Good evening, and welcome to the Augs industry webinar with Evasion Medical. Today's webinar is titled Next Generation OAB Neuromodulation. The surgery-free Vivali system is here. We hope you find the information enriching and empowering. Our speakers are Dr. Emi Brettschneider, Chief of Urogynecology and Reconstructive Pelvic Surgery at Northwestern University, Dr. Michael Cannelli, Professor, Department of Urology, Wake Forest School of Medicine, Atrium Health at the Carolinas Medical Center, and Jill Schiaparelli, CEO and co-founder of Evasion Medical. Before we begin, I'd like to review some housekeeping items. The presentation will run about 45 minutes. The last 15 minutes of the webinar will be dedicated to questions and answers. This webinar is being recorded and live streamed. A recording of the webinar will be made available in the Augs e-learning portal. Please use the Q&A feature of the Zoom webinar to ask any of the speakers questions. We will answer them at the end of the presentation. Use the chat feature if you have any technical issues. The Augs staff will be monitoring the chat and can assist. Our speakers, you may begin. Good evening, everyone. My name is Jill Schiaparelli. I'm the co-founder and CEO of Evvation Medical, and I sincerely want to thank you for spending some time with us this evening. I will let you get to Dr. Connelly and Brett Schneider shortly, but I thought it would be important for us to start with a little bit of background about the Vivaldi system and why we saw a need to create a new type of OAB treatment. I apologize, but my slides are not advancing. Phil, if I give it back to you, would you be able to do that? Thank you. We believe at Evvation Medical, and I think many of you do as well, that neuromodulation is an incredibly important new tool in our options, and we think it stands right alongside surgery and medicine for treating a variety of symptoms. But the problem is it's been very inaccessible because for most forms of neuromodulation for any disease state, a surgical implant is required in the brain or a spine. That requires a patient who's willing to have surgery and a surgeon who's willing to do it. So what we sought to do is make the promise of neuromodulation more accessible by eliminating surgery from the equation. And the first market we'd like to go to is overactive bladder. Phil, could you go to the next slide, please? As you all know well, OAB is a very challenging condition to treat. We all pee, but one in six adults have symptoms of overactive bladder. Conservatively, that's more than 45 million people in the United States right this second. And providers, all of you, face enormous patient demand and time constraints. And we know that patients consistently reject the many existing options. Next slide, please. You all know this far better than I do, but when patients look at the buffet of options that are out there for overactive bladder, they see things that are effective to some degree, but also very unappealing. Drugs, as you know, have side effects, some very serious. Botox bladder wall injection is not a pleasant procedure and obviously has risks of urinary retention. And then when we look at neuromodulation, everything is invasive, ranging from percutaneous tibial to the new and emerging implantable tibial stimulation, and of course, the long-term implantable sacral nerve stimulation. All of those invasive procedures have drawbacks associated with them, ranging from obviously invasiveness and time in the chair, and you need specially trained surgeons to do the implants. Another fact that you may or may not be aware of, next slide, please, Phil, is of the 45 million people, every year, 9 million people see a physician like one of you for help with their overactive bladder. But here's what's really interesting. Of those 9 million people, 6 million will do behavioral and physical therapies, 3 million will take a drug, and a quarter of a million will take what we've previously called third-line therapies. About 190,000 of those will get Botox, but only 60,000 will get neuromodulation, either SNS or PTNS. And that's due to the invasiveness, the cost, and the requirement for surgical training. So at Avation, we said, how can we take that very effective surgery, I'm sorry, that very effective treatment of neuromodulation, and move it earlier in the care pathway without surgery? And so what I'd like to introduce to you now is the Vivali system. We are next generation OAB therapy, completely surgery-free, completely non-invasive. It's a wearable that shifts prescribed therapy into the home. And what's unique about it, and we'll talk about this much more in the coming slides, is we are the first FDA cleared physiologic closed loop system. And what that means is we continually monitor the patient's EMG signal and personalized therapeutic output. It's easy to prescribe and monitor for prescribers. First, it can be offered to all patients in your care pathway, drug naive, drug stable, drug refractory. It's a simple in-office clinicals training that you or your APPs can do, and it takes about 10 minutes. It also allows you to monitor the patient remotely. It's also easy and convenient for the patient. We've managed to get therapy down to 30 minutes, as little as once a week. But if they need more, you and your patient can decide what's appropriate. It fits into their lifestyle very easily. They can move around while they wear it because of the closed loop feature. And it's surrounded with a mobile app that gives them additional support. Speaking of mobile app, our digital platform has three important things that I think you'll be interested in. First, the patient mobile app provides support, how to, and the ability to get reminders. The clinician app is what you use in the office to do the calibration and the prescription. And you also have access to a cloud portal where you can remotely track all of your patients. And finally, we do collect all de-identified patient data in a cloud. And over time, we will work with clinicians such as yourselves to mine that data so we can advance our collective knowledge of tibial nerve stimulation. Dr. Cannelli will talk a little bit more about this, but I'm sure the term physiologic closed loop may be new to several of you. Most neuromodulation now is open loop, meaning a static signal is put out to the patient, and that's what delivers therapy. However, you don't give the same dose of drug to every patient. So why should you give the same dose of electricity? So what physiologic closed loop does is we monitor a physiologic parameter in the patient, in this case EMG, and that continually is read by the system and automatically adjusts the output over and over again, about 20 times a second. This delivers personalized therapy for the patient. Phil, next slide. The other thing I wanted to tell you before we end my session is that the patient support app has four key features I wanted you to know about. First is an e-diary. If you're currently using a paper diary, the e-diary is an option for you, regardless of whether or not your patient is prescribed the Vivali system. We collect the standard things, but it's an easier way to do it for the patient. Voids, leaks, urges, fluid. More importantly, the patient can see tracking over time of their progress. We also send reminders. It's Vivali time, a reminder for them to be compliant to their therapy. And the app also includes a number of how-to videos so the patient is able to feel empowered should they have any questions. Next slide, Phil. So in summary, I think you're going to hear a lot more from both doctors on the call, but we've really tried to be thoughtful about having something that's patient friendly and provider friendly. Dr. Brettschneider will talk about our clinical trials. We've done several, but I want you to know that we're seeing very good results, very high patient satisfaction, and an impeccable safety profile with no serious adverse events associated with the device. I'd now like to turn it over to Dr. Cannelli. And again, thank you all for your time. All right. Well, thank you. And Jill and Phil, thank you very much. It's a pleasure to be here tonight. And I think listening to Jill and what your company is doing is really putting a step forward for our patients. As you know, there's a lot and a lot of patients who have overactive bladder. There's way too many patients for your gynecologist and urologist to be able to treat. We've got to somehow get better therapies out for these patients. So what I want to do is talk a little bit about kind of OAB and where we're at in guidelines. In my career, overactive bladder has really taken over. I've been in this space for about 30 years. And really, when you look at what we've done, we've evolved and changed. Instead of just pharmacologic therapy with Oxybutynin, we have many modalities. Recently, in 2024, as you can see, there's been an update to the guidelines. And the key components to the guideline updates are probably two main areas. The first is shared decision. Basically, we're really empowering the patient to have considerations of their values, their preferences, their treatment goals, things that they need to do to decide on management. Previously, we were on a stepwise therapy. You know, first step, second step, third line therapies, that's gone. It's really between the patient and what best fits their needs. The second area that I think is really critical is they added a new section about non-invasive therapies. Obviously, we know about some non-invasive therapies, which is using diet modification, caffeine reduction, pelvic floor physiotherapy. But really, if you looked in detail, guideline statement number three says specifically that clinicians may offer selective non-invasive treatments to all patients, not just any, all patients. And they really called out, if you looked under there, about transcutaneous life-thorough stimulation therapy. The issues with TTNS is that there's been different parameters, whether different number of sessions, how long the sessions are, what the parameters are. And so, the literature is a little bit weak in that area. There was a review of 15 articles specifically on TTNS, and they showed that it was equally effective to pelvic floor muscle therapy. So, at this point in time, they specifically called it out. One of the things that you're noticing here is the Vivaldi system actually got published after the cutoff for the AOASUFU guidelines, and consequently, getting better quality evidence, which we're going to talk about later, is kind of really key within that area. If you look back at the history, tibial nerve stimulation therapy has been going on for over 50 years. Back early in the 1960s, they started using tibial nerve stimulation on cats, and they showed that it can inhibit the afferent nerve signals and stop the trusovectivity in cats. In 1966, Ed McGuire was the first person to use transcutaneous tibial nerve therapy on humans for idiopathic OIB, and that subsequently moved it around. Later in 1989, Dr. Marshall Stoller also started using tibial nerve therapy on 98 humans. That was the first larger-term study. In fact, it got to the point that Dr. Stoller called it the Stoller Afferent Nerve Stimulation System, and in 1999, he actually received FDA clearance for that device. The device was manufactured, and then through a couple different companies, ultimately got purchased by Uroplasty. And in Uroplasty, in the year 2000, they got FDA clearance, and they updated it to 2005 to get further FDA clearance to what we know today as Urgent PC. Now, when it was cleared in 2005, just because it cleared doesn't mean there's actually coding or any reimbursement. So it actually took them until 2011 to finally get a code that we know is 64566 as a PTNS code. Once you get coding, then other companies get in the arena, and Neuro came out in 2016. So transcutaneous tibial nerve stimulation therapy from a percutaneous approach has really been around for over 50 years, and it's been a known commodity. Obviously, sacral nerve modulation therapy went similar along that pathway, started in the 80s, and came a little bit sooner to get cleared and then get coverage. But now you're seeing even this year, in 2024, we have tibial nerve implants with ECOIN and REVI, and a few others that are coming on. So clearly, the tibial nerve is a hot area for overactive bladder, and incidentally, as noted, the Vivaldi system also was cleared in 2024. So it really is innovative. And why is this nerve interesting? The main reason is that the tibial nerve is a mixed peripheral nerve. It has both sensory and motor responses within that area. And so that ability, having sensory and motor, is one of the key reasons why you can actually have a closed-loop system. As you activate the afferent area, you're going to see a motor response, and so you can constantly get that positive feedback, as we'll talk about. The other thing that you notice is the sensory thresholds are really down in the foot area, and the motor is more within the calf. And one of the things that you'll notice a little bit earlier is when you look specifically on the nerve as it's coming back, the nerve comes from the spinal segments of L4 to S3. Phil, if you could click the next slide, for some reason, there it is. So one of the benefits compared to sacral nerve modulation, with sacral nerve modulation, you're really just stimulating one sort of root area, typically S3. But within the tibial nerve, it actually branches, as you can see there on the right in the green. It goes anywhere from L4 to S3. And so possibly you're getting different afferents, different pathways to be able to go up the spinal column and then affect the brain in different areas. And so we're going to figure, we'll see things more over time and how that is. But it definitely has been a known entity to that area. Phil, if you don't mind passing. So as I talked about, what is different about this compared to, let's say, all the other therapies we do within neuromodulation? A physiologic closed loop means that you're actively monitoring what you're doing and then making adjustments. For example, if you're in your car and you're going on a cruise control and you're going up a hill, the car automatically senses that and will make adjustments. If you're going downhill, just the opposite. Whereas if we're using whether percutaneous tibial nerve stimulation, sacral nerve stimulation, or even TENS units to that area, it's an open system. I mean, it's just delivering amplitude to the area. Now, one of the things that's really critical when you're talking about a home therapy, something that patients are using at home, is that we want them to deliver the therapy. And this physiologic closed loop is automatically sending adjustments of the signal, the milli amperage based on is it activating the nerve and will treat it appropriately. And consequently, with that, you're going to get a better objective and hopefully better efficacious response when they're not being monitored specifically under the watchful eye of a physician. So the keys to here is if you have someone that's doing transcutaneous, say TENS unit, you know, patients can put it on, but the difficulty is they don't know exactly where it's located. They also don't know what's being stimulated is the threshold that they have to send something actually activating the real nerve or is it just a field effect? Whereas when you have a physiologic closed loop system, the way the valve system has is within the foot area, there's actually a sensor and that's sensing the actual motor response and intrinsic nerves of the foot that the TLA nerve, once it's activated, cause an activated EMG signal. And so it's constantly giving you this back and forth feedback that allows the actual device to change its parameters. Why is that important? It's important because you don't want people to be shocked suddenly. If they start to move around and move their feet or walk, you want it to change. If people are having heated over a period of time, meaning as this is on for 10 minutes and 15 minutes, 20 minutes, the actual warmth of the skin changes the impedance and you actually need to adjust the amplitude to be able to drive the energy to truly activate the nerve and then see a response at the EMG. And so it's a little bit more assurance from a clinician that the patient's actually getting a response as opposed to a sham response in that situation. So I think a closed loop system, specifically when someone is using something at home, so they're not wasting their time is really key. And so I'm glad that this therapy actually came out with that as a modality. So I'm going to stop at this point and hand it over to Dr. Brett Schneider, who will talk about some of the data that we have specific to this area. Good evening, everybody. Thanks so much for joining. And thank you, Dr. Cannelli, for that awesome review of the anatomy of the tibial nerve. So I am going to review some of the landmark articles, landmark studies on PTNS. So everybody's familiar, we can just do a quick review. As you know, PTNS has been around for over 15 years for the treatment of OAB. And there is a large body of high quality evidence now, including several really high quality RCTs and systematic reviews and meta-analyses. So I'm going to try to control the screen. There we go. So there are three main landmark trials that were really pivotal in demonstrating the efficacy of PTNS for the treatment of OAB. The ORBIT trial that came out in 2009, the SUMMIT trial that came out in 2010, and then the STEP study published in 2013. Sorry, that's a typo. Yep. So I'm not going to go into a ton of detail. I'm just going to give you kind of the broad overview here. But I'll go through the primary findings of each study and kind of highlight those for everybody. So the ORBIT trial was a multi-center RCT that enrolled about 100 patients with both urgency and frequency. And these patients were randomized one-to-one to PTNS or four milligrams of daily tolteridine. More subjects ultimately reported improvement or cure in that PTNS group than the tolteridine group, which was quite remarkable. The next study that they followed up with was a multi-center double blind RCT. And this was their SHAM study. So they randomized patients to either PTNS therapy, which included 12 weekly sessions of 30 minutes of therapy versus a sham kind of arm, which was more like a tens unit modality. Overall bladder symptoms improved more in the PTNS group than the sham study, than the sham group, with an improvement of 55% of symptoms in the PTNS group versus 21% in the sham group. And lastly, the STEP study is really a study looking at long-term efficacy. So they enrolled 50 participants from that initial summit study and followed them up to 36 months. And the participants noted moderate to marked improvement in their OAB symptoms, even at three years, with a mean voids per day that decreased from 12 to 8.7, nighttime voids decreased from 2.7 to 1.7, and UUI episodes decreased from 3.3 to 0.3. So those were all pretty significant differences. So, in summary, PTNS performed better than an OAB medication, better than sham in the treatment of OAB, and demonstrated sustained improvement in OAB symptoms over three years. So that's really great data. So from a systematic review standpoint, as I had mentioned, there are several systematic reviews and meta-analyses published out there, but this is the most recent one that included 28 studies, which reflected over 2,000 patients. And the bottom line, the authors found significant improvement in a number of OAB symptoms. And they did notice though, that while PTNS is effective, there are numerous barriers to therapy adherence in the real world setting. And clinicians who are taking care of these patients, such as you and me and Dr. Connelly, all know firsthand the challenges of PTNS in terms of patient adherence, due to difficulty coming into the office weekly, or financial burden of coming into the office for weekly appointments, and possible lack of standardization of needle placement and so forth. So while it's an effective treatment, there are barriers, and that's where Vivaldi really can step in. So how does Vivaldi compare to PTNS in terms of some real data? So I'm really excited to present this study to you all. Earlier this year, Vivaldi, that they published the first clinical study on outcomes in urology. So free OAB. This was a multi-center open label, single arm study of subjects with OAB. And it was conducted in two phases. So phase one enrolled subjects who were instructed to wear the device one to three times a week for 30 minutes for a total of 12 weeks. Bladder and quality of life outcome measures were collected at multiple time points, but the primary outcome of interest, the primary endpoint of interest, excuse me, in the phase one was 12 weeks. Patients were then reconsented for enrollment in the phase two study. Subjects completed only two 30 minute sessions per month, and the same bladder, diary, and quality of life measures were evaluated at six and 12 months. So the primary outcome was to evaluate the clinical efficacy, subject compliance, safety, and subject satisfaction of the use of this novel closed loop device. And the primary outcome, as I mentioned, was change in three day bladder, diary symptoms. And secondary outcomes of interest included quality of life measures as well as adverse events. So inclusion criteria were the following. The patients had to be greater than 18 years of age. They had to have at least three months of symptoms of OAB. And they had to have at least, on average, 10 voids a day, at least. They had to either be drug naive or drug stable on enrollment. All right. And this table describes the demographics of the cohort. As you can see, the majority of subjects were female and white. The average age was about 61 years. And you can see here that the baseline voids were 13 per day. UUI episodes were 4.7 per day. And urgency episodes were 6.9 per day. So this represents a pretty burdened population. Phil, I think I actually can control the slide. Sorry, I think we're fighting each other a little bit. Sorry about that. So here are the data for the primary outcome of 12 weeks. As you can see, when comparing baseline to 12 weeks, there is a decrease of approximately three daily urgency episodes, a decrease of approximately three daily frequency episodes, and a decrease of approximately two daily UUI episodes, which is pretty remarkable. So and in terms of quality of life measures, for all the measures, that's symptom severity, coping behaviors, concerns, worry, sleep, social interactions, and total health-related quality of life, all these measures improved significantly. That is, there was a change of greater than the minimally clinically important difference for each measure of 12 weeks, with several domains demonstrating a change of greater than twice the MCID. And so that's really remarkable as well. So onto the phase 2 results. So for the phase 2 trial, 50 subjects were enrolled. And the subjects demonstrated sustained improvement in daily urgency episodes, daily frequency episodes, and daily UUI episodes, even with only twice a month therapy schedule. So this mirrors the step study that I presented earlier, but the sustained treatment effect is noticeable. And I want to highlight, you know, the adverse event rates with this Vivaldi system was remarkably low. So device-related serious adverse events were zero, meaning that this is extremely safe. And there were some device-related less serious adverse events, such as foot pain, cramps, and whatnot. That was still really low, and patients did exceptionally well. So in terms of patient compliance and satisfaction, I'll go back to the last slide. Mean therapy and compliance, mean therapy compliance, excuse me, was 88.5%, and with 98% of subjects reporting that Vivaldi system was moderately or extremely easy to use. And lastly, 87% of subjects said they would be willing to use a system like Vivaldi for treating their OA beam. So the efficacy of therapy, as we discussed before, no matter what the approach, is hugely dependent on the patient's ability to continue with therapy. So these data are really important when we consider that patients report high satisfaction with the Vivaldi system and find it easy to use. Okay, and I just wanted to take a moment to put the clinical response rate of Vivaldi for treatment of OAB in the context of other FDA-approved treatments that Dr. Connelly and Jill had mentioned. So the clinical response rate of Vivaldi for other FDA-approved treatments that Dr. Connelly and Jill had mentioned earlier. And while these data don't represent head-to-head comparisons, these numbers show the global responder rates, which is defined as 30 to 50% improvement for one or more OAB symptom at six months. And you can see that the global responder rates for Vivaldi, even with minimal stimulation, following that initial 12-week period, was comparable to even the best advanced OAB therapies that we have, such as Botox and SNS. So it's right up there with Botox and SNS in terms of efficacy. Okay, great, and now I'm gonna pass it back to Dr. Connelly to talk about the care pathway and how we can integrate this really great technology into our practices. All right, thank you, Emi. So I've had the opportunity of using this therapy for the past five months or so in clinical practice, and I wanna share with you some of my thoughts, what patients have stated, kind of the practicality of using this therapy within the office type of setting. One of the things that's, if you could, to people ask, well, who would you use this on? And the reality is because based on the updated AUA guidelines, really it's for all patients. Remember, this is a non-invasive, non-medication, non-surgical therapy. And so non-invasive therapies are really encouraged before any intervention, even pharmacotherapy. And everything is really about risks versus benefits. And as you've been seeing, the benefits that we're seeing from the evidence and things using transcutaneous tubular neurostimulation therapy actually does have great benefit. So for me, I kind of look at things a little bit differently. Who would I not choose this in? And that's kind of to the right. And really there's very few who are contraindications. One is really a pacemaker. Even though it's far away, it's just because this is a home therapy where patients are using home, unsupervised, pacemakers are contraindicated. Obviously, people who have actually sores within the ankle area above the medial malleolus, that would be not a very good idea to do it. Or if people actually have metal within that area, it's just, it's not been studied, but they just recommend that that's not the case. A couple other things are patients who actually don't have the cognitive skills or ability to really use the device. Remember, there is an app. It has to be on their phone. So they need kind of a smartphone to be able to use it, or they need to have a caregiver that's helping them out. But they've got to actually be able to put it on and remember to do so. And then the only other time would be, is if you're doing a personalization that you cannot get an EMG signal detected. In fact, if that ever occurs, and that's not occurred in my situation yet, but that means that's not a closed loop system. It's merely using like a TENS system. So you're really given a field effect as opposed to really delivering the therapy that you want. So when I discuss this with patients, obviously we're going to talk about behavioral therapies, lifestyle changes, urge suppression, time avoiding, diet modification. But I also bring up this therapy as a home treatment. To date, I've not had anyone say, oh my gosh, I would not do that therapy. People are not really wanting the therapies that we're offering. This is a huge unmet need. And so have an ability of something they can do at home on their own time when they want to do that to give them the freedom to do it is great. So obviously you see here on the left, people that don't want medicines, people that don't want our interventions such as botulinum toxin, using percutaneous tibia nerve or surgical therapies. And it's really for patients who kind of have tried different therapies. One of the things with the new AOA guidelines, it's actually guideline statement 14, is that monotherapy, if patients aren't getting well on monotherapy, you certainly can use multimodal therapy. I've been a big believer in multimodal therapy of overactive bladder, and this really fits in. The earlier you can start someone on this therapy actually provides significant benefit in that regard. So from a patient perspective, these are checking the boxes that patients want. They want something safe. They want it to be effective. They certainly don't want any of our drugs that we're been delivering. They're not really keen on surgery unless they really have to. You know, this is something they could do at home. Fantastic. You can check in with telemedicine. The other thing that they really enjoy is by the fact if you explain to them that it is a closed loop system, that gives a little bit more reassurance that actually they're getting the effect that they want because the safety is built into the system to be able to deliver that. And obviously 30 minutes a day, when they're trying to do it at their time and their convenience, they find the time and schedule that fits in well. And it certainly is pain-free. From the provider standpoint, obviously we want patients to do better. I, in fact, want patients to start on some type of therapy the moment that we see them. So the sooner that we can get them doing some multimodal therapy, the better. And I think the keys is that we've got to be able to treat more patients, improve them faster, so that the people that we do have some of our interventions such as surgeries and other modalities, they're really needed. And we get the real patients we need. The other nice part about here is that you're starting someone on the concept of neuromodulation. You know, neuromodulation is not going away. Over the last 30, 40 years, we've had great advances in that. And so I think that's also improved. The other aspect to it is really what do we do in our practice? At first, I started to, you know, patients, when I talked to them about it, I said, okay, well, let's, let me do the personalization right now. The challenge with that is it's too much for one visit because you're just introducing maybe all of the different modalities to the people. And remember, a patient-shared decision means they have to think about it. So what I do currently is I have a packet of various different treatment options that are available. And once we introduce things, I will let the patient go home and review different things. Certainly, that values one of them. And if they are interested in non-surgical, non-medicine, you know, home therapy, we set up an individual time that they come back in. So we try to get them back in quicker with our APPs or myself. And we set up a 15-minute visit. And in that visit, what we really do is do the personalization, which takes about 10 minutes. But what you're also doing is we're helping them out. So I make sure they download the app, they bring their smartphone in, we run through so they're actually doing the therapy on their smartphone so they feel comfortable in that. They can put the device on very easily. It's just a garment that is self-explanatory. The area goes in place, and then patients can begin using it. They have the beauty of using it both on the right or left foot. It doesn't matter. They have full ability to do that. So it's up to them, which they choose. My personal preference is trying and staying with the same one. My belief is I think if you do things on a daily basis starting out, that's probably gonna be better to do it. If you miss a day, that's okay. And then the next thing that we do is try to follow up with them. So it may take a little bit of time once the prescription goes in. By the time they work it out, and now there's a HCPCS code. And so insurance companies, as Jill will tell you, are starting to really allow that to be able to get coverage for it. And then we normally will follow up with someone, usually within a telephone visit, within a two to three period, just to see if they've been able to get the device, how's it going. And once they start on therapy, usually at four weeks, we'll also have another visit up to the patient at telemedicine visit or in office to monitor where their progress is. So it's becoming a very simplified, easy approach to doing it. And what we found is when we do that, it's simple. In fact, today I was talking to someone on telemedicine visit. She happened to be a physician who is using this therapy. And I was asking her how easy. She says, absolutely, very easy. I found it 30 minutes a day. I found the time to do it. I have no trouble putting it on. The charge that you see with the click stimulator actually holds for about a month when you charge it. So it's a very long charge. And I asked her about her phone and the app, and she found that to be very simple and easy pain-free type of setup. So I think from a usability from a patient side, Jill and the team from Vivaldi are actually doing well on that area. And I think the app is a good app. I've asked the patient today about how she found the app. She's got a few comments, which we can talk later, but it's always in process and development. But I think overall this therapy is fitting the needs of patients, which is wonderful because the efficacy of this therapy we're gonna see over time with the closed loop system will really provide, I think, a better outcome for people. So I'm gonna pass it back to Jill if you wanna make any kind of comments here. Yes. Thank you, Dr. Brettschneider. Thank you, Dr. Cannelli. And again, thank you for all of you for listening. Innovation Medical, I hope you've seen that we've tried to be thoughtful about bringing a product to market. That is simply another option, another arrow in your quiver for patients. We realize that there are a lot of different products out there. We just wanna be among the choices. And if we make sense for you and for your patient, we hope you'll consider Vivaldi. So could you go to the next slide, please? Before we move to questions, just a reminder about the system. Is it not moving? We really wanted to take a common sense approach to OAB. This is a lifestyle condition, we acknowledge it. It's not cancer, it's not heart disease. So by putting the patient first and delivering something that's easy, effective and safe and fits easily into their lifestyle, we feel that we have a good option. And then again, for the providers Dr. Cannelli spoke about, we want it to be easy to calibrate and allow you to monitor remotely. So with that, I do thank you for your time. I thank my fellow panelists and I'm happy to address any questions as I know the other panelists are. Phil, would you like to read some of the questions that have come in? Yes. Thank you, Jill. We have one question. I'm gonna give this to Dr. Brettschneider. Dr. Brettschneider, how well does Vivaldi work in the frail elderly woman, say with dementia and assisted living? Was it not studied in that population? So thank you so much for that question, Janet. It was not specifically studied in this population. I do think it's a great option for say patients that may not be able to say come into the office for PTNS or have any other kind of more invasive therapy. So given that it has that closed loop aspect to it, like Dr. Cannella described and Jill as well, I think that alone would help deliver high quality, you know, neuromodulation for patients with OAB. Granted, often there's other factors that are involved in patients with dementia and it can be a little bit tricky to figure out actually what's going on. But I think if they do have OAB, it could be a really nice first line therapy for them. Where I've seen it kind of happen the most is oftentimes the daughter will bring the mother in and the mother actually has obviously some challenges. They may live a distance away. Medication-wise, we don't have great options. Some of the beta-3s are a little bit expensive for them. They don't really want to have anything invasive. So this really does check the box for them. And if the family lives close by, it's an easier thing that they certainly enjoy doing. It's kind of a no-brainer that they would like to do that. Thank you. Next question is for Jill. Is this available outside of the US? I'm in Canada. Thank you. Hello to Canada. We are not yet available in Canada. We are currently FDA cleared in the United States, but as you can imagine, as a small startup company, we have big visions. We will be with you soon. Thank you. Anything else? Yep. I may have missed this in the beginning. Is the therapy daily for 30 minutes forever? Any therapy holidays? When should patients start to see symptomatic improvement or maximum improvement? I could start and then I'd like the doctors to weigh in. When we were debating what to put in our clinical trials, there isn't a lot of guidance. You have what PTNS typically is, which is 30 minutes once a week. And then you have the 24 seven of sacral nerve. So somewhere in there, we had to make a decision. And because it was a home device, we wanted to be thoughtful about balancing the demands and burden on the patient and still get a good clinical outcome. And so we studied once a week and three times a week in the free OAB. But in our FDA indication, there is no requirement. It's a shared decision between the clinician and the patient. So I'd like Dr. Cannelli or Dr. Bretschneider both to weigh in with your philosophy. One other thing, we are telling people to start at a minimum of three times a week. And then after the first 12 weeks, they can reduce. Dr. Cannelli? My practice, you know, when people are there, I think that people need a jumpstart. And part of the process here is also building a repetition and a routine. And so they're trying to find the time. I think when someone does something just once a week, it's very easy to forget it. And so part of my philosophy is I encourage them to do it on a daily basis to kind of get a quick start. It also gets them attuned to how to use the device, any other issues, they can call us if they have any questions. But that way, once they get their routine, then if they want, they can sort of liberalize that area. And it's nice to know that in the study zone once a week, but to me, I think that's difficult. I had one patient who was just using it once a week. I was called them at the six week mark, said, how's it going? They said, oh, it's going fine. I said, well, how often do you use it? Oh, I just use it once a week. And I said, well, you know, you can use it more. And they were like, oh, I had no idea. I thought just once a week was all we needed. And the point is they would like to do it more because it gives them a time to kind of see that. The other part is, remember the app actually has the ability that they can record while they're doing the app, they can put down how their treatment is. And this actually, the more that kind of they use it, that's a time that they're with the app that they can put a recording in that then allows the providers to go look at that to see how they're doing. Part about the provider website is that as we go on and look at it, you can kind of see how many times they're doing it, for how long are they doing it and what some of their responses are. So it's a good feedback. It's kind of a good team effort. But as I say, my view would be kind of daily if they could. Thank you, Dr. Cannelli. Jill, we have a couple of questions on- I think Dr. Brettschneider was gonna weigh in before we go to that. Oh, I mean, I was just gonna add, I think I agree with Dr. Cannelli, but I do like the flexibility of it. Some patients really like to be able to do it daily and it's reassuring that it's safe to be able to do daily and can potentially impact patient's engagement and investment in their treatment. But the fact that they can use it once a week, that flexibility gives the patients that, I don't know, I think that gives them more options. And then also because there's that built-in app for check-ins and the bladder diary and whatnot, it can engage patients on a regular basis. So I think that there are lots of different aspects about this therapy that can be really beneficial from patients on many different levels. So just wanted to add that to you. I think another key is just as you're seeing in that picture, this is totally portable. If someone's traveling, going out of town, it's basically just the garment and it's that little click controller. That click controller maintains a charge for a long time. And those are the only two items you need. So you don't need to plug it into anything else. You have your phone with you on the app, but you don't, it's a very user-friendly portable device that they can travel with it easy and fit into the lifestyle. Great. Jill, we have a few questions on the cost insurance coverage, billing codes, and the financial side for patients and providers. Sure. So I had a feeling that would come up. Let me talk to you about this two ways. First, let's talk about CPT codes for providers, and then we'll talk about insurance coverage and patient costs. Phil, I did create some slides for this. I think it might be the next slide. Can you go there? Yep. So we were very deliberate and designed the Vivaldi workflow around existing CPT codes. Maybe one more. Thank you. So this is an in-office procedure, and you would obviously be able to bill the normal office, whether it's a new patient or an existing patient. And I'm not a coding expert. By the way, all of these billing estimates that I'm about to show you are for illustration only, but you already know what the office visit codes are. But in addition, while the patient's in the office, you can also bill for a nerve conduction study, which is done on the patient app. That's code 95905. You see the work. You see the RVUs and the National 2024 Average Payment Rate. In an office visit, you would do the left foot and the right foot. And you might be wondering why. Well, we know from physiologic closed loop that patients can have two completely different personalizations in each leg. We also recommend that you repeat the calibration roughly every six months. Two reasons for that. One is we don't believe there's nerve habituation, but there might be. And the other thing we've noticed in some of the early patient calibrations is we set a range. The lower range is EMG and the upper range is patient sensation tolerance. And I think just because patients are feeling it for the first time, there's almost a hesitancy to say, go higher. So some people stop and then they realize after a while they have a very short range and they go back to the physician and say, I want more. And then finally, you've heard a lot of references to the app and remote monitoring. Your cardiology colleagues have made good use of the remote monitoring therapy codes. And those range from 98980 to 81. And you're able to build that every time you look at the patient's information online up to once a month per patient. We don't believe that people are gonna do it every month. I think each of you will come up with your own way of doing that, but it's available to you. You may realize that this is probably generating more CPT code revenue than for example, a drug prescription. And we know that probably 85 to 95% of your practices are drug prescriptions. Again, just for disclosure, I am not a billing expert. This has been reviewed by many, many reimbursement experts and we've gotten confirmation on these codes. The second question I get a lot, and just hang on one second before you go to the next slide Phil is, what are the patient out of pockets and what's the insurance coverage? And there's a lot of different ways to think about it. We designed this product to be less than almost every other OAB product cost on the market both for commercial payers, as well as for patients. And one thing you need to know about a product like this, it's a DME that stands for durable medical equipment. And in order to meet the criteria set forth by CMS for Medicare, it has to be a product that lasts for three years. So a lot of our economic analysis, when I say that we're less is based on three years. So what you need to know is we looked not only at what payers pay, but we looked at what patients spend out of pocket on co-pays, typically 20% for drugs and surgery and PTNS, as well as diapers and nighttime urine collection systems like the Pure Wick. Diapers and Pure Wick are entirely out of pocket. So I'd like to show you an analysis that we did and then I'll talk about insurance coverage. Could you go to the next slide, Phil? So right now we know that depending on whether people are doing management, which are diapers and Pure Wick, treatments which could be drugs, Botox, you know all of them where they pay 20% or a combination, the average out-of-patient cost per month is somewhere on the order of a hundred to a thousand dollars. And that would be in the case, obviously of an SNS. We had a patient speak at Suna last week. He's using Vivaldi. He's continuing to use Remir Betrick and his out-of-pocket cost every month is $280. So we actually, as of yesterday have a new HICS fix code for commercial claims. And that includes Medicare Advantage. It does not include traditional Medicare, more on that in a moment, but right now we are able to process claims and patients would typically pay whatever their co-pay is or DME. I can't speak to every policy but it will generally be about 20%. If a patient either does not want to put in a claim or wants to self-pay, we have a fee of $149 a month. And what we're trying to do again is make this accessible to everybody. Hence our decision to make sure that it is economically less than most of the other treatments out there. We are in the process of signing contracts with some of the major payers and we anticipate having Medicare coverage by the middle of next year. And the reason we do not have Medicare coverage yet is because Medicare requires or does not allow for a system that is downloaded onto a patient's phone. There's some legislation from the 1970s that doesn't know anything about software. So we have not yet come out with a kit that includes a smart device. We are working on that and anticipate coming out with that next year. So again, we're a startup company and unfortunately it sometimes takes a little bit of time to get all the insurance in place but we're trying our best. I hope that answered all of the different economic questions I see coming in here. One more follow-up to that, Jill and we'll pass this off to Dr. Canelli or Dr. Bretschneider. Do patients' insurance require medication failure prior? So the answer is no, right? At this point in time, because there was just a hicks-picks code, insurance hasn't even seen the opportunity to kind of cover it. But so they don't have a policy necessarily. Again, this is a DME product. And so consequently they typically don't set policies in that regard. The other thing to look at is based on the 2024 AUA-OAB guidelines, non-invasive therapies, which this is, is actually prior to any pharmacotherapy or toxin therapy or implantable neuromodulation. So this is really guidelines-based as that all patients should have some offering of non-invasive therapy. Thank you, Dr. Canelli. Phil, Dr. Canelli is right. When we were developing Vivalium before we did our clinical trials, we asked payers how they thought about this. And they said, we want to see you as early in the care pathway as possible. But they also said, we want to see how you perform in drug-naive patients, which is why in our studies, and we have another one that will come out soon, we deliberately study drug-naive, drug-stable and drug-refractory so that we could demonstrate to the payers we could be used anywhere in the care pathway. Furthermore, unlike a lot of surgical implants, our FDA indication does not have any requirements for prior surgery. So again, shared decision-making, it's between you and your patient. It appears that there's a question in the chat that I think would be beneficial for other providers to hear the answer to as well in terms of contradication. Say, I think there's a question about whether edema is a contradication, neuropathy. I think there was, I don't know if we have a slide prepared for that, but I think that Jill or Dr. Cannelli can probably speak to that a little bit more. So in the FDA, our primary contraindication is the presence of a pacemaker, as Dr. Cannelli talked about. And then he also mentioned, we should not use it on patients where you cannot get an EMG. We think that, and it's been a relatively minor percentage of people, but we believe that if somebody had severe neuropathy, that might be a patient where you can't get an EMG. I do get asked that question a lot though about large ankles, either due to swelling or due to adipose tissue. We did a study when we were designing the product and it was published in, oh, I think 2021 or 22 in, I'm gonna butcher this, Neuro Urology and Neurodynamics. And what we, yes, it's a tongue twister. But we studied 40 patients and deliberately had a percentage of them with very large ankles. And what we really wanted to see is can we activate the tibial nerve as evidenced by EMG and have it be pleasant for, well, not painful for the patient, because there's always a concern when you put electricity through the skin when you activate the sensory fibers. And we were in that study able to activate the nerve in more than 85% of people including large ankles. And in fact, it was actually 95% because there were a couple of cases where the off the shelf unit we were using, which was not ours at the time, just wasn't strong enough. So we certainly have had people where we could not get the EMG signal. I would estimate it's in the two to 3% if that range, it's a very small amount. And I hope that answered the question sufficiently. I think that's also one of the good things about this therapy is that physicians actually are the ones that are personalizing it for the patient. And physicians, by having that closed loop system, knowing that you can activate and see that when you're doing it, that the EMG is activated, you're setting the thresholds for that patient. And in my practice, I've not come across anyone yet that we don't get the EMG, but I think that that's a good thing. I think that that's reassuring for the physician that, hey, they're really getting the therapy that they're committed to get as opposed to just trying things. Previously, I've tried a lot of things for rectal bladder. I have patients previously that's been on TENS units, but in all honesty, they don't know exactly what they're getting. There's no reassurance. Patients to do something, spend a half hour at a time on their own, want to be reassured that, is this worth it? Am I actually getting something? So I like the fact that closed system is inherent in this product. Apologies for the coughing. Looks like we have one more question. Why in this study did they only include drug-naive and drug-respondent? What about drug-resistant? Do you think that would affect the results? We did have drug-resistant in there. We had all three categories. I have the breakdown on another presentation somewhere, but it was maybe 40% roughly drug-naive, about 40% drug-stable, and maybe about 20% drug-refractory. So we were very careful to have all those groups. Apologies for the missed information. No, that's okay. That's all the questions. Great. I certainly want to, once again, thank everybody. If you're interested in the product, you can reach out to us at Customer Care. We are a small company. We're trying very hard. And as Dr. Cannelli said, we're very open to feedback. Things like software and product design is something we excel in, and we are very happy to take in feedback and make modifications and learn along with you. And I thank you in advance for giving us that feedback. And thank you to AUGS for hosting us today, and also to my fellow panelists. I hope you all have a great evening. Thank you, everybody. See you at AUGS. Good night. Thank you.

Vivali system

overactive bladder

neuromodulation

surgery-free

EMG-monitored

Evasion Medical

drug-refractory

cost-effective

insurance billing