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 President of the Board of Directors that 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 Sunti. 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 2021 and the successes we will have through fiscal year 2022 through 2024. Scott is then also going to be very excited to talk about for 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 medtech today.
Scott will then also talk about our Aireon laser. Aireon was our peripheral atherectomy device that we launched last year. We're very pleased with the performance we saw in fiscal year 2021, and we're very excited about the prospects for Aireon President as we head into 'twenty two and beyond. We'll be joined by Jake Brumbaugh. Jake manages our NanoKnife platform.
Jake is very excited to share with you the mechanisms 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 talked about today at Angio. Juan Carlos Serna 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. President. 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. President, 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 the 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 Vice President of 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 ks 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. President. 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 and 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 non thermal IRE ablation tools. Each of these products are foundational technologies that we believe we can iterate from and build new technologies on. They'll also create opportunities for 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. President. First is research and development. You've already seen new product launches from us utilizing our R and D process. It's really good.
We've invested 50% more in R and D than we did 3 years ago. That's an important driver for us and we're seeing the outcomes in the new product launches Through our process. 2nd, we're 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. 1st of 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 and A. We've utilized M and 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 and 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 Centee, who will walk you through our mechanical thrombectomy business and give you the first look at our new Alphavac product.
Thank you, Jim. My name is Scott Cinti. 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 veno 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.
Venothromboembolism. What does it mean? It's often referred to as VTE, and simply put, it's comprised of both a DVT as well as a PE. As a matter of fact, most patients that have APE 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 a blockage or an occlusion, and if left untreated, could vice. 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 3rd 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 were 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 of 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 advanced, 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 if 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 if that clot or a patient presents with a little bit more leg swelling and everything else, there is what we call catheter directed thrombolysis. It's a catheter that will deliver analytic 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 pharmaco mechanical. 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 lytic 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, Doctor.
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 Rhythearth thrombus removal. And as Scott was saying, I'm the VENUS director, director of the PE response team and founder of the VENUS service 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 DBT, we talk about clots within the legs that typically either stay within the legs and called DBT or move somewhere else either to the heart called right heart thrombus or to the lungs called PE. And putting that all together, that's VTE or venous thromboembolism. This is extremely common. It's an enormous health burden on our system. About 900,000 Americans are going to experience of VTE events in this year.
And these patients are debilitated by it or at risk of death from us. And indeed, it's the 3rd 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 DBT treatment. And so I really see the changes that have happened in, 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 a VTE or vent 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, an 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 may be winnowed down over the next decade or so as we find out who are the best people to treat and with what which devices. One of the ways that we've seen this over the last decade or so has been the move 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 in a cath lab where we put licensed catheters in to dissolve the clot.
And that has expanded hugely in utility and scope over the last few years. The dissolving of clothe is catheter directed thrombolysis brings with it several risks. These are predominantly around 2 things. 1 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 the agent, the cathode directed license going in over a period of usually 24 to 48 hours, and these patients having to be in ICU for that length of time.
So in order to get rid of those two main things, the Move towards 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 clot that's in there, all at one time So there's the need to give them that clot busting drug that can cause the bleeding is 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 clot that's causing the problem directly.
And I see that going the same way with DBT and VTE, where we're planning to directly suck out the clot 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 we're 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 our bespoke devices that are dedicated to the needs of the Venus 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 interventionist 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 director of this is use of angioVac, particularly with the removal of very large volumes of clot from the right heart and from the IBC, 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've seen a huge change where some of these patients would have been mandated to have a big open heart surgery, you know, the full zipper in the chest Where they would have had days of ICU admission, a sub a substantial morbidity and a long recovery.
And thanks to the ability to directly suck out these blood clots, for example, using antiovac to remove a clot in motion within the right heart, We can now turn that big procedure into one that is over and done with within an hour or 2 and the 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, you know, the the F2220 for removal of a clot in the IVC or the, or the 22, 180 for removal of a clot 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, that we actually have. This has also been backed up by data that has, Some of it is still ongoing, and I think it's going to come to fruition over the over the next few years. But there is no doubt in my mind that the sea 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 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 Emails, direct messages from patients who are searching out a better act a better result 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. Pubix and where things are going. And, I look forward to, the journey that that we're going to see over the next little while where we improve our patients' lives with these with these devices. With that, I'll thank you very much.
So thank you, doctor 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 partly 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 in 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 tip 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 AngiVax 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 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.
Introducing the new multipurpose mechanical aspiration device, the Alphavax system. The Alphavax system incorporates our proprietary funnel tip technology that we offer today. But instead, These catheters are paired with a multipurpose mechanical aspiration handle that acts as the engine and eliminates the need for perfusionist support, allowing for quick Emergent therapy. The alpha back cannula is indicated for the non surgical removal of thrombi or emboli From the Venus system, the Alphavac handle is indicated as a vacuum source for the entire multipurpose mechanical aspiration system. The Alphavax system is intended to be a easy to use option that offers advantages not seen in the market today.
The Alphavac system incorporates our proprietary funnel shaped distal 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 Pure 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 Alphavax system can be used to remove material found in the inferior vena cava, superior vena cava, iliofemoral veins, Claude 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. The cannula comes with either a 20 degree or 180 degree self expanding funnel shaped distal tip. This technology embodies a Nitinil 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 suctioned 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. President. The AlfaVac is an easy to use percutaneous option for large bore material in the Venus 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 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 clot 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 pull. 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 cc's without a great bolus of blood. And once they get onto the clock, there will be a tactile feel 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 TC to be able to pull more of that powerful aspiration back into the handle itself Now, once they are there, we talk about that of continuous aspiration with AngioVac.
All they have to do is lock the actuator or 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 cannula, 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, venothromboembolism 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 torturous 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 ks clearance for our first two AlphaVac products, our f 2220 and our f 22180. F 22 representing the cannula French size, and a 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 F1885 of AlphaVac cannula, which was developed with an 85 degree tip angle to better select the pulmonary arteries. Once on the market, we will immediately enter into our PE IDE for product indication. And lastly, we know size of the cannula or path that 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 sure to keep you updated with our progress on that front. So I had the pleasure of walking you through all of our r and 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 AngiVac and Alphavac Products. We will continue to make investments to develop clinical data that demonstrates the unique science and outcomes that our products enable. President. 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, Doctor. John Mariotti. President of the United States. The registry was designed to evaluate the patterns of use, safety and efficacy of the AngioVax 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 mastas in the right heart, 36% had caval thrombi, 9% had catheter related thrombi and approximately 2% had a pulmonary embolism. Using the AngioVax 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 AngioVax system can safely and effectively remove vascular thrombi and cardiac masses across a broad range of patient populations. For the possibilities of using the AngioVax system in patients with PEs.
In PE, our engineers have listened to our customers and have developed of the F-eighteen-eighty five PE device Scott just announced. The FDA will require clinical study to support that indication President. Using a very collaborative pre submission process with the FDA, our clinical and regulatory teams feel very prepared President of the United States. Lastly, to learn from the initial launch of the Alphavac F-twenty two product family, We intend to launch a new study to capture real world experience with the new off circuit device for larger venous anatomy, which includes Clot and Transit in the Right Heart, Cable Vasculature and Proximal ileofemoral 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 physicians, but more importantly, the needs of these patients that are suffering from venothromboembolism.
So over the next several years, we will be launching technologies and expanding indications on an intentional timeline that will strategically unlock access to more cases that affect even larger patient populations in the need of improved innovations and advanced patient care and wellness. And when we do this well, which I know we will, our intent is to offer 1 of, if not for 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 Vice President and their feedback into the design of Alphavac.
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. President. We look forward into growing this segment. Now, let me welcome Scott back to speak to you about Aireon, for our PAD device.
Thank you, Jim. It was November 1, 2019 when AngioDynamics first announced its acquisition of Eximo Medical and their B 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 Arian, 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 President during its 1st 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 ARION. Starting with the incidence rates, over 8,000,000 Americans over the age of 50 have peripheral arterial disease, and these same patients are 6 times 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 credibly 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 $600,000,000 market growing at 6 to 8% 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 doctor Tony Doss, interventional cardiologist from Baylor Heart Institute in Dallas, Texas. And for those of you not familiar with Doctor. Doss, 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 interventions for peripheral vascular disease.
Good afternoon, and thank you very much for that kind introduction, Scott. My name is Doctor. Tony Doss. I'm an interventional cardiologist. I practice here in Dallas, Texas.
My special focus in the cardiology world was actually endovascular or lower extremity intervention. I've been involved with a multitude of clinical trials As either a primary investigator or sub investigator and published, live, widely in this field. I've also been involved with lasers since 1997. In fact, I was trained with the original father of lasers, Giancarlo B. Amino in Germany, and learned the technique and the technology of Of, total occlusion therapy, etcetera, with him using lasers and have published on that field.
And since that time, we've done, many 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 this SARION laser, can do, its capabilities, and also some of the uniqueness to the device itself in the space. As 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 do improve outcomes, reduce limb loss, and overall, we're looking for therapies that are beneficial in this space. If you think about the ARION laser, its unique properties at 355, nanomol nanometers is a very specific wavelength.
What we know about the different wavelengths of laser is that they treat the plaque differently. The, 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 a mechanical and photochemical effect on the plaque. So what does that mean? That means that when you're evaporating the buildup in 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, is it easy to use? The Spectrinetics laser, which is now the Philips laser, has a longer setup time. It's a very heavy device, compared to the ARION 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 has a solid state device as opposed to excimer laser basically means excited dimer, which the SpectroGenics 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 At the Ariane laser, it's immediate plug and play, and, there's really no setup time, which is actually advantageous to us. In addition, it does aspiration. So Kind of pulling that plaque out, I think, is very important. The other thing we frequently look for are companies that have a great relationship with We physicians that want to improve the technology.
One of the things I was very impressed with is the desire for the agent dynamics group and particularly Scott and his team to reach out to users and say, we're gonna do a trial called a pathfinder. We wanna 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 We all enrolled, 10 or 12 patients a piece.
And after enrolling over a 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 it needs improvement on, Like the end of the catheter needing a little bit more tapered tip, they changed it. We said, well, we need a few other things, and they're working on them. So I think that the the Collaboration between the company and the 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 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 significant amount of experience and to be able to work together I'm trying to make better devices. So with that, I thank you very much.
So thank you, doctor Das. Very well said. I appreciate you sharing your insight and discussing the overall disease state, The challenges that physicians are continually faced with and how the Arian 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 Arian 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 may seem boring, but to physicians and end users and to us at AngioDynamics are vitally important.
And to help you visualize the mechanics of how the laser works within the vessel. I want to show you a quick video.
The Arianne system is the next generation in peripheral atherectomy technology. With 4 different sizes to choose from, Arianne 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 ankle. The Aireon 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 or severely calcified, the Arian 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 Maybe eliminated through the efficiency of the Ariane 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 Orion 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 Advanced technology is designed to meet the ever growing challenges of your atherectomy needs.
Arianne, this changes everything.
As a reminder, Arianne 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 touchscreen 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 ARION system is designed to deliver an optimized wavelength and pulse width that would 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 lesions without harming the native vessel wall. The Orion system does this by changing the game across laser science, which includes providing a new wavelength, pulse width and amplitude to the PAD treatment options. So starting with the 355 nanometer laser classification, The Aireon 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 Arian system was developed to deliver optimal amounts of energy for effective treatments, but without compromising the integrity of the laser fiber. Up until now, no one had been able to deliver the amount of energy through a fiber without the catheter degrading to a point of failure. It's the ARION difference in the pulse width that creates the optimal amplitude for plaque modification.
Let me take you one level deep on this point because it's important. Our shorter pulse width allows Arian to deposit energy quickly And repeatedly, up to 8 times faster than the competition, and the contact of the laser to the vessel wall is so short There's no time to damage the medial layer. So what does all this laser science actually mean? Why should you care? Why do physicians care?
It's because the Arian system has a unique and leading technology that allows it to treat any lesion a 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 REN 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 Arian 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 Commerce Registry to evaluate the use of the ARION laser in a real world setting to treat the novel, Restenotic and ISR Legions 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 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 President of the United States. 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. Pacific interest has been expressed in the below the knee application of Arianne.
We will continue to listen to our physicians who guide us President of the United States. As they consider the best treatment options for their patients, and we'll continue to invest in data sets that quantify the unique outcomes President 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 a 132 customers that contributed over $11,000,000 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.
As we still have a tremendous amount of growth and upside in meeting the increased demands of our practicing physicians, All while listening to our advisors, 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 ARION 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 Aireon and how they've taken this amazing technology to the market Place over the past year. You know, 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 non thermal energy, it decellularizes targeted tissue and leaves the extracellular 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.
The NanoKnife system harnesses the power of irreversible electroporation, IRE, to effectively destroy diseased tissue without the need for thermal energy. 2 or more minimally invasive needle electrodes are positioned in or around the diseased tissue using real time ultrasound guidance or CT. High voltage pulses are delivered between the electrodes and can be confidently delivered in all segments of an organ To create irreversible nanopores within the cell membrane. This stimulus Induces an apoptotic like cellular death resulting in the complete ablation of tissue within the electrode configuration. The body responds to the apoptotic like cell death by initiating the removal of cellular debris.
Delivery of non thermal 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,
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. 1, they can go on active surveillance, where they will be continuously monitored President of the United States.
I'm excited to
announce that we're going to
be able to provide a brief update on our The other option is a patient will immediately qualify for whole gland therapy. This is radical surgery for 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 Board, where a local treatment is not part of the standard of care for eligible patients. There has been a growing consensus President of 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 US 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. President. One, the current technology has less than ideal outcomes. It still has a negative impact President on urinary and erectile function of many patients.
2, the current data supporting focal therapy is less than optimal President of the United States, as it often includes patients with low risk disease within the study cohorts. If AngioDynamics is going to bridge that gap In 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.
President. If we can execute those two 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 President 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 and 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, Northern Healthcare, UCSD and many others have chosen to participate in this study. Accompanyed with our recent ICD-ten 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. 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 President of NANO knife in intermediate risk prostate patients.
We are honored to have 2 PIs that will steer the study. President of the United States. They are Doctor. Jonathan Coleman at Memorial Sloan Kettering and Doctor. Arvind George at the University of Michigan.
President. We anticipate having 15 sites in the U. S. Enrolling patients starting early next calendar year. This important study, along with our recently announced PPT3 codes will be an essential milestone to ensure patient access to our unique technology.
Variety of investigator initiative studies to further support these sponsored studies. These include the PAN FIRE III study investigating the use of IRE for pancreatic cancer in combination with Immunotherapy. The CROWS, a multi center society run 400 patient prostate registry and many others that will to further validate the value of our technology. Leading one of the IITs is prostate cancer specialist, Professor Philip 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 Garvin 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 1, radiotherapy and surgery or what we call whole gland therapy caused quite a lot of side effects such as impotence, incontinence and rectal damage and often is deemed to be unnecessary and overtreatment. Whereas focal therapy, such as used with NanoKnife therapy, Causes much less side effects, almost no incontinence, definitely no rectal 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 that the best of the available technologies to treat localized prostate cancer. The reason for that is, 1, it's safe. Out worrying too much about the nature of the tissue. Number 3, it can be used in every segment of the prostate and indeed we've published on this.
And number 4, even if it fails after even 2 attempts, salvage treatments such as surgery and radiotherapy is still possible, So no bridges have been burnt. 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 cancers, 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've become more impressed with time rather than less impressed, and it's been the subject of over 10 publications from our unit. The market size is enormous.
Between 10% 20% of all primary diagnoses of prostate cancer Would be amenable to it. This brings a question as to who is the right patient for. Obviously, an intermediate grade cancer is suitable. But as we get better at selecting these patients, maybe with new markers in addition to Excellent modern imaging with MRI and possibly PET scanning 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 is even has the potential to stimulate the immune system against humans. So I am 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.
Doctor. Stricker is clearly an important voice and I'm excited he had the opportunity to share his experience for 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 and 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 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 and why we're making this a really valuable business opportunity. Now let me welcome Chad Campbell, 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 President and CEO of our Chief Financial Officer and Chief Executive Officer and Chief Executive Vice President and CEO of the Executive Vice
President and CEO of
the Executive Vice
President and CEO of the Executive Vice
President and CEO of the National Association of in the transformation of AngioDynamics. These products drive a lot of earnings for the company that help us invest in our MedTech portfolio. President. 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.
President. 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. 1st is our portfolio. 2nd 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 and A. First, we have a value line of midlines and PIKs, which have been a great balance to our BioFlow portfolio. President.
2nd, 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 BioFlow PICs into our clinicians' hands to serve patients. And third, we've launched our family of Smart Port Plus and Smart Port Plastic Ports, which marries our Vortex technology with our BioFlow catheter. It's been very well received by patients and clinicians around the world. 2nd 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. 2nd is our WOM differentiator and that's our BioFlow technology. That has given us more access to patients around the world. President. And third, our Corporate Accounts team has done an amazing job earning committed contracts.
What we've learned is the improvement in our portfolio
President of the United States. In combination with our
BioFlow 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 is our execution. President. 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.
You know, 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, for 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
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, President. 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 health care 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-ten 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 President. In July 2020, a series of new Category III CPT codes 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 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 Arian 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 Arian 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, in our technology, and in our people, adding new capability to AngioDynamics. Now, let me bring Steve Trowbridge back to
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 President. As we continue to focus on our medtech 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. And you've also heard about our more mature medical device businesses President and how they provide the engine for investment in our growth drivers. This morning, during our fiscal year 2021 Q4 earnings call, We discussed our guidance for the upcoming fiscal 2022 year.
We expect revenue to be in the range of $305,000,000 to $310,000,000 representing growth of 5% to 7% over fiscal year 'twenty one. As a reminder, our fiscal year 'twenty one included approximately $5,000,000 from a one time NHS order. Excluding this order, our FY 'twenty two guidance implies a growth rate of greater than 7%. President of the United States. This revenue growth will primarily be driven by our MedTech platform technologies, Aireon, AngioVac and Alphavac and NanoKnife.
President and we are pleased to end FY 2021 with $11,100,000 in revenue for Arian. And we expect Arian to contribute $18,000,000 to $22,000,000 of Panu in FY 'twenty two, driven by increases in both new customers and existing customer utilization. Our AngioVac platform grew 47% during FY 'twenty one, representing solid performance. But FY 'twenty one comparisons are somewhat skewed President of the COVID-nineteen global pandemic. We expect our mechanical thrombectomy businesses, comprising both AngioVac and Alphavac, President of the United States.
To be a growth driver in FY 'twenty two, delivering greater than 30% growth. We finished FY 'twenty one with strong sales of NanoKnife disposables, President, and we expect NanoKnife probe sales to grow approximately 20% for FY 2022. We expect adjusted EPS for FY 2022 President of Investor Relations. As we've discussed throughout today, Andrew Dynamics is in investment mode. President.
We've identified and prioritized significant investments in our medtech platforms, and we are committed to making the necessary investments to drive top line growth. As illustrated throughout our FY 'twenty one, we will continue to prioritize these exciting investments while being good stewards of the bottom line. Now we expect gross margin in FY 'twenty two to be approximately 55%. President. This would represent an increase of 110 basis points over where we ended FY 'twenty one.
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. President. 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 medtech platforms. President.
However, during the back half of FY 'twenty one, a number of external pressures resulted in gross margin headwinds that we anticipate could extend through the next several quarters. President of the United States. The tight labor market has resulted in high labor and manufacturing costs. And in addition, we've experienced significant freight cost pressures, President, 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 twenty twenty one, President 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 Aeryon 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 'twenty two and beyond. So as we move into FY 'twenty three and FY 'twenty four, we'll remain in investment mode President, as we continue to advance the strategic transformation that Jim talked about. For our FY 'twenty three, we expect revenue growth to be in the range of 7% to 9% or $330,000,000 to $336,000,000 By FY 'twenty four, we expect AngioDynamics to be a 10% to 12% revenue grower, with projected revenue in the range of $360,000,000 to $375,000,000 As we've discussed throughout the morning, This revenue growth is predicated upon our medtech platform technologies of Aireon, mechanical thrombectomy and NanoKnife President, becoming an increasingly larger contributor to our overall revenue base. Throughout the planning horizon from FY 'twenty two through FY 'twenty four, President.
We expect our medtech platforms to provide a compound annual revenue growth rate of 30% to 35%, and and we expect our more mature medical device businesses to provide a compound annual growth rate of 1% to 3%. President. As we start our FY 'twenty two, our medtech platform contributes less than 20% of our overall revenue. By the time we complete 2024, President. We expect those platforms will contribute approximately 35% of our overall revenue base.
Revenue growth and sales mix will drive gross margin Pension. And while we do expect to see some expansion during our FY 'twenty three and 'twenty four, we expect the headwinds I just discussed to partially offset the product mix benefits provided by this revenue growth. The performance during FY 'twenty one that we guest this morning, and our guidance for FY 'twenty two is a direct result of the focused and targeted investments that we have made in our growth drivers. President. We will continue to be in this investment mode through 2022 to 2024.
We will continue to invest in internal R and D. Now we've had some great successes come out of internal R and D, including the AngioVac and NanoKnife 3.0 product launches, and we're looking forward to the exciting Alphavac launch Plan 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 in 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. Not just as important as investments in R and D on investments in our sales and marketing organizations.
Throughout FY 'twenty one, we discussed how we were investing ahead of the curve to support our Aeryon launch. President. We will continue to do just that as we head into FY 'twenty two and beyond in support of both our AURION platform and our mechanical thrombectomy platform. President. As illustrated throughout FY 'twenty one, we're committed to making the necessary investments in our business to drive future growth, President, which tempers our operating leverage expectations even as revenue growth accelerates over the next 3 years.
President. We will be good stewards of the short term bottom line, but we will also prioritize the investments we discuss today to drive sustained long term profitable growth as we move into FY 'twenty four and beyond. Coming out of the very challenging environment created by the COVID-nineteen global pandemic, President. 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, President, 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. We'll remain opportunistic and disciplined in our approach for 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 'twenty one. We're proud and humbled by the perseverance, dedication and performance that everyone in the AngioDynamics family exhibited.
President and CEO of the Executive Vice President of the United States. We're going to take those same principles as we move into FY 'twenty two and beyond and as we complete our strategic transformation President to become a double digit top line grower in large, fast growing, high margin markets in 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 President I am today. With that, I'll give it back to Jim.
Thanks, Steve. Hopefully, you 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.
Thank you. Thank you. And our first question comes from the line of Jayson Bedford President of Raymond James. Please proceed with your questions.
Hi, good morning, guys. Can you hear me okay? President. Okay. Maybe just President.
I'd like to hit on a few of the key products here. First on Orion, 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 Can you just comment on your plans for the coronary indication?
Sure, Jason. So, the 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 And what enhancements I'd like to see. So I'll have Scott really give you a couple details about what we're looking to do.
Yeah, thank you, Jim. Yeah, as Doctor. Tony Doss mentioned, you know, we've been listening to the physicians President 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. President.
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 Jason asked about explaining indications and 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 3 55 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 Prime 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, President. 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?
President. Sure. Scott? Yes. So we have some of the data that we've collected already through the RAPID registry, which I know John Maury or Doctor.
Maury already talked a little bit about in the 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, alphabet system will be able to Accomplish.
And Jason, you can look at what we did when we launched Arian 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. President. 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 expand expect to expand the sales force for this initiative. And then also, can you just comment, have you filed For the 18 French device, yes.
Sure. Go ahead. Yes. So, to answer your first question, Jason, it's a good one. Right now with our Restorative Flow Therapies Venus sales team that currently sells, and 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 portfolio, so our angiographic catheters, which is also in that same portfolio, works really closely with the interventional radiologists as well as the of the surgeons where the 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. Sorry, go ahead, Charles. And I'm sorry, can you remind me of your second question?
Yes, the 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 5 Cancun Clearance for the F-twenty two-twenty and the F-twenty two-one hundred and eighty 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 getting back to the other 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 Surgeon, Call Point. Again, as you know, Jason, one of the challenges that we have or the limiting factors with AngioVac is just the access to perfusion. Interventional Radiology and VASA 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. President.
And so we see that the AlphaVac system will play very nicely in that space along where an ARI input number are currently playing as well.
Okay. Thanks.
Our next question is coming from the line of Matthew Mishan with KeyBanc. Please proceed with your
questions. Hey, great. Good morning again. Just a big picture question for you guys. And when you look at the organization, I feel like you've always had technology in larger TAMs, but we're never ever really fully realized the opportunity.
President. It seems different this time because what are the more the most important changes kind of you've made President 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 the slide we put forth, you'll see we're actually competing in larger markets than in the past. But you're right, we were 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 and D resources, clinical resources, We're 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 in these areas with the larger TAMs, the faster growth rates, so we can be prepared to take advantage of those.
President. And then as I look at Orion, I remember when you acquired the device, The goal was to get up to about 10% market share, which I guess would be around $60,000,000 President. Are you far enough along where that may be the most real where that is a realizable share target? And is that something you can do you think You can do within the time frame of, your 3 year LRP.
You know, 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 President. Now we know so much more about our device. The feedback we've gained from our users has 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 2021, 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.
Matt, we're very pleased with what we on 'twenty one for Aireon. 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-nineteen pandemic. So we were happy with the performance that we had. And an additional part of that COVID-nineteen 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 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 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.
President. And when you look at that market and you broke it out by laser versus mechanical, to get to that 8% to 10% share, President. Are you is it taking laser share or are you actually converting some mechanical too as well?
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 it 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?
Yeah. Thank you, Jim. I 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 Aeryon 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 Arianne, 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, you know, 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've seen in some of those other competitive devices working as well with our laser system. And I think that's what gives us President. 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?
Yeah. 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 30 cc, you know, 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 10 cc's, then over into 30 cc's.
The other key feature is the tactile response. I think when you talk to a lot of interventional, or interventionalists, they love to use their hands. They look for some sort of sponsor and 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 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 the Angio VAC. But they said, if you're going to develop an off circuit product, which the Alpha VAC became, they wanted more control at their hands. These are still 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 we showed you today at the AlphaVac, President. That came right from their voices to our design elements in 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.
President.
Our next question is coming from the line of Bill Blazendijk with Canaccord. Please proceed with your question.
Great. Thanks. Good morning. Can you hear me okay? Yes.
Great. Thank you. 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 2020 and what 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?
Sure. Yes. So the mix between capital and disposables, primarily we were driving disposables as we got through FY 2021. Our Q4 we talked about about $3,500,000 for NanoKnife. Vice President of the United States.
So we were closer to that 15% number for the full year, primarily driven by disposables. As we talked about FY 2020 was a big capital year for us even pre pandemic, President, 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 2021. 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 2022, 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 $15,000,000 for the year and what percentage of that was Principal.
So the capital percentage would be of Nano, let me just get my numbers right for President. It's just north of 10%.
Okay, great. That's very helpful. Thank you. And then, as we look at Arian, just as you get into that market And that product comes out. Today, just atherectomy is President.
It has a 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 President of the Investor Relations Officer. 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 Ariane system. And now what President. 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, You know, 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 President 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. President. 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 ARION 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 instant 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?
Yes, 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 Angio Vak 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 users choice, as Doctor. Moriarty said in our video earlier, and give these physicians confidence to treat more people utilizing this approach towards this disease. So 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.
Okay. Great. That's all I had. Thank you very much.
Our Our next question is a follow-up from the line of Jayson Bedford with Raymond James. Please proceed with your question.
President. Good morning. Just a couple of follow-up questions. First off on AlphaVac, and I apologize if I missed this, but Are you increasing the size of the sales force just to support the off of that launch?
We may have not answered it for you, Jason. 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? So 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 Salesforce 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, Jason. 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 different president. 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.
Okay. Thank you.
Thank you. There are no further questions on the phone. I will now turn it over to the AngioDynamics team to take questions that were submitted through the webcast.
Great. Our first question, in understanding the intermediate and high risk DBT market, can you frame the mechanical penetration into the market?
Sure. President.
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 T, you know, addressable market. If you reference our Slide 18 in the presentation, we've actually taken that one President. 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 when it was 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, President. But we also know that we're somewhat limited just based on the size. So as you go more distal into the lower extremities, you know, we're Challenge a little bit with the size and with our F22, 20 and our F22, 180, it's a 22 French device. So, we're targeting that IVCSVC 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 iliacs and maybe even further distal until we get our F18 85 on the market.
Our next question, what characteristics or product families would you likely target when looking at Tuck in M and A Opportunities.
So really we love the 3 platforms we have today. We talked 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'll give you a way to look at our company and 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 Aireon, 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. 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 three products To grow in the marketplace and drive growth for AngioDynamics, I don't think you'll see a major M and 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.
President. Thank you. That concludes our questions submitted online.
Great. I want to thank you for joining us today. Hopefully, you 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 President of the United States. We're excited about the opportunity to get a better understanding of our business. We're excited about the