All right. Next fireside here, we have Inspire. We have Chairman and CEO Tim Herbert and Ezgi Yagci from Investor Relations. I think, Tim, you want to start off with a little presentation, and then we'll jump into Q&A.
I think that's great. I want to jump off and respect so much for having us again. We really appreciate coming up here and spending time with everybody. It's an exciting time for us because we get to talk about Inspire V and how the launch is going and the benefits that that's going to really provide patients and really take the therapy even a step further. Before we get into that, it was a good opportunity to say, let's put a couple of slides together just to kind of describe what we're talking about. We know that we've already demonstrated a 20% reduced implant time with Inspire V because we did an initial study in Singapore, and we've also done a limited market release here in the United States. Now we are in full launch and have been.
It is pretty exciting to move forward and keep talking about this. The Inspire V, the key to the device is moving the pressure sensing lead from external wire or lead to becoming internal to the device using an accelerometer. The necessity to that is to measure the respiratory waveform to make sure that when we provide stimulation to the hypoglossal nerve to move that base of the tongue forward, that it synchronizes when a patient inhales. Rather than me trying to describe that, I thought what we might do is we're going to show a video. This video was not created for this conference. This video was actually a standard training video we use. It is for physicians. It has been around for a while. It really shows the necessity to do sensing and synchronize stimulation.
After that, I'm going to come back and I'm going to show three slides on data that was released just last week at the American Academy of Sleep Medicine meeting in Seattle. Let's run the video and take a look.
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 4, respiration was detected using our proprietary pressure sensing 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 5-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. Stefan 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 5 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 don't think a lot of people have really seen the inside of a neural stimulator, but that was a good picture right at the end to show how the electronics are really a minor part of the overall device. The size of the device is really predicated on the size of the battery, and the battery dictates the battery life, of course. The larger battery, the longer the life. With the current design with five, we've maintained the 11-year battery life. We found that to be an effective time frame, and that does not require any recharging. That's a great video. Again, we show that to physicians as part of the introductory to Inspire and especially the necessity to do closed-loop stimulation. As you exhale, you blow the airway open. Think about when you sneeze, right? Your whole airway just blows up, right?
It's when you're inhaling is the only time the airway really obstructs. In our quest to optimize patient outcomes, we certainly can send amplitude to be able to move the tongue forward. Now we can set the respiratory signal to maximize what's called inspiratory overlap. That's the measured metric that we use. The next step is to take therapy adherence to the highest level. I told Rich I wouldn't run out the clock on them, but I do want to just show a couple abstracts that were presented. First, I'm going to go back to Sleep 2024, and this is the data, the clinical study that we ran with Inspire V to get the FDA approval. I know it kind of looks like a big scattergram over there on the left.
Kevin, I'll make you look over at the other slide over here. You can see the scattergram on how the stim is. It's really about timing how we can synchronize with respiration. You can maybe read the data on there when we're looking at the inspiratory overlap on the right-hand side, right up in here. I don't know if I can kind of read that. The commercial systems are kind of running at, is that about a 78% inspiratory overlap? When we get to the accelerometer, we can run that up to 86% overlap. The initial picture, we're showing a tighter respiratory signal and our ability to synchronize with respiration even a step further from Inspire 4 was.
The conclusion was the accelerometer is an improvement in sensing, and that's what we're going to continue to prove as we kind of move forward. That really is going to optimize outcomes going forward. Really an important feature is the closed-loop stim. We did an initial study in Singapore, as you all know, last year. We did 46 patients, I believe, or 44 patients. All the implants were successfully completed. All 44 of those patients are on therapy right now in some phase. You can see the timeline going through here. We're probably just here. We just have a few patients that have gone through their six-month AHI. When we get to the International Sleep Surgical Society and the American Academy of Otolaryngology meetings this fall, we'll have some of that early AHI data to be able to look at.
If you kind of look at the results, kind of walking through here, the key is they showed a 20% reduction in surgery from their baseline, which is really exciting. If you get down to the key, this is the next area of focus where we start talking about Inspire 6. There are features added in Inspire V that a lot of people aren't aware of. We now have a ramp feature. Instead of stimulation turning on, stimulation will now turn on. It's a lot more comfortable for the patient. You can see therapy adherence is over six hours in Singapore with these first patients. That's what it's all about. Set the right energy to move the tongue forward, make sure we synchronize with respiration, and then make sure we maximize the time at which the patients use therapy.
That alone will drive therapy outcomes, right? Now, the other feature is just allowing the patients to titrate their own therapy. They use their remote control as a plus-minus device that helps them turn their amplitude up. Inspire 4 had increases of a tenth of a volt increases. When we go to five, we determined that was not quite specific enough. Now they can walk it up in 0.05 volt increments. Another really key feature going forward. There have been arguments out there talking about efficacy of supine AHI. Supine AHI has been an important part of Inspire since I have been working on the project. Yes, I will admit I started in 1996 working on Inspire, not exclusively. I have done other things, but it has been a key part of it. Everybody knows when you lay on your back, it is gravity that the tongue falls back.
We need to make sure that when we titrate our patients, that they are in a supine position such that if they roll to their side, we're over-titrating, right? I think that that's been an important feature. When I went to the sleep meeting, I found an individual who did his own research. He's from St. Luke's Medical Center in St. Louis. Here's a completely independent study that they did because they heard the talk about it. They said, "Oh, this Inspire works great in supine position." Here he's got data to show it. Very probably difficult. Oh, I'm so sorry. Difficult to kind of show and read those numbers down here. Not only did he show the conclusion that results suggest that hypoglossal nerve stimulation is effective regardless of sleep position, but this is also new data, right?
We're not talking about comparing to where Inspire was during the STAR trial, which was back in 2012. We've changed our technology. We've changed patient selection. We've changed the implant procedure. We've changed programming to optimize outcomes. We're even getting better. Look at those responder rates of 80% at this independent study. That's impactful. That's what we're all about, really focusing on the patients. As we kind of move forward with the therapy, we're going to continue to rely on patient outcomes to drive the therapy because it gives physicians, gives patients more confidence that we certainly have the right therapy and we're going in the right direction. Five is just the start. It's a new platform and allows us to move forward into Inspire 6 and beyond. That's only going to take outcomes even a step further.
Very excited where we are with the full launch of Inspire 5 and making good progress. You probably have a couple of follow-up questions with me.
Yeah. Yeah.
Okay. I'm done.
You promised not to take the whole thing.
I did not. I was going to run out the clock on you, so.
Okay. Maybe I want to get inside Inspire 5, but just on that last slide. Do you have data from your pivotal trial that informs supine, non-supine?
We always monitor that. We always measure that. It wasn't published with five because it's inclusive of the overall population. Interesting enough, in the STAR trial, we screened out patients who only had non-positional sleep apnea, meaning they didn't have sleep apnea on their lateral sides, right? If they only had sleep apnea on the back, we actually filtered them out of the STAR trial. It's actually a more worst-case clinical study. Yeah, we've been monitoring supine AHI since the beginning.
Okay. There is no data set that you have that.
It's actually inclusive in there. Yeah, we get it. Here's data for you right there that should put the argument to bed.
Got it. All right. Going to Inspire V, would love to just hear what the initial physician feedback has been. You showed obviously a 20% reduction in time. What does that do for a doctor? Are they actually doing extra procedures, Inspire procedures, in particular with that extra time?
Yeah. Let's back up a little bit and talk about the primary feature of Inspire V is putting the sensor inside the can. We all know that we have an ear, nose, throat. It does not talk about a thoracic surgeon or putting a sensing lead in the chest wall. The benefit of not placing that sensing lead is overwhelmingly the number one comment we hear from all the surgeons, in that they're comfortable putting the electrodes around the hypoglossal nerve, tunneling, placing the neural stimulator, but it really streamlines the therapy. That is primary. The secondary benefit, it's a shorter procedure, right? While it's early to be able to start showing data on increased number of procedures in a given day, we know that's exactly the hypothesis. With the reduced procedure, it does provide for them to add additional procedures. We know the highest procedures.
I think there's a surgeon in Hamburg, Germany who has done 12 cases in a single day. In Arizona and in Texas, there are surgeons who do nine cases in a single day. That's with Inspire 4. As we're able to reduce the time, we do believe surgeons are going to be able to do double-digit cases in a given day. That really is optimizing efficiencies where they can really stack case days. That's one of the things that we try to work with physicians on so they understand the efficiencies with that, not just for themselves, but for the OR staff so they know what sterile trays to have in the room. The coding and billing people know what codes they're going to be billing on that day.
From a software standpoint, from Inspire, we can have our field clinical reps supporting cases in a single site, not having to drive across town to go cover cases on another day. It is really something that we focus on going forward.
Obviously, it's still a hypothesis, but let's just say the hypothesis gets validated, and there will eventually be an incrementality to the capacity from Inspire V's faster procedures for a minute. It sounds like even if that plays out, that is not going to show up probably until 2026 at the earliest. It takes time to adopt and then to find the time and then to figure out the efficiencies and to do it right. As a capacity expansion driver, is it fair to say the real benefit of this is going to be probably further into next year, or could we start to see it in 2025?
Yeah. Let me kind of back that up a little bit too. I think we'll see physicians increasing their utilization this year. We want to try to drive efficiencies by getting them on the same day. There's really four groups of ENTs that we're really focused on with the launch. The low-hanging fruit is exactly what we're talking about. It's taking our existing surgeons who know the procedure, they can get quickly comfortable with Inspire V because they don't put in the pressure sensing lead, and to allow them to help reduce their backlog and move cases forward. You would see benefit this year. The second group is the partners of the existing surgeons because we can show those surgeons not only their own backlog, but the demand outside the door of the patients waiting to get an appointment to be seen for Inspire.
It is enough of a demand that these individual surgeons cannot do it on their own. It is time to start training their partners. Especially with five, where they do not have to be worried about the pressure sensing lead, they can get comfortable around doing that. The third group, for lack of a better term, we will call them the dabblers. Those surgeons who only do a couple of cases, and maybe there are other reasons for it, but we believe one of the reasons is just the comfort with the procedure and the comfort with the complexity of placing the pressure sensing lead. We are going to go back to those surgeons saying, "It is time for you to do more now." Now that we have five, it is back into your wheelhouse as an ENT surgeon, and it is one of these surgeries that you can pick up.
We're going to be pushing those groups because they're already trained. The centers are active, and we can start moving patients to those centers if we can get those centers or those surgeons to really start ramping up with five. The fourth group is the same. We continue to open new sites. As we get into Q2, we want to make sure that when we're opening new sites, we're opening them with Inspire V, not kind of opening them with four and then quickly transitioning to five. There's really a really focused area, and we want to see this start to make progress now, right? We're not going to just wait till 2026.
It's always new product launch. You've got Inspire 4. You have inventory on that you got to work with your accounts to work down. You've got Inspire V launching. There's training. You provided guidance for 2Q. You said there's $10 million-$15 million of revenue that should shift out of 2Q, and you had the street basically put it into the 4Q. What I'd love to just focus on is how to think of Inspire V within the context of the next two quarters of RAM. What kind of visibility do you have into your procedures such that you were able to quantify that $10 million-$15 million? I know there was a little bit of maybe patients deferring because they're waiting for Inspire 5, but there's also a component.
[crosstalk]The inventory.
Just is it 50/50, 80/20? Walk through that. What kind of visibility do you have really in 2Q and 3Q such that you did not tell the street to do anything with their third quarter number? You just deferred from 2Q to 4Q.
Sure. I think the way we operate, number one, every single device has a serial number on it, and we know where the inventory is at all times, including after a patient receives Inspire. We track those serial numbers with individual patients for quality reasons, obviously. We know what the inventory level is by center throughout the world. I think that as we manage this, we also know the pipeline and how we know the backlog at individual centers. We expect the centers will burn down their Inspire 4 inventory. Either in tandem, they may have 4s and 5s at the same time. They may take all their 4s down and then replenish with 5s. It is more of a timing issue.
[crosstalk]We've actually picked up some anecdotal feedback that people aren't working down to zero, that they're okay having a couple of 4s on the shelf. Is that reasonable?
That is fine. We continue to sell in four today as well. Four is going to be available in the future. We are very confident that once centers get up and running and transition to five, that is going to rule the day. There is no question about that. Four will be available because we need to keep the inventory to support the European and the Asian markets. I think when we start looking at the second quarter, we knew we were going to be in a transition period. It is not just the transition. It is always a disruption with even the territory managers during the second quarter because they have the three steps to bring a center on board, train the surgeons, get the contracts in place, get the new programmer in place. We see the pipeline, and we know we have to work through the inventory.
As we did the limited market release, that's when we started to see more of the patients who want to wait for Inspire V, which is great. We think that's wonderful. When we did the guidance, we kind of had that knowledge, and we knew when we were going to launch a product. We had a good feel for what the transition period would be. That's kind of how we kind of laid out that guidance.
You were pretty prescriptive to the 2Q and more so to 2Q shifting to 4Q. I guess one of the questions I've been getting from investors increasingly is how much visibility does the company have? Let's just say the 2Q plays out as expected. Are there some of these trends that could spill over into 3Q and we end up with an even more back-and-loaded 4Q, which could be a problem because you have capacity constraints? Can you just help us think through?
When we put the guide out, we take that into consideration, right? We do have visibility to the patients who come to our website, to making calls, to being patients in play, we call it, or patients in process, our implants. We know the rates at all of our centers with scaling of our sales team. Yeah, we had knowledge when we put our guide out there. Like I say, we're prescriptive on the second quarter. We just continue to run our plan and execute. We're very happy with the performance of fire. There's no question about it. Happy with the rollout. It's a pretty straightforward process to transition centers to be able to take on Inspire V. Centers are excited to do so, as I'm sure you've done with your checks.
Any unanticipated either frictions or bottlenecks that have emerged since you went full launch?
I think the one obvious question that people ask us is Sleep Sync is so difficult to do. Today we had meetings with a lot of great investors, and thank you for that. Just think about if you're going to add software to your computer at your firm, and you got to call in the IT to make sure it's clear to be able to put that software onto your computer. That's really what it's all about. We don't tie into the electronic medical records of a facility today. That's long-term. We'll talk about that because that's going to be a transition later on because that's going to be a key benefit of Sleep Sync down the road. Today, it's just about putting new software on the computer and making sure we interface with IT to make sure we're comfortable with that.
We do not interface into their servers or into their networks. The key to it is we are out of the tablet business. Now physicians and nurse practitioners will use their own laptops, their own tablets to be able to log into Sleep Sync. All the programming screens are right there. It is a standard process. It is not really a key challenge. It is just one of the three steps.
I guess it's something we, as investors, have just heard a little bit more about in the last two weeks from you. Is this something that incrementally is potentially something you have to contend with as a challenge that you weren't expecting when you're?
No.
Is this something you've always been expecting? You're just highlighting it as something that.
It's a step in the process is what we're highlighting. I think the new programmer was actually approved a year ago, right? Many of the top centers are already on Sleep Sync, right? The key is going to be just getting everybody else on Sleep Sync. We're highlighting it as one of the three steps that you go through to transition to 5.
Nothing that would have altered the outlook you provided previously.
We.
This is something new and incremental.
We knew all this when we set out the guide at the last earnings call.
Okay. I think that's helpful. Then, Tim, you have a lot of dynamic kind of market considerations over the next 6 to 12 months. You have potentially rising competition for the first time, right? Alternatives that are out there. We have GLP-1s in the backdrop, right? We've discussed that ad nauseam. You've got capacity constraints.
The EMTs.
[crosstalk]That you're working on.
Our four steps.
On building. The efforts there, including faster procedure times, may not all align perfectly on the calendar year. What I think investors are trying to gauge, what's the minimum level of growth that you should be able to power through all of these challenges with such that even if there are transient bumps, is this a double-digit grower? Pretty much no matter what. I appreciate you guided 2Q to below 10%, but that's very, very specific to this handoff from Inspire 4 to Inspire V. Is there any reason why you're not a 10-15% grower over the next two to three years, even as you go through all of these kind of, I don't want to say challenges, but.
I get it. Those challenges are what we deal with every day. A lot of them may play or may not. GLP-1s are still early on, so maybe it's more of a discussion here than it is actually for our field team when they're dealing with patients. Inspire V, showing improved outcomes, improved benefits. No pressure sensing lead really is a big play. The demand from the patients is exciting. We're increasing DTC now that we have launched five to fill the funnels again. Increasing. We're going to solve the capacity problems with surgeons. That's definitely doable. As a company, we put our guide out at the last earnings call, and you should see the growth rate associated with that. We're focused on growth.
We're very proud and happy to be able to say, "We can do that as a profitable company right now." There's no question about it. Even going to Inspire V, we get an improvement in gross margin. There's no question about that because we don't have to make that pressure sensing lead. The focus for us is to remain on growth. We're going to keep increasing our DTC. We're going to keep scaling up our business, training more surgeons. Remember, as we train more surgeons, new more procedures, we're going to push the onus to the sleep physicians. We have to manage all these patients. That's what Sleep Sync's all about.
We're getting all of our centers have to be on Sleep Sync Inspire V because that's building built-in efficiencies into the model to help them manage more patients, to optimize those outcomes, and really facilitate ongoing growth. Growth is really what we continue to be focused on. Again, we're very proud and supportive of our shareholders to be able to do that in a profitable setting and to be able to generate cash along with that.
Okay. Great. Thank you very much, Tim. We really appreciate your time. I got to.
You still got 20 seconds?
I got 20 seconds. Okay. Maybe on profitability.
Yes.
How should we think about that as you balance, you say growth is the priority? How do we think of this ramping up?
That's a very good question with eight seconds to answer it. We really want to keep focusing on the growth, but we're going to maintain and continue to grow profitability. That's a little bit of a balancing act. If we can focus on the growth with the strong gross margin that we have, we can show leverage in our DTC, leverage in our field, leverage with the technology, obviously, that we're developing. Technology is everything, and we're going to keep a strong R&D line as well because we're already working on Inspire 6, gearing up for seven, eight. We're about to start our dual-channel device and a big investment into our digital program with Sleep Sync. We're keeping our eye on both, but the primary focus is revenue growth.
Great. Thank you very much.
Thank you, everybody.