. We put some of that data out a couple quarters ago showing patients actively receiving Inspire therapy while on a GLP-1.
We know it is real. Again, a little bit early days, but we do expect that that will continue to. GLP-1s will continue to increase awareness of sleep, which is great. We will be able to treat patients with a high BMI and hopefully reduce their lateral wall collapse to make them qualify for Inspire. For those patients that do not have tongue-based obstruction and they can take a GLP-1 and reduce their AHI to a mild or normal range, that is great. Those have never been our patients anyway because they do not have tongue-based obstruction. We like the GLP-1s and we continue to monitor the progress and think that it will be complementary to Inspire in the long run.
Hey Tim, I'm sure you monitor kind of the top of the funnel. You probably have, you know, hits to your website. You maybe you monitor, you know, dice tests and things like that, other data. Are you seeing any impact of GLP-1's positive or negative to kind of the top of the funnel?
It is hard to even pinpoint that. I think that we continue the funnel, but that is more of a function of our DTC and how we build our awareness. We purposely took our DTC down a little bit at the beginning of the year as we were preparing for the launch. Now that we have gotten into five, you are going to see that increase through the year. It is kind of hard to see what is driving that activity. I think we have monitored the GLP-1s and it is just not that evident yet. We continue to communicate with our sleep physicians, our ENTs to see the patient demand. We know the demand remains high and we know most of our big systems are working off quite an extensive backlog.
Right. So let's talk about comp. You're going to face the first competition potentially, you know, second half of this year. Assuming Nyxoah gets approval in the second quarter, maybe at a high level. How do you think, what's the basis of competition here? How do you think physicians and patients are going to choose, you know, one device over the other?
Right. Oh, again, let's go to the highest level. I think just like we talked about GLP-1 being beneficial to the overall sleep market, diagnostic tools get better and are increasing the overall diagnostic rate for sleep. Competition could be a good thing. Competition can build awareness and can show credibility for the technology. The challenge is the competition has to provide the proper level of safety and efficacy as well. Any competitor coming out and if they get approval, they're going to make sure that in a real world setting that they continue to deliver that and the market's going to decide their presence going forward. Yeah, I think with the success that we've had with our new technology, we know we're going to have competition. There's no question about that.
We know there are numerous players out there, but we've really dug in and we've worked hard to develop our technology and really build our position. Just launching Inspire V and showing evidence that comparing to our data back in 2012. No, no, no, no. The market's evolved and the efficacy expectations are much greater. Having all patients receive proper therapy is really important. The safety profile is something that the market's going to closely monitor, I think. If they get approval, I think, yeah. The academic centers, it's their job to test new technology to see how it stacks up. Do they have a positive experience with it, are the patients going to weigh in? We know those sites are going to do trialing, and we don't have any issue with that. I think that's fine.
I think that we'll continue to do our job with our new technology, continue to invest in our R&D as we talked about, and keep pushing outcomes higher and higher and higher and keep raising the bar and making it challenging for the competitors to adapt technology and be innovative, to be able to bring new things to the market. I'm sure we'll continue to have competition in years to come.
Tim, the, you know, Nyxoah has tried to differentiate themselves with the supine versus non-supine data. Do you think that the data you showed us earlier, 59 or so patients retrospective, is that enough to kind of neutralize, you know, their kind of marketing message? What's the plan for that center to publish that data?
First off, it's always been a non-issue that since I've started on Inspire, back when I worked at Medtronic, we knew, and I think it was in the video, I think that it talked a little bit about synchronization and also talked about without synchronization, an increase in AHI and especially in supine AHI. We all know you have to treat supine AHI primarily, and if you roll on your side, it's a lot easier to treat those patients. We've been dealing with supine AHI since the beginning of the Inspire project. It's part of our FDA approval process. We titrate our patients in a supine position, so it's a non-factor patient. Here we have an independent site conduct their own research to kind of put that to bed.
We're going to continue to show more and more data about how we treat supine AHI. We don't think that's really going to be a significant factor at all.
How are you guys going to address complete concentric collapse, another area that Nyxoah and LivaNova are trying to differentiate themselves?
The key is going to be they both stimulate the hypoglossal nerve. We know the hypoglossal nerve stimulates and innervates the genioglossus muscle, which is the tongue muscle. Both of the therapies move the tongue forward. I think the key to it is by moving the tongue forward, you cannot stiffen the lateral walls. I think that as they progress in time, and we need to see the data. To this point, you have not seen any data on the ability to treat complete concentric collapse. I think even when you do see data, the first thing you need to look for is BMI. The predictor study has already shown the patients that have a BMI less than 32, very few of them really have significant lateral wall collapse and leading to complete concentric collapse.
What we're talking about with complete concentric collapse is high BMI patients that have significant lateral wall collapse. These are patients that have apneic events, not hypopneic events, real true apnea events. We know LivaNova screened out patients that had high apnea index, meaning they're not treating the severe patients at the beginning. They're really not treating complete concentric collapse anyways. I think our dual channel device is one that's going to really go after the high BMI. Today we're relying on GLP-1s to help those patients lose weight and relax the lateral walls. I don't think any of the players are really going to have much success treating complete concentric collapse in a high BMI patient, and in low BMI patients, those patients don't really have complete concentric collapse anyways. That's what we've shown from the predictor study.
Tim, one more on competition. I think Nyxoah expects to use the same CPT code as Inspire V. If you look at the description, it calls for, you know, an implantable pulse generator. It's not clear if they truly are, you know, implanting a pulse generator. Do you have an opinion as to whether they're going to have success using that code and how that, you know, I'm interested to know how that might impact the, the ramp, you know, the adoption, which obviously impacts you.
I think, Larry, this is above you and I's pay grade. This is all determined by certified coders. These are people that go to training, they take their test, they're qualified and certified to look at procedures and to determine the proper CPT code and if a proper procedure is applicable. The certified coders looked at Inspire, and that's why we're using 64568 versus our previous 64582 because we do not have the pressure sensing lead anymore. With the implantable neural stimulator, I do not want to opine on that, but we'll leave it to the certified coders to determine if an external source is the same as an implanted pulse generator. I think the jury is way out on that one.
Until they really get approval first and then get some publications out there to show payers that covering their device is warranted, that the next step after that will even be the coding. I think we're quite some period away before you'll hear more on that.
Is that something that'll take like 6- 12 months before we, you know, we and physicians learn, like, how long does it take before the market understands that, if payers are going to accept that code?
Payers are going to make sure that you got to have peer reviewed publications to show that your data is safe and efficacious before they're even going to look at it. Getting an FDA approval is not evidence that you're safe and effective. It is. The FDA does a great job at looking at the studies, seeing if you hit your end points and if they give approval that's an endorsement that they can proceed onto the reimbursement phase. Then it's a whole new world. Larry, you've been with us for a long time. You remembered it took five years for us to have sufficient evidence, large studies, five year data to be able to get proper coverage. That just takes some time.
All right Tim, two minutes left. Of course I have to give you the last word. We covered a lot of ground but I'd love to hear from you again maybe at a high level. Key messages, anything you wanted to cover that we didn't have time to cover. Thank you for your time.
Oh, thank you, Larry, for again hosting us on these R & D spotlight calls. It's so fun, being an engineering background myself, to really kind of highlight the focus that we put on the R& D efforts and specifically around patient outcomes. Every employee here knows patient outcomes is everything. That's the one slippery slope you never go down with the payers to take care of patients. We gain patient confidence, we gain our physician confidence that they know when they prescribe Inspire, that the team Inspire is going to be behind our device. We're going to do everything we can to make sure every patient has the best possible outcome. We're committed to that. Thanks for all the coverage that you do.
You bring to light a lot of the concerns that investors have over the environmental factors such as the GLP-1s. We didn't touch on some of the other drugs in investigation, and we know the history that's showing that they're set up to be able to treat more of a mild population. It builds awareness to it. The technology is building the awareness around it.
And.
We also understand the concerns that when you do a new product launch, there's always a challenge on the patient flow by going from the Inspire IV technology into our Inspire V and the concerns around coding. You are able, with your work, to show the concerns that the investors have. We at Inspire remain committed to our patients, remain committed to our customers, and, of course, remain committed to our shareholders. We work as hard as we can every day to deliver what we promised, make sure we deliver the strong patient outcomes that we believe will, in turn, continue to lead to our increased and continued growth of Inspire. Now we can do it in a profitable manner, as we did last year and as we kind of lean into this year.
Thanks, everybody, for attending and hearing the story and for your confidence in Inspire and ongoing support of Inspire.
Oh, perfect. Tim, Rick, Ezgi, thanks so much. Everybody on the line, thanks for listening. Hope everybody has a great weekend.
Thank you. All right, Larry, very good. Take care. Thanks much.