All right. Good. Am I on? Oh, can you hear me? Yeah. Okay. Good morning, everyone. Thank you for joining us at the UBS MedTech Genomics Summit, and very happy to have a company I know very well, covered in my prior life, hopefully will cover at some point again soon. Silk Road Medical CEO, Erica Rogers, CFO, Lucas Buchanan. Thank you guys so much for joining us. Let me start. You had a very strong Q2. Maybe level set us on where Silk Road is today from a sales growth and margin profile perspective, and most importantly, where Silk is from a market penetration perspective. Absolutely. Well, first of all, let me say thanks very much for the invitation. It's always great to be here. Secondly, where are we? Well, it's still really very much early innings for this company. You know, we are five plus years into our commercial trajectory in the United States. We're up against a 70-year standard of care in carotid endarterectomy. That is the majority of procedures today. Based on our guidance, we'll end this year at roughly 15% penetrated in this $1.2 billion market opportunity. The prospects for the future are growth toward the standard of care. That's really our goal. If you think about where we ended in Q2, you already pointed this out, at $45.3 million in revenue, which is roughly 37% year-over-year growth. Our guidance indicates about 30%+ growth for the year. Mm. Yeah. One thing I want to touch on before I get to the next question, which is going to be the most controversial thing we talk about today. Before we go there, just from a TAM perspective, you did get the moderate risk indication within the last, was that 12 months or so? Right. how did that Maybe talk a little bit about how that expanded the TAM opportunity and that shift towards a TCAR being standard of care. Absolutely. It was about a year ago that we received not only FDA approval, but importantly, CMS coverage for the standard surgical risk patient population. That patient population, mathematically, is about a third of the market overall. This gives us, to your point, full access to that $1.2 billion, which is 170,000 procedures, roughly, in the US every year. It's more than just about the TAM expansion. It really was about putting TCAR on a level playing field with carotid endarterectomy, because our customers don't really divide their universe of patients in this very scripted way of standard risk and high surgical risk. That is nomenclature that was born out of FDA and CMS 30+ years ago, 20+ years ago, actually, in the early days of transfemoral CAS, and transfemoral CAS trying to find its niche and its home. The thought process back then was that the high surgical risk patient population, meaning patients who are at high risk of a complication from carotid endarterectomy, that that would somehow be the, the place where transfemoral CAS would find its home. Of course, now we know after 20 years of history, that that's simply not true. Those patients, in fact, don't do well at all- Yeah ... with transfemoral CAS. This is really not how our customers think. We've spent the last 5+ years doing the hard work of educating our customers on what high surgical risk means, what standard surgical risk means, what are the criteria, very specifically, that allow them to use TCAR and get paid. Now we don't have to do that. We don't have to use valuable selling time dividing the market in this artificial way in front of our customers Yes, I would say most importantly, any patient that comes to a physician, now, there isn't a question from the physician perspective of trying to figure out if. Precisely. patient is moderate or high risk. Precisely. You've nailed it. Dan, yeah, we, we like to say that 100% of the patients are at risk of a devastating stroke. Yeah from their disease process. Yeah. A 100% of patients are at risk of a major complication from a procedure, right? Whether it's a surgical complication from an invasive open surgery or, God forbid, a neurologic complication from kind of the, the old method. Yeah ... of carotid stenting until TCAR arrived. Yeah. We are, we are at a great point in time to, to solve problems that have been around for, for decades. Yeah. Now we have the clinical evidence base to say those problems are solved, and we also have the FDA labeling and CMS coverage to go do our good work. Yes. Okay, well, let's talk about this controversial on carotid artery stenting. Not controversial to us, to be clear. Yeah. You know, I know you get to gotten this question a lot, but I have to ask it, so don't shoot the messenger. How could the recent CMS proposal to reimburse for carotid artery stenting potentially impact TCAR? I have a few questions after that, but let's start there. Okay, we'll start there. Well, first of all, just broadly speaking, this is good news, right? This is broadening coverage for minimally invasive stent modalities, including TCAR. Yes. This is going to remove even more barriers to utilization than we had before. The way to think about this is this is coming at precisely the right time for TCAR, for Silk Road. We have spent years developing real-world evidence. We've spent years training physicians and establishing territories and opening hospital accounts. The momentum is there, and now they've just opened up the floodgates and the coverage for TCAR. This is perfect timing for us if it goes through as proposed. Yes. You know, the CMS well recognizes the challenges with transfemoral CAS. It's well known through our physicians in the community what the risks are, and so they've added some governors to minimally invasive stenting procedures. Those governors are meant to shift the responsibility to physicians and to hospitals to make the right decision regarding these modalities, right? They're shifting that to the providers. You know, broadly speaking, we see this as an opportunity to provide more diagnoses, more attention to carotid artery disease, which we see as a rising tide, kind of lifting the boats- Yep - phenomenon, and removing all of the barriers that physicians previously had. Namely, you do a TCAR procedure, you must enter that into the real-world evidence database in order to get paid. And so all of that, potentially goes away. Right. in this coverage. Yep. Okay. I was surprised by the proposal. I'm gonna ask you if you were surprised, just given, and I'll tell the audience here, the high periprocedural stroke rate with carotid artery stenting. This is not new. It's been around for- 30 years. Okay, decades. 30 years. Decades. Yeah. It's always been well known as a very high-risk procedure. Yes. I was very surprised. Were you surprised by this proposal? The, the short answer is no, because this was in the realm of possibilities. By the way, we've been kind of war gaming around this possibility since the dawn of our existence. Very early on, you know, it wasn't clear really how TCAR would even get covered. Of course, we did that through establishing this real-world evidence database in partnership with VQI and CMS, right? So we've had multiple discussions with the agency over many, many years, and so we're not overly surprised. I'll tell you why. This is about access, and if you think about where CMS is, broadly speaking, across disease states and across, you know, drugs and devices, they are looking for ways to broaden access to care, and that is what is at the root of this proposal- Mm-hmm when you read their intent, right? By that, you know, we believe there will be broadened access to care. More patients will get screened, more patients will get treated. In summary, you know, not surprised. Okay. To my earlier point, CMS does understand the risks. Yeah. Right? So they've put these governors in place, namely validated shared decision-making, which is a tool that does not exist today, right? That's gonna be interesting to see if that goes through. That could cause, you know, a delay in the ability to do transfemoral CAS. TCAR, meanwhile, will still be covered in the real-world evidence VQI database, right? Yeah. No matter what delay there is, TCAR remains covered. Shared decision-making is one of the governors. Imaging is one of the governors, and finally, pre- and post-neurologic exam of these patients to uncover, you know, the effects of a 2x risk in stroke. Yes. Yeah. Okay. You alluded to this, but already, but maybe talk a little bit more about how we should think about this proposal as potentially market expanding, expanding the number of patients getting interventions at all, given that there's still a lot of patients out there that don't even get an, an intervention. Yeah, precisely, Danielle. I mean, this is the whole point. There are 400,000 patients diagnosed every year in this country with a critical carotid stenosis, meaning they've had an ultrasound of their carotid artery disease, and the lesion is critical. A lot of those patients don't get treated. There are only 170,000 that get treated every year. Right. This is the whole point. More patients need to be treated. There's this very disturbing disconnect. There are about 250,000 strokes from carotid artery disease in the US every year. We're only treating 170,000. Yeah. We're clearly not getting to everybody, right? Now you'll have more practitioners thinking about this disease state, more patients thinking about this disease state, more companies thinking about this disease state, and that's going to lead to increased diagnosis and increased procedures. Yeah. Okay. Danielle, I'll just double-click on one thing, which is the, the reimbursement proposal is in asymptomatic patients, is for patients with a stenosis greater than 70%. Yeah. The practice of medicine is generally more conservative, more at 80%. 80%, yeah. There is this question between kind of 70% and 80% of, should I make sure the patient is compliant on their meds, or should I do that plus a procedure? If you're going to do a procedure in that patient where there's more equipoise about what to do, it better be a safer procedure. Yeah. Right? so TCAR has the ability to fill that gap because the risks of surgery and transfemoral CAS are understood after literally decades of trials. Yeah. TCAR is well understood because it's happening every day, every procedure we've performed commercially was captured in a database that says what's actually happening in the real world. So there's, there's just gonna be a rising tide of what we hear anecdotally all the time is a, a very underdiagnosed disease, right? Yep. Patients don't walk around with brain pain, right? They need a stethoscope on the neck, or they need to have a stroke to know that you have the disease. We're gonna have more screening, more diagnosis. That's gonna grow the whole pie, and then we may have this further encroachment of starting to treat in that 70%-80%... You know, TCAR is kind of arriving as a fully clinically proven, trusted modality now at just the right time. Yes. That is still minimally invasive- Yes. by the way. Right. Are there, though, patients that would make more sense for CAS versus a TCAR or CEA? I mean, is there a sort of patient that we can think about, like, that's a patient that maybe should be getting a carotid stent? Yeah. I'd say that it's, it's a minority, right? Yeah. Certainly that's borne out in kind of the% of patients who get a carotid stent, a transfemoral carotid stent today in the already covered patient population. Remember that symptomatic high surgical risk is fully covered for transfemoral CAS. We've taken share in that segment of the market. Yes. Right? Yes, there are some patients, a minority of patients, who might do well with a transfemoral CAS, but as Lucas just said, there are more inclusion for TCAR and CEA than there are for transfemoral CAS. This is really driven by a minority of very vocal interventionalists. The thing to click on there is minority. Yes. Right? There are a few physicians in this country who can do transfemoral CAS well, who are trained to do it and do it well in a few select patients. So that will probably persist, and those physicians who are interested in this, in this modality and who do it today might do a little bit more, is kind of the way to think about it. Yeah, that's a good point. Okay. I, I was curious about just the referral pattern here for the patient. You know, you work with vascular surgeons. CAS is being done by interventional cardiologists. Do these interventional cardiologists even get the patients referred to them? I mean, who's the doctor that owns most of these patients? Vascular surgeons? Is that gonna change? Yeah. I'll, I'll go into that, but just one, one, one thing to address right away is, transfemoral CAS is performed by interventional cardiologists, interventional radiologists, some neurovascular specialties, and historically, the, the largest group were vascular surgeons. So when Erica mentioned we've been competing, vascular surgeons said, "I'm, I'm reluctantly doing this dangerous procedure, maybe because of the patient I wasn't willing to operate on." That came to TCAR right away. Yeah. The pie got even smaller as a function of TCAR because the primary group doing transfemoral CAS had a better way to do it, right? To answer your referral question, we like to look at it through First of all, we have 70 years of history of CEA to study. We have 30 years of history of carotid stenting and 5 years of TCAR to study. Where do procedures happen, and who does them, how are they referred to them? The data is, you know, CEA is about 75%-80% of the procedure volume. The vast majority of those CEAs are performed by vascular surgeons- Yeah but also some cardiothoracic surgeons and some neurosurgeons on the margin. 10%-15% of the market is TCAR. Same, same, same physicians as doing the CEA. They're all endovascular trained. They do a ton of endovascular work, but in the carotids, because of the data, they do mostly old-school open surgery. Same, mostly vascular surgeons, some cardiothoracic and neurosurgeons. Then 5%-10% of the market is transfemoral CAS, as we just talked about, a more mixed bag of specialties. That, you know, adds up to 90%-95% of the time, a referral ends up going to a surgeon for surgery. Those are our customers already, right? 2,600 physicians trained, 1,200 hospitals, so we are deeply embedded in the practice of medicine. About 30%-40% of the patients are symptomatic, meaning they had, they did have, a minor stroke or a TIA. They're generally, whether they come through the ER or otherwise, under the care of a neurologist, a bow tie-wearing, very conservative neurologist. They refer to vascular surgeons because they trust that they will not cause a complication in their patient. The cardinal sin is causing a stroke in the pursuit of preventing a, a future stroke, right? That's, that's a big chunk of the patients. The asymptomatic patients, generally under the care of a primary care physician or an internal medicine specialty, whether it's cardiology or geriatrics or, or, something like that, same thing. The, the patients are asymptomatic. They're, they're not having brain pain. They're not having other lifestyle issues. They just have a ticking time bomb. That referral, that referral generally starts being, by being sent, "Stethoscope on the neck. I, I hear something. I'm gonna send you to the vascular lab for a definitive ultrasound." Those labs, are often controlled by vascular surgeons, but that's where you'll get your definitive diagnosis, which generally leads 90%-95% of the time to a surgeon for what to do. Yep. That's a very multi-decade, well-worn referral pattern. Yeah ... where the most important thing is not causing something bad to happen. You know, do no harm as a function of the procedure is what the referring physician cares about, and certainly the patient and their family. Yeah. Fix this thing, but don't cause a new problem, please. Yeah. Yeah, it doesn't make a lot of sense to cause a stroke to prevent a stroke. Right. Exactly. Categorically. Thank you for saying that. Counterproductive. Yeah, a little bit. What are you hearing, though? There are some big players in CAS that have kind of like left it to... You know, they don't really pay attention to it because it hasn't been a growth market. Is there any worry on your end that, you know, some of these sleeping giants could wake up and start to really try to push CAS? Yeah. Well, first of all, you know, we're focused on our customers, our patients, our referral channels, right? We're very, we're very focused on that and not really, you know, focused necessarily on, on what other folks are doing. You know, what I will say is that, you know, that it's a crowded space in transfemoral CAS. The multinationals who are in that space have lots of other really important competing priorities. Yes. You have to wonder, if this is sort of their top priority. You know, it's been many years since those sales professionals have been trained on the disease state or, you know, they've been detailing on those products. You know, remains to be seen, but, I can't imagine this is the top priority... Yeah in those multinationals. I think- For what is known. Yeah definitively third line therapy. Yeah. Yeah. Right? Exactly. In the hospitals that treat this disease. They're, they're all gonna be competing for that, you know, call it 6% of the market or 5% of the market that Lucas just talked about. Yeah. Yeah. I think I agree with you. You did this on the second quarter call, but I'd love if you could do this here for us and those listening. Just a high level safety and efficacy comparison between CAS and TCAR, as well as things like differences in length of stay, cost, et cetera. Sure. Well, I'll let Lucas take the back half of that question, on, on the first half, you know, it's, it's, you know, it's, it's pretty cut and dry. Transfemoral CAS is 2x the periprocedural stroke rate of TCAR or carotid endarterectomy, that's well documented in the literature in both randomized controlled trials against carotid endarterectomy and in high propensity-matched, large volume, real-world evidence comparisons in TCAR versus transfemoral CAS. I'll just point the, the group to a publication from 2019. We talked about this on our earnings call, Marc Schermerhorn et al., who looked at over 3,000 patients in a propensity-matched fashion, which is sort of the next best thing to a randomized trial, retrospectively look pairing these patients up, right? In that study, there, you know, it was, it 2x the stroke rate. There's just no comparison. It's well known. Yeah. This is not new to referring physicians. It's not new to treating physicians. It's not new to interventional cardiologists. They understand the risks. So you do have to ask yourself, how many of those physicians are willing to take that risk? If you're not already trained in transfemoral CAS, you're probably not gonna take that on- Yeah ... given the rest of the work that you're doing. Yeah, you've got other, I think you've got TAVR to do. Correct. So, You have coronary interventions, which is where the vast majority of interventional cardiologists spend most of their time. Yeah. A small number spend time in TAVR, and a small number spend time in peripheral artery disease. Yeah. Okay. You did also talk about this extensively on the call, but the... Sorry. Do you want him to take your- Oh, I'm sorry. Length of stay. Yes ...economics? Yeah, I can touch on that. The back half. really quickly. I got excited. Sorry. Sorry. Well, I think, you... Look, the good news is, for physicians making decisions, there's lots of data out there, right? Decisions are made, you know, based on, some of these data that Erica just referenced. So the economic argument is secondary. The good news is, carotid work is profitable for hospitals, and when we compare ourselves to the 75%-80% of the market that, that is CEA, the, the short answer is, is, CEA reimburses less, costs less. TCAR reimburses more, costs more. The profit margin is about the same for the index procedure. Where TCAR wins is it's just more efficient. Yes. You have a shorter procedure time with a, with a smaller standard deviation, so you can crank more procedures through the, the hospital factory in a day, weeks, months, years' worth of time. You can just utilize your OR overhead more efficiently, as well, as well documented in the data, shorter length of stay, less discharge to skilled nursing facilities and other expensive sites of care, things like that. Now, we don't usually get into a discussion with hospitals about the economic comparison to transfemoral CAS because of the, the 2x stroke and death rate. We do have all that data, and the answer there is, is TCAR and transfemoral CAS are coded the same, so they pay- it pays the same. When you add up all the costs of care beyond the devices, they're roughly similar. Okay. Stroke, in-hospital stroke is really expensive, and there's a lot of data on that in terms of extending the length of stay and extending, you know, expanding the cost. We don't typically get into economic arguments in the first place, but when we do, we're in a very favorable position against both procedures. Just sort of one final point on that. I mean, Lucas, you say this better than I do, but, you know, there is a misperception out there that the devices are, you know, holistically less expensive than the TCAR devices. Transfemoral CAS is less expensive, and that's just simply not true. These, these devices have, you know, maintained relative price discipline. You're talking about a stent and a neuroprotection system and guide wires and guide catheters and all of the rest of it. Yeah. Just want to clear up that misperception. Yes. Thank you for doing that. That's a good point. You did talk about this extensively on the call, but patient is the customer here, and I would totally agree with that, assuming the patient's educated about, you know, the risks with CAS. How educated are the patients? Even how much is driven by the patient versus the referring or, or treating physician, I guess is my question. Yeah, it's a great question, and it's top of mind for everyone right now, particularly in an environment where there may be required shared decision-making with a validated tool. Of course, a validated shared decision-making tool means that you have validated the patient's ability to comprehend what is on that, you know, kind of decision-making document that you're sharing with that patient. So that part remains to be seen. As it relates to today, we've put a lot of effort into patient education. We have a patient-dedicated website, protectionfromstroke.com, and we've done some really interesting work as of late, which I talked about on the call a little bit, which is taking certain geographies and really doubling down on our social media and search engine optimization to test and see: Can we drive participation to that website? Yes, we can. What we see is increased traffic on the website, and we also see, very importantly, increased downloading of our conversation guide. We have a patient conversation guide. We're spending a lot of time and energy now, because it makes sense to do it now. Yes. Now that you have 2,400 plus trained physicians in the United States, and a patient can walk in and say, "I'd like to have TCAR," and the physician says, "I know what that is, and I've done 100 of them. Yes. Right now is the time to really educate patients, so we've been focusing on that. That said, I think there is more work to be done on patient education. Today, most patients in this category, because they're older, they rely on their healthcare provider. Yes -to help them understand, and that is across the whole healthcare continuum. It's nurses, nurse practitioners, PAs, physicians, and we're getting to all of those with our education materials. Yeah. Okay, well, let's stop talking about cats- and let's talk about fun things. Good idea. Fun things like the long-term, the near-term growth outlook, because you did recently update your guidance. Sales growth guidance is now 30%-33% for 2023. You delivered your seventh straight sequential increase in seventh straight quarter of a sequential increase in procedures per physician. How much of this growth is unit utilization growth versus revenue per procedure uplift? Then I have a few more questions. It's really the, the former. I mean, procedure growth, you know, our, our, our top-line hierarchy is kind of starts with our North Star: patient outcomes. If we deliver pristine patient outcomes, that will lead to more procedures. With more procedures comes more unit reorders, which drives revenue, right? We're, we're really focused on delivering pristine patient outcomes and driving procedures, and then hospitals just simply reorder units. Okay. That's where our confidence comes from. Okay. Yeah, I just to reiterate there, you know, you, you called it out. We did raise guidance on the Q2 call on the backs of a really strong quarter, which we're very proud of. We raised guidance in the face of our revenue per procedure numbers, which are in a zone of around $7,000 or plus or minus per procedure. What that tells you is we have incremental confidence in the number of procedures- Yes That will be performed this year, which means incremental confidence in adoption. Yes. Okay, you know, there has been this backlog workdown through the health system, obviously more elective procedure impact there. Have you guys seen any sort of backlog impact in TCAR procedures? If so, I imagine it's worked down, what might go wrong? Yeah, I mean, certainly not as a function of, of COVID, right? Where we, where we saw some of those deferral of procedures, but a lot of that would clear intra-quarter, right? Because once the decision has been made to treat, then everybody's worried, right? Yes, you have to. Because we don't know if that stroke is gonna happen... Yes ... tomorrow or, or, or a year from now, and, and so there's high anxiety. Oftentimes, schedules were deferred, you know, weeks, not, not months. Yeah. Q3 normally, is seasonality affected in the form of vacations, right? Yes. As we all know from our friends, everybody's taking their kids to college or putting them back in school this week, which medical device companies love because that means physicians are going back to work, and patients are going into the OR. It's always kind of a, a back half-loaded quarter. Yes. If, you know, they just, you know, the surgeon decided to take a two weeks vacation instead of a one week, and the procedure got deferred, that'll make itself up. Yeah ...within the quarter, usually. Okay. Okay, now with the seventh straight sequential increase in procedures per physician, is it safe to say we're in the midst of an adoption inflection, or is this still more of a steady ramp through market development, given the high number of asymptomatic patients that are treated here and the training requirement around physicians? Well, we couldn't be happier with seven straight quarters in a row of incremental growth in procedures per physician. That said, as we've said all along, this is a gradual progression toward the standard of care. The reason for that is, as we've said, the brain is the end organ. If you think about the adoption journey for an individual physician, right? It's one physician at a time. Yeah. It's not the whole 2,400 cohort moving forward all at the same time, right? If you think about that journey, it starts with training. It starts with their test drive training, and then they go from training through this period of time, where they are gaining their skills and their confidence and their decision-making around TCAR. That period of time is, you know, anywhere from 10-15 cases and anywhere from a year to a year and a half, right? There's that journey. You get into the part of adoption where their own experience is driving faster adoption. Our job always is to get that physician to that faster part of the adoption curve. Each individual surgeon has an inflection point, and we're, we're studying that. We know where it is. We can predict where it is.... We focus on it on an individual physician basis. Collectively, as a whole, we're gonna see gradual, high growth over time until we become the standard of care. Yep, okay. You have accelerated, so there is a high touch. This is a high-touch sales model, so you have accelerated sales rep adds, and the establishment of new territories. How quickly can these reps ramp? What does current guidance reflect as far as productivity of those recent rep adds? You want- Yeah, we ask that question to our, to our commercial leader all the time. Yes. How, how, how fast can these folks get productive? The short answer to your question is there is a time to productivity. Obviously, we have a lot of kind of data points to study. It is factored into the guidance. They go through, and as Erica detailed on the call, they go through an incredibly intensive, grueling training program because we expect them to be true partners in, in the continuum of care and in the clinical practice of medicine in this disease state, which, by the way, is unmatched, right? There, there's no other commercial team that is fully dedicated and trained the way we are to, to help customers and help patients. It's, it's all factored into our guidance, and the whole point is not... Expanding the sales force isn't necessarily to cover new hospitals and train new physicians, it's to take accounts we already have and physicians we've already trained and spend more time with them. We actually reduce the number of physicians and hospitals that they call upon in order to be more frequent. Yep. Okay, got it. You also are very active on the innovation front, so you've launched new products, you've launched ENFLATE. How are these new products contributing to sales growth? Just to clarify a point for myself and others, this is reflected in revenue per procedure, right? Right. These are incremental products to the TCAR procedure. Right. You want me to take that? Yeah. There's kind of two opportunities. One is to constantly innovate the existing products and launch next generation versions, that, that helps, first and foremost, to be in service to the adoption curve, as Erica mentioned, better, fit, faster, safer, easier. The second opportunity is, is new products, right? Way back when, we developed a flow reversal system, then we developed stent, then came a transcarotid guide wire, then a micropuncture access kit, then most recently, our balloon product. We're now selling five individually packaged products into 1 procedure, and we are the only company, you know, supplying TCAR products in the marketplace. New product, new, new versions of existing products helps with price discipline, but again, first and foremost, to drive the adoption curve. The latest new product, the balloon, will, over time, have a slight lift to our kind of revenue opportunity per case. Okay. Let's shift gears a little bit to the longer term here. You did talk about 15-ish% penetration today of interventions that are getting done. To be clear, there's a lot of potential growth there still, just from an intervention perspective. Where do you see the 15% going over time? You know, how quickly can this get to standard of care, which I'd be curious how you define it, but I would think over 50%. Yeah. I, I would say we would define it similarly. Yeah. Certainly over 50%. Minimally. Yeah, yeah, yeah. Minimally, exactly. That's, that's the, the minimum bar. Yeah. Yeah, so that's the journey that we're on, is, is really getting to well above that 50% of the time TCAR would be first-line therapy. If you think about where the world stands, where the United States stands today, which is, you know, carotid endarterectomy, first line still, TCAR, second line. transfemoral CAS, distant third line therapy. Yep. Right? But the one thing that, that we talk about with this proposed new kind of coverage is that opportunity to drive minimally invasive procedures faster. If you think about vascular surgeons who now have TCAR, they certainly have TCAR available to them, and potentially in their hospital, they may have an interventional specialist who wants to start thinking about transfemoral CAS. Well, the best way for that surgeon to be offensive in that environment is to do more TCAR. We think that not only is there gonna be broader awareness around minimally invasive therapies in general, but surgeons leaning in faster on TCAR, on the minimally invasive procedure they trust. Yeah. What, what are the barriers to adoption still? One of the things, when, you know, when I was actively covering you in a prior life, having conversations with some of these vascular surgeons, and they're just like: "Oh, CA, I can do CA really well. Like, I'm really good at this," blah, blah, blah. Yeah. I mean, how do you shift that mindset? Yeah, it, it is what we're doing. We are shifting that mindset, right? Yeah. If you look at our top quartile of physicians, just to say, what is the art of the possible, they are in that 50% and above category already, right? We are chipping away at what is simply inertia. Yeah. But there's no way to rattle inertia than, you know, more noise around minimally invasive procedures. So that's why I made my previous comment. It's really about this methodical, bringing physicians up through their adoption journey, and that experience curve of when I hit my stride and I've done enough, I've done, you know, enough TCARs, that I can predict the outcome in my own hands. So that's what we're, that's what we're working on. And it, and it's. The counter to that is, if they've been doing carotid endarterectomy for 20 years. Many of them, or even 15 years, they've done 400 or 500 carotid endarterectomies, maybe more, right? That's a big experience set that they trust. Yes. We're chipping away at that. Yes. it's just a matter of. Yep. -education. Yep. Have there been any physicians that you've encountered that you're like, "We're never gonna get this person to do a TCAR," that you've, you've gotten? Yeah, so the straight answer to that is yes, right? So what, what is the profile of that surgeon who's like: This is just not for me? Generally, they're older. Yeah. They're much older, and they're very- I was just gonna say retired. Yeah. Yeah. The profile is they're now retired. They're retired. Five years ago, they had five years left. Yeah Today they're retired. Yeah. Exactly. Yeah. That's, that's the, the best way to put it. If you, if you're, you know, late in your career, you're just not gonna take on a, a new modality. Yeah, that's fair. Okay, let's talk about the pipeline. How should we think about the upcoming launch and ramp of the tapered ENROUTE technology? I think you said first half 2024. Yep. Correct me if I'm wrong. Excuse me, how does this either improve procedure efficiency or increase the number of treatable patients? Right. Well, the tapered configuration of the ENROUTE stent was really in response to demand from customers to offer more configurations in order to treat more patients. Where taper comes in is when you have a disconnect between the internal carotid artery and the common carotid artery in terms of size, and you don't necessarily want to line that whole bifurcation with, you know, the same size pipe. This taper configuration allows them to treat those patients where there is that disconnect, and so certainly it'll have an expansion effect. It also is. It continues to delight our customers. It tells our customers that Silk Road is responding to the needs that we have, and that's an important thing to do. We'll, we'll continue to do that across the neuroprotection system. You probably also heard that we got a 510(k) cleared for the NPS+, which offers some new features and benefits for physicians to reduce the complexity, once again, of this procedure. Those are the kinds of things you will continue to see from us. Okay. Just as far as the cadence of product launches and iterations like this focused around TCAR, TCAR, what is the primary focus of ongoing innovation, and how frequently should we expect to see? Well, you can you can look at sort of the frequency we've been talking about, right? We launched the ENFLATE balloon in earnest, a couple, a month-ish ago, right? With full-scale launch. We're planning on our limited launch of Neuroprotection System+, NPS+, at the end of this year, and then we talked about the stent in kind of, early 2024. So you can see this sort of cadence, and it's important to not layer them all, all, all at the same time. Right. Because that's hard from a, you know, sales attention, span and control kind of point of view. That kind of regular cadence is, I think, what, what we'll look for here in neuroprotection systems and other ancillary devices for TCAR. Okay, got it. Acute ischemic stroke, still very early, but anything you can say about the update on the NITE 1 Study and anything you can say on timing, next steps here, what we should be paying attention to from the investor perspective? Right. NITE 1, feasibility. First time ever, that flow reversal and a transcarotid approach have been used in the setting of acute stroke thrombectomy. It's a feasibility trial, as you pointed out, very early days here in this project, and so there's not a lot to report right now. Yeah. What I can say is we're learning a lot. Okay. Okay, kind of next steps to pay attention to would be regular updates on the earnings call. Maybe at some point, we get beyond feasibility into what's next? Another way to think about it, Danielle, is, I think as of the end of Q2, we had crossed 70,000 TCAR procedures, primarily in the US. Therefore, next year we'll cross 100,000 at some point in time. Before Silk Road existed, transcarotid procedures did not exist. We now have a huge group of physicians and referring physicians and people that understand now transcarotid procedures, given what we've done with TCAR. Yes. That gives us opportunity to invent and solve other clinical problems. Gotcha ... over time, right? TCAR itself was five products and a lot of clinical and regulatory work and reimbursement. You know, we like to think big in developing new ways of practicing medicine, not just a new widget in an existing market. These are the types of things we're thinking about over the longer term. Okay. Got it. Thank you for that. International, it sounds like you're making some progress there from a regulatory perspective. When can we start to see international really contributing to sales here? Right. We've made great progress in both China and Japan. That's kind of our focus right now, against what is, you know, a $2.1 billion+, conservatively, opportunity around the world. $2.3 billion, sorry. So we're just getting started- Yeah ... and it's gonna look a lot like the United States, where you train physicians, you move physicians up an adoption curve. So I think, you know, we haven't really talked about exactly when we're gonna launch in those countries, the ramp will look similar. Okay. Got it. As we go from 15% to over 50% in the U.S. Yeah ... we're gonna, we're gonna try to make it a, a real competitive race internally to, to be meaningful, because the U.S. is so meaningful. Mm-hmm. Yeah. ... right, and has so much room for growth. Yep. Okay. You have been... Shifting to the P&L, talking about leverage here, you've been adding sales, sales reps, you continue to innovate, but I'm curious if we're nearing an inflection from a positive leverage perspective, given the high level of sales growth that we've seen? ... Yeah, so we, so we are, and you can see it in the numbers, and we talked about this on the Q2 call. Even as we brought forward our 2023 hiring plan in the commercial organization and accelerated that investment, we, we still saw a decrease in OpEx as a% of sales, right? We have room to, to increase on the gross margin line and, and decrease OpEx as a% of sales as we continue growing revenue by going deeper, not wider. That's, that's, that's capital efficient, so to say. And, you know, we had over $200 million in cash as, as of the end of Q2. If you back out our significant stock comp, non-cash stock comp expense, like, like a lot, like most medical device companies, people are the main expense, right? You can do the math, and we're not burning significant amounts of cash relative to that, that cash balance and that operating leverage potential. We, you know, we, we have said and continue to say we're well-capitalized to get, to get to profitability and, and ultimately be, you know, a very high-margin MedTech business. Great. Well, in the last minute here, I wanted to ask you guys, you know, it's been a, it's been a tough few months. What do you think the Street investors are missing about the Silk Road story? Well, I think it starts with what, what is TCAR, and why does it exist? TCAR, it was in response to the problems of transfemoral CAS. In response to the need for a minimally invasive procedure against carotid endarterectomy. This is the solution for both. Yeah. Reversing time and going back 30 years and making an assumption that 30-year-old technology is suddenly going to take the world by storm, I think is flawed thinking. It is based on a lot of assumptions, not facts. I think when the facts are understood, like the periprocedural stroke hazard and others, I think people will come to the right conclusion. Yeah. Okay. Well, thank you guys so much for joining. Thank you, Danielle. Great to see you guys again. Thanks very much. Great to see you.