I really want to thank everybody for joining us this evening. I want to thank Augs for sponsoring the fellows' webinars, which I've been able to participate in for many, many years. So happy to continue doing that. And we're really excited to share tonight's webinar, Transforming Sacral Neuromodulation and Improving Patient and Physician Experience with the Axonic System. So just in time and we've got Dr. Kenton joining us and we're going to go through the presentation tonight, but we have the obligatory disclosures on, you know, indications, contraindications, warnings, and precautions with the Axonic System. Now, the objectives of our talk tonight are to just, you know, go over and understand how sacral neuromodulation works and its place in your practice, learn about the Axonic System and some of the unique advantages and aspects that we have with our product that are provided to the patient. And then most importantly, is this is a, you know, a very academic group. We want to review the most recent long-term clinical study data in sacral neuromodulation, which both Dr. Mahal and Dr. Kenton were part of. And then Dr. Mahal is going to share with us how he's incorporated the Axonic System into his practice. And I'd like to welcome our esteemed faculty. I'm very excited to have both Dr. Kenton and Dr. Mahal here with us. And I'm going to let each of them take a moment just to introduce themselves. Dr. Kenton, thank you for joining us. Sorry about the trouble. No worries, technology in 2021. That's exactly right. Good evening, everyone. I'm really excited to be here with you tonight. For those of you that don't know me, I'm a professor at Northwestern Feinberg School of Medicine and I'm currently a study investigator for Axonics. And I've been lucky enough to participate in a couple of their studies. Great, thanks, Kim. I don't think that you need any introduction to this audience for sure. And Dr. Mahal, you take just a moment to also introduce yourself. Sure, well, again, I want to thank everybody for joining. I know it can be difficult when you're a fellow to have time for this kind of thing. I recently graduated from fellowship a few years ago and joined a practice here in the Midwest. I hope to just add a little bit insight into the impact that adding a new technology can have to a practice. And I would challenge all of you fellows out there to think really critically about when and why you might add a new technology like Axonics to your practice. And hopefully I can share with you some of the insights of how this has worked out for me. Yeah, and I think having both Dr. Kent and Dr. Mahal as our participants tonight and our faculty is really exciting because they are both well-versed in sacronary modulation and both of them have actually participated in the Artisan Trial which was our pivotal trial and now are also participating in our Artistry Registry Study which just launched in November. So very excited to have them involved in that study as well. Before we get started to the sort of the heart of the presentation, I just wanted to review a little bit about the philosophy from Axonics. And one of the questions that I get asked a lot is what went into the decision-making process for me to sort of leave academic medicine which had been my entire career and then actually join industry. And a lot of it revolves around this philosophy that we have at Axonics. And I had spent really my entire career in academic medicine and I got introduced to sacronary modulation pretty early in my career. In fact, Kim, I think you and I met at the time when I was first introduced to sacronary modulation. And so it became a really a focus of my practice and a focus of my clinical research. And I was very passionate about this therapy and had been involved with research in advisory boards with the prior, the, gosh, the legacy device, sorry about that. And again, became really a focus of my practice. And as I got into more leadership roles in medicine and in the university, I started thinking about what was the next step for me in my career. So these two things kind of came together. And when I met the leadership at Axonics, it was very clear to me that they had a lot of thoughtful people in their team. And so I was very fortunate to be able to meet them and it was very clear to me that they had a lot of thoughtful innovation. So one of the things, and it's a core value for us is this thoughtful innovation is that the company, when they came to me, they didn't develop a product. They didn't have a product in hand and say, hey, Karen, what do you think of this? What they did was that they actually went out and listened to the voice of the customer. And they interviewed patients, they interviewed physicians and said, what are your unmet needs? What are your pain points? What would you like to see out of a product? What are the challenges that you're having? And that's what informed the product that we have. And that was very unusual for me as a physician who had worked with other industry partners that they actually listened to the voice of the customer before they actually developed it. Also clarity of purpose. We are just focused on treating patients with pelvic floor dysfunction, treating patients with bowel dysfunction and fecal incontinence. We don't have any other competing priorities. So we have this clarity of purpose where we can continue to innovate in a field where we hadn't seen a lot of innovation. And certainly one of the things that was so important to me from a company standpoint was having a lot of integrity and quality around the product. And what we say kind of at Axonix is that quality is a religion for us. And to actually watch the process from product development, that thoughtful innovation to having the thought process that research is really important to be able to share with our physicians and putting the emphasis behind that. And then bringing a product for FDA approval and then to market was something that was really quite the experience for me. And as I saw this process and I saw that we could impact so many lives with this technology and provide this therapy to so many more patients that really kind of spoke to my heart and kind of was the next step for me. And so I certainly haven't looked back and I get to continue to do the things I love to do which is teach and do research and to work with my colleagues. So it was certainly took a lot of soul searching to do that but it's been a great decision. And I'm really super happy with the fact that we can provide this therapy to so many more patients. So with that, I think we're gonna go into the presentation and I'm gonna ask Dr. Kenton to start us off with just going over our system and maybe introduce the fellows to the axonic system and kind of some of the differences that you've seen in your practice as well. All right, thank you, Dr. Novlitt. So again, first I'm gonna just do a quick overview of sacral neuromodulation. Obviously we're not gonna be able to do it justice in one slide, but we have a short time. And as most of you probably already know sacral neuromodulation has been available in the United States for over 20 years now. In fact, I can remember putting in my first sacral neuromodulation device when I was just a resident. Dr. Tom Benson, who I don't know if you guys probably have never had the opportunity to meet him, you're too young, but you should go Google our PubMed, J. Thomas Benson because he is a pivotal person in our field in so many ways. First with moving the surgical field and randomized surgical trials forward. And then ultimately in neurophysiology and sacral neuromodulation. But anyway, probably Dr. Novlitt was there too. He and Dr. Benson came to Rush when I was a resident with Linda Brubaker and supervised her while she did her first implant. And so that is, I can still remember that day. And we implanted four people that day. And one of them was a 33 year old woman who had multiple sclerosis, who remained in our practice for many years and whose life was absolutely changed with sacral neuromodulation. She's important because she comes up again later in this talk. But as you all know, simplistically, sacral neuromodulation delivers electrical impulses to the sacral nerves, typically S3, in order to restore normal neural communications to and from the brain. Fortunately, there's many high quality published research studies that demonstrate that sacral neuromodulation is highly effective and it's a safe treatment for urgency incontinence, urgency frequency, urinary retention and fecal incontinence. Unfortunately though, there were several challenges that we all dealt with for many years with the sacral neuromodulation device that we were all using and it limited our ability to offer it to all the patients that could have benefited from the therapy. One of the biggest, what I found to be one of the biggest limitations with sacral neuromodulation was that patients weren't allowed to have an MRI. And this 33 year old patient that I told you that we implanted when I was a resident whose life was literally transformed. Her, she had progressive disease and by the time I was a junior faculty and she was in practice, she really needed to have an MRI for her MS. She was willing to go to Canada. She was willing to go to Europe. I mean, she did not want to give up her sacral neuromodulator and unfortunately eventually had to remove it because she wasn't able to have an MRI. Obviously some other limitations with the device were that basically impeded me from offering it as freely as I otherwise would have is the battery of the pulse generator was kind of large. It wasn't infrequent that patients had pain at that site. And the biggest thing was it needed to be replaced every three to five years, depending on what level the patients were using it at. In addition, I mean, this improved a lot over the years but both the programming and the accessories while they improved over the years, they were still clunky for both the patients and the surgeons. So now I'm gonna talk a little bit about some of the different aspects of the Axonix device which we're here for tonight. And I would say that like kind of one of the neatest things to me about the Axonix system was it really came along and it helped disrupt an industry that really hadn't seen a lot of advances in the technology in about 20 years. And I was super excited because it really made some significant innovative changes that I think pushed our field forward again. And they did that by really focusing on things that were good for the patient and good for the clinician or the surgeon. This includes a number of firsts that I'll go into more detail on the next slides but it included a smaller rechargeable stimulator. It had simple intuitive accessories for the patients and the clinicians. I wish I could show you the original box. I mean, the initial box that we had to do programming was literally like the size of a small suitcase. You probably couldn't get it on like European airlines. And obviously the ability for patients to have an MRI which I just think is huge. And one of the exciting things for me, those of you that know me know that I love data and I love research and there's really some high quality prospective long-term data for the Axonix device. So let's start with the neurostimulator itself which has several important improvements. First of all, it's smaller. You can see here it's pictured with a quarter. It's about the size of a quarter. One time Dr. Noblitt said made in comparison to an Andy's chocolate mint and it is exactly the same size as an Andy's mint. It's made out of titanium and they actually incorporated ceramic in which allows for efficient communication and energy transfer so that device won't overheat and cause patient discomfort. It also delivers a constant current stimulation for more consistent delivery over time which here's the big punchline. So it offers 15 years of functional battery life in reducing the need for replacement surgeries. So when we used to have to take a well-placed device the patient back every five years to change the IPG or the pulse generator with the Axonix device with their neurostimulator we only have to change these every 15 years which I actually think is just an amazing thing when you talk to patients about it. It also uses a high quality durable grade lithium battery that has a little degradation over time. Dr. Noblitt had to sort of explain to me what that meant. And so the way I like to think about it, I'm on the, I get a new iPhone every year because it makes me crazy when it loses the battery it loses power and it has to be recharged more frequently. And this does not happen with the Axonix battery. Major bonus, maybe they can teach Apple. So again, I mentioned this earlier but Axonix is the first rechargeable system which contributes to its longer half-life remember 15 years versus about three to five years. At first, when I heard it was rechargeable I had a lot of questions about are the patients gonna be able to do it? We actually use this in some of our older patients as well. And the good news is the recharging is super easy. We even have data that shows that the majority vast majority, like upwards of 90% of patients find it really acceptable and easy to recharge. And it only takes about an hour, once a month the patients actually have to stop and recharge. So this is a picture of the patient remote control which again is just amazing to me. It looks about like your car key fob. It's actually less complicated than my car key fob and it's easy to use. It fits in patient's pockets. It connects with the stimulator with just one click in one hand. I mean, this was something that patients really struggled with in initial when we initially started doing sacral neuromodulation 20 years ago and how to connect with their device. Nicely, it indicates for the patient when it's time to actually recharge so they don't have to keep track and try to figure it out. Like you can see the up and down arrows you can easily increase or decrease the stimulation. And there's even a really simple process for confirming that the patient's ready to undergo MRI, which I can't even tell you makes it so much less rigmarole going back and forth between the patient and the radiology when a patient does need an MRI. So this is now talking a little bit about the MRI functionality and capability. And I'll admit like I didn't know a lot about the differences in MRI specs prior to getting involved and using this new neuromodulator from Axonix. But it turns out that Axonix has the broadest and the most patient-centered full body MRI settings on the market. For those of you that may be less familiar with this like I was, let me spend a couple of minutes defining some terms. The first that you're gonna see up at the top of the slide is SAR, which stands for specific absorption rate. And this limits the amount of exposure that the device can have to a magnetic resonance field. So the key here is higher SAR limits equate with faster and easier scans and better quality images for the images. The next are scan time and wait time. Scan time is obviously how long can the device be subject to an MR field. And the wait time is who knew, but I've never had an MRI, maybe you have. But some MRIs take longer than the amount of time that the device can be exposed to. So then you have to take them out and wait for a period of time before you can actually proceed with finishing the MRI. And as you can see from this slide, the wait time in between scanning sessions with the Axonix device is only five minutes. So what does this mean for your patients? Well, if you have broad SAR conditions, it means that you have more feasible scans and they can result in higher quality images and less times. If you recall from the last slide, the continuous scan time only allows us about 30 minutes. So the device can only be exposed to the scanner for 30 minutes. That means if a patient needs a longer scan, they have to stop and wait. And again, the good news is they only have to wait five minutes. Can you imagine how your radiologist is gonna respond when you say, okay, you can do 30 minutes and now you have to take the patient out of the scanner or leave the patient in the scanner and block the equipment for 60 minutes before they can finish the scan. So now let's get down to the data. For me, this is the fun part. So there've been two prospective trials on the Axonix device. The one I'm gonna talk about tonight is in the effort of, in the interest of time is the Artisan trial, which was the larger of the two. And basically in the Artisan trial, there were 129 patients with urgency incontinence who were recruited from 19 centers across the United States and Europe. To be included in the trial, patients had to have urgency incontinence for at least six months. And they had to have at least four urgency incontinence episodes on a three-day diary. And they had to have at least one episode of urgency incontinence a day. All the patients then underwent a single stage implant. So I think it's important when you read this trial to like mentally, although we can't actually do this, this is really kind of novel and revolutionary that all these patients went straight to full implant. They followed them for two years with, they also reported data at six months in one year, but we're basically gonna focus on the two-year data. So 121 of the 129 original participants completed the two-year follow-up. That's a pretty impressive long-term follow-up rate. And 93% of those met our criteria as being treatment responders. And the way we define treatment response was if patients had more than a 50% reduction in their urge incontinence symptoms. So this next slide, we have time on the X-axis. You can see baseline six months, one year and two years, and the average number of urgency incontinence episodes on their diary on the Y-axis. You can see on average, the patients had almost about five and a half to six urgency incontinence episodes per day at baseline. This decreased to about one by six months and that patients maintained that one throughout through two years. So that's a pretty impressive reduction in urge incontinence episodes. And overall, it turns out to be about an 82% overall reduction. But you can imagine for a patient who's leaking five or six times a day, that's not leaking one, that's a big deal. What it was the magnitude of the reduction at two years? Well, again, in order to be a treatment responder, we said patients had to have a 50% reduction, but actually most of the patients had a much bigger reduction in urgency incontinence than 50%. Of the people that were treatment responders, over 82% of them had a more than a 75% reduction in their urgency incontinence leaps. A number that I think is a super important one when you're talking to patients is, almost 40% or over a third were completely dry at two years. I mean, that's a big deal. None of the overactive bladder medications, Botox, none of the other things that we offer patients has that high of a dry rate. So although the artisan study wasn't designed to look at fecal incontinence, the people planning the study were astute enough to realize that many of our patients have fecal incontinence as well as urgency incontinence. So they threw in some validated measures to assess fecal incontinence. And they use the Cleveland Clinic Florida fecal incontinence score. And basically on this scale, if you have a score of six, greater than or equal to six, it's considered bothersome fecal incontinence. And so you can see again, time is on the X-axis, the score is on the Y-axis. At baseline, there were 42 patients who met the definition of bothersome incontinence using this validated scale. And on average, their scores were 9.3, and that decreased to 3.7 by two years, which was a statistically significant decrease. Similarly, they also assess fecal incontinence just by having patients self-report whether or not they had symptoms of fecal incontinence. And 45 patients actually self-reported fecal incontinence, although only 42 met the Cleveland Clinic scales criteria. And 82% of the patients who self-reported fecal incontinence were satisfied with their bowel control two years after having Nexonix device. This slide shows the adverse events of the population up to two years. And then you can see the adverse event profile was excellent. Uncomfortable change in sensation or with the magnitude of stimulation was the most common adverse event at 7%. And what I would consider the more significant adverse events, such as stimulator site pain or infection, lead fracture, migration, discomfort during charging occurred in less than 1% or 2% of the patients. So really, I mean, this is pretty, as someone who's in a lot of research studies and trials over the year, this is a really impressive safety profile. So what were the patient's long-term satisfaction? We just asked them a simple satisfaction questionnaire. And as you can see, and I almost think that this is probably the most important slide of all, because we can talk a lot about, you know, going from six to one urgency incontinence episode, but really matters, like, are the patients happy? Is it working for them? And 94% of patients said that they were satisfied with the therapy and how it was treating their condition. And 93% would undergo the therapy again if they knew they were going to have the exact same results that they did. So in conclusion, 93% of implanted patients had more than a 50% reduction in their urge incontinence symptoms at two year. Remember, 82% of those actually had more than a 75% reduction. You know, over 90% of patients sustained therapy success over the two year timeframe. So it wasn't like they were getting implanted and we had to explant them or the therapy wasn't working as well. They had clinically significant improvements in their quality of life. Patients had high satisfaction with the therapy and the safety profile is consistent to, if not actually better than other SNM experience reported in the literature. So in conclusion, the Axonic system is highly safe and effective at two years, and I think has really been a life altering thing that I could, procedure that I could offer my patients. And I'm gonna turn it over to Dr. Mahal. Thank you guys for tuning in once again, and thank you, Dr. Kenton, for going through some of that great research that was completed. We can go to the next slide. I'll just kind of introduce myself here. I'm a recent graduate, like I said, finished fellowship just a few years ago from Stanford, and I sought to join a practice here in the Midwest, both with community and also academic ties. Like a lot of fellows getting out, and for those of you who are fellows currently, I didn't really know what to expect when I finished. I was hoping that I would have all these fistulas lined up that would come through the door in these complex cases. But as I got out into practice and I started, realizing what was coming in and what was needed, I found that there was a huge need for urinary urgency and Urge Urinary Incontinence treatment that was not really being met in my community. And I think that's really been proven by the amount of impact that we've had and the amount of patients that we've been able to implant here in the first year of use, about 120 patients in under a year since we've launched. And I found this to be incredibly important for my patients. It's improved my patient satisfaction and definitely improved my overall production as a physician since I started in with this device. So I kind of wanted to take the next couple of slides and just go through some of the thoughts you may have as you're coming out into practice and maybe help fill in some gaps that you may be worried about. So when you finish fellowship, no one's gonna decide for you when to take on a new therapy or when to try a new procedure. And you're gonna be left to your own devices to decide when is the right time. You know, FPMRS is always changing. It's always innovating. And you're gonna need to be on your toes to be able to kind of adapt as those things change. And so here are some of my personal criteria and some of the things I thought about when I started using Exonix. I wanted a product that was highly efficacious and was proven through rigorous clinical trials. And I think we've shown that in the previous slides. I wanted something that was easy for my patients to understand and to use. Something that had a high patient satisfaction rate. And also I wanted something where I had the support I needed as problems or concerns came up. And with the therapy here with sacral neuromodulation, I've never found myself flat-footed or looking for help from representatives either with patient questions or with patients in my office. So I have found it to be fitting on all four of those categories. So once you've decided that you have a therapy that you wanna use, how do you go about getting that into practice? And here are some of the bullet points of things that I may be tripped up on. First of all, getting that great product, but also having your discussions and the way you wanna discuss this with your patient down pretty pat. And I'm happy to discuss this in the question and answer session, but knowing how you're gonna describe something in simple terms, so the patient feels confident and comfortable moving forward with the therapy. Obviously having patient materials. I know you guys hear it at all the conferences and all the talks. Having those handouts, those OEB pathways. So the patients kind of know where your brain is at and why you're moving forward with this therapy. And one of the small mistakes I made was maybe not talking to my own nurses and my own staff about what I was doing. Sometimes patient would call in asking for exonics and my nurses had no idea what was going on. So make sure you've got your support staff around you. I had not done a lot of peripheral nerve evaluations, which is another way to test for the exonic system. And I found that having an OR that was set up smoothly and efficiently really helped with my patient satisfaction with the device and with the trial, making sure that my radiology team was in place, making sure that I had everything in the room that I needed. Simple things, but they made a huge difference to the patient. So once I had all those things in place, I was a little concerned. How do you find that first patient who wants to go forward with the therapy? And honestly, this was much easier than I expected. As I started asking my patients and talking about these problems, whether these patients had come in for their cystoceles or they were there for pain with intercourse, a lot of them had tried OAB meds before. They had tried behavioral therapy before. They had maybe even talked to other doctors about this and had not gotten the response they wanted. And so a lot of those patients had already lined up and said, I'm ready to take on this new challenge. I'm ready to try something that maybe can give me some relief with these symptoms. I did try some social media campaigns as well because I felt it was needed to have people understand that this was a therapy that was being offered. I don't know how impactful that was. I think a lot of this came down to personal connection that I made with the patients that were implanted and how happy they were. They reached out to church groups, family and friends, community leaders. They kind of helped push the information out there for me. And talking to my collaborating physicians. So those internal medicine docs and family medicine docs that refer into our practice, reaching out to them and telling them about this new therapy. You know, a lot of those guys are not able to stay on top of the OAB literature or on top of your gynecology treatments and helping them kind of offload some of those patients from their practice. They were happy to have another option for them. And this kind of just helps kind of simplify how this has changed my practice. Before I was using the Exonix system, I did find myself using sacral neuromodulation less frequency because I was worried about getting people in for these two steps, worried about what their response would be. I found that my patients did struggle quite a bit with a controller and they were constantly kind of going through some analysis paralysis of trying program one, trying program six. And I didn't necessarily find that that was very advantageous for my patients. And I was having good outcomes in my first two years of practice, but maybe not what I was looking for. Once I moved over to the Exonix system, I really found that I was more open to trying this therapy, even on patients who were maybe not as bad as what was listed in the ARSEN trial, not at that six leaks per day, but maybe having two or three leaks per day because I saw such a great improvement with them. The simplified remote control really made a huge difference The simplified remote control really made it simple, up, down, not a whole bunch of programs to flip through, gave my patients confidence when they were using the device. And of course, going from those good patient outcomes to great patient outcomes really helped me to kind of think this is a therapy that I wanna get out to more and more patients. So I think the proof is really in the numbers. In our first year here in the office, we had about 120 total implants and that does not include the ones that came through on the ARSEN trial. It's true that a lot of them were OAB wet, but also a fair number of OAB tri and fecal incontinence patients, which also don't have a lot of good treatment options, certainly favoring the P&E for our trials. And I'll mention this in passing again, if it comes up in questions and answers, happy to answer it. I had not done a lot of P&Es in the fellowship. And I think a lot of people coming from academic institutions maybe do more of the staged lead placements, but a P&E is definitely something that you can pick up and use in your practice using those same criteria I listed above. It's efficacious, it works well, it's easy for the patients to understand. So I do wanna leave a little bit of time for questions. So just in conclusion, I think that this is a great product from a great team here at Exonix. They're really dedicated to sacral neuromodulation. This has been a simple and highly effective design, both for me and the ORTUs, as well as for the patient. The battery remote control and charging system are very simple and easy to use. The MRI compatibility as listed by Dr. Ketton has really helped for some of those patients who need those imaging studies. And this has been clinically proven over several years now. So with that, this just kind of goes back through those same bullet points. I think we can probably turn it over to questions unless Dr. Ketton or Dr. Noblitt has anything else they wanna add before that. No, great. I just wanna thank Dr. Mahal and Dr. Ketton for such great presentations. And if you guys have questions, please put them into the question and answer box and we're happy to spend a little time. We wanted to leave plenty of time at the end for you to be able to tap into the expertise of again, our esteemed panelists here. So we don't have any questions right at the moment. So perhaps Dr. Mahal, I'll give this question to you since you brought up the programs a couple of times. Have you noticed a big difference in having a patient who's been in the ICU and then being in the ICU for a couple of weeks and then being in the ICU for a couple of weeks and then being in the ICU for a couple of weeks? Have you noticed a big difference in having the ability to have just one program or seven or 11 programs? Has that made a difference for you in your practice? Yeah, I feel like this is kind of like the showing up at the car lot and having a few too many options of leather, not leather, sunroof, not a sunroof. At some point, you just want something that is utilitarian and works for you. I find that with Exonix, and I know Dr. Noblet, you can talk a little bit more in detail about this, but the way that the trial allows you to pick the best programs for the patient and start them right there on the best potential option has eliminated a lot of that kind of back and forth, come back to the office, reprogram, try again. I have not seen that clinically. And also, speaking to the efficacy, we list a pretty high success rate with our implants. And that's what I've seen in practice also in my first years. I know I've got some questions coming in also, which I can address here. Someone was asking how I learned how to do P&Es without doing them in fellowship. It's a really good question. First of all, the landmarks and everything don't change. It's still the same procedure in that you're trying to get down and get a good response. But both companies that offer this device offer great training as kind of outpatient courses, or excuse me, out of office kind of courses to help get you there if that's something you want to add to your practice. And I think you can do that safely and effectively. Yeah, I think you hit on one aspect earlier when we were talking about programs, there's a couple of questions here about the number of programs, is that within our clinician programmer, it does use interoperative information from your patients and has a proprietary algorithm built in. I think that you mentioned that gives you the best four programs to start with. And certainly we feel like this, it makes sense, right? You take the patient's information and use that to inform the decision on which program to start with. And this is certainly something that we feel has impacted and something we'll be looking at in the registry study as well. I think that that's huge for patient ease. I mean, I think that's really a game changer in my opinion. Yeah. This is something that comes up quite a bit and I think it's been a challenge and I think a barrier. So I'm glad that this question was asked, but it can be difficult to have a talk track with a patient and to bridge that gap from taking a medication to having an implanted device. And obviously you both have had very successful practices in adopting sacroineuromodulation. And how is it that you talk to your patients and introduce sacroineuromodulation and more explain that to the patients? Yeah, I mean, so for me, honestly, I'm trying to avoid anticholinergics as much as possible in our patients. I mean, I think that the, you know, I was a little skeptical of the initial data that was coming out about the association between dementia and anticholinergic medications. It was sort of like a weak association, but the data keeps mounting. And I think it's actually really compelling. I wouldn't want to take one. So I think that once you explain that to patients, it quickly moves them to like the next line of therapies, which really for me comes down to Botox or sacroineuromodulation. And honestly, having someone who was very, like Dr. Noble, very interested in neurophysiology and did extra training in EMG and did my first sacroineuromodulation during my residency, I used it very sparingly in my practice. And I think it was because there were so many obstacles, you know, getting the, when we started, when Dr. Noble and I started, there weren't like nine programs. There were an infinite number of programs that you can, you know, literally, I mean, like imagine zero, one, like case zero, one, two, three, and any combination thereof. And so between that and that you had to repeat, you think patients couldn't get MRIs and that you had to take them back to the OR every five years, you know, on a good day. I really leaned towards Botox and this has really changed that for me because, you know, I have enough patients now that have been in my practice for, you know, 15 years getting Botox that have to come back every nine months that I'm actually now starting to flip those people back over to Axonix because, I mean, they can be like good to go for 15 years with really high satisfaction. So I think it's really easy to talk to about patients. You can take a pill every day that gives you dementia. You know, you can come in for Botox, which is actually okay. I have nothing against Botox, but, you know, you'll have to come back probably every nine months or so, you know, 5% if we use 100 units are likely to have some prolonged retention requiring catheterization and you're gonna have some uptick in urinary tract infections. Or you can have this treatment that we can put in as a temporary, like as a staged procedure. You don't even have to commit to it. You can wear it for a week if you like it. We can implant it and, you know, through a little tiny incision and you're good to go for hopefully 15 years. That's great. Anyone, do you have any? Yeah, yeah, I know. Do you have any pearls that you'd like to add? I think, are you trying to address the question by? I think it's just, yeah, introducing it in your practice. Cause I think that is a big barrier, you know, and, you know, obviously you guys have been very successful in, you know, getting patients to adopt this therapy because we get this question all the time. How do I talk to my patients? And yeah. See, I mean, you need to use whatever terms can help appropriately counsel the patient on the risks and benefits, but also have them understand it in a very tangible way. And I've always found the analogy of a light bulb and a light switch to be very helpful. When you're using anticholinergics, mirbagiron or Botox, you're really just treating the end organ. You're treating the light bulb. You're trying to help with whatever's wrong there. But if you're trying to affect the wiring or trying to help with something kind of, you know, up the pathway, that's where sacral neuromodulation can be a better therapy and potentially a better long-term therapy. And I think that kind of speaks to patients in a way that kind of makes it within grasp for them. And I was just trying to look through some of these other questions online and try to answer as many as I could, but hopefully that kind of addresses what you're talking about. Yeah. And have you guys had a challenge in going from, you know, offering one device to another in your practice? I think, I mean, you mentioned that you should have told your nurses. Are there, were there any other challenges or things that you had to overcome with your practice? No, I mean, I will say that the, you know, the other, the competitor has good customer service, but Exonix has been amazing. I mean, they've come in, they've trained our nurses, they're always available. So it's actually been kind of seamless for us. Well, I could tell you, I don't know if seamless is the way I would put it for myself. I would say that when you're coming out of fellowship and I tried to address this a little bit in the talk, you're kind of wondering what your practice is going to look like and what are the best therapies for your patient and when is it time to take on a new therapy? And those were kind of the biggest hurdles. They were more internal of making that decision. Like I need to continue to evolve my practice. I need to continue to look for the best thing for my patients. And once I kind of got over that hurdle, you know, the rest of it, I could get with Exonix and with the team that we have here as far as help on a local level, help with getting information out to patients. That part was easy. The harder part was internally making sure that I was making the right decision for my patients. We did have a question in the Q and A about any trouble with insurance coverage. Have either of you had challenges in getting this covered? No. So it's not any worse or better than other third line therapies. I find that I have a drop packet that I have in my office and this contains the AUA guidelines as well as the ACOG guidelines on OAB treatment. And if I can go through and highlight those things and say, look, this patient has tried these other therapies. This is a reasonable next therapy. You shouldn't be declining my patient on a good therapy for her. I have not had too much fight with that, but occasionally it will get bounced back. And I think once I can provide supporting evidence that we've tried other therapies, I have not had an issue. Yeah, it's actually a bigger challenge to get covered actually. Botox, as you said, Kim. Yeah, that's true. Yeah. Yeah, I think then we look at the therapy, it's the same codes, the same diagnoses and all that. So fortunately we had that in place when we got approval. One of the things that I think that you guys also had reservations about that some of our other PIs did when we started Artisan was about this recharging. Cause that was a big difference for patients, right? That they were gonna have to do something on a regular basis. And I know that we've seen high success rates and high satisfaction, even after two years with the therapy, which includes the charging. We have some four-year data in our RELAX. But what if, and it's a clinical trial. So what have you seen now with your commercial implants that have you had the same reproducibility or have you noticed anything different than from the Artisan? Yeah, I mean, honestly, the patients haven't had, I haven't had anybody struggle or kind of complain about the recharging. I think I had many patients had much more difficulty in older models of sacral neuromodulation when they had this ginormous programmer that was like the size of not your Kifa, but your TV remote control that they had to reach around to their buttocks and position just perfectly over the device. And I think that was much harder for them than this. I mean, that's one of the things that I think Exonix has done really well is they've really thought about how to make it easy for the patient. And maybe that's because they did listen to patients and clinicians when they were designing it. And by this point, we knew all some of the limitations of the older device, so no. Yeah, I think, I don't know if the, I don't think we presented the data, but I think we were just under what was presented in the research trials as far as our success rate, even in real world applications in its first year out. So it's pretty spot on. Yeah, yeah, I think it's one of the things that we didn't highlight, I think at the slide deck, that I think would be interesting for the fellows to know is that we did dichotomize the data into those 65 and older, those less than 65, both with satisfaction and charging ability and outcomes. And we didn't see any difference between the two groups. So I think sometimes we think maybe our older patients might not be as tech savvy or might not wanna adopt this. And we just didn't see that in the clinical trial. So we do have a question for both of you. Are you still using InterStim? And if so, why and what instances? I actually, I mean, I haven't, it's still available at my institution, but I haven't implanted anyone with InterStim probably in a year and a half. I feel like I've used it in select patients, but it's been pretty few and far between. And mainly I feel like I can speak now through the numbers that we've just had such good success. It's hard to counsel patients maybe without that bias, but I feel like we've had such good success with the Exonic system. I really haven't wanted to go back and use the InterStim device. I also think some of the limitations that we talked about today make me a little bit more reticent to use it. I mean, their MRI capabilities are actually really different. So, you know, if there's anyone that really may need an MRI down the road, which could be anybody, there are some limitations. There's not really adequate poise between the two devices and their MRI capabilities. I also, data is really important to me. So in full disclosure, I mean, I started using the Exonics device as part of a clinical trial. I usually wait, either I try to be part of the group that's getting the data or I wait till there's data out there. And we now have two year data. And although Medtronic has made some changes and perhaps upgrades, there's no data on that yet. So, you know, as I say, when I talk to them, you know, show me the data. Yeah. Any, I think we're getting, you know, towards the end of the hour. We really want to, again, thank you guys for your expertise, your pearls of wisdom, you know, all the advice that you've shared. And just wondered if there's any last minute advice that you'd like to share with the fellows out there. I guess I would say, if you have interest in new technology, make sure that you not only take our word for it, but research it yourself and make sure you're comfortable with what you're using. And if you have, if we have piqued your interest at all in trying this therapy, you should definitely reach out to us and we'll go from there. And to the, there was someone that asked about, like, if you didn't learn PNEs during your fellowship, you know, like, how do you learn? I mean, I think that the most important thing that you learn during fellowship is how to use critical thinking skills and basically just basic surgical technique and surgical procedures. And I would hope that all of you will be doing very different things in 10 years than we are now. Like, nothing that I learned in my fellowship as far as actually the surgery that we're actually doing is what I do mostly now. I mean, I actually tried to avoid all laparoscopic surgery during residency because I would just tell people, I'm like, oh, there's no role for laparoscopy and reconstructive work. And I knew I wanted to do a urogyne. But if you learn basic surgical skills and basic problem solving, then I think you're gonna be able to adapt and do a lot of different things that you didn't do during your fellowship. Yeah. Yeah, and I just wanna say too, to the fellows again, having been in academics for really my entire career until I made this jump over, one of my goals is to continue developing educational platforms. And this is something that we have dedicated a lot of resources to at Axonics. And we are in the process of putting together a very robust training program that includes online training, virtual simulated training in mock OR in our training center, as well as setting up virtual preceptorships and proctorships. So this is something that we're gonna have a lot of educational resources. We wanna reinvigorate the fellows course again. So hopefully more to come in the future from that, because that's something very near and dear to my heart. So there are a lot of opportunities for ongoing medical education, ongoing training that we can help provide you as well. So, and Dr. Kenton, Dr. Mahal will be part of that process as we go forward. So I think we're just again at the top of the hour. I wanna thank again, Dr. Kenton, Dr. Mahal so much for taking some time with us this evening. I wanna thank Augs for putting this together and continuing to sponsor these kinds of programs to continue the educational process for the fellows. I wanna thank our audience for spending some time with us this evening for your questions. And we look forward to continuing the conversation through 2021 and hopefully maybe somewhat in person as we get later into the year. So thanks very much. Thanks guys. Take care everyone.

webinar

sacral neuromodulation

Axonics System

patient experience

physician experience

long-term clinical study data

Artisan Trial

urgency incontinence

MRI compatibility