How is that not a miracle? It's a miracle. If she had stumbled into almost any hospital in the world other than that one on that particular night with Dr. Tu on call, she almost certainly wouldn't be here. He's the only person in the world who had the skills and the tools and the knowledge of the disease state. It's not even uncommon, right? Now we're treating many hundreds of patients a week. We do our very best to connect our people, the people in this room or the people in this building to these stories. We're not just making widgets. We're not just doing accounting or HR. People have committed to a cause, to something much more important than themselves, much more important than business. There are now thousands of people on this planet who otherwise wouldn't be here without the work being done in this building, the work that our people are doing. There are thousands more whose lives have been changed. The trajectory of their lives changed in fundamental ways. Every one of these patients has a story. They have a history, hopefully a future. They've got people who love them, and it matters, right? Our team has committed to things much more important than just business. Every one of them could do something, do their job they're doing right now somewhere else in Orange County, and that's not what they're doing. Every one of our people in the field could work for any other med tech company, and they have. They come here for a reason. This has been a very personal journey for me. The disease impacted my life and my family's life in really important ways. When we sold my last company, my daughter was going to school. She was going away to school, the first of three. I was kinda depressed. I didn't wanna sell the last company. It was a pretty cool idea as well. The first thing that I stumbled into when I lifted my head up and started looking around was this company with this disease state. There was no question that all the decisions that I had made personally and professionally, everything that I'd experienced, had led to this moment. What I'm really surprised by is the number of people in the company who have told me the exact same story, right? There's no accident, right? Extraordinary things happen when people commit themselves to ideas bigger than themselves, things that should be impossible. One patient at a time, one device at a time, one case that's blue-collar, grinding execution that changes lives in fundamental and beautiful ways. One after the next. Change the world that way, just a little bit. When I was growing up, my dad was a blue-collar worker. Not different from some of the lowest paid people in this building, our manufacturing people, quality assurance. A little dirtier job than the clean rooms we have here, but similar idea. He was my hero. You all have parents. You know what that's like. Many of you are parents. You know how it feels on the other end. My brothers and I- I'm 55 years old now. My brothers and I still talk today about what it was like when we saw our dad not being treated like a hero, right? The lack of respect, it changes you, right? We see this, and it's going on everywhere all the time. It's important to me that every single person that we work with, every single person in this building is treated with love, trust, and respect. This isn't some neo-hippie nonsense. This is who we are. This is not what we do. This is who we are. It matters. We're in this together. You've seen the building. There's no offices. Every single room, every single conference room has windows, not opaque doors. We're either in this together or we're not, and we are in this together, and you will see that, from our people. One last thing I wanna leave you with. Responsibility, not opportunity. I've been asked by many investors over the last couple of years, some of you, "When are you gonna get into the stroke space?" The answer is we're not. Not because it's not a big opportunity, right? There's lots of room to grow in that space. It seems, as we've done the analysis, that the clinical problem that technology can solve is being solved pretty well. Get the clot out pretty quickly, right? I recognize that because we build really good thrombectomy devices, because we're really, really good at selling stuff, we can make a lot of money. That ain't why we're here. Lots of people are entering the stroke space. Lots of people are entering this space. I'm a capitalist. God bless more competition. It's probably better for everybody. That's not what we're here for. Contrast that to what you're gonna see a little bit later on. There's a million people, I'd say, walking around, but they're not walking around. A million people with venous leg ulcers as a result, specifically of untreated or undertreated DVT called post-thrombotic syndrome. It's venous hypertension caused by the scarring of the deep veins because the blood clots were left behind. We're working on the acute phase. As you know, you've seen the devices. You know what we do. We've committed ourselves to curing, not healing, curing venous leg ulcers. With great gifts comes great responsibility. It's not good enough to make money, right? What we're here for is something more important, and it matters. It joins all of us. This unity of purpose has an extraordinary impact on the pace, the things that people are willing to do for this cause. Right now, venous leg ulcers are treated literally with Band-Aids. Expensive, fancy Band-Aids, but they are literally treated with Band-Aids. No one's even bothered to think about the underlying cause. I think we're gonna cure venous leg ulcers. I'm a short-timer, as many of you know. Less of me, more of this amazing team is probably better for all of you. I want to introduce the next CEO of Inari Medical. I don't need to introduce him. You've seen him. Drew looks a little different than I do. He sounds a little different, but there's not a shred of difference between his commitment to our people, to our cause, to these big ideas. We take care of patients, we take care of each other. We think as big as we possibly can. Drew is the single best problem solver that I've ever seen, the single best executive that I've ever had the privilege and honor to work with. All of the systems and processes that have resulted in this spectacular deluge of data that's coming down the pipe, the cross-functional communication that's resulting in this ridiculous wave of new products continuing, he did that because I couldn't. I've made the case to all of you, and I'll make it again, he's gonna be a way better CEO than I ever could have been. The pure problem-solving, the pure intellect, and he's pretty good. My friend and the next CEO of Inari Medical, Drew Hykes. Thank you, Bill. You are a tough act to follow, as always, both literally and figuratively. I hope already in that patient video and in Bill's remarks, you've gotten a sense of this mission, this commitment we have to putting patients first, to making no small plans, to taking care of each other. That has certainly been the foundation of everything we've built so far. It was clearly the foundation of Bill's remarkable leadership over these last 8 years, taking us from a scruffy venture-backed company with no approved products to where we are today, 1,100 clot warriors, closing in on 70,000 patients treated. That mission has guided us at every step and will continue to be, the guide for everything we do on a go-forward basis. As a result, we thought it was the absolute best place to start this management presentation this morning. I'm gonna continue with an overview, and then we're gonna spend a fair amount of time walking through each of our five growth drivers. Not only the remarkable progress we've made in each up until now, but also how we're thinking about each of them on a go-forward basis. After that, we'll have a quick break, and then we'll reconvene here. Dr. Tu is gonna host a physician panel with two physician guests, Dr. Huff and Dr. Abramowitz. Mitch will come up and conclude our prepared remarks with some content on our financials. Then, if we're doing this right, we ought to have about 30 minutes at the end of this for some dialogue and some Q&A from you guys. Along the way, you're gonna get to hear from this group. You may think this is a webpage from an Orange County modeling agency. No, this is our executive team. This is the most capable team I believe in med tech. The expertise, the breadth and depth of talent we have here is remarkable. I would put this group up against anybody else in med tech. You're gonna have a chance to hear from many of them throughout the course of the day, and a lot of them are here as well. What's most remarkable about this group, though, is the sense of commitment and unity of purpose that we have in this mission. I hope you see that as you engage with them. Let's go ahead and dive in. This is why we're here. This horrendous disease, venous thromboembolism. Clots on the venous side of the body. Obviously, think big vessels, low flow, low pressure, and as a result, clots forming slowly over time with worsening symptoms. This is what folks have for genetic clotting disorders. This is cancer. These are patients that have just spent too long on an airplane or a car. Oral contraceptive use. All of those risk factors for venous thromboembolism. We're focused on two manifestations of that. The first is DVT. So this is a clot between the back of the thigh and your belly button. On its own, not a highly mortal disease, but a horrible condition with truly burdensome morbidity. In fact, the quality of life scores for the 50% of these patients that go on to develop PTS is as low as heart failure and cancer. If that DVT embolizes, flows up through the right heart, lodges in the pulmonary artery, that's what causes a PE, and that is absolutely a highly mortal disease. In fact, it's the third leading cause of cardiovascular death behind stroke and MI. A truly horrendous disease and a very widespread disease. We estimate here in the U.S., incidence alone, 710,000 patients presenting with either iliofemoral DVT or intermediate high-risk PE, and you can see the breakdown at the top there. When you apply our ASPs against those two TAMs, we believe a $5.8 billion TAM here in the U.S. alone. When you look internationally, that number climbs to north of $15 billion. What's striking about both of these markets is how modest the existing interventional penetration is in each market, somewhere between 15%-20%. Even within that segment, lytics today are still the predominant interventional modality. The vast majority of these patients, 80%-85%, are being treated with conservative medical management, with anticoagulation alone that does nothing to address the existing clot, simply tries to prevent a new clot from forming. We didn't build Inari. We didn't commit to this mission to take share from the existing modest interventional segment of the market to take share from lytics. We committed to this mission to change the standard of care for this entire group of patients, to move patients from conservative medical management to definitive catheter-based intervention. That's a movie we've seen before. You go back decades to how MI used to be treated, conservative medical management, lytic-based intervention, and finally the emergence of definitive catheter-based intervention, what we know today as the modern-day armamentarium of interventional cardiology. More recently, the same story has played out in stroke, the migration from conservative medical management, lytics to now definitive catheter-based intervention. We believe that same evolution is inevitable in VTE, and that evolution is already underway, and we are leading that evolution. The biggest driver of that evolution is purpose-built solutions designed from the ground up specifically for venous thromboembolism. You saw those in action next door. Completely different technology platforms, completely different mechanisms of action. That's because they've been designed specifically for the clinical and technical challenges of removing DVT clot versus clot from the pulmonary arteries. They share many of the same common advantages, right? A single session intervention, the ability to remove all the clot, minimal blood loss, simple, intuitive, no use of thrombolytics, no consequent ICU stay, and as a result, a very favorable economic value proposition. Along that whole list, what's most important is that ClotTriever and FlowTriever take out all the clot, and that matters. That matters to these patients. It matters in the acute phase of their disease. You can see that as their hemodynamics improve on the table, as their symptoms resolve as soon as you get the clot out, and it matters longer term as well, protecting their pulmonary function, avoiding the onset of this dreaded post-thrombotic syndrome. Taking out all the clot matters, and we designed FlowTriever and ClotTriever and have iterated those platforms to achieve that very result, taking out all the clot. As we brought those two technologies to market, our efforts have been focused on executing across five growth drivers, and we've made remarkable progress in each of these five areas. You're going to hear more about each of them. Quickly, the first expansion of our U.S. sales organization. When John Borrell and I started 5 years ago, this week, actually, we had four sales professionals on the team. We now have 270+, and we've deployed that group into a very intentional, deliberate, unique commercial system that John will tell you more about. He'll also share our plans going forward in that first growth driver. The second growth driver is driving penetration. Nobody even knew what a VTE program was 5 years ago. Fast-forward to where we are today. VTE Excellence is a codified, comprehensive market development program designed to support accounts in developing a systematic approach to this disease, just like you've seen in stroke and MI. We've made a lot of progress. The fact of the matter is these patients are there in the hospital. Our physicians are there in the hospital. All we need to do is connect the two. It's a maddeningly simple but still a complex problem. We are going to solve that problem. That is a problem we can and will solve. Eric Khairy will tell you more about the efforts we're making there. Our third growth driver in clinical evidence. 5 years ago, we were focused on small IDE studies, surrogate endpoints. We've now subsequently enrolled the two largest prospective studies ever done in DVT and PE and are now moving into randomized controlled trials. We have built a clinical evidence machine at Inari. Tara Dunn will tell you more about that growth driver. Fourth growth driver is the innovation machine that we have built. 70 R&D engineers. We now have five purpose-built toolkits focused on unmet needs across five different TAMs, with much more to come. Tom will take you through that, and then I'll come up at the end and talk about some of the new markets we're entering, both from a patient population standpoint as well as our efforts to expand internationally. When you take all this together, this is a $20 billion TAM with the new markets we are entering, and that is in addition to the $10 billion prevalence opportunity we have, responsibility that we have that is associated with chronic venous disease that we'll talk more about. Although it hasn't been our goal explicitly, along the way, we've also generated premium financial performance, 133% growth in CAGR, 91% gross margins, and with the secondary that we did in the spring, $330 million on the balance sheet to continue to invest in these growth drivers and continue to invest in helping these patients. Along the way, we have established what we believe are some really important competencies and capabilities that are gonna be scalable, not only to continue to do the work we need to do in VTE, but increasingly to help new groups of patients. The ability to identify an unmet need, to develop purpose-built solutions and toolkits that address that unmet need, a really efficient commercial system that takes that technology to physicians and to patients, and then a clinical evidence engine that supports all of that with really good data from a safety and effectiveness standpoint. All of that resting on a foundation of operational and manufacturing excellence. Those are the capabilities that we have invested and installed and built here. That's what we're going to leverage as we move forward. Despite all the progress that we've made, I think you'll hear as we walk through these growth drivers, we are just getting started, and there is lots and lots of runway out ahead of us in each of these five areas. With that, I'd like to switch gears, and we'll dive into our first growth driver. I'd like to introduce John Borrell, our Senior Vice President of Sales. As I mentioned, John started 5 years ago. His fingerprints are all over the expansion in the sales organization, both strategically and tactically. He brings 25 years of sales leadership experience to this role, big companies and small companies. He is also a Division I hockey player, a fierce competitor. He has purple in his veins, and he wakes up every morning looking to win. JB? Can you hear that? That's better. Hey, everybody. Thank you, Drew. If there's anything that I like talking about, it's our sales team and the growth in our commercial system that we have. Thank you for giving me the opportunity to do that. As you've seen, we've had tremendous growth in our sales team over the past couple of years, going from 75 sales representatives to over 270 in a very short period of time, almost quadrupling the size of our sales team. At the same time, we grew our account base and the number of accounts that we serve, and so going from 650 to roughly 1,400 in that same period of time. All of this with intent and purpose to increase density and to position ourselves for deeper penetration in the future. While we added more salespeople, we were also splitting territories at the same time. Even though we doubled our account base, we were able to shrink territory size down to about five accounts per rep on average from nine 2 years ago. What does that mean? It allows the reps to be much more focused, put much more time into the accounts that they have, and ultimately go deeper and drive more high-quality activities in each of the accounts. Critically important to our success, and it is working. To date, we have focused mostly on growth and density and not as much on productivity, but yet we've been productive nonetheless. You can see that we've had a nice growth in revenue over time that has outpaced growth in territories, which is great to see. All of this suggests that we are making some headway on productivity as well as penetrating the accounts that we're serving right now. That's all great. While we were aggressive in splitting our territories, we still saw an increase in cases and productivity with our reps and the people that were being split. That is a great sign. Our new salespeople come on board, and they are productive right out of the chute. In month 1 or 2, they're already productive. Every rep, over the course of time, is increasing productivity with their tenure. We have a significant footprint, greater than 270 salespeople currently, but we believe we're just in the middle innings of that build-out. We continue. We believe that we'll continue this pace of growth over time as we continue to penetrate the VTE TAM and tackle new market opportunities, and unmet needs, and eventually growing into the largest interventionally focused sales team in the industry. As we've grown our sales team, we've also built a very robust non-sales commercial team to support our go deep efforts. The capabilities of this group were installed specifically for the huge opportunity that we have in VTE. Think of it as peer-to-peer approach for every key stakeholder in the hospital to help them develop their VTE program. I'm gonna focus on a couple of these, to start here. The health economics and market access team. This is a group of certified coders and billers that Inari has employed that works with our sales team at early-stage accounts on the VTE curve, VTE Excellence curve. They are fairly new accounts, and the goal is for this team of people to work from a peer-to-peer perspective with the coding and billing team of the hospital to make sure that they're coding and billing properly and that they're not missing anything. What this does is it allows the account eventually to recognize and realize the impressive economics they can see from a strong VTE program and as they treat more patients. That piece is critical as we take that account along the VTE Excellence curve. On the very other end of the spectrum is the Inari Solutions group. This is a group of former hospital administrators that we have employed that work with our sales team at later stage accounts on that VTE Excellence curve. They work from a peer-to-peer perspective with hospital administration of that target account to help them build their VTE program. Again, from a peer-to-peer perspective, using their experience to do so. When you look at this team as a whole, in the entirety of the commercial team, we rival some of the biggest med tech companies in the space and in the industry. The competencies that we've installed, I wanna make sure that everybody understands this. It's not just sales competencies, it's market development competencies as well. That's what this is all about. No other company in this space is doing this. Nobody. We're the only ones that is out there developing these programs, thinking about the patients and the untreated patients, identifying those patients, risk stratifying those patients, and getting them referred to a treating physician who knows what to do with them. We've done this, and this is a differentiating factor of Inari. Our customers tell us this all the time. Nobody else is doing it, and it's seen. At the center of our success is the one-of-a-kind commercial system that is designed to serve patient needs, not necessarily sell more products. It is every element of this system that we have here is designed with purpose to be high touch. It is very efficient as it is effective. It is scalable, it's repeatable, it's transferable, it's consistent, it's sustainable over time, and it is proven to be effective at developing large markets. We've got this. Let's talk about this system that we have. It begins with the people that we have and who we hire. We have a very unique hiring process. Our sales, the candidates for a sales position, they have the ability to demonstrate what they can do. Do they fit our team? We can see that through this interview process they run. By the time that person is hired, they've had a chance to dig in on our company, our opportunity, our culture, our people, our physicians. They're running at this thing with their eyes wide open, with passion and hunger, and they're fired up. Think about it, when you're hiring 20 people and they're all bringing that enthusiasm, it is an amazing feeling. The energy is second to none, and I have never seen anything like it on this team. When we hire people, we're not necessarily looking for the best people on paper and resume and experience. We're looking for the right fit for our team and our culture and our people. That is critically important. We're looking for people who believe in our mission right along with us. If you were to go to our national sales meeting that we had in April in Houston, you would have gone into the room, you would have appreciated the clinical acumen, the technical acumen, the business acumen. You would have appreciated the energy. I think what you really would have seen and been impressed with the most is the commitment and the passion to our mission. It literally, you could feel it in the room, you could feel the energy, and it was all consistent. That is what Inari is. That's what we have. You heard Bill talk about it earlier, you heard Drew. It is real. In addition to that, we want our team to be the most clinically sound sales team in the industry. It is critically important to us and to our customers, and we believe we've got that. We hear it from customers regularly. Our people make a difference. They're in the cases regularly. It's because of our training program. We've got a one-of-a-kind, best-in-class training program here that allows us to hire the right people and train them up to be the best. We want our accounts to want these people in these cases. Our people are not just product experts, but they're disease state and procedural experts as well. We want them in every case. We have a single-tier sales team, no clinical specialists, and that's intentional. We want all of our people in every case. We want our customers to want them in every case as part of the team because there's a critically important thing that happens in every procedure, where physician and product and patient come together. The information and feedback that comes from that interaction is critical to our success as a company in helping us make decisions. We want the very best person that we can possibly have in that interaction in every case, because that information, as it's funneled into the company, allows us to make decisions on product development, marketing programs, clinical research, messaging, and on and on and on. It is critical to what we do, and it's critically important to our success. That is our system. It's unique, it's different, it's not easy, but it's extremely effective, and we've got this. Because all the pieces of this are in place, it is transferable to new products, to new TAMs, even internationally. We built this system, we know this system, and we can execute on this system over and over again. It really, in many ways, empowers us to think big, to go after big unmet needs, to big markets, those that require a high-touch sales commercial system, those that require a market development lift. We know that we've got the system to do it and the people to do it. We know also that we've got a long way to go in the VTE opportunity to penetrate that to the level that we wanna be at. We've identified a couple of adjacent disease states that lend themselves to this commercial system, and it fits perfectly. Bottom line is we're not looking to develop me-too products, to sell me-too products. We want large markets with unmet needs. We've got the system, we've got the people. We're confident that we can do this over and over again, and we believe we're just getting started. I want to introduce the next person up to talk about driving deeper penetration. Every sales leader wants a good marketing partner. I have over the course of my career had good and bad. I will tell you that Eric Khairy is the best that I've had. He is. He's, to begin with, very intelligent. He is soft-spoken, he's humble, and he's extremely good at what he does. He has been an incredible partner to me and plays a huge role in the success of our commercial team. Eric, I'd like you to come up. Our SVP of Marketing. That was awesome, JB. Thank you. Nice job. Nice job describing how we've built out our commercial system. That structure and those competencies are what enable us to drive deeper penetration in VTE. We'll walk through our second growth driver in this next section. All right, let's first start with the significant responsibility in front of us. You heard Drew highlight earlier that the VTE market in the U.S. is significant. If we look at a macro level, we've got 430,000 addressable DVT patients and 280,000 addressable PE patients. Combined, that gives us a total addressable market opportunity of 710,000 VTE patients per year. Today, only 15%-20% of these patients are receiving any sort of intervention. Despite our growth and our execution to date, less than 5% of patients that should be treated are being treated with Inari products today. We've got a lot of work to do and a lot of room to grow. While we'll continue to open new accounts, our growth increasingly is going to come from driving deeper penetration within our existing accounts. Why is VTE so undertreated? One fundamental reason is the lack of a systematic approach to identify, screen, and triage patients within the hospital. You heard Drew highlight earlier that VTE has a lot of comparisons to MI and stroke, but there's one very important way in which VTE is different. VTE patients are already identified in the hospital. These patients have symptoms. Either they can't breathe, they're short of breath, their leg's painful, swollen. They make it to a hospital, and they get diagnosed. Early in MI and stroke, part of the challenge was getting these patients to identify symptoms and get to a hospital. Ambulance drivers needed to be educated. There was a significant market development lift to get the diseases identified. With VTE, these patients are already in the hospital. You don't need to go out and find them. They're already there. The interventionalists are also there that want to treat. You've got this whole maze in between them, and because of that maze, patients slip through the cracks. As Drew said, this is maddeningly simple, and this is a problem that we can solve. We know that VTE patients present uniformly. We can see that at a macro level, these patients, we've got 710,000 of them across the country, and we've got 740,000 acute care hospital beds. That gives us a ratio roughly of one VTE patient to one hospital bed. If you've got a 500-bed mid-sized community hospital, you can expect to see around 500 addressable VTE patients per year. We've actually tested this assumption. We've worked with several of our accounts. We've had them pull their own diagnosis data, and it very closely matches this 1:1 ratio. When we show this data to accounts, they immediately recognize this as a quality issue. The problem is that there's just no system in place to connect the VTE patients that are in the hospital to the VTE experts that are also there. As a result, patients are being treated extremely conservatively because they're not being seen by the experts that understand their disease. For the most part, they go home on anticoagulation, completely unaware of the severity of their disease and that definitive therapies are now available. We've already shown, Tara's going to tell you more about the 2,000 patients that we've studied to date. The clinical outcomes have been excellent. The economic outcomes have also been fantastic. That's why we have our health economics and market access team that John described earlier to help us communicate this story. What's really missing here is that systematic patient pathway, and that's a problem we think we can solve. VTE Excellence is how we describe our approach. It's a comprehensive, codified market development process to build VTE programs. We've identified key elements that need to be put in place to make this all happen. There are three stages to the process. It starts with ENGAGE, where we build the foundation, and we find champions. We've got EMPOWER, which is where we start to create patient pathways, awareness, and we assist with coding and reimbursement. Finally, EXCEL is where we implement consistent patient algorithms. We put VTE coordinators in place, and we start to get full administrative buy-in. If you look across the 1,400 or so accounts that we're currently in, we've got around 1,250 or so in ENGAGE, about 120 in EMPOWER, and 20 or so in EXCEL. While we continue to fill that ENGAGE bucket with new accounts, we're systematically moving accounts along this continuum. We've very successfully been able to do that predictably. The good news is we've gotten really good at moving accounts along this continuum. That really matters because way more patients get surfaced in these later stages. If you look at our EXCEL stage, 4x more patients get surfaced in that part of it than do in ENGAGE. The bad news is, though, if you look at this, that 80% of patients that should be treated are not being treated, even in our best accounts. We have so much responsibility remaining. There's a long way to go. Even in our best centers, we could be doing so much better. Realistically, how deeply can we expect to penetrate the VTE TAM? If we look at MI, we can start to get a sense of what's possible. With MI, nearly all patients today are being treated with intervention. What makes MI a reasonable proxy? Well, PE and MI are both acute thrombotic diseases that kill patients. If you look at PE, it's the third leading cause of cardiovascular death. It's the number one cause of preventable in-hospital death, and the 30-day mortality for intermediate-risk PE is 15%. That's 5x what it now is for MI. The vast majority of PE is caused by DVT. We absolutely believe that VTE should be intervened upon as systematically as MI. We've codified and we're scaling our approach to get there, but we still have a lot of work to do. Convincing hospitals to build VTE programs takes more than a high-powered, high-touch commercial system. It also takes compelling clinical evidence to support a physician's decision to treat. To walk through our third growth driver, building clinical evidence, I'd like to invite up our Senior VP of Clinical Affairs, Tara Dunn. Tara was our VP of Marketing before she stepped up to build and lead our clinical organization. She's a fierce competitor, and she's got a commercial mindset, which has served us extremely well. Her Division I hockey team actually won a national championship. Tara, please come on up. Thanks, Eric. Great job. Hi, everybody. Thanks for making the trek out to see us today. Really, really appreciate it and look forward to sharing a little bit about our clinical program here today. I've been with Inari for about 6.5 years last June, leading the clinical program, and take this really seriously because I've worked at a number of companies, startups, large cap, and this is the first time in my career where I've had the benefit of working with therapeutic products that Brian and his team made that I believe hands down is what patients deserve. It's my job and our team's job to prove it with clinical evidence. We need to make those decisions easier for physicians and arm them to know who they should treat, when they should treat, how they should treat. As I said, we're here to do the right thing for patients. We've assembled a high caliber team, for which I'll talk a little bit about in the next slide, and we take this seriously. We're working at a fast pace because every single day a patient doesn't get treated, they're either gonna die or they're gonna suffer. One in two on the DVT side, as Drew said, and one in three on the PE side go on to suffer lifelong problems because of the clot left behind, and this is a great opportunity for us to transform medicine. From a market development perspective, we're not here for science fair projects. We are here to understand the hurdles to adoption and be very deliberate with our clinical evidence generation to treat more patients and make decisions easier for physicians. Highly integrated with John's team, with Brian's team and Eric's team to understand the customer needs and tailor-make our studies to answer those questions. In doing so, it sets the bar high. By working at the pace and generating this new evidence, it makes it incredibly difficult for new entrants to achieve those same results, and it does set the standard for which they ought to compete. By the numbers, we've studied over 2,000 patients to date, 250 peer-reviewed publications, 20+ active or completed investigator-initiated research studies, and on top of that, six major prospective studies, including two RCTs. To put this into perspective, our team took a quick look on PubMed to get a sense of how many patients have been studied by our competitors in VTE, how many peer-reviewed publications do they have? Just taking a quick look at the last year, Inari has generated more patients studied and more peer review publications than all of the competitors combined. This is recognized and appreciated by customers that we are investing in this growth driver and making their decisions easier. I talked a little bit about the team. We've installed capabilities that are nimble, that are high quality, high caliber, so we work at an incredible pace. We're not outsourcing things. We have people who care about what they're doing and are really committed to producing results, producing them quickly. We're structured. We're highly integrated, but we are structured in four pillars within clinical. We have a clinical insights team. This is a group that helps design the trials, real-world evidence, healthcare economics. I'll give you an example. We purchased a dataset, 20% of inpatient encounters. We've been analyzing that with some data scientists and look forward to releasing data later this year, on that effort. From a trial execution perspective, we have an operational engine that is capable of scaling in new TAMs as well as globally. From an analytical perspective, we have biostats and a statistical programming team that can help us with sample size calculations and quickly cutting our data for rapid dissemination by our scientific communications team with help, which helps with our podium and our publication efforts. To that end, a lot of stakeholders, paucity of data, people need to know what to do. We've been highly present. This is just a sampling of the journey we have taken from a clinical perspective. If you look way over on the left, you'll see the FLARE IDE study. That's the ticket to enter the market for PE. 2016, we did this. It's a 100+ patient study that FDA requires. We've moved on now to these large-scale registries, largest in class, as Drew has mentioned, and now randomized controlled trials. In fact, we were blessed to have three late breakers accepted. This Sunday, we'll have our 800-patient FLASH registry data release at TCT Conference. Then end of October, we have two late breakers on our CLOUT registry, and Dr. Abramowitz will be presenting one of those two data presentations. Right now, we have five ongoing studies. Over 2,500 patients will be studied across the five of them, three in PE, two in DVT, two of them randomized controlled trials. Each of them, the largest in their class, as well as expanding the patient population that has otherwise been treated in and studied in other studies. I'll talk a little bit about each one now. Happy, of course, to go into more detail when this wraps Q&A and what have you. FLASH. You'll hear more about this on Sunday. This is our prior release dataset with 500 patients. Why is this important, right? There's not a lot of data in the field for folks to make decisions, right? Most get anticoagulation therapy, and if they don't get that, they typically get lytics. We don't think that's right, right? 2% of these patients have a brain bleed if they get lytics. Up to one in five could have a major bleed. Removing the clot matters and doing it in a safe way matters for physicians, it matters for patients. Excellent safety. No device related MAEs. If you look at mortality today in the PERT registry, so very large, broad registry where physicians can contribute their data, one in 10 patients are dying. If you don't die, one in three of those patients go on to have post-PE syndrome. Right now, we're seeing a 1% death rate with our FLASH registry. This includes high risk massive PE patients, 63 of them. We're seeing on-table results. Patients feel better on table. "Gee, doc, I can breathe again." That matters. Versus sitting in an ICU room being woken up every single hour to make sure that you're not having a bleed and that you're doing okay. As I said, one in three get post-PE syndrome, and we're seeing a rate of 1.5%. FLAME. FLAME is our second PE or third PE study, pardon me, second one concurrently running. FLAME is a dedicated high risk with massive PE patients, about 5%-7% or so of the total PE population. These folks are circling the drain, arriving to the hospital, often getting CPR. They are dying. Up to one in two of them die. It's a big deal. Usually get systemic thrombolytics and maybe some ECMO treatment. We designed this study in lieu of the AHA guidance as to how one might study this patient population, so we think there's a great chance that some guidance change with the results of this study. We've studied over 100 patients to date, all comers, whether they get FlowTriever or not, so that there's context for how FlowTriever performs vis-Ã -vis other technologies. We think that this might have an opportunity for a broader market development list because if you can traverse the right heart in a patient that's actively dying, circling the drain, remove that clot, restore them to normalization on table, why wouldn't you treat intermediate risk patients where you have more time to deliberate as a physician and remove that clot with far less stress? Interestingly, if you didn't read the headline here and you're focusing on my Canadian accent too much, the guidance today, eight patients, that's it. Four patients randomized to lytics, four in anticoagulation. The AC patients died. That is where the guidance today comes from. Eight patients, right? We have studied over 100 here and really look forward to seeing how that study comes along. Moving forward, our first RCT. Our PEERLESS study, after completing our 800-patient cohort of FLASH, we've had an opportunity to be thoughtful about how we are gonna pursue a randomized controlled trial. The first one we've embarked upon in PE is to answer the question of patients treated, what is the superior treatment. This is not a non-inferiority study. This is a head-to-head study of FlowTriever versus catheter-directed lytics. 550 patients randomized 1:1. Because some patients just simply cannot get lytics, we've actually included a registry arm for those absolutely contraindicated that will be treated with FlowTriever only, so we can provide perspective on how those patients do as well. Today, 60% of patients that do get treated get treated with lytics. As I said, I just don't think that's right. We're here to show that that belongs in the rearview mirror and no patient should suffer the bleeding risks that are associated with lytics. Moving on to DVT. Two late breakers, as I mentioned, coming up at The VEINS-VIVA meeting in October. One will be our CLOUT 500 patient dataset. The other will be our CLOUT 500 dataset vis-Ã -vis a propensity match with a raw NIH ATTRACT data. We've had a chance to dissect that information and provide context there, and that'll be released in October. 500 patients studied. Two out of three of those patients had subacute or chronic clots. Those patients ordinarily would not be studied in other trials. This might be an expansion of the potential, patient population that could be evaluated for treatment. Zero instances of vessel or valve damage, excellent safety profile. We're removing all of the clot in the majority of patients, and that matters. As you can see, excellent post-thrombotic syndrome scores at follow-up. Freedom from moderate to severe PTS matters. In fact, those with severe post-thrombotic syndrome scores, they score similar to cancer and heart failure patients on their quality of life scores. It matters. DEFIANCE, our second RCT, first in DVT, head-to-head against anticoagulation alone. Anticoagulation is standard of care. The purpose of this study is to make ClotTriever standard of care. Head-to-head comparison looking at treatment failure and that of, post-thrombotic syndrome through 6 months. In summary, we've installed capabilities to make this a very productive and deliberate process in our clinical department. High caliber team generating evidence that matters and can make decisions easier. In doing so, it sets the bar higher for those to come in the field. With that said, Well, Tom doesn't need an introduction. Everybody, I think, knows Dr. Tu. But one thing maybe I'll add. I've worked with a number of CMOs over the years, and I have to say. Tom has this knack for engineering. He can look at products, experience them in you know, some of the setups that you saw today, and he has an ability to provide some engineering feedback that's second to none. Additionally, his excellent business judgment. You don't see that sometimes in clinicians and Tom has it all. It's a great privilege to invite Tom up to the stage here. Thank you. Thank you for those kind words, Tara. Appreciate it. How's everybody doing? You guys excited yet? If you're not, you should be. I've got the tremendous privilege of talking about our fourth growth driver, which is our innovation machine, led by our Senior Vice President of Engineering, Brian Strauss. It wasn't that long ago, just a few years ago, where Inari Medical was a single product, 510(k) approval company. In just a few short years, we have now developed 32 products over five TAMs. We've treated almost 70,000 patients. How do we get there? It starts with a foundational principle, starting with a great unmet need and developing tailor-made products to suit that need. It doesn't come from taking existing technology, trying to repurpose it into new areas of the body where we can possibly make money. No, it's solving great unmet needs. Where does that begin? It begins with our engineering and commercial teams in the field working with physicians, where the patient, product, and physician all come together, taking that knowledge, funneling it into the innovation engine that you saw some of today. The in-house capabilities, the vertical integration plan, results in rapid prototyping. I have literally seen physician feedback being translated into a workable prototype within days. That's why we're on generation four of our core products. Here's one great example of this innovation engine at work. Look at that clot. This is pulmonary embolism. This is a clot as thick as a rope, as long as your leg, 1,000x the size of a clot that causes a heart attack and stroke. It stands to reason that the best treatment for this is to get out all the clot as safely and effectively as possible. Why haven't we been able to do that up until recently? It's because the technology didn't work. You can't repurpose technology into the space and expect good results. Just creating a channel with a catheter isn't good enough. Trying to dissolve the clot with lytics causes bleeding and is ineffective at resolving a clot. We've discovered you need a large tube with high flow rates and a large mouth to engulf this clot in order to remove it safely and effectively. It works. It works tremendously well, but it's part of a larger ecosystem. What we realized is that you need multiple tools to deal with the variety of disease you might approach. If you took our Triever catheter and attached it to a continuous pump, you would exsanguinate the patient in 30 seconds, right? We've developed the FlowSaver system to return the blood. We've developed purpose-built syringes to limit the amount of blood loss. You have innovation from the access all the way to hemostasis to provide a complete solution for physicians and patients. Imagine having a competitive widget that now has to compete with this entire ecosystem. You can't simply just fold one new device into this and expect it to work. Let's change and now talk about deep venous thrombosis, right? I've just shown you we are the experts in aspiration. Why didn't we go with an aspiration approach for DVT? It's because we started with the patient and the problem. DVT starts with wall-adherent thrombus. The acute part of the clot is only what's in the middle. Everything else is subacute or chronic and adherent to the wall. That's what ClotTriever does. It safely gets in between the vessel wall and the clot to physically remove it. Why is this better than aspiration approaches? We know. We've collected hundreds of cases in which competitor devices have been used, and ClotTriever had to be used in follow-up to remove the residual thrombus that was left behind by ineffective therapy. What happens when you don't treat this disease by removing all the clots? You're left with post-thrombotic syndrome. We're gonna talk about that a little bit. ClotTriever exists in a larger ecosystem, a family of products, to address these complex scenarios. I do wanna highlight one element in the product family, and that's the ProTrieve catheter. Many of you are here 'cause you wanted to hear about ProTrieve. ProTrieve is a 20 French sheath which is designed to go from the internal jugular approach. It has an embedded nitinol funnel, which can expand to greater than 30 mm. That funnel is intended to be deployed within the inferior vena cava. This device is one of the most exciting devices that physicians have given feedback about because it takes the most complex IVC and DVT cases and makes them safe and easier. This device is going to be very well-received. The point you've been waiting for, right? Many of you traveled all the way across the country 'cause you wanted to hear about these three new TAMs. Here's where we get to talk about them. I'm gonna present the disease states and the devices, and then after that, Drew's gonna come up and talk about the markets and the commercial strategy. The first disease state, chronic venous disease, post-thrombotic syndrome. You've heard us talk about this a little bit before. Thousands of patients with DVT that's under-recognized, under-treated every week. What happens to those patients? That clot scars into place, resulting in complete occlusion of the venous pathway. That results in pain, swelling, trouble walking, and in the worst cases, venous ulceration. As you heard Bill say, there's over 1 million people in the United States right now who have venous ulceration due to obstructed veins. How are we treating those patients? What's the standard of care? Compression therapy, leg elevation, local wound care. Literally putting Band-Aids on this, covering them up, don't look at it anymore because there's nothing else we can do. We're not getting into the wound care space. We're talking about fixing the underlying cause of this, getting to the root cause and curing this disease. We believe the best way to do that is to remove the tissue and restore flow. ClotTriever BOLD is the first tool in the toolkit to address this complex problem. This has been built on tens of thousands of safe and effective ClotTriever cases. We know this approach works. We made it more aggressive to deal with the more chronic and wall-adherent thrombus. This device has been used extensively, and we know it's safe. In fact, we have cured venous leg ulcers in patients that have been present for over 10 years using ClotTriever BO LD. That case series has been presented by one of our physicians. This disease state, you can imagine, is very complex. Nobody's been able to tackle it before. We envision a whole family of products oriented towards the chronic venous disease state. ClotTriever BO LD, you've heard about, but you can imagine that you might need a tool to be able to cross these difficult occlusions. In addition, once you get across, you need something to restore flow, a recanalization device. One particular tool in this toolkit I wanna highlight, because I think it's incredibly special, is the stent cleaner device. You all probably cover venous stent manufacturers, thousands of those being placed. I think there's gonna be an investment in occluded venous stents in the future, and there's no effective therapy for that to date. The stent cleaner device, I think, is gonna be highly useful in this scenario. At the lunch session, you will get a chance to see some of the elements in this toolkit and, judge for yourselves, are we on the right path? That's disease state number one. Disease state number two, arterial thromboembolism, consequence of atrial fibrillation, peripheral arterial disease, patients presenting with an acutely cold leg that, may be threatened with limb loss. For those of you who guessed Artix is related to arterial, you're right. Absolutely. This is an established market, right? There are other products out there to treat arterial embolization. Where's the great unmet need? Tom, you guys talk about unmet needs. Well, guess what? Patients today with arterial occlusion oftentimes end up with surgery because there's no good therapies. Distal embolization, vessel trauma remain big limitations. When you can't get the clot out, which happens a lot, you end up using lytics, which we know cause bleeding, blood loss. We think we have a better solution. That solution is the Artix system. Again, a family of products. We have two elements that we are sharing today. The first is the Artix balloon guide sheath, and the second is the Artix mechanical thrombectomy device. The advantages of this system is it combines the best of both worlds, the best of mechanical thrombectomy with aspiration thrombectomy. Our 8 French sheath has 4x the aspiration flow of a comparably sized suction catheter. Additionally, it has a balloon that is used to achieve flow arrest. When there's no flow, you don't get distal embolization. These procedures are made much safer. This product is in limited market release. We've seen tremendous results. We have saved limbs with this device already. All right, third new TAM, small vessel thrombosis. What kind of disease are we talking about? We're talking about clots in the veins, in vessels now from 4 mm-10 mm. Where is the biggest impact, I think, clinically? Is in dialysis access. My dad's a dialysis patient. He relies on his AV fistula to stay patent so that he can live. It has to be patent every day, 3 days a week that he gets dialysis. What happens when that access gets clotted? You know what state of the art is? We intentionally push that clot into the lung, causing a pulmonary embolism. That restores flow so he can get dialysis, but you're investing in repetitive pulmonary emboli over time. There's got to be a better way to treat that, right? Doesn't it make sense to remove the clot rather than push it to the lung? There's other disease states in this small vessel thrombosis category, including upper extremity DVT as well as lower extremity DVT. We think the limitations of current therapy are just the wrong approach, taking this clot and pushing it as opposed to removing. Secondly, all of these treatments are highly recurrent because they're ineffective. You can't get out the chronic clots. You can't deal with large clot burdens. Our solution is the InThrill system. Many of you know this as the mini ClotTriever. That's how it was named in the FDA approval. The brand name is going to be InThrill. It consists of the InThrill sheath, an 8 French funnel tip sheath, very similar to what you've seen with ClotTriever, and the InThrill catheter, a laser cut nitinol mechanical thrombectomy device. This combination is highly effective at removing clots in vessels from 4 mm- 10 mm. The idea behind it is to transform fundamentally how we treat patients with AV fistula, AV graft occlusion. Three new products in three new TAMs, but we're just getting started. Everything I just told you is just 2022. Our pipeline is filled with products 2023 and beyond. I have them all detailed. No, I don't. I'm not going to be able to share those with you, but what I do want to leave you with is a sense of the capabilities that we've built here, right? Hopefully, you've seen in the tour the personnel, the in-house capabilities, the philosophy that we can count on continued innovation to come. With that, I'm going to now transition back to Drew. All of the accolades that you've heard of Drew are true. I will add one thing, though. You know, we had a CEO transition recently. We spent a lot of time messaging and listening internally to our team, knowing the charismatic nature of our outgoing CEO. The universal feedback that we received from our team was that there's extreme confidence in Drew because he's been there from the beginning. He's designed most of the processes and structure that we have in place, and his continued leadership are going to allow Inari to continue to win in the future. Drew Hykes. Great. Thank you, Tom. Okay, home stretch. Fifth and final growth driver, expanding into new markets. As you heard us describe, you know, really for the first 8, 9 years of the existence of Inari, we were just focused on PE and DVT. About 2 years ago, we felt we were far enough along with these competencies, with these capabilities that we could begin thinking about what we could do in some of these other disease states. You're seeing today the outcome of that work in these first of three new target addressable markets that you heard Tom describe. Rest assured, we are making no small plans, and we have got a lot of very interesting projects in the pipeline in this dotted circle outside the scope of what we're going to be talking about today. Stay tuned. This innovation engine is cranking on all cylinders. Before we go into those three new TAMs, I did want to spend one more minute talking about ProTrieve. Tom introduced this from a technical standpoint. We are in the end stages of our limited market release with this product. We've gotten fantastic feedback. We think this is going to be applicable in about 15% of our existing DVT cases, and it's going to allow those procedures that we're already doing, that we're already present in, to be done in a more safe and more effective manner. We have priced this product because it's going to be used in so many different ways as an independent SKU-based price of $4,000. As we move into Q4, you'll see us shift into full market release with ProTrieve. The first of these three new target addressable markets is chronic venous disease, a completely distinct patient population from the acute DVT market we've been focused on up until now. It is a huge market. 100,000 patients, we believe, presenting with new chronic venous disease from an incident standpoint every year. That's a $1 billion TAM from an incident standpoint. What is most compelling about this patient population is the prevalence pool. Think about those patients year after year after year without definitive treatment of their DVT and being relegated to trying to manage their symptoms in wound care centers across the country. We believe there's a million of those patients with chronic venous disease, and as a result, that represents a $10 billion prevalence opportunity for us for this patient population. We've already begun helping these patients, right? 3,000 patients treated with B O LD, a meaningful number of those suffering from a chronic component to their disease. We're already evaluating how best to serve these patients. Many of them are in wound care centers, and we're going to be doing some market development pilots here as we move through the end of this year to understand how best to identify those patients and get them in front of an interventionalist who can help treat the underlying aspect of their disease. That's market development work that we know how to do. That's a lot of the same capabilities and competencies within that commercial system that you've heard us talk about. We believe it's a lot of those same capabilities that we're going to be able to leverage. From an interventional standpoint, obviously, it's the identical call point that is currently using ClotTriever today. We're going to add to that toolkit as we move forward. Again, at the break here at the end, you'll be able to see some of the new tools that we're adding to this toolkit going forward. So another incremental patient population and revenue opportunity for us going forward. Second, unlike VTE, unlike chronic venous disease, arterial is obviously a developed market. There's no need for a heavy market development lift, but a significant unmet need, what we believe we can address in this market as well. It's another fairly large patient population. We estimate 80,000 patients with acute limb ischemia each year in the U.S. alone. That's a $600 million opportunity. We're already underway with the LMR for Artix, with the first two components of the system getting really good feedback on the proximal flow rest, really good feedback on the ability to aspirate directly from the sheath, and good feedback on that mechanical component. We're still working through the LMR, but we believe this has got a significant overlap from a site of service standpoint as well as an interventional call point standpoint. We're targeting a $7,500 ASP for this system. As you heard Tom describe over time, we would anticipate, as you've seen us do in VT, adding additional tools to the same arterial Artix system. Then lastly, on small vessel thrombosis, another sizable market. On the AVF side of this market, we believe between 150,000 and 200,000 AVF patients with thrombotic complications per year. We believe on the upper extremity and below the knee, another 80,000 patients in that category. Collectively, another billion-dollar incremental market opportunity for us here in the U.S. We've started this LMR back in August, and we believe there is going to be a significant overlap from a site of service. We believe about 20%, maybe as much as 30% of those AVF patients are being treated in the hospital, where we're already present. That will be our focus on the AVF side of this market opportunity. We're targeting a $4,000 ASP for this system. Again, the same theme over time, we would anticipate adding new tools into this InThrill system, to help further refine and iterate on the platform. When you take that together, in addition to the $5 billion TAM we already have in VTE, we believe with the addition of these three new markets, it's an $8 billion TAM here in the U.S. alone. The same competencies and capabilities, identifying an unmet need, purpose-built tool to address that unmet need, and as a result, new patient populations and three incremental revenue opportunities as well. All of that in addition to the $10 billion we have from a TAM perspective on the prevalent side of the chronic venous disease. When you take that all together and look globally, we believe from an incidence perspective, this is a $20 billion target addressable market across all five of those disease states on top of the $10 billion prevalence opportunity. Tons and tons of work to do for us, tons of patients to try and impact as we move forward. That's new markets from a patient perspective. I wanna shift gears and spend the last minute or so here talking about the new market opportunity we have in our international expansion. As you know, we're about 2 years into our international work. Primarily, we've been focused initially on Western Europe. We've got the initial commercial footprint established. VTE, just as prevalent, just as unmet, spectacular and unmet need internationally, as what we see here in the U.S. We began really focusing on Western Europe. We've done cases now across all of the Western European markets with both technologies. We're seeing really good feedback and enthusiasm from the docs. Obviously, the same unmet need, same response to our purpose-built solutions. As a result, we're seeing nice sequential growth month after month, quarter after quarter. In addition to Europe, we've also done cases opportunistically in a series of other international markets, Canada, Chile, Singapore, Puerto Rico. So as we move forward, you'll continue to see us gain clearance and enter some of those markets. We've got some that are right on the cusp here, Australia, New Zealand, Argentina, Colombia, up next. Then longer term, looking over the horizon, we are already doing regulatory work, have been for some time now, to gain access to the mega markets in Asia Pacific, both China and Japan. We've been pretty clear, this is the longest term of our five growth drivers. This is not a material contributor yet to our overall commercial franchise. Over time, given the unmet need, given how many patients need our help internationally, we absolutely believe this can be a really important part of the overall revenue mix going forward. We'll keep you posted on our international efforts as we move forward. Okay, we made it. We're gonna take a 10-minute break. We would ask for your cooperation to stick to that timeline because again, we're broadcasting this and need to come back after the break. I hope over the course of this session, you've gotten a much better sense of those five growth drivers, the progress we've made and the road ahead. We'll see you back here in 10 minutes. All right. Thanks for getting back from the break promptly. We're now going to transition to our physician panel. We're joined by Dr. Steven Abramowitz and Dr. Chris Huff, and I'm going to allow them to introduce themselves. Why don't you tell us about yourself and your practice? Like you said, I'm Dr. Chris Huff. I'm an interventional cardiologist and vascular medicine doctor out of Columbus, Ohio. I do hearts like other interventional cardiologists, but my focus has really been on peripheral arterial disease and venous disease. About 50% of my practice is the treatment of venous disease, both PE and DVT. My name is Steven Abramowitz, and I'm a vascular surgeon, and I'm the chair and the director of the department for the MedStar Health System in Washington, D.C. This question will be for both of you, but Chris, maybe you can start. You said you're an interventional cardiologist. How does one get into venous thromboembolism? Maybe tell us a little bit about your journey as well as kind of how your treatment patterns have changed over time. Sure. Well, I started Dogwood Elementary School. Maybe fast-forward a little bit. No, it's pretty interesting. I did my cardiology training at the Cleveland Clinic, where you're trained to do structural heart disease, valve replacement, as well as peripheral arterial disease. Most jobs, just because it's a lot to do coronary artery disease, structural heart disease, and peripheral vascular disease. 'Cause most jobs want you to do one or the other. I will tell you that in training, there was zero focus on the treatment of venous disease. It was not a thing. We did no DVT or PE treatment. In fact, PE was only treated with anticoagulation. When I got into practice, initially in Birmingham, Alabama, there was a huge unmet need for the treatment of venous disease. I sort of taught myself, but this was before Inari was even a company. I started using lytic-based therapy. I used some small thrombectomy devices. Actually, I grew to dread the treatment of venous disease because it was very inefficient. It took a long time. It was often a 2-day procedure. Even though I did a lot of it, 'cause no one else did, I tended to dread it. When I was hired at my practice in Columbus, I joined a group who also did a lot of venous disease, which was helpful because it's not fun to be on an island. You want people around you who you can bounce things off of, who want to help advance the field and treat patients. Interestingly, that transition was actually the start of Inari. It's when Inari sort of took, you know, came to the forefront of treatment for venous disease. I was there at the beginning, you know. I was part of one of the first advanced user forums. I remember sitting at dinner with Brian Strauss, looking at these devices that the engineers were making, thinking, "Wow, this is really gonna make my treatment of venous disease way more efficient." It proved to be true. It is efficiency and effectiveness evolved. I moved towards an Inari-based therapy, non-lytic therapy. Steve, how about you? You're a vascular surgeon, so maybe, same or different journey for you? A little bit different. I think that when I first got involved with venous disease, it was because I was frustrated. You know, I would. You know, when you're a vascular surgeon and you're starting out in practice or you're in training, if you have a clinic of 40-50 people, you know, I'd say over half of them come in, and they got leg swelling. They just, you know, leg swelling not otherwise specified, and they're looking for a solution. For the most part, you know, when you're in training, they're telling you, "Oh, we'll just put them in compression and just see how they do." It was incredibly frustrating to not have solutions available for those patients to know that their disease state and their disease process started with an acute event. Now you're dealing with this more chronic condition that you really didn't have a suite of solutions for. Yeah, it was incredibly frustrating to be the venous person in the group and also feel like you were secretly frustrated, and you secretly were very unhappy with your day-to-day interactions with the patient in the interventional suite. Finding that there are devices out there that are able to eliminate the disease state before it becomes a chronic condition and then also have applications for the chronic condition themselves is immensely satisfying. It's really changed the way I feel about talking to people about venous disease and treating it. Maybe, Steven, you can address this first, and then Chris. Why is Inari frontline for you, whether it's in the DVT or PE space? Well, I think for me it's ease of use and the procedural success. So it was kind of exciting to see all the data in one place when you guys were putting it up earlier because when it's come to data as it exists for the treatment and management of DVT, it's really been limited to pharmacomechanical interventions or catheter-directed interventions. There's been nothing until recently which is really focused on what we can do in a single session in a mechanical means of removing the clot. Then how does that impact the outcome? The incredible influx of data and validation of data really sort of allows you to do something in the procedural space, you know, in the operating room or in the procedural room, and then say, "Yeah, I'm getting that same result too." It's actually gonna make an impact because that result is being seen in other facilities with other patients. When I think about Inari, it's easy to use. Then more importantly, when I'm done with the case and I have a great technical result, I have data to lean on where I know that that result is reproducible and that the patient's gonna benefit. Chris, how about you? Yeah. You know, very similar. As an interventionalist, you want a device that's efficient, effective, and a great safety profile. You eliminate the use of thrombolytic therapy. You don't have to worry about intracranial hemorrhage. You can do a procedure in less than 1 hour. That's a win. You can do an effective procedure in less than 1 hour. It's a double win. And as Steven said, it's repeatable. You can do it over and over again and on every patient and expect very similar results. The last thing I'll say is it's a device, whether PE or DVT, that can be offered to all patients. The way we used to treat venous disease was we would be called to the bedside, say, you know, this patient, let's take PE for example. This patient has a submassive pulmonary embolism. They're really sick. You say, if you look at their CT scan, you look through their story, you said, "This patient definitely needs advanced therapy. This patient definitely needs something more than anticoagulation. We're gonna give them a lytic therapy. We're gonna do a catheter-directed thrombolysis." Oh, they don't qualify for lytics. Okay, anticoagulation only. You already decided they needed advanced therapy, but you had nothing to offer them besides lytics, so then they didn't get advanced therapy. Now we can say, "Hey, we have a device whether you can have lytics or not. We think it's the best device, and we can give it to you." That's great. I'm gonna ask both of you to make some predictions about the future. Both of your practices have grown substantially with this new innovation in the venous space. Yet you've heard us talk about how we've only treated 5% of the potential patients that we think we could benefit. Even adding all the other competitors together, it's still just a small drop in the bucket. How does the venous market grow over time? Does it grow? Are we capped at some maximal level or what's the future hold? I mean, I personally think it'll continue to grow for two reasons. One, you mentioned the lack of training. Additionally, when I was in training, there was no dedicated pathway forward for me to learn about the treatment and management of venous pathology. That's completely changed. You know, for example, I'm part of the American Venous Forum educational course next week in Seattle. We thought it was gonna be a lot of fellows coming and wanting to learn about the management of venous disease, but that's not it. They're now getting that training, and we're seeing people who are further into their practice now coming to these training sessions to learn about how to manage acute and chronic pathology. As these people progress, and I think people who haven't been trained on these you know, acute or chronic management tools kind of retire or leave practice, you have more people who are able to identify those patients that will benefit. That's automatically gonna increase the number of interventions seen. It's communication. You know, DVT, as you guys have talked about, and PE, they're disease states where people are diagnosed at various points of their interaction with healthcare. The more education that's done with intensivists, emergency room physicians, or hospitalists, that's where we're gonna see those patients that are currently being missed captured by the interventionalists. Yeah, I agree. I agree with Steven, everything he said. I mean, we're at the tip of the iceberg here. The amount of venous disease is, you know, it's gonna grow exponentially, right? The prevalence of venous disease in VTE increases with age, right? Younger patients, the incidence is about 1 in 100,000. Over the age of 80, it's about 1 in 100. We live in an aging population because we are taking care of patients, and they are living longer. All we can expect as interventionalists and surgeons to actually be overwhelmed by venous disease. I find that it has taken over my practice. You know, sometimes I'm like, "Enough. Enough venous disease. Let me do a heart." There's just so much venous disease out there. It's only gonna get more. There's one other point to that which, you and I were kind of separately gossiping and talking about earlier today, right? There are medical therapies out there designed to prevent atherosclerotic or arterial disease. There is no medical preventive equivalent for venous disease. So insufficiency, hypercoagulable state, it's not like patients are walking around, and all of a sudden, they're gonna start popping a pill because their primary care doc is engaging in venous preventative maintenance, right? That doesn't exist. That's all over the arterial side of our understanding of disease state management. I wanna shift and talk a little bit about technology now. We pride ourselves in really getting to the root problem of unmet needs and offering purpose-built solutions. In fact, I see several of you drinking boba tea. You had a choice of straws. You had a 12 French straw and a 24 French straw. Which one did you pick and why, right? You intuitively know the answer already. Speaking to innovation, right? Tell us a little bit about the Inari innovation, your experience with our team, the kind of products we've been bringing to market. Sure. Well, let's just talk about Inari and why I prefer it. As Steve, you already mentioned this, it's a very simple device. I mean, it's a big straw that you apply suction to, so it's not gonna break. There's no capital equipment. There's no electronic component to it that may not work. It's simple, and it's effective. In terms of evolution, and they showed slides on this, I mean, we're on the fourth generation of the Inari ClotTriever device, you know, and I can tell you that, you know, all the generations have been a little different. They have rapidly evolved, and they've rapidly evolved because this is a company that the physicians have a direct line to the engineers. You know, I'll text Brian. I'll call Brian. I'll be like, "Hey, this catheter is too flexible." You know, "I need a catheter that has a little less flex," or, "The basket on the ClotTriever is too long. Can we make it a little shorter?" I'm not the only one who does that. Steve does that. Other people do that, and they pivot very quickly. To have a very effective device that's very simple to use, unlikely to break, no capital equipment, that I have a direct line to the engineers, and they will adjust things very quickly, for my use, I mean, that's a win. Steven, you have a lot of experience with ClotTriever BOLD. Maybe you can share that experience. Yeah. There's been no greater joy than working with the design and engineering teams here because you think about DVT and the incidence of patients who will have a recurrent DVT as a result of post-thrombotic disease from a prior DVT, and you need a device that's gonna treat both the acute part of that and the more chronic and organized part of that. You know, you talk about BOLD, or you talk about iterating the device to have this unmet need met, and then next thing you know, it's in your hand, and there's an engineer on an airplane flying it out to you, making a red-eye and you know, asking if you can use it in your next case. You know, that's a very different process, whereas I've worked with other partners in the industry where I'll get an email, and they're like, "Hey, following up on that thing you said 3.5 years ago, we think you have two engineers who may wanna talk to you." Whereas here, you'll say something in passing, and then, like, 2 days later, I'll be like, "Here are the four schematics. Can you think about this?" It's just a very different beast, and it's actually a real joy to work with. Yeah. I'll just touch on that one more time. I think that goes towards what Bill spoke about. This is passion for patients. This isn't just passion for a device in disease process. It's passion for patients. When you tell them you want something to work better, they're very passionate about it. They change it quickly and because they want a good outcome. Maybe we'll talk a little bit about clinical data, right? You've heard big data releases coming up in just a few days at TCT. Again, two late-breaking clinical trials at The VEINS-VIVA meeting. How important is the generation of clinical data in this space? Is there a quality difference amongst the different folks in the space? Yeah, I mean, you know, clinical data comes in a lot of different forms, and I'll tell my trainees that it's like airplanes. You know, you could fly a Cessna to Dubai, or you could be in first class on an A380 on Emirates, and it is a very different experience. You know, when you're dealing with data, you need something that is robust, well thought out, well analyzed, and designed to eliminate bias. One of the things that I think has been so exciting about Inari is you tackle the problem head-on. Investing in large registries, investing in RCTs, that is essentially saying, "I wanna further the disease state," right? Because other devices will probably benefit from a change in the understanding of the landscape. The reality is this is about that care and that passion for the patient. High-quality data benefits everybody across the board. You know, benefits Inari, but benefits the patients most of all. You know, I agree with that. Let me touch on it a little bit differently. I think data is important. I do. I also think we have to make data. Early on with Inari, a lot of people would ask me, "Well, where's the data? Where's the data?" Well, as an operator, you tend to treat patients, again, based on efficiency, effectiveness, and prior outcomes. I can tell you in the cardiac space. The data will change monthly. It will say, "Do this. Oh no, don't this. Do this now. Do this." And so if you get hung up on that data, you know, you get sort of left behind. I think data is important. Do I think that the data is needed to continue to grow the use of thrombectomy devices? I think no. I think people have seen the outcomes and their effectiveness. Remember, in hospitals, the doctors that are referring you patients are. They wanna see a few things. Number one is they wanna see good outcomes for their patients. They wanna see no side effects. But really a big focus has been lately, get this, how do I get this patient out of my ICU and how do I get this patient out of my hospital? If you can do those two things for the physicians that are referring you patients, you know, even if you don't have great data for it, they're gonna continue to refer you patients. I would say, you know, the people who use are gonna continue to use. If you're talking about how do you capture the other 95% of the patients that should be treated, it's the data that's gonna resonate with the people who would otherwise not have referred. That I think that's why it's important too, because you'll have the old school ER doctors like, "Oh, well, I read this," and, you know, "I'm stuck on the data." Yeah, that's very true. We have about a minute left in the prepared discussion before we open it up to the audience. Audience, get your questions ready. A minute is probably all we need to talk about competitive messaging, 'cause that's about the level of importance I think it plays. Rotolo, have you even heard any of this? Do you know any doctors who are aware of this? What's your take? Rapid fire. Yeah, rapid fire. This has come up a couple of times, and I would say like just three quick things. A single center quality analysis is going back. If you're comparing the Cessna to the A380, it's the Cessna. In terms of what they were reporting, there none of the standardization that we would use for understanding what was being treated was actually there. I appreciate what they were trying to do internally, but it doesn't translate large scale, and I think it plays into a misconception. If you're gonna say tube, not tube, you know, there's bias in terms of stents, whether they were there or not there, whether people were on IFU, off IFU, none of that's discussed. The other thing is there's this idea that's being put forward like, oh, endothelial damage. But the reality is, for vascular surgery, we've been dealing with endothelial devices that are in apposition with endothelium for 50, 60 years, and we haven't seen that on the arterial side with Fogarty balloons or Fogarty catheters, and we haven't seen it on the venous side. It's a misconception that devices fit perfectly in the middle of the vein. It doesn't happen. There's wire bias. There's device bias. These veins don't move in a perfectly straight line. Even from a mechanism of action standpoint, if competitors are saying that their device doesn't touch the vein wall during its advancement or its use, it's preying on a misconception of how devices function within the body. I mean, that's. I could rail more, but that's all I'll say. Yeah. I think always be cautious with single center data. I mean, you don't know what you're getting. You don't know how experienced the operator is. You don't know what the patients were like. To touch on two things, reocclusion, we've looked at all of a large amount of our patients who underwent a ClotTriever thrombectomy, and proceeded with a 30-day ultrasound on follow-up, and 97% of them had completely normal flow in their venous system. So we do not see reocclusion. In terms of valve damage in the veins, the clot damages the valves. The way to help the valves is to get the clot out. So it's not the device that's gonna hurt valves. It's certainly the clot. We have plenty of. We have a study where we sent our clot off for analysis and there was no valve or vein tissue in it. We also have plenty of angiograms that show, you know, normally functioning valves in the vein. I have zero concerns about that. Great. Thank you for that. We can now open to the audience for questions. Please raise your hand if you have a question for Dr. Abramowitz or Dr. Huff. The microphone's coming. Hi. Rich Newitter from Truist Securities. Thanks for participating today, and thanks for the analyst day. Just going back to the data question and what kind of data is gonna be needed to maybe you know, accelerate broader penetration or the velocity of penetration in the market, specifically with respect to PEERLESS. You know, how much does the endpoint matter and with respect to PEERLESS because you're looking at it versus an intervention already, not against anticoagulation. You know, how much of an issue is that, and how impactful do you think something like that could be? I'd be curious to hear your thoughts there. I mean, I think it can be very impactful. You know, as was mentioned, the current guidelines for the use of thrombolytics in PE were based on eight patients, and those guidelines have held for a long period of time. We all see that mechanical thrombectomy has been beneficial. We've seen based on registry data that the mortality is low. The question that has been out there is there a big difference when compared to catheter-directed thrombolysis? That's what PEERLESS is gonna address. I think the outcome, the primary outcome here is probably the correct real-world outcome. You know, there's a lot of benefit for patients besides just mortality. Mortality is the number one benefit, hands down. As I've told you, people look beyond that. People do look at ICU stay. People do look at length of stay. People do look at bleeding complications. All of that encompasses good outcomes for our patients. I do think it's a very important study. Any additional questions? Marie Thibault from BTIG. Thanks for the event and thanks for being here. While we have you, would love to just hear your first reactions to the product pipeline. Anything that stands out? Anything you're really excited about? PTS. One of the things that I would say I got into the treatment of venous disease for was, I don't know how many of you live in New York, and this is just like happened to me when, you know, it is summertime, and the subway rolls up, and there's an empty subway car, you don't get in it 'cause usually it means the air conditioning is broken or something bad is going on inside. For me, it was kind of walking in and seeing a guy sitting there with weeping leg wounds and ulcers being passed over. The system has very little to do with that 1 million patient prevalence in the United States. That's really upsetting to me because there are things that are just sexy right now and be like, "Oh, aneurysm this, aneurysm that." There are 40,000 aneurysms to treat in the United States every year, right? 100,000 patients, and you're saying 95% of them aren't getting intervention, which means 95,000 people every year just tick off back into that PTS bucket. When you throw up a slide where you're like, "Hey, we're putting an investment into the management of post-thrombotic syndrome and chronic venous insufficiency," that to me is music to my ears. So it gives me some hope. For me, it's. I haven't even seen it yet, but it's the treatment for stent occlusion or in-stent restenosis in the iliac venous system. You know, the use of stents for May-Thurner disease or chronic post-thrombotic closure of the iliac system has really changed, you know, outcomes in patients with venous disease. The stents are fantastic. We get great results, but where we still can't manage well is stent occlusion. There's no answer for that. Maybe one last quick question. Great. Thank you. Cecilia Furlong, Morgan Stanley, and again, thank you for all being here and hosting this event. I wanted to ask just on BOLD, how that's shifted your mentality in terms of whether you're going in with BOLD, with the straight ClotTriever. Is it TAM expansive or is it just really kind of being able to get a more efficacious outcome? I'm just curious how you've woven it into your practice to date. I think it's both, and I'm not trying to hedge on that. The reality is, where a lot of other devices fail currently is their ability to treat thrombus that is of variable age. That's also where a lot of the data has fallen off because most people were excluded from trials. There are other registries out there that have very strict guidelines of how old clot can be to be enrolled in their registry, and those limitations didn't exist. For me, if I think that the thrombus is old or the patient's presenting to me after they were given anticoagulation and they failed, I'm a BOLD first type of person. If you told me that I was, you know, only had access to BOLD, I'd be totally fine with that. I think that, again, there are less physicians doing this intervention than should be, and as they expand their practice, they may wanna start with something that they feel it's a gut, not because there's data behind it, is safer because it has less radial force. Giving people the option is going to be important, because no physician wants to hurt somebody. If we're gonna increase the number of patients who are treated, we need to increase the number of physicians doing these interventions. A lot of that is buying into this idea that people kind of need that entry device to say, "Okay, I'm gonna use this, and if it doesn't work, then I'll switch to my BOLD where I know I've done the less radial force option first." I think we're going to bring the physician panel to a close. We do have the benefit of Dr. Huff and Dr. Abramowitz sticking around after the conclusion of the meeting for additional questions. Please seek them out. Thanks, Steve. Thanks, Chris. Appreciate it. Next up, I have the great pleasure of introducing my friend Mitch Hill, our Chief Financial Officer, to talk about financials. Mitch's wise counsel and steady hand helped us get through an IPO during the worst pandemic in modern history. We've also been able to successfully complete a secondary fundraise at the start of what some thought was World War III. His financial guidance continues to put us in an enviable position. Mitch, please come on up. Thank you, Tom. Appreciate that introduction. Great to be here with all of you today. I I just wanna thank Tom and Dr. Huff and Dr. Abramowitz for that really terrific physician panel. It's great to hear how the FlowTriever and the ClotTriever product families are being used and impacting, you know, patients today, and also to get a glimpse past some of the new products that we've announced earlier today and what kind of opportunities there are for those as well. I think my financial update plus some Q&A that'll follow is about all that stands between us and lunch. So I'm gonna jump right in and talk about that. We'll start out with some revenue. I think you're all familiar with the company's revenue ramp over the past 4 years, from $51 million back in that 2019 timeframe when we first began to commercialize the products to our midpoint of 2022 guidance, which is that 365 number that you're familiar with. A little less than 100%, compound annual growth rate over that period of time, and about 32%, when we looked at 2021 and compared that to 2022. Thinking about the company's, kind of revenue potential, I think everybody's familiar now with the U.S. TAM for the VTE market, so that $5.8 billion. Our sense is that across the PE and DVT markets, we're looking at about a 20% kind of blended, interventional penetration into that market. You've heard us kind of think about where this penetration percentage can go over time. I think both Drew and Eric talked about this stroke market and the MI market, the 30%, 90%. I think for the purposes of our presentation today, we'll just pick something kind of right in the middle. Think about 60% potential penetration, and then we can look at the opportunity for the business as basically we continue to see this market mature over time. Here on the Y-axis, we're looking at the interventional penetration rate, and you can find that 20% that I just referred to, and then look at this 30% and even the 60% growing over time. On the X-axis, you're looking essentially at the market share capture of, let's say, the leading company in this particular segment or this industry. There we're suggesting, you know, it could go from approximately 30%, which is our estimate of kind of where we are today, towards a 60% figure over time. Look at the numbers now as we move upward and to the right. They get pretty big, pretty interesting, you know, kind of that $1+ billion, even potentially $2+ billion range with these things kind of coming together over time. If you reflect back on the growth driver discussion we've had today, so let's think about Tara, for example, talking about clinical evidence. Think about the readout, you know, let's say, over the next few years of the DEFIANCE trial for the treatment of DVT, you know, versus anticoagulation, let's say. Think about the PEERLESS trial, which is again, comparing on a superiority basis the performance of FlowTriever versus its lytic-based, you know, interventions. I think, you know, we're very excited about the changes that we see coming. You know, for example, with respect to PEERLESS, you know, it seems to us like the fat lady may already be beginning to kind of clear her throat to start to sing. We think that's gonna be something that, well, I guess maybe I shouldn't say that anymore. The fat, bald white guy is clearing his throat. I guess that's maybe me. We're excited about that. On the X-axis, so horizontally there, think about the discussion we had today led by Eric in VTE Excellence and how we're building programs. You know, we're trying to establish as a measure of quality the opportunity for each patient who's diagnosed with PE or DVT to be evaluated, to be given a consult. Pretty basic idea, almost brain dead idea. It doesn't happen today. That's something we see changing, and we're getting great traction with those customers as we move them along that continuum towards excellence. We see the kind of market share pickup that we can get sort of as a percentage of each hospital's theoretical penetration rate. We're extremely excited about the future of the company's revenue potential, and we hope that's something that just helps you kind of understand why we're so excited about it. The last thing I'll say here is I'm just talking about the U.S. TAM for VTE. If you reflect back for a moment on Drew's comments, you know, think about the OUS portion of VTE, and also let's add on the TAM for the other products we've announced today. We're talking about some numbers that could even be quite a bit bigger than the ones you see here. Shifting over to sort of talk about profitability. Everybody's familiar with the company's you know, really amazing gross margin profile. That 90% over the past couple of years. For the first 6 months of this year, just over 88%. As that gross margin produces some significant gross profit dollars, which we've been able to invest really across our growth drivers in the 2022 timeframe. You've heard a lot about that, you know, during the course of our presentation this morning. We were doing that because we want to, you know, move this market. We wanna change the standard of care. We wanna treat more patients. In the Q2 timeframe, obviously, we announced about a $9 million operating loss, and we even guided towards additional operating losses in Q3 and Q4 of this year. In thinking about 2023, we've messaged this idea of kinda intermittent profitability, and that's kind of where we will go, I think, next. Then as we move forward into the 2024 timeframe, we believe we have all of the elements to become a company with sustained operating profits, and we're kinda targeting that towards the first half of 2024. Again, that's a function of our ability to access this very large and attractive market. The gross margin profile of the business, which along with some ramp in our commercial productivity, will put us in that position to deliver these sustained operating profits. Finally, I think we've discussed this point where we really feel like we have an ability to modulate our investments in those five growth drivers that we talked about. That's again something that helps us in thinking about the profitability potential for the company. We put this all together. We really believe we kinda have all the puzzle pieces of a company that will have a premium financial profile over many years to come. I'll just highlight a few of those here. This market leadership, essentially, in this very large and under-penetrated VT space. When you combine that with the OUS plus the new products, we're talking about an approximate, you know, $20 billion TAM. That doesn't count this other $10 billion TAM, essentially, for the prevalence population in CVD that really is not being treated today. That combined with this exceptional gross margin profile for the business and this disciplined investment approach puts in a position where with growth, we're able to drive some really attractive operating leverage in the business. That will put us in a position to deliver this sustained and consistent profitability for the company as time goes on. Finally, I'll just mention the company's strong balance sheet. We're sitting with $330 million of cash, you know, kind of as of the Q2 numbers, and then allows us significant financial flexibility for the business as we think about the future. We tried to kind of future-proof the balance sheet in a way in terms of looking at some of the opportunities that the company is gonna have. I'm gonna close, maybe with just one quick note. In the 2019 timeframe, probably mid-2019, our management team and board met together on a number of occasions, and we decided on an independent kind of pathway forward for Inari Medical. We were very excited at the time about the potential for the FlowTriever and the ClotTriever product families. We also felt the company had the opportunity to become this multi-product platform company to kind of grow into that. We've talked about this with many of you over the past couple of years. It's really terrific and even gratifying to be here today with all of you to kinda witness this next step forward as we are sorta making that transition. I wanna thank many of you who have been with us through this journey. I'm kinda looking around the room and boy, we've kind of all done this together. It's really terrific to think about that, and we appreciate your support. We don't take that for granted for a minute. In thinking, we hope the business that we're building is something that will continue to engender your support as we move forward and together treat many more patients, you know, who are struggling with the five disease states that we've talked about today and others that we will get into, you know, down the road. With that, I will assemble my team up here for the management Q&A portion of our presentation. I'll just say one more thing. Go Purple Wave. Hi. When you ask your question, if you could start by saying your name and firm, that would be much appreciated. For those of you joining remotely, the Q&A button is in the center bottom of your screen, where you can submit your questions there. Thank you. Thanks a lot. Larry Biegelsen, Wells Fargo. Drew, I'll start with you or Mitch. You talked about having a premium financial profile, but I didn't see you define that. You know, obviously, you know the Street's at about 20% growth next year, mid-teens CAGR over the next few years. Maybe could you quantify, you know, what you're trying to communicate today and how much you're expecting from the new TAMs? Yeah. I had one follow-up. First of all, Larry, I'm shocked you got the first question in. Didn't see that coming. Maybe I'll start with some qualitative, and you can jump in. Hopefully, what you've gotten a sense of through all five of those growth drivers is how much runway we see out ahead of us. The fact we're just 5% penetrated, the work in VTE is really beginning to gain traction. You add that on top of the three new TAMs, the global expansion, we feel really, really confident in our ability to continue to grow sustainably for the foreseeable future. Mitch tried to frame that on that slide to give you a sense of no matter if you look on the Y-axis in terms of the market expansion, the X-axis, our ability to continue to convert share away from lytic-based therapy into FlowTriever and ClotTriever. All that points to us as lots and lots of runway out ahead of us to continue to grow and build a very, very large, formidable commercial franchise. Maybe with that as a backdrop, do you wanna add anything more specific on that? You know, just to mention, Larry, you know, we've wrestled with this idea of attaching a specific year, for example, to, say, whatever revenue number or, you know, specific, let's say, operating margin target or percentage to a specific date, let's say. What we're trying to do today, I think, is just give everybody confidence that we see this becoming a very, very big business as time goes on, and a very profitable business as well. I think because of the early-stage issues that you heard us talk about in terms of just getting started, it seems almost premature or even borderline, you know, inappropriate at some point for us to kind of get ahead of ourselves in terms of those kind of commitments. It can be big, it can be very profitable. You know, we're at the early stages of this journey, you know. We hope you all share our excitement for, you know, where this business is going. That's helpful. Then maybe, Mitch, you know, one of the data points you put on the slide was the penetration, pegging that 60% in between stroke and MI. This may be a question more for Tom, but, you know, I checked, MR CLEAN came out in 2015, so, you know, some data, you know, decades old, you know. What's the timeline, you know, when you could get to, say, 60% penetration? Thanks. Yeah, I'll tackle that one, Larry. Yes, we very intentionally use myocardial infarction and stroke as comparators, because those are the top one and two cardiovascular killers. You'd think we'd learn our lesson by now, that we move from conservative therapy to lytic-based therapy to definitive catheter-based management. Our hope is that we can leverage the global experience from those two other disease states to say, "Yeah, it stands to reason. We need to build these programs." We don't have to create it from scratch. We can follow the model that we have from those other two disease states. I will point out the big difference between stroke and heart attack and PE is we don't have to do any of that upstream work, right? It's not a matter of convincing patients to learn the symptoms of PE and educating ambulance drivers. Our TAM is defined based on patients in the hospital with the diagnosis. Our goal, our plan is simply to draw connections between the interventionalists and the patients that are already in the facility. I think it's gonna go a lot faster than those two other diseases. Great. Thanks. Bill Plovanic at Canaccord. You gave us some broad strokes. I'm actually gonna parallel off of Larry's question, but you know, as financial folks, we always wanna get more granular. As we think about it, you mentioned you're in the early stages, but what type of data points do you plan on providing so we're able, as investors, to evaluate your progress as we talk about these new products, these new markets? I mean, what can we look forward to that you'll show us like, "Hey, this is it, and here's how we're doing?" Yeah, no. I think going forward, obviously, first and foremost, you're gonna see the growth continue, and that's gonna be indicative of, obviously, continued progress, continued penetration, continued development of the market. I think we will continue to talk about the number of centers that we penetrated in the U.S. That's a number we've shared. I think that'll give you another kind of lens to view that progress on. I think we'll continue to give you some sense of how we're expanding the sales organization. You know, the commercial system that John described, we've been pretty consistent about sharing some additional information and some guidance on how that piece comes together. I do think as some of these new products gain traction, and start to really become a more meaningful component of the business, I think you could imagine us also providing some visibility at that level. By the same token, I think on the international, you know, it's not a material contributor today, but I think as that business also continues to grow and mature and gain traction, I think that's another area at some point we'll likely provide some additional visibility too. I think all of those things will hopefully, in addition to just the qualitative information, give you a sense of how things are progressing. Hi. Marie Thibault from BTIG. Maybe I can try to drill down a little bit more on the financials, Mitch. You gave us 85% gross margins in 2024 for half of 2024. You know, talked about operating profitability. What's built into those assumptions in terms of new sales force teams for things like Artix? What's the margin profile of some of these newer products? Any detail you can give there would be really helpful. Yeah. I'm happy to do that, Marie. We're a little bit early probably to talk about the specific, you know, guidance in terms of where we're trying to go from a commercial team point of view, let's say in the 2023, 2024 timeframe. You have gotten a sense that we believe this will become the largest interventional, really, sales force in the space. That's kind of where we're headed longer term with the business. We will have some more specific guidance, as you just heard from Drew, as we get later in this year or early next year about the targets for 2023. We feel, just in general, though, that this, kind of this concept of operating leverage is one that is really starting to become more apparent for us as the revenue scale of the company has grown, as we're thinking about where we'll be in the 2023 and 2024 timeframe. That's really a lot of what's behind our confidence in this concept of, you know, intermittent profitability kind of moving into sustained and consistent profitability in the 2024 timeframe. Adam Maeder, Piper Sandler. Thanks for taking the questions here. My question is actually just on pipeline, and you talked about small vessel chronic venous disease and arterial. But if I was to ask and test my luck here, you talked about 25+ projects, even beyond those in current and new TAMs. Is there a way that we should think about kind of how the story could even further evolve from here in terms of regular product cadence in 2023, 2024, 2025? Just how do we think about kind of the future? Thanks. Yes, I can jump on that one, Adam. I'm not gonna put a slide up that shows the 25 projects. But what I can tell you, if you think about the 25, I think broadly speaking, they would fall into three different buckets, right? The first is a group of projects that are continuing to do refining and iterating on the existing VTE platforms, FlowTriever products. There's still work to do there. There's a second group of projects that are going to identify and address unmet needs still within VTE. ProTrieve is a great example of that kind of project, and there's some in the pipeline that fall into that bucket. Then there's a third bucket that are focused on these new patient populations. Obviously, the three we've talked about today are the first three of those examples. If you looked back in that pipeline, we absolutely believe with the competencies and the capabilities that we've established, a systematic approach to identifying unmet needs, to developing purpose-built toolkits to address those unmet needs. We have applied that now in those first three that we've talked about today. Further back in that pipeline, in that third bucket, there are other unmet needs, other patient populations where we see and think we can make a difference with the stuff we're good at. And I think you're gonna see that emerge over time beyond the scope of, you know, what we're obviously talking about today. In terms of the specific cadence, maybe the last part of your question, we did five major product launches. I'm looking at Strauss. Five major product launches in 2021. We've done six to date so far year to date in 2022. We've got a couple more here that we may sneak in between now and the end of the year. I think going forward, we're certainly committed to maintaining, if not even accelerating further, that same cadence of meaningful product introductions, new toolkits, major product intros. Anything you'd add to that, Strauss? Just more to come. Yeah. Cecilia Furlong, Morgan Stanley. I wanted to ask just back to the sales force and kind of your longer term target, but you brought on a mega class, I think, as you termed it in 2Q. How do you think about with all of these LMRs turning into full market releases, what's the cadence of adding new reps? What do you need to see? And then also just wanted to ask you put up a lot of information on ASPs, just the strategic thinking through that pricing versus what you've done with FlowTriever and the per procedure pricing model. Thank you. Yeah. Maybe I'll get started. John, maybe you'll wanna back me up. You know, we pulled in that mega class very intentionally for a couple different reasons. The first was we wanted the team established and settled without having to do a lot of additional recruiting this fall to focus on these new product launches, focus on these limited market releases that we have underway. We also wanted to clear the deck to allow them to really focus on VTE Excellence with the improved operating environment. Really the first time in, I don't know, since the beginning of the pandemic, the last 4 or 5 months, where we've had clear runway without a lot of distractions, where we could really focus in on executing on that VTE Excellence. We pulled that group in, we did the mega class. We hit the $275 or nearly the $275 goal. I think as we move through, you know, the end of this year, the ads will be more opportunistic and kind of filling in from there. I think longer term, you know, John, maybe you wanna talk longer term about, you know, how you see beyond the end of the year in terms of ads, from there. Thanks, Drew. You know, right now with the LMR, I think a lot of that. We're seeing it. We're learning as we go what the sales team looks like and what type of potential distractions could be there for a team that is selling arterial AVF as well as VTE products. We're learning right now. I mean, the LMRs are underway, and so I think that'll be telling as we move forward. You know, I think that what we're seeing right now, I mean, with our current base of customers. I think I showed a slide that showed five accounts per territory on average right now. Even that's a lot. If we are going to execute on VTE Excellence in the way that we plan to, and we are going to, it requires a focus. It requires people to be very ingrained in the accounts and working closely with administration and utilizing that full team of non-sales folks that we've added. Drew, I don't know if that answers the question, but I think- Yep. ... time will tell here. Yep. I think the second part was on ASPs for the new products. We shared those ASPs today, right? The CVD portfolio will clearly be, you know, a toolkit-based price, you know, in that $10,000 range of our existing per procedure prices. ProTrieve is $4,000. Artix, we're targeting a $7,500 price point. InThrill is also a $4,000 price point. You know, part of our system as we identify these unmet needs is also evaluating the commercial landscape, the reimbursement landscape, the economic landscape. Those price points, those ASPs, have been chosen pretty deliberately, just like we chose the ClotTriever and FlowTriever ASPs historically. I think from a margin standpoint, you know, Mitch touched on that a little bit. I think we also feel good about how these new products are gonna stack up alongside the existing portfolio from a margin standpoint. Just to add a bit there on the margin side, you'll see the change over. We talked about a low- to mid-80s% gross margin over time in the business. That would be changing from where we are today as a result of the internationalization of the business. The new products that we're announcing and then continued sort of additions to the price per procedures, let's say. You've seen a change, for example, over the past couple of years for FlowTriever, from four SKUs in that product family to nine SKUs today. That's something where we're charging the same price. There's been basically a drop in the gross profit of that price per procedure. The reason we're kind of in that business though, is we wanna do the right thing for the treating physicians and offer them all the capabilities to get the best possible outcomes, you know, for their patients as you heard a few minutes ago. Hi, thanks for taking the question. Rich Newitter, Truist Securities. Two from me. The first one, just on the timing of some of the new product launches that you guys are talking about, especially the ones for which you have some products approved, and then you, I think, said you saw ones coming, like Artix, for example. It's in limited market release. You said you have, you know, two of the four products that you need for that entire system approved. So I'm just trying to get a sense for what is the definition of limited market release from a timing standpoint? Start with Artix, and then maybe talk about the others. Do we think of 2023 as still being a learning year for most of these products with contribution more weighted into the 2024+ timeframe? Any color there would be helpful. Then I have a follow-up. Sure. I think you can think of this maybe in different phases, right? I think with all three of these new products, the first thing we do after we gain clearance is these limited market releases. That's not something unique to Inari. That's, you know, pretty standard operating procedure for a new medical device. You wanna get the product out, in the doc's hands, used in cases, and we're collecting certainly clinical and technical feedback on how the products are performing. We're also gathering commercial input and trying to answer some of the commercial questions that we have, some of the kinds of questions that you heard John pose. Most of our LMRs for these kinds of products range between 50 and 100 cases, and they usually take, you know, a number of months to complete, some a little faster, some a little slower. After we exit those LMRs, we then shift into what we call full market release, where we're actually broadly commercializing, the products. Even then, as you guys know, that's a process. You have to work your way through back approvals. You have to gain access to these accounts, begin establishing a footprint, and rolling it forward from there. That'll be the next phase, that you'll see, play out here for these three new products as we exit, the LMR. I think beyond that, as we understand these disease states better, as we understand how the existing tools are functioning, that will inform some of these additional additions to the toolkit over time. That's exactly the playbook you've seen us undertake in ClotTriever and FlowTriever, right? ClotTriever nine tools today. ClotTriever or FlowTriever nine tools, ClotTriever five, right? Those didn't exist 5 years ago. Those were, you know, single product families. I think that's the last phase of this, is you'll see us learn more and add to these toolkits incrementally over time. From a contribution standpoint, I think these are gonna start having a meaningful contribution to the commercial footprint in 2023. I think here in Q4, we're still gonna be finishing up these LMRs and shifting into the early FMR phase. I think it's not gonna be until 2023 that these are gonna contribute in a kind of measurable way. Definitely real contribution to in 2023? Yeah. I think that'll clearly be, you know, once we roll out 2023 guidance, we'll clearly take these new products into account as we put that guidance in place. Okay. Maybe just a second one. Any color that you could provide on third quarter trends or what you're seeing, you know, since the second quarter. If you're willing to comment on consensus for 2023 and how comfortable you are with the forecast. Thank you. Yeah. I think, in general, we like what we're seeing right now. If you rewind the clock to what we were seeing as we set guidance in place, at the end of Q2 or reaffirmed guidance at the end of Q2, contrast shortage was top of mind. Staffing shortages were deteriorating, you know, week after week, it felt like. We had the summer seasonality ahead of us. We had just taken on this big bolus of work to bring on board this mega class. All of those things contributing some pretty significant headwinds. Fast-forward to where we are today, contrast clearly completely resolved at this point. Staffing, as we've talked about recently, feels like, although it's not resolved, it's still clearly there across most of our accounts. It nonetheless has stabilized. We don't get a sense it's deteriorating further, and I think in some ways accounts have gotten more adept at navigating their way around some of those staffing shortages. We've got the mega class in place. They're 75 days into their territories now, ramping through their productivity curve and really approaching kind of the sweet spot of their productivity. We've got summer seasonality behind us. We've got these three LMRs underway, generating a lot of excitement and enthusiasm from physicians. We've got three data readouts here coming up in the coming weeks, which will give us, you know, a lot of great data to continue to point to. I should just say, we like what we're seeing as we sit here today. Do you wanna talk about? Just that, you know, I feel like I need a nap after listening to that list of everything going on from Drew. Today's a little bit early again for us to comment specifically on 2023 guidance, but we'll figure that out and we'll circle back. Hi, Stephanie Piazzola, Bank of America. I guess just touching a little bit more on the staffing headwinds. Can you remind us what was assumed for the staffing? I know it was factored into the guidance as a headwind, but does that assume that staffing got worse or better or stabilized like what you're seeing now? Based on the stabilization you're seeing now, if you know, that's still reflected in guidance. Yeah. I'll just comment. In the early August timeframe when we did our Q2 announcement, as Drew just mentioned, you know, we felt like we were seeing the end of the contrast shortage issues, but the staffing shortages were very much on our mind, and we're finding with many of our hospital accounts at that point in time that a lot of uncertainty in terms of their ability to operate their cath labs. There were, you know, procedures that were being rationed. You know, believe it or not, sometimes MIs and strokes and, you know, VTE procedures were kind of taking their turn. Some MIs were being treated with drugs in a manner that you wouldn't really imagine, and we're still doing that today. I think as Drew mentioned, the staffing shortage issue has not deteriorated further, and I think the hospitals have developed a way of, you know, sort of dealing with that and dealing with their needs in terms of providing for their, you know, cath lab capacity in a manner that's different today than it felt back in that, you know, early August timeframe. I think as we think about Q3, you know, we like what we're seeing, as Drew just mentioned, and we're you know operating the business and feel like, you know, we're doing our best to deal with some uncertainties still which are out there in the marketplace. I'm happy to see if either Drew or, you know, John, who's actually dealing with this day-to-day in terms of the staff, have anything to add to that. Thanks, Mitch. No, I think you guys covered it. I think it's you see it stabilize. It's still out there. We still hear about it. We fought through it. Would have been a good question for Dr. Abramowitz and Dr. Huff, I think as well. Yeah, I think it is, it's there, and it does affect you, but it's not overly concerning at this point. Anyone else? Drew, the new market, the three new TAMs, which ones are you most optimistic about? You know, what are the headwinds and tailwinds for each, and which ones do you think are, you know, gonna be easier for you to penetrate, and why? Yes. I think they each have some unique aspects to them. You know, in the short term, I think you know, Artix and InThrill, for instance, I think are in some ways more accessible early on here. Certainly Artix existing procedures, you know, developed market, site of service, complete overlap, interventional call point, almost complete overlap. I think those are gonna be more accessible in the short term. In terms of the longer term opportunity, I mean, this chronic venous disease patient population is so enormous, the unmet need so spectacular that I think longer term, although there's undoubtedly more of a lift there from a market development standpoint and probably a technology standpoint as well, I think longer term you know, again, it's a $10 billion prevalence opportunity for us and a $1 billion incidence. You heard Dr. Abramowitz talk about what a spectacular unmet need exists for those patients. I think longer term, that one's clearly got some really interesting potential for us to really make a difference in a whole new very large, very underserved patient population. Thank you for your questions. Okay. We're gonna do closing here in one minute. Before that, though, a couple quick housekeeping announcements. Just as a reminder, between now and when you leave the facility, three things you guys can do. The first is all of us will be available for additional discussion, Q&A, a dialogue. Come grab us. We'll be out lingering. Second, you can see out here we've got, I think, five separate tables set up showcasing five different toolkits staffed by our R&D team with existing products as well as some of the prototypes that are a little bit over the horizon. By all means, if that's interesting, stop by, get a sense to see these toolkits up close. Lastly, we got lunch on your way out too, if you have time to grab something to eat. With that, first and foremost, just to close, thank you, all of you, for making the effort to come out here. I know this is a particularly busy week. This is a long way from the East Coast for most of you, so thank you so much for your time and commitment to be here. Thank you also for your support. We're so humbled so many of you have invested into this effort and have supported us in this commitment and this mission. I hope you're leaving here with a much better sense of that commitment, this mission, this shared sense of purpose we have for these patients. I hope you're leaving here with a better sense of the capabilities and the competencies that we have established and built across the company, be that our commercial system, our innovation engine, the clinical evidence machine, how we're leveraging those capabilities to not only continue to do the work we need to do in VTE, but also increasingly in some of these new patient populations where we think we can make a difference. I hope you're leaving with a much better sense of the technology, the toolkits. You've had a chance to see them in action. You've had a chance to touch and feel them. I hope you take advantage of that on your way out. I also hope you've gotten a better sense of the team, the breadth and the depth of expertise that we have, the unity of purpose that we have. Lastly, and most importantly, I hope you guys are leaving here as convinced as we are that despite all the progress that we've made, we are just getting started. Thank you, guys. Safe travels. God bless.
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