Morning, everyone. Suraj Kalia, Senior Medical Device Analyst at Oppenheimer. Pleased to have management from EDAP presenting at our conference this morning. From EDAP, we have CEO Ryan Rhodes and CFO Ken Mobeck. Gentlemen, always a pleasure to connect with you. I'll let you take the floor, and I'll resurface five minutes towards the end for Q&A. Great. Thank you. We're glad to be here. Again, we're EDAP Focal One, the global leader in therapeutic ultrasound. Our corporate focus as global leader is really in the areas of therapeutic ultrasound for both the treatment of cancer and benign disease. It starts with a large and growing market opportunity in urology and specifically also in prostate cancer. If you look at the data and look at the large market opportunity around prostate cancer across these six global regions, it's nearly 1.5 million newly diagnosed cases each year. This is a growing market. Based on The Lancet Commission on Prostate Cancer, which was recently published, this number will double to 2.9 million by the year 2040. In about 14 years, we'll see, over time, an increase in this disease state of diagnosis. When we talk about prostate cancer, we believe strongly Focal One answers an important unmet need for a large underserved patient population. As noted here, prostate cancer is a heterogeneous cancer. It's not one cancer, it's millions of cancers, and it's about stratifying patients by their risk classification. For low risk, a patient may receive no treatment or be on active surveillance, which essentially is a protocol. If you have high risk, you may be prescribed radical treatments to include surgery and radiation. As noted, there is a gap here in the middle, crossing low risk, intermediate risk, and into the category of high risk. That's what we solve for or answer with Focal One robotic HIFU as a first-line treatment. We're also a desirable treatment already written into the guidelines for salvage. That is, failures of primary radiation therapy where patients don't have a very good option based on a cancer recurrence. We feel strongly that there's a large population of patients that fit into this category. We look at the patient value equation, it's really important to understand what patients are looking for. If we look at active surveillance, we know active surveillance has a high quality-of-life preservation. It's not really a treatment, it's a protocol. But in terms of efficacy, because of it not being a treatment, it scores low. When we look at the treatments, surgery, which has been around for 100 years, and radiation therapy, they score high on efficacy, but they score low on quality-of-life preservation. If you think of where patients want to be, they want to be in the upper right quadrant. They want high quality-of-life preservation, and they want adequate cancer control and proven efficacy. That's where we believe Focal One delivers with targeted Robotic HIFU therapy. This is an important slide because it really shows what's happening in the market. The traditional market was primarily made up of three things. Surgery, radical prostatectomy, which is a radical surgery, active surveillance, and radiation therapy. We're now in the category of emerging markets, and this new emerging market itself is starting to appear, driven by HIFU therapy. The future market at maturity, as you can see, will be a large market opportunity for growth, meaning that we're going to be taking share away from surgery and radiation as patients demand a highly efficacious treatment that brings lower morbidity and higher quality-of-life outcomes. This is important data that was published from Medicare out of their claims report from CMS. If you look at the compounded annual growth rate between calendar years 2022-2024, what you see here is HIFU is growing exponentially. Surgery, radical prostatectomy, is flat and radiation therapy, brachy, and cryoablation are declining. Focal One is best-in-class technology. Focal One i was launched last year, 2025, in late April. It is a huge improvement on our platform, based on the following principles. We've expanded fusion capabilities to include the ability to bring in imaging from MRI, PSMA, PET, some of the AI tools in the market like Unfold AI, Oncoferia Prostate, biopsy maps from Koelis, DynaCAD, which is part of an ecosystem in terms of 3D biopsy. It improves on streamlined workflows. It has the ability to have video embedded into the system where you can record your videos, stream those videos, and is set up nicely for proctoring and telecollaboration. We've also made this system endometriosis treatment ready for markets where we have current approval or CE mark. Focal One core technologies are built around the following, HIFU, which is in our domain expertise, advanced imaging, robotics, AI, and also the ability to provide remote connectivity. Strong supporting clinical evidence today shows that the trifecta outcomes, which are what were benchmarked in terms of prostate cancer as a treatment, starts with cancer control. It also includes the important domain functional outcomes of maintaining urinary continence and preserving sexual function. There's been over a thousand peer-reviewed publications supporting use of HIFU in the treatment of prostate cancer. If you look at the data summation here, you can see on the left, we have cancer control, quality of life, and even patient burden. You know, we have to think about the patient here and those outcomes that affect those patients who are in fact treated. If you look on the left side, active surveillance, which essentially is a protocol, and on the right, whole gland treatments to include radiation, surgery, there's a gap in the middle here. This gap is what we fulfill or answer to in using Focal One robotic HIFU as an organ-preserving treatment. If you look at the data here, we're equivalent to the gold standard treatment starting with surgery, but also inclusive of radiation. We are far better on the functional outcomes in the notion that we preserve the organ. The risk of complications for our treatment with robotic focal HIFU with Focal One are actually very well. If I look at landmark studies, first the HIFI study, which was published in December of 2024, which is the largest study of its kind ever published. It's prospective, it's comparative, 46 centers, 80 physicians, 3,328 patients treated. 90% of the HIFU patients were treated with Focal One and the other balance with our other platform system, Ablatherm. So these are exclusive to EDAP TMS. If you look at the primary endpoint, we showed and demonstrated comparable cancer control as the primary endpoint, but we showed superior functional outcomes for HIFU versus surgery across preservation of urinary continence, the ability also to maintain those patients' erectile function. This has been a landmark study and is being now demonstrating, again, proven efficacy with use of Focal One. Additionally, the FARP randomized controlled trial, which is focal ablation versus radical prostatectomy, results from this landmark study were published last year or presented last year at AUA. Similar to the HIFI study, we showed similar types of outcomes, starting with cancer control. It was a non-inferiority study, and we showed cancer control at three years to be comparable to gold standard treatment of surgery. We were superior again on the functional outcomes after focal ablation versus surgery. The trial itself included 213 patients, but importantly to note, 25% of the patients who were randomized for surgery refused surgery. They wanted HIFU therapy. Another important paper, which was published in the International Urology and Nephrology Journal in October of last year, points to radiation. HIFU demonstrates equivalent 10-year survival as compared to radiation therapy. If you look at the data and the outcomes from this important study, there was lower mortality at 10 years post-HIFU as compared to external beam radiation therapy, 9.2% versus 16.7%. There was also a lower cancer-specific mortality after HIFU at 5.4% as compared to 9.2% for external beam radiation. On the front of being compared to radiation, we're showing excellent oncologic control. Turning our attention to hospital reimbursement and physician reimbursement, we're at category APC6 and demonstrated here the new payment mechanism went into place in January of this year and importantly increased another percentage point, 4.3%, for HIFU, CPT code 55880. What's important to understand here is that the payment here is getting very close to what surgeons would be paid for in performing surgery. Again, this is a Medicare payment number. This is not commercial insurance payers, which arguably will pay somewhere between 1.5x-2x. When we turn our attention to the physician payment for HIFU, CPT code 55880, HIFU awards a work RVU of 17.29, which is a strong payment for urologists who perform this treatment. It is notably very close in proximity, nearly $200 difference than what a surgeon is paid for surgery. We have a growing global installed base. Focal One is being adopted at major U.S. hospitals around the country, both academic and community hospitals. As you can see here, we have 87 Focal One systems installed as of December 31, 2025. 42 academic, 45 community hospitals. Focal One is now in some of the most top-rated cancer hospitals and academic centers in the United States. Mayo Clinic, Cleveland Clinic, MD Anderson, Memorial Sloan Kettering. Every University of California teaching hospital now has Focal One incorporated into their program. We're in Kaiser. We're in HCA hospitals. We have 10 hospital systems that have bought a second Focal One, so we're being widely adopted around U.S. markets. Here's our ranking among U.S. News & World Report. We're in 7 of the top 10 hospitals, as noted here. In the SUO, which is the Society of Urologic Oncology, we're in 22 of the 35. 63% of those programs now have incorporated Focal One Robotic HIFU, and we're in 55% of the National Comprehensive Cancer Network hospitals and growing. We're growing, and these numbers will continue to increase. When we turn our attention to the European market, we also have momentum building in Europe. As noted here, we have a number of centers throughout Europe that have adopted Focal One Robotic HIFU. Not only centers with fixed systems, but some centers that are serviced as clinical mobile sites, as noted here in the light blue dots. As we continue to build this market, we're seeing more momentum coming off at the European Association of Urology meeting, which was held in London this past week. We have 41 Focal One systems and 254 Focal One treatment clinical sites throughout the European market. Turning our attention to BPH and endometriosis. First of all, BPH we know is a very large market. 94 million global cases based on calendar year 2019. 15 million U.S. men are affected by BPH or lower urinary tract symptoms. 600,000 U.S. men aged 65 or older newly diagnosed annually. A large market opportunity for us to focus on beyond prostate cancer. As noted, we've been involved in a number of clinical studies. As noted here, a feasibility study, a phase 1-2 study, and we have an IRB-approved in a U.S. academic site that will be treating patients here the first half of this year. We also have two studies going on outside the U.S. We're excited about this, and we think BPH is another opportunity to use the same platform, Focal One, to treat a different category of disease. We're excited and we'll provide additional updates as we progress. Additionally, the U.S. endometriosis market or the global endometriosis market is quite large. These are data for the U.S. 66.5 million women are diagnosed with endometriosis. 20% of the cases are what we call deep infiltrating endometriosis, which are stage 4 endometriosis cases, and it affects 11% of U.S. women. We've been actively involved with a number of key landmark studies. We received last year in March, CE mark for use of Focal One for the treatment of deep infiltrating endometriosis. To remind everyone, the option for these women at stage four is typically a surgical procedure, a rectal resection, partial rectal resection, or also a serosal stripping procedure. If we can provide a frontline therapy that addresses their endometriosis and reduces the pain, we may save these women the morbidity of these more radical conventional treatments. We're excited about this. We have launched in Europe in a limited launch. We're training some new centers today, and we're excited for more progress throughout calendar year 2026. Key business trends. Looking at our momentum, this is the compound annual growth rate for calendar years 2021 through 2025. We've had 52% combined Focal One installation growth over these years and 44% on procedure growth. We continue to drive more new system placements and sales, but also do more procedures. Additionally, here's a breakdown of where the revenue is distributed. Today, we're arguably dominant with a lot of capital sales, but also as well disposables and treatment-based revenues. We also generate incremental revenue from service on new system sales. As you can see here, we're continuing to grow with a projection on the far right for calendar year 2026. Looking at the opportunity with Focal One, we talked about prostate cancer, a large growing market. We talked about BPH, and we also talked about stage 4 rectal endometriosis. 3 very large disease states that could be served with use of Focal One robotic HIFU. We're positioned for growth with large addressable markets now both in men's and women's health. We have a growing global install base of leading tier one academic and community hospitals with more sales coming each quarter. We have differentiated non-invasive robotic HIFU technology, which solves a notable unmet need for both prostate cancer, BPH, as well as endometriosis. We have a strong body of clinical evidence with favorable reimbursement in place, and a proven management team from industry-leading med tech companies such as Intuitive, Medtronic, Stryker, Boston Scientific, GE HealthCare, Johnson & Johnson, and others. Thank you. Okay. Gentlemen, thank you for the presentation. Ryan, you know, your comparative treatment outcomes for HIFU versus watchful waiting, that slide, I want to go into that. You know, as you go on in prostate cancer and, how do you define the key target physician or site, you know, that would be ripe? Are you looking for somebody just looking to expand their practice, or are you really going into de novo sites? Where I'm headed with this is a lot of the docs, you know, they're so ingrained in da Vinci prostatectomy. Help us understand how do you all make the calculus, "I need to go with this doc versus that doc for targeting or site for that matter. Yeah, great question, Suraj. So, you know, we obviously look at a lot of different data. We look at biopsy data. We look at the existing program. How many men are in that program under active surveillance? We have some large centers that have 1,000 or in some cases 2,000 men on active surveillance. That shows to me that they have a robust program, you know, knowing that these men will be monitored under this protocol, and many will convert to treatment. They'll convert to treatment for one of two reasons. One, disease progression, which can happen. At 5 years, you know, 40% to upwards of 50% of men will have some notable disease progression. What are they gonna progress to from no treatment being on a protocol to a radical treatment such as surgery or in the cases of radiation? We're in a new era of treatment, and, you know, we're able to provide, you know, again, a treatment that's highly efficacious that treats the cancer but preserves the quality of life for those patients. Many of the centers today when we think of, you know, targeting, we look at current centers that are leaders in treating prostate cancer. We coexist with da Vinci. There are some patients that do need surgery, but there's also many men out there who are better served with the use of focal therapy. I think we're really on the cusp of the explosion and growth of this market opportunity. You know, surgery's been around for over 100 years, as has radiation. Surgery is not organ preserving. You're still performing a radical surgery, a radical prostatectomy. You're cutting, you're suturing, you're creating traction injury, you're dissecting, you're reconstructing the urine channel at the end of the procedure, and it's still a radical operation. For many of these lower grade, low risk, indolent cancers or favorable intermediate risk patients, these patients will do far better with use of focal therapy and use of HIFU. I think today we see the market to coexist with surgery centers that already have da Vinci programs or do surgery, but there's also a number of hospitals even out in the community that are looking for where the market is going. As we say, skate to the puck. Is the puck moving to radical treatments, or is it moving away from radical treatments? I would argue we're moving away from radical treatments because we've overtreated disease for quite a period of time with radical treatments. Why we're able to demonstrate this today is because the advances in imaging. The fidelity of the prostate cancer biopsy has improved immensely. We're using things, you know, now that we weren't able to use 20 years ago, including genomic testing, to better risk stratify patients. We're really in a new era of emerging treatment. I will say, you know, that I attend a lot of scientific meetings. Focal therapy is one of the hottest topics, if not the hottest topic right now in prostate cancer. We fit right in that space with our technology. Fair, fair point. Ryan, your slide on FARP outcomes, if you look at the delta in sexual function, that was really eye-catching. Since the publication, have you all seen a tangible shift, in the growth trajectory, let's say, between HIFU versus DVP? Because that contrast is quite jarring, obviously, in favor of HIFU. Yeah. I think it goes back to, again, you know, surgery is removing the gland, cutting through things, and it's a radical surgery. We are preserving the organ and only treating the cancer. I think what we're seeing here is the benefits by leaving the organ in place undisturbed, but only focusing on treatment of the cancer itself. I think with the FARP clinical study, we're excited to see this. Just to remind everyone, it has not been published yet. It will be submitted this year and ideally published this year, 2026. It was presented in a number of scientific meetings to include AUA last year in Las Vegas in April, late April. We're excited for this one to come out. Now, a lot of people are asking for when it's coming out because it'll be a landmark paper as it is a randomized controlled trial. You know, these kinds of studies are hard to recruit for, as we know. What I like about it is it's a high level of evidence. The comparative is to a gold standard treatment surgery, and at the same time, it mimics or equals the patterns of outcomes we saw with the large HIFI study. That is, we are not inferior in terms of cancer control or oncologic control, but patients will fare better with preservation of sexual function and urinary control. What you don't see is the comparison and complications. I can tell you the complication profile for a surgery patient is going to be a lot different than a patient treated with robotic HIFU. Yep. Fair enough. Ryan, one last question for you, if I may. There's obviously Aquablation is a therapy that comes up regularly. It's on both sides of the debate, positive and negative now, and I'd love to get your take on Aquablation for BPH and within the realm. Obviously, they're doing a trial and PROCEPT is doing a trial in prostate cancer. Any of your thoughts would be appreciated. Yeah, my understanding of the study or trial they're doing in prostate cancer, most people I've spoken to mentioning that this is gonna be a whole gland treatment. That begins to, you know, open up a lot of questions. It'll be interesting to see what happens. I think, you know, there's been data published in the literature about use of Aquablation for treating BPH. There's been a lot of references to bleeding or delayed bleeding. Water is not very hemostatic at all. So it'll be interesting to see what comes out of that study. You know, equally, you know, we're anchored today in the area of prostate cancer. As noted in our presentation today, we are working forward with the activities around BPH. What's important to note there is when we've been treating prostate cancer patients, we've seen commonly that the urinary symptom scores improve for these patients, and that would make sense. We're ablating tissue inside the prostate gland that is commonly putting pressure on the prostatic urethra. If we can ablate those areas, predictably, with the studies that we're doing right now with BPH, we open up another market opportunity for us, in treating BPH. I'll leave the comments there. I don't know enough about their study, but I would say we're well positioned for the activities as described in looking at an expanded indication into BPH. Fair enough. Gentlemen, always a pleasure to connect with you guys. Yeah. Thank you for taking the time this morning. We look forward to continuing the conversation. Thank you so much, Suraj. Thank you. Thank you.