I want to welcome you, I am Dr. Eric Rungian and I will be the moderator for this evening on expanding ENT referral networks. I'm joined by our speaker, Dr. Cherie Sparks. A quick note, the AADSM does not endorse any services, products, devices, or appliances. The use mentioned are depiction of any services, products, devices, or appliances during this webinar should not be interpreted as an endorsement, recommendation, or preference by the AADSM. Any opinions expressed or communicated regarding any product, device, or appliance during the webinar is solely the opinion of the individuals expressing or communicating that opinion and not that of the AADSM. This evening is going to begin with a brief presentation by Dr. Sparks followed by a special interview between the two of us. Before I turn it over to Dr. Sparks, though, I wanted to provide you a little bit on her background. It's quite impressive and we're very glad and appreciative that she's joining us here tonight. But Cherie Sparks, MD, has served as chief medical officer since July 2023 for Inspire. In addition, Dr. Sparks served on Inspire's board from July 2022 to July 2023, including as a member of the nominating and corporate governance committee. Previously, Dr. Sparks served as chief medical officer of Applied VR, Incorporated, and it is a privately held company focused on virtual reality-based treatments that address the complexity of pain and other conditions since February 2022. Prior to this, and since 2016, she held various roles at Dupuy Synthes, Incorporated, an orthopedics company, and a member of the Johnson & Johnson family of companies, including as vice president integrated leader of trauma, CMF, and biomaterials from September 2018 to February 2022. Dr. Sparks holds a BS from Wichita University and a MD from the University of Kansas School of Medicine. She completed her residency in orthopedics at the University of Arkansas Medical School and a fellowship in orthopedic trauma at Harvard Medical School. It's my pleasure to introduce you and turn you over to Dr. Cherie Sparks. Thank you, Dr. Runyon, and hello everyone. I'm so excited to be here. This is going to be a great conversation. So thank you for the invitation. And let's get started talking about Inspire. And what I want to share with you is the evolution of Inspire. And the thing is, before 2014, where we got FDA approval for the implantable device that we're going to talk about tonight, this was a spinoff. Inspire was actually a spinoff from Medtronic. So Medtronic didn't think it was a great idea. And our chief executive officer, Tim Herbert, took the idea of neuromodulation for the hypoglossal nerve and spun it out of Medtronic. They gave him a couple of years to find success. He found success. He found venture capital to support it. And that then led to the FDA approval in 2014. The basis of Inspire has always been around clinical evidence to support everything that we do. So developing the mechanism of action to delivering the therapy, to targeting the right portion of the nerve, and additionally, now the sales, what this line on this chart depicts is what the sales and how penetrated the device was. And you don't see that it meets an inflection point until we actually got commercial coverage for the device in 2019, early 2020. And then all of a sudden you see the exponential rise. And this is based on that foundational clinical evidence and real world outcomes of over, now it's, I should have updated my slide, I apologize for that, it's 280 peer reviewed publications to support that. One of which is from the Journal of Sleep, of the Sleep Research Society, which outlines the clinical pathway that gets us to the best outcomes after patients have been implanted with the Inspire device. And from that clinical evidence, we went from a three incision technique to implant the device to two incisions that now is approved by the FDA. We have done much public awareness. I think probably many of you have seen some of the Inspire commercials. And if you're really honest with yourself, you kind of chuckle because they are kind of cute. And so that's been a big program. And not only are we a medical device, an implanted medical device, but we're also moving into digital health to support the therapy. And that is using our app-aided and in-office programming device on the Digital Health Solutions Network. And so to date, up to February 1st of this year, we've implanted over 63,000 patients have been treated with Inspire. And what's really important is the care pathway that we talked about has been adopted and printed, published in the Journal of Sleep Medicine. And that's a big deal for a care pathway for an implanted device to be highlighted. And which led to that recognition that hypoglossal nerve is now was added as an additional treatment for OSA. Because at first, CPAP was the first-line therapy. There were no other surgical solutions, implanted devices as surgical solutions. And to get that designation from JCSM is really an accomplishment. And that is due to the continued use and continued generation of evidence to clinically support the device. And for those of you that are trying to understand what the mechanism of action is, it is a stimulating cuff and with neurostimulation through the hypoglossal nerve, using the tongue protractors and excluding the tongue retractors. And so using neurostimulation, this is a depiction. So what you would see on an endoscopic view of the tongue base, because Inspire works at the level of the tongue base, not at the level of the palate. You have tongue-based obstruction for indication. But here's what, in essence, if they are coupled, what you would see with no stimulation. And then the base of the tongue after neurostimulation, so stimulation of the hypoglossal nerve. And you can see the difference between the two. And then the coupling with the opening of the palate. And this is titratable. So the amount of stimulation that we can generate through the device, we are able to titrate that. So it is custom-delivered solution to every patient. And you can just see what effect you can have using the titrated effect of this device. And this is an overview of a sleep study without stimulation versus stimulation. And what you see, the number of events versus the solution of those and dissolution of those events. And so high level, what we have done is, again, the best result is tongue-based, when the obstruction is tongue-based. It is a cuff electrode, so it actually encompasses the hypoglossal nerve. It is synchronized, so it mimics the biology. And then it lowers the ability for collapsibility of the oropharynx. So who and when should we, or who's indicated, and when should, what are the patients that we should be looking for? And the FDA indication is adults 18 or older with a BMI of 32 or less. Now we have an extended label to a BMI of less than 40. That is new, and we are still doing our post-market, or excuse me, post-indication studies on that. But now we have expanded the label to less than 40 BMI. So it starts with moderate to severe OSA and an AHI from 15 to 100. That's also an expansion of the label. And failure of use of CPAP or intolerance or inability to tolerate CPAP. And then the appropriate airway, so no concentric collapse, complete concentric collapse. It has to be a tongue-based obstruction. And then on your sleep study, less than 25% central sleep apnea. And the biggest thing that I want to really get across is this is a journey for patients when they interact with the Inspire therapy. The commercials make it look really simple. Like you press the button and everything is perfect, and the day you have surgery, you turn on the device and everything works. And some patients even come in and think that they don't have surgery, we just give them that remote, and all of a sudden their tongue moves. And we have to really share with you that it is a pathway. So the patient screening is really important. So first getting those high-level indications, being qualified using those high-level indications, age 18 or older, BMI is appropriate, AHI is appropriate, and the complexity of the airway. Then after you have undergone the DICE procedure, so the drug-induced sleep endoscopy, to really ensure that this is a tongue-based obstruction, then you are then scheduled for surgery. That is when we would prefer that you see the sleep physician first to do all of that, so then you know that after the implantation, you can return to a sleep physician, and you go to the ENT surgeon for the implantation of the device. Actually you need to let the surgical wounds heal for 30 to 60 days before the device is actually turned on for the patient. So we want to manage that expectation that it is not an overnight, so after you have your surgery, you will not be using the Inspire device right away. You will follow up in 30 to 60 days with your sleep physician after the healing process. After that, then what we do is we titrate, or your sleep physician takes you through a titration measure where we monitor you for another 120 days post-op, and during that time, you may or may not undergo another sleep study, which is called a titration sleep study, where we actually, where they actually dial in exactly what voltage needs to be generated through the neurostimulator. And let me add a little caveat to that. So whenever I say the voltage, people go, oh my gosh, it's going to shock me. I just want to remind everybody that the hypoglossal nerve is a purely motor nerve, it is not a sensory nerve. So you will feel the tongue move, but you won't feel that jolt. And then we have tools to manage, to evaluate the management of the patient throughout the rest of the journey, and as the sleep physician feels appropriate for the follow-up. So I just want you to know that it's not a one and done. You do have to, you are on a care continuum when you interact with this device. And then even further, for those implanters and for those sleep physicians that choose to interact with our therapy, what we want to do as a company is ensure that they're doing all the things that will help impact the patients that you're serving in a way that gives us the best outcomes. So we actually do some certification of those providers. So not just everyone who says they want to be an implanter or they want to follow Inspire will be allowed to really do that. We have them go through a certification process so they understand how not only to implant the device, but manage the device and the patients over time. And we have a certification process, which does that. And so with that, I want to turn it back over to Dr. Runyon, that was an overview. So now you see how that all works. And at the end, we'll talk about some tools that we may have available for you to use. Awesome. Thank you, Dr. Sparks. I think it's essential that we kind of get that background and know all the options out there for our patients, us as dental sleep medicine providers, not to inform our patients to get the best results for our patients. And I love, I'm going to coin a phrase that you and I were talking about that you came up with that said we need to be collaborators and not competitors, because the more we can collaborate, the better results are going to be for everyone and the better, and especially the patients. And then that's going to kind of all boats or all tides raise the boats. Everybody's going to do better with better collaboration. So knowing what Inspire is doing can really help us in those conversations with our patients and with the surgeons doing Inspire. One thing I wanted to ask on the Inspire Care Pathway, is there anything as dentists that we can do to help partner with Inspire to like the surgeons or our patients about a long-term care? I think that's a great question. And I love the fact that we're talking in collaborative terms, because I think that's what drives the most impactful results for our patients and most impactful outcomes. And I think the biggest thing is you see these patients probably more often than the ENT will or the sleep physician will. And so that screening is so important. So continue to ask the questions. Are they interacting with the therapy? Is the therapy meeting their expectation? If they're not using the therapy, why not? And then help us through you to leverage a conduit back for the patients to meet back with their sleep physicians to get back on track. So I think you're a very integral part of maintaining and the maintenance and the longitudinal care of patients, because they must interact with the device for it to have any therapeutic effect. So yeah, and as dentists, we're kind of used to that interacting with our CPAP patients and keep monitoring to make sure they're compliant with theirs. So you would say it's very similar to with Inspire to keep that monitoring going there. The other question I would have for you is, have you seen anything to your knowledge? Has there been any reports, because with tongue movement, sometimes with tongue thrust, you can have malocclusion or tooth movement. Have you seen any reports coming out from patients that have Inspire to report any of those side effects? There haven't been any published reports of malocclusion. There have been reports of tongue irritation. And so anything that dentists could do to make it more comfortable for the tongue to glide over the teeth because of the protrusion of the tongue, I think that would be an excellent way for us again to collaborate and just tell patients there's an option for us. So as we're activating patients, we can tell them if you have some abrasion of your tongue, there are some solutions for you that your dentist can provide. Perfect. So yeah, we can make retainers, night guards, tongue retaining devices. So yeah, so that's really great to know. And speaking of collaboration, a new policy came out from UnitedHealthcare, and I think it gives us another pathway for us all to collaborate better. I'm going to read the policy just so those of us that aren't familiar with it have an idea, and then we'll kind of dive into that and unpack it. But the policy, which is going to be effective March 1st, basically says it establishes oral appliance therapy as a prerequisite therapy for surgical treatment in adult patients with moderate to severe OSA. Surgical treatments such as hypoglossal nerve stimulation, UPPP, adults with mandibular osteotomy and maxillary osteotomy and advancement can be used following failure of an adequate trial of oral appliance therapy, and a trial of CPAP is also required. This is a new policy that has come out. UnitedHealthcare is the first one to adopt this. So I'd like to start out by saying, do you think this is going to be the trend? Do you see other insurance companies following suit and adopting similar policies? So far, we have not been signaled that other insurance companies are following on. In most cases, they let one company be the leader and see how it goes. And so I think there's still some open questions. But what we have heard is that, I mean, we have not heard anything additional that no other insurance companies have made this a policy condition. Thank you. Also on that, what implications and impacts do you see these policies having on the field of obstructive sleep apnea and for practitioners in the field? I think for me, actually, I think it's exciting because we have another set of providers taking a look at patients in an underdiagnosed condition. And so if we can provide some solutions where there were no solutions provided before because we just because there was not a raising of awareness, then I think that's what we have to think about. We don't have to think about here's my biggest piece of the pie versus your piece of the pie. It is how do we impact patients? How do we deliver the care that they deserve? How do we make a dent in this disease state that is so underdiagnosed? Rather than fighting one another, let's help one another and provide the multitude of solutions or not just one or two solutions. There are multiple solutions and multiple kinds of patients that need to get these solutions and have access to these solutions. And so I think the more people that become aware and the more people that patients are interacting with that can help screen them, help them identify and get them toward diagnosis, or if they've been diagnosed, remind them and actually encourage treatment. I think that's better for everyone. And do you see this possibly being like an influx of or do you think, you know, with the collaboration, do you think there might be a more influx of referrals coming back to the dentist in that way and and just kind of your thoughts on that? Yeah, I think now is the time to for us to develop lines of communication where we can have just that, where you educate ENTs and ENTs educate dentists, sleep doctors included in that, and show each other that what we really want to do ultimately is really change the trajectory of health for our patients. And if that doesn't mean a surgery, then really surgeons aren't going to be interested in doing that surgery. And if there are other solutions outside of some of these big procedures, and we produce the kinds of results, then our patients are the ones that win. And we win because we do not have patients in the clinic that don't need to be there. So you actually become more efficient by providing the solutions and only seeing the patients that either desire surgery or qualify for surgery that can't be helped by the other solutions. And so I think really, let's talk about that. Let's say that out loud that what we want is for what is good for the patients. And if a non-operative treatment is what is necessary, then I think we ought to go to the best people qualified to do that. And those are those that are qualified in dental sleep medicine to provide the custom devices that are necessary. So you don't get the dental issues, but I'm gonna let you talk about the dental issues because that's your job. So we appreciate that. Yeah. So on that, so sometimes you brought up a point that, you know, sometimes dentists with trying to collaborate with their medical colleagues, there can sometimes be some barriers into making those connections with medical providers. Do you have any insights or advice on how you would go to start mutually beneficial conversations between a dentist and a medical provider? You know, transitioning out of clinical practice to industry, what I find is everybody likes a free meal. So there's an opportunity. And I would think about at a dentist practice, just maybe holding an open house and inviting the sleep physicians that are in the region, the ENTs that are in the region into your practice to see what you do and how you do it and actually see the product because many of them probably won't have any idea what the actual custom made appropriate oral appliance looks like. They are probably used to having people get off the street, you know, hey, I bought my night guard or whatever it is, my sleep, my snore protect off of Amazon. And what we really need is for them to be able to talk to you. And I think all of us as healthcare providers, we're scientists at heart. And so if you follow that up with the latest peer reviewed evidence that shows the efficacy of the devices that you're providing, I think that also opens the window, just like you're having this webinar. I think ENTs are craving the same kinds of information about oral appliances. So that kind of leads to a follow-up question that you kind of walked into there was, how can we as dentists demonstrate to the ENTs, to the physicians that we are the most appropriate for delivering oral appliances? Yeah, I not like what you said, got it over the internet or somebody outside of the dental field making it. What could you give us kind of your, your insights on that as well? You know, everything that's driving healthcare today, especially on the medical side is value-based or evidence-based. And so I know the, and thank you, Dr. Run, you gave me a wonderful bibliography of supporting evidence to demonstrate the safety and efficacy of oral appliances, and then showing even comparatively from those that are over the counter, so to speak versus custom made devices. And so I think that's what will drive it is the evidence to support it is so, so important. And so for those of you that don't, that don't know Dr. Sparks, I actually went on the, I got the resources from our AADSM website and used our organization for support that has a list of those articles. And I pulled some that was of specific interest to Dr. Sparks and presented that to her. And that's how we kind of fostered our relationship. It just so happened she was in my backyard. So, so that it worked out great, but, but I encourage all of us as dentists to, you know, utilize those resources because they can be a huge, a huge eye-opener and conversation starter. And I'll tell you after Dr. Sparks shared Inspire stuff with me, I shared oral appliance stuff with her and we went to dinner over it. And I don't remember how long we were there. We had a, I think we closed the restaurant. So it's truly on a personal level too, you'd be surprised how those, how that little bit of information can open up doors and windows with everything there. The other thing I was gonna circle back to is what are your thoughts on the best ways to collaborate with ENTs? I think one thing I want to really share with this audience is the ENT is just one part of the continuum and the care pathway for patients with Inspire. I think we have to, it's really, really important to know that it is an implantable device and the ENT is sort of the start of that process with implanting the device in the appropriate patient appropriately. But really the key to outcome success is the follow-up with the sleep physician. So I want you not to only think about how do we interact with ENTs, but how do we also interact and enhance our relationships with our sleep physician partners as well? But I think that the, it has not been detrimental for anybody to just reach out to an ENT practice to say, Hey, I'd like to learn more. And if you need some tools to do that, we can help you through Inspire. So we have physician finders, so we can help you highlight who's in your area. We can share both on the ENT side and the sleep side through our website and the physician finder. There's also some tools that help educate you more deeply about the process. And we have a program called the Inspire Ambassadors, where these are actual people that we do not pay that have the implant that will take your call and answer your questions in a first person voice. And so I think those are tremendous opportunities for us to get the conversation started and keep it going. So I just wanted to highlight one thing you brought up is there is a website. So if I'm interested in reaching out and making a connection to collaborate in my local area, wherever I practice in the United States, I can look at your website and I can help me find providers who are doing Inspire, both from ENT's perspective and from Sleep Doctor perspective. So that could, in a sense, I could take that information and go to them to try to help grow my referral network and a better collaboration between myself, my local community, and therefore enhancing the outcomes of my local patients. Yes, inspiresleepalloneword.com. And this might be a time. Yes, go ahead. And then I want to interject a question. So you finish with your thought. No, go ahead. Well, I'm monitoring the questions and there's a lot of interest on this chat about this relationship with an ENT, right? And the consensus kind of seems to be that they may call an ENT and not get a response. And I could also say that from a dentist perspective, especially if they're relatively new to dental sleep medicine, starting the conversation with an ENT can be pretty intimidating in that they may feel the ENT doesn't want the education. Maybe not every doctor is as open as you are, Dr. Sparks. So could you make some suggestions that way? Yeah, I think you're absolutely right. As a surgeon, we as surgeons, when we see patients, it is really, we're trying to see patients that we can operate on. I mean, that we have to be honest about that. So the more qualified patients that you share with ENT, so those that, not that are 100% ready for surgery, but should be an appropriate surgical candidate. And the more quality of those kinds of referrals that you send to them, the more that they take notice. And so that's what we would love to help you hone that skill. So how do you pick them out? Because nobody is going to know, especially about Inspire until after the DICE is completed. So you have to actually look at the airway, but the other things checked off, have they had a recent sleep study within two years? Have they been diagnosed with OSA? What is the AHI? Does it meet the criteria? And then, I think we have to understand who the providers are of the insurance coverage so that you know in the network who can provide care. And then from there, but also having a relationship with a sleep physician. So you can say at the end of that, that the ENT can return this patient back to the sleep physician for the longitudinal care that the ENT doesn't provide. They don't provide unless they are dual boarded. Now there are some dual boarded ENT and sleep physicians, but that's probably not the majority. And so they also want to know if you have already a relationship and this patient is established in a sleep practice, that takes another burden off them from trying to find follow-up for the patient. So the more complete sort of the package is that the patient goes to the ENT with, the more open they will be to accept new referrals, I would feel. Dr. Sparks, in your experience, you know, one thing is you talk about DICE slot and that's with Inspire. And you know, as dentists, we don't always get to see that. And would that be one way you could break down a door at the ENT? Do you think ENTs would be open to us if we came to them and said, hey, I want to learn more. Can I watch or step in on one of your DICE procedures? How open do you think ENTs are for that? And is that a pathway in? Yeah, I think if you have established a relationship with an ENT, I think probably cold calling an ENT and saying, hey, can I come watch a DICE probably isn't the best thing to do. But if you have an established relationship and maybe you have an established relationship with a sleep physician who then also has a relationship with a ENT, you can get the sleep physician to you can get the sleep physician to introduce you to the DICE procedure done by the ENT. So I'm not sure you always have to have a direct conduit to the ENT. The sleep physician is going to have that relationship as well. If they're doing Inspire especially, they're going to have that connection. And I think you leverage them if you have a better relationship with sleep than with the ENT. And the only thing I would caution about is because it is a procedure that is done with anesthetic. So sometime there are some credentialing that you must do because of the site of where the DICE is done. If they do it in their office, it's different. It'd probably be easier for them to let you in and observe. But if they're going to do it in an outpatient facility or even in the same day care of a hospital, there may be a credentialing issue that you must do to just have permission to be in the hospital and be in the operating room in the procedure room with them. And just as a follow up too, I thank you for those insights. But since we brought up DICE, and I just want to kind of do one tag onto the DICE is when they when they evaluate for hypoglossal nerve stimulation and DICE, are they evaluating in the supine and non-supine position? Or is it just in one position? It really now that is variable. It really depends on the experience of the patient. I mean, excuse me, the provider actually doing the procedure, but typically early in, especially with Inspire, they do it both in the supine and the side on the patient with the patient on the side to see if positional changes will either induce a concentric, complete concentric collapse, because we don't want to implant patients that have that, versus supine to really trying to make sure that that is not going to be a complication for us. Gotcha. That's perfect. And then so I wanted to circle back to that, the UnitedHealthcare policy that was adopted. And, and about being oral appliance providers, there's some rumors kind of flying around that, that some positions might consider using temporary appliances for patients to satisfy the, the adequate trial. And that's a little bit of a concern there. It's a major concern in our field, because the evidence contrasting the effectiveness of temporary appliances to those that fit the E0486 code, which is for a custom appliance, doesn't support their use. And the ADSM defines an oral appliance based upon a review of current efficacy research and CMS guidelines that define them even more narrowly, which in both instances kind of exclude the temporary appliances. So therefore it, it can make for an inadequate trial. The question I pose to you is, would you give your kind of insights on the matter on, on what you're hearing from your side of the field? I think what's really, we got a direct communication from UnitedHealthcare, just on this subject, what constitutes a trial and what constitutes a failed trial. And their verbiage is prior to the approval of surgical treatment for RSA, our policy requires a failure of an adequate trial of oral appliance therapy. This is determined by the reasonable judgment of the patient's sleep medicine provider based on the individual's patient's circumstances. Now, what does that say to you? That the field is like wide open. And so I think, but I think the key there is that the determination has to be made by a sleep provider. And that's why I think we don't lose sight of the relationship that dentists have with sleep medicine, not just ENT with sleep medicine, because all these things have to talk to each other. And that's why this collaboration is so important, because what we want is that adequate trial, because what we want are good outcomes for our patients. And if we can't help educate sleep providers in what an adequate trial is, then they may default to just what you said. If the patient came in and said, I bought this last night, and it was terrible, and now they deem that inappropriate, because the guidelines do not specify certain number of nights, do not specify what kind of device. So I think it's incumbent upon us to continue to communicate with our sleep medicine physicians. So that's one. And I think, again, hitting back on the key theme tonight seems to be the more collaboration, the better it is for not only ourselves, but the patient. And that's the end goal of everybody. And at least I like to believe that's why we all got into the field is to better somebody's life and save their lives. And in this instance, what we're talking about. So this might be something where using those resources of finding physicians in your area and broadening our connections in that area would be somewhere maybe you could try to reach out, show them evidence-based papers about temporary appliances compared to custom appliances and those appliances that fit the E0486 code, and have that conversation, and maybe with the sleep doctors in your area, try to come up with a define on what you agree is an appropriate trial in your area. Could be one solution to this, just to try to get everybody on the same page. Is that something you would agree with, or is there more input you want to add to that? I think that's perfect. And when you start talking about procedural codes or diagnosis codes, that's important to other providers. And so, because those are based in guidelines. And so, I think that's a really important highlight that you just shared with us. And so, I think that's the way to go. And if you are able to establish those relationships in your responses back to them in following up the patient, do what you just said. Add those resources for them to read more about it, so that they become more confident in the evidence-based journey that they're on for their patients. And providing them with the articles, providing them with the data, I think only solidifies your position. And then just on top of that same subject, is Inspire doing anything to provide guidance to their providers about what constitutes a failed trial? We have not. And so, I was hoping that in our conversation tonight, we might touch on that. And then we might figure out how we follow up, so that we work together to find out to decide what information we want to disseminate that is unbiased, that will actually facilitate the care of patients, not impede or deny access to patients, and not unduly alarm those that are caring for these patients. And so, I would love to hear your thoughts on what can we do as Inspire to help bridge that gap? Well, first off, to start, I appreciate your openness and inspiring. That's great hearing from the Chief Medical Officer about how open Inspire is to wanting to be evidence-based and do the best by the patients. One thing I'd like to point out for dentists is, and you can get this resource, you can look it up, which is an article that came out, which is Identifying the Appropriate Therapeutic Position of an Oral Appliance, which is a paper that came out. And that is a way that you could almost outline how a trial might run. So, for those of us out there, if you haven't read that paper, it's something that I would encourage us all to do as dentists. To come back to your question, though, about what can Inspire do, I think the big thing is, for dentists, one of the things, and is breaking down the barrier, is kind of a lot of the questions I think that Trish went, that Dr. Braga brought up, and that is, some dentists just find getting in the door is the biggest hurdle. And then when they get in the door, so sometimes with the ENT, they might not get to there. They might just be the front desk that they work with and they kind of get walled off, or it might be, hey, we try to send these referrals and we're getting nothing back. As dentists, we're big into embracing co-therapies. We know kind of the, we know the efficacy of oral appliances and we know its limitations. And so we know like, for example, a patient that side sleeps a lot, that lays on their back and supine, we might encourage side sleeping. We also, for patients that have a mouth dependency in terms of breathing through the mouth, that's where we might partner with an ENT. We're trained to, as an academy, we work as part of our screening protocols to take a look at the nose. It's not just the mouth. And kind of get those. And if we see something where there might be a deviated septum, that correcting that may make it easier for the patient to wear the oral appliance. So I think a big thing in our field is just kind of breaking down those barriers to get access. And I think that's something maybe that I was intrigued to learn about Inspire's website, that may be having that connection to saying, having Inspire saying, hey, ENTs, do you want to learn more about this and fostering this collaboration? Like you said, like we can be adjunctive. They do Inspire and they're having tongue soreness. Well, instead of the patient showing up in their office complaining all the time, we can get that referral back. And likewise with our field, embracing, knowing our limitations and really making the ENTs and the sleep doctors a priority to help us improve on what we're doing. So that would kind of be where I would head with that. I don't know what your thoughts are on that. The only other thing I would add is go to your friends first. I mean, the people that you already have relationships with. And I think that's the conversations that we need to have because once you've established that with their patients, your shared patients, that you are providing good care, they're going to tell their friends, they're going to make that introduction for you to the next provider. And then that provider, once you establish that relationship, so it may be a grassroots from the bottom up. There probably isn't anything that we could blast on a commercial or anything like that that we could do. So it is probably going to be some groundwork because these are new rules. Nobody likes new rules. It sometimes seems like one more step. But I think when you have the kind of relationship, because I'm sure there are other dentists that you get referrals from. And when you get those referrals from the good dentist, you go, yay. When you get them from the bad dentist, you go, ooh, that's really bad. So I think that's the same thing with sleep. You get the patient prepared. You provide as much education as you feel comfortable with providing. So they go in eyes wide open about why they're going to see this person. And you've provided the foundation for that. And then you follow up and then you ask for follow-up. I think you and I have said it from the beginning. It's communication and collaboration. And it may take some work, but I think we can get there. Definitely. Yeah, and I think that's something too that would be interesting, like for us knowing that there's a website that you have where we can go find providers for this to open the doors. It's something too I would encourage you to share with your providers that they can find, the AADSM has a qualified and diplomat on the website where they can look up in their area. So if they do, they can also find qualified dentists to kind of partner with. So they get that, ooh, this is a good referral mindset going on there. So that's somewhere maybe we could collaborate together on that. Another question I had for you in this, this might be a little bit of towards your personal opinion, but in your opinion, oral appliance therapy and Inspire both can help a lot of patients and both have a lot of crossover in the patients that we're treating. So the question might become, should we explore all non-surgical options before surgical options versus how much should the patient preference sway the decision? So I just would love to hear kind of your personal take on that debate. Yeah, the biggest thing that we have to remember or I have to remember with Inspire is that it's indicated from moderate to severe sleep apnea. So we're not going to treat every patient that has an obstructive event. And so we appreciate that. And that's why we have the rules that we have. But as a prior practicing physician, I just find it so important to get the input from the patient because any one of these interventions for sleep apnea, adherence is what's most important. And so the patient must buy in. And so if they are just, number one, not all patients, once they see what the process is for Inspire and once they know that it's not just like the commercial, they hold the little device up and the green light turns on and it works. Once they know that they have to have a surgery, they're like, nope, no thanks, don't want a surgery. So we know that there are going to be some patients that say no to surgery, but should you deny them the opportunity if all non-surgical approaches haven't been tried? And I would say no, because if you force people to just go through it, just going through the motions, I think that's when we have an opportunity or that's when the realism that comes up with lack of adherence or even just lack of trying, they say, oh, it's just one step, I got to go do it. And they're not going to give it a good faith effort. So the patient and their view of that therapy and their desire to be treated is so important in this space. Thank you. Yeah, I think it also goes to the fact like when we're knowing that, I did not know a lot about Inspire until I met you and my eyes were kind of opened with how much I was missing the gap. And I know that can help then in talking with the informed consent and that can also go in with kind of lighting the patient's eyes up to knowing all the treatment options rather than just kind of putting them in a box. And sometimes, yeah, when you tell the patients that there's this process, they go, oh, well, maybe I do want to try one of these other ones before I go through that whole journey. Exactly, yeah. Yeah, the other thing, and I don't know, because I know this policy is new, so I don't know if you'll have an answer for this one. So if not, that's okay. But one thing we sometimes run into in the field is the same and similar rule with getting insurance coverages, meaning let's say we had a patient that is great for an oral appliance, but they did their CPAP first. They're non-compliant on the CPAP, but insurance already paid for that. So insurance tells us, we're not going to give you anything here. Has you heard anything with the insurance companies? Have they said anything like, if this procedure is done first, we're not going to cover, inspire if that procedure were to fail? We have not heard that overtly, no. But I think what we have to do is wait till March 1st, because now they're adding it as an additional requirement. So we have to see how they're going to respond. So I'm not sure that we're going to know exactly what that process is going to be until we try to do the prior authorization for payment for these patients. Thank you. And then I do have some other questions, but I also want to give a chance for some question and answer, because I think it's very important we incorporate our audience into this and hear what they have. So I'm going to have Dr. Braga come back on, and we're going to go through questions there. If we have any time left over, we can go through a couple more, but we got about 10 minutes, so we'll see what we get through. And I'll throw up- Okay, and I- Dr. Braga's doing that, I'll throw up the size of the device. Oh, thank you, yeah. Oh, yeah, that's a good idea. Can you hold it out in your hand a little bit? It's a little obscured, yeah. There it is. Yeah, so it's only about a third of an inch thick, I think, right? Yeah. And then two and a half by two and a half, maybe? So that's what will go in your chest there. Yeah, so let me do it on this side. Is that better? Yeah. Yeah, we can see it. Perfect. Okay, and then we'll have- And then you can paint that on either side, or is that- Yeah, so it can go on either side, and in some areas of the country where they do a lot of shotgun shooting, we have to move it to the other side. It usually goes on the right side versus the left side. And it can go in, if the patient has a pacemaker, it can go on the opposite side of a pacemaker. That's really important, though. And actually, Trish, one last question I had that I think is important to highlight before we jump into it was when Teresa and I were talking, the shotgun thing is interesting, so your patient on that side, but we also talked about the importance of everybody and the sleep doctors and everybody collaborating together, because I remember when we were talking, you said one thing Inspire learned is patients with insomnia sometimes need to get that treated first, otherwise it can have some issues with Inspire. So just like we screen for everything there, that is something to extra note. Could you speak a little bit on what you found with patients that have insomnia and OSA and Inspire? Yeah, I think that that's really important, because sometimes the insomnia is not recognized. And when you have a device that actually physically causes a response, it may preoccupy them even more and make the insomnia worse. And so we're not treating their real problem, we're actually adding to the problem. So that's why it's really important to engage with the sleep physician so they get an accurate diagnosis of all the comorbid conditions that they may have as well. All right, Dr. Braga, if you read some of the questions you have there. Yeah, I'm gonna combine a few for efficiency. The Q&A room was used more as a chat feature, I think, than a question. So I was furiously trying to look through where the questions were. So I'll combine a few. So one theme, of course, is that as dentists who treat patients with a medical disorder, we're very aware of efficacy. And we've all been frustrated how when a case doesn't respond the way we want it to respond, either symptomatically or in the metrics that are evaluated in an objective study. So one of the questions has to do with what is considered to be a failure of the Inspire surgery. And the add-on question I would put to that is is it expected that it be evaluated in 90 days? Is it a 90-day trial with an expectation about AHI? I think I wanna turn that around. No, it is not usually a 90-day. We probably don't get to adequate titration, so the exact level of therapeutic effect with patients before really probably six months. And the second sleep study to actually do what we call is a titration sleep study. So we actually turn on the device at different voltages during the sleep study to get to the most accurate level. And so that can take some time because you don't wanna do the sleep studies too close together because you haven't gotten to the therapeutic effect yet. And we move the dosage or the voltages in increments over time. So it is not just a zero to 10 overnight or zero to 10 in a week. It is over a period of time based on the comfort level of the patient. And so it takes time. So we usually don't really talk about, and I don't really like to say, I think an abject failure is just when the patient will not interact with the device anymore, when they just won't use it. And we do not have a hard and fast, I mean, so I think many physicians that are using Inspire are trying to understand mean disease alleviation versus pure AHI reduction to a certain level because it depends on where you start. And then it depends on subjectively how the patient feels after that. But yes, our indication is so bringing the, using the share criteria, reducing the AHI by 50% and lower than 15%. And so those are the levels that we look for, AHI of less than 15. So I guess you would call that a success, but if somebody starts at an AHI of 100 and you get to an AHI of 17, is that a failure? Because- In other failure situations, if a patient, for example, doesn't want to interact at all, is it generally removed? Typically, no. Patients will just leave the device in place and just not turn it on, just not activate it. Okay, is the incident of central events sometimes an issue? Right, and that's why it's really important on that sleep study that you have less than 25% central apneas. To begin with. To begin with, to meet the indication criteria, yes. And Dr. Sparks, how long does that device, what's the lifespan of the Inspire device implanted and also of the remote there? The IPG, so the little silver thing, the generator, the battery life is 11 years. And so at 10 and a half years or 11 years, you would then have another surgery to exchange the battery. And what else did you, I'm sorry, I lost the last piece, but- And then also, like that remote, is there- Yeah, that's a battery, that's a battery. Yeah, yeah. Can I get two more questions in under the wire? Absolutely. I'm happy to do that. So I don't disappoint my audience. Yeah, sure. Okay, so one of them is, if you do have the Inspire, can you be defibrillated? Will that impact anything? And can you have an MRI or CT? Okay, so the MRI, we just got the label for full-body MRI compatibility. So what that means is, in a 1.5 Tesla MRI, so you need to know the specifics of the MRI. And so what we encourage people to do is to take or go to the website when they're having their MRI so the tech can read the specifications because it's lined out specifically what parameters need to be met to have an MRI. But typically in a 1.5 Tesla MRI machine, we are MRI compatible, so you can have an MRI. Defibrillation is kind of the same thing. We need to know what the device is that is doing the defibrillation, but typically it is safe to have a defibrillator with the Inspire device. And the biggest thing that patients sometimes forget is many of these incidents happen overnight, so the device is activated. So we need to remind caregivers that they have to take the remote with them because they need to turn the device off when they go to the emergency department and or just have an awareness. If the device is activated, they typically, you need to have the remote there to deactivate the device. Okay, and then one more, I think if you would share kind of a range of expected surgical price for the insertion of an Inspire, is that something you would share? Well, the device has one price in the United States. And when I say it's one price, it's $25,000, but it may be $25,049 or 25, you know, but it's, let's just say $25,000 for the device. Do you think that that's a part of the UnitedHealthcare policy to want to look for less expensive options first? I think they have used less, I mean, they have defined less expensive options, you know, with CPAP and saying that you must do CPAP first. And so I'm not sure that it's additive to that, but I think if, I think, and all the criteria must be met before you qualify, and there is a prior authorization. So it's not just automatic, just because you say, I hate my CPAP that I get Inspire. There is a prior authorization process that you must go through, and you must get permission to get this device. So I'm not sure if I answered that completely, but I don't think it's additive, that they want to try to say, do everything that is not operative before you go to an operative solution. Okay. All right, I'll respect your time. This has been a fantastic presentation. Thank you. Dr. Raga, do you have lots of extra questions left there? You know, there's a few. There's a good one about concentric collapse occurring in postmenopausal women. There's a question about interfacing with ENTs with regards to children, which I know is not really your specialty. So there's not a lot. There's just a couple left now. Is that something- Well, children, let me just say one thing. We do have a pediatric indication, but it's only for children with Down syndrome, age 13 to 18 with Down syndrome. So Inspire is indicated for kids 13 to 18 with Down syndrome. Okay, and since you're willing, there's some indication that postmenopausally, women who might've been anterior-posterior collapsers at the tongue base then become concentric collapsers. Do you have a protocol for follow-up on that, or would the device tell you when it's not working anymore? The device doesn't necessarily tell you. Well, yes, okay. The outputs from the device will tell you once you interact with the remote and that app and the programmer that I talked about will talk about, will show you the AGI, and you probably will see an increase, and they will become less responsive to therapy because of the complete concentric collapse. Okay, I think we've covered most everything. I think the takeaway is we're gonna have new conversations with ENTs.

Inspire device

obstructive sleep apnea

collaboration

dentists

sleep physicians

ENTs

AHI reduction

titration

MRI compatibility

patient adherence