Good afternoon. My name is R. K., and welcome to the H.C. Wainwright Conference. And this afternoon, we're gonna have a company presentation by Ryan Rhodes, CEO of EDAP. And so to talk about EDAP, Ryan, please take it away. Thank you. Thank you to have us here, presenting today. A couple things to go over here. A company overview real quick, you know, EDAP, Focal One. EDAP, we are the global leader in the innovation and delivery of advanced ultrasound technologies for both the diagnosis and treatment of disease. As a company, we have three business divisions or three sources of revenue: our proprietary HIFU technology, led by Focal One, which I'll talk about throughout this presentation, advanced imaging, which includes our ExactVu twenty-nine megahertz, seventy micron ultrasound that's used in prostate biopsy, along with some other distributed products, and then, importantly, our legacy deep knowledge in extracorporeal shockwave lithotripsy, used for treating kidney stones. We've offered ESWL and developed products and distributed products for forty years in this space. So we have three distinct business divisions and three sources of revenue. On a global footprint, we have seven global subsidiaries to sell and distribute our products. In the U.S., an office in Silicon Valley, which is an office I'm from. We also have a distribution and operations center in Austin, Texas. We have office locations, primary location in Lyon, France, with additional offices in Germany and Switzerland. And then in Asia, we have offices and distribution in Japan, Tokyo, Seoul, Korea, and then in Malaysia, Southeast Asia. Turning our attention to growth milestone timelines. So when we talk about Focal One, we talk about the FDA clearance back in 2018. Three years following, we received our Category 1 CPT code, and then importantly, last year, January 1, we received an APC facility payment of APC 6. What this means is the Medicare reimbursement went up nearly 90%, and so some notable milestones. Below that are some milestones relevant to endometriosis, a new indication we are focusing our attention on. In 2022, we completed our phase II study. In 2024, this year, in January, we completed our phase III double-blinded randomized controlled trial, and then in March of this year, we had submitted and received an FDA Breakthrough Device Designation, which we're working through right now with the FDA. If you think of HIFU technology specific to EDAP or technologies we license, we have the ability to treat throughout the body. On the left side, you have prostate cancer, certainly a large addressable market, 1.4 million men. BPH, which I'll talk about today as well, a very large market, 11.3 million men. But in the middle category, other technologies we either developed or licensed our patents for, in the area of treating benign thyroid nodules, the ability to ablate solid organ tumors, to include those in for liver cancer and pancreatic cancer. And then on the far right side, the ability to treat breast cancer, at some future date, the ability to develop HIFU technology to treat benign conditions like breast fibroadenoma, and then, of course, rectal endometriosis. So there's a large, both incidence rate of cancer and non-cancer indications that are amenable for HIFU-type treatments. If we turn our attention to prostate cancer specifically, one thing we'll see is that it is a large addressable market. And as we look at the U.S. here, nearly three hundred thousand newly diagnosed cases each year, a million prostate biopsies performed. Sadly, to say, over 35,000 men dying from this disease, but I think importantly, the first bullet there, 3.3 million men are walking around and living with their prostate cancer. They're living with their prostate cancer, and if you wanna look further, this is the reality we're faced with. Prostate cancer is a heterogeneous cancer, and it's not a one-size-fits-all treatment. If men today are diagnosed with low-risk disease, they would be commonly prescribed active surveillance. If they're diagnosed with high-risk disease, they would be commonly prescribed surgery or radiation. What about men who fall into either intermediate risk or favorable intermediate risk as a category? They don't meet really the requirements to be on active surveillance, but they also would be overtreated with radical treatments such as surgery and radiation, and this is what we solve for with Focal One robotic HIFU. Additionally, on the far right side, salvage treatment HIFU. So patients who have primary radiation therapy, who have a recurrent cancer, what do you do for these men? They don't have a lot of great options. Surgery may be an option, but you're taking out a radiated gland. That's a hard operation. If you choose to re-radiate them, that presents other challenges, like radiation toxicity, risk of secondary cancers attributed to radiation, or even having that patient go on simultaneous hormone deprivation therapy. So HIFU is a really good option, and in fact, we're written into the NCCN guidelines as a salvage treatment. But why has this occurred today? It's occurred because the advances in imaging and the ability to perform an MRI-guided biopsy allow us to better risk-stratify patients, which leads us right into the discussion with focal therapy. If you look at the addressable market, and we're talking about the U.S., approximately ninety-five thousand plus procedures are out there in this market. Those come from first-line treatment, so that's time of diagnosis. The next bucket is, you know, patients who are on active surveillance who progress. We know at about five years, 50% of patients progress from active surveillance. What do they progress to? Many of those patients are better suited to have a focal ablation than going directly to an aggressive treatment, such as radical prostatectomy or surgery, and then, of course, there is a market segment out there for salvage treatment. So there really is a notable addressable market, and again, these are U.S. numbers. When you turn your attention to the global opportunity, first looking at prostate cancer in totality, it's nearly 1.5 million newly diagnosed cases each year. And here's a bit of a walk down from the various regions: Europe, Asia, North America, Latin America, Africa, the Oceanic region, et cetera. If you apply the same methodology to the U.S., you can see here, on a global basis, there's a large market opportunity for use of HIFU to treat these cancers. When we talk about prostate cancer treatment trends, it's important to understand the history of other treatments. If you look back at the history of treating breast cancer, back in the early days of breast cancer, it was about radical mastectomy, removing the woman's breast, pectoral muscle, and performing an extensive axillary dissection. This was highly morbid, it was very disfiguring, and led to lots of complications. That operation then was, years later, modified, as in the technique described here, modified radical mastectomy, which preserved the function of the pectoral muscle. Fast-forward today, it's all about organ-sparing treatments. A woman can have a lumpectomy and retain the integrity of her breast. And so if you look down below, with prostatectomy, open radical prostatectomy has been performed over a hundred years. The robotic approach, da Vinci, changed the way we do surgery, but we're still doing surgery. It's still a radical prostatectomy. We're cutting through the blood supply, the levator muscles, the neurovascular bundles in many cases, the bladder neck. It is still a big surgery. Today, on the right, we can serve a population of patients with robotic focal HIFU and keep the integrity of the prostate gland and score higher on the functional equation, which I'll talk more about. What's really important to understand is this emergence of the focal therapy market. It really is an emerging market. The traditional market has been served by active surveillance, surgery, and radiation. The emerging market is this new pie that is emerging here of focal therapy, and it's in play right now as we talk. It is here. It has arrived, and we can see better today where cancer is. We can better define its borders and look at better options to treat it, and that's why we're talking about focal therapy. But if you shift to the right, this market will be very large in size. It'll be as large as the standalone categories of surgery and/or radiation, and so it's an exciting future as we see this shift playing out in the treatment of prostate cancer. As you can see here, this is Medicare claims data that supports that hypothesis. In the years 2022 and 2023, you can see here surgery on a percentage basis, robotic prostatectomy surgery reducing, brachytherapy seed implant, radiation seed implants declining, cryoablation declining. The only category that's showing growth is HIFU, and we're just the beginning of this exciting story. HIFU is showing itself as the fastest-growing, new, emerging treatment option for men diagnosed with prostate cancer in the U.S. If you turn our attention to Focal One, we talk about best-in-class technology, and it really starts with the images, imaging advances that have been made in the last 10 to 12 years. We can see better than ever where prostate cancer is today, and that's thanks to MRI-guided biopsies, fusion biopsies, the ability to see the delineation around the tumor boundaries in a very precise and prescribed way. We can then turn our attention to using robotic ablation through technologies such as Focal One to ablate these tumors, and kill cells. The Focal One system itself is the most advanced platform in the market today. We have a five-axis robotic positioning system. We have an integrated fusion platform. We don't care where the imaging comes. It can come from their PACS system in the hospital. It can come from direct MRI marked-up images. It can come from 3D biopsy samples, come right into the machine. We set up the treatment plan in real time and then deliver that treatment. The dynamic focusing probe is a very proprietary part of the Focal One system. We have the ability to very purposely prescribe HIFU pulses in a very directed way, only to the areas we wanna treat. The system has built-in no-fly zones, as in the case of the rectal wall. It's an integrated workstation that can be moved amongst OR rooms and hospitals or outpatient centers. So it is a very capable platform. The U.S. installed base is growing. As demonstrated here, we have now 60 Focal One systems placed in the U.S., 21 in academic centers, and 29 in community hospitals. Sorry, that was 31 and 29. Anyway, we are in some of the top cancer hospitals of the world, right? Mayo Clinic, Memorial Sloan Kettering, we're in every University of California teaching hospital, on the West Coast, USC, MD Anderson. We're in Kaiser. We're in HCA accounts. We're growing on a quarterly basis, so we continue to penetrate more and more hospitals, as you can see on this map. We also, based on that map, show a deeper penetration set up. Seven out of the 10 best hospitals ranked by U.S. News & World Report run Focal One technology. Forty-nine, almost half of the Society of Urologic Oncology fellowship programs now are offering Focal One robotic HIFU, and we're in 42% of the National Comprehensive Cancer Network hospitals, 14 out of the 33. So we are growing and adopting an acceptance of the technology in multiple hospitals across the US. Turning our attention to reimbursement, we have very strong reimbursement. We received APC six-level payment in 2023, and we continued this year, 90% increase, and we expect to maintain that level six throughout this year. In the proposed rule, you can see here, there's a proposed 4.9% increase, and this is at the facility level, so very strong reimbursement as compared to other treatments. If you look at the professional fee, CPT code 55880, 17.73 work RVUs. And what's interesting here is that the RVUs here are only for the primary treatment. There are secondary billable RVUs for a confirmational re-biopsy and re-image of the prostate, typically given at 10 months, that are not captured here. Strong growing evidence. As noted, over a thousand peer-reviewed publications support HIFU in the treatment of prostate cancer. When we look at the outcomes, we look at the trifecta outcomes. One is providing adequate cancer control, two, maintaining urinary control of that patient, and three, preservation of sexual function. One of the most exciting clinical papers to come out is the HiFi Study, which is a prospective, multicenter, comparative study that involved treatment of 3,300 patients across 46 centers, and the primary endpoint was salvage free treatment survival, compared to the gold standard treatment of surgery, radical prostatectomy. We show equivalent cancer control outcomes, but we show superior functional outcomes by leaving the gland in place and only treating the cancer. We score very high on urinary continence, and we score high on preservation of erectile function post-treatment. This will be out in a peer-reviewed publication, likely by the end of the year. It's under review right now, and we'll see it published here, ideally in the next 60-90 days. The FARP Study was another study, but this is a level 1-A evidence clinical trial, was randomized, comparing focal ablation versus robotic prostatectomy. This study is still underway and will likely be published out a year or so. But these patients were randomized for HIFU ablation with Focal One, or surgery, as noted, radical prostatectomy. And again, we see a very similar pattern in terms of outcomes, equivalent oncologic control, and we score very high on the functional equation. BPH and endometriosis, again, very large market opportunities for expansion. When we think of BPH, we know it's a very large addressable market. Ninety-four million new cases on an annual basis, fifteen million men affected by BPH or lower urinary tract symptom scores, and six hundred thousand U.S. men aged sixty-five plus, newly diagnosed annually. So it is a large market opportunity, and we're excited as we look outward in kicking off a new study. So looking back, we performed a feasibility study involving nine patients. It was at a single center and really confirmed both the safety and the potential for improvement of patients' BPH symptoms. One thing we've noticed is when we've treated patients historically for prostate cancer, their lower urinary tract symptom scores improve. So we believe we have an opportunity here. So we've kicked off a combined phase one and two study. We're currently enrolling, and we'll be treating patients the end of this month, September. It is a phase 1 study to really look at dose escalation. That is the amount of power and energy that we want to apply. And then phase 2 is really looking at, you know, treatment parameters as defined based on the power settings of HIFU. And so our goal here really is to take the study here, take the outcomes, finish enrolling this, and then being able to publish some data on this combined phase 1, phase 2 study. So we're very excited about BPH. Turning our attention to endometriosis, we know this is a very large disease state, affects 1.3 million women. 11% of U.S. women suffer from this disease. We have completed three studies, and we're following up on these patients now. One thing we're doing right now is we'll be back in front of the FDA here before the end of the year, and we're excited about presenting more updates on where we go with endometriosis. Key financial data, again, we see continuing growth in revenue on a year-over-year basis, notably here, 5.2% year-over-year growth, driven primarily by HIFU, and then we continue to maintain a strong balance sheet and with little to no debt. I'll stop there. Thank you.