Hi all, and welcome. My name is Caroline Borowski, and I'm a member here at the J.P. Morgan Healthcare Investment Banking team. It is my pleasure to introduce Jim Clemmer, President and CEO of AngioDynamics.
Good morning, and thanks for joining. Thank you to J.P. Morgan for the great conference, and thanks for the invitation. Let's talk a bit about AngioDynamics. First, to remind you, everything I say here today are our goals, our intentions, and our plans. But as good investors, I'm sure you'll do your homework, make sure you do research on our company, and make sure you validate the assumptions that you'll make regarding our performance and our projections going forward. AngioDynamics is a company in transformation. We're really proud of the work we've done over the past five years, steering our portfolio into areas that we think are highly attractive to companies like ours that serve the needs of healthcare, the healthcare community, and investors looking for opportunity for growth.
Our company's gone through a journey, really, to transform from more of a stable operating company with a kind of less exciting portfolio to a new portfolio. Today, we're a really strong company. We've done a lot of the work necessary for this transformation, made a lot of investments in research and development, clinical and regulatory expertise, opening up new markets. We've also done this while keeping a really strong balance sheet. We have zero debt on our books, and we'll end this year with a positive cash position. So we're really ready for our next step, which is execution now in the markets that we set up, and the markets will serve. So I look forward to sharing more with you about us. We're set up today in two operating segments. You'll hear more about that in a few minutes.
But the way we've structured our company, we want to serve needs in the two largest causes of mortality globally: cardiovascular disease and cancer. We're set up well to treat these two large mortality segments with innovative technologies we've developed over the last number of years. Our company has a unique fiscal year, I'll remind you. We start on June 1 each year. So on November 30th, we finished our Q2 of our FY2025. We presented those results last Wednesday to the public markets. So if you haven't seen them, please go online and check those out. We also put an investor segment available as well, teaching you about our view of our new NanoKnife product with its new indication to serve intermediate-risk prostate cancer patients. So AngioDynamics has a unique portfolio. We've set up, again, in cardiovascular care and cancer as our disease states that we'll serve.
We also have our two operating segments, as you can see on the slide here. In the middle of the slide shows our med tech segment. This is really the future of our company and our growth. We're focusing most of our energy, efforts, and resources towards our product portfolio in these segments. On the bottom, our med device portfolio. Really important to us, our med device portfolio is made up of world-leading brands, products that are necessary. We primarily serve the interventional radiologists with most of these products. They're well-known, well-served, don't require a lot of energy and effort. We've got a really great team that manages them, and they provide us with the cash and the capital to invest in our med tech segment. So we've done a lot of work, as I said, over the past few years. We're not in the first inning of this transformation.
We're well along our journey. We had a lot of milestones that were really important for us transforming this company through our portfolio. We've made three divestitures in the last five years of things that we didn't think were as important to us as it would be to others. We made one important acquisition along the way as well and done really good work in R&D and clinical and regulatory pathway expansion to open up markets. I'm actually really proud of the calendar year 2024 that we just finished. In 2024, we actually launched two really important R&D projects for our Auryon PAD system, enhancing the usability and the opportunity there to continue to grow. We actually got two CE marks approved for the Auryon system and our AlphaVac to treat PE in the CE markets.
And we got two FDA indications for our AlphaVac to treat PE here in the U.S. and for our NanoKnife approval to treat prostate cancer in the U.S. So there's a bunch of really important regulatory milestones, along with we got the CPT code approved for NanoKnife prostate, approved back in October through the CPT panel, and that'll kick in January of 2026. So we'll have reimbursement aligned with our indication for NanoKnife prostate. Really important milestones. We have a really great team of people at Angio that we built over the last five years. New muscles were built, new capabilities, which allow us to do the work necessary to pull off the transformation. So today, here's where we sit. We've done that work to position ourselves for our future. This is the company we are today. We've got the right products and right technologies.
I'm going to take a few minutes and share our ideas with you. But what's most important, these aren't just products. These are platforms. Each of these product categories are focused on, whether it's PAD, a thrombectomy, or solid cancer treatment, each of our product technologies have more than one application over time. We've got research and development projects behind them. We've got clinical and regulatory expansion products behind them and opportunities to grow using our current pipeline. We don't need to look to M&A to grow what we have already. We've got a really great pipeline of growth opportunities for years to come. We're also in the right markets. We're in the markets people want to be in. We learned a bit about that last week. You'll hear about our AlphaVac in a few minutes. We've got a really great innovative product to treat PE.
As we saw last week with Stryker buying Inari, there's a lot of folks interested in getting into that space. Inari is market leader. They've done a great job, but we're number three, and there's a lot of folks chasing. We wish them luck, but we've got a great product in a great market, and we're in the right space, so we've steered our company purposely into really large, interesting markets, and finally, our company's set up for our future. We spent the last three or four years investing in our future. We didn't make any money, so we're even in negative during those past couple of years as we invested through even the journey of COVID that we all went through, inflation, other challenges. We still kept our pedal down on our investments to get our transformation done. That was important.
What you saw from our results last week, we actually reported positive EBITDA for the first six months of this year, and we guided positive EBITDA for the full year and really from here on in. So we're a company that'll be positive EBITDA. This year, we'll use cash for operations, and next year will be EBITDA positive, cash flow positive, and growth. So this company's really in the precipice of getting to where we've steered it to be for years. So let's learn more about us. Let me talk about our three segments that we two segments in our three product areas. So first, with cancer care, we can treat solid tumors in two ways. On the bottom of the slide, you'll see in the yellow box says Solero. We have a thermal solution. We have a great microwave product. We'll compete with J&J and Medtronic for microwave treatment.
We can treat different tumors, different parts of the body. But we're most excited about our NanoKnife, which is a really unique product you'll learn more about here in a minute. For us, getting approval into the prostate market to us is the game changer. NanoKnife, we think, can serve this market like none other. As many of us know here today, in the U.S., 300,000 men are diagnosed annually with some level of prostate cancer. Now, if you have a severe case on the far right-hand side of the scale, you probably need a radical prostatectomy or maybe radiation treatment, as we know terrible side effects are usually associated with those treatments. On the left side of the scale, if someone has a really mild level of prostate cancer, watchful waiting is usually the approach.
Told to go home, we'll monitor you, but we don't think the cancer's going to progress at a high rate. In between that is the intermediate-risk patient that we're concerned about. It's about 40% of those patients. So in the U.S., that's 120,000 men, or 10,000 every month being diagnosed. It's a really large market, and we can serve that. The problem here is prostate cancer is growing, and it'll continue to grow as our aging population grows. People are living longer, and the prevalence of prostate cancer is growing. The side effects don't get better. Side effects are really debilitating to men with sexual dysfunction or incontinence. Really undesirable side effects affect quality of life. We're here to help. We think that focal therapy is a middle ground.
We can leave the prostate in the body, treat the gland using our energy-based treatment, and help the man get the treatment they seek without the side effects that can really debilitate their life. How do we do that? Nano is unique. We use a generator, which provides energy that we deliver through our probes, which are placed in the body using a brachytherapy grid that urologists are familiar with. So very little training and education needed to be done in specialized training for urologists. They're pretty familiar with how to do these procedures. Our probes are placed. They really bracket the tumor that we're targeting using image guidance. And the bracketed probes create an energy field that creates nano-sized particles in the cell wall of the tumor, allowing it to die naturally. We don't affect the surrounding tissue, vascular structures, or other parts of the body. Remain healthy.
It's a really unique way to treat the tumor and not affecting the body. NanoKnife is unique in how it works. It's really effective. There's been studies done around the globe for years leading up to this. But we thought it was important to get on label for this procedure so we can talk about it and educate men and create awareness with not just the patients, but the urology community about this unique device. A few years ago, we set forth on our journey, and we set up the PRESERVE study, which follows a pathway the FDA opened up for companies like us to target focal treatment options. We think the FDA did a great job with this pathway.
The PRESERVE study was a really well-run study our team did with two leading PIs who did a great job setting up the sites in the U.S., and we finished the PRESERVE study in July of 2023, fully enrolled, all men were treated. There was a 12-month follow-up period. July of 2024, we collected the data, submitted that data in the fall, and then again in December, we received our FDA clearance and indication for this market. What PRESERVE showed is what we expected it would show by the mechanism of action of our unique product. We're able now to show that men after treatment, 84% of the patients were free from clinically significant disease in the targeted area. That's important. Is it effective? Yes. Is it now safe? We think so as well.
We're also seeing that men who've been treated have no higher rate of sexual dysfunction than men who don't undergo any level of treatment. So really, really effective for those men looking for a safe alternative and not affect their quality of life. Then for incontinence, a very low level. 99% of the men treated didn't have any level of incontinence after treatment. So really impressive numbers that our product performs. This is not an accident. We knew it would. So what are we doing about it? Getting on label is important for us. Now we can talk about it, create awareness and education about this unique device. Then, as I mentioned earlier, we worked with the CPT panel and received our approval in October. So we'll have a CPT I code coming live January of 2026. So we'll now have indication, product, targeted market, and reimbursement pathway.
A really good movement for us in the future. We think this is about a $7-$900 million market opportunity in the U.S. alone and over $2.5 billion globally. We'll do the market development and awareness to create and open up this unique and exciting market for our company. Next, I'll shift over to the other side of the fence here with our cardiovascular products. Two really important areas that we can treat. Starting off first with our venous products. As we saw last week, again, there's a lot of interest in treating venous disease, treating VTE, which is the combination of DVT and PE. I try to stop using acronyms, but it's hard to do in this industry. We have a unique device and a unique pathway to get there.
We think that PE treatment is on the rise with mechanical interventions as a really good way to do it. And we'll give two of our colleagues, Inari and Penumbra, credit with really establishing a really good pathway now to using a mechanical intervention to treat the clot, remove the clot from the body, and use less of the older lytic-based therapies or blood thinners, use less medical treatment, get the clot out of the body sooner, get the patient healthier, have a less invasive approach, and get them to walk out of the hospital, not sit in the ICU afterwards. So PE is a problem area. About 500,000 people will be diagnosed in the U.S. this year with PE. And it's a really important thing that we can treat it well. Our product portfolio is unique here at AngioDynamics.
Our AngioVac product's been on the market for nearly 10 years. AngioVac is really intended to treat right heart issues and remove massive clot burdens in severe cases of trauma and threat. AngioVac uses a simultaneous re-infusion system, which allows the physician to remove the clot and blood and put the blood back in the body simultaneously. It's really important for a high-risk situation. The unique parts of AngioVac that allow it to work are the vortex funnel tip you see on the right side of the slide here and the large bore catheter allowing us to take mass clot burden, remove it from the body, pull it through the catheter, and get the patient healthy and safe faster. We've had a lot of great feedback on AngioVac over the years.
Doctors told us about four or five years ago, "Hey, if you could take this off circuit, off of that circuit, give me a handheld way to use this in a mechanical aspiration way like the Inari product's doing that we like to use for PE. We would really think this could be a great PE device." Well, we did. We started to develop our AlphaVac. On the left side of the screen, you'll see what we did. We took the vortex funnel tip, the large bore catheter from AngioVac, and built a purpose-built handle, working with our physicians who helped us design the product. They told us what they liked about the other products and what they didn't, what they thought could be better. We built those into our product.
You now have a blood loss limiting switch in our AlphaVac, limiting the amount of blood that'll be pulled out before the physician finds the clot. You've got unique steerability components allowing them to navigate the tip of our device through the tortuous path of the body where you want to treat. And then again, a purpose-built handle to pull the clot, aspirate the clot, get it out of the body in a safe and effective manner. On the right side of the screen is actually a situation from a real procedure that we did. This is the first time this physician did a procedure. It's amazing, you look at that picture on the right-hand side of the clot pulled out of this patient's body, how healthy they got within minutes after the procedure by removing that clot burden. We get these pictures every morning. We get excited.
This is what we do. We're a mission-based company. We get thrilled when we get these pictures in the morning. We see someone that walked home the next day that maybe would not have without our product and our intervention. This is an important market for us. It's a really fast-growing market. We saw that last week with the interest in Inari by Stryker. We think other companies are going to look to get into this market. We're third here today. Stryker did a, excuse me, Inari did a great job getting off as market leader. Penumbra's got a good suite of products. They're number two. We're number three. This year between our AngioVac and our AlphaVac, we'll do about $40 million in revenue. We've got a good base. We're a strong three. We hear there's a bunch of people behind us trying to get into the market.
We understand why. It's not easy. We did really great work. Our product is the best product in the market. We're really confident. We had the ability again to design later. We made other products better. So we put unique, innovative design elements into the AlphaVac that make it unique and special. The APEX study that we sponsored to get on label proves it. Here was the data. This was just published Monday in the journal, JSCAI, the SCAI Journal. We presented it last May at the SCAI Conference. The data proves the product's really effective. If you look at the bottom on the left, the reduction in clot burden that AlphaVac did was far above the other two leading products in the market. The picture I just showed you is really unique. That happens when you use AlphaVac. You can pull more clot burden out.
It also showed how effective and efficient it is at the same time. We can do it in about one-third less time than the competitive product. Why? We designed in elements to help the doctor be more efficient. Our product does not need a guidewire. When you first talk to an interventional cardiologist and tell them you don't need to drop a wire, they look at you like you're crazy until you say, "Just try it," and they do it. And then when they flip from the left PA to the right PA instantly, that's where the light bulb goes off. They say, "Wow, guys, this is pretty cool. This is special. I just saved 20 minutes," which is a lot of time to an ICU doctor. So effective, efficient, safe. That's what AlphaVac is.
The combination of AlphaVac and AngioVac together gives us a really good platform in this fast-growing and burgeoning market. We think today between Inari Medical, Penumbra, and AngioDynamics, the market's less than 20% penetrated. There's a lot of market development upside for years to come here. All three of our companies will work hard to educate the market, inform the market about our unique devices, let them choose which one they think is best. We think we can treat people in a better, safer, faster manner and grow our company for years to come. So this is our venous side of our cardiovascular business, treating veins, venous disease. We're also very interested because we had the AngioVac product in our bag, AlphaVac in development. We were looking to get an arterial solution as well to treat PAD.
We came across in 2019 a company called Eximo Medical that developed a really unique piece of science to treat safely and effectively peripheral arterial disease, break up the calcium and the plaque that blocks those arteries and prohibits people from being healthy. Well, we bought that company in 2019. We launched the product in September of 2020. So six months into the pandemic, our small company launched the Auryon system to treat PAD. We had zero revenue when we started. We had 14 amazing engineers in Israel when we bought the company and nobody in the U.S. We now have 70 people in this business, 35 direct salespeople in the field, 35 clinical support members supporting the patients and the caregivers during the treatment. And today we're taking share from all four established players, really good companies. We're a small company.
The other four players, as you may know, are Medtronic, Boston, Philips, and Abbott, really good companies. We're taking share. Our product is better. It's safer. It's more effective. We built a great team here. The Auryon system is a great avenue for us to grow in cardiovascular business. So our company today has this unique cardiovascular business with venous and arterial treatments going forward. Auryon works well on how it delivers energy. It's a laser-based approach to solve this problem. We deliver that laser through our catheters that we sell. That's the razor-razor blade model. We'll put the laser on site. We'll sell the catheters to deliver that energy in the body safely and effectively. The way Auryon works differently, Philips has a laser in the market. It's been out for many years. We use a 355-nanometer wavelength for those of you physicists out there.
We deliver more energy, more power safely. It bounces off the vessel wall, keeping it safe, but breaks up the plaque or the calcium. We can also do in-stent restenosis, pick up calcium plaque and treat that. We think Auryon is a platform technology. We think we can treat coronary arterial disease over time. We're studying the pathway now to set up a potential indication to get into the coronary market and maybe other diseases. What we found is physicians here are excited by this technology. They want us to invest in more data and potentially more outcomes to treat more people in more intended disease states. So you'll hear more about Auryon over time. Again, went from zero revenue when we launched. This year we'll do over $50 million in revenue this fiscal year that'll end May 30th. So here's our company today.
You just heard about our three areas that are our med tech. These are our growth areas. We're up about 16% over prior year in our first six months in those three areas combined. We're a growth company hidden within this old operating company. On the bottom of this slide here shows our med device segment. Don't want to forget that. It's really important. About 55% of our revenue still comes from our med device segment. Doesn't require a lot of energy or effort from us to manage it. We've got a great team that runs it really well globally. But it also gives us the cash and the EBITDA to help fund our investments in med device. This company's platform is really, really strong. These med device products are made up of kind of, as I said earlier, brand-leading products. Physicians know them well.
They serve us really well. So here's AngioDynamics today. We just completed, like I said, our Q2 earnings call last week. We had really good growth in our top line, really great growth in our med tech segment, our future. We're up 16% after our first six months in med tech. Our gross margin was strong. When med tech is up, our mix gets better. The med tech business is in the mid-60s gross margin. Our med device is in the mid-40s. So you're going to have a nice mix for years to come as that med tech segment becomes a larger and larger piece of our population going forward. We also, earlier this year, we guided in July, gave you guys guidance for our fiscal year. We didn't think we'd actually be EBITDA positive. We thought we'd be close.
But here, after six months, we're EBITDA positive and we'll be EBITDA positive for the full year. So we're going to make money. We're not going to burn a lot of cash, and we're going to grow. It's a pretty interesting company. And we're in the right places. So this is our company today. Again, we've gone through a transformation purposely. We had the courage and the knowledge to exit markets that were not interesting or exciting, enter markets that are interesting and exciting. Well, they're also not easy to get in. There's high barriers to entry in the clinical arena as well. And there's also really good competitors. We knew it takes innovation, unique devices, and then a willing market to accept these devices. We've done a really good job steering our company through this transformation. Now our job's to execute, do a really good job.
We've built a company that can grow, provide profitable growth for years to come. We think we'll provide a lot of value to investors for many years to come. And thank you. I'll take a few minutes here and we'll take some questions. Caroline?
Thank you. So I guess just starting off, the company has been through a fairly significant transformation over the course of the last three years. Can you talk about the evolution of the business and why you think you're in a good position to be successful moving forward?
Thank you for the question, Caroline. Steve Trowbridge, our Executive Vice President and CFO, is joining us. I'll let Steve take that question.
Yeah, thanks, Jim. Thank you, Caroline. You're exactly right.
I think as you listen to Jim's presentation, he was talking about the transformation that Angio has been on over the last five or six years. Before we started this transformation, we were primarily focused on products that were serving the interventional radiologists, but we were focusing on more mature legacy products that were not high-tech, didn't have a significant technology advantage. We were playing in a combination of markets that had a lower growth profile and were much smaller. The important part of the transformation is we wanted to move into higher growth markets with higher margin profiles where we had a technology advantage where we could win that would benefit patients.
And the transformation that Jim talked about started with our portfolio, pruning some of the products that we had that are now in our med device segment and bringing in some new products like Auryon and doing some new R&D introduction in areas like thrombus, and then focusing on clinical research and regulatory pathway expansion in areas like NanoKnife. So today we have two segments that we report in. Our med tech segment, which is where our high-growth, high-margin platform technologies reside. And that's where the most of our investment is focused today. And that's where the lion's share of the growth is going to come. That's going to be our story going forward, the performance of that med tech segment. Our ability to invest in that med tech segment is driven by the med device foundation that we have.
So the med device products that Jim talked about, market-leading products, really good products that we've been making for a while, it provides a cash generation and an earnings foundation to allow us to make those investments into med tech. When we started this transformation, our overall revenue, only about 17% of our revenue base was coming from that med tech segment. In the last quarter that we just announced, 43% of our overall revenue was coming from that med tech segment. So you can see the shift in that overall revenue base. That's also going to provide gross margin accretion as we move forward. And then, as Jim had mentioned, all of that is going to drop to the bottom line as we shift into being positive EBITDA and then positive cash generation going forward.
Over the last couple of years, we were also doing some divestitures in that med device segment. We were making the trade-off of getting some cash on the balance sheet to support the investments in a time where you had rising interest rates and you had a little bit of a tighter capital market, but we were able to make those transactions at a pretty healthy multiple of revenue for those businesses and where we were trading at the time, so we thought it was the right decision from a capital allocation perspective, but where we're at now, it's important for us to make that turn, get back to have positive EBITDA going forward, positive cash generation to really prove out the business model.
And at a high level, you have two segments of the business, med tech and med device.
Can you help us understand how those two segments work together and why it makes sense strategically?
Yeah, it's a great question. As I said earlier, you have the financial aspect too. First of all, as Steve said, and we both said, it gives us one gives us the leverage to invest in the other. But there's also a tie-in. Our company was founded serving the interventional radiologists. They know us well. They trust our company. And really, a lot of our med device products are still, that's our primary call point there. So we have a really efficient sales force, a really great team that can serve those patients well, serve those customers well. And it gives us a springboard to talk about the investments we've made in our tech segment. So it's really a good platform. You look at treating PE right now.
When we initially designed the AlphaVac product, we thought that the IR doc would be one of the highest users. It's kind of shifted a little bit, so the IR doc, that pathway we have, got us into the cath lab now, talking about PE treatments, how to compete for those procedures. We're finding more interventional cardiologists, cardiothoracic surgeons are now coming aboard and getting to know our company, our technology, but it wouldn't have happened if we didn't have that springboard first without that IR doc utilizing that med device segment. So, Caroline, I think there's a good synergy for us, but over time, you're going to see the med tech segment become the largest segment of our company.
And a lot of your focus of the strategy is to drive growth around your med tech segment.
Maybe we start with the mechanical thrombectomy franchise, which AngioVac and AlphaVac help us better understand those technologies and the synergies you've been able to create across those two products.
Yeah, it's a great question, and we're very excited about our mechanical thrombectomy portfolio. You were asking the question of how med tech and med device fit together, and I think Jim was talking about both the financial aspects that they make sense, but more importantly, the product portfolio, how they make sense now. Very similar story when you think about mechanical thrombectomy. As Jim mentioned in his presentation, AngioVac was the first product that we had. It's been on the market for a while. It can do something that none of the other products that are on the market can do.
And that's driven by the fact that it's got the expanding funnel tip and then in connection with the simultaneous re-infusion circuit. So those two things together allow us to address very complex thrombectomy cases. As Jim mentioned, physicians really liked the expanding funnel tip, but they wanted to take away a little of the complexity of setting up that re-infusion circuit. And that's what led to AlphaVac. We have found, since we've launched AlphaVac with the full market release that we did in June 1, which is the start of our current fiscal year with the PE indication, that there is a lot of synergies between the AngioVac product line and the AlphaVac product line. So, as Jim mentioned, the AngioVac is typically focused in the right heart and on the right side and endocarditis. AlphaVac is really focused for us in the PE space.
But those two disease states are being treated by the same physician, the interventional cardiologist that Jim talked about, and the ability to have two tools, one that is purpose-built like AlphaVac with a handle that really gives the physicians the control, the maneuverability, the steerability that they're looking for when they're going after PE. But then the other side of the coin, a technology that allows them to go after those really complex cases when they find them. We're finding out that those two are working really well together. And with the results that we announced in Q2, you saw our mechanical thrombectomy business showing very impressive growth in both areas of AlphaVac and AngioVac. And we think that's going to continue.
And now turning to NanoKnife, there have been a lot of updates there recently around the clinical regulatory and reimbursement aspects.
Maybe walk us through the opportunity there with the prostate indication and how you'll be working to drive growth in the oncology space with that product.
Yeah, the oncology is the other disease state that we're focused on in AngioDynamics. As Jim mentioned, we're focused on cardiovascular disease, and that's when we talked about thrombectomy. We'll talk about Auryon as well. Then we're focused on oncology, and that's where NanoKnife and particularly prostate comes in. You're right. We were very pleased with some of the news that we saw in December leading up to our quarterly results. We had two very big milestones that we had been planning for for a very long time. It's been years that we were working to get a specific indication for NanoKnife coming from the PRESERVE trial.
And then at the same time, we've been parallel pathing a lot of work to get a specific CPT code for the physician payment side of NanoKnife. So those two things together are critically important. It's really three areas that we have to continue to focus on to drive growth in NanoKnife because there's a little bit of market development that we're doing here in the prostate space. We needed to get the indication. That's table stakes to be able to promote the product. It's very important to make sure that there's going to be predictable, stable reimbursement. Those are the two things we just talked about. And then the third is increasing the awareness. There's definitely this move in the urology community of folks looking for a focal treatment option.
As Jim mentioned, there are really two ends of a spectrum right now for men who are diagnosed with prostate cancer. One end of the spectrum is active surveillance. It's not really a treatment. It's more of a protocol where we're continuing to monitor the disease. Or the other end of the spectrum is radical prostatectomy. So they both have their drawbacks. On the one side, you're not doing any treatment, and that can be pretty burdensome to somebody to have that mental anguish of knowing that you've got a disease that's not being treated. Or on the other side, you can be treated, overall survival rates are pretty good, but the incidence of really debilitating quality of life side effects are horrible. And that's where we think NanoKnife as a technology really fits in.
For those intermediate risk prostate cancer patients that are right on the cusp of either going to active surveillance or maybe having a radical treatment, we think a focal treatment with NanoKnife is really the right option. Jim talked about the cancer control, and 84% of men that were in our study had no clinically significant disease in the treated zone after 12 months. So great options there, really good when you look at some of the other focal competitors in terms of their data. And equally important, the avoiding the quality of life side effects that we saw in PRESERVE coming from men who were treated with NanoKnife, both in terms of avoiding urinary incontinence, almost 99%.
Then the other data that we think is very meaningful is that you're not seeing any increased level of sexual dysfunction in men that were treated with NanoKnife when you compare to what you see every day for men who are not treated. Those two things together, we think will drive NanoKnife. It is going to be important for us to continue to do some market development to get the information out there. We think the PRESERVE study is the start of that. We're going to continue to invest in data generation as well as other information initiatives as we continue to build out this market.
T he final component of your med tech franchise is Auryon, which has consistently been a double-digit growth story. How do you continue to drive sustained growth in that business moving forward?
It's a great question.
First of all, the base science, the way Auryon delivers energy through our catheters to break up the calcium or plaque inside the vessel wall is amazing. So we have enough opportunity, we think. We're taking share from the other four players who are really good companies, but our product is innovative and it's breaking ground in what we're doing. What we've done purposely when we launched this device, as I said, in September of 2020, the hospitals were kind of giving all of us medical device companies the Heisman. Stay away, guys. Let us deal with patient care during the uncertain times of COVID. So the OBLs were the most receptive opportunity we had. We got a lot of business right away in the OBL settings. They're really important customers for us.
But in the last 18 months or so, when hospitals have kind of reopened again and got back to normal, we've purposely targeted those customers. We've done a really good job. So in the quarter we just presented last week, almost 40% of our revenue came from hospital customers. That's up from under 10% two years ago. So that's an important growth segment for us. We have a lot of room to grow there. The two new products we launched last year are radial catheter. Only one of the four other companies has a radial approach, gives wrist access opportunities to doctors. Patient can leave sooner, get healthier faster. And the new, more powerful 1.7 mm catheter delivers more energy to break up more hard calcium in the body. So our R&D team is terrific. And they're innovating all the time. We're in the new spaces, like I said, the hospitals.
And we also just received our CE mark clearance. Our great international team has distributor partners and clinical partners to help support our growth internationally. So as of now, almost all the revenue we've generated in the past four years has been U.S.-based. You're going to see our international team bringing new growth and revenue as well. So, Caroline, we think we have a really good plan with the product, technology, innovation, and market access driving growth for years to come.
Awesome. And as you mentioned, you've had a lot of wins around the portfolio over the last 12-18 months with new indications, geographic expansions. What should investors be expecting to see from a portfolio evolution perspective as we look out into the future?
Yeah, so Steve and I both sit around every day with our colleagues and look at where to invest next.
So one of the challenges we just, you heard about our portfolio. It's amazing. We're really proud of how we steered our company into these three markets. Let me give you the flip side there. Some of the folks we compete against, either they're really large and have more resources when they have multiple portfolios, or they're singly focused. They do one thing all day. We're in the middle of both. So there's good and bad there. The challenge we have is every time we have an opportunity to invest resources, we kind of have an internal bake-off where it makes the most sense. So over time, that's a resource constraint any company our size would have. A larger company wouldn't, or a more focused company wouldn't either. So those are the challenges we have. They're really good ones.
Let me tell you, I've been in the med device business for 35 years, and a lot of companies, we'd really love to have that as a problem, let me tell you. So we're going to do a really good job allocating our resources to where we think the best opportunity lies. Some of that's the R&D development opportunities we have. Our R&D team is great, and they're really good at hitting the timelines and cost structures they put forth. Our clinical and regulatory team has opened up these pathways over the last two years. These guys are really good. Our healthcare economics team is good. So we have a lot of trust and faith internally that we can expand these platforms as we go. We don't need to do M&A to bring in somebody else's product here. We have enough opportunity here to drive growth over time.
We'll invest them forward
And maybe turning to the P&L, you just posted a very strong fiscal second quarter where you generated positive EBITDA and operating cash flow. How should we be thinking about your path to profitability and why you're confident you'll be able to transition to becoming a consistently profitable company in fiscal year 2026?
Yeah, I mean, thank you. Good question. I'm going to let Steve comment. Let me make one comment I failed to mention earlier. So when the COVID hit all of us a couple of years ago, the biggest challenge we had with inflation, push inflation aside, we all dealt with that. But we have some manufacturing sites in Upstate New York where a company was founded. We couldn't get access to labor.
A lot of the folks who worked in our factories and our operations teams for years, it didn't come back to work. So we had a problem serving our customers' needs while we're growing. About a year ago, we announced a change in our operations footprint. We're going to move some of the more high labor content assembly items offshore to a longtime partner we've had in Costa Rica. That'll enable us then to move those items offshore and balance our workforce, keep one operations center in New York with really good people who are focused on building some of our med tech products going forward. So we'll have the right balance in our supply chain to keep it robust and secure. Over time, then we can also take out about $15 million of stranded overhead cost that didn't benefit our customers or our shareholders will come out.
So just so you know as well, we had a really good way we're going to drop more gross margin EBITDA through our P&L in the next 18 months, Steve.
Yeah, and we were very pleased with the quarter that we just announced and the positive EBITDA. And we think it's critically important for our strategy to prove out the business model that the two segments that we have working together will lead to profitable growth and then a ramping of the EBITDA margin for this business. So as we continue to grow the med tech segment, we saw 25% growth in med tech in the quarter. You're seeing the leverage of some of that growth with our high margin products in thrombectomy, Auryon, and NanoKnife providing some of that earnings accretion to the bottom line.
The stability of the device business working with the tech segment that we have, allowing us to drop EBITDA out of the bottom line and generate cash. As Jim said, our manufacturing transition plan will just work to increase that both at the gross margin level as well as the EBITDA margin level. We expect to see the full benefit of that transition for our fiscal year 2027. Now, we have a fiscal year that starts June 1. So June 1 of this coming 2025 is actually the start of our FY2026 fiscal year. It's not that far off in terms of the benefit that we're going to see from the manufacturing transfer that Jim talked about. We think it's critically important when you've got the two businesses that have some different profiles to make them work together.
It's important for us to drive growth in the med tech segment, but to have the overall company generate profit. And that's where we're at now.
And maybe before we wrap up, but just as we think about the new calendar year of 2025 and everything that's been happening, what are you most excited about? And is there anything you kind of want to leave us off with before we wrap up?
Yeah, thanks again for the opportunity to join your conference. We have a really good plan this year. We have a global approach towards the growth of these businesses. Our international teams are excited now with CE mark opportunities for AlphaVac and Auryon. We've got really great teams there that have a really good plan to grow those businesses globally.
Here in the U.S., we actually have four sales forces, a dedicated team that sells our device products that are really focused on those. Then one for Auryon, one for AlphaVac, AngioVac, and one for Nano. They each have three independent goals they have this year. We're excited, but for us, really opening up the new access, the prostate market for us. You look at, in the oncology market in the last year and a half, almost all the sales reps we've hired have come with a urology background. That was purposeful. We want people who know that market well, have relationships, established relationships, know how to sell to urologists. We've kind of shifted what we're good at and targeted there. So that team has a lot of goals. We're going to have a lot of fun this year, educating and creating awareness about our unique device in the market.
We'll learn how to best position ourselves for growth in the future. Then again, back to thrombectomy with treating PE. A really exciting space. We have a great selling and marketing team there. We purposely changed them and focused them about a year and a half ago, preparing for this launch. So today they sell AlphaVac and AngioVac alone. They're well prepared. We've got 40 people in the U.S. just dedicated to sell those, and that will grow. We'll probably end this fiscal year with more than that, and next year we'll end with even more. That's a growth opportunity for us, and we showed with Auryon. We started with zero reps. There's now 70 people there. We've learned how to invest for growth, so creating a startup with a 35-year-old company can be a challenge. We learned a lot in this process.
We think we've set up AngioDynamics for our investors that are interested for a company that will have high growth and profitable growth for years to come.
Thank you. That wraps up for today. Thank you so much. Really appreciate it.
Thank you.