AngioDynamics, Inc. (ANGO) Earnings Call Transcript & Summary

Good morning, and welcome to AngioDynamics Investor and Technology Day. I'm so glad that you could join us this morning. My name is Stephen Trowbridge, I'm the Executive Vice President and Chief Financial Officer here at AngioDynamics. I've been with this company for over 13 years, and I'll tell you, I have never been more excited about our future opportunities than I am today. So we're really excited to tell you about our products the markets that we're going into and our strategic transformation. We will be joined today by many members of our team, and they're going to take the opportunity to talk about the fast-growing, high-margin markets that we're going to be taking our products into. We're going to be joined by Jim Clemmer, our President and CEO. Jim is going to talk about the strategic transformation that AngioDynamics has undertaken and how we're going to be looking at 3 main growth drivers that we call our MedTech products. And those growth drivers are going to be mechanical thrombectomy, peripheral atherectomy and then NanoKnife, our irreversible electroporation product. We'll be joined by Scott Centea. Scott is our Senior Vice President and General Manager of our Endovascular Therapies business. Scott will first walk us through the exciting AngioVac platform and talk about the successes that we've had through fiscal year '21 and the successes we will have through fiscal year '22 through '24. Scott is then also going to be very excited to talk about the launch and unveiling of our AlphaVac product, one of the most exciting launches that we have coming up in this fiscal year. AlphaVac is our multipurpose mechanical aspiration device which we think will be a major player in one of the most exciting hottest growing markets in med tech today. Scott will then also talk about our Auryon laser. Auryon was our peripheral atherectomy device that we launched last year. We are very pleased with the performance we saw in fiscal year '21, and we're very excited about the prospects for Auryon as we head into '22 and beyond. We'll be joined by Jake Brumbaugh. Jake manages our NanoKnife platform Jake is very excited to share with you the mechanism of action of this very unique technology and to talk about what we think are some great opportunities to treat patients in the oncology space. Chad Campbell will join us. Chad is our Senior Vice President and General Manager of our Vascular Access business. Chad is going to talk about how he's driven that business over the last several years and turned it into an engine to provide investments for the rest of the businesses that we could talk about today at Angio. Juan Carlos will join us. Juan Carlos is our Senior Vice President for Science and Clinical Affairs. Juan Carlos is going to talk about the data generation and evidence-based approach that is going to be supporting all of our growth businesses. We will be joined by Linda Upchurch, our Vice President of Global Healthcare Economics. Linda will talk about the healthcare economics team she leads and the vitally important initiatives we are undertaking to secure market access for our technology platforms. And throughout today, we will be joined by some of the nation's leading physicians as they talk about the disease states and the unmet patient needs that AngioDynamics products are aimed to address. Prior to becoming AngioDynamics CFO, I was a General Counsel for a number of years here. So I am really excited to remind you that today's presentation will contain forward-looking statements. as defined under the Private Litigation Securities Reform Act of 1995. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We encourage you in connection with this presentation to also read all of AngioDynamics public filings, including, without limitation, our annual reports on 10-K and our quarterly reports on 10-Q. In addition, during this presentation, you'll be hearing from some of the nation's leading key opinion leaders, some of whom may be paid consultants of AngioDynamics. The views and opinions expressed by these key opinion leaders are their own and do not necessarily reflect the views and opinions of AngioDynamics. Now I'd like to welcome in Jim Clemmer.

Thanks, Steve, and welcome. Thanks for joining us today. Today, we'll share with you the transformation of AngioDynamics the transformation of our portfolio and how we're becoming a medical technology company. So let me tell you how we started. 33 years ago, we started as a catheter company in upstate New York. What was then once known as Catheter Valley, a lot of companies started here and new technologies were spun off. Over time, we became a trusted partner to the interventional radiology community by providing high quality tools and devices that they trusted for care for their patients. Well during our journey, we added to our portfolio. We became a more complex company, but taking a look back over the past couple of years, we made some decisions to narrow our portfolio and focus it. So in 2019, we actually sold our largest single business, our NAMIC fluid management business. We didn't feel we were the right owner for that technology. We're going to continue to change our portfolio into areas where we can compete through our technologies that have competitive advantages the technologies drive those outcomes that can be measured by physicians and change physician behavior. When we look at our company today, we see 2 different portfolio approaches. The first and the one you hear the most about today, is our medical technology portfolio. Our mechanical thrombectomy products, our atherectomy products and our nonthermal IRE ablation tools. Each of these products are foundational technologies that we believe we can iterate from and build new technologies on. They will also create opportunities for our portfolio expansion over time. We think that each of these platforms create opportunity for growth driven by the unique science and technology behind these products. Today, you'll learn a bit more about those. So we're going to change our portfolio based on 3 important levers. First is research and development. You've already seen new product launches from us utilizing our R&D process. It's really good. We've invested 50% more in R&D than we did 3 years ago. That's an important driver for us, and we're seeing the outcomes of the new product launches through our process. Second, we are utilizing what we call clinical and regulatory pathway expansion, opening up new areas, new pathways for us to use these technologies to treat patients in need of care. You'll see our pipeline has 2 important aspects. First are the new products that we'll launch over the next 3 to 5 years. And second are the pathway opportunities. that we're investing in, in our pathway expansion approach. And the final leg is M&A. We've utilized M&A in the past to add technologies to our portfolio. 2 or 3 years ago, we were only about half the size that we are today in the markets that we compete. 3 or 4 years from now, we'll double that again. So it's really important for our investors to know our technologies drive outcomes. They're unique and special, but they're also competing in areas where the markets are larger and they're growing much more rapidly. These are part of the journey to value creation. So we're excited today to share with you more details about our technologies and our products. You'll see from us what they are, how they work and why they matter. You'll also hear from some global KOLs why they matter from their perspective and how our technologies make a difference in how they treat patients in need of care and in need of wellness. So we're really proud of the portfolio that we've built. And we're excited about our future as we'll continue to invest in this portfolio and add on to new opportunities for growth for our company and opportunities for value creation for our investors. So now let me welcome Scott Centea who will walk you through our mechanical thrombectomy business and give you the first look at a new AlphaVac product.

Thank you, Jim. My name is Scott Centea. I'm the Senior Vice President and General Manager of our endovascular therapies business unit here at AngioDynamics. And I'm extremely proud, privileged and excited to share with you all things that we are creating and expanding upon in our thrombus management portfolio to better address and meet the needs of patients with venous thromboembolism. So I wanted to start there. Before we get into really the meat of the presentation, I think we should level set and talk a little bit about the disease state itself. Venous thromboembolism. What does it mean? It's often referred to as VTE and simply put, is comprised of both the DVT as well as a PE. As a matter of fact, most patients that have a PE actually don't get one until they actually have a DVT. So let's start there. Deep vein thrombosis, what is it? It's basically the accumulation of blood over time in a vessel that creates a blockage or an inclusion. And if left untreated could actually break off from the vessel wall, thus becoming an embolus or an emboli and traveling north, right? When it gets into the right heart, it becomes a clot in transit before developing into a PE and going into the pulmonary arteries. As you can see, this is the third leading cause of death right behind heart attack and stroke. So it is important. And up until recently, most of the therapy or the way that they are treating these patients was a little bit more conservative. So I want to share with you a little bit about those treatment options and more importantly, how physicians are treating these patients differently and how we at AngioDynamics are starting to address those device innovations. So we break it out in really in 2 different segments. We look at both the procedure type from simple to complex or advance. And we look at both lytic-based therapy as well as non-lytic based therapy. So as you can see from the left here, we share that anticoagulation of a patient is at high risk to develop a DVT, they go on anticoagulation, something to thin the blood to help prevent clots from even occurring. Now is that clot or a patient presents with a little bit more leg falling and everything else, there is what we call catheter-directed thrombolysis. It's a catheter that will deliver a lytic agent to the actual area of the clot. Now it's been proven effective, but it also comes with some inherent risk and safety profile to where that patient has to be monitored due to the potential of increased bleeding. Now as you can see, everything kind of shifts to the right, you guys might be familiar with the Boston Scientific AngioJet, which is a pharmacomechanical. It uses both a mechanical aspiration component along with a lytic to help dissolve, break up while aspirating that clot out. And what's happening is there's a shift now to go non-linac based, let's reduce the risk of bleeding for some of these patients and have the control of removing the clot or the thrombus in its entirety. And we call those mechanical thrombectomy systems or mechanical aspiration. And then last but not least, all the way to the right, a little bit more of an advanced procedure, a complex procedure. You need certain support staff to do this. We call this AngioVac. And before I talk a little bit about AngioVac, I wanted to introduce John Moriarty, Dr. Moriarty, who is an interventional radiologist out of the University of California, Los Angeles, who will share with you a little bit more about the disease state itself as well as some of the complications and/or challenges that physicians have within this patient population. John?

Well, thank you very much, Scott. And it's a real pleasure to be here with you all today. I'm honored to be able to talk a little bit about something I'm very passionate about, which is clot management, DVT, PE and right heart thrombus removal. And as Scott was saying, I'm the Venous Director, Director of the PE response team and Founder of VenaService at UCLA. And so it's a pleasure to be able to discuss some of what I hope will be an interesting short few minutes on DVT therapy. So when we talk about DVT, we talk about clots within the legs that typically either stay within the legs, or DVT, or move somewhere else, either to the heart cold, right heart thrombus, or to the lungs call PDM. Put that all together, that's VTE, or venous thromboembolism. And this is extremely common. It's an enormous health burden on our system. About 900,000 Americans are going to experience some VTE events in this year. And these patients are debilitated by it or at risk of death from us. And indeed, it's the third most common cause of cardiovascular mortality after MI and stroke. And when we look at things like MI, myocardial infarction or heart attack, we are very comfortable in attributing a huge resource towards that. We dedicate cath lab time. We dedicate novel therapeutics like drug-eluting stents, thrombectomy devices particularly new and invasive ways of removing the problem. And we are doing now the same when it comes to DVT treatment. And so I really see the changes that have happened in stroke and in cardiac disease as being a little bit of a pathway as to where I see things going with DVT. Most patients who have a DVT, who have VTE event, come to some sort of imaging, whether it's an ultrasound or CT and then go to a vascular specialist. And one way that these vascular specialists differ to some other areas of vascular medicine is that they come from many different backgrounds. And so that can be a cardiologist, a vascular surgeon and interventional radiologist, a pulmonologist, there are multiple different types of physicians involved. And I think what that tells us is that there is scope for improvement and homogenization with lots of different approaches currently that I think maybe win out down over the next decade or so as we find out who are the best people to treat and with which devices. One of the ways that we've seen this over the last decade or so have moved from a pharmacologic therapy only, in other words, where people got given drug therapy, typically in the olden days that was Coumadin, now it is with a whole range of DOAC therapies to moving towards a far more patient-centered approach, which involves interventions. And these interventions have been performed typically in a hospital, in a cath lab, where we post license catheters in to dissolve the clot. And that has expanded hugely in utility and scope over the last few years. The dissolving of clots is catheter director thrombolysis brings with it several risks. These are predominantly around 2 things. One would be the risk of bleeding to the patient. And then the second is the cost associated with having the patient in a hospital with the agent, the catheter-directed license going in over a period of usually 24 to 48 hours, and these patients happen to be in ICU for that length of time. So in order to get rid of those 2 main things, the move towards a single session aspiration thrombectomy has been really huge over the last few years. And this has the benefit of turning that patient that previously had been going to the ICU for a few days into someone who maybe could go home on the same day as well as hopefully sucking out breaking up, removing the blood clots that's in there, all at one time. So this the need to give them clot posting drug that can cause the bleeding is far, far, far less. And so where I see this kind of natural extension going is a little bit similar to what happened with stroke and with heart attacks is that previously, we only gave heart attacks and strokes medication, then we gave them a medication directly into the blood vessel. And now in both heart attack and stroke, we try and move the clots that's causing the problem directly. And I see that going in the same way with DVT and BTE, where we're planning to directly suck out the clots that's there. There have been a couple of devices that have really changed the way that we have approached how we go about sucking out these blood clots. There are -- these devices originally were kind of bastardized from other areas of Interventional Medicine. For example, they were used in the arterial system to remove blood clots and then were moved into the veins with little change to the device. But over the last 5 years to 10 years, what we're really seeing now is our bespoke devices that are dedicated to the needs of the venous system, and therefore, I believe, are significantly better than what we used to have. And so the results are better, the patient experience is better. It's far better from the interventionalist point of view because as a doctor, what you want to do is you want to get the right device first time. And so the ability to choose the device that's right for that patient and get it into the patient safely, remove the blood clot and then move on is really critical. And one of the areas that I think we've seen the transformative effect of this is use of AngioVac, particularly with the removal of very large volumes of clots from the right heart and from the IVC, which is, as you know, the main blood vessel that links the legs to the heart. And in my kind of lifetime of doing interventional therapies, I have seen a huge change where some of these patients would have been mandated to have a big open heart surgery, the full zipper in the chest, where they would have had days of ICU admission, a substantial morbidity and a long recovery. And thanks to the ability to directly suck out these blood clots, for example, using AngioVac to remove a clot in motion within the right heart, we can now turn that big procedure into one that is over and done within an hour or 2 and a patient that only has a small bandage over the neck or groin. And this has really been, I think, a transformative change, and it has led us as a field to be extremely excited about what we can do now, but also what we can do in the future. It's not going to be one tool that fixes everything. But rather, you're going to want to have a range of devices that are specific to a particular job. And so whether it's the F2220 removal of the clot in the IVC or the F22180 for removal of a class that is kind of on the back wall of the right heart. These are, I think, important changes that we're going to see that are going to lead us to be able to deliver care to more patients and better care to the patients that we actually have. This has also been backed up by data that has come to fruition over the last few years. Some of it has come via multicenter trials, registries, some of it is still ongoing, and I think it's going to come to fruition over the next few years. But there is no doubt in my mind that the sea of change of moving from a purely drug-based therapy to one that is more personalized and interventional to get our patients better, faster and also deliver better long-term results, is undoubtedly one that's going to continue over the, I think the years and decades to come. And -- to that end, the interventional PE market, interventional right heart thrombus market, interventional DVT market, I think, is only going to expand. And as we see improvements in patient outcomes, we're seeing drivers for that expansion coming not only from physicians, but also from the patients themselves. And it is extremely common where I get e-mails, direct messages from patients who are searching out a better results than the one they're getting with just medication, and they want to go to someone or a center where they have access to these high-end devices, high-end therapeutics and hopefully high end results. So that was a very brief run through of what I think is one of the most interesting and sexy areas of medicine at the moment, which is BTE Therapeutics and where things are going. And I look forward to the journey that we're going to see over the next little while where we improve our patients' lives with these devices.

So thank you, Dr. Moriarty. You are an important voice, and we appreciate you sharing your insight around not only the disease state, but the innovation that is needed to better treat those patients. So one of the devices that he mentioned that he has a relationship with is our AngioVac system. And let me just unpack this a little bit more and share with you some of those details and more importantly, the advantages that AngioVac offers physicians and more importantly, the patients today. One of the biggest differentiators of our AngioVac system is our funnel tip shape design. So although this is a 22 French cannula, the funnel actually opens up to a 42 French to be able to better treat in an efficient manner, grabbing that clot and that thrombus. As a matter of fact, I had a physician tell me not too long ago, he imagines it as an anaconda eating a goat, which kind of paints the picture for you right there. In addition to the funnel shape and the angle as to which the cannulas are, it is a continuous aspiration system for that powerful and efficient clot removal while simultaneously removing the blood back to the patient. So there is no risk of additional blood loss. Now all the great benefits that help the physician with the AngioVac system also offer it as more of an advanced or complex procedure, knowing that you have to have perfusion support to be running that centrifugal pump. So being led by physicians and listening to them and having them tell us, we would love the benefits of the AngioVac system, but more in the control of our hands without the need of a perfusionist in the room. We took all of that, and I'm extremely excited to introduce to you for really the first time our next-generation AngioVac system, which is what we're calling the AlphaVac. [Presentation]

Introducing the new multipurpose mechanical aspiration device, the AlphaVac system. The AlphaVac system incorporates our proprietary funnel tip technology that we offer today. But instead, these catheters are paired with a multi-purpose mechanical aspiration handle that access the engine and eliminates the need for perfusion and support, allowing for quick emergent therapy. The AlphaVac cannula is indicated for the nonsurgical removal of Thrombi or Emboli, from the venous system. The AlphaVac handle is indicated as a vacuum source for the entire multipurpose mechanical aspiration system. The AlphaVac system is intended to be easy to use option that offers advantages, not seen in the market today. The AlphaVac system incorporates our proprietary funnel shaped distilled tip technology and combines it with the ergonomically designed AlphaVac aspiration handle to create a one flow through procedure without interruption and no need to reset the vacuum. The molded handle is designed for secure comfort and superior control when squeezing the handle. The aspiration handle also offers a volume limiting switch in order to minimize blood loss while navigating to and hunting for clot or burden. The vacuum locking mechanism allows for negative pressure to be maintained, while freeing up a user's hand or while the material is being aspirated through the cannula. The AlphaVac system can be used to remove material found in the Inferior Vena Cava, Superior Vana Cava, iliofemoral veins, clot in transit and material in the right heart. The AlphaVac system can be utilized using 1 of 4 access sites, the left and right jugular vein or the left or right femoral vein. A cannula comes with either a 20 degree or 180 degree self-expanding funnel shaped distill tip. This technology embodies a [ night mill ] framework to establish consistent, predictable and efficient deployment of the aspiration cannula in multiple anatomical locations throughout the vasculature. Once the cannula is navigated to the desired anatomical location with material present, pull the handle as needed, creating a controlled movement to engage with the material. Once the material is engaged, you can continue to either manually pump and aspirate using the handle or use the 30 cc setting and engage the vacuum lock mechanism to maintain negative pressure to ensure all the material is being aspirated while minimizing blood loss. The material is then sectioned into the cannula through the syringe barrel and into the transparent waste bag, which ensures a visual measure of how much blood and material has been taken out. The AlphaVac is an easy to use percutaneous option for large bore material in the venous system. Lead with confidence. Attack with precision. AlphaVac.

It's powerful. It's controllable by the end user or the physician, and it's versatile being able to be used as a first-line treatment by taking into account all of the benefits of the AngioVac cannula, the funnel tip shape, the angle at which we have, but putting it onto a mechanical and manual handle to give more control and reduce the risk of some of the challenges associated with treating these type of patients. And to start with the handle because this is where a lot of thought and attention being led by our physicians went into this. We listened to them and said, what are some of the challenges that you are having? What are the risks associated with it? The biggest one being, hey, we need a simple, very intuitive device that is efficient enough to us to be able to remove the most amount of clots in the least amount of time without having a lot of blood loss. First, I want to start with the volume limiting switch. We have a switch on the handle itself that will toggle between a 10 cc as well as a 30 cc aspiration or pool. Now what this means to the physician is that as they are tracking or they're hunting for the clot, they can pull back 10 ccs without a great bolus of blood. And once they get onto the clot, there will be a tactile field that will allow them or alert them that they are then there. They can easily toggle them between a 10 cc over to a 30 cc to be able to pull more of that powerful aspiration into the handle itself. Now once they are there, we talk about that continuous aspiration with AngioVac, all they have to do is lock the actuator, the handle, in place. And now all of a sudden, you get the continuous aspiration and unblocked removal of the clot back into the cannula. And then finally, very important is that this is a completely closed system. And what I mean by that is as you remove the clot from the patient into the canister itself. For every actuation, you're actually moving that into a waste bag in a completely closed system. So there is no resetting of the candle or resetting of the syringe or dumping it on the back table within the lab. It's safe, it's controlled. It's simple, it's intuitive and more importantly, it's powerful. As discussed, venous thromboembolism is not conditioned to one area of the body or vessel. It can happen and occur from your neck to your knee, and everywhere in between. Interventionalists who are trained to navigate tortuous anatomies with catheters and cannulas need devices that are purposely built for varying vasculature, which is why, at AngioDynamics, we'll be strategically launching our portfolio of restorative flow therapy products, both on circuit to expand the AngioVac line and off-circuit to enter into the non-lytic first-line mechanical thrombectomy market. So the engine or handle, if you will, coupled with the unique cannula sizes, tip angles, lengths, torque ratios and funnel, allow the physicians to choose from a comprehensive suite of devices to best treat their patient population. And as you've heard, we've recently received our 510(k) clearance for our first 2 AlphaVac products, our F2220 and our F22180. F22 representing the cannula French size and 180 referencing the tip angle or the degree, both of which matter when treating DVT and PE. Both size and tip angles are available in both our AngioVac and AlphaVac platforms. Releasing soon after that will be our latest 1885 AlphaVac cannula, which was developed with an 85-degree tip angle to better select the pulmonary arteries. Once on the market, we will immediately into it into our PE IDE for product indication. And lastly, we know size of the cannula or catheter can be limiting our reach distally to the lower extremities where DVTs commonly reside. And we're currently working on the next AlphaVac F1310, which will allow physicians to use the advantages of our AlphaVac system with a funnel tip cannula in the lower extremities. I'll be certain to keep you updated with our progress on that front. So I had the pleasure of walking you through all of our R&D investments. And now I have the pleasure of introducing Juan Carlos, our Senior VP of Scientific and Clinical Affairs, who will walk you through the importance as well as the investments we're making on the clinical side of all things thrombus management.

Thank you, Scott. To support our AngioVac and AlphaVac products, we will continue to make investments to develop clinical data that demonstrates the unique science and outcomes that our products enable. We are committed to developing the data sets that will allow us to get regulatory approvals, get payer access for patients and win in the market by having competitive data. Last November, we announced the safety and efficacy results from the RAPID study. Results were shared by principal investigator, Dr. John Moriarty. The registry was designed to evaluate the patterns of use, safety and efficacy of the AngioVac system and the bulk removal of undesirable intravascular material. The registry enrolled 234 patients across 21 sites surpassing its 200-patient enrollment goal. Among enrolled patients, 49% had masses in the right heart, 36% had caval thrombi, 9% had catheter related thrombi, and approximately 2% had a pulmonary embolism. Using the AngioVac system, 70% to 100% thrombus or mass removal was achieved in the vast majority of patients. What the rapid registry data demonstrates is that the AngioVac system can safely and effectively remove vascular thrombi and cardiac masses across a broad range of patient populations. It also validated our belief that physicians are not satisfied with the current treatment options for PE and are starting to explore the possibilities of using the AngioVac system in patients with PEs. In PE, our engineers have listened to our customers and have developed the F1885 PE device. Scott just announced, the FDA will require clinical study to support that indication using a very collaborative presubmission process with the FDA. Our clinical and regulatory teams feel very prepared to submit that trial for an IDE approval later this year. Lastly, to learn from the initial launch of the AlphaVaC-F-22 product family, we intend to launch a new study to capture real-world experience with a new off-circuit device for larger venous anatomy, which includes clot in transit in the right heart, caval vasculature and proximal iliofemoral DVTs. We recognize the importance of validating our technologies through data collection that can help guide payers and physicians to better treat their patients. Back to you, Scott.

So thank you, Juan Carlos. Well said, as always. So we spent a lot of time talking about our technologies and the innovations and our product portfolio and specifically AlphaVac. And as a reminder, let me share with you the total addressable market to which these devices will meet not only the needs of our physician, but more importantly, the needs of these patients that are suffering from venous thromboembolism. So over the next several years, we will be launching technologies and expanding indications on an intentional time line that will strategically unlock access to more cases that affect even larger patient populations in the need of improved innovations that advance patient care and wellness. And when we do this well, which I know we will. Our intent is to offer one of, if not the most comprehensive thrombus management portfolios in the market, which will ultimately continue to help drive AngioDynamics transformation, which I'm incredibly proud to be a part of. Back to you, Jim.

Thanks, Scott. You can see why we are so proud of the design and the development work that went into our new AlphaVac mechanical thrombectomy device. We listened to the users of AngioVac. We listened as to why they thought it was unique and special. We incorporated their voice and their feedback into the design of Alpha vac. We believe that we'll be part of the confidence that users need to treat more people with different types of VTE using mechanical thrombectomy tools. We look forward into growing this segment. Now let me welcome Scott back to speak to you about Auryon, our PAD device.

Thank you, Jim. It was November 1, 2019, when AngioDynamics first announced its acquisition of Eximo Medical and their laser technology designed to treat patients suffering from peripheral arterial disease or as we refer to it, PAD. And in the 20 months since then, we've been busy. The team now known as Auryon has been laser-focused on executing a thoughtful and strategic commercialization plan to build a sales team of experienced professionals who are ready to partner with physicians to provide best-in-class service and secure and scale our supply chain to ensure that we can meet our customers' demand. We officially launched our technology during PAD awareness month in September of 2020 during an unprecedented period that gave everyone, not only us, new challenges to overcome and a new way of thinking to meet the needs of our customers. So as I stand here today and look back on what the team accomplished, during its first full year of product availability, I'm incredibly proud of our results. And I feel it's a testament and true reflection on the uniqueness of our technology and more importantly, the innovation that is allowing us to partner with some of the most experienced and knowledgeable physicians in the world to help advance patient care and wellness. So let me go back to the beginning and share a little bit about why we made the decision to acquire this next-generation laser technology known as Auryon. Starting with the incidence rates, over 8 million Americans over the age of 50 have peripheral arterial disease. And these same patients are 6x more likely to have a heart attack. And if left untreated for a long period of time could lose a limb or, unfortunately, their life. In other words, it's an incredibly large patient population who continue to rely on the care and attention of physicians and new advancement in technologies to help prevent and treat this devastating disease. Depending upon the severity of the disease, treatments can range from lifestyle modification to medical management to endovascular procedures, like atherectomy, to help open the blockage in the vessels in an effort to preserve limbs and save lives. The atherectomy procedure alone is currently a $600 million market growing at 68% year-over-year. So when you couple the need for better treatment technologies with an aging patient population within a growing and substantial market, it made for a very compelling acquisition opportunity. And although the market itself was convincing, it was the technology that ultimately demanded a yes. The intent during our time together today is to give you a closer look at the technology and share with you how it's beginning to change everything. That said, it's my pleasure to now introduce Dr. Tony Das, Interventional Cardiologist from Baylor Heart Institute in Dallas, Texas. And for those of you not familiar with Dr. Das, he's one of the most experienced and prominent figures in the treatment of peripheral vascular disease as being one of the first cardiologists to be board-certified in endovascular intervention for peripheral vascular disease.

Good afternoon, and thank you very much for that kind introduction, Scott. My name is Dr. Tony Das. I'm an interventional cardiologist. I practice here in Dallas, Texas. My special focus in the cardiology world was actually endovascular, lower extremity intervention. I've been involved with a multitude of clinical trials as either a primary investigator or some investigator and published widely in this field. I've also been involved with lasers since 1997. In fact, I was trained with the original father of lasers, [indiscernible], in Germany and learned the technique and the technology of total occlusion therapy, et cetera, with him, using lasers and published on that field. And since that time, we've done many live cases, including EuroPCR, TCT and others, for many years. I want to just talk to you a little bit over the next few minutes about my background, a little bit about what I think that the Auryon laser can do, its capabilities, and also some of the uniqueness to the device itself in the space. As Scott has mentioned previously, I think that the folks on this call understand that this is a field which is completely exploding. The vascular space itself has a high prevalence and interventions to improve outcomes, reduce lid loss. And overall, we're looking for therapies that are beneficial in this space. If you think about the Auryon laser, its unique properties at 355 nanometers is a very specific wavelength. What we know about the different wavelengths of laser is that they treat the plaque differently, they -- wavelengths around this 355 nanometers has the ability to act on soft plaque and hard plaque in the lower extremity in ways that are very safe, effective and allow both the mechanical and photochemical effect on the plaque. So what does that mean? That means that when you're evaporating the buildup in the arteries that you're also creating an ability to see what the underlying vessel makeup is. And I call it uncovering the lesions -- And when you use these type of devices, you have the ability to sort of treat very effectively. And with the ability to have a catheter that also has aspiration, you can actually suck out or pull out some of that clotted material, which is part of the plaque makeup. The other thing that we look for when we're adopting new technologies is it easy to use. The Spectranetics laser, which is now the Philips laser, has a longer setup time. It's a very heavy device compared to the Auryon laser. If you think about the ease of moving of a procedure quickly, you want to be able to plug in a catheter system and to be able to use it immediately. So this device as a solid-state device as opposed to excimer laser basically means excited dimer, which the Spectranetics laser has gases that are inside a very large device, which is heavy to push around and takes 5 to longer minutes to be able to set up. This is -- the Auryon laser is immediate plug-and-play, and there's really no setup time, which is actually advantageous to us. In addition, it does aspiration of cutting the -- pulling that plaque out, I think, is very important. The other thing we frequently look for are companies that have a great relationship with physicians that want to improve the technology. One of the things I was very impressed with is the desire for the AngioDynamics Group and particularly Scott and his team to reach out to users and say, "we're going to do a trial called a PATHFINDER. We want to pick 10 sites that have experience with these type of devices. And we want to learn from you like where does this thing work? Where does it not work?" So we embarked on a trial together. We all enrolled 10 or 12 patients a piece. And after enrolling over 100 patients, I think we learned that the device has tremendous capability, has the ability to vaporize plaque very uniquely and that the company was listening when we said that there are certain things that needs improvement on like the end of the catheter needing a little bit more tapered tip. They changed it. We said, we need a few other things, and they're working on them. So I think that the collaboration between the company and the users is very high. So it's a space where there's need for new tools. This is a tool that's been proven in the past. to have really improved outcomes. And now you have a company that's willing to listen to the operators and the users and say, hey, we're going to work with you on trying to make this thing useful. I think that all of those things make it quite unique in our space to have a collaboration like this because we think that these tools will continue to evolve. And as they evolve, they'll need to get better and better to be able to help our patients. So I just want to thank AngioDynamics and the team to be able to help patients and their outcomes by having devices like this and listening to operators that have a significant amount of experience and to be able to work together on trying to make better devices. So with that, I thank you very much.

So thank you, Dr. Das. Very well said. I appreciate you sharing your insight in discussing the overall disease state. The challenges that physicians are continually face with and how the Auryon technology has proven to address these challenges and help advance patient care. I wanted to take an opportunity to unpack some of his comments and provide some additional details that make the Auryon system so unique and special in how it's changing the way patients are being treated with our device. Let me start with the basics or the nuts and bolts of the laser system that to most they seem boring, but to physicians and end users and to us at AngioDynamics are vitally important. To help you visualize the mechanics of how the laser works within the vessel, I want to show you a quick video. [Presentation]

The Auryon system is the next-generation in peripheral atherectomy technology. With 4 different sizes to choose from, Auryon catheters have been designed to treat the full spectrum of peripheral artery disease. The catheter options provide the ability to treat both above and below the knee, including below the angle. The Auryon system's advanced technology gives you the power and precision for treating all types of lesions. The system delivers a laser with an optimized wavelength, pulse width and amplitude for the delivery of greater power without sacrificing safety. Whether you are dealing with a lesion that is thrombotic, were severely calcified, the Auryon system is clinically proven to handle all types of lesions and is even indicated to treat instant restenosis. The need for using multiple catheters during a single procedure may be eliminated through the efficiency of the Auryon system. The unique off center capability offers optimal precision and adds the potential to debulk in fewer passes. Engineered with your patient's safety in mind. The Auryon system offers built in aspiration to address the risk of embolization, while targeted biological reactions are utilized to reduce the risk of vessel wall perforation. With clinically proven performance, debulking power and discerning precision, the Auryon system's advanced technology is designed to meet the ever-growing challenges of your atherectomy needs. Auryon. This changes everything.

As a reminder, Auryon is a solid-state laser that requires no toxic gas or continuous calibration. It's small, it's portable, lightweight and is built with an intuitive touch screen for optimized user experience. The standard and convenient power source allows the customer to plug into any 110-volt power outlet without requiring the need to retrofit an existing office-based lab or hospital with a special outlet like the Philips laser requires. Lastly, each system is equipped with aspiration capabilities. And when used with our 2.5 and our 2.0 disposable laser fibers, it helps prevent distal emboli from occurring during procedures. However, as much as I like the physical features of our capital laser system, it's what's on the inside that matters most. So now I want to walk you through the science of our laser technology and more importantly, how it's changing the way physicians are able to treat their patients. And most importantly, how patient outcomes are improving as a result. The Auryon system was designed to deliver an optimized wavelength and pause with, that with increase the amplitude to remove multiple lesion types while preserving the vessel wall endothelium. Simply put, it needs to work across all mixed morphologies of regions without harming the native vessel wall. The Auryon system does this by changing the game across laser science, which includes providing a new wavelength pause with an amplitude to the PAD treatment options. So starting with the 355-nanometer laser classification, the Auryon system lengthens the wavelength distance, which enables the energy to be hard on calcium and soft on vessel walls. Longer wavelengths are absorbed at shallower depths than shorter wavelengths resulting in lower photon energies. Basically, the laser is sharp enough to penetrate plaque, but smart enough not to damage the vessel wall. So when looking at the pulse width that gives us a unique amplitude, again, the Auryon system was developed to deliver optimal amounts of energy for effective treatment, but without compromising the integrity of the laser fiber. Up until now, no one has been able to deliver the amount of energy through a fiber without the catheter degrading to a point of failure. It's the Auryon difference in the pulse width that creates the optimal amplitude for plaque modification. Let me take you 1 level deeper on this point because it's important. Our shorter pulse width allows Auryon to deposit energy quickly and repeatedly up to 8x faster than the competition, and the contact of the laser to the vessel wall is so short that there's no time to damage the medial layer. So what does all of this laser science actually mean? Why should you care? Why do physicians care. It's because the Auryon System has a unique and leading technology that allows it to treat any lesion of physician encounters all with a single device. From a smaller footprint, that's small, portable, has a convenient power source to our built-in aspiration, coupled with our comprehensive line of catheters for above-the-knee and below-the-knee applications, including our instant restenosis indication, the Auryon System is an incredibly intuitive powerful, versatile, proven safe and effective technology for our end users and their patients. To talk a bit more about the safety of Auryon and the compelling body of early evidence with the system and real-world applications. I'm going to reintroduce Juan Carlos, Senior Vice President of Scientific and Clinical Affairs. Juan Carlos.

We recently announced preliminary interim results from the PATHFINDER registry. The PATHFINDER Registry is a prospective multicenter, single-arm all-comers registry to evaluate the use of the Auryon laser in a real-world setting to treat de novo, re-stenotic and ISR lesions of peripheral arterial disease patients. The study enrolled 104 patients. Preliminary data shows a high procedural success despite a variety of challenging lesions, including long occlusions, severely calcified lesions and ISRs. The primary endpoint is successful revascularization of the target vessel defined as 30% residual stenosis at the index lesion post Auryon and final adjunctive treatment as evaluated by angiographic core lab. It is rare to have a registry study core lab adjudicated. Still, we thought it was important that the first real-world data available from our unique laser be independently verified. The safety profile is also looking promising and the primary safety endpoint is the percentage of subjects with freedom from periprocedural major adverse events. Complete 6-month results are expected by the end of 2021. The PATHFINDER study has generated additional hypothesis that our physicians are eager to explore. Specific interest has been expressed in the below-the-knee application of Auryon. We will continue to listen to our physicians who guide us as they consider the best treatment options for their patients. And we'll continue to invest in data sets that quantify the unique outcomes of our product, not only for regulators but for patients, payers and providers. Scott, back to you.

So thank you, Juan Carlos. So as I end with the beginning in mind, we started this journey 20 months ago with 0 reps, 0 customers, 0 inventory and 0 sales, but did so with one amazing technology. Today, we have 47 fully dedicated commercial representatives. We have captured over 5,000 procedures above and below the knee, and we have over 132 customers that contributed over $11 million of revenue, during one of the most challenging and unprecedented times in our sales history. Our journey isn't over. In fact, it's just beginning because we still have a tremendous amount of growth and upside in meeting the increased demands of our practicing physicians, all while listening to our advisers, our customers to capitalize on their experience and to optimize our technology so they can, in turn, better address the needs of their patients suffering from PAD. Lastly, beyond just the atherectomy, we are actively working on pursuing new markets with the Auryon technology. In the meantime, I'm incredibly proud and honored to have the opportunity with our teams to place this technology in the hands of skilled physicians from across the country. Together with our technology and their clinical expertise, we are helping advance care and wellness to patients who deserve improved treatment options. -- and in the process, helping drive our organization's transformation. Thank you. Back to you, Jim.

Thanks, Scott. I really appreciate the team at Auryon, and how they've taken this amazing technology to the marketplace over the past year. What we did here is indicative of how we're going to invest in our businesses over time at AngioDynamics. We're going to invest in the base technology and the science behind that, as you saw in our presentation. And then we invested in the clinical and regulatory work necessary then added really great selling and marketing people to support our customers. That's why when I talk to you about the investments that we'll make, it covers each of those parts of the spectrum. And each of those are important to grow our businesses. Now let me welcome Jake Brumbaugh to speak to you about NanoKnife.

Thank you, Jim. My name is Jake Brumbaugh, Senior PM of the NanoKnife portfolio, and I've looked forward to this opportunity to speak with you about our business and in another amazing AngioDynamics technology, the NanoKnife system. The field of oncology is at war with a complex group of diseases. Physicians are continuously seeking out novel therapies to provide comprehensive and personalized care for their patients. Unfortunately, local treatment for solid tumors come with substantial trade-offs. Traditional methods use thermal or mechanical energy that destroys everything in its path, including the underlying structure of tissue known as the extracellular matrix. For physicians, this nonspecific destruction is a problem. It can limit the patients that they provide treatment for. And for those that they do treat, can damage too much, reducing their quality of life. The NanoKnife system solves these problems through its use of nonthermal energy. It decellularizes targeted tissue and leaves the extra cellular matrix undamaged. This preserves the body's ability to regenerate functional vascularized tissue, including blood vessels and nerves inside the treatment area, empowering physicians to provide a local treatment while maintaining their patients' quality of life. Today, the NanoKnife System is revolutionizing the way physicians provide local treatment. By creating more opportunity to provide care to more patients, we are developing new markets that our competitors are unable to access. To better understand why our physicians are choosing the NanoKnife system more often, let's take a closer look at the science behind this technology. [Presentation]

The NanoKnife System harnesses the power of irreversible electroporation, IRE to effectively destroy disease tissue without the need for thermal energy. 2 or more minimally invasive needle electrodes are positioned in or around the disease tissue, using real-time ultrasound guidance or CT. High-voltage posits are delivered between the electrodes and can be confidently delivered in all segments of an organ to create irreversible nano-pores within the cell membrane. The stimulus induces an apoptotic like cellular death, resulting in the complete ablation of tissue within the electrode configuration. The body response to the apoptotic like cell death by initiating the removal of cellular debris. Delivery of nonthermal energy ensures the conservation of the extracellular matrix, the unique mechanism of action enables the preservation of vital structures inside the ablation zone, facilitating the histological and functional regeneration of tissue following treatment. The NanoKnife System reimagines localized therapy, improving precision, increasing preservation and expanding versatility to ensure treatments can be tailored with confidence.

Precision empowered, preservation redefined, versatility perfected. The NanoKnife system reimagines localized therapy for our physicians by enabling them to treat at times and locations previously unavailable to them. We are able to develop new markets for the treatment of solid tumors. Now today, the NanoKnife system is indicated for the surgical ablation of soft tissue. It is used in many organs throughout the body, including the pancreas and liver. But we'd like to talk to you about our next opportunity, the use of the NanoKnife System for prostate tissue. Now prostate cancer is the most commonly diagnosed solid tumor for American men. In 2021, it is estimated that 248,000 men in the United States will be diagnosed with prostate cancer. Now when a patient is diagnosed with prostate cancer, they have 2 available options. One, they can go on active surveillance, where they will be continuously monitored until the time a treatment might be required. Many of these patients may never actually receive treatment for their prostate cancer. The other option is a patient will immediately qualify for whole gland therapy. This is radical surgery or radiation of the entire prostate. These whole gland treatments can have a significant impact on a patient's urinary and erectile function. This means that prostate cancer is the only solid tumor where local treatments is not part of the standard of care for eligible patients. There has been a growing consensus that prostate cancer has a single dominant lesion that exhibits life-threatening behavior as imaging, patient staging and physician technique improves a local option to treat that solid tumor is growing in popularity. This is known as focal therapy and can be used to delay the need or even remove the need for a whole gland therapy, allowing patients to preserve their quality of life for as long as possible. Now it has been estimated that 38% of prostate cancer patients qualify for a focal option. That's nearly 100,000 men in the U.S. each year. Despite patient and physician interest, less than 5% of men actually receive this treatment. This means there's a big gap between patients that qualify and patients that are treated. And that is for 2 specific reasons: One, the current technology has less than ideal outcomes, it still has a negative impact on urinary and erectile function of many patients; two, the current data supporting focal therapy is less than optimal as it often includes patients with low-risk disease within the study cohorts. If AngioDynamics is going to bridge that gap and develop the prostate market, we have to provide a unique product that maintains a patient's urinary and erectile function. And we can do this by preserving the nerves and blood vessels within the treated area. We also need to perform rigorous data collection on the right patient population, those men with intermediate risk disease. If we can execute those 2 goals, we will be able to develop the largest solid tumor market in the United States. Now I'm going to pass it over to Juan Carlos, who will walk you through our clinical strategy for both pancreas and prostate.

Thank you, Jake. Physicians have used NanoKnife and its unique mechanism of action in patients with various tumors unsuitable for surgical resection. Target organs include the kidney, liver, pancreas and prostate. We have targeted the pancreas and the prostate for considerable investment in data development, not only for regulatory approval, but to address data requirements from patients, payers and physicians. We have made considerable progress on enrollment in our DIRECT study. This unique study design includes a randomized controlled trial and a real-world prospective trial to obtain the highest level of evidence and real-world evidence to confirm that the initial results published over the last several years are transferable to a broader use of the technology. We are pleased that world-class institutions, such as NYU, Miami Cancer, Mayo Clinic, Norton Healthcare, UCSD and many others, have chosen to participate in this study. A company with our recent ICD-10 codes specific to IRE use in the liver and pancreas, we believe that this is an essential step to expanding patient access to our unique IRE technology. Another significant investment in data generation surrounds our prostate initiative. We are also excited to announce that FDA has granted us an IDE approval for a prospective 100-patient study of NanoKnife in intermediate risk patients. In partnership with the Society of Urologic Oncology, we will be launching a multicenter 100-patient study to demonstrate the safety and efficacy of NanoKnife in intermediate-risk prostate patients. We are honored to have 2 PIs that will steer the study. They are Dr. Jonathan Coleman, at Memorial Sloan Kettering; and Dr. Arvin George, at the University of Michigan. We anticipate having 15 sites in the U.S., enrolling patients starting early next calendar year. This important study, along with our recently announced CPT 3 code will be an essential milestone to ensure patient access to our unique technology. A variety of investigator-initiated studies further support these sponsored studies. These include the PAN FIRE 3 study investigating the use of IRE for pancreatic cancer in combination with immunotherapy. The CROs and multicenter society run 400 patient prostate registry and many others that will further validate the value of our technology. Leading one of the IITs is prostate cancer specialist Professor Phillip Stricker, who has pioneered the use of NanoKnife in Australia. He joins us today to share his experience with the use of NanoKnife.

My name is Professor Phil Stricker, I work at St. Vincent's in Sydney and at the Garvan Institute of Research. I've been involved in prostate cancer research for almost 30 years. I have an enormous team of people working for me, both clinically and preclinically. I've been asked to explain my experience in NanoKnife or IRE. I suppose the first question is why would a clinician or a patient want to have focal NanoKnife therapy? And I think the reason why is because; number one, radiotherapy and surgery or what we call whole gland therapy, caused quite a lot of side effects such as impotence, incontinence and erectile damage and often is deemed to be unnecessary and over treatment; whereas focal therapy such as used with NanoKnife therapy causes much less side effects, almost no incontinence, definitely no erectile damage and minimal impotence. And so -- and it's a day procedure. So it's less invasive. It's a very safe technology and in my experience, having used many of the other technologies previously, I find it the best of the available technologies to treat localized prostate cancer. The reason for that is, one, it's safe; two, it's been proven to be highly effective and reliable in killing tumors without worrying too much about the nature of the tissue; number three, it can be used in every segment of the prostate and indeed, we published on this; and number four, even if it fails after even 2 attempts, salvage treatments such as surgery and radiotherapy is still possible. So no bridges have been burned. So a day procedure, safe, reliable particularly in the group of people that are recommended by the consensus in Europe, which is the intermediate grade gases would seem to be a logical progression forward. I've done about 400 cases of this so far since 2013 and trained a number of units in Melbourne, Brisbane and now more recently in the United States and Europe. The results we're getting is almost a 97% clearance of tumor and about a 15% recurrence in the rest of the prostate, which is amenable to further treatment, if necessary, over a 5-year period. There have been no major complications in our literature. And in addition to that, we have less than 5% impotence rate and almost 0% incontinence. We've used it after radiotherapy has failed as well, and we're indeed about to publish our results of our trial, the FIRE trial. A randomized trial is about to commence in Sweden, and I'm helping supervise that. So in essence, this is a very safe and reliable treatment. I've been doing it now for 8 years in 400 cases and I become more impressed with time rather than less impressed, and it's been the subject of over 10 publications from our units. The market size is enormous. Between 10% and 20% of all primary diagnosis of prostate cancer would be amenable to it. This brings a question as to who is the right patient for. Obviously, in intermediate-grade cancer it's suitable, but as we get better at selecting these patients, maybe with new markets, in addition to excellent modern imaging with MRI and possibly PET scan, will become better at selecting this group. So moving forward, I think NanoKnife is the best technology that I've seen for treating focal therapy. I think its future is very bright. Indeed, it even has the potential to stimulate the immune system against tumors. So I have a believer, I'm a strong supporter of the technology, and I'm impressed with the scientific results we've been able to achieve. So thank you for your attention.

Dr. Stricker is clearly an important voice, and I'm excited he had the opportunity to share his experience treating prostate cancer. Now as you've heard, many physicians around the world continue to refine and develop techniques for focal therapy. Some physicians outside of the United States have added the NanoKnife System to their toolkit to further investigate its use in prostate tissue. And we have been excited by the results. This data is coming back as positive and promising, showing that the NanoKnife system can provide a complete ablation of prostate tissue, but still preserve the erectile and urinary function of a men. You see we are so excited by the NanoKnife System because it is able to deliver a complete ablation with precise treatment margins. It can destroy tissue, but preserve the extracellular matrix, which leads to the functional regeneration of nerves and blood vessels, and it can be used confidently in all segments of an organ. This is what makes it an ideal technology for focal therapy. We believe the footprints we make today will be the traveled path of tomorrow, by providing a unique treatment option to help our patients live happier and healthier lives. Thank you again for the opportunity to discuss such an exciting technology. Back to you, Jim.

So I'm glad you got to see our approach to NanoKnife, while we're making this a really valuable business opportunity. Now let me welcome Chad Campbell, who will show you our Vascular Access business and why it's a value creator for our company.

Thanks, Jim. Hi. I'm Chad Campbell, Vice President and General Manager of our Vascular Access business. And today, I want to take some time and talk a little bit about our medical device portfolio. Each one of these portfolios have differentiated products and serve our patients day in and day out. If you look at this group of markets and portfolios, they're really strong and have been integral in the transformation of AngioDynamics. These products drive a lot of earnings for the company that help us invest in our med tech portfolio. Today, I want to focus a little bit on our vascular access business. In vascular access, we're really proud of the role that we play in helping nurses and doctors safely deliver medication worldwide. We've had 3 years of growth in vascular access that we're really proud of. And there's 3 main reasons or imperatives why that growth has come in our business. First is our portfolio. Second is improved market access. And third is our performance. So let me rewind back to our portfolio. Over the past 3 years, we've launched a number of products in our portfolio that have helped us better serve our patients and customers. We've done that through research and development, clinical and regulatory pathway expansion and M&A. First, we have a value line of midlines and PICCs, which have been a great balance to our BioFlo portfolio. Second, we acquired a C3 tip location asset that has helped nurses safely deliver PICCs without an x-ray. And that's been a game changer for us because that enables us to put more BioFlo PICCs into our clinician's hands to serve patients. And third, we've launched our family of SmartPort+ and SmartPort Plastic ports, which marries our Vortex technology with our BioFlo catheter. It's been very well received by patients and clinicians around the world. Second is market access. We've been able to improve our access to clinicians and patients by some of the product changes that we made in our portfolio. Second is our WAM differentiator, and that's our BioFlo technology, that has given us more access to patients around the world. And third, our corporate accounts team has done an amazing job earning committed contracts. What we've learned is the improvement in our portfolio in combination with our BioFlo story has allowed us to contract more effectively, not only at the local level with hospitals, but also at GPOs that cover large groups of hospitals. And third (sic) [ fourth ] is our execution. Our teammates across the regions have done an amazing job with our commercial discipline. Our sales and marketing plans have been executed by all of our teammates and really helped us bring value and growth to the company. We're really proud in vascular access of the growth we've achieved over the last 3 years. We're positioned to win today and in the future, and we'll do it by the same way that we got here, portfolio, improved market access and strong performance. Jim, back to you.

Thanks, Chad. You and your team have done a great job managing our Vascular Access business. Now let me welcome Linda Upchurch. She and her team lead our healthcare economics and market access team. They help to ensure that our devices and technologies can reach the patients that need them and to ensure that the caregivers can get adequate reimbursement for the care they deliver. Linda?

Thank you, Jim. Today, you've had the opportunity to hear about our unique technologies and the investments we're making to develop the clinical data sets to support our physicians, patients and payers to select the right technology for the right patient in the right setting. Alongside those investments, we continue to make meaningful progress in market access and reimbursement. One of the critical investments AngioDynamics has made over the past 3 years is our commitment to develop a world-class healthcare economics and market access team. We now have a team with experience in public policy, healthcare economics, health technology assessments, payer relations, patient advocacy, society relationships, to advance market access across our product portfolio. For example, we continue to develop customer-facing tools and resources to assure the customers we serve, understand how to accurately and efficiently build for the services they provide with our products. To support these tools, we now have reimbursement staff available to answer questions or provide references to our providers and their staff. Lastly, we have the market access models to demonstrate the clinical and reimbursement opportunity, helping physicians and the value analysis departments at hospitals understand how our devices can fit into their clinical offerings. In addition to the customer-facing tools, we've made great strides in working with our partners to develop new codes specific to our products. For example, in October 2018, Medicare activated ICD-10 codes for payment of irreversible electroporation in the liver and pancreas, when provided in the inpatient or hospital setting. In addition, with Medicare payment, we've heard from our customers that most private payers are also recognizing this service. All this means that now the right patients have access to the right technology in the right setting. In July 2020, a series of new Category 3 CPT code specific to irreversible electroporation became active for physician billing. These were the first CPT codes specific to IRE. Notably, the codes are agnostic to Oregon. These codes align well with the interventional radiologist use of IRE as well as with our prostate initiative. And we suspect that many physicians will choose to use IRE in the outpatient setting. Codes, as you know, don't just appear. The CPT codes for irreversible electroporation were requested and championed by the Society of Interventional Radiology, in partnership with the American College of Surgeons. These professional societies made obtaining codes for IRE a priority, recognizing the clinical value of the service and wanting to see that their members have a mechanism to bill for the services rendered. Once the new CPT codes were approved by the American Medical Association CPT panel, CMS reviewed and chose to propose inclusion of these codes in APCs or ambulatory payment classifications. Ambulatory payment classifications are the government's method of paying facilities for outpatient services in the Medicare program. The proposal carried into the final rule, where the IRE codes were assigned to an APC in the outpatient hospital setting with payment consistent with cryoablation and higher than other ablation modalities. The codes are also assigned reimbursement in the ambulatory surgery setting. This progression of CPT codes to APCs has set the stage for increased access to IRE in the outpatient setting. We are very grateful to the American College of Surgeons and the Society of Interventional Radiology for putting this in motion. You've just heard me highlight significant progress specific to NanoKnife, but the work is happening and momentum is building across the entire AngioDynamics portfolio. AlphaVac already fits within an existing code family and brings features like the patented funnel tip that will drive market use and access. With our acquisition of Auryon and the impressive market growth with that product, we're engaged in identifying market access opportunities and challenges for the PAD market as well as adjacent spaces where Auryon might be used in the future. I look forward to sharing more on those fronts in the near future. Lastly, I want to emphasize the partnerships we have developed with professional societies and patient organizations. At the heart of what we do at AngioDynamics are the patients, people, whose lives are improved or extended because of our devices and products and the physicians who strive to identify the right therapies in the right setting for each individual patient in their care. Like-minded professional societies work every day to advance the ability of their members to provide innovative and necessary care to patients. We applaud their efforts. And we're proud to partner with them to advance research and public policy. Back to you, Jim.

Thanks, Linda. We appreciate the work you and your team have done here. The group that Linda leads is an example of the investments that we're making in our portfolio, and our technology and then our people adding new capability to AngioDynamics. Now let me bring Steve Trowbridge back to talk to you about our financials and our outlook. Steve?

Thank you, Jim, and thank you for joining us this morning. The AngioDynamics management team really appreciates the opportunity to discuss the transformation that we have embarked upon. You've heard about many of the exciting investment opportunities in front of us as we continue to focus on our med tech platform technologies and enter fast-growing, high-margin markets, in which we have a technology advantage that can drive both improved patient outcomes and overall shareholder value. You've also heard about our more mature medical device businesses, and how they provide the engine for investment in our growth drivers. This morning, during our fiscal year 2021 Fourth Quarter Earnings Call, we discussed our guidance for the upcoming fiscal 2022 year. We expect revenue to be in the range of $305 million to $310 million, representing growth of 5% to 7% over fiscal year '21. As a reminder, our fiscal year '21 included approximately $5 million from a onetime NHS order. Excluding this order, our FY '22 guidance implies a growth rate of greater than 7%. Now this revenue growth will primarily be driven by our MedTech platform technologies, Auryon, AngioVac and AlphaVac and NanoKnife. Now we were pleased to end FY '21 with $11.1 million in revenue for Auryon, and we expect Auryon to contribute $18 million to $22 million of revenue in FY '22. And driven by increases in both new customers and existing customer utilization. Our AngioVac platform grew 47% during FY '21, representing solid performance. But FY '21 comparisons are somewhat skewed by the impact of the COVID-19 global pandemic. We expect our mechanical thrombectomy businesses, comprising both AngioVac and AlphaVac to be a growth driver in FY '22, delivering greater than 30% growth. We finished FY '21 with strong sales of NanoKnife disposables, and we expect NanoKnife probe sales to grow approximately 20% for FY '22. We expect adjusted EPS for FY '22 to be between $0 and $0.05. As we've discussed throughout today, AngioDynamics is in investment mode. We've identified and prioritized significant investments in our med tech platforms, and we are committed to making the necessary investments to drive top line growth. As illustrated throughout our FY '21, we will continue to prioritize these exciting investments while being good stewards of the bottom line. Now we expect gross margin in FY '22 to be approximately 55%. This would represent an increase of 110 basis points over where we ended FY '21. The increase will primarily be driven by sales mix. But gross margins do face a number of external and structural headwinds that mitigate the pace at which our strategic transformation can drive gross margin expansion. We do expect that gross margins will expand over time as we continue to execute on our strategy of driving growth in our high-margin med tech platforms. However, during the back half of FY '21, a number of external pressures resulted in gross margin headwinds that we anticipate could extend through the next several quarters. The tight labor market has resulted in high labor and manufacturing costs. And in addition, we've experienced significant freight cost pressures, and we have observed what we believe to be the beginning of raw material inflationary pressures. Many companies have discussed staffing challenges during the first half of calendar year 2021, and we're no different as we face challenges in fully staffing our Queensbury, New York facility. We have a talented and dedicated operations team that is focused on labor and service efficiency, material pricing opportunities and make versus buy analysis. However, the external factors I mentioned and the Auryon pricing dynamic stemming from the increased OBL mix that we previously discussed, will impact the pace at which our sales mix drives gross margin leverage through FY '22 and beyond. So as we move into FY '23 and FY '24, we'll remain in investment mode as we continue to advance the strategic transformation that Jim talked about. For our FY '23, we expect revenue growth to be in the range of 7% to 9% or $330 million to $336 million. By FY '24, we expect AngioDynamics to be a 10% to 12% revenue grower with projected revenue in the range of $360 million to $375 million. As we've discussed throughout the morning, this revenue growth is predicated upon our MedTech platform technologies of Auryon, mechanical thrombectomy and NanoKnife, becoming an increasingly larger contributor to our overall revenue base. Throughout the planning horizon, from FY '22 through FY '24, we expect our MedTech platforms to provide a compound annual revenue growth rate of 30% to 35%. And we expect our more mature medical device businesses to provide a compound annual growth rate of 1% to 3%. As we start our FY '22, our MedTech platform contributes less than 20% of our overall revenue. By the time, we complete 2024, we expect those platforms will contribute approximately 35% of our overall revenue base. revenue growth and sales mix will drive gross margin expansion. And while we do expect to see some expansion during our FY '23 and '24, we expect the headwinds I just discussed to partially offset the product mix benefits provided by this revenue growth. The performance during FY '21 that we discussed this morning and our guidance for FY '22 is a direct result of the focused and targeted investments that we have made in our growth drivers. We will continue to be in this investment mode through '22 to '24. We will continue to invest in internal R&D. Now we've had some great successes come out of internal R&D, including the AngioVac and NanoKnife 3.0 product launches, and we're looking forward to the exciting AlphaVac launch planned for this calendar year. We are absolutely committed to the data generation initiatives that Juan Carlos Serna walked you through today, including our PATHFINDER study, mechanical thrombectomy PE studies, our direct pancreatic cancer study and the NanoKnife prostate IDE study, the approval of which we announced this morning. Data is imperative to articulate our medical tech platform technologies value to physicians, patients and payers. Now just as important as investments in R&D are investments in our sales and marketing organizations. Throughout FY '21, we discussed how we were investing ahead of the curve to support our Auryon launch. We will continue to do just that as we head into FY '22 and beyond in support of both our Auryon platform and our mechanical thrombectomy platform. As illustrated throughout FY '21, we're committed to making the necessary investments in our business to drive future growth, which tempers our operating leverage expectations, even as revenue growth accelerates over the next 3 years. We will be good stewards of the short-term bottom line, but we will also prioritize the investments we discussed today to drive sustained long-term profitable growth as we move into FY '24 and beyond. Coming out of the very challenging environment created by the COVID-19 global pandemic, we were very pleased that we were able to strengthen our balance sheet. As we sit here today, we're in a net cash position, and we have a very strong banking group, providing us access to a revolving credit facility. We're confident that we will support all of the investments to drive our business through internal operations. We don't have any plans for equity raises or to put permanent debt on the capital structure. And we'll remain opportunistic and disciplined in our approach to external M&A as we look for tuck-in acquisitions that support our MedTech platforms. We were very pleased with the performance we disclosed this morning for our FY '21. We're proud and humbled by the perseverance, dedication and performance that everyone in the AngioDynamics family exhibited. And we're going to take those same principles as we move into FY '22 and beyond and as we complete our strategic transformation to become a double-digit top line grower in large, fast-growing, high-margin markets in which we have a technology advantage that drives patient outcomes. As I said earlier this morning, I have never been more excited about AngioDynamics' future than I am today. With that, I'll give it back to Jim.

Thanks, Steve. Hopefully, you've got a chance to see our company's transformation. You got to see our important products. You saw what they are, how they work and why that matters to our customers. You'll see that the basis of our transformation is our portfolio. But beyond that, we are in investment mode here at AngioDynamics. We're investing to grow our company. We're not just investing in our portfolio, we're also investing in the pathway expansion that our products need to get to market. And we're investing in the talent and capabilities of the people that drive our products and drive our transformation. Thank you for joining us today. Now let's move to the question-and-answer period.

[Operator Instructions] And our first question comes from the line of Jayson Bedford with Raymond James.

Can you hear me okay?

Jayson, thanks.

Okay. Maybe just I'd like to hit on a few of the key products here. First on Auryon, you mentioned 2.0 enhancement. Can you just detail a little bit on kind of the new features of the enhancements? Also, talk through some of the expanded indications that you alluded to? And then finally, you mentioned adjacent spaces for Auryon. And I guess can you just comment on your plans for the coronary indication?

Sure, Jayson. So 2.0 project really started when we first got the product in front of our users and our customers. They started to engage with it and treat people. So we're able to collect a lot of feedback on what they liked about the first design and what enhancements they'd like to see. So I'll have Scott really give you a couple of details about what we're looking to do.

Yes. Thank you, Jim. Yes. As Dr. Tony Das mentioned, we've been listening to the physicians from the very beginning of us implementing this technology into their hands and with their experience. And one of the things is really around the deliverability of the catheter itself. We've made some enhancements to the tip to round it out a little bit more to get help, get up and over the bifurcation. And then in addition to more of the near-term changes that we're going to be making around maybe a hydrophilic coating, just to, again, help with the advancement of the catheter itself.

And Jayson asked about expanding indications in other areas that we're considering.

Yes. Much like what we've seen with the existing laser in the market right now with the Philips laser, we know that they're in the coronary space. We're looking at, obviously, the benefits that we get with the 355-nanometer laser in the coronary space based on the safety and the efficacy. So we're looking at that. And we're looking at some other adjacencies as well from a thrombectomy standpoint, again, being led by the physicians trying to help guide us to where this thing can actually play even better than some of the existing technologies out there.

Okay. Maybe for AlphaVac, do you plan on having some data before the fiscal 2Q launch? And if not, when can we expect to see some data on the device?

Sure. Scott?

Yes. So we have -- some of the data that we've collected already through the RAPID Registry, which I know John Moriarty or Dr. Moriarty already talked a little bit about in the last presentation, we're utilizing some of that based on the advantages of the AngioVac platform. And then upon immediate release and launch and use of the AlphaVac device, we will be entering into a registry to further capture some of the clinical data and the results that we know are necessary to further conform and validate what we believe this thing or this AlphaVac system will be able to accomplish.

And Jayson, you can look at what we did when we launched Auryon as a good example of how we will handle the AlphaVac launch as well. So we won't have data at the time of the launch. We'll be doing a limited market release once that product is ready. But we will, as Scott said, be entering into a registry. We'll be collecting that data, listening to our physicians, understanding what data gaps they may see to help us drive commercialization in the future.

Okay. And then maybe a couple of others on AlphaVac, and I'll let someone else jump in. Can you just speak to the call point here? And the sales force -- do you expect to expand the sales force for this initiative? And then also, can you just comment, have you filed for the 18 French device yet?

Sure. Scott?

Yes. So to answer your first question, Jayson, it's a good one. Right now, with our restorative flow therapies, a Venous sales team, that currently sells and represents the AngioVac platform, the majority of our physicians that we're calling on today with that device is interventional cardiology as well as cardiothoracic surgeons. The benefit that we get with our core portfolios, so our angiographic catheters, which is also in that same portfolio, works really closely with the interventional radiologists as well as the vascular surgeons where they are predominantly doing the majority of these mechanical thrombectomy devices. So we have an existing relationship already with that special team and the sales force will be able to reengage with them or further strengthen those relationships with the introduction of the AlphaVac. And I'm sorry, can you remind me of your second question?

Yes. The second question is have you filed for the 18 French device yet?

Yes. So we are just about to file for that. Right on the heels of us, obviously, just getting the 510(k) clearance for the F2220 and F22 180-degree cannula. So we'll be filing for that indication within really the next month or so, and we hope to have an approval on that very soon.

Okay. And just, Scott, getting back to the earlier comment. Which physician subspecialty do you envision using AlphaVac the most?

It's really going to be in the interventional radiology as well as the vascular surgeon call point. Again, as you know, Jayson, one of the challenges that we have or the limiting factors with AngioVac is just the access to perfusion and interventional radiology and vascular surgeons are really that first line sort of treatment. So they want something where they have control. They don't have to worry about the scheduling and the production event. And so we see that the AlphaVac system will play very nicely in that space along where an Auryon and Penumbra are currently playing as well.

Our next question is coming from the line of Matthew Mishan with KeyBanc.

Just a big picture question for you guys. And when you look at the organization, I feel like you've always had technology and larger TAMs, but were never ever really fully realize the opportunity. It seems different this time. What are the more -- the most important changes kind of you've made with the organization that investors should know so they have more confidence you can execute on these important launches?

Yes. Good question, Matt. So a couple of things. If you saw today the TAM development on a slide we put forth, you'll see we're actually competing in larger markets than in the past. But you're right, we're still in large markets before, Matt. But we took a look inside structurally at how we do business. So we tried to align changes to our structure when we made the investments in the products and then in the regulatory clearances that we'd like to seek. So we look at a company now that has a bulk of its resources deployed towards these devices in the larger markets. So we've done some shifts in the internal resources, whether they were R&D resources, clinical resources or selling and marketing and customer service resources. So we've kind of shifted along the way, tried to time those shifts with the deployment now of these new launches in these spaces, Matt. So we'll be really well resourced to these areas with the larger TAMs, the faster growth rates, so we can be prepared to take advantage of those.

And then as I look at Auryon, I remember when you acquired the device, the goal was to get up to about 10% market share, which I guess would be around $60 million. Are you far enough along where that may be the most realize -- where that is a realizable share target? And is that something you think you can do within the time frame of your 3-year LRP?

Yes, Matt, you're right. When we talked about first acquiring the product, I think we mentioned 8% to 10% was a realistic, we thought, 3-year goal. And I think that still is a good range to look at. Now we know so much more about our device, and the feedback we've gained from our users have been really positive. So we still think that's a good range. If you look at what we did in year 1, which really the launch was until September, so partway through our fiscal '21, you saw the guidance we gave this morning for this coming fiscal year, I think we're still in that same range we identified early on. And if we see more there, we'll adjust with you.

And Matt, we're very pleased with what we saw in '21 for Auryon. Remember, as Jim said, we didn't officially launch it until September, and we were doing it in a year that clearly had a lot of impacts remaining from the COVID-19 pandemic. So we were happy with the performance that we had. And an additional part of that COVID-19 disruption is the fact that there's been a very big shift out of the hospitals to the OBLs. So as we talked about before, about 60% of atherectomy procedures used to be done in the hospital, about 40% in the OBLs. Over the last year, we saw that completely shift around in the broader market to where about 60-plus percent were being done in the OBL. And for our business, more than 90% was being OBL based. So we're looking forward to this year where we think hospitals are opening up, and we can start to shift a little bit. As we've said, we expect that shift to be sticky to a certain extent. It's not going to go back to where it was pre-pandemic levels. But it's another opportunity for us to continue to drive this business throughout our planning horizon.

And when you look at that market, and you broke it out by laser versus mechanical, to get to that 8% to 10% share, are you -- is it taking laser share? Or are you actually converting some mechanical too as well?

Yes. So you look at -- we're in a large market that's growing already itself. So there's market growth occurring as people are trusting atherectomy as an overall treatment of choice. So we're going to see that dynamic occur. And Scott today in the presentation focused on our laser science, and how it's different than the other laser in the market. But when you look at the adoption of our product now and how we can work above and below the knee, we're not targeting any one of our competitors. We're letting our customers lead us to where they have confidence. So really, we think we'll gain share in the market, take share from the current players and also be part of the market development that's occurring. Any comments, Scott?

Yes. Thank you, Jim. I think one of the additional comments I'd like to make is, in the beginning, right, I think the customers that were attracted to Auryon were already those laser established customers. And what we've seen over time based on the efficacy, the safety and the results that we're getting with Auryon, going after that mechanical application, we're seeing a lot of growth in that area as well. So not necessarily just taking laser share. But when we get into the below the knee, more complex lesions and highly calcified lesions, what physicians have told us that they enjoy most is the safety profile that they get with the laser technology, but the efficacy of that orbital rotational device that you see in some of those other competitive devices working as well with our laser system. And I think that's what gives us a lot of confidence going into not only this year but the years to come.

And then last question, and then I'll jump out. Around AlphaVac, just which of those features do you feel are most unique and most protected from competition over time?

Yes. So starting with, obviously, the AngioVac System and some of those benefits, the proprietary funnel tip design that we're taking advantage of and attaching to the AlphaVac mechanical manual applicator. That, in addition to the 10 to 30cc switch so that the physicians themselves have more control over where they are going and looking to deliver or actually remove the clot from that area. So once they get there, they're not removing a lot of blood. They can toggle between 10ccs then over into 30ccs. The other key feature is the tactile response. I think when you talk to a lot of interventional or interventionalist, they love to use their hands. They look for some sort of response in the devices that they're using. This one gives them that so they know that they're -- where they need to be to be able to remove that clot. And then when you put the vacuum lock on there, the continuous aspiration that we see with AngioVac, now coupled with AlphaVac to get that same sort of modality and mechanism of action, is what we're going to see, hopefully, some really exciting results. Our goal is to be able to remove the most amount of clot in the most efficient manner while reducing blood loss.

Matt, we did a lot of voice of customer work in the design and development phase of the AlphaVac. And the thing we kept hearing from our users was they loved the funnel tip design and the control that we gave them with AngioVac. But they said, if you're going to develop an off-circuit product, which the AlphaVac became, they wanted more control at their hands. These are skilled and talented physicians with incredible knowledge. They said, let us use that, give us a tool that we can use our skill. So you see the design elements that we showed you today at the AlphaVac, that came right from their voices to our design elements and our products. So we think there's a lot of features that will be well received when the product hits the market with these customers.

Our next question is coming from the line of Bill Plovanic with Canaccord.

Great. Can you hear me okay?

Yes, Bill.

Great. So I'm going to hit along the 3 MedTech. First, just start out with the Nano. Just can you -- since this is driving the future, what -- give us a ballpark for the 2021, fiscal 2021 revenues for Nano. And then how is that -- what's that mix between capital and disposable, just so we have a good base to build off of?

Yes. So the mix between capital and disposables. Primarily, we were driving disposables as we got through FY '21. Our Q4, we talked about, about $3.5 million for NanoKnife. So we were closer to that $15 million number for the full year, primarily driven by disposables. As we talked about FY '20 was a big capital year for us, even pre-pandemic coming on the heels of the launch of the NanoKnife 3.0. And we talked about this year, we expect capital to be roughly in line with '21. So the focus for us is driving disposable growth. We think that we can get disposable growth continuing at the 20-plus percent growth rate as we head through FY '22, driven by, as Jim said earlier on today's earnings call, increased awareness coming from the DIRECT study but also increased utilization coming from that installed base of the capital that we talked about.

Okay. I'm a little slow here. So total NanoKnife was $15 million for the year. And what percentage of that was capital?

So the capital percentage would be -- of Nano, let me just get my numbers right for you. It's just north of 10%.

Okay. Great. That's very helpful. And then as we look at Auryon, just as you get into that market and that product comes out, today, just atherectomy has very low penetration rate. And given the data you're seeing or at least the features and benefits of the improved safety and outcomes for this technology initially, just curious as to what you're seeing in terms of market share versus market penetration into the procedural opportunity. And kind of where do you see that headed?

Yes, it's a great question. I think early on, obviously, this is a pretty well-established market already with some of the 4 big players that came before us in a large market. So initially, it was this market share shift away from those devices over to the Auryon system. And now what we're seeing is based on what you just said, the safety, the efficacy, we're actually seeing more and more physicians looking to treat differently these patients before, again, through less medical management, more intervention or percutaneous intervention with atherectomy allowing them to be able to treat more of these patients with, again, the confidence of having that safe as well as effective procedure.

Okay. And as you look at the -- just given your perch and you see the features and benefits of this technology, I think the penetration rate today for atherectomy is about 5%. Do you see this as expanding that market? And if so, to what level?

Yes. I definitely see it expanding. I don't have numbers that I can quote at this point based on where we're seeing or what we're driving because a lot of our share right now has early on has been just that market share shift away from the competition over to our technology. But as I stated a moment ago, what we are seeing is more and more physicians, as they move into OBLs, which is where we're starting to see some of that transition or the care or delivery of care moving towards, we are seeing physicians want to treat these patients maybe differently than they have before. And with the Auryon device, we're making sure that they're well aware, again, of the safety profile as well as the versatility it allows them to treat both above as well as below the knee and including in-stent restenosis. So having that one-stop approach for these patients, I think, will be critical as we move into those markets even further.

Great. And then just on the thrombectomy segment, a technical question. But as you launch the cannulas with the AlphaVac product and the similar features that you see with the AngioVac, are those interchangeable cannulas? Or are they each specifically designed like AlphaVac has its own set of cannulas and AngioVac has its own set?

Bill, we took a lot of the design elements from AngioVac, as we spoke earlier, during our design and development process. But as we developed the AlphaVac, we saw there are so many new features we wanted to add to listen to our customers. We really have 2 different platforms here. So AngioVac gave us some of the funnel tip being obvious, the large bore parts. But really, those design elements were brought over, but AlphaVac is really a new product.

Okay. And then just last on pricing. As you look at the market, I mean, that's been a -- it's been a super fast-growing market. And as we see different players come in, how do you think about pricing versus the features and benefits?

Well, again, there's a couple of really good products on the market today. We think we're going to add and give people user's choice, as Dr. Moriarty said in our video earlier and give these physicians confidence to treat more people utilizing this approach towards this disease. So we're going to price this product today where the market sits at today. We think we have great features and benefits. We think the market pricing is about where we should be.

Our next question is a follow-up from the line of Jayson Bedford with Raymond James.

Just a couple of follow-up questions. First, on AlphaVac, I apologize if I missed this. But are you increasing the size of the sales force just to support the AlphaVac launch?

We may have not answered it for you, Jayson. So we did. We moved some people from other sales forces. I spoke earlier, a question was raised about how we're going to address these larger markets. And I mentioned about resource deployment. Internally, the first thing we look at is resource deployment. The second is expansion. We talked to you about the investments we're making. So we have added to the sales force that Scott described, and we'll still look to continue to add once we launch the product and get more feedback from our users. And we'll keep you in the loop as to how we do those additions in the future.

Okay. And then just a quick one on Nano. The PRESERVE study, does this result in a dedicated level -- sorry, dedicated label? Or is this study kind of bridging to another study that leads to a label?

Yes. Thanks, Jayson. No, we expect the PRESERVE study to be in support of a label for the treatment of prostate tissue. As we talked about before, the FDA came out with guidance last year where they were treating focal treatment of the prostate a little bit differently than they have some other cancer-related indications. So we agree with them. We think that they're approaching it right. And this is the study that would then lead to an indication for the treatment of prostate tissue.

There are no further questions on the phone. I will now turn it over to AngioDynamics team to take questions that were submitted through the webcast.

Great. Our first question, in understanding the intermediate and high-risk DVT market, can you frame the mechanical penetration into the market?

Sure. Scott?

Yes. I think when you look at the overall total addressable market with VTE, those are always combined, obviously, with the pulmonary embolism as well as DVT addressable market. If you reference our Slide 18 in the presentation, we've actually taken that one step further. We're segmenting those out, and we did so intentionally because of the cadence of which we are launching our products. So as you know, our F1885 although it was designed purposely for pulmonary embolism, it will not carry that indication to what is originally launched. So we just wanted to make sure we're clear that our adoption in that space will be limited until we get that indication. Moving over to the DVT side, right? If you look at, again, clot can occur from neck to knee, but we also know that we're somewhat limited just based on the size. So as you go more distal into the lower extremities, we're challenged a little bit with the size. And with our F2220 and our F22180, it's a 22 French device. So we're targeting that IVC, SVC space to primarily be our entry into the mechanical thrombectomy market from a DVT perspective. But we know that physicians are going to take us even outside of that, probably into the LEx and maybe even further distal until we get our F1885 on the market.

Our next question, what characteristics or product families would you likely target when looking at tuck-in M&A opportunities?

So really, we love the 3 platforms we have today. We talk to you about how we're looking at our company differently. If you look at some of the support data we gave you this morning in the slides, we gave you a way to look at our company in kind of 2 portfolio approaches: with our medical technology portfolio that we spent the bulk of the time with today and our medical device portfolio. And each of those will be resourced differently. And we'll approach our go-to-market strategies differently. And even our strategic additions to the portfolio. So we love the 3 platforms we talked about today with our Auryon, our AngioVac and AlphaVac and our NanoKnife. What I think you'll see from us are maybe smaller tuck-ins or iterations that can help support these products with our customers. But sometimes the customers are looking for ancillary products to use in addition to these devices. So right now, we're really focused on getting these 3 products to grow in the marketplace and drive growth for AngioDynamics. I don't think you'll see a major M&A move here. a transformative move. We've got the company that we're building internally that we have today. We like it. We like the foundations. And what you'll see that we'll probably add, we'll just iterate from there.

Thank you. That concludes our questions submitted online.

Great. I want to thank you for joining us today. Hopefully, you've got a better feel for the technologies behind our company, what we're doing with these amazing technologies and amazing people that work here that drive value and make sure our customers are aligned with our thinking and they can support the use of these products with the talented caregivers to make sure people can get care and wellness. Thank you for joining us today.