Inspire Medical Systems, Inc. (INSP) Earnings Call Transcript & Summary
June 10, 2021
Earnings Call Speaker Segments
Amit Hazan
analystAll right. I think we are back live here at the 42nd Annual Goldman Sachs Healthcare Conference Day 3. I'm Amit Hazan, the medical technology analyst. So we'll continue our med-tech series of conversations that we've had this whole week. And I'm really excited for this next one, perhaps one of the more exciting -- one of the most exciting small-cap, mid-cap medical device growth stories, Inspire Medical and we're really happy to have joining us again this year, both the CEO, Tim Herbert; and the CFO, Rick Buchholz. I will make their introduction in a second. And I also would say that from my team, I've got my partner Phil Coover on the line, and he's going to take care of the Q&A, and I'll drop into the background. But Tim and Rick, welcome again to the Goldman Healthcare Conference.
Timothy Herbert
executiveThank you so much. It's so great to be here and share time with everybody over these couple of days and look forward to someday doing this live.
Amit Hazan
analystHopefully, next year. Take it away, Phil.
Philip Coover
analystYes. And I share my appreciation for you guys joining as well. I thought what we've generally been doing with companies this week is starting on the recovery and sort of the near-term perspective. So maybe we can start there and then broaden out after that to some of the key recent news. So I think if we go back to the quarter, and start with the recovery update. I mean another great quarter, beat and raise quarter, but obviously, expectations have gotten quite lofty for the stock, especially in light of how well you all performed through the pandemic. And so I thought maybe what we could start with is giving an idea of how implant rates kind of trended through the recovery and up into 1Q to level set for those listening. And then maybe we can dig in a little bit more on what you saw from the 1Q print?
Timothy Herbert
executiveNo, absolutely. I think COVID, of course, is devastating for everybody not just med tech, but the whole world, and it still is something that the world has to deal with and always a challenge. We have been able to work through it as we got into the late Q2 and into Q3 last year is when we started to see sites really start to open up and had a really strong fourth quarter, of course, always have a strong fourth quarter with the high deductible insurance rates and people really scrambling to get their procedures done at the end of the year before those high deductible out-of-pocket expenses reset. But in January, we faced with our normal seasonality, again, based on the high deductible rates but really the shutdown in many parts of the United States. So January was the resurgence that had a little bit of an impact on us. We were able to turn that around in February and March and still have a really strong first quarter, albeit if COVID didn't exist, I'm sure we would have been a little stronger than that. But that's what everybody has to deal with. But we've really liked what we saw coming out of Q1, moving into the second quarter and for the rest of the year. So we significantly increased our guidance for the rest of the year to really show that confidence in the positive trends going forward.
Philip Coover
analystYes, absolutely. And so I'd imagine you guys had a pretty good idea of April when you made that decision to raise guidance and so maybe you could talk to what you saw or what you've seen so far in 2Q and maybe talk to how things are trending so far into May [ and then into June ].
Timothy Herbert
executiveWell, I think the key to Q2, and we're still in the middle of course will -- can only make certain comments on it, but the confidence that we had coming out of the first quarter is the number of new centers that we're able to open in the fourth quarter, I think it was like 52, and we did like 40 plus in the first quarter. And that really gave us a great confidence in being able to move forward with our new direct-to-consumer campaigns. And remember, last year, we spent a lot of last year developing our new call center approach, the adviser care program. And all of those are kind of coming into their own and starting to meld together. And then we had a couple of really key benefits, especially with the two-incision approval, has really had such a strong impact. But kind of leave it there generically. But that kind of shows on the strength that we had coming in, that's why we have the confidence to increase that guidance.
Philip Coover
analystYes. Yes. I think that's great. And we'll dig into a lot of those kind of elements that you touched on. Maybe just one more before we start working through the story. I'm wondering if you can opine on any of the sort of learnings or findings from your perspective through the COVID period, either from an operational cost standpoint or in terms of how your strategy might have shifted for entire therapy moving forward as a result of the pandemic?
Timothy Herbert
executiveWell, I think the -- from an operational side, I don't think it's really changed that much. It's still business as usual. But I think as we start talking about patient care and the introduction of Zoom and the focus more on telemedicine that's going to have a long-lasting impact and we engage that. We think this is a really strong opportunity for us. So a lot of our patients, when they have their first meeting with the physician, it does not have to be live. It can be a Zoom call or a telemedicine visit where the patient and physician can have a conversation and can learn about the patient's experiences, one, were they diagnosed with sleep apnea, have they tried CPAP? Why weren't they able to benefit from it? What other potential therapies that they have, talk about their lifestyles a little bit and get it more comfortable to see if they are certainly the potential for a good patient, a good candidate for Inspire. Then they can schedule the first live appointment, which would be the drug-induced sleep endoscopy. And then from there, they can go right into scheduling the implant because now they don't have the burden of prior authorization and getting insurance approval because we've had -- even the last Anthem win is even added to that. What we need to do is keep growing our technology to make telemedicine postoperative a real productive event. And one example of that is we have a new remote control that has been submitted to the FDA that will incorporate Bluetooth. It will allow information from the implanted product to go through the remote via Bluetooth to the smartphone and the patient's app and go right to Inspire Cloud, which is our cloud-based patient management tool. And the next step there is to work with the FDA to allow the physician in a telemedicine visit to do programming changes remotely. And that's really kind of a key step on moving forward. So I think if there's anything that comes out of the COVID, it's really the telemedicine and the ability to use technology to improve patient care.
Philip Coover
analystYes, that's great. That's great. And you touched on a lot of the things that we were going to hit on the pipeline section about evolution. So I think that makes a lot of sense and we'll maybe dig in just a little bit more. But you hinted at the Anthem approval. That was obviously one of the biggest pieces of news in the recent months. And so I thought maybe we could dig in and give a little bit more context on that front. You've talked about this being the first real commercial year for Inspire kind of at full force. But this was still a pretty sizable outstanding commercial expansion. So maybe just start by framing it up for us. Why Anthem made the decision now after having their annual review last fall and deciding to pass at that time? And then maybe we can dig a little bit deeper after that.
Timothy Herbert
executiveWell, I think the key is we've always kept encouraging Anthem and providing information to them as best as we can, granted it's an arm's length relationship, right? We don't have routine conversations. They do their business, we do our business. And for certain good reasons, there's always a little bit of a barrier. But we're able to provide, get information to them with all the latest clinical information. We certainly have encouragement to ask them to do a mid-cycle review. But I think what probably really did it is the increased demand for Inspire through Anthem. And they had a number of patients in the appeal process, and they see a conversion of approvals and those approvals starting to come earlier in the cycle, meaning might be the first level of appeal, the second level of appeal and then when we get to the third level of the external medical review, we would win the majority of those cases for the patient, which was really good for the patient, but it could take 50 days for that patient to get that insurance approval. So I think Anthem probably recognized the demand and the necessity for them to do a mid-cycle review. And they went back and again, looked at the data. And at that point, every Medicare is covered in every single state, right? All the other major payers from United to all the Blues to Aetna have all written positive coverage policies. And so they realize they're the last big payer and that it's appropriate, it's time to be able to do that. So now that they have written policy, I think we announced it like May 21 it became effective, takes a little bit of time for that to trickle down to the regional medical directors. But what we do now is we have a number of patients that are in the review pipeline. And we work directly with Anthem said, can we pull all those patients back out back to the beginning and do a prior authorization that can get approved in just 5 days. So there's certainly a short-term opportunity to be able to help those patients get Inspire therapy, which is great. Second step is work with the physicians. And let's go back a couple of years to see those patients that had previously been denied and contact them and say, hey, your insurance company, if it's still Anthem, is now covering Inspire therapy, and how are you treating your sleep apnea? And are you still interested and maybe you should come in for a follow-up visit. So it's a 2-prong approach to make sure that we capture the patients currently in process. We go back and get the opportunity to patients that were denied previously. And now going forward, it really helps the physician because they can now confidently talk to a patient. So when a patient comes in, says I have symptoms. I'd like to learn about Inspire. I have Anthem insurance and a physician could say, well, that's all good. Anthem covers Inspire. Come on in, let's have a discussion about what your needs are. And it no longer is a disruption to their communication saying, "Well, Anthem doesn't cover, you're going to have to wait 50 days". Now it's a positive. And so it's really going to be a win-win. And so across the board now, virtually all the commercial payers, all the Medicare, the VA, the Department of Defense Hospitals are all covering Inspire. So we can really focus on patient outcomes, driving patients through the process and scaling the business by opening centers and increasing utilization.
Philip Coover
analystOkay. That was a fantastic review. Maybe just one more follow-up on that front. Trying to help investors understand the size of the impact here. So obviously, that -- the situation was not black and white. It's not that no Anthem patients and now all of the Anthem patients very much in gray with the prior authorization that was in place. But it's a significant number of lives. I think by our math, it was almost a 20% expansion with the 40 million lives that they cover, more than 40 million lives. And so can you just kind of give us an understanding of how material from an acceleration standpoint this might be, those 40 million lives now you talked through the process, but can you help us understand how much of an acceleration that might incorporate?
Timothy Herbert
executiveWell, certainly generally, as we just talked about, but the overall average time to approval has been like 11 days, which is really good, but that also includes the Anthem patients that were running out at 50 days. So really it's too SKUs, either you get approved in 5 days or 50 days that mean being about the 11-day mark. So that really shows the impact that Anthem has. While their patients were being approved, now we'd bring it all back. And the time to approval becomes very, very quick in just a few days. So I don't know if the second quarter is going to see a big impact because the policy just took effect May '21. But I think as we get those patients in the process through the pipeline, I mean, it certainly have a little bit of a help in Q3, but it's more of a long-term play of consistent prior authorization approvals in just say, the 5-day mark, where physicians no longer have to delay scheduling surgery after sleep endoscopy, could just move straightforward and we'll get the approval in parallel with the time while they wait to get the insurance approval.
Philip Coover
analystOkay. That's great. And then maybe just one last one on the commercial side. Give us a check-in for kind of where we are now in terms of covered lives with that additional $40 million and anything else that's still top of mind from a commercial standpoint, maybe from a labeling or otherwise that you guys are still thinking about?
Timothy Herbert
executiveWell, I think the number of covered lives is well into the $200 million. If it's not pretty much all adults now are all covered. There's always small HMOs or smaller other policies that just haven't issued yet. But for the most part, we pretty much are nearing completion of that process. The next step for us, though, is to look at all the different companies and to drive consistency across all the policies. So in this new Anthem, it came out with a BMI at 32 as an example, CMS or -- I'm sorry, the Medicare policies across the United States are all BMI 35. And that has changed like UnitedHealthcare is now BMI 35. So what we need to do now is go back on the annual reviews and just make sure we drive consistency across all the various policies to make sure all patients get treated appropriately. Even without the patients, if you're a BMI of 34, we're still going to submit that patient. That is not an off-label patient from FDA viewpoint, but it's not on policy per Anthem. So we'll still submit those patients. And for the most part, Anthem will be approving those anyways. But it would -- it is the next step to get the policies consistent. But again, it just removes such a burden for the physicians and the patient that they don't have to deal with this whole prior authorization process.
Philip Coover
analystOkay. All right. That's great. And you touched on Medicare just for a second. Maybe you could opine just for a moment on your outlook or visibility that you have into the upcoming rate decision, I think our first view will be the proposed rules here in the next month or so. Any idea that you guys have in terms of where that rate is going to shake out?
Timothy Herbert
executiveWell, I think go back to the coverage side of it first when with getting all of those local coverage determinations put in place in the June and July time frame, that really kind of allowed Medicare to step up and allow those Medicare age patients that receive therapy. But remember, during COVID, that's the most susceptible population. And that's a population that was less desirable to go into the health care world. So they delay their cases. And I think what we're seeing now as we got out through the first quarter is really a ramp-up. And I think our current ratios, Rick, at about maybe 60% commercial, 30% Medicare, 5% VA. So Medicare has really had a significant growth there. So real strong from that standpoint. Step 2 is there's coverage, then there's payment. And as we do know, the OPPS rules are coming out usually about the week of the 4th of July, we'll see if they hold that timing or not. But the codes all been approved. It has been through the RUC process. I'm sure they went through their early reviews, and we'll be ready to make their proposal and what people all got to realize is this does that affect facility payment. This is only surge in fee payment. Facility, it's still going to map to the same level 5 neuro code. And with the same APC, ambulatory procedure code, which is wonderful because that reimbursement is strong today and it really helps hospitals and ambulatory surgical centers. But the surgeon fee right now is a little undervalued, even though they've had a raises of anywhere -- raises to about $1,000, $1,200 per Medicare and we'd like to think that there's going to be a proposed increase to that. And I think anything around $1,500 or $1,500 total for the procedure would be pretty acceptable. And then remember, commercial payers pay 1.4x that. So we just have to wait just a couple of weeks, but we're confident that, that surgeon fee will have an increase to it.
Philip Coover
analystOkay. All right. That's great. I think a comprehensive view on the reimbursement and coverage side there. So let's go ahead and move on to the first year from a commercial standpoint. So great centers number like you said in 1Q, well ahead of your expectations and raised the center guidance for the year on a quarterly basis. I think maybe just to open it up to what's driving that center expansion, what you're seeing, and maybe this is a good time to plug the impact that the two-incision approval has had on the business broadly?
Timothy Herbert
executiveRight. That's start -- two-incision is really impactful. But let's kind of back up to Q1 with opening the new centers. And with the improved reimbursement environment and with our continued growth of awareness of Inspire throughout the nation, there is a large desire for centers to open up the procedures. And we previously talked about several of the national contracts like USPI and SCI that we have signed. And with the number of opportunity that has for opening centers. Most recently, we signed a natural contract with Community Health Systems, or CHS. Here is a system that has 80 hospitals and another 30 ambulatory surgical centers. We just signed that a couple of weeks ago. USPI acquired a company to increase the number of ambulatory surgical centers that they have. These events are significant in that we get to the value committee upfront at the corporate level. And so when we get down to individual hospitals, it's about identifying and training the team. Who's the physician? Who's the surgeon? Who's the patient navigator? And being able to train that team to be able to manage a steady flow of patients throughout the process, it really streamlines that approach. But it also elevates the demand or the desire to open up additional centers from the corporate level. They do their value analysis. They understand this is a good procedure for their centers to have for both taking care of patients, but also for generating revenue. And so they really want to encourage your centers to be able to participate. When we get to the ENT level, we said, okay, now we have to find a sleep partner to be able to manage patients. So that works really well. The next thing is we got to continue to decrease the time it takes to conduct an Inspire procedure, such that we can increase capacity and make it more economical or beneficial for surgeons to dedicate a greater percent of their practice to Inspire. And a big achievement most recently was the FDA approval of the two-incision implant. And what that means is we used to plant the hypoglossal nerve stimulation lead, tunnel that down to the pocket for the neurostimulator, but the sensor would get tunneled to a different incision down in about the fourth or sixth intercostal space. But with the new approval, we can place a sensor just below the neurostimulator using direct visualization by the ENT. And that really adds confidence and comfort for the ENT so they can directly visualize where they're putting the sensor and it significantly reduces OR time by about 26 minutes was the clinical data that was sent in with the FDA. With that, after we announced it and we trained all the surgeons, we already have well over 90% of the U.S. approvals -- I'm sorry, 90% of the U.S. implants are now conducted using the two-incision approach. Europe is approved and we're in the process of transferring over to two-incision there. And in Japan, we're [ not even ] going to teach three-incision, where it's approved, we're just going to just start with two-incision. Let's talk about the significance of that. If I can just expand on that. Typically, today, hospitals might just block 3 hours for an Inspire procedure. But then there's an hour to clean the room, and then they can put another 3 hours. Well, that's 7 hours. They're not going to add a third case in a day. But now that we're doing several of these two-incision cases and we can collect the data of the time of the procedure and show that to the hospital administrator, saying, you get too much downtime in your OR, you don't need 3 hour blocks, go to a 2-hour block. And with time to clean, you can now easily schedule 3 cases in a day. That dramatically increases what the return on that operating suite for that day, not to mention the time the surgeon spends improves their own reimbursement for the day. It's great from a patient standpoint, both for comfort and for safety going down to two-incisions. And so it really is just a win-win and a great opportunity. Our next step now is to be able to demonstrate to administers, now it's the time to start scheduling three cases. And with the direct-to-consumer, we certainly have the demand to be able to fill those slots.
Philip Coover
analystIt's super. Extremely comprehensive. Again, as always, a couple of points I'd like to drill into a little bit deeper there. You mentioned the USPI and how that's impacting the business. Maybe you could put some context around the ASC opportunity, kind of I think by our math, you're going to cross the 500 center mark most likely this quarter at this point. So what percentage today are ASCs? And then where does that sit within your kind of broader outlook for maybe the -- if you, call it, 5,000 ASCs in the U.S., where you are in terms of your addressable opportunity within that?
Richard Buchholz
executiveYes. I'll take that one. Thanks for having us, Phil. We are still very early in the penetration and the rollout of the therapy. About a year ago, at the end of the first quarter, in a year ago, just under 10% of our centers were ASCs. At the end of the first quarter in '21, that number is about 17%. So we are increasing the number of ASCs that we have. And we've talked about the national network agreements with the ASCs, including CHS, a new hospital system that Tim talked about as well as USPI, 300 centers. SCA has 230. And so we are really focusing on ASCs. And we expect that number to grow nearly to about 50% on a longer-term basis as we continue to focus on moving this therapy to the ASC setting, where we have really good reimbursement in place for the facility as well as a physician.
Philip Coover
analystOkay. That's great. And the other point that you brought up through that discussion was on the ENT training side. And so maybe you could talk a little bit about the Inspire fellows program. And maybe an underappreciated part of the story is understanding when you have physician expansion or addition within a given center or a given system. So can you talk about that initiative and the focus on driving additional physicians within a given center that's performing procedures?
Timothy Herbert
executiveYes. We start with the fellows program. We really like this. And when you talk about expanding surgeons at existing centers, the best way to do that is to be training their own students. So we go to all of the leading academic centers and we invited them to submit an applicant to join the Inspire fellows program. And I think we had over 60 fellows participate over the year. And the first 3 quarterly meetings were virtual. But for the final meeting, we went to Chicago and everybody got together. And it's important because I think we had 50 ENTs and plus the staff, which are other very experienced ENT professionals experienced on Inspire are able to get together and those 50 create a fraternal group, right? They're part of the same training group. And as they mature, they get to know each other and they get to stay with them. This is the second time we've done the fellows program. We significantly expanded it this year from the prior year, and we're going to expand it again as we go into next year and ideally have more in-person meetings than just virtual Zoom meetings that they're all fine and educational, but you just don't get that relationship building that's necessary with in-person. So really opportunistic to be able to train ENTs as they're coming out of their educational process ready to step out and start their jobs. And the first thing they will do is want to start an Inspire program at their new center. So what is certainly a great opportunity. Second step is by looking at existing surgeons and looking and showing them the time demands of their current practice and how they need to bring in several of their other partners to also partner on the Inspire program, both as a backup as well as to increase productivity. And if we can show the economics that is profitable for both the practice and for the ASC and for the hospital to be able to increase utilization that's really the win, win. So we can go out and just continue to train additional surgeons. So I think the key is making sure that we have the proper partnership with the state physicians to manage the patient's long-term and whole technology discussion. We can talk about to make that patient management system easier, but really identifying the right ENTs and getting them trained. So a lot of great activities going on there.
Philip Coover
analystOkay. That's super. Maybe provide a few check-ins or updates on us from all of the other commercial direct-to-consumer sort of initiatives you have going on. Give us a sense of how many centers of the 500-ish number are now included in that adviser care program? Some context around the ramp-up in DTC spending website, any data points or checking that you can give us there around conversion rates and what you're seeing kind of in the grand scheme of your increase in utilization that's going on?
Timothy Herbert
executiveYes, we're -- I think the key to this whole process is the adviser care program and getting centers on that. And I think, Rick, we're approaching about half now of centers on the program, so we get the majority of that calls through the call center because we can get data from the patient and we can help them through their process and we can track, not only are they staying on track, staying in the process, but also help in controlling the time to get through the process to get the first part, get the sleep endoscopy, get them to their device procedure and the care program really helps us. We are in a process now. We're just going to scale that up. We're going to take another level in scaling that care program. And hopefully, that's going to be ready to go in the July time frame. And that really is going to allow us to accelerate that. Then we start going back and start analyzing the data that we have. And what centers are able to take appointments and help patients. And those are the centers that can remain on the website. And those centers that just aren't able to help the patients and not give the patients a good chance. But we're going to start taking them off the website to say let's focus where the patients have the best opportunity. And then take one step back, when we start targeting where we going to do our consumer spend, where we're going to do our TV ads. And we're going to run TV in the territories that are showing the best metrics from the care program. The three key metrics as a reminder. 90% of the phone calls to make an appointment need to be answered by a live person. We're not there yet. We're probably 70% right there but getting better. Because as we open a new site, that's one of the key learning curves is you've got to have a number of somebody who's got the appointment book. Number two, when you schedule a new appointment, that has to be within 2 weeks. Right now, we're probably running at about 21 days, and that's getting better. But even 21 days isn't too bad. But we can keep bringing that down to 2 weeks. And then 75% of the patients that are getting referred to the centers are qualified patients and we're doing very good with that. So I think the conversion from the care program is really showing to be economical and very efficient. So now what we have to do is keep moving more sectors to it and making more of the conversion from the website to physician contacts more through the call center than community health [indiscernible] and calls directed to centers. And then target our DTC in the territories that give the patients the best chance.
Richard Buchholz
executiveFrom a cost perspective, Phil, we spent $26 million in 2020, and that increase about 40% will increase our spend in '21, about the same, about 40% because we are seeing benefits from that investment. We had 27,000 doctor contacts in the first quarter. That was up over 102% from the previous year. And so by adding centers in the Advisor Care Program and increasing that number to nearly 500 by the end of 2021, we think that can help the conversion rates and get more procedures completed.
Philip Coover
analystYes. That's great. And maybe just skipping around just a little bit because we brought up costs here, how to think about OpEx, generally speaking. The way that I kind of took a step back and looked at growth rates from a sales perspective through 2020, it looks like you guys basically spent as the pandemic didn't happen, growing OpEx ahead of sales. But if you look at it kind of 2021 over 2019, it's basically 50% annual sales growth and 50% annual OpEx growth. Is that roughly the right way to be thinking about it? And then kind of from a contact standpoint, is it right to think about leverage to that OpEx line going forward from that strong sales growth?
Richard Buchholz
executiveYes. We're -- again, we're still early in the penetration of not only procedures but ENT surgeons and potential centers. So we're going to continue to focus on our commercial expansion. And so we're still early in the rollout. So we're going to continue to invest. We'll see improved leverage down the road. But right now, we're really focused on getting the commercial expansion completed. And so we're investing across the entire company, not only from a market development and a patient awareness, but also from our R&D initiatives with our Inspire V, the Inspire app and our digital health, which will provide really strong interconnectivity with our sleep doctors, surgeons and patients. And we think that will improve outcomes in the future. So the fact that we have 85% gross margins, that allows us to invest and continue to expand and really drive the top line.
Philip Coover
analystYes, absolutely. And gross margin is already outperforming in 1Q and rate for the year as well. So just about 5 minutes left, I think, maybe touch on a few more of the key updates and growth initiatives, and then we can end with the pipeline if that's okay. So from an international perspective, a few pretty notable updates that happen. Maybe just give us some context around the positive Japan decision. We have a new DRG coming in Germany and then there's also a positive reimbursement update in the Netherlands. If you could kind of touch on all 3 of those key international geographies would be great.
Timothy Herbert
executiveYes. Let's jump on these really quick and get through this with just a few minutes. Japan milestone this week on June 7, the Inspire was officially listed in the Japan reimbursement. So they targeted June, they came through and we are now formally listed, which is really good news. We are working with Japan Lifeline in preparation for bringing Inspire to Japan. It's all -- everything is a go. So it's all fantastic. We're going to be looking for our first training, probably the beginning of the fourth quarter and doing implants soon thereafter. So we will do the first implants this year. But as we previously said, we're really gearing up to use the rest of this year as preparatory and then having a launch in 2022. Japan remains locked down right now because of COVID and especially with the Olympics coming, we just are not allowed to go to Japan for any in-person -- I think by time September happens, that will really have clear there'll be vaccinations available, and I think we'll be in a much stronger position to be able to start in the October time frame. So very, very promising from that standpoint. Germany continues to move. Not a big impact on COVID anymore. They're strong with their vaccinations and we're ramping in Germany quite well. The DRGs are being negotiated at individual centers for the first year. Negotiations have gone well with an increased reimbursement level, which is great for the centers and the physicians in Germany, and that's going to continue to move forward. Netherlands have the big win. Netherlands previously had a committee of cross-functional physicians that were required to review each individual case or individual patient before the 2 centers were allowed to move forward with implants. Well, a couple of weeks ago, it was determined that committee is no longer needed. So individual patient review has been eliminated, and physicians can now make their own medical decisions, which is the appropriate step. Number two is they changed the AHI, apnea-hypopnea index. It used to have a tight range of events of 20 to 50. That's now been expanded to the full range of 15 to 65. And most importantly, they think that the availability of therapy needs to spread the Netherlands. And so we're already working to open up 3 additional centers from the 2 there right now. So we'll really start to grow the Netherlands as well. So real positive from the international front, and we'll continue to focus. But we always highlight that the great majority of our investment is continuing to grow in the United States, of course. But we certainly want to continue to grow adoption of Inspire in the countries that have reimbursement.
Philip Coover
analystSure. Sure. Some great opportunities kind of growing down the road there. Maybe the last couple of minutes, we can focus on the pipeline. And you already touched on sort of the learnings from COVID and how that's being kind of reflected in your connected device Bluetooth and Inspire Cloud all coming together. You already kind of talked to the context of it, maybe you could talk about how it's going to be monetized. Is any of that going to be an add-on from a cost perspective that's going to help ASPs? Or is it just really kind of contributing to the total portfolio there?
Timothy Herbert
executiveWell, historically, we don't do annual price increases. And when we do our price increases is when we have additional features in the device. So when we get to the new remote and the connected product, I think there will be a small increase there. I think a more significant increase would be when Inspire V comes out because of the advancements of the technology right there and the advanced capabilities of that device. And we're still proceeding with Inspire V. Remember, the key attribute of Inspire V is a microprocessor-based neurostimulator, and it's going to have sensing internalized inside the titanium can. So we're going to get rid of that pressure sensor altogether and be able to detect respiration using an accelerometer. So closed-loop stimulation is essential to proper treatment using neurostem, and I think we're going to actually have improvement in performance using an accelerometer inside the can versus having an external device, or certainly more so than open-loop stimulation. So I think great progress. We are working with the FDA to keep them aware of our technology road map after the connected remote and the new app, the next step that we're going to be working on is actually working with the FDA to get approval for remote programming. So a physician could do programming during a telemedicine visit, which will only help with the management of a greater number of patients as we continue to drive utilization at existing centers. So a lot of investments on our technology platform. We think we can really continue to improve outcomes and can improve patient adherence and in turn, that's just going to increase utilization at centers.
Philip Coover
analystIt's a great way to bring it all together at the end. I think that was a great review of the company. We certainly appreciate you all being here and participating in the conference. So Tim and Rick, thank you so much for coming.
Timothy Herbert
executivePhil, thank you very much. And Amit, thank you very much for hosting us again and really appreciate Goldman. Thanks a lot.
Amit Hazan
analystThanks, folks. Thank you so much from my side too. Take care.
Timothy Herbert
executiveAll right. Bye-bye.
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