Hello, and thank you for joining us. I'm excited to share the inspiring journey of AngioDynamics' strategic transformation, a transformation designed to deliver innovative medical technologies that address some of the world's most urgent health challenges, drive measurable outcomes in patient care, and create significant value for investors. At AngioDynamics, our mission is to improve care when it matters most, and our focus is clear: to tackle cardiovascular disease and cancer, two conditions responsible for staggering global health burdens. One in three deaths globally is caused by cardiovascular disease, and one in six deaths globally is caused by cancer. Three years ago, we began a deliberate shift to reshape AngioDynamics. Our focus has been on active portfolio management and the strategic deployment of capital in areas that deliver better care to patients with unmet needs while delivering measurable outcomes that create value.
This transformation has enabled us to enter larger, faster-growing markets, opportunities that were previously out of reach. As part of this journey, we have become a more focused MedTech company by aligning our business around three strategic areas of investment that we believe will drive growth. Auryon, its advanced laser technology, has become a game-changer in addressing arterial blockages and enabling AngioDynamics to compete in the rapidly growing market for Peripheral Arterial Disease. AngioVac and AlphaVac, these innovative medical thrombectomy systems, are revolutionizing thrombus management and addressing critical needs in vascular care. And NanoKnife, which recently received a key indication from the FDA that sets our organization on a path to recognize our vision for this innovative technology, with its proprietary Irreversible Electroporation, or IRE, technology becoming the standard of function-preserving treatment for men with prostate tumors.
These proprietary platforms position AngioDynamics to compete in rapidly growing markets, gain market share, and create new opportunities for patient care. Our team is excited to share an in-depth look at one of those proprietary platforms with you today: our NanoKnife System. Driven by their deep commitment to improving patient lives, our capable team has accomplished amazing things with this one-of-a-kind technology. Their partnership with physicians, societies, and patient advocacy groups has played a pivotal role in our journey to revolutionize prostate care. A member of that team, Jake Brumbaugh, our Global Vice President for Marketing in our Oncology business, is eager to share with you the great work underway to improve the lives of men. Jake.
Thank you very much, Jim. Hello, my name is Jake Brumbaugh, Vice President of Global Marketing. Today, we are excited to speak with you about the NanoKnife System and our recent indication for the ablation of prostate tissue. Now, here at AngioDynamics Oncology, our vision is to become the standard function-preserving treatment for men with prostate tumors, and we believe we can make this vision a reality through the NanoKnife System, an innovative, versatile, hour-long prostate treatment. This technology can address critical gaps in the current standard of care for prostate. It is the first and only non-thermal, radiation-free ablation technology cleared for use in prostate. This unique mechanism of action enables physicians to deliver treatment outcomes that patients are looking for and has been validated in clinical studies across thousands of patients around the world.
But if you are looking to change the standard of care, you need more than just a unique technology. You need a passionate team dedicated to developing new markets, and that is the team we have here at AngioDynamics. Over the past few years, they've worked hard to expand our global footprint and improve patient access for this technology. They've partnered closely with physicians to deliver comprehensive clinical support and best-in-class physician training, and they have stood side by side with patient advocacy groups to ensure greater awareness and education around this critical disease. This work has created a strong foundation for the NanoKnife System, and with our recent indication and upcoming changes to reimbursement, we are well-positioned to achieve the significant growth that our investors are looking for, and more importantly, to help improve and expand treatment options for men around the world.
Now, before we talk more about our unique technology and our commercial strategy, we'd first like to share some information around our market, the patients we serve, and the physicians that manage their care. Prostate cancer is extremely prevalent. In fact, it is the most common cancer diagnosed in men in 112 countries around the world. This year, it's estimated 1.5 million men will be diagnosed with this disease, and that number is only growing. You see, prostate cancer is highly associated with an increase in age, so as our population gets older and as men continue to live longer, the incidence of prostate cancer is continuing to rise. In fact, government and policymakers are fully expecting the incidence rate to double within the next 15 years, and this is a major concern because prostate cancer is also extremely debilitating.
I know we all have heard men will often die with prostate cancer rather than from prostate cancer, but we believe that statement does a disservice to only focus on the mortality of this disease because prostate cancer takes more healthy years from men's lives than any other type of cancer. Yes, there are physical side effects from the disease and subsequent treatment, but these also have a negative impact on a man's financial and mental health. This can reduce their overall independence and place greater strain on their relationships with family and friends. Now, to understand why this disease is so debilitating, it will really help to understand the biology of the disease and the current treatment pathway. About 90% of men diagnosed will have a localized form of prostate cancer. This means the tumors are contained within the organ.
This is good news because localized prostate cancer can be relatively slow to progress, and this is why 25% of men will opt for active surveillance. Now, active surveillance is not a treatment. It is a protocol of repeat biopsy and repeat imaging so that a physician can monitor the disease and only intervene when absolutely necessary. On the other side of the coin, localized prostate cancer is often multifocal, as you see in these images. As a result, the standard treatment option is to treat the entire organ or prostate. These are known as radical treatments, whether that be a radical prostatectomy, surgical removal of the prostate, or radical radiation, complete radiation of the prostate. Now, about 72% of these men opt for this definitive treatment, and while these treatments are highly effective, they are also associated with long-term urological side effects.
In summary, men can either pursue active surveillance or have a radical treatment. This can put men in a very challenging position when deciding how to best manage their care. Men today are being forced to compromise between choosing their quality of life with active surveillance or treating their disease with a radical treatment option. Now, for those men that do choose active surveillance, 25% of them will avoid a treatment in their lifetime, but this population will also face higher rates of disease progression, potential metastatic disease, and progression to Androgen Deprivation Therapy . On the other side, men who opt for a Radical Treatment or Definitive Therapy can face a major impact to their overall quality of life.
The two core metrics that are most often measured are going to be urinary continence the ability for a man to control his bladder, and erectile function, the ability for a man to maintain an erection sufficient for intercourse. These quality of life metrics are essential to a man's overall mental and physical well-being. Patients today are increasingly aware of the risks associated with these traditional treatments, and they are looking for alternative options. Patients want to be able to treat their tumor but preserve their overall quality of life. This is the unmet need for patients suffering from prostate cancer. The good news is that over the past 15 years or so, there's been some major technological and clinical developments which have uncovered new treatment options for patients.
These options are known as Focal Therapy, and they serve as a middle ground between Active Surveillance and a Radical Treatment option. The goal of Focal Therapy is to deliver a localized treatment to the prostate and preserve the anatomy of the organ while maintaining a man's sexual and urinary function. These innovations began with imaging. First, there were improvements in transrectal ultrasound, mpMRI, and PSMA PET. These allowed physicians to better identify and visualize the lesion inside the prostate. Next, there were improvements in biopsy and staging and grading of patients, which led to improved patient selection, really understanding which patients best qualify for Focal Therapy. And finally, there was the clinical research that honed in on the index lesion. Within prostate cancer, metastatic disease is caused by a single cell. This cell can be found in the highest grade, largest tumor within the prostate.
If physicians are capable of visualizing that tumor, delivering a local treatment, they potentially could reduce the metastatic potential of the disease, downstaging that patient to avoid or delay the need for a Radical Procedure. Now, currently, there are three main modalities for Focal Therapy. That is going to be cryo, freezing the tumor, HIFU, burning the tumor, and brachytherapy using radiation to kill the tumor. These Focal Therapy options have been shown to delive 5x- 10x improved quality of life results versus either Radical Prostatectomy or Radiation Therapy. They are really what patients are looking for. Despite these clear patient benefits, Focal Therapy lacks adoption in the U.S. This year, it's estimated that 300,000 men will be diagnosed with prostate cancer. Yet, less than 3% of these men will undergo a Focal Therapy option.
Now, as you can see on the graph, over the past two years, there's been a slight uptick as reimbursement has changed for several technologies, but overall, the rates of Focal Therapy within the U.S. have been relatively stagnant and detached from the growing rate of prostate cancer incidence. This indicates that Focal Therapy is being performed in a few key centers around the United States but lacks overall adoption across the urologic community. Of the 100,000 men who may benefit and qualify for a Focal Therapy option, only around 7,000 men actually undergo this treatment in the U.S. So why is this more localized treatment option not gaining in popularity? Through our work with physicians across the country, what we have found is that the current Focal Therapy market is extremely fragmented.
Today, the treatment options are really ideal for a certain segment of the prostate, and each treatment can be limited by the tumor location, size of the prostate, calcifications, or other anatomical features of the prostate. HIFU is ideal for posterior lesions or the back of the prostate. Cryo is ideal for anterior lesions or the front of the prostate, and brachytherapy is often used for apical lesions or the bottom of the prostate near a lot of sensitive vital structures. Now, for those tumors that abut the urethra, periurethral tumors, there's not really a great option today. This means physicians who are looking to adopt Focal Therapy today and offer it for all patients who may qualify face a series of complex requirements. They need to adopt multiple technologies, each with a distinct learning curve.
They need to develop expertise in delivering these treatments and selecting the patients for each individual modality. Most importantly, they must work hard to integrate these processes into their practice. This requires extensive education all the way from their referring physicians to all relevant departments, including purchasing and their OR staff. This can make it extremely challenging to offer a Focal Therapy option at scale with consistent high-quality results.
This is the unmet need for our physicians. This is why we're so excited to be here today and speak with you about the NanoKnife System. This one-of-a-kind technology has the ability to drive large-scale adoption for Focal Therapy because it is able to treat all segments of the prostate efficiently. It's able to be easily integrated into a physician's practice, and finally, it delivers excellent clinical outcomes that patients and physicians need. To better understand why this one-of-a-kind technology can address the unmet need for both physicians and patients, let's take a closer look at the procedure and the underlying mechanism of action, which really differentiates the NanoKnife System from any of its competitors.
The NanoKnife System is the only function-preserving therapy that uses electricity to destroy prostate tumors. The procedure takes about an hour and has minimal recovery time. During the procedure, electrodes will be placed to bracket the targeted prostate tumor. The physician will use ultrasound to guide the placement of the electrodes. This therapy precisely targets the prostate tumor with electrical pulses that destroy cells. Talk to your doctor to see if you are a candidate for the NanoKnife System procedure. Use the physician locator to find a physician who utilizes the NanoKnife System near you.
As you can see, the NanoKnife procedure is a straightforward needle-based procedure, but the real magic happens with the underlying mechanism of action. The NanoKnife System is the only technology that utilizes electricity to destroy prostate tissue. Now, this mechanism of action is officially known as Irreversible Electroporation, or IRE. Now, what makes IRE unique is that it selectively targets cell membranes. When a cell membrane is exposed to a sufficient level of voltage, it opens up permanent ion channels. Fluid will flow in and outside of the cell, leading to a loss of homeostasis and resulting in an apoptotic-like cell death. Now, the real value of this technology is that it can target resident and disease cells alike, but it does not target proteins or collagen, which make up the underlying structure of the tissue.
This enables NanoKnife to be extremely versatile and treat all segments of the prostate, even across vital structures such as the urethra. We know this can be a relatively complex mechanism of action, but what we have seen in the field is that the value proposition of the NanoKnife System can be pretty straightforward, and our patients and physicians recognize the value of this non-thermal technology. More importantly, physicians have taken on this technology and found ways to communicate it in a patient-friendly way. To hear an example of this, let's listen in to Dr. McClure from Weill Cornell as he explains his patient pitch for the NanoKnife System.
Patients will come in, they'll meet me or whoever is doing the ablation. We put them to sleep with general anesthesia. We bracket that area of cancer very precisely to target that cancer that we've identified on the biopsy.
We kill the tissue and the prostate cancer with the Irreversible Electroporation, which in essence is essentially I kind of equate it to cracking an egg. So if you look at a milk carton, think of that as the prostate, and with some ablative therapies, in order to remove the bad eggs or the part of those eggs that shouldn't be there, you either have to burn them or freeze them, and then in doing so, you destroy the box as well. So kind of the structures that are holding that prostate together. What IRE does is lets you crack those eggs so the structure of the prostate remains, but the cells have been killed.
As you can see, there's many different ways to talk about NanoKnife's mechanism of action, whether you're talking about electrical fields that create permanent ion channels to open up, leading to an apoptotic-like cell death, or eggs being cracked without destroying the egg carton. There's many unique ways to share the value of this technology. In the end, what truly matters is does the NanoKnife System deliver the clinical outcomes that patients and physicians need? The answer lies in the compelling clinical evidence and real-world experience of our physicians. We know the NanoKnife System delivers exceptional benefits supported by a wealth of international data. Its ability to efficiently treat all prostate segments, integrate seamlessly into clinical practice, and deliver strong outcomes has been well documented. However, many of these studies were retrospective, registry-based, or single-centered.
What we needed was a chance to validate these findings in a robust, large-scale U.S. study. That opportunity came when the FDA released new regulatory guidance for the ablation of prostate tissue several years ago, a moment we recognized as pivotal. By initiating the PRESERVE pivotal study, we became the first company to align with the FDA's updated guidelines. This study allowed us to confirm the NanoKnife's international results in a U.S. population and demonstrate its clear clinical benefits in a prospective biopsy-monitored cohort. This study, conducted across 17 U.S. sites, was done in partnership with leading academic institutions and the Society of Urological Oncology. PRESERVE sets a new benchmark for prostate tissue ablation studies. At the end of July, we completed the 12-month follow-up for our PRESERVE patients and submitted the data to the FDA.
This milestone led to the FDA granting us a prostate tissue indication for the NanoKnife System. But now the key question is, does the PRESERVE data confirm the NanoKnife's strong value proposition and clearly demonstrate its ability to address the unmet needs of both patients and physicians? In numerous clinical publications, physicians have found the NanoKnife's ability to destroy cells while preserving the architecture of the prostate sets it apart from other Focal Therapy technologies.
As demonstrated during our PRESERVE study, physicians were able to have unparalleled versatility in their treatment algorithm. They were able to treat a strong mix of patients across anatomical segments of the prostate, and their average treatment time came in at 54 minutes. This value proposition was confirmed during the PRESERVE study. Now, let's take a listen to the co-PI of the PRESERVE study, Dr. Arvin George, as he shares his experience with the NanoKnife System.
IRE has a number of core advantages over existing ablative energy modalities, and I think the primary three that I think I see in clinical practice is, one, its ability to be largely athermal. It overcomes issues regarding heat sink, so warming a urethral warming catheter can limit the effect of an ablation. The ability to be able to treat through tissues and still preserve the core architecture, I think, is incredibly important. The second is how facile it can be in terms of its speed of use. We are always burdened with the efficiency of our treatments, and the quicker that we are able to treat patients, the less time that we're able to keep them under anesthesia, the quicker that we're able to send them home and reduce their convalescence time.
I think that is a unique aspect of IRE. I have not seen another technology that is currently available that is as quick in terms of the treatment, and that really appeals to clinicians in terms of the limited amount of time that we have to be able to manage patients. And the final major advantage, I think, is its versatility. There are a number of technologies that are limited by the size of the prostate gland or specific anatomic features like prostate calcifications and the AP diameter of the prostate. That is largely not an issue with IRE. You can treat anteriorly. You can treat posteriorly. You can treat across vital structures and still have preservation of architecture. And so those three key features, I think, is what sets IRE apart from other ablative treatment modalities.
Now, while it is valuable to be able to provide treatment to most patients that qualify for a Focal Therapy, it's also important that technology can be easily integrated into a practice. This was another unique opportunity from the PRESERVE study. This study provided an opportunity to glean valuable insights on the learning curve required for the NanoKnife System. As you can see, the PRESERVE study captured many physicians' initial experience with the technology. In fact, 14 of our 17 sites who enrolled patients had little to no experience with the NanoKnife before the study began. What we found is physicians' existing skill sets and the use of image guidance, such as Transrectal Ultrasound, and needle-based procedures, such as prostate biopsy, helped to minimize the learning curve required for the NanoKnife technology. This confirms that the NanoKnife System can be easily integrated into a clinical practice.
This low barrier to entry is essential for any technology that is looking to be adopted at scale. Let's listen to one of our newest treating physicians, Dr. Brent Sharpe from Georgia Urology, on his initial experience bringing the NanoKnife System into his practice.
Integrating or being able to apply NanoKnife in my practice with prostate cancer was extremely easy for several reasons. Number one, we always, urologists, do prostate biopsy, so we're very comfortable with ultrasound. We're very comfortable with placing a needle within the prostate, as we do every day with the biopsy, to make the diagnosis. Having started a Robotics Program and understanding taking an open operation to a Robotic, there was a lot of learning curve, and in this one, there's not because, again, we're all comfortable with that basic ultrasound and a needle in the prostate.
Also, those that do seeds, like myself, I used to do seeds, so placing a needle in a very, very discrete, specific area within the prostate to target that man's prostate cancer in a localized area was very familiar. So the adaptability, the learning curve on this is very adaptable to almost all urologists for the betterment of the patients.
We know the NanoKnife System provides unmatched versatility. It's a relatively short procedure time and is easy to adopt within the clinical practice. But does it provide the strong clinical outcomes that patients and physicians need? In the most recent meta-analysis and systematic review of all primary studies reporting the outcome of Focal Therapy, the NanoKnife System, or IRE, has once again set itself apart.
While most focal therapies have strong outcomes in regard to the preservation of urinary function, there can be variability in their preservation of sexual function and tumor destruction, or the ability to avoid clinically significant in-field failures. As you can see in the recent meta-analysis, IRE has demonstrated the lowest impact on sexual function and provides excellent in-field control of clinically significant disease. These strong clinical results were replicated in the PRESERVE study, highlighting that even during physicians' early experience with the NanoKnife System, they can quickly bring the technology on board and deliver outcomes patients need. From a urinary continence perspective, there was a 1.2% decline from baseline, and from an erectile function perspective, there was only a nine% decline from baseline.
When you add this together with 84% in-field control for clinically significant disease, you can see why the NanoKnife System is such an exciting opportunity within prostate care and why this technology will lead to greater adoption of Focal Therapy in the future. Now, let's listen in to some of the patients who were enrolled in the PRESERVE study and what the NanoKnife System means to them.
Yeah, my name is Ricky Gibbs. My name is Zachary Rahman. My name is George Amos. I'm from Fredericksburg, Virginia, and I was diagnosed with stage 2B prostate cancer in April of 2021. There was a second biopsy done, which was guided by this MRI, and it disclosed cancer. I asked to do a biopsy, which I did, and the biopsy showed that I had prostate cancer.
I looked at the other options, the surgery, which had potentially bad side effects together with a long, perhaps weeks or months of recovery. All the options were very poor with the side effects. Most of those treatments have serious quality of life considerations. After much research and process of elimination, we came to the conclusion that IRE was the best, and he told me if it didn't work, I still had all the other options available. He told me whether it was surgery or radiation, so the NanoKnife treatment, which, to be honest with you, was easier than getting a biopsy. It was very, very good. I mean, it was uncomfortable to have to wear a catheter for three days. As far as recovering out, it was really a pretty simple thing. I mean, I had no pain, no bleeding. There's just nothing to talk about.
NanoKnife technology is different than all the other technologies. It's really something worth looking at. From a quality of life standpoint, it's just been amazing. I mean, it's really different. I'm back to normal. I walk and jog and bike and swim and work out seven days a week with a trainer or kind of feel like I'm pretty much back to normal and very quickly.
As you can see, prostate cancer is extremely prevalent and on the rise. Patients who are unsatisfied with the current treatment paradigm are actively seeking a more localized approach that allows them to treat their tumor while preserving their quality of life. The current Focal Therapy technologies have been restrictive and prevented large-scale adoption of a Focal Therapy option for patients, but the NanoKnife System can clearly address these unmet needs of both physicians and patients through its unique mechanism of action, IRE.
With the NanoKnife System, physicians can treat all segments of the prostate, even across vital structures. This technology is not limited by gland size or anatomical features, enabling physicians to build expertise in a single technology and optimize patient outcomes. They can also easily integrate this hour-long prostate treatment into their practice using existing biopsy and imaging skills without extensive or complicated training, and finally, they can provide reliable ablations with generous margins that don't negatively impact the quality of life that a patient is looking to keep. This is why the NanoKnife System will be able to drive large-scale adoption in Focal Therapy, letting us achieve our vision of becoming the standard function-preserving treatment for men with prostate tumors. We have created a unique technology, the NanoKnife System, that is capable of addressing the unmet need of patients and physicians.
With our recent indication and upcoming changes to reimbursement, our team is ready to execute our commercial strategy that will drive long-term sustainable growth. The Focal Therapy market today has several technologies that rely on a large-scale capital purchase to drive revenue. The NanoKnife System is different. It's designed not only as a capital equipment sale, but it also has a robust recurring revenue engine powered by our single-use disposable electrodes. These disposables are critical for each procedure and provide a consistent revenue stream tied directly to procedural volume. When tied together with the sale of our capital system, this provides a balanced and scalable revenue model. This approach allows us to capitalize on increasing procedural adoption while maintaining predictable and growing cash flows. It's a model that positions us both for short-term growth and long-term profitability.
We are excited to apply that sustainable growth model to the prostate cancer market. Now, as we've discussed, the prostate cancer market represents a significant global opportunity with a total addressable market of $2.7 billion. Our team is committed to a rigorous three-step process to develop this market successfully. First, we are focusing on regulatory excellence, meeting and exceeding all required regulatory milestones to ensure compliance and readiness. Second, Strategic Market Access. We are focusing on securing reimbursement pathways and demonstrating strong healthcare economics that supports the widespread adoption and accessibility for patients. Finally, we are looking to drive clinical adoption. This can be achieved through effective patient awareness and education campaigns and comprehensive physician training programs. When looking at our regulatory approvals, we are excited to announce that for the first time, the NanoKnife System has achieved tissue-specific indication in our two largest markets.
We have gained both our CE mark and MDR approval in Europe, as well as our recent FDA approval here in the United States. These milestones were made possible by leveraging the robust clinical data from our international markets and validating it through the PRESERVE pivotal study here in the U.S. Tissue-specific indication is a significant achievement for our business. This will enable us to more effectively communicate the value of the NanoKnife System specifically within prostate and will lead to the transformation of the Focal Therapy market around the world. Alongside achieving our broad indication for NanoKnife's use in prostate tissue, we are driving growth through strategic market access initiatives. In the U.S., Irreversible Electroporation has secured inclusion in the Medicare fee schedule since 2021 and recently, we obtained our CPT Category I codes for use in prostate and liver. These will become effective in January 2026.
Globally, we are expanding access through pivotal trials and government partnerships as they seek to mitigate the rising costs of healthcare. In Canada, the WIRE trial is building clinical momentum, while in the U.K., NICE has upgraded the NanoKnife System to special arrangements, which will support service expansion and new data collection. Key randomized controlled trials in Sweden, the Netherlands, and the U.K. will provide critical insights into clinical outcomes and the economic impact of the NanoKnife System when compared versus the current standard of care radical prostatectomy. Finally, in China, inclusion in Beijing's medical insurance catalog will cover 85% of procedural costs for patients, highlighting the NanoKnife System's growing accessibility across the globe. These strategic milestones underscore our commitment to establishing NanoKnife as a global standard of care and position us for sustained growth and strong shareholder value creation.
With the recent wins in our regulatory and market access strategies, we are now able to focus on developing these markets around the world. Our commercial strategy, first and foremost, is built around the largest commercial team within the Focal Therapy space. We are also making significant strides in patient awareness with our "Destroy the Tumor, Preserve the Man" campaign. This aligns with the growing trends of patients turning to the internet as their primary source of health information. Through message testing, we know this campaign resonates with patients and empowers them to take charge of their healthcare decisions. Finally, our commitment to strong physician education is evident through initiatives like our masterclass series and our life symposiums, which ensure clinicians are equipped with the knowledge and skills to adopt the NanoKnife technology effectively.
These pillars, an exceptional sales force, patient-centered awareness, and robust education programs are driving the adoption and market expansion for the long-term value creation of the NanoKnife System. While we are still in the early experience of the NanoKnife System's use here in the U.S., we've already established a strong foundation of key opinion leaders and customer advocates. These champions of our technology are instrumental in supporting other clinicians as they onboard and adopt the NanoKnife into their practice. Looking at the breakdown of our active centers, we see a diverse mix of care sites, which highlights the broad potential for growth across all segments of urological care. This distribution reflects not only our early success, but also the significant opportunity to expand adoption across each of these segments.
By leveraging the expertise and advocacy of our early adopters, we are well-positioned to accelerate growth and ensure broader access to this transformative technology. As you've seen today, the NanoKnife System is uniquely positioned to capitalize on a large and growing addressable market. This innovative, versatile, hour-long prostate treatment is able to address the unmet needs for physicians and patients alike and has been backed by strong clinical evidence. With our recent indication and upcoming changes to reimbursement and a robust revenue model built for growth, our highly capable commercial team is ready to drive the significant expansion of this technology. Taken together, we are confident the NanoKnife System will be the standard function-preserving treatment for men with prostate tumors.
Thanks, Jake. You did a great job laying out the opportunity in front of us today. AngioDynamics has set a path forward to be an innovator in these areas of care. You can see how NanoKnife is the right product at the right time. We've got the right team to develop this unique market opportunity. Now that we've enabled access to these markets with the right technologies at the right time, we're in the right places. We have a company set up to grow with the capability to deliver products that are innovative, safe, effective, and efficient from a clinician's point of view and really efficient for the patients that we treat. Our company has the foundation it needs to grow. We have the capital structure necessary to focus our investments and our energy in the right places. We look forward to focusing our energy to grow our company and grow value. Thank you for joining us today.
Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone's keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your questions on the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Thank you. Our first question comes from the line of Jon Young with Canaccord Genuity. Please proceed with your question.
Hi, Jim. Steve and Jake, thanks for taking our questions again this morning. And thanks for this really informative presentation. I just want to start. Could you just talk about the feedback you've heard from the field since the press release results were released? And then secondly, just as we think about the cadence of the ramp, obviously, there's some pretty big catalysts coming. We have AUA end of April, and then obviously the reimbursement on 2026. But can you talk about the revenue ramp that you're expecting from prostate specific? Thank you.
Hi, John. It's Jim. And Steve will pick up after me. John, we've really been impressed. Our field team reports in to us constantly on feedback they're getting about increased awareness. It's only been three or four weeks, as you know, since we've received the FDA's indication for the prostate area. We will have a live on our website on 12/12, actually. And we posted information that people can now go see and access and learn about this as an opportunity for treatment.
We've gotten a tremendous amount of interest through our physician finder and through our portal already, not just from patients who are interested in learning more and seeing they can speak to a physician, but in new physicians as well interested in using this technology to treatment options. So, John, not even a month into it, we're really pleased. We had a plan. We had a level of expectations, but I think we're at or above those expectations for just initial early feedback. Steve?
Yeah, John. As Jim said, we're really excited about the feedback that we're getting. But I think the other point here is that this has been something we've been planning for a while. This is the result of work that we've done over a number of years back when we first started doing trials for NanoKnife. We're really excited about the opportunity.
We know NanoKnife is the right product to fill this unmet need. And as we said, there's really three legs of a stool that are going to drive NanoKnife over the long term and over the medium term as well. Getting the indication was table stakes. We had to get over that first. That's very important. Second thing is going to be reimbursement that we've talked about. We were really pleased that we were able to go through a process to make sure that we put reimbursement in place in October, right around the time that we were getting this indication. We didn't have to wait a whole other year. It was important for that parallel path work that we've been talking about doing over the last few years. And then third is increasing awareness.
As Jake said in his presentation, only about 2% of men who we think are good candidates for Focal Therapy have gotten Focal Therapy. And we think that's because of the limitations that have been out there with the other devices before NanoKnife. So something like what we're doing today, the feedback that Jim talked about that we're starting to get from the field, we're really seeing those efforts pick up in terms of that awareness. And we know that that will drive market development over the short and medium- term.
Great. Thanks. And then just as a follow-up, maybe can you talk about just the economics of NanoKnife versus other focal options and then just the other options in terms of radical prostatectomy in terms of incentives for physicians? And then also, will the PRESERVE study itself have any economic outcomes that we'll be seeing?
Yeah. So starting with your last question, PRESERVE is not really about the economics. That was more about the efficacy and certainly the quality of life. Now, one of the things that does come out of PRESERVE that Jake talked about was the efficiency that you get with the NanoKnife procedure and how it can be done in the meantime that was in that study in under an hour. That, of course, will have economic impacts to physicians as they start thinking about building this into their practice. More than anything, we really think it's important to first start with what is the patient benefit. And that's why we think NanoKnife is such the right opportunity. Give patients options, give them good control of their cancer, avoid those quality of life side effects at the levels that we talked about in this trial, and then preserve future treatment options.
Economics, of course, are going to be a big part of that. And as we go through the RUC process and we get the CPT codes and you add that to the ICD-10 codes, we're very confident that this is going to be a procedure that is going to be economically beneficial and viable for the physicians. It's hard if you want to do a real apples-to-apples comparison to something like surgery. There's surgery codes and there's different amounts that go into that. But we really start with the patient option first. We think that, bar none, this is the best option for patients. And then the economics will be there so that we think that there won't be any barriers whatsoever to physicians adopting this as we continue to build out awareness and build out that dataset.
Great. Thank you.
Our next question comes from the line of Steve Lichtman with Oppenheimer. Please proceed with your question.
Thanks. Hi, guys. Thanks, Jake, for a great presentation. I wanted to ask first on the direct-to-patient work. Can you talk a little bit more about what that looks like? Is it all online or is there any commercial work? And I know it's early, but any early comments you can make in terms of what you're seeing from patients specifically as a result of those efforts?
Yeah. It's a great question, Steve. And we'll have Jake jump in. He can give you the details on this. As Jim said, we're in the very early stages of what our activities are in terms of going direct to the patient. With respect to NanoKnife, kind of very different than almost any of our other products. We think that there is a lot of benefit in getting that information out direct to the patients. We've started early. We've got some plans that Jake will fill you in on. We've been really happy with what we've seen so far, but we still are kind of just at the early stages.
Yep. Perfect. That was Steve. It's Jake. So it's been really exciting as we've kicked off this market awareness campaign. And really, as we start off, primarily, we are focused mainly on internet direct-to-patient just because we have an ability to really target the audience that we're really trying to hone in on. Now, this direct-to-patient campaign really focuses on three key principles. One, it's delivering the message not only on our technology, but also on a function-preserving option.
Keep in mind, many of these patients might not be aware that there is an organ-preserving option available to them. And so one, just driving awareness around the focal market in general. Second, highlighting the technology and its application for patients. And then finally, having some messaging that really speaks not only to the patient, but also to their family and friends.
One of the things that we see is that these men have time to make a decision around their prostate cancer care. And so they are leaning closely on their peer groups, on their family and friends to make those decisions. So being able to provide information and drive awareness not just to the patient, but to their support network has been really valuable. So still early stages, but as Jim said, we're extremely excited by the positive response we've seen.
And we think that the direct-to-consumer is going to be a very important part of this. We do expect that there's going to be pull-through coming from those patients, being driven by patients as they understand what the options are available to them, as Jake said. We know that the unfortunate times when people are diagnosed with cancer, they become very educated about what their options are. And so it's important for us to make sure that we continue to get that information out there. And we think that that DTC efforts will definitely be a big part of marketing going forward.
Great. Appreciate the update during the presentation on the number of U.S. facilities. I think you said it was about 120. Can you remind us of what you see as sort of the denominator there, the opportunity for you guys over the medium to long- term? And then, maybe tie in with that your capital outlook. On the call earlier today, we talked about it being down year- over- year, I guess, on some tough comps. But how should we think about the cadence of capital over the next number of quarters?
Yeah. It's a good question. I'll let Jake give you some of the details in terms of what we think the opportunity is for NanoKnife. It's a little bit different for us when we think about the prostate opportunity than when we were talking previously about liver or pancreas, where I think they tend to be a little bit more concentrated in university centers, whereas we think that prostate has an opportunity to be much more broad-based in terms of our installed base going into some of the cities, but also some of the more regional hospitals.
From a capital perspective, one of the things that we've talked about over the last couple of years is we don't want capital to be a barrier to physicians or hospitals adopting this technology. So we're looking at a variety of ways of getting capital into their hands. It could be from purchasing, could be through lease arrangements. We're working with other parties that can help provide the leasing to companies. Could be through usage agreements. So there's a little bit of that that goes into our expectations around capital sales.
You're right. There was a tough comp. We said we've seen kind of historically almost in every other year cadence as hospitals are going through their capital budgets. So we're continuing to get systems into the field, and Jake can give you some more details on that. But we don't want the price of capital or the hurdles that go into placing capital to become a governor on folks adopting this treatment and really driving those disposable sales.
Yep. Now, and then as it looks towards the overall growth, as you said, 120 facilities currently in the United States. Now, when you look at the urology market specifically, it's good to keep in mind that urologists are often managing many different facets of the patient's care. So not only are they specializing within oncology, but they also might be working in several other procedures. So on that slide, what you saw is 3,000 estimated accounts that are really specializing in the oncological care of patients. And so that number could fluctuate over time as you see other physicians that are looking to maybe integrate or bring a Focal Therapy or oncological solution into their practice.
But as of right now, that's really the opportunity that we're looking at for those that are specializing in treating patients with prostate cancer, not doing some of the other procedures within the urology space.
Thank you. I just wanted to ask one last one on international. Jake, you talked about some of the progress during your presentation. How big is international today? And do you see that as a material driver for the world in the next couple of years, or will it be more U.S.-focused near term?
Yeah. So right now, international is about half of the business, so we're roughly 50/50. I do think you're going to see a little bit faster expansion in the U.S. than in the international markets. We've got a little bit of a different go-to-market strategy in the international markets. We're direct-based here in the U.S. We're more through distributors for all the reasons you can understand in the international markets. I do expect that international growth is going to be meaningful to this product line over its life cycle. Probably very early on, you might see some more accelerated growth here in the U.S. and then international catching up behind that.
And then the only bit of color I'd like to add to that is when you think about the international market space, obviously, you saw some of these RCTs that were listed. So one, there is a lot of interest, and there have been some strong key opinion leaders within the Focal Therapy space as evident by our international data being the major source of data for the NanoKnife System.
But as those RCTs really move to completion and look at focal therapies' comparison to radicals, not just for clinical outcomes, but also their impact on the healthcare economic system and the overall cost to patients, that's going to be an extremely important driver within the international market as well. So just reiterating, I think in the initial years, you definitely get to see more growth here within the U.S.. But especially with the completion of those RCTs, that should be a real big driver for our international space.
Great. Thanks so much, guys.
Thanks, Steve.
As a reminder, if you would like to ask a question, press star one on your telephone keypad. Our next question comes from the line of Marie Thibault with BTIG. Please proceed with your question.
Hi. Good morning. Thanks for hosting this event, Jake. Appreciate the detail today, and hi to Jim and Steve. A question here. Can you just remind us on your sales force plans here for NanoKnife, the size of your current sales force, any plans for expansion? And when it comes to targeting physicians, are you largely looking right now at the centers and the doctors who are already doing Focal Therapy, already being kind of on the cutting edge of things, or are you looking kind of across the board at folks who also do surgery and others?
Hi, Marie. It's Jim. As far as our sales force today in the U.S., we've got about 30 dedicated sales reps and a clinical support team behind them to make sure that our doctors are trained and educated on how to use the device and can do it today. We have planned in our three-year model with now getting indication clearance, and next year with the CPT-1 code kicking in, we'll have sales force expansion built into our models going forward. But we think we have the right sales force today combined with the awareness education we'll do offline to do what we need to do to stimulate interest and awareness. And Jake?
Yep. And then to follow up on the second question, which I think is great, is around the targeting. So when we think about the current market today, now we do play within each segment, but the way we kind of think about it is first, there are physicians that are extremely experienced within Focal Therapy, those that have currently practiced, understand patient selection, staging, and are doing those procedures.
That is obviously one of the primary targets and many of the physicians that were actually involved initially in the PRESERVE study. The second group is really looking at physicians who have those practice skill sets, as you heard from Dr. Sharpe on the video itself. So those are physicians that are doing seed placements or transperineal biopsy that will have a relatively low learning curve to adopt the technology. And then finally, we do have those physicians who have never done focal before and may be limited in their transperineal experience. We do have those physicians that are coming on.
The only difference there is that we do spend more time with the physician education portion, making sure they really are understanding the data not behind just the technology, but Focal Therapy and building up those skill sets that when they do bring on the technology, they can deliver the outcomes that patients are expecting. But we are playing and working with all three of those segments today.
Got it. That's very helpful. Follow up here on reimbursement. Congrats on, of course, the regulatory wins and then the reimbursement win here with CPT coming in 2026. How important is the payment level to sort of the commercial equation here? And just remind me on catalysts. Will we get an idea of the payment level with the PFS draft this July, or what's kind of the timeline for some of that? Thank you.
So Marie, it's a great question. And obviously, economics are always a huge driver, and the level of payment is going to be very important. Yes, we do expect you'll start to see the indication in July with that publication. As we said, we're going into the RUC process now. It's a pretty independent process, as you're aware, where they're going to go out and do surveys. We know who they're going to. We've got a pretty good idea of where we think it goes, and we think that it should be at a level that is very supportive of what our overall strategy is.
Okay. Very helpful. Thank you and good luck.
Thanks, Marie.
Thank you.
We have no further questions at this time. I'd like to turn the floor back over to Mr. Clemmer for closing comments.
Thank you for participating in our call today. We hope you view AngioDynamics as a company not just centered on this unique NanoKnife technology and the prostate market opportunity, but really a company that has spent the last three or four years transforming our portfolio, creating a terrific Medical Device segment that can treat cardiovascular disease and obviously cancer care. And again, our company's investments are supported by our Medical Device segment, which is our largest segment, provides us with the cash capital stability necessary to have our company grow for years to come. Thank you again for your interest today. Talk to you all soon.
Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.