Shockwave Medical, at its inception, was an idea of taking this sort of large machine to break up kidney stones and downsizing it onto a catheter to crack calcium in arteries. Sort of crazy idea. When you think back to just the genesis of Shockwave, innovation is really in our DNA. That's one thing that's great about Shockwave. It's got the balance of a big company in terms of the stability and the resources, but also still that energy and drive of a smaller startup. We take a proactive approach to innovation and understanding the opportunities to improve our core products, but most importantly, looking for that next idea that can become the next breakthrough technology or therapy for us. We have a pretty regular cadence, almost monthly visits. We'll bring in groups of 6-12 physicians. But then we also try to get engineers to go out into the field to go see live cases and to go to conferences. Because it's really as many different perspectives as you can put together, the better chance that you'll end up at the right point. It all translates into how do we more effectively and efficiently provide a better solution for our customer that then results in a better outcome for our patient. What's exciting about Shockwave is that we're far from reaching the full potential of what IVL can do. When I look to the future, there'll be a whole new generation of products that are out there, and I want us to be at the forefront of that. We'll grow by further expanding and improving through a constant stream of new product designs. We'll also grow by pulling in new patient populations, such as we will with the refractory angina population. Innovation doesn't just live within R&D, it lives within Shockwave as an entire organization. Ensuring that everyone knows that their ideas matter, and by carving out enough time and space for people to work creatively together, it seems to stimulate ideas across the organization. As a result, we are generating a remarkable pipeline of new ideas. Innovation is part of everything here at Shockwave. We're a company that's done great things, that's gonna do more great things. It's a really motivating place to be. Good afternoon, everybody. Welcome to Shockwave Medical's Investor Innovation Day. It's great to see so many of you in person, and thank you for those of you who are joining us online. You enjoyed the video? I think it's a great snapshot of the culture at Shockwave, innovative and collaborative. Before we start, a few housekeeping items. We're gonna be making some forward-looking statements during our presentations today, and are also going to be talking about some products that are not yet available. So you can read these in their entirety, when we post our slides, at the end of the event. In terms of today's agenda, we're gonna have about two hours of formal presentations with a bit of a break in the middle. We'll wrap up with a Q&A, so please hold your questions until then, and then at the end of the day, you will have some time to go through some product demos and look at our products up close and personal. And then we'll wrap up with our Shocktail hour at the end of the day. This is our fabulous team that you'll be hearing from today. Before I turn it over to Doug, I'd like to thank each one of them, as well as the wider Shockwave team, who have worked tirelessly to get us to today. With that, I'll turn it over to Doug. Thanks, Deb. Welcome, everybody. I successfully avoided doing an investor day for about 17 years as a CEO, so finally had to cave in and do one of these. So glad you could all join us, and for those on the web, welcome as well. I hope you find it interesting and helpful. So a little bit about where we've been, and then we'll turn it more towards where we're going. First, as we were getting started, the genesis of the company was to become the standard of care for treating complex calcified arteries. And while we have a tremendous road ahead of us to continue on that mission, we're thinking more broadly now. What do we want to be sort of when we grow up or as we grow up? And so now our goal is really to become the premier growth company in medtech by transforming the treatment of poorly served patient populations with paradigm-changing technologies. So we're we wanna be the growth company, and when you're thinking medtech growth, we want everybody thinking Shockwave, which is a tall task, and we are excited about the challenge, and hopefully, what you see today is that we are building the foundation to achieve this objective. So how do we do it? First, we have to penetrate our existing markets and do so by improving the performance of the technologies, giving our customers a better product constantly. So we are enabled to address the unmet needs of the patients we treat today. We also need to expand the populations that we treat, so beyond the core and peripheral arteries that are served today. We'll need to improve economics for the customer. We will continue to invest in the high-caliber research that we've done to date, and our clinical research is expanding significantly relative to where it's been in the very recent past. You'll meet some new folks on the team that you haven't met before, and hopefully you see that we've got a really strong team. But as you walk, for those who are here today, not on the web, you'll also get to meet a lot of the engineers who are really at the core of the innovation that is driving the success of this company. And we're really fortunate to have such a strong team, but we have to keep getting stronger. And we also know that we don't have all the good ideas. So if we find something that's really special, and we think we can maximize it and improve the performance of, we will occasionally, selectively acquire from the outside. So these are sort of the pillars of our, what we believe will be a sustained growth franchise. But we've also accomplished a lot already. So a quick snapshot. We've got about 4,000 customers around the planet. Three hundred and fifty publications on peripheral, coronary, and other places. About 260+ events, eight thousand generators currently installed, globally. We've treated about 400,000 patients, and obviously, we're pushing a 100,000+ per annum, across the globe. We have about 10 sq ft of clean room in Santa Clara. We're adding 30,000 sq ft in Costa Rica, so a substantial increase in our ability to scale at a very cost-effective location, so that we can do R&D in Santa Clara and then drive volume in Costa Rica. We've grown 125% since 2018, which is, I think, a pretty good number. That's leading to the trajectory of our guide of $725 to 730 for this year. A lot of our growth has also come globally as we have sort of started in 2016 just in Germany. In 2017, we launched in the US We built steadily geographically over the years and really sort of picked up steam, adding a lot of countries in the 2021 to 2022 timeframe. We're now in pretty much every major medical market that you would want to be, with about 70 countries. We'll add selectively here and there in coming years. We are able to serve just about every major geographic medical market today. Just like we've grown geographically, obviously, our revenue has grown nicely. So I started in 2017, and we did $1.7 million, so we rounded it up to 2 because that's a bigger number. But back then, like, okay, I hope this works. I hope people want to use and buy this product, and luckily, our customers just kept telling us how great the product was. But you can also see that over the course of time, you can start to see the benefit of the investment we've made in R&D as we launched C2 in the US in 2021, and then M5+ last year and 2 new product launches this year, and we're starting to see the fruits of the investment we made in R&D. Today, we'll spend, well, almost all of our time talking about what those future fruits are from the investment we've been making the last few years. One of the other things—in fact, when I started, one of the things people warned me against was sort of, "Don't join Shockwave because they'll never get reimbursement." And luckily, a lot more people said, "This product is amazing. It's an epiphany, it's a game changer." And I figured, well, some people will pay for a game changer. If it's really that good, we'll figure out a way to get reimbursement. But we built the company in the early days on clinical utility, clinical benefit, and our customers sort of found novel use cases for the technology that got us enough utilization that then helped us start to get reimbursement. So we had nothing until Rob Fletcher and his team figured out how to get codes and payment for peripheral, and we got ourselves in a position where we are now within a very comfortable financial position for the hospitals to use our products on the periphery, with future upside on OBLs that we're increasingly optimistic about. On the coronary side, we launched in the US with nothing, but it was a very short period of time when we had nothing, and luckily, the novelty of our product enabled us to get breakthrough designation, which then got additional passthrough and got an NTAP. You're seeing the tremendous benefits of having those temporary codes because CMS can look at the cost data and figure out what they should pay us permanently, and we end up with incredibly favorable DRG for inpatient, which just went into effect a couple of weeks ago. And then, fortunately, and equally encouraging CPT code, which we'll know the final numbers on here in a week or so. So we're for great inpatient, great physician payments, and we think January of 2025, we'll complete the story with where we'll land on APC, with 5194 being where we expect to land for the outpatient. So we've got tailwinds, significant tailwinds on the coronary side, real stability on the peripheral side, with future upsides on both peripheral and coronary. So whereas we started with reimbursement being a who knows, maybe never, to a tailwind that is carrying us after we built the company on clinical benefit of the product. And yet, as we look forward, you know, where we are today is nowhere near where we want to be in the future. We love the, we love the portfolio we have now, but there's so much more to do. And at the beginning, when all we had was a peripheral catheter in the US, and all of our doctors said, "You know, why are you selling this for me in the SFA? I really need something for iliacs and common femorals and large bore access." We've sort of listened to our customers since then, and they have been saying things like, "I need something to treat aortic valves. I need something for mitral valves. I need something for coronaries, for Reducer. I'm glad you're evaluating the product for obstructive angina, but I kind of need something for my non-obstructive, my ANOCA patients." It feels smarter to listen to your customers than to ignore your customers. And so what you'll see today are these locations and others where the customers, this is what I need, and our R&D team has responded marvelously to put ourselves in a position where we can address the needs that our customers have expressed to us. So where we were just two years ago, we had 7 programs going on in R&D, and we were spending $50 million. Now we have 27, spending $150 million this year, inclusive of, of clinical trials. But what, what I love about this, this graphic is we went from no sort of early-stage research kind of programs to 8 + 6 tech dev, so 14 years, if you think about it, you start with the funnel at the top, and you've-- you want stuff that's early stage, and it doesn't all make it down to the bottom of the funnel. But if you don't fill the top of the funnel, you don't get really changing technologies at the bottom end. And our team is, has found a really great balance of sort of big R, big D. So it's not just iterative product development. We're really looking to push the envelope and create new therapies. And where we have been today is we've had a platform. We've had a balloon-based intervention lithotripsy platform. Great, we love it. Can't do everything that our customers are asking us to do. If you can't get a balloon across the lesion, that's a problem. If you need more power, we can't put that much power into our current system. So now we have two new platforms: system for balloon uncrossable lesions, and we have a high-power system because if you're treating aortic stenosis, you're treating the mitral stenosis, our 3-kilovolt generator just isn't going to get the job done. And yet our current product can't handle more power than 3 kilovolts. So we had to sort of start from scratch and create a system that could generate the kind of energy required to treat structural heart calcification. So we expect multiple products to sort of, and iterations to stream off of these three new platforms, just as they have the balloon-based system has fed the portfolio we have today and many of the products you'll see later today. So we just launched 2 products this year. We are expecting, going forward, we're going to launch at least 2 products a year. So some years it's 2, some years it's 3, some years it's more. When we aggregated the, the, the launch cadence that we see through 2027 to 2028, we see probably about 12 product launches, and by the end of the decade, we anticipate starting 5 new markets. So you'll, you'll see really all of those described today. We just have some other things in the cupboard that we just didn't feel like bringing out just yet today. So we think there's a very robust portfolio above and beyond what you're going to see today. But hopefully, you will enjoy yourselves and learn a lot about why we believe we're going to be the premier med tech growth company going forward. So with that, many of you know Rob Fletcher because he teaches me everything I know about reimbursement, and you've heard him on our calls. So he's gonna take it from here. So, Rob? Thank you, Doug. All right, before we get into this tremendously amazing pipeline, I thought what would be beneficial is just to sort of have a foundational moment and talk about the IV, the core of the IVL system. So this is the generator and the other system components, because we believe that this is a source of advantage today and in the future. So when you're in a cath lab or an OR suite, and the decision is made when faced with a difficult, challenging, calcified lesion, the decision is made to utilize some sort of plaque modification therapy. The flow in the room changes. The techs that are circulating or the nurses go run off and find the components of the system that are to be used. Sometimes additional utilities are required. For example, in the case of rotational atherectomy, you need to go find the compressed air tanks and wheel them in because there's a pneumatic component to the system. In the case of laser, for example, there is a large laser generator that weighs about 650 pounds that needs to be wheeled into the room, plugged in, the system needs to be turned on, warm up for 15-20 minutes, calibrated, and then you can go on and do the case. And then oftentimes, these systems are quite expensive. You can imagine a laser system is $several hundred thousand, so there's typically one of them. And so if you're sharing, if there's multiple cath lab rooms, you've got to go find which room has the generator. One of the advantages of the Shockwave system is just the small, lightweight component that is the Shockwave generator that I'm holding up here for you now. As you can see from this, it does not weigh 650 pounds. I mean, I have been working out, but not that much. So the system does not really have any external connections at the back. It's a battery, it's a rechargeable battery system, so really, it is not tethered in any way to the wall. You don't need to plug it in. You can mount this onto an IV pole and wheel it around the cath lab. You can small enough to be placed in any kind of little nook and cranny that's available. The system's very easy to operate. There's no settings on it. You just push a button, the system turns on, and as you plug the other components into the front of it, it knows what catheter it has and sort of does, takes care of all the setting for you. So you'll get a chance to see these up close. I encourage you guys to look at the back at the end of the presentation today. We'll have some of these systems available. But one of the other sort of key advantages from a business standpoint is that these generators are also relatively inexpensive. So this, combined with the size, means that we can place a generator anywhere in every cath lab. And our goal, as Doug mentioned, is to expand on the 8,000 generator install base today to make that even larger going forward. One of the things that helps us do is as we introduce new products, they all plug into this same simple system, and so that allows us speed of execution as we leverage sort of our large installed base. So, I just wanted to spend a minute to make sure that, you all were sort of aware of that in the background, because we're going to talk now more about the business end, of these new catheters that are under development. So with that, I'd like to get into the peripheral, IVL market, and, I'm going to have Pat Stevens come up and join me. He's our head of R&D, and we'll do this part together. So, we've made a lot of progress in recent years introducing peripheral IVL, which is our first technology that we brought to market back in 2017. Most recently, growth was accelerated by favorable changes in reimbursement and new products. But as we sort of look ahead to sort of future opportunities for growth, which we'll get to in a moment, it's important just to get a sense of perspective of where we are today in terms of penetration. So I'm going to spend a moment on that now. But the opportunity that remains ahead of us is massive, and I just want to make sure that I impress upon you just the scale of that. Let's look at the US market a minute. This is the largest global market for peripheral interventions, with nearly three-quarters of a million procedures being performed annually in the US Calcification is frequent in the lower extremities, with approximately, in aggregate, about 60% of interventions involving severe or moderate calcification. Yet today, even with that, impressive ramp that I showed you on the previous slide, we are only 5% of peripheral procedures performed currently. When you kind of do the math and just look at what we define as the total available market here, which is PAD interventions involving complex calcium, severe or moderate calcium, that means we've just penetrated just under 10% of the opportunity, with 90% ahead of us. So the room for growth here is massive. One thing that's important to understand, about this, about peripheral interventions, is really that they're performed in the US in two primary settings of care: in the hospital, which you may expect, and also in physician practices that are known as physician office-based labs or OBLs. So from a market access standpoint, these two sites of care have different reimbursement systems and different rules of the road. So just to sort of appreciate where we are, let's look at the hospital side of the market, which is the majority of procedures, especially the complex procedures. And there, we've been carefully putting the building blocks in place over the recent years to establish hospital reimbursement in both inpatient and outpatient, and then in the ASC, which is in a related reimbursement system to the hospital. Still, when you look at procedures just performed in the hospital, which I would say is the vast majority of peripheral IVL procedures currently, and you look at, estimate the segment that involves severe and moderate calcium, we've still only penetrated 15% of that market opportunity. We have 85% to go, and we have all the reimbursement pieces in place we need to go get that. In the future, we anticipate that we should be able to access the OBL segment of the market. This would come through creation of CPT codes for IVL, which are currently sort of in a state of construction as the entire lower extremity baskets of CPT codes are under revaluation and reconstruction. This is primarily being carried out today by the specialty medical societies, by the American Medical Association, in conjunction with CMS. So as that lower extremity basket is redesigned, we anticipate that IVL will be included within that, and we certainly meet requirements at this stage for a Category One CPT code. Now, the question is the timing of when that occurs, and so we estimate that at present sort of dynamics that we expect will come into fruition in the 2026 to 2027 time frame. So this will be a nice good guide for us in the future as we continue to penetrate the market opportunity in the hospital, and then we get a nice addition in the future, we anticipate, through entry into the OBL market. Let's double-click a little bit on interventions in the periphery a minute. So it's a vast space involving a lot of different segments. It starts up in the lower part of the abdomen and goes all the way past the ankles. And so, as you might imagine, the variation in anatomy and different clinical situations is quite significant. Peripheral interventions are grouped into three different sort of arterial territories. There's the iliac artery, which composes about 25% of all peripheral interventions done in the US Vessels here are larger, and calcium is prevalent in these cases, over 70%, involving complex calcium. These arteries are typically stented most frequently after the calcium is dealt with. In the fem-pop space, this is now the leg, and through the knee. This composes nearly half of all peripheral interventions. Here, calcium can be a little less frequent, but still problematic when it occurs at 50% of these procedures involving complex calcium. Really, the sort of standard of care here is highly variant. It's a real grab bag as far as what types of different procedures, both definitive and prep, are performed. As you can see from what the slide shows, we've made more gains recently in penetrating this opportunity, mainly because of both reimbursement and new products that we've introduced in 2022 and 2023. So that's why we kinda see a little bit more traction there in recent times. But as you go down below the knee, this is where we think there is a lot of significant opportunity. Below the knee, these arterial territories, called the infrapopliteal space, and we'll just kinda call that below the knee for simplicity here. And here in this case, these patients tend to be much more difficult to treat. These patients have sort of higher acuity. They are sicker. They're at more risk of mortality and morbidity, this comes from some very complex disease that is also very small, very far away from the access point, and also can be quite difficult to treat. So as we've sort of introduced one of our first-generation products here back in 2018, we believe this addresses part of the market, but is not sufficient to address the entire opportunity. So let me tell you a little bit more about that now. There's basically two main things you need to remember about interventions below the knee. The first are that these lesions are long, and so here's a distribution on this graphic of different lengths of lesions, less than 5, 5-15, and greater than 15 centimeters. So you can see by the composition here that most of the lesions that are are indeed long. And so the current product, Shockwave S4, is a relatively short device in a space that involves relatively long lesions. So now this can address part of that market segment, but one thing that's important to keep in mind is as you have longer lesions in a shorter device, you just need to reposition and retreat repeatedly. And so this works well in the short lesions, but as you get to longer lesions, it can be more cumbersome and less efficient to treat these longer length lesions. The other thing that's important to keep in mind, the second factor that is common with below-the-knee lesions, is that they're often difficult to cross, and so this means that they involve at least points in the lesion where the narrowing is very, very tight. And so these are sometimes also referred to as occluded lesions. And so, you can see here that by this chart that this is relatively frequent. Almost half of lesions below the knee involve these sort of very tight, difficult-to-cross points, and that frequency increases with the length of the lesion itself. So as we've had S4, which is a device that is appropriate for shorter lesions, we also realized that in order to effectively capture some of these sort of 250,000 procedures that are performed annually here in the US, we need more of a toolbox approach to this. And so this is what Pat and company have been working very hard on. Great. Thanks, Rob. It's really nice to be here, and it's the culmination of a lot of work, and so I'm really looking forward to sharing with you some of our new products in the pipeline. So for those of you that are online, hopefully we convey exactly what we've been working on over the last several years. And for those of you that are here, welcome the opportunity to have you back at the end of the presentation and see the current products. So the first product that we'll have in this toolbox approach is the E8. And the E8 is specifically designed for some of the challenges that are seen below the knee. So with the longer balloon length, with the ability to reposition less, with faster pulsing, you can treat 95% of below-the-knee lesions with E8. It can also be done 40% more efficiently than S4 for the longest lesion that S4 can treat. You know, typically when you go and you make a longer balloon product, one of the things that you give up, is you give up deliverability. But I'm happy to say that the engineering team has done an outstanding job making it 30% more deliverable than our current products, both M5 and S4, and we anticipate a market entry for E8 in 2024. But as Rob talked about earlier, there's still a lot more challenges, below the knee. So if you look at the, the video on the left-hand side of the screen, what you'll see is a traditional IVL procedure. And these types of procedures, you'll cross with the wire and subsequently balloon, inflate the balloon, which helps deliver the IVL. You can see the IVL goes out, modifies the calcium, and lets the, the balloon dilate the artery. However, there are lesions for which that's more difficult. So these are tight, difficult-to-cross lesions that you'll see on the left-hand side of the screen. For those lesions, what you see is that you can typically get a wire across, but you can't necessarily get the balloon across. So if you're to try to facilitate crossing with the balloon catheter, you can see there's... Oop, I'm sorry about that. You can see there's two problems associated with that. First problem that you have associated with that. Let me get through this for you. I apologize for that. Well, the first problem that you have is that you'll see once you get the balloon catheter there, that the emitter is too far away from the lesion itself. When the emitter is too far away from the lesion, even if you were to inflate the balloon and subsequently try to use it to facilitate crossing, it's too far away to modify the calcium. The other thing that typically happens when you inflate the balloon is you degrade the performance of the device itself. So the crossing profile is large; it's increased. The deliverability, the pushability is also diminished. So we've created a new platform to help address this, and I think Doug was alluding to this earlier. This is a non-balloon catheter-based platform to deal with these challenges. And it would be remiss of me not to, you know, thank the significant work that went into this from the engineering team. As you can imagine, further miniaturization of the IVL technology, putting it into a non-balloon-based catheter system had significant technical challenges, and the team really rose to the occasion in order to create this platform. The first product out of that platform is the Javelin Peripheral System. So the Javelin Peripheral System has the radiopaque emitter. It's shifted to the front end of the catheter, so that takes care of part of the problem that we discussed earlier, which is now you get enough sonic output at the tip of the catheter, such that it can facilitate crossing. In addition, it has a high-performance, hydrophilically coated catheter, which allows it to navigate tortuous anatomy and provides subsequent pushability that's needed in the below-the-knee segment. So let's see how it works here. So if you look at this here, you can see, as we had before, this is a difficult to cross lesion. It's tight. The wire crosses, but the catheter cannot. But now you see that the sonic output at the tip of the catheter facilitates crossing. So you can simultaneously pulse the catheter, get modification of the calcium at the tip of the catheter, and cross the lesion. But in addition, because the emission from the catheter is in a spherical pattern, you also modify calcium radially outward. So that allows you then to complete the IVL treatment and go back with a subsequent commodity PTA balloon for post-dilatation of the artery. This particular product is the first of its kind. It's currently in an IDE study, and we anticipate that we'll be in the US market in 2025. Oops. With that, I'll hand it back to Rob, who'll kind of walk you through a case. Yeah, let's see it in action. I think the cartoon really helps explain sort of the theory here, but let's look at a case. So this case, let's start on the left-hand side. This is a right tibial artery. You can see the bone running in the middle of the image here, and the white arrows point out where an artery is supposed to be. This is the tibial artery. If you look at the furthest northward arrow here, you see the stump of the tibial artery filling here, and then after that, you can hardly see it, and then it fills as you get later down the screen here, and you have some collaterals coming in. So, this is certainly, you know, this is basically a 20-centimeter lesion here, and this fits all the things that we've been talking about. This is a long lesion that is occluded and has some extremely tight stenosis in here. So one thing is clear, we don't have to be vascular surgeons or interventional cardiologists or interventional radiologists to understand that this is going to be difficult to get anything across this kind of lesion. Enter the Javelin, which is shown here in the middle frame, and as sort of Pat described, you advance the catheter up to the beginning of the lesion. You apply the pulses, you advance the catheter, and what happens is it creates a channel within the artery itself. Now, because the lithotripsy is delivered, it's fractured that calcium, which then allows a balloon to come into place and sort of finish the job, and so that's what we see on the right-hand side of the screen up here is that the flow's been restored to the area that this tibial artery services, and then the patient goes on, and this is a successful treatment. So, just to summarize the approach here, the below-the-knee opportunity, those 250,000 procedures that are performed annually, and what we alluded to is a toolbox approach. The below-the-knee lesions are long, and they're difficult to cross. And today, the Shockwave S4, we estimate, can address about 30% of those shorter lesions below the knee. But with the addition of the Shockwave E8 for longer lesions and the Shockwave Javelin for these difficult to cross cases, we effectively believe that we can triple the addressable market opportunity below the knee. So speaking of the toolbox approach, let's just kind of maybe take a step back now and look at where we'll be in 2025 from a US interventional portfolio of products here. This is a suite of purpose-built devices that is designed to treat anatomical challenges and disease state challenges of calcified PAD. So we have, starting with the large, up here with the L6, introduced this year in 2023, more aimed at iliac artery interventions, all the way down to the very smallest at the bottom with the Shockwave Javelin, which is designed to go very, very distal, in the below-the-knee lesions and treat all the way, all the way down. So, one of the key advantages that I tried to set up at the beginning is that this portfolio of products will all connect into a single generator that's easy to use. It's smart, it's got all the programming on board. We believe that we have, favorable, hospital economics that make all these treatment therapies viable, so we can go get, the hospital opportunity. Meanwhile, we believe the opportunity in the OBL may be ahead on the horizon in the 2026-2027 timeframe. So in total, as I mentioned earlier, the peripheral market opportunity is it's a large market with 1.8 million procedures to treat PAD globally. 60% or the majority of these lesions involve severe and moderate calcium. One thing that we didn't expressly talk about in this presentation is that an additional use of peripheral IVL therapy in this same anatomy is to enable transfemoral access of what's called a so-called large bore procedure. These being procedures that involve larger payloads that you need to insert endovascularly. IVL can treat the iliac and the common femoral arteries in order to enable access of those large payload therapies and keep it transfemoral instead of having to go with an alternative access route. So sort of this all summed together, we believe, is a $3 billion global market opportunity for peripheral IVL. So, let's go up the body now to the coronaries, and talk about this opportunity, and we'll hear from Dr. Dawkins here in just a moment. But, just to sort of level set where we are with coronary IVL today. So as many in this room will undoubtedly know and appreciate, adoption of coronary IVL has been phenomenally rapid. So this chart shows just sort of over this short period of time, these two years since IVL has been introduced. In 2023, we estimate that coronary IVL will be utilized in 8% of PCIs. This is against a 30% of PCI opportunity involving severe and moderate calcium. So, what's remarkable is when you think historically, that plaque modification therapies here, despite the fact that there's 30% severe and moderate calcium, plaque modification therapies have never really exceeded more than 4% or 5%. So already within these first year to be twice that, is quite remarkable. One of the things that we, our outlook for the future here is that that adoption curve is going to continue to grow rapidly. We have a number of catalysts that are just sort of entering the picture here, with hospital inpatient reimbursement that's just going into effect here in earlier this month. These are the first new DRGs in 20 years in the field of PCI. In addition, in January, we expect physician reimbursement to come into place, and then we have a new product in Shockwave C2+ that we'll explain a little bit more to you about in just a moment. So, we are very sort of bullish on that, that continuing continuation of the momentum that we've seen here. So, one thing that, you know, I want to point out just as foreshadowing, looking at the gray bars here, we see that atherectomy, which is one of the other primary plaque modification therapy that's used, still maintains about 4% of PCIs, and there's a reason for that. That is treating different patient types, and oftentimes they're used concomitantly. But really, atherectomy is aimed at and able to address some lesion types that we're not able to address today with coronary IVL. So that represents an opportunity for us in the future. In the US, there's 1 million PCIs approximately that are performed annually. As I mentioned, this 30% severe and moderate calcium figure. PCIs are growing at a very modest clip of about 1% to 2%. But one thing that we want to make sure that investors are aware of is our view on calcified procedures. And that, for a number of factors, we believe is growing at a greater rate at approximately 7%. So modeled out here in this chart, we believe that this, towards the end of the decade, will significantly increase in terms of the size of addressable patients. So calcified PCI procedures are a large and growing segment, and to understand a little bit more about why that is, I'd like to introduce Dr. Dawkins. Oh. The burden of calcification, of course, is very important to Shockwave, and changes in population dynamics are working with increasing the burden of calcification both in the US and globally. If you just look initially at the left graphic, this is vascular calcification in men as identified by CT, and you see that by the age of 50 years, the prevalence of calcification is 70%, but by 60 years and onwards, calcification is ubiquitous. But it's not only that it increases with age, it's that the shape of the population is changing dramatically. So if you look on the right, this is the US population in 1960 and the projected US population in 2060. You can see not only is the median age of the population gone up, but the shape of the population has dramatically gone up, and therefore, there is more calcification in the population, both in the US and elsewhere, and this is, of course, the substrate for IVL. There will be some of you in the audience who attest to the group think that there's a putative improvement in calcification with the GLP-1 drugs. We should go on the record as saying that there's no evidence whatsoever that GLP-1s modify, inhibit, or cause regression of vascular calcification, and I think that's important. We're very proud at Shockwave. I mean, it's one of our pillars of the company that we've developed a huge amount of clinical data in a very short time for such a young company, and that's important, I think, to support our products. This slide summarizes the clinical data for just the coronary application of IVL. We now have more than 5,000 patients in clinical trials, more than 250 peer-reviewed publications, and importantly, 23 investigator-sponsored studies, which are synergistic to the studies that we do internally. In the blue boxes around the circle, you can see groups of patients and lesions that we've investigated, and many of the studies looking at these patients and lesions have already completed, as shown by the check marks in blue. But we're not naive. We know that there are still anatomies that our present technology cannot address adequately. When we talk to physicians in the field, they want more pulses for longer lesions. They want more pulses to treat difficult calcium morphologies, particularly nodules and eccentric calcium. And they would like to have devices that have a lower profile with improved crossability for tight lesions and tortuous anatomy. When we look at this group of patients, there are a small group of patients that are untreated with conventional PCI, and these difficult-to-cross lesions or occlusions are often treated with optimal medical therapy, perhaps most commonly. There are dwindling numbers of patients who are treated with surgical revascularization, CABG. And as Rob has just said, perhaps 4% of patients are treated with complex PCI, including other atherectomy devices. And now we'll go on to talk about how we're going to address these groups of patients and lesions. Pat? Thank you, Keith. Good. Well, thank you, Keith. I appreciate that. You know, where we stand today with our, with our C2 and C2+ products, we're going from a single product to a family of products, and I want to kind of walk you through a little bit of that journey today. As both Rob and Keith alluded to earlier, the C2+ is the next iteration for the coronary product. C2+ increases the total number of pulses from 80 to 120 or a 50% increase. And that's particularly important when we think about the ability to treat long, diffuse, eccentric, and nodular calcification. This product has been commercially available in Europe and very well-received over the course of this year, and we're proud to unveil it at the TCT meeting this week in San Francisco. But as they also alluded, there's more to do, and there's a lot more to do in the coronary space. In particular, the most common feedback we get about C2 is the ability to deliver the device. So the next iteration past C2+ is C2 Arrow. C2 Arrow is a device that is designed specifically for more deliverability. It has a lower profile tip entry and significant features along the length of the catheter to make it more flexible and deliverable. In fact, in bench studies, it's 2 times more deliverable than our current C2 product, making it a significant improvement from our current product. We anticipate this product will enter the market in 2025. And just as we talked in the periphery, the coronary interventions also have a significant number of tight, difficult-to-cross lesions. So we're specifically designing a Javelin product to address those needs. That product will be a rapid exchange system and significantly more flexible, such that it can address the difficult and tortuous anatomies that you see in the coronary arteries. As you can see in the video, it's a very similar procedure to those seen in the periphery. You have crossed the device or crossed the lesion, I'm sorry, with the guide wire. Subsequently, take the Javelin device up to it and simultaneously pulse and deliver the Javelin to facilitate crossing. Just like with the peripheral catheter, you modify calcium in the radial direction in addition to at the tip of the calcium, such that you can post-dilatate with a PTCA balloon. This is a really important product in the portfolio, and we anticipate market entry for it in 2026. With that, we'd like to share some clinical data with you. Thanks, Pat. I'm sure you would agree that it's important not to just see cartoons of new technology. I'd like to share with you this first Shockwave Javelin case from an early feasibility study using a peripheral over-the-wire device. This was undertaken by a friend and colleague, James Spratt, at St George's Hospital in London. You can see on the left-hand panel a critical, complex, heavily calcified lesion in the proximal right coronary artery. Despite the best efforts, this sort of lesion is not possible to cross with conventional IVL technology, even with all of the supporting tools. But using the Javelin device, just as Pat described, the Javelin device was easy to cross the lesion. You can see in the middle panel, and opens up a channel so that a drug-eluting stent can be implanted on the right panel, fully inflated, without any complications. And so this is a testament obviously to the engineering prowess of the company and shows that the device is actually working in real life. ... Thank you, Keith. So to summarize our approach in the coronary space w e see the addressable market as the 30% of PCIs that involve severe and moderate calcium, and as described, well, before, we believe that percentage is growing. In order to better address that opportunity, we will continue to improve our balloon-based platforms to iterate on the performance and continue to push the boundary there. We believe that the reimbursement required to capture this opportunity will come into place over the coming years. And then for this segment of PCIs, which are really not addressed well with a balloon-based platform, this sort of 4% to 5% of PCIs where atherectomy is primarily used today, we believe the Shockwave Javelin will be a better solution, a safer solution, and easier to use solution in the future for these lesion types. The coronary IVL market is large, with 6 million PCIs being performed globally on an annual basis. We've talked about many times the percentage of severe and moderate calcium, so in sum total, we believe the coronary IVL TAM to be a $5 billion market opportunity. So, let's continue our journey northward and start to talk now that we've covered the two core markets for coronary IVL. Let's talk about some of the new markets that Doug alluded to. For this, I'd like to invite up my colleague, Dr. Nick West, to talk about IVL in the carotids. Thank you very much indeed, Rob. Disease of the carotid arteries, which are the vessels that, as you may know, transport blood from the heart to the brain, is a principal pathology driving the occurrence of stroke. Again, I'm sure you all know that stroke is second only to coronary heart disease as the highest cause of death worldwide. In addition to which, it's a major cause of morbidity and disability among patients. Now, patients with carotid artery disease do have treatment options. They're shown on the left-hand side. There are pharmacotherapies that can be applied, antiplatelet therapies, statins. There are surgical interventions, a wide variety of techniques, and also increasingly, endovascular interventions. But it's very important to point out that those patients with severely calcified carotid lesions have limited and suboptimal treatment options. You've seen from the slide that Keith showed, how common vascular calcification is with advancing age. If we look at how patients with carotid disease are currently managed, you can see from the graphic on the left that the majority receive, appropriately, medical therapy, with smaller minorities receiving, in addition, either surgical or endovascular treatments. Now, the endovascular market, in particular, has some tailwinds. There are quite a few novel technologies being developed to either make the procedure safer or make the effects more durable. There's also favorable reimbursement recently, recently announced, which will probably also improve the frequency of these procedures being performed. Additionally, vascular surgeons have really taken on the TCAR, transcarotid approach, which is also driving further growth in this segment. Against this, severely calcified lesions mean that patients who might otherwise be suitable candidates for endovascular procedures either have to have surgery at some risk or are not treated at all, or medical therapy alone. The risks we're talking about associated with calcified carotid artery lesions include the increased risk of dissection or tearing of the vessel during the procedure, which may cause stroke itself, an underexpanded stent at the end of the procedure, and that itself leads on to the future risk of stent failure via either fracture or re-narrowing. So we believe that the IVL technology is a potential solution to address this and to enable safe and effective completion of carotid stenting procedures in patients with calcified carotid artery lesions. We know there is already considerable interest and excitement in the physician community for this approach. There have been 14 peer-reviewed publications already, not run by us, and we hear at least 1,000 off-label uses of the technology in this patient group. Based on the feedback we've received, certainly it appears to be safe and efficacious, but we know that in order to succeed in this market, rather than rely on off-label usage, we will need to prospectively establish both the safety and the efficacy of this treatment. Additionally, it needs to be seamlessly integrated into the workflow for these stenting procedures. So accordingly, the R&D team have been working very hard to derive a purpose-built, rapid exchange system with an optimized balloon and emitter design, expressly for the purpose of transfemoral and transcarotid approaches to carotid stenting. We believe this is a major step forward. We are answering, again, as Doug pointed out, an unmet need that's been expressed by the community, but also critically for patients, and we hope to have US market entry in 2027. Thank you, Dr. West. So, our view of the opportunity for carotid IVL is that upwards of 500,000 procedures and surgical interventions may be candidates for carotid IVL. About 40% of these lesions involve complex calcium, so that leads us to a total market opportunity of $750 million for carotid IVL. I want to return to a point earlier when I held up and showed you the central small, brilliant generator. And as the technologies that we've shown you today, here, there will be a total of eight purpose-built design catheters, all powered by the same generator and plugging into the same system. We anticipate, again, ensuring that we are increasing our installed base of generators. We estimate that we'll increase that from where we are today by about 50% by 2026. Again, just want to return to the point that we sort of see that as a source of key advantage going into the future, and that will enable us to more seamlessly introduce these therapies in the future. So with that, we've now arrived at a planned break. So we'll take the next 15 minutes, and please feel free to use the restroom or stretch your legs, and we'll resume the program in 15 minutes. Thank you very much. ... If everyone can take their seats, I think we're ready to resume. All right, thank you. Welcome back. Keith Dawkins and I have the opportunity- through technology, into new treatment areas, and into new markets. Severe calcium remains a challenge in treating valvular patients today, and we think there's a- an innovative catheter-based platform to s evere calcium remains a challenge. Because physicians today are using our existing therapy or preparing a native annulus for a TAVR or bridging a therapy. Excitement around a destination therapy for mitral stenosis patients, patients for pumps, and then addressing challenging MAC while facilitating a trained model that includes optimizing TAVR and improving bridge therapy. Or significantly delay valve procedures for a significant SAVR experience is promising. But we do believe that a purpose-built maintaining the hemodynamic stability of the patient, and all in that same simple, predictable, single-button, easy-to-use platform that customers have come to expect from Shockwave. So as I said, we believe there'll be multiple valve applications for this platform moving forward. We'll start with patients with aortic stenosis. Challenging calcium can compromise the successful treatment of patients with aortic stenosis. As valve-for-life, life continues to increase in focus, in optimizing the therapy for valve patients over the lifetime of that patient continues to move to the forefront of clinical thinking. Whether that's intervening early, intervening with moderate symptomatic stenosis patients, whether that's delaying a valve replacement or optimizing that valve implant, addressing challenging calcium is critically important. If that treatment choice is balloon aortic valvuloplasty or BAV, the outcomes of BAVs, the efficacy and durability are frequently unpredictable. And we estimate a third of patients, TAVR patients, have challenging calcium, particularly those bicuspid patients. Challenging calcium can force a physician to compromise either in valve size, implant location, implant depth, or even valve platform, balloon expandable versus self-expanding. And studies show that severe calcium in TAVR is associated with increased procedural complications and higher mortality. While ultimately, clinical experience will elucidate what role IVL will play in treating patients with aortic stenosis, our goal for this platform is to help physicians optimize their outcomes and reduce the compromises they need to make as they treat their valve patients over the continuum of their life. Whether that's sustained gradient reductions or increased valve areas in improving bridge therapy to either TAVR, SAVR, or for a different procedure, whether that's optimizing the TAVR implant to reduce IVL or increase the circularity of the valve to help reduce late valve failure, or ultimately as a destination therapy, providing long-term, durable symptom relief. And with that, we'll have Keith talk to us about our path forward. Thanks, Mike. This slide maps out the clinical trial cadence for the Crescendo device in the management of severe calcified Aortic Stenosis. In the first half of 2024, we plan the first-in-human study, which has two arms, a transcatheter arm and a surgical arm ahead of Surgical Aortic Valve Replacement, will then be a small early feasibility study, which will precede a US pivotal trial, where we will explore Crescendo in the treatment of pre-TAVR patients as well as destination therapy. We anticipate that we'll have commercialization in the US market in 2028. Now, those of you that follow the structural heart field will know that there's a lot of interest now in the mitral valve, and particularly Mitral Annular Calcification or MAC. Earlier in the talk, I was expressing how important it was to look at the age of the population in relation to calcium. As the population ages, the presence of MAC becomes ubiquitous, particularly in elderly women. The presence of MAC by itself doesn't necessarily mean that there needs to be intervention, but MAC does impede the effective treatment of mitral valve disease, be it by surgical mitral valve replacement, TMVR or clip procedures. MAC itself can present as mitral stenosis, as mitral regurgitation, and there is an association of increased cardiovascular risk in the presence of MAC. We plan to leverage the Crescendo platform, developing a specific mitral catheter, one or more catheters, to address MAC, which will allow, first of all, primary treatment of the disease, but also, facilitate treatment of the MAC with any number of technologies as I've just explained. We anticipate the first-in-human study in 2025, followed by an early feasibility study and a US pivotal trial with commercial US commercialization anticipated in 2029. We'll wrap up this section talking about the initial addressable market for this IVL platform. While we think there are broad applications across valvular procedures for this platform, the model, the initial TAM that we modeled includes optimizing TAVR, as well as improving bridge therapy. If you look at the 900,000 procedures done globally to address aortic stenosis, we estimate about 30% of those patients have challenging calcium. Opportunities as a destination therapy to prolong or delay TAVR or replace TAVR, as well as mitral applications, that would be on top of this initial opportunity. So we're excited to get this new high-powered platform into the hands of our customers and extend the reach of lithotripsy into new markets. Now we'll close out. We'll ask close out on the new platforms and ask Nick to join me up here, and we'll be talking about the reducer technology, a large, exciting new therapy, refractory angina for Shockwave. About six months ago, we completed the acquisition of the reducer technology. We think this is an opportunity to develop a new therapy with a unique first-to-market position and the opportunity to lead that market development with science and with a device that our current customers today will implant. We'll talk a little bit about the two patient populations with refractory angina. The first one is obstructive coronary artery disease with refractory angina. We're all familiar with obstructive coronary artery disease, the buildup of plaque in the arteries restricting blood flow to the heart muscles. These patients are often treated with revascularization, either PCI or CABG. But despite that successful revascularization, 25% to 40% of patients are still experiencing chest pain one year later. The other larger population is the ANOCA population, the non-obstructive coronary artery disease with refractory angina population. This is a large group that previously had been somewhat unregarded and underdiagnosed. But recently, there's been an increase in this focus on identifying and diagnosing these patients to help relieve their symptoms. There's been an increase in the number of catheter-based diagnostics to identify these patients, but still without a good treatment option today. And that's important because these patients have substantial morbidity, and ANOCA with refractory angina is present in up to 30% of patients undergoing angiography. Despite that increase in focus on diagnosing these patients, the reducer is the only device shown to improve symptoms of refractory angina. It's a safe procedure. It's a catheter-based procedure in which a stainless steel, hourglass-shaped implant is put in the coronary sinus, which is the outflow vessel from the coronary arteries. It's a catheter-based procedure done by interventional cardiologists under local anesthesia in a safe, approximately 30-minute procedure with very low complication rates. Once that device is implanted, the putative reducer mechanism of action, the narrowing in that implant, creates back pressure and redistributes blood flow to the ischemic areas of the heart. Using advanced imaging techniques like PET, you can actually visualize the perfusion of blood back into the ischemic areas of the heart. With that, I'm going to turn it over to Nick to talk about some of the foundational science. Thanks very much indeed, Mike. I think it's fair to say there's already a considerable body of data that has highlighted and maybe even proven a clear reduction in angina burden with the use of this device. I want to highlight two of the studies for you now. So looking on the left of this slide, this is the COSIRA study. This study was published in the New England Journal of Medicine, quite a high bar in 2015. It's the proof of concept, if you like, and it's the highest grade of evidence. It was a sham-controlled, randomized controlled trial. So in this trial, patients with severe and refractory angina were randomized to either receive the coronary sinus reducer or a sham procedure, and the patients were blinded to what they'd had done. If you look at this graph and focus perhaps on the blue bars, those are the patients that received the Coronary Sinus Reducer. What you can see is that patients experienced a significant reduction in anginal symptoms. Now, this was judged by what's called the Canadian Cardiovascular Society Angina Grade, which is from 0 to 4. Patients in this study had to have 3 or 4, which are the worst grades, in order to get in. 3/4 of the patients that received the reducer improved by at least 1 grade, and 1/3 of them improved by 2 or more grades. That's clinically very meaningful and impactful for patients in terms of their quality of life, and that was reflected in other endpoints in the study. It's reassuring then, when we move from that sham-controlled randomized trial to a single-arm study on the right, the Reducer-I Study, that we see that again at 6 months, the same degree of benefit, with around three-quarters of the patients experiencing at least one angina grade improvement and around 25%, 30% experiencing two or more grades. And what you can see from this interim result on the right-hand side, from the Reducer-I data, those benefits are sustained and durable out to a 2-year time point. Now, we're very excited because next year there will be a larger body of patients. This was interim results. There'll be more patients, and follow-up will go on to 3 years, and we hope those data will be presented in the first half of next year. So really, these two studies-... provided the clinical evidence foundation for the COSIRA-II study, and this is the US pivotal study towards IDE. This study is designed not only to get regulatory approval in the US, but also to facilitate market expansion in those geographies that already have approval for the coronary sinus reducer. This, again, is a prospective, double-blind, sham-controlled trial being performed here in the US. 380 patients with documented coronary artery disease, refractory angina, and no revascularization option will be randomized in 1:1 fashion to receive either the reducer or, again, a sham procedure. Now, in contrast to the first COSIRA study, which there was some criticism for a slightly subjective endpoint of patients' experience of angina grade, this has an objective endpoint of exercise duration on an exercise treadmill test. There are other data being collected to look at the safety of both the implant of the device and safety further down the track after the implantation of the reducer. This study is currently actively enrolling in the US, and we hope and expect FDA approval by 2027. I do want to highlight that within the COSIRA-II study, there are some important pre-specified subgroup analyses and also registries. There are two imaging substudies. One, Mike has already mentioned about positron emission tomography or PET, which is a technique where we can look at the redistribution of blood flow to the heart muscle not receiving that blood. This will help to unpick the mechanism by which the coronary sinus reducer exerts these favorable effects on angina. It's also important to show safety, and a CT angiogram will be performed in 12 months in a proportion of patients to check the position and the ongoing function of the reducer. For those patients who are not eligible for randomization into the study due to exclusion factors, exclusion criteria, we will be addressing those patients with non-obstructive coronary disease, ANOCA, those with ischemia predominantly in the right coronary artery, and those unable to exercise on a treadmill. Now, that's important because that expands the potential of this device into those other markets, into those other patient groups who are currently not served by this technology. So we think this is a, is a very bright future for this technology in these patients. And I'm now going to hand back to Mike just to close this out. Thank you, Nick. So we'll close out talking about our commitment to building out this new device therapy. We're lucky, we're building on a strong foundation that was put in place by the legacy Reducer team, as well as 100 Reducer patients studied to date across a variety of studies, including the two that... In addition, there is over 4,800 commercial implants done to date. In the US, the device has Breakthrough Device Designation, highlighting the significant unmet need around these patients. Our priority is accelerating the COSIRA-II trial. As Nick said, it's the approval trial for the US market, but we also believe it will be the landmark clinical trial that will help develop this market globally. A few things we did shortly after the acquisition to accelerate that trial. We are now supporting the device, study devices free of charge, as well as the procedure costs, and we've updated the protocol to increase from 50 to 60 sites in the US. In alignment with our history of executing clinical trials well at Shockwave, we're adding additional resources as well as to both drive site openings as well as randomizations, with the goal of accelerating this trial to get to approval mid-2027. In addition to COSIRA-II, we'll continue building on the momentum of this device by investing in our commercial teams and our direct markets in Europe, as well as piloting and putting in place programs to drive the market development. We'll continue to invest in the already large and growing foundation of clinical evidence, including the COSIRA-III trial, company-sponsored trial, to expand the indication to address those ANOCA patients in the US market. We expect first patient in 2025. So we're very excited about this new technology and the opportunity to treat more patients, as well as to reach new large markets for Shockwave. The obstructive coronary artery disease with angina population, we estimate that there are 300,000 patients each year in the US and Europe. In addition, another 500,000 patients suffering from refractory angina and ANOCA each year, together representing a sizable TAM of $5 billion. And with that, I will call up Doug to close this out. Thank you, Doug. Thank you. Thanks, everybody. As we try to do at Shockwave, I think we are exceeding expectations ahead of schedule. That's what we try to do every day. We'll try to wrap things up and open up the Q&A. I'm going to try to sort of summarize everything that you've heard today and then some. As you sort of look at what you saw and what we have on the market today, we've got C2+; we're launching this right now, L6, which we launched earlier this year in the US We will be commercializing E8 next year and then Javelin peripheral the next year. So, creating a growth driver out of the below-the-knee segment, which, to date, we, we've sort of dabbled in with S4. Nice product, proves that lithotripsy works, too short for most clinical conditions and certainly too short for most of the below-the-knee heavy, heavy-duty operators. They want something longer, and they want something that crosses sort of balloon uncrossable lesions. Sort of check, check with E8 and Javelin. C2+ gives us an opportunity in combination with improved reimbursement on the inpatient and physician payment side to further accelerate our coronary business and address those long and eccentric lesions that that Keith spoke about. And thus far, the feedback, both in our launch internationally and our early limited launch in the US, has been extremely positive. But what, in addition to, sort of the sort of economic friction of I wish payment were better, which is now being well addressed, on, on the reimbursement side, the other really big need on the coronary side, if you speak to the cardiologists out there, is they really wanted our device to be more deliverable. And, and, the feedback we've gotten on Arrow in, in all the bench testing has been exceptional. It really is demonstrably better. So, the biggest unmet performance need will be addressed with Arrow in 2025 on the coronary side. Many physicians do not like using atherectomy for uncrossable lesions, and even those who use it kind of wish they didn't have to, and they wish there was a lithotripsy alternative for those balloon uncrossable lesions, and we'll deliver that to them with Javelin in 2026. We'll be addressing biggest unmet needs below the knee, biggest unmet needs that have been expressed by our customers on the coronary side. We're obviously quite enthusiastic about expanding into new market opportunities with Reducer, with carotid and creating that market, and with Crescendo for aortic stenosis, and we're not even... Sort of I ran out of dates here, so we didn't put in the mitral opportunity, which is sort of like the coronary side. Every doctor you talk to about our coronary catheter says, "I wish it was more deliverable." Every cardiologist we talk to about Crescendo says, "Yeah, but give me something for MAC. I got nothing for mitral stenosis." And so once again, sort of it would be dumb to ignore what your customers tell you. So, that's sort of the next in queue program now that we've developed this high-powered system. So that's everything we've talked about today. What we haven't talked about is everything else we're gonna be launching. So we've got both iterative product enhancements on the coronary side, on the peripheral side, that we have line of sight to. We have some really interesting novel alternative design concepts that are also fairly well advanced, either prototyping or well past prototyping. The sort of drumbeat of product launches is going to actually get louder over time. Rob Fletcher's gonna have a problem launching 5 products in 2027, but he claims that he's up to the challenge. It's gonna be sort of an increasing cadence, an accelerating cadence birthed by all that investment that I talked about earlier today. We're, we love the setup of our pipeline. And two years from now, if we do this again, you'll get to see all this and other things that we have in the cupboard that we have not, we didn't think we needed to share with you yet today, and certainly didn't need to share with somebody who might want to compete with us in the future. So, we think we're in a great position with 12+ thousand generators in a couple of years, and improvements to our hardware that will be forthcoming as well. So, we think this puts us in a great position to avail ourselves of the obviously sizable position. So if you added all the TAMs that Rob and Mike talked about today, it aggregates to close to a $15 billion total addressable market, sort of slightly larger than the $6 billion we thought the market was when we launched our IPO back in 2019. There have been some pleasant surprises, frankly. We did not realize how big the unmet need was in carotids. We knew doctors kept using it, and now kick myself for not starting this program a couple of years earlier because it's a, it's a more sizable opportunity than we thought. But obviously, for now, we are heads down, driving penetration on our core IVL platform and the tools that we have today, and particularly the tools that are gonna be in our team's bag, starting with E8 next year, Arrow, et cetera, are gonna be really fun, and fun for our customers, which they seem to really like. Like what we have so far, and they're gonna love what we have going into the future. So what does that translate into? What do we think the business is gonna do over the next few years? We're anticipating 25% compound annual growth through 2026. We think we're gonna get about a 500 basis point improvement in operating margin over that plan period. And Pat, where are you? Pat's gonna be working his tail off, as is, as are Keith and Nick, driving clinical trial activity. So we think we'll be well north of $600 million in R&D investment, which then sets us up for that sort of continued growth and our objective of being the premier growth company in med tech. And so we're... We like our position, and we've we almost have too many things to work on, and yet we're making such great progress on them. We're continuing to fill that funnel with our early-stage development and technology development platforms. And so here at Shockwave, we have been cracking calcium since 2016 and continue to look forward to continuing to crack well into the future. With that, thank you, everybody, for your time and 18 minutes ahead of schedule. Ahead of schedule. We are, we're going to open it up to Q&A. Yeah. So if I could invite the whole team back up for the Q&A. If you have a question, please raise your hand and just wait for the microphone. If you could state your name, your firm, and then your question, that would be great. I'll also be taking questions from online. So if you're joining us online, please just type in your question directly to the portal. Adam? Thank you very much. Adam Maeder, Piper Sandler. Wanted to start on BTK, a multi-part question. So I guess first, you know, remind us where we are on reimbursement below the knee. Is there still a little bit of work to do to get that, I think, mapped? And do you have thoughts on timelines there? Latest thoughts on timing for the DISRUPT PAD BTK II study, is that a 2024 event? And then third, how do you think about pricing as it relates to E8 as well as Javelin, just given, you know, kind of the current reimbursement situation? Thank you. So Rob, Rob, you and I can tag team on that. We expect BTK readout to be next year, in trial. Trial's enrolled very nicely. We'll update once we know roughly sort of what meeting it'll land on and the like, but it'll be probably less than a year from now. We have not settled on pricing yet. We're cognizant that we've, Rob and team have done a very thoughtful job on pricing our products to date that has accrued to the benefit of our customers because it has led to the positive reimbursement changes that we've had both in coronary and peripheral. Rob, you want to talk about the process? Yeah, on reimbursement. Yeah. Yeah, thanks for the question, actually. I think it's a bit of an underappreciation that the fact that there sort of is dedicated coding in payment on both the outpatient and inpatient side for below-the-knee type of procedures. Generally speaking, that below-the-knee payment are quite high. They both map to the top two endovascular bands in that sense. And so it's actually the same reimbursement as we are above-the-knee, which is really a very sort of viable economic condition. Generally, those procedures pay higher, which means, you know, there's an ability to fit inside the economics here. One of the things why things move so much on the above-the-knee side of things is actually, we started at a much lower payment here. The initial sort of payment assignment for the above-the-knee procedures for IVL was around $5,000 for the hospital, which was, you know, certainly... You know, the cost of the device itself was over half of that. So that really needed to move up in order to enable above the knee, and that's why we see such a big bump. Below the knee is starting off in a very different position here. So the majority of, you know, our procedures are already at those top two endovascular APC bands. Might we want to continue to improve around the edges? The answer is yes, but we're in a totally different scenario here, where we've got access and the economics that we need to capture some of the opportunity there. I'd say we outcomes below the knee matter a lot more, safety matters a lot more below the knee than above the knee. Below the knee tends to be, "Am I or am I not going to amputate this foot or leg?" And so when you're treating a population that is biased towards critical limb ischemia, reimbursement plays a lesser role in terms of, "Well, I could make a little bit more using atherectomies." Well, you're also going to spill debris into the open wound if you use atherectomy. So, they... It's kind of like the coronaries, where even when we launched and we had no reimbursement whatsoever, "Yeah, but this is just better for my patients, so I'm going to do it." I think below the knee, you get that same phenomenon. So we have adequate payment below the knee, and you want to get the right outcome below the knee, so you'll tend to use what you believe is better for your patient versus above the knee, where it's like, "Well, cats and dogs, you can kind of use whatever, and I'll put a stent in because I don't care." Below the knee, you care. To Rob's point, I think we're in a comfortable position. We'd like it to be better, and we'll see what we can do to move it that way, but we're fine as is. Mike Polark, Mike Polark, Wolfe Research. A lot of good stuff shared today. I'm curious, and you rolled it up for us financially, 25% CAGR through 2026, but can you force rank that product roadmap, the one or two most impactful things, financially for Shockwave over the forecast horizon? So Arrow is going to be our new platform. I'd say Arrow, Javelin, Coronary, just because of the scale of our, of the coronary market globally. Do you agree with that, Rob? Yeah. Yeah. Yeah. Yeah. I mean, right now, BTK is a dramatically underpenetrated by our platform. It's a sort of perfect clinical setting for Shockwave and an imperfect first-generation design that just sort of is more to, like, prove that it works versus build a real business. But I think the scale of the coronary procedure volume globally probably puts sort of Arrow number one as the workhorse and Javelin number two. ... Beyond external investment, it was, I think, the bottom bullet point on one of the first slides. Shockwave raised a convertible note of $650 million, and, you know, we've all been wondering what you intend to do with it. I think T-bills at 5% is maybe not the permanent destination. So kinda how do you think about M&A? You know, everything you've laid out thus far and accomplished thus far, you've been a first mover. You're developing a new market. Is that Neovasc would be developing a new market? The valve stuff is developing a new market. Is that the North Star, or is there a world where you might have interest in being a fast follower? I'm just curious philosophically there, and then in terms of kinda call point or destination in the body, if there's a piece of the cardiovascular systems that's more interesting than not. Yeah, so we are, as I said in that slide, we will be highly selective if and when... well, if we do any more M&A. We're encouraged thus far that every interaction we have with sort of Reducer and Reducer data and the feedback from customers is, we found a diamond in the rough, but there was a lot of rough around that diamond that Mike and team are having to clean up. And we like building markets responsibly, as we've tried to do both in peripheral and coronary. That's a big lift, though. So we're, we look at things that are already existing markets, that already have, sort of existing payments, et cetera, as, as areas that we, we could consider going into. We're not- it's not like we're allergic to nearer-term revenue. We're, we're, we're receptive to that, but we also look at this pipeline we built, and if, if in the end we, return the money and we've made some, interest on the- on our investment from the convert because we didn't find anything that was good enough, we're, we don't feel, we don't feel like we have to go buy something. But we did want to put ourselves in a position where if something was demonstrably better than anything on the market or demonstrably better than sort of nothing, as we have with the reducer, that just there's a vastly undertreated population, we wanted to be in a position where we could move strategically on it. And so this seemed like the least dilutive source of capital by far and gave us strategic latitude and flexibility that we wouldn't have had if we just. If we saw something we really liked, we thought we'd be on the outside looking in, had we not done that convert. Hey, over here. You got Patrick forward standing. Oh! Hey. Hey. I've got two, just quickly. One, any sense of the cadence on that 25% CAGR? How should we think about the shape of that over the coming years, faster to slower or slower to faster or? Yeah, we have an idea of what that shape is, but we're not ready to guide for next year. So I think that's a way for you to back me into guiding for next year. I had to, I had to try. I guess the other one is, like, just conceptually for you guys, the thoughts around the margin expansion, because you're kind of quite ahead in a lot of these markets. Wasn't it tempting just to shove every dollar into pushing the market expansion as fast as possible across all of this? I mean, the marginal dollar spent today drives a hell of a lot of growth over the midterm. And so how are you thinking about that investment rate? Is it just the clinical paradigms take time to shift, so it just would be wasted money, or how do we think about that? Well, we want to be thoughtful about how we spend. We also don't want to starve the opportunity. So, if I were to guess, I would guess that you'll see a bit more margin expansion sort of after next year, but we do see line of sight to improvement next year as well. And, I mean, Pat's team is well-staffed, the sales team is well-staffed, but we also know that the clinical workflow is going to increase relative to where it has been as we do sort of larger, more sophisticated, complex trials. Like, we're in an IDE right now for Javelin. We'll have to do an IDE for some of the other sort of next-generation coronaries things we're working on. Clearly, if once we leave first in human and move to EFS, et cetera, for the high-powered systems, those will be clinical trials. So we have a meaningful clinical lift to do. And yet, given the top-line acceleration, we think we can afford to both do all that investing we need to do and see sort of modest margin improvement year on year. Great, thanks. Oh, hold on, I can't record. Just two questions. One on Javelin reimbursement. Is that going to need different reimbursement because considering the different form factor, or is that covered under the current reimbursement policies? The second question is just, you know, when you first launched in the coronary, there was a lot of discussion on the commercial structure, and as you continue to get larger, does it make sense, you know, does it make sense to split it? I see that you didn't let Isaac up on the podium here, so. Yeah, do you need to split that down the line or see a, in the US, a need for that? Thanks. I think Rob and I would both agree, Javelin is IVL. IVL is reimbursed as. So in whatever the reimbursement is for IVL and whatever vessel bed, it should apply to Javelin. You know, so many of our customers do both coronary and peripheral. Granted, vascular surgeons don't, but cardiologists sort of meet at the iliacs. So if you're a peripheral guy, you'll do iliacs. If you're a structural person, you'll do iliacs. And so thus far, there's so much synergy, and beneficial synergy. Like, we're in the middle of launching C2+ at hospitals. Now, you're gonna be hanging out in the cath lab for four or five days, training everybody on sort of thinking about longer lesions or eccentric calcium, et cetera. And oh, by the way, you've got a peripheral case the next day. So, we think the sort of unique architecture of our system, same generator, like, it all works so seamlessly together. While there are some temptations because peripheral is a little bit more labor intensive than coronary, thus far, we'd rather add more specialists to cover versus split the team. TBD on OBLs. We don't. We don't have to think about how if there's gonna be a separate sleeve of selling or if that's gonna have a semi-split, we don't know yet. Certainly, there's a lot of cases and a lot of patients are getting treated in OBLs, and we wanna help those patients, too. Hey, Ryan Barokas from UBS, in place of Danielle Antalffy today. Thanks for hosting us today, guys. So first question from us on the coronary pipeline. So just how do you envision the coronary portfolio shaking out in 25 when Arrow comes to market? And what role do you see C2+ playing at that point in time? And with C2+, you decided not to raise price. Is it fair to assume with Arrow and some of the additional innovation announced today, that there will be the potential for price increases? And with that, how do you view the sustainability of the mid- to upper-80s gross margins, with all the new products discussed today? Rob, you want to do launch? Which one- Arrow's, Arrow and C2+, how, how are you gonna transition or? Yeah, I mean, we largely see Arrow as a better version of C2+, so that'll be a replacement for C2+ and a better mousetrap, essentially. In terms of pricing, like, I'll say the same thing I said about peripheral. No comment yet on what we're gonna do. Fortunately, we think we'll be in a very good position on gross margins, given sort of volume increases, combined with sort of back end of next year, Costa Rica coming online. We think that's, to use Rob's words earlier, it's a good guy for us, gives us further potential upside to gross margins. First product that goes to Costa Rica is gonna be C2+. That'll be sort of... We got to get it out of Santa Clara because we've got all these new products that need space. The model is gonna be Pat's team designs, pilots, moves into the clean room. Once it matures, Luis, who's our new head of operations, he and his team take it from Santa Clara and optimize it, and expand in Costa Rica. So we think that gives us sort of maxes out our the sort of the partnership with operations and R&D to bring products to market most rapidly, but also takes advantage of the skilled talent, skilled team we're starting to develop down in Costa Rica and gives us some margin upside. Yep. Hi, Larry. Hi. Hey, Doug. Larry Biegelsen from Wells Fargo. Thanks for taking the question. Just follow up on M&A. Is the focus still, you know, vascular, if you will, coronary, peripheral? How are you thinking about, you know, pre-revenue versus revenue, and what kind of dilution are you willing to accept? And I had one follow-up. We don't have a sort of dilution threshold that we're applying to things we're looking at. Before we did this convert, we believed we kind of had anything we looked at had to either be tiny, which is not interesting, or sort of needing many years of development just because of the price we could have paid for them. Now that we have more financial latitude, we've actually broadened our purview a little bit to think about things that are maybe closer to market in the US, not just internationally, like Reducer was. So we're open to things that are more mature and certainly that as long as that it doesn't... We don't want to buy anything that dilutes our IVL selling efforts, at least for the next few years. Whether that means we buy something that has a separate sales channel, like, if you think about a lot of cardiovascular companies have somebody who sells coronary products and then somebody else who sells structural products. So, so, just because it's in cardiology or cardiovascular doesn't necessarily mean it would be the same sales channel anyway. So we look at every opportunity sort of independently. We look outside of cardiovascular. The person running BD for us had done BD for BSC and gone into venture, so had a very good... Rob Berman, he invested in a lot of non-cardiovascular stuff, so he knows what's out there. But we also realized that to move outside of the cardiovascular space, we'd better be really, really, really sure that it's the right thing, and recognize that we don't have subject matter expertise. So, it's a very high hurdle for us to buy anything. It's an incredibly high hurdle for us to buy anything that's outside of cardiovascular. ... Just for my follow-up, you know, I know we talked about this before. $15 billion-dollar TAM, I think you put out at $14.5 billion today. Yeah. You're about 5% penetrated, yet you signaled today, you know, the strategic change, you know, from focusing on calcium to, you know, this, you know, you called it, I think, you know, premier med tech growth company. Why this change now when you're so early in the penetration of your TAM? Thanks. Well, it's really not a change because we just bought Neovasc a few months ago. We are already. So if you think about it, where we were, we wanted to be standard of care for arterial calcification. So now we've got high-powered for structural heart, we've got reducer for angina. So it's an articulation, in essence, of a strategy that we were already embarking upon, and sort of clarifying that we are, like, we're ambitious. We wanna, we wanna grow for the next decade and be very high growth, not just growing at a few percent for the next decade. And while it's obvious from the numbers, we're scratching the surface of coronary and peripheral disease, and then you throw in carotid, and there's huge upside to carotid. We are sure that there are other ideas out there that maybe we can optimize, and if so, then we'll think long and hard about it, but we would consider bringing them in as well. Luckily, we feel no obligation to go buy something. We just wanted to be in a position where if we found it, we could, we'd have the ability to do so. Imran, over here. Oh, Imran. Thank you very much. Imran Zafar from Deutsche Bank. Can you just talk about the growth outlook, US versus O.U.S., just in terms of, you know, your opportunities for some of your pipeline products and sort of economic appetite for some of the premium products, maybe? Thanks. Yeah. So international versus US growth, Japan, Germany, are doing phenomenally well right now, exceeding US growth rates. Other international markets where reimbursement is more challenging are not growing as fast as the US So there's... In some countries, you can develop, as you know, you can develop a reimbursement pathway and secure payment. We'll have payment uptick in reimbursement in Switzerland starting next year, for example. But in a lot of countries, it's, "I'm gonna buy your device, and I'm gonna take money out of my hospital budget," and that puts sort of a lid on upside in a lot of markets. Where we have payment, we do incredibly well because there's such a huge appetite for IVL because it's safe, it's reproducible, it's straightforward, and integrates into the procedure so seamlessly. It sort of matches everything a doctor would want to optimize outcome for their calcified patients. It's just, well, if my hospital says you can't use more, then you gotta kinda be more selective. For the next few years, Mike, Mike will be selling more product internationally for Reducer than we can in the US because we're not approved, and won't be approved in the US We think the uplift in Reducer, as he articulated, is gonna be COSIRA-II data, and COSIRA-II data then will prove to the world how effective that device is for treating refractory angina, and that will be a real boost in the sort of 2026 timeframe internationally, followed by launch in the US We prefer products that have global utility. We found the sort of cadence of launch C2 internationally in 2018, learn everything about how to sell that product and build a really strong base for C2 leading into the US launch, and continue to have a tremendous international business for C2. Like, products that have global appeal and resonate globally to us are so much more meaningful 'cause it suggests that the product has such a compelling clinical benefit versus products that are completely dependent on US reimbursement idiosyncrasies. And we think with our IVL, we have a global platform. We think with Reducer, we're gonna have a global platform. So our preference is to find things that work globally, but for better or worse, the US system does give you better financial, sort of air cover than almost any other market once you are able to secure payment. So US is... We would rather have a business that is really equal US and international. Because of reimbursement and what that means in pricing, US is gonna be a bigger business for us than international. Okay. Then I know China's a pretty small market for you guys right now, but I'd love to hear what you guys are seeing on the ground, just given all the acute headwinds vis-à-vis anti-corruption, price caps, things like that. Anything notable that you're seeing there? Yeah. We have a great partner with Genesis in China, and we are getting sort of weekly updates from them. Initially, the anti-corruption thing seemed dramatically different than past ones, 'cause it's not the first time they've gone after corruption. We are anticipating a few more updates between now and our earnings call to sort of give a sense of where we think it's going. It doesn't— it might not be quite as different than past ones, but we want to make sure we have a pretty good sort of sense of what we think the trajectory is going to be before we project out what we think China is going to be doing. Adam Maeder, Piper Sandler. I wanted to ask about aortic stenosis, and was wondering if there's any early learnings that you can share. I think you guys have, you know, done a handful of patients in Australia and New Zealand in the 2016, 2017, 2018 timeframe. You know, just any learnings there, level of confidence that you got it right with the catheter redesign, and then, you know, what duration of efficacy do you think the product needs to be a viable commercial product for standalone therapy? So what I learned from the first version was that was a bad product design. I can say that because I inherited it, so, like, the team, the team here is not, is not at fault. The way we looked at those early data, and Keith was part of it, too, anytime somebody says that you have a user-dependent design, that means it doesn't work. We had a design that, like, it was basically three pigtails that were supposed to go on the leaflets of the aortic valve, and sometimes it seemed to work, and sometimes it didn't seem to work, and you try to sort of blame the operator, and, like, that's just a bad idea. So, what was interesting in that process as we tried to figure out, do we kill it or do we keep going? Circa 2017, most physicians said, "You know, TAVR is perfect. Why would you get into Aortic Stenosis? Why would you try to make something else?" By 2019, 2020, more and more physicians were saying, "You know, I've got these leaks. I don't want to talk about the leaks very much, but they're bad when I get leaks. And I've got... I'm trying to treat bicuspid, but it's not that great with the valve, so I could use something. And now I'm starting to think about valve for life, and if I had something that enabled me to sort of push off a valve, that would be awfully attractive, because I don't know what's going to happen 20 years from now, putting in a valve. Or how many valves can I put in a valve if I've got a problem with the first one? So the need for something was frankly greater than it felt like the need was back when we were tinkering with the design that was underpowered and sort of kludgy. So that led us to sort of where we are today. And Keith and Mike, you can talk about the sort of perception of how long it needs to be. I think it was, it was underpowered, it wasn't steerable. And since then, and Doug and, Mike touched on this, this valve for life, this planning for the life of the patient has become really important. So instead of saying you're going to have a TAVR tomorrow, and, you know, bye-bye, it's which four procedures are you going to have during your life or even more? And can we move the first procedure to the left and then delay the second procedure to the right? So I think that's—everybody is interested in that. And then the other thing, of course, is that now we're seeing late TAVR failure and actually SAVR failure, and we think that, the circularity of the annulus is really important. And of course, that's a, that's a challenging thing to model and to do a clinical trial to address. But if you can get a circular annulus by making the annulus more compliant with the Crescendo device, then you might hope that, you know, the late results of the subsequent procedure are better. So there's plenty of material out there, lots of patients, and of course, this is on the background of TAVR, TAVR results getting better and better, and probably tomorrow we'll hear some more good results. But there's a need because of the amount of calcium, which causes anxiety with the operator. That's really helpful. If I could just- To your how long does the need last question, you guys have probably both done valvuloplasty balloons. Like, Yeah. I mean, because I'm the oldest person in the room, I did about 150 BAVs before there was TAVR, and some of them would last, you know, four days, and some of them would last six months, and you couldn't actually identify which ones were going to do well. And when you understand the pathophysiology of the valve, it's not surprising. Yeah. BAV is, you know, it doesn't do very much, frankly. In the US, it's used a little bit more than in Europe. Many European cardiologists have abandoned BAV altogether. If we could create a reproducibly, you knew as a cardiologist, it almost always lasted for 6 months versus BAV, it might be 6 days, it might be 6 months, it might be 3 months, I have no idea. Six months would be meaningful. A year would be more meaningful. 2 years would be hard to believe, like, amazing. But if you, if, if you could just create a sort of for every patient who, "God, I really don't want to put a TAVR in, I don't want to put a TAVR in right now" for whatever other comorbidity, if we could buy a patient 6 months reliably, almost every time, that, that's a real market. Anything greater than that is realer market. Just one last clarification question on the early approval in 2028 for aortic stenosis. Is that specifically for adjunctive therapy, or does that include destination therapy as well? Just wanted to clarify that. Thank you. Yeah, it would be, it would be adjunctive. It'd be too, that'd be too early to get a longer-term follow-up. ... Question online from Travis Steed from B of A. Two questions. First, 2024, are you still comfortable with the Street's 25% growth? We have confirmed that we are comfortable with the current consensus for 2024. Yes. His follow-up: How are you thinking about GLP-1s and the impact to TAMS, in particular, STRIDE GLP-1 trial and peripheral artery disease, GLP-1 trials? Nick and Keith have spent a lot of time thinking about GLP-1s. We do. because we keep asking them. So, we'll let them share our view on GLP-1s. Where, where should we start with GLP-1? Well, we were getting in a question, so you start. Okay. So, the GLP-1 receptor antagonists have clearly caused a lot of anxiety in the entire cardiovascular space. They have been around quite some time. They're not brand-new drugs. They have been around quite a while for treatment of patients with diabetes to improve glycemic control, but there's been a lot more focus recently on the slightly more fashionable weight loss reduction. What we've seen from some of the trials that are reported out, they have shown some reductions in composite endpoints that include major adverse cardiac events. Some of the data, for example, that Novo Nordisk released in August from their SELECT study, don't really tease out exactly what was affected. They've quoted the composite, and I think we're all waiting for those data to be presented so we can understand exactly what's going on. I think what we can say about GLP-1 receptor antagonists, as Keith pointed out, there is no evidence that these drugs affect vascular calcification. They may affect glycemic control, and for those of you who know about diabetes, whilst diabetes certainly is associated with coronary disease and it's a risk factor for the development of coronary and peripheral arterial disease, glycemic control appears to preferentially affect the microvasculature, so it's the eyes and the kidneys. And links between coronary and peripheral events and glycemic control is not so strong. All that said, I think that what we're going to see in addition to the population dynamics that Keith mentioned about increasing calcification with an increasing age of the population, we are going to see other effects. Now, notwithstanding the effects of GLP-1 receptor antagonists on weight of patients, which might slow down progression to diabetes, doesn't cure diabetes, it may slow down progression to diabetes. That change in the shape of the population, if you like, quite literally, as you go to older patients, more older patients in a population, you're going to have a lower lean body mass index, so the obesity thing will go down anyway. As far as the generalization of a GLP-1 receptor antagonist to the entire space, but data from the recent SELECT study showed that their uptake may be limited by side effects. 80% of patients in that trial had at least one side effect, and 20% stopped the medication, and that's in a randomized controlled trial where the patients are under scrutiny, will be encouraged to continue the drugs. In real-world cases, and this is some of the slightly earlier drugs, which may be less well tolerated than the new ones, discontinuation rates due to side effects could be as high as 70%. As far as the STRIDE study goes, which was mentioned in the question, the STRIDE study is looking at, I think it's Semaglutide. I can't remember which agent it is. But it's looking at exercise capacity in patients with intermittent claudication. There are no MACE or MAL, that's Major Adverse Limb Event, endpoints recorded, so not on ClinicalTrials.gov, and it's purely looking at exercise capacity. Now, I don't want to go down the rabbit hole of intermittent claudication. Intermittent claudication really is a separate thing to below-the-knee disease. It really is something. There is some controversy about the need for intervention, as opposed to for CLTI, critical limb-threatening ischemia, where some form of intervention is almost always warranted to improve limb salvage. Do you want to add anything to that? No, I mean, I would just say that, the penetration of, IVL and in fact, all calcium-modifying technologies is so low when we know that one in three patients, for example, has coronary calcification, that the headroom is huge. And, many of these patients will not be able to afford $15,000 a year for the meds. And, diabetic patients are notorious for not sticking to their regimen. So I think it... no one can doubt that GLP-1s are an important development, as were statins, and statins made some changes to acute coronary events very effectively. And GLP-1s will have an effect, but I... my personal view is it'll take a generation. And we are right at the, you know, we're at the hard end of the calcium end, and that, I think, is safe. And I know you're all wondering, was it a job requirement to hire somebody that had a British accent? It was not. It's just a coincidence that they're both from the UK. It was not a requirement. It's actually an English accent. In England. Yes, that's right. To be more specific. One more from me, Mike Polark from Wolfe Research. Just IVL competition, I think we now know at least two large companies are working on something. Some smaller private companies have raised capital. What's your expectation over the next three to five years in your, you know, 2024 to 2026, 25% CAGR? Have you contemplated competition? What timing, you know, best guess, peripheral coronary as you, as you look out? Best guess is peripheral 25 with a laser console. I don't know when a non-laser hits, maybe 27, since nothing's in the clinic yet. Coronary, end of 26 into 27, maybe. So we're, so we have tried to factor in, and we actually are more conservative on launch timings than what I just described. So we, we, we do assume competitive entrants, in that CAGR. Thanks, Doug. Carotid clinical and regulatory pathway, I don't know if I saw that. Yeah, we're, we are seeking to have both transfemoral and transcarotid indication. If we went only transcarotid, our surgeons would kill us. If we went only transfemoral, our other way, transfemoral surgeons would kill us, transcarotid, our cardiologists would kill us. We think we're gonna be able to have sort of one product meets both, but we'll have to do two arms of a trial, we believe. We indicated a 2027 approval. So but it's gonna be a, a- ID trial. ID, ID. Single arm, you know, or you'll have to have a control arm? We're not anticipating a control arm, at least in the current sort of design as we're thinking about it. Doug, the 25% CAGR implies over $1.4 billion in sales in 2026. Street's at about $1.3 billion. Where do you think the disconnect is between kind of the 25% CAGR and what consensus models today? Thanks. Yeah, we did the math. We realize it's a little above the street right now. We knew our pipeline, and you didn't before today, so we think we're pretty bullish about what reimbursement now, Arrow in the future, C2+ next year, E8, Javelin creating a real below-the-knee business. And what we're seeing, the very positive results out of international, both sort of fledgling development of peripheral markets internationally, but more importantly, the really strong traction we're getting out of Japan and Germany. We have one last question from Imran. Thank you. Just one quick clarification. You haven't talked about the tricuspid valve. Is that because calcification is just not an issue there? It's very uncommon compared with the other valves, and I think if you look at the prevalence of... We're doing the valves in the right order. So we're starting with the aortic valve. Clearly, MAC is coming to the fore, and many of the tricuspid solutions are effective clipping, and then obviously more recently, percutaneous valve replacement. So I would see that definitely as number three, and I'm not sure that the need is there in terms of the amount of calcification. Thank you. All right. Is it for questions? I think that wraps up the Q&A. We've got demos in the back and cocktails outside. Cocktails outside. Shocktails. Cocktails outside. Yeah. So enjoy. All right. Thanks, everybody. Shockwave Medical, at its inception, was an idea, taking this sort of large machine to break up kidney stones and downsizing it onto a catheter to crack calcium in arteries. Sort of crazy idea. When you think back to just the genesis of Shockwave, innovation's really in our DNA. That's one thing that's great about Shockwave. It's got the balance of a big company in terms of the stability and the resources, but also still that energy and drive of a smaller startup. We take a proactive approach to innovation and understanding the opportunities to improve our core products, but most importantly, looking for that next idea that can become the next breakthrough technology or therapy for us. We have a pretty regular cadence, almost monthly visits. We'll bring in groups of 6-12 physicians, but then we also try to get engineers to go out into the field to go see live cases and to go to conferences. 'Cause it's really as many different perspectives as you can put together, the better chance that you'll end up at the right point. It all translates into: How do we more effectively and efficiently provide a better solution for our customer that then results in a better outcome for our patient? What's exciting about Shockwave is that we're far from reaching the full potential of what IVL can do. When I look to the future, there'll be a whole new generation of products that are out there, and I want us to be at the forefront of that. We'll grow by further expanding and improving through a constant stream of new product designs. We'll also grow by pulling in new patient populations, such as we will with the refractory angina population. Innovation doesn't just live within R&D, it lives within Shockwave as an entire organization. Ensuring that everyone knows that their ideas matter, and by carving out enough time and space for people to work creatively together, it seems to stimulate ideas across the organization, and as a result, we are generating a remarkable pipeline of new ideas. Innovation is part of everything here at Shockwave. We're a company that's done great things, that's gonna do more great things. It's a really motivating place to be. Shockwave Medical, at its inception, was an idea, taking this sort of large machine to break up kidney stones and downsizing it onto a catheter to crack calcium in arteries. Sort of crazy idea. When you think back to just the genesis of Shockwave, innovation's really in our DNA. That's one thing that's great about Shockwave. It's got the balance of a big company in terms of the stability and the resources, but also still that energy and drive of a smaller startup. ... We take a proactive approach to innovation and understanding the opportunities to improve our core products, but most importantly, looking for that next idea that can become the next breakthrough technology or therapy for us. We have a pretty regular cadence, almost monthly visits, where we'll bring in groups of 6-12 physicians. But then we also try to get engineers to go out into the field to go see live cases and to go to conferences, 'cause it's really as many different perspectives as you can put together, the better chance that you'll end up at the right point. It all translates into how do we more effectively and efficiently provide a better solution for our customer that then results in a better outcome for our patient. What's exciting about Shockwave is that we're far from reaching the full potential of what IVL can do. When I look to the future, there'll be a whole new generation of products that are out there, and I want us to be at the forefront of that. We'll grow by further expanding and improving through a constant stream of new product designs. We'll also grow by pulling in new patient populations, such as we will with the refractory angina population. Innovation doesn't just live within R&D, it lives within Shockwave as an entire organization. Ensuring that everyone knows that their ideas matter, and by carving out enough time and space for people to work creatively together, it seems to stimulate ideas across the organization. And as a result, we are generating a remarkable pipeline of new ideas. Innovation is part of everything here at Shockwave. We're a company that's done great things, that's gonna do more great things. It's a really motivating place to be. Shockwave Medical, at its inception, was an idea of taking this sort of large machine to break up kidney stones and downsizing it onto a catheter to crack calcium in arteries. Sort of crazy idea!