Morning, everyone, thank you for joining us for a panel discussion between our Executive Medical Director, Dr. Sumaira Macdonald, and two well-respected vascular surgeons, Dr. Michael Stoner and Dr. Sonya Noor, who are leading practitioners in the treatment of Carotid Artery Disease. I'll turn the line to Dr. Macdonald to introduce our KOLs shortly, but first, I want to acknowledge that we are fortunate to have her here at Silk Road. Many of you have had the chance to hear from Dr. Macdonald in the past, but for those who have not, she was a vascular radiologist and honorary clinical senior lecturer at Newcastle University and the Freeman Hospital in the United Kingdom before joining Silk Road. She is well regarded for her career-long efforts to improve endovascular interventions, dating all the way back to her PhD, where she focused on neuroprotection and flow dynamics during carotid artery stenting. She was an early adopter of the transcarotid approach, offering TCAR to patients as early as 2011. In addition to being the co-editor of the Springer Carotid Stenting: A Practical Guide, she has authored over 70 medical publications on vascular disease. She is the recipient of many academic society honors, serves on the editorial boards of a number of scientific journals, and is highly sought after as a speaker, having given over 300 international lectures. Dr. Macdonald will moderate today's candid conversation. This is intended to be the first in a series of educational events that we will host over the coming year to connect analysts and investors directly to the experts. Our goal is to open the dialogue around the benefits of TCAR, the adoption journey, and the role of shared decision-making, all of which is especially relevant as we acknowledge National Stroke Awareness Month. Following our panel, we'll welcome your clinical questions during a Q&A session. I will now turn it to Dr. Macdonald, I'll be back on as we launch into the Q&A portion of our event. Thank you, Erica, and good morning. I'm here today with Dr. Michael Stoner, who is the Chief of Vascular Surgery at the University of Rochester, and Dr. Sonya Noor, Director of Endovascular and Vascular Services at the Gates Vascular Institute of Kaleida Health. As Erica mentioned, we'll take Q&A from the line in 30 minutes or so, but first, I would like to give both Doctors Noor and Stoner a chance to introduce themselves and share their current areas of clinical focus, and then we will delve deeper into their individual TCAR experiences. Dr. Stoner? Good morning. My name is Michael Stoner. I'm the Chief of Vascular Surgery at the University of Rochester, which is an academic medical center that also has four or between four and six, how you count it, referral hospitals inside its network that refer into it. I am a vascular and endovascular surgeon. I focus on minimal access surgery and perform a great deal of minimal access carotid surgeries, like TCAR and minimal access surgery as well. My open surgical practice is typically on complex reoperative surgery. Thank you, Dr. Stoner. Dr. Noor? Sonya Noor. Like Michael, I am a vascular surgeon in Buffalo, New York. I work in a slightly different setup. Ours is a privately owned hospital that... Can you hear me okay? Yes. Okay. A privately owned hospital where it's, it has an academic presence in that there are residents and fellows, but it's a multi-specialty hospital in that neurosurgery, vascular surgery, cardiology, cardiac surgery, we all work together. Our encatchment area for our hospital, I looked up our numbers in the last two years, has been somewhere around in the city of Buffalo. All of the hospitals, both our hospital system and the Catholic Medical System, is somewhere around 400-500 carotid procedures are being done by vascular surgery, and another 300-400 are being done by neurosurgery, which is a very large group in our area. Of them, it seems like there has been an increase of conversions to the number of TCARs done versus carotid endarterectomy. Definitely in the neurosurgical side of things, transfemoral carotids, because of the studies that they are involved in, has been increased. Carotid, the area of carotid surgery is a passion of mine, mostly because, as Michael said, minimally invasive and, you know, in this era of shared decision-making, where patients know more and more about minimally invasive surgery, certainly, we are talking and discussing and educating our patients and referring doctors more about it, and it seems to be the much more preferred pathway for them. Thank you, Sonya. Let's get started with some specific questions. Mike, how were you introduced to TCAR, and what brought you to implement this procedure into your clinical practice? What is it like to adopt a new therapy? That's a great question. You know, you and I have spoken offline, and I was a skeptic, as skeptical as one can be about TCAR when I found out about it in 2015. I, that was during the ROADSTER 2 trial era, and I started TCAR in a very, very high-risk subset of patients. In fact, a neurosurgeon and I did them together, and essentially, we decided to split every other case and maybe loaded four or five cases up of real... I mean, the colloquial term, kind of train wreck patients, into the system, both physiologic and anatomically high-risk patients. Outside, you know, outside the trial, just as kind of first, the first concept at the institution. I-... I'll tell you, like, the first, I mean, everyone on the call, this is before TEST Drive and all the other things, like the first TCAR, older system, older technology than we have right now. First TCAR was cumbersome, right? It was hard for me to learn. TCAR three, four, or five, somewhere in that, even using the older technology, this is before the dedicated wire, before the better access sheath. About that time, this process clicked, and we suddenly looked at this and say, "Wow, we can do two or three of these," and these are still train wreck patients in a day. What swung my adoption, because if you fast forward, I'm a, you know, heavy 80% TCAR for cerebral vascular revascularization right now. What swung it forward, and we might get into this, I bet, is this rapid, or I guess you'd call it, like a pretty flat learning curve. Like, by case five, I have steps are evident, it's elegant. You know, case one, you know, not so much, to be honest with you, back in that era, but this thing rapidly becomes something that was so reproducible that the technology was very easy to pick up, and more so than endoluminal Triple A, which I lived through that era, as did probably all of us, all the doctors on this call. Like endoluminal Triple A had a much longer learning curve, and I really didn't think it would catch on, you know, either. This is something that became, you know, within two years of being introduced to it, had already took over a third to half the carotid practice at our institution. Yes, thank you. It really is a very acceptable, very short learning curve for anything that we would ever do in the vascular or endovascular realm. Sonya, how many TCAR procedures are you performing on a weekly or perhaps a monthly basis? anywhere between two and four. I think, Mike, you mentioned this previously, that your TCAR program or starting your TCAR program attracted patients with vascular disease in general to your practice. Can you comment on that? I mean, it's a, it's a bit of, you know, everyone's got their own sort of practice environments that are different. When I came to the practice here around that time, I came in 2013 to Rochester, TCAR was one of the foundational elements that we used to reestablish a practice here. There was a bit of a nadir at that time. We were able to use TCAR as one of the 3-pronged, sort of minimal access technologies that we could market in the area to, like, family doctors, which is our principal referral source. That, that essentially, without knowing, without even having to advertise much about the procedure itself, to let them know that there's a minimal access technique for at that time, it was all for high-risk patients to have carotid surgery that could be done safely and reproducibly. It really became one of the pillars of the sort of marketing campaign I had. The other was, like, you know, fenestrated endovascular aneurysm repair, and vein procedures, and ultrasound imaging, to kind of rebuild a practice here, and it's been highly successful in that it just shows that it's a contemporary practice that can take care of high-risk patients with excellent outcomes. Sonia, you told us you were doing two to four TCARs a month. How does that compare with the case mix for other vascular and endovascular procedures that you do? Do you see this evolving with time? We are going to get into referral pathways later on in our discussion. When I started doing TCAR, Ma, I started, you know, my partner had just started doing a few. I guess I got to the party a little bit late. I took the TEST Drive, so I took the course that was offered by Silk Road, which I found very helpful. Then the support that Silk Road offers, which is the reps are trained very well. You know, Sumaira, you review difficult cases, you're accessible to us, to talk to us if there are questions. For me, I completely agree, it's a very short learning curve. You can get consistent, reproducible results, pardon me, from trainees, because we are a training program as well. What I noticed about TCAR is, as I got comfortable, I did more, but I was able to train our residents and fellows to do TCAR as well. As they have gone out to the community, something that interesting has happened, they have joined our community as well. The number of open carotid endarterectomies at the other hospitals have reduced. Overall, if we do somewhere between 400 and 500 carotid procedures a year, and this is the vascular surgery numbers, the percentage of a TCAR is now slowly changing over to, I think, citywide, it's somewhere between 5%-10%. Our practice, like Mike, is 80% or 90%. It's like a wave sweeps through with these trainees. As they get more comfortable with the procedure, they take it with them and empower other physicians, their attendings, them as a new attending in other hospitals, to do TCAR, which is a really interesting phenomenon. We've seen it with, like, Dr. Stoner was talking about in EVARs, but not quite this quick in this conversion from endarts to TCAR. That's just a very interesting phenomenon that's happening. Remember, we compete heavily with the neurosurgeons, who are a very large group. They do a lot of transfemoral carotid stenting because they're part of, you know, every possible study known to mankind, and they do an amazing job with it. Even their TCAR numbers have gone up, and their carotid endart numbers have gone down. It's, you know, it's an interesting place to be. You make a very good point about trainees. There was a recent publication on the involvement of trainees in TCAR, and their involvement did not negatively impact the outcomes at all. I have yet to see a publication like that for any other carotid revascularization modality, and we've all amongst us, trained fellows. Is there anything that limited or accelerated your adoption? Mike? Yeah. Sorry, I was just coughing. I think that the only real, I guess the answer to the question, first part, like, that may have limited adoption for it. I mean, really, for us, it was increasing comfort with anatomies that were getting close to the limit of what you can do with TCAR. We did cherry-pick some cases based on access, et cetera, like that. As you become more comfortable, you become more comfortable with maneuvers to use the technology in adverse anatomies, and that probably happens in our practice around case 20 or so, where you figure out, you know, what you can actually do with the device. It's interesting because around that time is when you realize that there's this great sort of surgical economy to it, I always call it, which is that, you know, if you have a day with four TCARs, now I'm at an academic medical center that's not going to be the most efficient place in the world, four by four, right? And that's what we always say. We have four TCARs, and we're all out of the room by four. So, and that may not sound great, but again, it's an academic medical center. Once you get to that point, you realize that there's this, like, they're all reproducible, doesn't take a lot of time. You want to start extending it to other patients. Like I said, that's around case 20 for me, where you can say, "I can take these anatomies that look a little more challenging," and it really doesn't take any longer in the case either, as you get facile with it, because I know the outcome from it will be so reproducible. The surgical economy, which is time spent in the OR, and patient outcome. Yeah, I love that four by four. I think I might steal that from you. Just sticking with you for a second, Mike, you did share with us about your regional community, so 200-bed hospitals in your region that can expect great outcomes and comparable outcomes for TCAR, as might be expected in a more Ivy League academic institution. Can you tell us a little bit more about that, the generalizability, reproducibility, predictability of outcomes? I mean, real quick, not to get in the weeds about it, but we have rural community hospitals that are, you know, about 45 minutes from here, with full faculty there. The unique part about that is that they're faculty, they're also at the academic medical center. You bring that expertise locally. We've started a TCAR program in a small, smaller town, Canandaigua, great, you know, great lake town south of us, 45-minute drive. I think a program there two or three months ago, and we've done now eight TCARs at that site. What we're able to do is, it scales, it scales in that opposite direction. It doesn't have to scale up the volume in larger hospitals. It comes from larger hospitals and disseminates down to the smaller ones. We've had no complications. We trained an OR team, we brought supplies in, all that sort of thing. It's something that, you know, I would like not to bring commodity cases to an academic medical center. It's a mistake. We're overwhelmed with complex patients. We have an ER that looks like, you know, you wouldn't believe, right? Just filled with people trying to get in. My job is to have surgeons out there in the community doing academic surgery-level care with minimal access technology, with great outcomes, not to bring those patients to the practice up here. That's a TCAR has been a great example of that, where it's more reproducible, to be honest with you, than carotid endarterectomy. We look at cases in this rural hospital that doesn't have great support at night and all that, and we go, "Why not TCAR in every case?" The outcome is so reproducible that we're more worried about the CEA, because the surgeon's going to drive 45 minutes to go back home at night. What if they have a problem? We are not worried about the TCAR. It's very cool. That's an excellent point. Dr. Noor, you did share with us previously a little bit about your experience around your own TCAR program growth. You thought at one point you might have been saturated, but then you did some education of your referring physicians. Can you share that with us? Yeah. You know, often a question, you know... Buffalo is a small town. I've been here a long time. These referring physicians have, you know, we've kind of grown old together, you know, they, one of them, they ask you, like: Why TCAR? Do you trust it? Would you have it done? You know, would you have a family member have it done? I found myself thinking about my why started. Why did I adopt TCAR? I loved carotid endart. We bragged about how quickly we could do it. It was my favorite operation, unquestionably. It was quick, it was extremely satisfying. Why did I flip over? I hardly do, you know, three or four carotid endarts a year nowadays because they're not TCAR candidates. I think it's because a lot of what you're talking about is you get with good endovascular skills. That's a requirement. Most of us have that now. With good endovascular skills, after your initial training curve, you start to believe in this procedure is actually safer and better in your hands, your experience, your why, not just the VQI data or the results, is that you can do a better, safer operation in your patient. You start to believe that very quickly. On top of that, there's the VQI data, which shows across the board, where it's not even the high-volume institutions, but across the board, TCAR has very good results, and it's by far better than the endarterectomy. Nowadays, with shared decision-making, where you're talking to the patients, they're more educated, they're going on the internet, they're going to Dr. Stoner's site, they're coming to our site, they're looking at patient testimonials. To be told you're going to have an incision a third of the size of an endarterectomy, like it's not there, but it's that small. It's a shorter operation, there's a lower stroke rate. You're going to be able to drive sooner, get back to, you know, activity sooner. I had a golfer who wanted to golf in two weeks because he was in a tournament. I mean, you know, these things are important to our patients. They're, you know, they're older, and they look forward to spending as much time as they can doing the things that they love to do. They are opting out of carotid endarterectomy, coming to us for a second opinion to say, "Hey..."... Can we have a TCAR instead? I saw on your website you do this fancy thing, and you do it for carotids. For referral marketing, of course, we do the testimonials and things like that for our consumers directly, for the patients to be able to read it and get educated about it. Also for the referring docs, there's that gap. Once you leave med school, and you don't go to a lot of, you know, vascular conferences or specialty conferences, it's really us regionally, locally, trying to educate our cardiologists, our primary care, our family practice, that this is a new procedure that, you know, vascular surgeons are now starting to do around the country that is extremely safe and can be very beneficial for patients. Once they see that's an aha moment for them. Then our practice actually grew. New referring docs started referring into our practice because we marketed ourselves as minimally invasive across the board, including one of the newest techniques available now, TCAR. I almost doubled my TCAR volume in less than five or six months. Well, that's great. We're going to circle back with you on the shared decision-making piece. But also, you touched on the fact that these community hospitals' outcomes are logged, and we reliably know their outcomes data because of the VQI CAS registry and that requirement for data entry. I want to ask you a little bit more about the evidence first before we delve further into shared decision-making. Mike, do you think we need more evidence to be compelling to physicians to start adopting TCAR, or do you think we have enough volume of real-world evidence in the VQI? That's a great question. You know, I'm on the fence with it, to be honest with you. I would've been. I'm not as much now, but what I've been asked a lot because I'm a TCAR adopter, I present at meetings, and people will always bring up questions about need for randomized trials, right? That's the, that's something that we have prospective data, prospective adjudicated data through the ROADSTER trials on TCAR. We have a huge volume of registry data through VQI. It was done very, very well, very high-quality data. The problem, you know, the retort I have, because early in the process of it, early in my adoption phase, I thought this thing probably needs a randomized trial as well. I don't believe it does now, and that's based on the huge volume of VQI data. You know, personal experience obviously is one thing, but huge volume of VQI data. The other part is, as you look more and more at randomized trials, and it's outside the context of this call, but like the BEST- CLI trial, which just came out, which cost an ungodly amount of money from the NIH to fund, is now being shot to death, right, by all naysayers. The problem with randomized trials, I've been saying this for a very long time at different meetings, is obviously it cherry-picks out cases, and it doesn't represent real-world data, and they're incredibly expensive, and by the time they're done, they're not applicable to the patient population you want to apply them to. I, you know, I would've said randomized trial, like, if you asked me this question in 2016, maybe not, maybe 2015 when I first started, when I was a naysayer, I'd say: "Where's our, you know, ACAS of TCAR that I'm going to believe in?" I think that the VQI, the unbelievable strength of the huge amount of data in VQI is that it agrees, that the data are reproducible, the outcomes are excellent, and they mirror all the other outcomes that are center outcomes, ROADSTER outcomes, et cetera, all asymptotically approach the same exact number. There's not divergent data in that set. Because of that, it's real data. There's an amazing consistency in the periprocedural rates of any complication, and they're very, very stable with time. Sonya, I just want to ask a little bit about why do you think it takes some vascular surgeons a while to increase their TCAR procedure volumes? I think- Some get going pretty quickly. Sorry. Some do not. What are your thoughts about that? I think it's, you know, for a vascular surgeon to adopt anything, they have to believe it's safe and efficacious, which, like you guys talked about in the data, there's only three ways to treat TCAR right now, and even though there's no randomized, controlled, head-to-head study, they are well-established ways of treating TCAR. Your initial, you know, approach to treating Carotid disease is going to be whatever you are most likely to be trained in, what you're comfortable in. For vascular surgeons, it's been carotid endarterectomy. If you have good enough minimally invasive skills, which I believe definitely the new generation, the current generation, and some of the older folks who probably won't be in practice in another five or six years, that generation will phase out. TCAR will become more commonly adopted and done because they will have the minimally invasive skills to do it. That really leaves us with TCAR or transfemoral carotid stenting, which transfemoral carotid stenting and TCAR have may have not had, you know, like a head-to-head randomized controlled study, but there's enough data to support both of them and show really TCAR has better data. It has better safety and efficacy, and on top of that, it's easy to do. Any new vascular surgeon, I think, will now in the next five or six years, I think you're going to see a change. A lot of the baby boomers will retire. People who are doing carotid endarts, who bragged about how quick they were in a carotid endarts, simply did that because they were not good at minimally invasive. I'm being honest. I think that's really what the truth is. Once that generation goes away, Our kids would rather do a TCAR than do a carotid endart, just like they would rather do a minimally invasive procedure than a femoropopliteal bypass or an open aneurysm. It's just, it doesn't float their boat. Like, nobody wants to work that hard. Work smart, not hard, right? That's evolution, isn't it? Yeah. Well, of course, you know, everyone here knows it's sacrilege to bash a randomized trial, and I would consider myself a serial trialist. We also know that, to the point made earlier, that the Achilles heel of the randomized trial is the generalizability, not just to the patient population that deserve carotid revascularization, but to the operators performing the procedure. Let's talk a little bit about your referral channels. Sonia, we've heard about your outreach and educational efforts for referring physicians. Let's just talk about screening of Carotid Artery Disease in your current vascular patients. How important Mike, first, how important is that screening and screening endeavors to your patient funnel? I think that's something that even vascular surgeons have some heterogeneity in their screening practice. Societal guidelines recommend carotid screening on patients with PAD undergoing invasive procedures, right. Especially if you're having aneurysm surgery, et cetera, recommend carotid screening on it. I think that the point would be, you know, the naysayers on screening are going to argue that if you overscreen, you're going to overtreat a population. You're going to spend a lot of money on screening, and you're going to do too many procedures. You end up having, you know, unskilled operators doing things they shouldn't be doing. I think that screening has to be done correctly, right. If you look at the PAD and the CAD population, coronary and peripheral arterial disease population, the incidence of carotid disease is actually relatively high. Of it, of carotid disease, it's significant enough that you would follow, like a 50% stenosis that you would follow, get in the system, start best medical therapy, et cetera. That it's something that should be employed more often. The problem becomes, the screening problem I run into, and it'd be interesting to hear, even Sonya, what you think you see in the practice in Buffalo, because it's different even a couple of hours away from each other, is that the general docs out there that send them in, like the family docs, don't often connect the dots between things like coronary disease and peripheral vascular disease. Getting them on, like, a high-dose statin, checking the carotids, you know, if they're diabetic, someone checking their feet, ABIs, all that kind of thing. I think that there's a little bit of an opportunity there that's a challenge that's outside the vascular space. It's getting down to the family doctor in the rural area that's underserved and at-risk population of patients in discovering who has carotid disease. I think when you make it up to the vascular surgeons, we do a pretty good job. It could be more homogeneous with screening. It's that first step coming up that's a challenge, I think, right now. Sonya, do you think that the current trends in screening and diagnosis effectively capture the true prevalence of patients with Carotid Artery Disease, specifically those that may warrant revascularization? No. I think it's a very underdiagnosed disease, you know, the thing that you have to factor in is once these patients... We're collaborating and partnering with our hospital system because there's not enough vascular surgeons to go to all of these remote sites and even spend one day a month or one day a week, whatever, you know, whatever they think their needs are. We're trying to develop a partnership with the cardiology clinics to put in a decent vascular lab there. Inherently, the screening is only as good as the person who's screening you. What we're trying to do is develop these outreach places where they can have a carotid Doppler. One of the vascular surgery people can read it remotely, so we don't have to be there, and then when the patient comes to see you, appropriately treat them. If they're not a high enough stenosis, put them on the medical management. When it gets to the point where it's high enough, then treatment. It's not overtreated, yet they're getting their appropriate diagnosis in a timely fashion. The issue becomes this: the patients find out they have a 70% stenosis, 75% stenosis. Now, they're nervous. I think as this screening picks up across the board, we're definitely going to see many, many, many more carotid disease appropriate treatment to be done that is not being done right now. That's a really good point. It ties in very nicely with what I want to ask you next, Sonia, which is: What is your current threshold for treatment? Okay, somebody out in the community has had a carotid duplex. It's a certain percent stenosis. It's maybe asymptomatic. What is your algorithm, relative to symptom status, relative to degree of stenosis? Symptomatic patients, it's easy. If you're symptomatic and you have a carotid lesion, I think even with a 50% stenosis, people will argue you've had blindness for so many seconds, or you've had a face, you know, TIA, your face is dropped, your arm is weak. I don't think you can ignore that. They have an underlying lesion. I think you need to treat it. That's easy. The asymptomatic ones, I do like to go on a higher threshold to treat because I think our medical management has improved significantly, so I do like to hold it to the 80% bar. I'd like to see 80% or higher for an asymptomatic. I will tell you, I've had younger patients in their 60, 65 range who are at maybe 75%, 77% by CT scan, carotid stenosis, and I have treated them with TCAR. I probably wouldn't do endart on them because of the invasive nature of the procedure, and they probably wouldn't sign up for it either. They'd be, you know, wait till it gets to that point. Because it's a less invasive, easily recoverable from procedure, and they're anxious, nobody wants to walk around within their mind what could be a ticking a time bomb. That's one area that if they're younger, and they're very anxious about it, I will treat it sooner. Maybe at 75%. Right. Let's just talk a little bit about the label expansion for the ENROUTE Stent to cover patients who are considered to be at standard surgical risk for carotid endarterectomy. Mike, how frequently do you offer standard risk patients TCAR as opposed to high surgical risk patients? I know you have, you know, a sort of tertiary referral carotid practice, but we'll also ask Sonya the same question. What's the kind of breakdown of standard surgical versus high risk patients that you see and offer TCAR to? ... I'd say the standard risk cohort of patients that we see, and again, like, the patients that come to see me at the academic medical center are different than the ones we see at the rural hospital, et cetera. I would say that the breakdown offer there and what ends up coming out to TCAR is at least half of those standard-risk patients now with the label expansion. The, you know, the reasons not to offer it become back to most of those are anatomic selection. There's some, there's some, you know, a little bit patient-driven from time to time, which is some misconceptions about stents and patency rates and, you know, the success rates long time. Most of it becomes anatomy-driven. What we'll do in standard-risk patients, we're much less likely to go through the hoops to make an adverse anatomy work for a TCAR that we would do for a higher-risk patient. We're pretty much following the IFU exactly as written for the ENROUTE system when we have a standard-risk patient. We're not going to, you know, do some tricks to make it work, essentially, if that makes sense. Right. Obviously, the durability of a stent in the carotid bifurcation is a given, right, compared to a stent anywhere else in the anatomy. Yeah, I think that's a good point. This is what I meant by that, because a lot of people will say, like, sometimes people won't want a stent because they'll say, "Oh, my neighbor got a coronary stent, and then they got to redo it, you know, a year later," or whatever. I think that's a great point because when you educate someone on it, and you look at the data, the durability of carotid endarterectomy and carotid stenting are mirror image durabilities. In fact, there's some data, even some subsets, carotid stenting is better. They have mirror image durability, so there's a misconception around it, which you can educate patients on as well as part of the shared decision-making process. Because you're effectively putting a short stent into a low-resistance, high-flow circuit, right? Mm-hmm. Sonya, can I ask you a little bit more about your case mix of high surgical risk patients and standard risk patients being offered TCAR, and how do you expect the balance, of that mix to evolve in the future? You know, to answer this question a little differently, if I have a patient who could have both, the standard risk, they qualify for having a TCAR versus an endart, almost always they're going to choose TCAR. They're not going to want an endart. For the standard risk, it's really hard now for me to justify, even in a younger patient where we go over durability data, that, you know, endart's been around for 50, 60 years. It's a very safe procedure. It doesn't work in the lifestyle. People are now more educated. They want the better option if it's the as safe as, and when you say it's safer, I mean, they're not going to opt in for the endart. Really, by default, the only endarts I do now that cannot be done safely with TCAR, whether it's a runway issue or a calcium issue or something like that. The high risk, for me, it's a no-brainer. High risk, I'm not going to put them through an endart unless I cannot do a TCAR, which really now rarely is the case. Almost all of these can be handled with TCAR. The standard risk, the patients will prefer it, so it's not even, you know, my decision. I'm giving them the information for both procedures, but they will actually choose to do a TCAR over an endart. Well, let's just pull on that thread a little bit because we have alluded to shared decision-making and patient preference. Mike, I know this is a subject close to your heart. You have published on shared decision-making. Have you had patients who have had an endarterectomy on one side and a TCAR on the other, and they've had their own personal preferences and experienced different differences in just the procedure itself, the recovery itself? Yeah, I think I'm sure Sonya's had the same, where we've had patients who've had endarterectomies in the past, we get a TCAR, and there's a dramatic recovery distance. We've actually published some on the narcotic use after TCAR versus CEA, et cetera, the analog pain scale, all that sort of stuff, and shown that TCAR is a much better tolerated procedure. It's much more likely to result in a discharge on postoperative day number one than the CEA is. It's a lower resource utilization operation as well in that regard. The bottom line, when I say this example all the time, is that there's. You know, I've been doing surgery, I've been training for just shy of 20 years, and in that 20 years, there's no example of a minimal access technology that doesn't eventually replace the open surgical version for a good 80% of patients, right? We watched laparoscopic cholecystectomy replace open cholecystectomy during my training. There's a patient preference that will drive this selection process over time, and that shared decision-making process. The last point I'll make is there's not a single patient I have in the office who goes out for that CT scan to figure out how you're going to treat them, what the modality could be, transfemoral stent, endarterectomy, TCAR, who doesn't come back in the office when I say. It's still a shared decision. We're going to talk about all those options. As soon as I say, "Yes, your anatomy supports a TCAR," they all go, "Oh, thank God!" Yeah. You know, I say, "Well, let me tell you about the other two first, and then we'll come back to TCAR," you know, to do my job. Patients want it because they realize we talk about the outcomes, and it's an intuitive procedure, and when they go off for that CT scan to delineate their anatomy, they come back wanting a TCAR. Sonia, do you have a similar experience there, around shared decision-making? You know, how you implement shared decision-making in your clinical practice in clinic when you see a patient with carotid disease that warrants revascularization? You know, I have a couple of funny stories because I have a, there's a group of, they play poker together, they play cards, and three of them needed carotid surgery, right? The 1st one comes in, it's like a joke. Walks into a bar... No, no, kidding. Walks into his clinic, right, gets their study. This guy needs a carotid. He gets a carotid done. He goes and brags about his incision and his surgeon, and, you know, blah, blah. The next guy comes along. By then, TCAR has started. I offered him a TCAR. The 1st one comes back for a follow-up appointment. He's mad at me. He's pissed. He's like: "Well, why did you do that to me? How come he got the small scar and I got the big scar?" It's interesting, but, you know, word spreads. We're a referral basis, right? The patients refer one another. I've had a patient who's had a carotid endart on one side. We were on the cusp. He was actually a high... He didn't make the standard risk category, so we had to wait on him. We had done the one side before as an endart. We did a little bit. Once it was standard risk, we did the TCAR on the other side, and he's one of our testimonials on our website. He absolutely couldn't believe what a difference it made and how much better he felt, and less pain he had, swelling. I mean, as surgeons, I feel like sometimes we separate ourselves from it so much you kind of forget what the patient goes through for an endart. Right. Even though it's short-lived, it's only about, let's say, a month or six weeks of, you know, of swelling, but it's shaving. It's, you know, for men, it's that, it's that cut, it's the, you know, the pain, the drainage. You know, it doesn't get infected often, but it's not, it's not a fun experience, and then you can't drive, you can't turn your neck, you can't pick up weights, you can't, you know, go. You know, even if you do some grocery shopping or helping around the house, you can't do any of those things, and that matters. I mean, I think it's important to ask what you would want for yourself, right? I would certainly want to get back to my baseline sooner rather than later, within days, not within weeks or a month. Let's just talk a little bit more about the ongoing debate around optimized medical therapy or best medical therapy, however you want to phrase it, and other modalities of carotid revascularization. We clearly have an NIH-sponsored, ongoing randomized trial that's focusing on the role of optimized medical therapy in asymptomatic patients. Mike, do you have any concerns about the CREST-2 randomized trial construct? Well, I think that if you look at the surface of CREST-2, I don't know on the call how many people are abreast of this, but CREST-2 is an NIH-sponsored trial that will randomize medical treatment versus anatomical treatment, be it surgical or stent, for asymptomatic carotid disease. The one big issue I have with it, I think this has been echoed by others in editorial articles, is that the selection criteria of the patients they're inputting into the study are pretty low-grade asymptomatic patients. They're going to load into the study a lot of patients who will not have an adverse event in either one of the arms, just from their disease process itself. What happens is if you start loading a trial in with a bunch of people who really... I mean, I'm going to tell you honestly, a lot of the people who are being loaded into CREST-2 probably don't need surgery, to be honest with you. They wouldn't get surgery in my practice or Dr. Noor's practice, because early on, I agree 100% with her selection criteria, which is about an 80% stenosis. If you load in a bunch of, like, high 60%, low 70% stenoses into this trial, those people, probably they wouldn't have been touched in our practice, but now they're going to be randomized off to surgery or best medical therapy. In that surgical arm with stenting as well, they're going to have some adverse events from those procedures by the very definition of those procedures. The problem is that if you load in a bunch of people who are unlikely to benefit from the invasive therapy, you're going to skew the outcome towards the non-invasive therapy, the medical therapy. I have a huge amount of problem with it. In fact, we are a CREST-2 surgical site, CEA versus medical management. We actually decided not to participate after going through all the NIH paperwork and all that because of the selection criteria. I actually had to call back and say, "Is this really the selection criteria?" I had to double-check the imaging criteria. We were worried about essentially going down a pathway of offering surgery to patients we wouldn't offer surgery to in the past. I have a lot of reservations about the trial. We'll see the data as they come out, though. All right. I think there's probably a major problem with equipoise or lack of equipoise amongst the participants of the trial. If they have a patient that has a rapidly progressing or, you know, certain characteristics of asymptomatic stenosis, they're not going to randomize them where there's a chance of best medical therapy. They're going to take them out of that possibility and offer them the intervention, right? Those that are needing an intervention are getting the intervention, outside of the trial. Yeah. I know that both of you submitted comments in the last public comment period around the reopening reconsideration of NCD 20.7. Dr. Stoner, a public comment on behalf of your group, and Dr. Noor, you were a co-signatory on a coalition letter. First, Sonya, is TCAR here to stay? Yes. Very categorical. I like it. Mike, would you say anything different to that? I'm going to say yes. I guess as it corresponds to national coverage decision, expansion, possibilities, and things like that, yeah, I think that's I think that's kind of where you're at, you're asking me inside that context. Our group, and I wrote a letter on behalf of all the vascular surgeons in Rochester. They all co-signed the letter with me to CMS about it, which is that we felt like unfettered expansion of transfemoral stenting through coverage, you know, of allowing Medicare beneficiaries to undergo transfemoral stenting would actually be harmful to Medicare beneficiaries because of the VQI data. All the other data we talked about demonstrates European data, et cetera, that transfemoral stenting, when scaled, doesn't scale.... At centers of excellence by someone like Dr. Macdonald, by a certain select high-volume neurosurgeons, it scales well. As soon as you scale, it doesn't scale like TCAR. You go out in the wild with transfemoral stenting, you get bad outcomes. That's what VQI shows. It's all these large scale SPACE, EVA3S, all these things show. As soon as you start to get it out of the people who really get it, and you put it out in the wild, you have bad outcomes. We're actually worried that that would happen to CMS beneficiaries if there was widespread expansion of it. I would only even lukewarm support such expansion if it included strict registry tracking of those outcomes, because I think it's actually going to be harmful. I don't think it has any impact on TCAR at all. In fact, the increased awareness of CRAD disease actually only elevates TCAR's gain, to be honest with you. Right. I think we have some very compelling evidence that for 10, 15, 20 years, that transfemoral stenting, being a transfemoral stenter by background, it incurs excess risks in elderly patients, in female patients, in symptomatic patients. How can that be a cogent strategy for, you know, Medicare and its beneficiaries? Sonya, would you have any other comments about the NCD 20.7 and really the role of transfemoral stenting? Do you believe that there would be an increasing role for transfemoral stenting going forward? I think we have to acknowledge that transfemoral stenting is a procedure that is done in this country. If it goes through, where transfemoral stenting is reimbursed, right? Let's just address that. If it becomes reimbursed, is it going to be adopted as quickly, and is it going to spread like wildfire, and people are going to do it? Who does these procedures? Right now, more vascular surgeons do carotid work than anyone else. I think of the vascular surgeon population that do it currently, I think we're going to see changeover like we have in every other realm of vascular surgery, to a more minimally invasive technique, which means TCAR will predominantly be their go-to procedure because of training, because of how they feel about it, safety, efficacy, et cetera. That leaves us with the transfemoral. Are there a handful of vascular surgeons who will do transfemoral? Maybe. Who else is going to do transfemoral? Neurosurgery, interventional radiology, perhaps some cardiology, because they don't do the cutdown portion of the TCAR. I don't think CMS is just going to let this pass. I think this will pass with guardrails, pretty strict guardrails, and almost all hospitals now look at their outcomes, and they are evaluated based on their outcomes. There may be an initial rise. I would predict there's an initial rise of a lot of maybe transfemoral stenting happening, but prior to that, there'll be increased screening happening. That will then maybe generate more transfemoral stenting, but I don't think that will continue to increase because of what we talked about. It has been shown time after time after time, it is not as safe as the other two accepted procedures. It'll have a very short runway. If anything, if we've learned from our structural heart programs, where the cardiac surgeons were so worried about losing valve replacement, they actually do more valve replacement now, and there's more TAVR being done than ever before. I think the market actually will grow. There will be more screening done. I think more patients will get treated, maybe initially transfemoral. Now, transfemoral will also improve. I think there are newer devices out there, ASPIRE, Contigo, I mean, to name a few. Maybe there's going to be drug-coated stuff. You can't stop that evolution. That will continue. The premise on which they're doing it, the complication rate, I don't see that changing anytime soon because it's arch-related problems, and these are inherent to the type of process that they're using to stent in the carotid transfemoral. Transradial, could that pick up? I mean, that's all conjecture, but I don't think we need to worry about that. There may be an initial uprise, but I don't think that that's going to play out to be long term. Yes, it's interesting that you bring that into the discussion because VQI data from Schermerhorn shows quite clearly, actually, transradial or transbrachial and upper extremity approach for carotid stenting is worse than transfemoral. If you look at the periprocedural stroke death MI risks at 30 days, and also the surrogate markers of new white lesions on the brain, it's actually worse than transfemoral. I guess I'm hearing you both say that this is probably positive for TCAR or likely to be positive for TCAR in terms of volume, or am I just putting words into your mouth? No, I agree with that, Steve. Yep. Go ahead, Michael. Oh, yeah. I thought, that's it. Just saying I agree. I think it drives-- quite aware this drives volume up. We have a better mousetrap through TCAR, to be honest with you, it drives that volume up. Well, great. Thank you. Unless you have any questions, for me, Mike and Sonya, we will open the line to the analyst questions. Any questions from you two first? Comments? I'm good. Thank you. Nope. Okay, operator? We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question will come from Rohin Patel with JPM organ. You may now go ahead. Hi, thanks so much for taking the question and for the brief comments. I guess I just had one with a few points. Can you just talk a little bit more and elaborate more on PAS specifically and how that fits into the treatment paradigm? Maybe more on kind of how it differs from TCAR from a safety standpoint, given there is talk and perception among patients that it might seem a bit safer, given you don't have to cut open the carotid artery, obviously. And then as a follow-up to that, wouldn't it ultimately be better for patient access if kind of this was open to interventional cardiologists as well as vascular surgeons? Kind of what would you say to the doctors who do hundreds of these cases and maybe see, like, four strokes essentially out of 100, and then, like, which to them isn't that significant, even if TCAR, maybe all else being equal, results in about one to two? Sorry, that was a lot of questions. Appreciate it. Okay, Dr. Patel. I mean, it matters to the patient, right? Whether or not it matters so much to the operator. Dr. Stoner, do you want to take the question on the differences in the safety profile of transfemoral stenting? You've done a heck of a lot of those, as have I, versus TCAR. That was the first part of the first question. The second part of that first question was, you know, we're still doing a cut-down. How is that tolerated? Right. I guess, you know, the cut-down for the CE, the TCAR, rather, is great, well-tolerated. We do them under local anesthetic. I know that's not the national practice per se, but it certainly could be. We do all those under a local anesthetic, so we've turned that into a very minimal access procedure. I mean, the question you ask is a really interesting one about how well, kind of like the tolerance of the procedure and the safety and the stroke rate. You say, well, if it's a percentage point difference out of 100 people, if I'm reading correctly into that question, you can correct me if I'm wrong. You know, if you're talking a prophylactic procedure, though, which both symptomatic and asymptomatic carotid revascularization is, because you're trying to prevent a future neurological event if there was one before or not. That one stroke results in a dramatic difference in the Number Needed to Treat of patients who have to have a perfect outcome for me as a surgeon or an operator in any way to say, over my career, I've leveled that down, and I have prevented strokes in the population of the thousands of patients I've seen, referred to me for carotid disease, right? That one event makes a huge difference in that Number Needed to Treat, right? Right now, our Number Needed to Treat for asymptomatic carotid disease, we use, like, endarterectomy as a reference. It's around 49 patients. It's actually lower if you sub in the TCAR number, because it's so much, it's safer, you know. If you're going to do transfemoral stenting, that Number Needed to Treat where it's perfect probably, you know, becomes 60, 70, something like that. It becomes a lot higher number, so the bar goes up as you have event rates happen. I think that's really important, that the one extra stroke you have every few years is a big deal if you're practicing real-life, evidence-based, population-based medicine, which is the job of a doctor, you know? Dr. Patel, you also asked about interventionist access to TCAR. Well, case in point, I'm an interventionist, and I did TCAR, but one of our national PIs of ROADSTER 3 works very, very closely with her interventional cardiologist. They form a so-called duet, and there are a number of those operating throughout the United States. Soni, would you like to add anything to answer Dr. Patel's questions? I think it becomes It's how to operationalize having two specialists work together for a case consistently. What do I mean by that? The TCAR procedure requires a cut-down in the neck, which traditionally some kind of a surgical specialty will do. Vascular surgeons do both, so we do the cut-down portion as well as the stent placement portion. Other cardiologists or interventional radiologists will work with a cardiac surgeon or with a general surgeon. Once they get the cut-down and they put the, you know, the access in, shall we call it, then the stent and the wire, the ballooning, et cetera, is done by the interventionalist, which would be the interventional cardiologist, interventional radiologist. To get two specialists to work together consistently where you want to do, you know, two a month or something, it's not an easy scheduling procedural thing. They have their own schedule, they work on a different site. These guys have their own schedule, they work on a different site. It's hard to do. You could do it in a, like, a retired situation where the general surgeon's close to retirement or retiring, and they're helping, you know, interventional cardiology, interventional radiology, or cardiac surgeons are doing something like that. That's not going to be a high-program, high-volume kind of center. Right. There's plenty of scope in terms of access to a surgeon with the requisite skills to do a cut-down, but the scheduling may be complicated. Hopefully, we answered your questions, Dr. Patel. Yeah. Thank you. That was very helpful. You know what, I was going to dovetail on something real quick because it's interesting, because we just wrote a paper on this for CEA, actually, is that. I just thought about this as we were talking. You know, that you asked a question a little bit about access to care, I think, which I think is a fascinating question, because if you make things stringent, you actually can become restrictive to access of care, right? I'm trying to run a system in a rural part of New York as well. The cool thing about TCAR is that that learning curve is so shallow, it's so quick to get up to speed, you don't need to refer a TCAR case to someone who did 100. My outcomes at case eight are the same as they are at case 300. I can guarantee it. The data shows that as well. The learning curve data shows as well. TCAR does scale to these little nothing hospitals. You could have a cardiologist and a general surgeon, and by case five, their outcomes, they're done, they're up to speed, their case economy is the same as mine. I think it's a, it's such an easy, intuitive procedure to learn. Right. It's very difficult to say the same about transfemoral stenting. Mm-hmm. Even endarterectomy, for that matter. Do we have more questions? Our next question will come from Adam Maeder with Piper Sandler. You may now go ahead. Great. I hope you guys can hear me okay. Thank you for to Silk Road for putting this event on. Thank you to the clinicians for their insights. You know, I guess the first question is actually more on just kind of the broader market. I was hoping you could just clearly, a lot of volume has shifted in your practices to TCAR over the years. Would also just love to kind of better understand just your carotid volumes kind of more holistically. You know, have those been stable? Have they been growing? How do you think about carotid interventions kind of going forward in coming years? Do you expect growth? Maybe just talk about kind of some of the key variables that could, you know, impact the market kind of on a go-forward basis, and then I have a follow-up. Thank you. Sonya, do you want to start to answer Adam's question? Yes. With the pandemic, here's what I learned. We have to find a way to reach patients and reach referring docs. Interestingly, we have started. Because of all of those relationships we made, we have an outpatient center that remained open even though the hospital was closed, and New York had a lot of mandates. If you're from New York, you know what I'm talking about. We were forced to get creative on how to see patients, treat patients, keep in touch with our patients, video visits, referring docs, et cetera. What I learned is, you really don't have to be there in person. There's a lot of things you can do to improve your presence in a rural area or an area that you don't often visit, and some of that is just being available to them to ask, you know, the other ERs ask questions or general community clinics have questions, and basically being able to screen. Because of all of those efforts, I think our carotid volume has actually doubled in the last since we've been tracking it post-COVID. We came out of COVID, I'm going to tell you, probably this after the 1st quarter of 22. If I look at the last six months of our carotid volume versus the six months in 22 before that, it's actually double now. Those cases are out there. We just never found them. We just never did screen, we didn't communicate, we didn't effectively look for. This blew my mind. I had no idea that there was this untreated volume that we weren't even touching. The other thing we started doing is working with high volume, and we're essentially a private practice, we're not part of the university. High volume, other private practice places, and we're collaborating with them for the screening part of it. They have uncovered almost another 20% revenue for them comes from screening carotids because they're inherently a cardiology practice. It's really incredible what else is out there that we've never looked for. Mike, can you answer this question from Adam as well? I mean, you've already spoken about Number Needed to Treat and the fact that the periprocedural risks for TCAR are so low that it may be appropriate to offer TCAR, where you would not have offered a carotid revascularization in the past. Yeah, I mean, I think that actually, the interesting part about that, as far as it gets to the asymptomatic disease, right? It gets to that. Right. If I have an incredibly reproducible sub 1% stroke death rate procedure, I can offer that to an asymptomatic patient, knowing I'm following the data and the evidence base that I'm actually preventing stroke in these patients, right? I think that's. That, and CEA is the same if you're very high volume. That's where CEA doesn't scale to rural small hospitals because the surgeon who does five CEAs a year can't offer a 1% stroke death rate for CEA like TCAR can. I think that's part of, like, I think there's a growth opportunity or basically a market share increase opportunity for TCAR around that asymptomatic disease. especially as, you know, and then, as CREST-2 is coming out, you know, because some people would say, "I'm worried that CREST-2 is going to come out and get rid of surgical treatment of asymptomatic disease." I already told you why that's not true. The really interesting thing about it, to play off, like, you talk about the market growth opportunity of it. it. The pandemic switched us over. It's what made me become an all about TCAR guy, right? Is because hospitals were shut down. This place had half as many patients in it, were ready for the COVID surge. I needed a reproducible, I can guarantee the CMO of the hospital, this patient is going home tomorrow, procedure, and that's what TCAR provided. We kept doing carotid surgery during the pandemic, 100% just kept doing it because a stroke is a terrible thing. We switched over a lot of us to almost all TCAR because you knew that patient was going home the next day. Now, if you couple that, come out of the pandemic, we don't switch back, we keep TCAR going, and then the growth in here is going to be the baby boomer surge. You know, 10 years ago, I'm in a town that closed down one too many hospitals. All the consultants said, "Well, everything is going to be outpatient. We're We're going to get rid of hospitals," blah, blah. Turns out everyone's living longer. We have so much vascular disease, endless supply, and I think that overall market of just peripheral vascular disease will continue to expand. Well, hopefully, Adam, that answered your question adequately. That was great. Thank you very much for the color there. If I could sneak in just one more, you know, would love just to get any feedback from the clinicians on the ENFLATE Balloon, if you have experience with that technology. Then I guess the second part of that question would be just future innovation. Anything in particular that you'd like to see from Silk Road as it relates to the TCAR system, you know, coming down the pipe? Thanks again. Thank you. Sonya, have you used the ENFLATE? No, I don't think I'm familiar with that. you have that to look forward to. It's carotid specific, the balloon. Mike, have you used it? Yeah, I've used it. Rapid, up and down, ground, perfectly sized for a stent. I've used it for leg things, too, and leg bypasses and stuff like that, because you can stick it, or you can stick it right next to an anastomosis and fix a problem. I've already used it for, like... Yeah, yeah, I know. I know, whatever, some FDA on the call, the leg's not as bad as the carotid. I think that balloon's great. Awesome platform. It is a and it actually is nice having that short shaft balloon, you can use it in other parts of the body, actually, it's fantastic. The technology behind it, like, where you'd want the Silk Road roadmap to go, there's some things you could argue about stent. I mean, you have awesome outcomes with the stent platform we have right now, which is the PRECISE Stent platform is awesome. You know, there may be some role for stent, other stent design changes, micromesh stents, and things like that. Then the big elephant in the room is: how do you make this technology even more minimal access? Does it become percutaneous or available through an even smaller incision? We practice local anesthetic, but you'd like it that 80% of people doing it practice it local anesthetic. How do you remove anesthetic barriers, I think. Right. Sonya, would you add anything else that you would like to have on your wish list for TCAR? Yeah, I think I will pick here than Mike. I would like to see a better stent. You know, I think it's, you know, it's done its job, but it is old, and I think there are newer, better stents that are available. I'd love to see that change. I understand that requires a whole overhaul from Silk Road to, you know, to be able to do something like that. I think the two critical parts of the TCAR procedure, one is access, like Mike mentioned. It can be challenging in deeper necks, you know, shorter necks, shorter runway. To be able to eliminate some of that by whether it becomes fully percutaneous or some other better delivery system, I think that's something that could be improved. Calcium. I think, frankly, calcium is our next barrier that we need to overcome. You know, whether we do it with another specialty balloon or there's a different way to treat calcium. I think if we could eliminate that, frankly, then you've completely boxed out your competition. It doesn't matter whether transfemoral carotid stenting got approved tomorrow with, you know, a ribbon on top because they had this amazing stent that would go. It wouldn't matter. Like, you would take care of that problem altogether because I think that TCAR would really have developed to becoming available to be done on any patient, any time. The ENROUTE Stent may be mature, but it means it's better understood. It's very well understood. On to the next question, I think. Our next question will come from Mike Pollock with Wolfe Research. You may now go ahead. Good morning. Thank you for taking the question. I have just one. I was going to ask on calcium, but that was just addressed, so I'll leave that one. My question is this: It sounds like the doctors you mentioned at the very beginning, you know, TCAR is a portion of your carotid case count, I heard 80% to 90% today. You know, that's at the far right end of kind of the distribution. I mean, you sound like some of the most TCAR forward centers in the entire country. The depending on how you measure it's maybe four, five, six times kind of national average. As we digest everything that was shared here today, and there's been a lot of great color. I mean, how would you force rank, and this requires you to speak on behalf of your peers, but force rank the constraints or the limitations for the rest of the market around TCAR. What are the one, two, three most difficult things you think for the market overall to overcome? you know, kind of maybe share some of your personal experience in working through those matters? Dr. Stoner, do you want to start answering this question? Just what are your ideas around this? Yeah, so about, like, I guess if I'm reading the question correctly, sort of, what are the adoption barriers right now for people who are not predominant TCAR sites like Dr. Noor and I are? I think those adoption barriers are one, is that, you know, carotid endarterectomy is the single most studied vascular procedure that exists, has randomized data around it, is the sine qua non, is the reason, is the nature of being a vascular surgeon for 1,000 years, is the operation I thought that made me become a vascular surgeon. Sonya probably feels exactly the same way. So that's a, that's essentially a nostalgic operation to many surgeons. I know that's a really funny way to have some investor relations call to talk about nostalgia. I do think that what happens over time, I think that that operation, you know, there's like tons and tons of Sonya, I'm sure, is that someone, how do you get these 10 to 20 clicks and you realize this is in the procedure is highly reproducible and always works, like I said. That is gonna not happen for some people, to be honest with you. I think there's going to be some older surgeons who will need to phase out over time. If you come forward to the surgeons in their first 10 years of practice, these doctors, in fact, if you take the people in training right now, this is what they all want to do. This is going to be a workforce change that will take place probably over the next several years. Fellows and trainees come out in the market, they are all going to do TCAR. That's all my two fellows who are leaving now to go practice in the next two weeks, they're leaving. This is one of the reasons they got hired. They're TCAR people. They're going to be the TCAR people in Philly and in Iowa, where this other guy's going. They're both, you know, that's what they're going to do. I think that this is going to really be the dissemination of trainees out there that causes this adoption to take place? Soni, would you like to add anything? During our Q&A previously, we did discuss, you know, the end of focus of the fellows, the trainees. Would you like to? Yeah. Add anything to Michael's question? Yeah, just that, see, Silk Road is the only company in this SPACE, right? That offers a solution, a complete solution to a problem like this, and it has an incredible support system. You know, not to, you know, inflate Sumaira's ego, but she is just incredible. She's such a resource for us to easily reach out to her, talk to her about a difficult case. I've reached out to Mike. I mean, it's a community that really helps each other and say, "Hey, I have a difficult case coming up. I've got a patient who's on two blood thinners. You know, what do you think I should do? There's a whole community of us who help each other, and this is a great community to be a part of, and the fellows and residents know that. Think about it, about the people who are employing them. They're employing them because there are these vascular surgeons who are phasing out, who have these mature practices, and they need someone to take over that. More importantly, they want to be the practice that has this new technology. They can find someone who can do a carotid program. They're going to steal from those interventional cardiologists who may be starting or thinking about starting a practice because they are actually fully trained, fully supported by Silk Road to do this kind of a procedure. There's a lot of support system that makes you feel good as a surgeon, that you're not alone out there doing this procedure. It's just suffering through the pain of changing over those first five to six, seven cases, that can be stressful. Even a carotid endarterectomy, it may have been my favorite operation, it wasn't stress-free. TCAR is you know, it takes me half the time, and I can have my second cup of coffee, you know, before I go into the next case. I mean, that, as a surgeon, that makes me live longer. It makes me feel better. It's an emotional comfort, provided I get through that discomfort of change for the initial few cases. Well, hopefully, Michael, on the call, that answered your question. If it has, I believe that this concludes our questions and answer session. I would now like to turn it back to you, Erica Rogers, our CEO, for your closing remarks. Well, great. Thank you, Dr. Macdonald. Just what a terrific conversation. I'd like to again thank everyone who joined us for today's session. We hope the conversation provided more detail around how TCAR is implemented into a practice, and of course, what the opportunity is ahead toward building toward the standard of care. I'd also like to deeply thank our panelists, Dr. Noor, Dr. Stoner, for your participation in this discussion and the important work that you two are doing every single day. With that, I will turn it back to the operator. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.