Edap Tms S.a. (EDAP) Q4 2024 Earnings Report, Transcript and Summary

Good day, everyone, and welcome to today's EDAP TMS Fourth Quarter and Full Year 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note today's conference is being recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to John Fraunces. Please go ahead.

Good morning. Thank you for joining us for the EDAP TMS fourth quarter and full year 2024 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer; Ken Mobeck, Chief Financial Officer; and Francois Dietsch, Chief Accounting Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain forward-looking statements, which include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. I'd now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Thank you, John, and good morning, everyone. I'm pleased to report another strong fourth-order performance which reflects our continued success in establishing Focal One as the leading robotic HIFU technology used by urologists in the management of prostate cancer. But before discussing our strong performance, I would first like to share some very good news that we received just yesterday. As mentioned in today's press release, Focal One Robotic HIFU has just received CE Mark for the treatment of deep infiltrating endometriosis. As a reminder, deep infiltrating endometriosis impacts a notable subset of women diagnosed with endometriosis. More specifically, it is a severe chronic inflammatory disease affecting young women in reproductive age and is also recognized as the most aggressive form of this disease. Deep infiltrating endometriosis is located in the posterior area of the pelvis, infiltrating the rectum and surrounding structures causing chronic symptoms including both pelvic and digestive pain. This disease is also commonly associated with increased risk of fertility disorders. Endometriosis has a profound effect on psychological and social well-being and imposes a substantial economic burden on society. This CE mark represents a significant regulatory milestone that allows us to proceed with a controlled market entry while we continue to work with endometriosis experts and thought leaders to further refine and expand our clinical development efforts for addressing this severe and debilitating disease. We also believe this milestone represents the first step in enabling women to gain access to this important non-invasive treatment alternative to surgical intervention, which is associated with notable complication side effects and extended recovery times. Now turning our attention to our financial performance in the fourth quarter. Our core Focal One HIFU business continued to experience strong growth. We reported HIFU revenues in US dollars of $9.3 million, increasing by 15% year-over-year, reflecting continued Focal One adoption and strong year-over-year procedure growth. Total worldwide revenue in US dollars was $21.5 million in the fourth quarter, representing a 1.1% growth on a year-over-year basis. And on a full-year US dollar basis, our 2024 global HIFU revenue was 15.3% over 2023, which again reflects the underlying strength in growing demand for Focal One by an increasing number of urology centers. EDAP reported full year 2024 worldwide revenues in US dollars of $69.2 million, representing growth of 5.7% over 2023. In the fourth quarter, we recorded a record global number of Focal One systems at 11 sales, which included US sales of seven systems and additional sales in OUS markets. Of note, two of the seven US sales included operating lease conversions, one from Brigham and Women's Hospital in Boston and the other from St. David's Hospital in Austin, Texas, part of HCA Healthcare, the largest network of hospitals in the United States. These conversions from operating leases to cash purchases reflect the strength and adaptability of our Focal One commercial strategy. Focal One also continues to expand its presence in the US in the fourth quarter. We placed our first Focal One systems in the states of Arkansas, Idaho, and Georgia. A Focal One system is now installed in over half of all states, and we expect this percentage will continue to grow. We also made notable sales in the outside US markets during the fourth quarter. We sold a system in Dusseldorf, Germany, while also selling our first Focal One systems in both Portugal and Turkey. As we look outward, our pipeline remains strong and growing, with an increasing number of community hospitals looking to acquire Focal One technology. Turning our attention now to procedures, Focal One procedures, we continue to see growing strength with the number of procedures in 2024 growing approximately 51% over 2023. And during the fourth quarter, US Focal One procedures grew approximately 31% on a year-over-year basis. This positive trend in procedure volumes tells that a growing number of urologists in the US continue to adopt Focal One as an important treatment option for delivering targeted focal therapy to their early-stage prostate cancer patients. We also believe the recent publication of the landmark HIFI study in European Urology will help drive additional Focal One procedure growth, particularly as a first-line treatment option. As a reminder, the HIFI study is the first perspective, multi-center, non-inferiority comparative study evaluating HIFU and radical prostatectomy in the management of localized prostate cancer as a first-line treatment. HIFI was a seven-year study that involved a total of 3,328 patients across 46 centers. Results from the study demonstrated Focal One’s excellent oncologic control while also highlighting the procedure's significantly better functional outcomes with respect to the preservation of sexual function and urinary contents when compared to radical prostatectomy. It's important to note that European Urology has the highest impact factor amongst scientific journals focused in the field of urology. We therefore believe that the publication of these important and positive results from such a large study in this widely read and respected journal will drive awareness and accelerate adoption of Focal One. Over time, we believe the HIFI publication could have positive implications in two key areas of our business. First, we believe the study may help advance treatment decision guidelines by potentially expanding Robotic HIFU into the first-line treatment setting. Secondly, results from the HIFI study could further help accelerate future policy level coverage for the Focal One procedure. Larger rigorous clinical studies such as HIFI provide the type of clinical evidence that health insurance plans typically require before establishing a policy-level coverage for a new treatment. Over time, we expect to see this dynamic to play out with Focal One, which will help drive greater patient access as well as facilitate procedure reimbursement to physicians and hospitals. For those of you interested in learning more about the HIFI study, I would encourage you to visit the website hifistudy.com which provides an excellent summary of clinical data from this seminal clinical trial. I will now provide a brief update on Focal One reimbursement. As noted on our prior call, HIFU procedures continue to be supported with favorable reimbursement from the Centers for Medicare & Medicaid Services. CMS finalized its 2025 Medicare hospital outpatient payment rate of $9,247 as a national average for the adjusted corresponding local wage index factor. This rate went into effect on January 1st and represents a 5.4% increase over the 2024 payment amount. More recently, at the beginning of 2025, the American Medical Association released a new CPT Category III code for use of trans rectal HIFU for the treatment of benign prosthetic hyperplasia or BPH. This new code is scheduled to take effect on July 1st and will enable hospitals and ambulatory surgery centers to file claims to Medicare and commercial payers for BPH procedures utilizing Focal One robotic HIFU. Longer term, we view this as a positive development with respect to enabling the use of ultrasound guided transrectal HIFU for the treatment of BPH. As I will discuss later in this call, we have entered into both a clinical study and development program to evaluate Focal One for the treatment of BPH. And we are excited about the potential to address this large and underserved market. Turning to our clinical development progress, we continue to make significant progress advancing Focal One Robotic HIFU beyond prostate cancer. In January, we announced that the first patient had been treated in the PULS trial to evaluate our proprietary HIFU technology for the treatment of pancreatic tumors. The PULS trial is a combined Phase 1, Phase 2 multi-center study for patients with locally advanced and unresectable pancreatic tumors. The Phase 1 part of the trial is evaluating the tolerance of intraoperative HIFU intervention on the pancreatic lesion. The Phase 2 part of the study will then evaluate the preliminary efficacy of the HIFU intervention. As a reminder, pancreatic cancer has one of the highest mortality rates with a five-year survival rate across all stages of only 11.5%. Early detection and treatment are essential towards improving patient outcomes and through the initiation of the PULS trial, we are demonstrating our commitment to develop new innovative treatment approaches by leveraging our proprietary ultrasound technology to address an area of significant unmet need. As referenced earlier in our supportive activities for BPH in October, we announced that the first patients were treated in a combined Phase 1/2 study evaluating Focal One Robotic HIFU technology for the treatment of BPH. This Phase 1/2 study is a company-sponsored prospective multicenter trial designed as a two-part study. Part 1 of the study is taking place at three leading BPH centers in France, each with recognized expertise in the use of Focal One HIFU. Part 1 is designed to define the optimal treatment parameters to effectively treat BPH and its related symptoms with minimal side effects. Part 2 of the study will expand patient enrollment across a larger number of treatment centers in order to validate the safety and efficacy of the parameters as defined in the first part of the study. As I mentioned earlier, BPH represents a large disease state which impacts millions of men each year. HIFU therapy offers the opportunity to introduce a less invasive approach towards treating BPH by better preserving and protecting the integrity of the urethra and other critical structures. Focal One could therefore be ideally positioned to deliver this type of treatment solution for BPH and represents a logical next step in expanding our HIFU technology beyond prostate cancer. Turning our attention to endometriosis. In November, at the 2024 American Association of Gynecological Laparoscopists Global Congress, we announced clinical data comparing Focal One HIFU versus surgery for the treatment of deep infiltrating endometriosis. The objective of this study was to compare treatment with HIFU versus surgery by evaluating treatment related symptoms and morbidity for the management of rectal endometriosis. This trial was designed as a comparative retrospective multi-center study that reviewed treatment outcomes of 120 patients taken from two prospective databases. The first cohort comprised 60 consecutive patients from the Endo-HIFU-R1 Phase 2 study. These patients underwent a Focal One HIFU treatment of their deep infiltrating rectal endometriosis lesions at four different centers. The second cohort was comprised of 60 patients from a large surgical database with complete surgical excision of their endometriosis lesions. The presentation was delivered by Professor Gil Dubernard, principal investigator of the study and acting head of the gynecology department at Croix-Rousse University Hospital in Lyon, France. When compared to surgery, patients treated with Focal One HIFU showed positive outcomes with a reduced rate of complications, shorter operating time, and a reduction in the length of hospital stay. Additionally, the frequency of both moderate and severe post-operative complications was significantly lower after treatment with HIFU as compared to surgery. We believe these findings suggest that the use of HIFU has the potential to become an alternative to surgery in select patients with rectal endometriosis and we continue to see this as an important opportunity to address a significant unmet need in women's health. As a reminder, last year, the Focal One platform was granted breakthrough device designation by the US Food and Drug Administration for the treatment of deep infiltrating endometriosis, which reflects the agency's recognition and the need to develop new and improved treatment options for this painful and debilitating condition. I would now like to briefly discuss some of our recent strategic collaborative activities. In November, Meridian Hackensack University Medical Center, or HUMC, announced the first prostate cancer treatments with Focal One Robotic HIFU using the Philips DynaCAD urology platform. Dr. Kevin Basralian, Director of Diagnostic and Focal Prostate Cancer Therapies at HUMC, and Dr. Nitin Yerram, Director of Urologic Research and Co-Director of Urologic Oncology for the John Theurer Cancer Center at HUMC, performed these first groundbreaking treatments combining Focal One Robotic HIFU with DynaCAD. Philips DynaCAD is an advanced post-processing imaging system for prostate MRI analysis that offers a comprehensive set of tools for real-time analysis, review, and reporting of multi-parametric multi-vendor MRI studies. By combining the Focal One and DynaCAD systems, we are thus enabling urologists to now operate precise and integrated approach from diagnosis to treatment customized to every prostate cancer patient. In February, EDAP and Cortex AI announced the successful completion of the world's first OnQ Prostate assisted Focal One Robotic HIFU procedure at the University of California San Francisco Prostate Cancer Center. As the only FDA cleared solution for restriction spectrum imaging MRI, OnQ Prostate provides more detailed information about the tissue microstructure that can help urologists identify which patients are the best candidates for focal therapy. This collaboration demonstrates our commitment to expand the capabilities of Focal One to assist urologists in delivering a precise, customized treatment solution for their prostate cancer patients. With these collaborations, we continue to demonstrate why Focal One is the most compatible, scalable, and sought-after technology platform for focal therapy. I would now like to discuss our recent scientific conference activity. We recently attended this year's annual European Association of Urology scientific meeting which was held from March 21st to the 24th in Madrid, Spain. EAU is Europe's largest scientific meeting focused exclusively on urology and therefore represents one of the most important events for us to discuss, the Focal One platform with many leading urologists. This year, we had our largest presence ever at this meeting while engaging with many of the leading urologists who attended throughout Europe as well as other countries from around the world. Throughout the meeting, EDAP offered numerous hands-on simulations with Focal One, while also discussing the treatment implications from the recently published landmark HIFI study. The feedback we continue to receive from the global urology community is uniformly positive and again points towards a broad-based adoption of Robotic HIFU as an important and necessary treatment option for prostate cancer. We also attended the annual Society of Urologic Oncology meeting, which took place from December 4th through the 6th in Dallas, Texas. The annual SUO meeting is a highly prestigious medical conference that attracts some of the most renowned researchers and physicians specializing in prostate cancer. There are now 35 SUO-approved fellowships in the United States, and I am proud to note that we have established Focal One in over 50% of these institutions. Of note, in the fourth quarter, we added another SUO fellowship program with the addition of Loyola University Medical Center in Chicago, which has one of the largest prostate cancer practices in the United States. By establishing a strong presence within these fellowship programs, we can accelerate both the training and adoption of the next generation of leading urologists, which reinforces Focal One as the necessary treatment option within a comprehensive urology practice. Looking ahead, we plan to have our largest presence ever at this year's annual American Urological Association Meeting, which takes place from April 26th to the 29th in Las Vegas. The AUA is the largest meeting in the world focused on urology, and we anticipate a significant number of presentations highlighting the growing body of clinical data that's being generated from Focal One HIFU procedures. In front of the AUA meeting, we have partnered with urology team from the University of Southern California to hold the first ever master class on Robotic Focal HIFU for prostate cancer. We are the sole sponsor of this event and Focal One is the exclusive technology presented during the program. This unique event will be led by world-renowned expert faculty and will feature several live Focal One procedures along with offering hands-off Focal One simulations for attendees. This event will take place on April 24th and 25th in Los Angeles, two days in advance of this year's AUA meeting. Before turning the call over to Ken to review our fourth quarter financial results, I first want to provide an update on our overall corporate growth strategy and how we see our business continuing to evolve. First and foremost, our business model is focused on entering high growth market opportunities where we have a distinct and sustainable competitive edge. This is why our leading Focal One platform is the cornerstone of our company's growth strategy. Through the Focal One platform, we are now able to deliver this valuable and proprietary technology into large and underserved patient populations around the world. Starting with prostate cancer, Focal One is addressing a significant medical need by providing a treatment option that lies between active surveillance and radical therapy. As Focal One continues to grow in the prostate cancer market, we are also making significant progress advancing Robotic HIFU in two additional disease areas, endometriosis and BPH. These two additional indications represent large and underserved patient populations who are less invasive and highly targeted treatment approach using Robotic HIFU technology as a potential to deliver improved patient outcomes. Based on these market dynamics, we believe Focal One is well positioned for strong and sustainable long-term growth. As we continue to build and invest in Focal One, we also intend to reduce our future investments in EDAP's lower-growth, low-margin businesses. Regarding the ESWL division, we have made the decision to stop selling the Sonolith i-move lithotripsy product line. Final system sales are currently scheduled to conclude in the second half of calendar year 2025 and going forward, we will continue to support our install base. And thus, in addition, we've also continued to reduce our investments in our legacy distribution business. As you know, we've also been steadily transforming EDAP to become a more agile and efficient organization that is able to execute on this high growth strategy. An important component of this transformation has been the careful selection of new Board members, each of whom brings a unique set of skills and experience to help guide our strategic decision making. We recently announced the appointment of two new Board members, Glen French and Joshua Levine. Glen is a highly experienced public and private medical device and technology executive who has spent more than 25 years developing commercializing diagnostic and therapeutic products. He co-founded, built, and sold three medical device companies and took a fourth company public. Josh Levine is also an accomplished executive in the medical device and technology sector who has an outstanding track record of growing shareholder value by focusing on transformative high-growth business strategies. As we execute on our growth strategy, Glen and Josh will play an integral role in helping shape our strategic vision and execution as we are excited to have them as new members of our Board. I will now turn the call over to Ken, who will review our fourth quarter financial results and also touch upon potential implications from the recent US tariff activity.

Thanks, Ryan, and good morning, everyone. I will briefly review the full year 2024 performance before getting into greater detail on our fourth quarter results. Please note that all figures except for percentages are in euros. For conversion purposes, our average euro dollar exchange rate was $1.058 for the fourth quarter of 2024. EDAP set a calendar year record for revenue in 2024. Total revenue for the full year of 2024 was EUR64.1 million, an increase of 6.1% as compared to total revenue of EUR60.4 million for the full year 2023. The increase in revenue was due to higher revenue in the HIFU segment versus the prior year. Notably, we reported HIFU revenue of EUR23.8 million, representing growth of 15.7% year-over-year, which reflects both an increased number of Focal One placements as well as procedure volumes that grew approximately 51% year-over-year in the US. Now, I will review our fourth quarter results. Total revenue for the fourth quarter of 2024 was EUR20.3 million, an increase of 3.6% as compared to total revenue of EUR19.6 million for the same period in 2023. The increase in revenue was due to higher revenue in the HIFU segment, which grew 17.9% year-over-year. Looking at revenue by division, total revenue in the HIFU business for the fourth quarter of 2024 was EUR8.8 million as compared to EUR7.5 million for the fourth quarter of 2023. The increase was driven by 11 Focal One systems sold in the fourth quarter of 2024 versus 10 systems sold in the fourth quarter of 2023, as well as year-over-year growth in disposable revenues of 28.5%. Total revenue in the ESWL division for the fourth quarter of 2024 was EUR2.4 million as compared to EUR2.3 million for the fourth quarter of 2023. The lithotripsy business experienced nominal growth during the quarter and as previously discussed, system sales will conclude in the second half of the year and the focus will be on supporting the existing customer base on a go-forward basis. Total revenue for the distribution business for the fourth quarter of 2024 was EUR9.1 million as compared to EUR9.9 million for the fourth quarter of 2023. The decrease in distribution revenue was driven primarily by product mix. Gross profit for the fourth quarter of 2024 was EUR9.1 million compared to EUR8.6 million for the year-ago period. Gross profit margin on net sales was 44.8% in the fourth quarter of 2024 compared to 43.7% in the year-ago period. The increase in gross profit margin year-over-year was primarily due to higher revenue in our HIFU division, which drives higher gross margin. This included a higher number of Focal One system sales in the US, including the conversion of two operating leases to capital leases. Operating expenses were EUR12.8 million for the fourth quarter of 2024, compared to EUR12 million for the same period in 2023. The modest increase in operating expenses was primarily due to focused investments in our HIFU business segment, as well as variable compensation. Operating loss for the fourth quarter of 2024 was EUR3.7 million compared to an operating loss of EUR3.5 million in the fourth quarter of 2023. Excluding the impact on non-cash share-based compensation, operating loss for the fourth quarter would have been EUR2.8 million compared to an operating loss of EUR1.8 million in Q4 2023. Net loss for the fourth quarter of 2024 was EUR1.9 million or EUR0.05 per diluted share, as compared to a net loss of EUR5 million or EUR0.14 per diluted share in the year period. Inventory decreased to EUR18.5 million in Q4, as compared to EUR21 million at the end of Q3 2024. The decrease in inventory levels was due to focused efforts to more effectively balance our demand and supply base. Total cash and cash equivalents at the end of Q4 was EUR29.8 million as compared to EUR25.5 million at the end of Q3, 2024. The increase was driven primarily by additional short and midterm borrowings and strong working capital management. We continue to monitor our cash closely, focusing on working capital management while prudently balancing the need to invest and grow in our HIFU business. Given the potential changes surrounding tariff policies by the new US administration, I want to briefly touch on this issue. As you know, approximately 80% to 90% of our Focal One components come from France, and 100% of the Focal One system is assembled in France as well. Based on our latest assessment, there does not appear to be any material issues impacting on our business. In addition, historically there have been exemptions from tariffs for certain goods related to the medical device area. We will continue to monitor this dynamic very carefully. I would now like to turn the call back to Ryan for closing comments.

Thanks, Ken. With our increasing strategic focus on our higher growth HIFU business, I would now like to provide our outlook for 2025. Following our strong fourth quarter performance, we believe our HIFU business is well positioned for continued growth based on the growing demand for Focal One, continued strong procedure growth, and a strong pipeline of new business opportunities. In 2025, we expect HIFU revenue to grow between 16% and 25% on a year-over-year basis. As previously discussed, given our position of becoming a pure play market leader in therapeutic HIFU, we expect our non-core ESWL and distribution business to decline between 20% and 25% in calendar year 2025. As noted earlier, we continue to see a strong and positive reception of the landmark HIFI study across the urology community, which we expect will further help drive demand for Focal One in 2025 and beyond. It is increasingly clear that Focal One is gaining more recognition as a necessary treatment option for the management of prostate cancers and is now poised to become a mainstream technology that enables a highly efficacious, less invasive, and safer treatment approach for addressing early and intermediate stage prostate cancer. With that, I will now turn the call back over to the operator for questions. Operator?

[Operator Instructions] We'll take our first question from Michael Sarcone with Jefferies. Please go ahead.

Hey, good morning and thanks for taking the questions. I guess just to start, thank you for some of the guidance on the HIFU sales growth. I think you said 15% to 25% year-over-year. Do you think you can give us a little more detail around what's baked in there from a systems placement standpoint and procedure growth standpoint?

Yeah, we will expect to see, again, continued demand for Focal One. As noted, we've had sales both in the US and certainly outside the US markets. Our pipeline has been the strongest and healthiest it's ever been. And again, we'll obviously see continued increase in Focal One system sales, so that's a driver. We do generate recurring revenue both from procedure, so obviously procedure growth. And the other, Michael, is our service revenue based on our install base. So again, further demand on Focal One systems, again, procedures growing across our install base, and then of course service-based revenue. All of that contributing to our projected growth here in 2025.

Got it. Thanks, Ryan. That's helpful. And then just around the, called the non-core ESWL and distribution business, I mean, is the intent that over time these basically phase down to zero? I guess how rapidly do you see these decelerating over time?

Yeah, so when we look at the, you know, we'll call it non-core distribution products, these are legacy regional-based agreements and relationships that we are transitioning over across different timeframes. So again, this impacts down to the subsidiary level. So again, I think we're at the beginning of redirecting our attention, certainly, away from some of these areas of focus. I can't really project if it goes to zero, but certainly, we are winding down some of this business to allow more defined focus on our high growth HIFU business. And again, it's based regionally and it's not necessarily product specific.

Yeah, and Mike, I'll just add another comment. So we talked about our lithotripsy business and we will stop selling units here second half of the year. That business will continue as a service business and from a service perspective in lithotripsy, that margin is actually a little credo versus the system margin. So even though revenue will go down, we will see margin pick up a little bit.

Got it, and then just squeeze one last in there. What kind of impact do you expect this to have on your run rate, OpEx?

Yeah, so, good question. So when I look at OpEx next year, we gave directional guidance here on system revenue. I would see OpEx pick up a little bit in the mid-single-digits but what we're really trying to do is some of those businesses that are ramping off, it will have a positive impact on some labor costs, of which, it'll be nice that we can reallocate some of those dollars to HIFU growth without you know making major investments in the business going forward.

Got it, thank you.

Thank you. And we'll take our next question from Jason Bednar. Please go ahead.

Hey, guys. This is Joe on for Jason. Thanks for taking the questions. Kind of a higher-level question on the capital environment here. Do you mind just walking through how you kind of characterized the capital equipment purchase patterns from hospitals so far during ‘25? Would you say they're improving off 2024 levels and are capital sales cycles and decision-making processes kind of still elongated? Thanks.

Yeah, so again, when we look at our active pipeline accounts, obviously that group of accounts continues to grow amongst our sales teams. The sales cycle times still remain kind of how they are and we've adjusted strategy to be more effective in working through these various processes. Again, they vary by hospital. But I also remind everyone we sell a clinically necessary strategic revenue enhancing service line in the number one cancer diagnosed in men. And I know that's a mouthful, but that means something to a hospital. We're anchored in prostate cancer today with the ability to expand out in the future into new indications. So, again, thinking about our core business today, we've been better adapted to working through [that] (ph) committees and whatnot to be able to close deals in a timely manner. And certainly, it could be an exercise of math, right? You need a larger pipeline to be able to activate accordingly, looking at quarterly sales. And we've really adjusted our strategy as noted. So I feel very confident in the things we're doing out there to build our market, build our business. And again, we expect to see notable growth here throughout 2025.

Great, thanks. And then one more just on the reimbursement side of things. So, as you mentioned, CMS reimbursement was increased when effective, Jan 1. Have you seen, like, any uptick in incremental interest from hospitals from adopting Focal One just since that reimbursement went effective a few months ago? Thanks.

Well, yeah, it certainly helped us. Again, we've been -- the last couple of years, we work effectively with hospitals when they pull together a pro forma analysis, right, looking at adding this important treatment to their cancer-aligned services. So when we go through that process, we do analysis with them and you can imagine the prostate cancer patient is very valuable to a hospital. It's not a patient that they would like to lose. It would be a patient they would like to attract in terms of services. So again, the increase of 5.4%, I think it helps us a lot more in those pro forma analysis. Again, we're at APC level 6. And the bigger story is it allows more patients access to our technology with that reimbursement in place. And if you look at compared to other treatments, we're in a strong position for reimbursement. And again, the increase that went into effect January only helps us. We'll see throughout the calendar year the impact of that. But again, as we noted, or as I noted, we sell something that is clinically necessary today to answer to. That is the growth and acceptance and adoption of focal therapy. And we've got best-in-class technology to offer our customers.

Great. Really appreciate it.

Thank you.

And next we'll go to Swayampakula with H.C. Wainwright.

Thank you very much. Good morning, folks. This is RK from H.C. Wainwright.

Good morning.

Good morning. So I got started on the call a little bit late. I'm just trying to understand your strategy on endometriosis, especially to how soon can you start commercializing on it? What's the strategy there in terms of getting the CE mark?

Yeah, so RK, again, we just got word that and awarded this CE Mark for Focal One for treating deep infiltrating endometriosis. So really, what it really allows us right now, we're continuing to expand our efforts in terms of working with endometriosis experts and very important key thought leaders to really further refine and expand our clinical development efforts as we look at a kind of a Phase 1 launch, call it. And so we're really in that early process now. We expected and anticipated getting CE Mark, but again, here that we're limited in the CE Mark countries, which is a notable number of countries, approximately 26, we have freedom to operate and being able to offer this treatment to women. And I know there is a growing interest of folks out there that want to see this technology advance. And we're working with experts right now. And again, it's early, but it's exciting, because now this doesn't hold us back, receiving the actual formal CE Mark. So we'll be working accordingly with expert physicians. We've got some activity that we've been involved in since we've done our original clinical studies, and we continue to work down that pathway. And we will be able to share more with you in the near future.

Thank you for that. And then when you are talking through the pancreatic tumor study, I know you just started the study, so when do you think we can start seeing some data and also what sort of -- in what geographies are you doing the current, I mean, the PULS trial?

Yeah, so the study is a -- it's a small study of patients who are early in patient recruitment. We have treated, I know, I think we treated at least our first patient because we put that announcement out. We're further working with the institution around patient recruitment. So, I'd say we're early in that process. The study itself is being conducted locally in France with some of our centers that we've worked with in the past. And a lot of the development work in pancreatic cancer, or I should say, solid organ tumor ablation using HIFU, is transcended over a number of years here. And now we're at that study phase. So we're excited for the opportunity to look at another potential new indication. And again, I think on a macro level, HIFU is early in its overall adoption cycle, meaning that we would expect to see HIFU emerge throughout treating other soft tissue disease throughout the body. We know that. And so I think this just gives us another one of those opportunities. And again, I don't have a lot I can comment on other than we're early in this clinical trial or running here locally in France.

Okay, thanks for that. And then, just going back to your guidance on the HIFU revenue of growth of 50% to 25% year-over-year, I'm trying to triangle it that with the increased reimbursement dollars. You said there's about a 5.4% increase in the 2025 rate, plus getting a better -- I mean getting a code on the BPH starting from July 1st, how much of that was taken into account for the revenue growth? Or your expectation is purely on what you're seeing in the pipeline and the needs that you have currently?

Great question. So, it is really directed toward our core business. That is ablation of prostate tissue or focusing on prostate cancer. So it's not taking into consideration BPH and some of the other things we're working on. We see our core business, and we're so early in this market adoption with so much potential upside that, again, we've been conservative in our approach to looking at these models, we want to provide some range of guidance and that's what we've done here. So yeah, it's really really focused kind of on our core business today and really based on a snapshot of our active pipeline. And of course, we're committed throughout the organization both in the US but certainly in outside US markets, building our pipelines as well in those markets. As referenced last quarter, we sold our first systems both in Turkey and Portugal. So, we're entering new markets, and we'll continue to do that, I believe, throughout 2025.

In our case, this is Ken, the other thing I've asked is, as our install base grows, right, and our systems come off the warranty, the contract revenue will kick in and then obviously as doctors build their practice, right, and their customer base grows for the HIFU procedure, that's going to obviously draw more disposable sales which will increase other lines of revenue between system procedures and service.

Okay. Thank you very much, Ryan and Ken, for answering all my questions. Thank you.

Thank you. And that does conclude our question-and-answer session. I'd like to turn the call back over to Ryan Rhodes for any closing remarks.

I want to thank everyone for joining us today on today's call. And we look forward to seeing you at the upcoming AUA Conference or later in the year at the Jefferies Healthcare Conference in June in New York City. Thank you all.

Thank you. Ladies and gentlemen, that does conclude today's conference. We appreciate your participation. You may disconnect at any time.