EDAP TMS S.A.

Good afternoon, everyone. Welcome to today's Vocal Therics second quarter 2026 conference call. At this time, all participants are in a listen-only mode. After the prepared remarks, you will have the opportunity to ask questions during the question-and-answer session. To register to ask a question at any time, please press star 1 on your telephone. If you would like to remove yourself from the queue, press star 2. And please note, today's call is being recorded. It is now my pleasure to turn the meeting over to Ms. Louisa Smith from Gilmartin Group. Please go ahead, ma'am.

Good afternoon. Thank you for joining us for the Focal Therix Second Quarter 2026 Financial and Operating Results Conference Call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, and Ken Mobeck, Chief Financial Officer. Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and involve risks and uncertainties that could cause actual results to differ materially from those anticipated. We direct you to the risk factors section of our most recently filed annual report on Form 10-K, for the year ended December 31st, 2025 as filed with the Securities and Exchange Commission as well as our other filings with the SEC for a description of factors that may cause such differences. These statements speak only as of today's date and we undertake no obligation to update or revise them except as required by law. Additionally, this call is being recorded and constitutes a public disclosure for purposes of regulation FD. I would now like to turn the call over to Chief Executive Officer Ryan Rhodes.

Thanks, Louisa, and thank you all for joining us on our call today. Before I turn to our second quarter results, I want to take a moment to frame up today's call. We view this as a transformative moment in the evolution of our company's history, including the transition of our name from EDAP to Focal Therix, as a pure-play, high-growth, market-leading focal therapy company. In the first half of this year, we have completed the steps necessary to become a U.S. domestic filer, and we are now reporting our business in U.S. dollars. Initially this quarter, we moved our ESWLN distribution businesses to discontinued operations to further establish clarity in our financial reporting in alignment with our strategic priorities. and now with recently announced equity offering, we believe we are fully capitalized to drive meaningful growth while penetrating our large addressable markets and thus becoming a breakout success story within the healthcare landscape. Our team is encouraged by the notable progress we have made today and we're even more excited by the large global opportunity that lies ahead for Focal Derricks. I am more confident than ever that we are positioned to emerge as the market leader in the growing category of focal therapy, along with our ability to create durable shareholder value. Now turning to our results. We delivered another strong quarter with $13.2 million in HIFU revenue, representing 39% year-over-year growth. We recorded 13 focal one capital system sales in the second quarter, A 44% increase, making this our best second quarter ever for Haifu Capital Systems sales globally. Our total worldwide install base now stands at 184 systems, with 96 in the U.S. and 88 internationally, reflecting the continued broadening of our global commercial footprint across hospitals in both academic and community settings. In the U.S., we recorded eight capital system sales, including two conversions from existing operating leases at Vanderbilt University Medical Center and the University of Michigan, both of which are NCCN member institutions, NCI-designated comprehensive cancer centers, and SUL-approved fellowship programs. Adoption of leading academic institutions such as these allows the next generation through their accredited fellowship programs, which we believe helps build broader clinical awareness and scale as those surgeons move into clinical practice. We now have 15 U.S. hospital networks that have invested in two or more focal one systems. During the quarter, there were four hospital networks that invested in an additional focal one system, including another placement within Cleveland Clinic, which marks our fourth in the U.S. and sixth within their worldwide healthcare network. We also added a second system within Kaiser Permanente expanding into their San Diego market following the strong performance of their first program in Los Angeles. This expanding footprint across many of the country's most respected healthcare systems continues to validate Focal One's position as the platform of choice for hospitals building a comprehensive focal therapy program, and we believe it reflects growing confidence amongst some of the most influential thought leaders in the field of urology. Internationally, we delivered five capital system sales in the second quarter across Europe, India, and Latin America. This reflects the strength and continued expansion of our global commercial infrastructure, Imperial College London in the UK, one of the pioneering and most highly published vocal therapy programs in the world, has converted their Haifu activity from a competitive Haifu technology to Vocal One, reinforcing the growing preference of our technology platform amongst some of Europe's most established vocal therapy programs. In France, we completed a new capital sale following the recent announcement of the universal coverage for use of HIFU by the French National Health System. This reimbursement coverage outcome was the result of a landmark large prospective multi-center HIFI study published in December of 2024. We also continue to expand our footprint in several important developing markets outside of Western Europe. including India, where we completed two additional capital system sales as we build our presence in one of the largest and most under-penetrated prostate cancer markets globally. Turning our attention to utilization, U.S. FOCA I procedure volumes increased 47% year-over-year, demonstrating strong usage by existing programs as well as the impact of new FOCA I programs launched during the quarter. This sustained growth demonstrates the durable, recurring revenue streams created by each new focal one system placement. As our install base has grown over the past several years, we continue to see procedure volumes scale, and this quarter's results are a continuation of this positive trend. Turning to our clinical and regulatory program. In July, we submitted a 510K application to the FDA for Vocal Connect, our proprietary remote connectivity technology. Vocal Connect enables remote maintenance, remote proctoring, peer-to-peer collaboration, and unlocks the opportunity to accelerate surgeon training and broaden patient access to expert care. For example, an experienced focal one surgeon can remotely support a physician in real time, whether that connection spans across a single large hospital campus or across a broader regional network. Last year, we demonstrated the scope of this capability with the world's first transcontinental focal one telecollaboration, where two surgeons within the Cleveland Clinic Network in Ohio and Abu Dhabi collaborated to perform a focal one patient treatment while more than 7,000 miles apart. On the positive reimbursement front, CMS has proposed an increase in HIFU facility payment of approximately 12% for 2027 compared to the current rate for 2026. If confirmed in the final rule, this would represent the fifth consecutive annual increase by CMS in the facility payment for use of focal one robotic HIFU. We believe this proposed increase continues to provide hospitals and physicians with a clear and predictable Medicare reimbursement pathway which supports and justifies an investment in Vocal One as the core foundation of a world-class vocal therapy program. We will continue to monitor the CMS payment rule as it moves forward toward finalization, which we expect in late fall. We also continue to make progress expanding from prostate cancer into new indications with our BPH clinical program. Through a natural orthosis approach and direct access to the prostate without an indecision or blood loss, the FOGLE1 platform is ideally suited to treat BPH or benign prostatic hyperplasia and its related symptoms. Leveraging our growing install base and existing community of urologists specialized in prostate care and trained on focal one, we believe that upon regulatory approval, we are positioned to capture a meaningful share of the large and highly fragmented BPH market. Our ongoing study in Latin America continues to progress with 14 patients treated to date. As a reminder, this initial clinical work is led by U.S. physicians who have received IRB approval to expand their research at the Icahn School of Medicine in Mount Sinai in New York. The first BPH patients in the U.S. are planned for treatment with Local 1 later this year in New York. As for education expansion with endometriosis, we recently announced that Toulouse University Hospital in France became the site of our first commercial endometriosis program in Europe and has since treated several additional patients since the initial program launch. More than 10 additional hospitals across Europe, the United Kingdom, and Latin America are now moving through our clinical training pathway. With a dedicated CE marking for this clinical application, we continue to view the treatment of deep infiltrating endometriosis as a large and growing market opportunity, offering a treatment option to women suffering from this highly debilitating condition while avoiding major pelvic surgery and its associated complications and morbidity. Together, BPH and endometriosis represent two significant opportunities We estimate that across prostate cancer and our expanded indications into BPH and endometriosis, this represents a total addressable market of more than 4.3 million procedures and over $10 billion in potential revenue. With an updated company name, a fortified balance sheet, and a refined reporting structure, is now fully aligned to capture the high growth opportunity in front of us. Going forward, we will remain focused on the discipline execution of our strategic growth plan as reflected in our near and long-term financial targets. With that, I will now turn it over to Ken to review the financials in more detail.

Thank you, Ryan, and good afternoon, everyone. Before I turn to our results, I want to spend a moment on a change to our financial reporting. As Ryan mentioned, beginning this quarter, we are classifying our non-core ESWL and distribution businesses as discontinued operations. Consistent with our continued and disciplined focus on our core HIFU business. As a result, going forward, our financial statements and related commentary will reflect our HIFU business as continuing operations. I will walk through both our continuing ISOO operations and our discontinued non-core operations to provide a clear basis of comparison as we transition to this new presentation. As we have discussed previously, we believe this removes a layer of complexity that has made it difficult for investors to understand ISOO's underlying financial trajectory on its own terms. The growth rate, margin structure, and the level of investment required to support this core business going forward. We recognize change introduces a new set of comparisons for investors to work through and we intend to be as clear and consistent as possible as we present this new reporting classification going forward. I'd also like to highlight a key subsequent event related to raising additional equity. On August 14th, we expect to close an underwritten public offering with gross proceeds of $40 million. This amount will be reflected in our cash balance and shareholder equity in the third quarter of 2026. With our recent cash raise, we now feel confident that we have sufficient financial resources to execute on our previously announced strategic priorities. All my commentary, unless otherwise noted, is in reference to the HIFU segment, which is now classified as continued operations. As Ryan mentioned earlier, this was our best second quarter for revenue, which grew 39% compared to the second quarter of 2025. Revenue for the quarter was $13.2 million, as compared to $9.5 million for the second quarter of 2025. The 39% year-over-year increase in revenue was driven by 13 capital system sales in the second quarter of 2026 versus 9 capital system sales in the prior year period, as well as a 38% increase in FOCA-1 treatment-driven revenue. As mentioned earlier, FOCA-1 procedures in the U.S. grew 47% year-over-year. Gross margin was 55.6%, up from 51.1% in the second quarter of 2025. The 444 basis points increase in gross margin is due to lower Focal One system costs and a disciplined global pricing strategy for our capital system sales. Operating expenses were $15.4 million in the second quarter of 2026. Compared to $11.5 million for the second quarter of 2025. The increase in net loss was driven by an incremental operating loss of $1.4 million and unfavorable foreign exchange rate impact of $400,000 compared to the prior period, as well as a $6.3 million non-cash charge related to the change in fair value of the European Investment Bank warrants, as well as interest expense on the Tranche A and Tranche B drawdown. Turning to the balance sheet, cash and cash equivalents at the end of the second quarter of 2026 were $21.5 million, compared to $15 million at the end of the first quarter of 2026. As previously reported, approximately $14 million for Tranche B was drawn under the credit facility agreement with the European Investment Bank in April of 2026. The shareholder equity at the end of the second quarter of 2026 was negative $3.2 million. The negative equity is the result of our recurring losses as well as the impact of recording changes in the fair value of the warrants issued to the European Investment Bank. These non-cash fair value changes are reflected in our statement of operations each quarter and have resulted in an increase in accumulated deficit and the increase in shareholders' equity of approximately $9 million since the first drawdown of the credit facility. As mentioned above, our recent equity rates will be reflected in the balance sheet during the third quarter of 2026. and will provide a meaningful increase to shareholders' equity. The tariff impact on the second quarter statement of operations and balance sheet was approximately $500,000. Now I will provide you with the financial results pertaining to our non-court ESWL and distribution segments, which are now classified as discontinued operations. Total revenue for discontinued operations for the second quarter of 2026 was $5.6 million, a decline of 34% or $2.9 million compared to the second quarter of 2025, driven primarily by our ongoing termination of distribution agreements in the U.S. and France. Gross margin for discontinued operations was 36.4% in the second quarter of 2026 compared to 32.9% in the same period prior year. Operating expenses for discontinued operations were $2 million in the second quarter of 2026 compared to $2.7 million in the same period prior year. The reduction in operating expenses was due to our strategic shift to invest in our core ISA business. Operating income for discontinued operations was $21,000 in the second quarter of 2026 compared to operating income of $76,000 in the second quarter of 2025. Net loss for discontinued operations was $75,000 in the second quarter of 2026 compared to net loss of $51,000 in the second quarter of 2025. Inventory balance pertaining to discontinued operations was $4.5 million at the end of the second quarter of 2026, compared to $5.1 million at the end of the calendar year 2025. Turning to guidance, we are reiterating our full year 2026 guidance, with continuing operations core HIFU revenue in the range of I would now like to turn the call back to Ryan for closing comments.

Thanks, Ken. As we looked at the second half of 2026, our priorities remain focused on continued commercial execution across our U.S. and international hospital networks and advancing BPH and endometriosis toward broader commercial launch. We remain confident in our ability to build on the momentum established in the first half of the year. We are proud of the work behind our transition to focal Terex and refining our high-growth strategy and have tremendous confidence in our ability to capitalize on the opportunities ahead. With that, I will now turn the call back over to the operator for questions.

Operator? Thanks very much, Mr. Rhodes. Ladies and gentlemen, at this time, if you do have any questions or comments, simply press star 1. If you do find your question has been addressed, you may remove yourself from the queue by pressing star 2. Additionally, to get to as many questions as possible, we do ask that you please limit yourself to one question and one follow-up. We'll go first this afternoon to Anthony Patron with Mizuho.

Hey there. Thanks, guys. Congrats on the quarter. You've brought on for Anthony today Maybe the first one just wanted to talk about box orders, you know, some promising systems getting their second incremental boxes. Just maybe wanted to refresh us on what a mature department looks like. And then also, you know, when they're buying a second box today, is that just for the prostate cancers that they're seeing? Is that for additional throughput there? Or is it too early to evaluate some of the other indications? Thanks.

Yeah, so our pipeline remains extremely strong. As we showed at the Investor Day event in New York, we have 300 additional deals that we're working through that are qualified, and by no means that are TAM. TAM is significantly higher than that. But back to the sales we made this quarter, one thing of importance is we're growing both in the U.S. and outside U.S., as shown and demonstrated. I think the other Thank you. Thank you. Again, the utilization today is really anchored on our prostate cancer business. BPH and endometriosis are incremental and do play into the narrative for accelerated sales, but we're not materially seeing that as of yet. I think over time, as we progress, that'll become more obvious in our business model.

That's helpful. Thanks. So then maybe just one you touched on, utilization, but You know, you've had some strong placements over the last few quarters, you know, three straight quarters and, you know, over 10 systems placed. Imagine that the procedure utilization kind of ramped. So maybe just a reminder on, you know, when these boxes placed can get to full capacity and kind of how we should think about, you know, I guess specifically the number you gave, the U.S. high for procedures number, you know, in the back half of this year. Thank you.

Yeah, so we get better all the time onboarding and building programs. And in many hospitals, especially in the U.S., we typically see patients already booked in advance of them receiving their POCA-1 machine. And that's a positive sign. That means there's obviously patient demand for this type of treatment. and hospitals then waiting to receive their focal one system and then training the team and then onboarding them. So some will ramp faster than others, but typically we've gotten better at our metrics in terms of the onboarding process. And I think that theme will continue to grow and evolve as we sell more centers. Again, there's some hospitals that have invested in the technology because they don't want to lose those patients to a neighboring hospital. But I think most would understand the value and utility of focal therapy is real. And you've got to answer to that. And I think, as we've demonstrated, focal one is the top priority when you look at capital purchases supporting their focal one type three program or focal one program in prostate cancer.

Thank you. We'll go next now to Jason Bednar of HyperStandler.

Hey, afternoon, everyone. Thanks for taking the questions. With the recent raise in hand or effectively in hand, can you talk about the pushes and pulls of future cash use in order to build out FOCA-1 as a platform across multiple indications and, you know, the resourcing that's necessary to accomplish this as you aim for that 40% growth profile? What kind of additional sales resources should we be thinking about, and also how are you planning for incremental R&D spend to advance this multi-education approach?

Yeah, so we've socialized. The equity raise really supports three buckets of growth. The first is commercial, accelerated commercial growth. So it could be investments that we want to make either in sales structure, marketing, and anything tied to market development and accelerated commercial growth. The second bucket is really the investment we're making in the expanded indications. That includes both BPH and endometriosis. We may run some clinical studies in the U.S. as well that will be material of value. but we've got a process in place and we're executing on that. The third area is in new innovative technologies to include the work we're doing in histotripsy. We're very excited about that. As demonstrated in June 1st or yesterday, we've already filed some very important patents and we want to accelerate that development process as well.

So, you know, also when we look at making these investments, We're also looking to optimize our current infrastructure inside the company and trying to act more efficiently so we can be very responsible about the additional spending we add to the P&L going forward.

All right. If I can double-click and come back just to follow up on specifically the sales resources and Any quantification you want to give there, Ryan or Ken, around how much additional upside in, say, the sales support line or the R&D line that we should be thinking about as we build our models forward? And then a separate question, I think your disposables and procedure volume growth has been very good for the past 12 months. I think you're coming up against some tougher comps here in the second half of the year. Can volume growth continue to outpace that of total system growth as we look ahead?

Yeah, so I'll answer the first question. So when you look at the investments we need to make into the future, when you look at R&D and SG&A as a percent of revenue, as we grow the top-line revenue, the percentage investments in each of those categories will come down a few percentage points each year. So I think that's a good way of looking at your, as you're building your models for R&D and SG&A. R&D will ramp down a little bit, and then SG&A will, as a percent of revenue, will come down nicely because in the U.S., for example, we'll have targeted areas that we will need to invest in the sales growth to build out a few channels, but we won't have to do anything radical.

And I would also mention, you know, with BPH, we're already in the urology call point. So, we're in those hospitals already. We're working with the same, typically the same urologist or the same urology team. So, we've not looked at adding notable headcount as we move forward with that new indication. I think we can do more with less and scale accordingly.

All right. I'm sorry, just a volume growth question. relative to the capital growth question?

Yeah. So, again, the way I would look at it is, obviously, you know, we're growing in both categories, right, in capital, in the recurring revenue models, both from our disposables, razor blade business, as well as our service. The lion's share of revenue will still come from the capital system sales side as of now. were encouraged because that was one of the investments we're making to do more on the same platform. If we can offer multiple treatments to include endometriosis in women's health, that allows us obviously to grow our procedures and thus grow more recurring revenue tied to our disposable or consumables. but in the near term obviously capital equipment is going to be the bigger driver but we will see, you know, notable increases in revenue coming from both capital and from our disposables business. All right, understood.

Thank you. Thank you. We'll go next now to Michael Sarcone with Jefferies.

Hey, good afternoon and thanks for taking the question. I guess just to start, another one on utilization, but just looking at it a different way. When you think about surgeon users, focal one adopters across your different accounts, how many surgeons are adopting in your highest utilization accounts versus your lower utilization accounts? And I guess what's the average number of surgeons for an account?

So we've spent more time training incremental doctors where appropriate. I would say we've come up in the number of divisions who are accessing or using the technology at a site. Some of our busiest sites, it's commonly, you know, at least two doctors. We have some that have as many as seven doctors who have privileges and who are trained and have access to do focal one procedures. So it does, it ranges by institution. But I'd say if I was going to average it out, I'd say it's, you know, the number would, you know, be somewhere probably around 2.5 and trending upward. Some of our busiest sites, you know, if you look specifically across the board, 130 to 140 procedures a year on the higher end. And, again, that's with the prostate cancer indication, nothing else. and then if you truncate down into kind of a middle group, you can have that number somewhere around that. You know, it takes time to launch and build a program, but we've gotten better at that onboarding process and we typically see, as I mentioned earlier, a faster ramping coming because more hospitals today have a bolus or a backlog of patients who are already requesting a full-blown treatment. But again, we're excited for the momentum we're building. There is additional requests for training new doctors, and we answered that request. and of course, as I referenced earlier, new indications will be important as we think outward in the models in terms of some level of growth. Now, we've been very conservative in some of our models just because, you know, we want to be accurate in terms of, you know, what the impact would be at the time of launching, say, BPH or in the limited launch we have going on with endometriosis. But we're encouraged with the direction we're going. I think we have a structured launch plan as we think about adding in these new indications over time.

Okay. Thanks, Ryan. And then the second question, I think in mid-June you announced an agreement with Melling Medical to expand access, you know, for veterans. So I just wanted to get a sense for how meaningful is the opportunity at the VA or at different VA hospitals? Are you in? Any VA hospitals today and, you know, when you mentioned that 300 system number for the active, for the qualified leads, you know, how much of that is in VA hospitals? Thank you.

Yeah, so one of the good things in our install base is we're notably well represented and continuing to grow our penetration into leading academic centers. and typically there's a VA hospital in close proximity. So right now I can actually say that the engagement with Millie Medical allows us to live deeper at government accounts, VA and even military accounts. And I can tell you where we have three we're working on at our immediate near term hospitals, VA hospitals. and I think we've got good progress coming together there. The doctors who will come over there in some cases will have already been exposed to vocal run because the academic center is likely in very close proximity to that VA hospital. So, that works out really well for us and what I like about it is it exposes both residents and fellows to Focal One Robotic Haifu, which they can learn there and then adopt and maybe practice or implement clinically at that VA site. So anyway, but back to that number that I mentioned earlier, there are a handful of VA hospitals that are referenced in those 300 pipeline accounts that we're going after that are qualified. I can't give you the exact number, but they are counted. Some are counted in that number, not all of them, but some. So a lot of upside potential. We're excited about the momentum, again, as we look outward with VA hospitals. That's helpful. Thank you, Ryan.

Thank you. We'll go next now to Sean Lee with HC Wainwright.

Good afternoon, Ryan, Ken, and thanks for taking our question. I just have one on the gross margin. So it's great to see the improvement this quarter versus last year. What contributed to this increase, and what else do you need to get to the 60% gross margin that you highlighted in your long-term plan?

Yeah, thanks for the question. So there's several things that are attributed to our strong Gross Margin Increase, notably, we finished last year 48% types of gross margin. Q1, we finished 51% and Q2, 55%. The things attributed, number one, really a global discipline pricing strategy. We implemented our Focal One Eye system at the end of last year, and we're seeing the good, strong pricing with that product. worked on lowering our bond cost reductions with certain materials. And as a result of our increase in demand, we're also seeing good, strong factory absorption. And then when you layer in the increase in consumables and the growth rates of that, that's also attributing to strong gross margins to date. As we move forward, we're going to continue to focus strategically on further bond cost reductions and we will also see as procedure volumes continue to grow that is a very accretive margin to our total gross margins. So those are the main factors that will contribute to the gross margin improvement today and in the future.

I'd also say real quick that notably the proposed rule came out from CMS and it's calling for an 11.6% increase in reimbursement. As Ken referenced, we're methodical and Very structured in how we offer pricing. This will be the fourth year in a row that HIFU reimbursement has gone up from CMS. And that's important because it allows us to revisit our pricing models, which will play accordingly in the improvement of gross margin. So again, I think there's three areas that we can continue to focus on. We're excited about the direction we're going, and we're excited about continuous in terms of margin improvement.

Got it. That's very helpful, and thank you again for taking your question.

We'll go next now to Alex Nowak with Lucid Capital Markets.

All right. Great. Good afternoon, everyone. In the upcoming clinical data that we need to watch out for, the one in particular that I'm watching for is the HIFUSA study. but anything else we should be watching and then also on the high fuses study, when could we see a readout for that? And just maybe speak to how important that one could be.

Yeah, great question, Alex. The high fuses study, to my understanding, the patients have been done and treated, I think we're, again, just in that follow-up period. We will likely see this readout. I would assume it would be potentially the very end of this year and some form factor or maybe the beginning of next year. It is an important study because it is looking at active surveillance. and so I think again I'm going to be with the principal investigator on Monday this coming week and that's one of the questions I'm going to have for him in getting an update. But my understanding is that we should see that published out fairly soon. I can't give you an exact date but I think it will be an important study. It's one that many people have been asking about. and, you know, we're excited because we know that it will likely be favorable to the story, right? The story today about use of focal therapy amongst a patient population to include low to intermediate risk.

Yes, absolutely. Good to hear. And then with the first endometriosis program coming online in Europe, How material do you expect this disease state to be towards the revenue line over the next few quarters? Is this going to be something we're going to see a few more systems get placed directly related to endometriosis? And then it might be a little premature, but any update on the regulatory strategy for the U.S. market there?

Yeah, so right now I would say we've got 11 centers that are going through the training pathway and we're managing that group. We really don't want to expand it yet just because we're in this onboarding training process and we want to get these centers up and running. Toulouse was an example of one of those sites. In the first quarter of this year, we had three focal one system sales that were attributed to hospitals knowing that they could treat endometriosis and prostate cancer on the same machine. So that's a favorable data point. We'll likely see more of that in the future, especially as it relates to CE mark countries where we're cleared now for endometriosis. But in terms of the numbers contributing to revenue, I think it will be very small and we'll start playing out more next year in 2027 when we really start ramping up things. And I'm excited about this because I think, you know, again, it allows us to define ourselves not only in men's health but in women's health. Where are we in the U.S.? We've already won a breakthrough device designation award and the manuscript for the randomized control trial will be published later this year. That's the expectation. I know it's being submitted to a top-tier, high-impact journal, but that data set is really important for us because that data set allows us to get back in front of the FDA and have the next conversation as to what is necessary to win a new indication or clearance on endometriosis with FOCA-1 in the U.S. And so we're awaiting that publication to come out.

All right, excellent. Well, I appreciate the update. Thank you.

Thank you. We'll go next now to Josh Jennings with TD Cowen.

Hi, good afternoon, Ryan. Again, thanks for taking the questions, and it's great to see you continue momentum here. I wanted to... just circle up on one of the standouts of the Investor Day. And I think you mentioned earlier in the call, Ryan, on the HISTRIPSY development program with the new capital, you're going to be able to fund that development more fully. And it seems like the team is very confident that the development program will be successful, and ultimately you'll have a combo HIFU histotripsy technology offering that could be super differentiated. But maybe just help us frame up just, I mean, I know you're not, it's too early to talk about regulatory timelines and next steps, but is this a three- to five-year horizon that we should be thinking about and maybe just reiterate or review why your team is confident that this development program will be successful? Thank you.

Yeah, so on the Investor Day event on June 1st, we talked about this, and I'm glad you brought it up. I think it's an important discussion. You know, as referenced, we've been in sound-based therapy for well over 30 years. So, you know, sound-based therapy is in our DNA, and, of course, our history in the lithotripsy for treating kidney stones naturally sets us up well for adding new technologies to our platforms. So we've got a full development team in place. We filed a couple patents, as we referenced on June 1st. And if I had to point out to a timeline, I would say it's more in the one- to two-year range. Now, again, we've got critical milestones ahead, and we're working on some of these in the near term, but we have others in front of us. So it is a high focus for us. and I think because of our background and work in lithotripsy and of course in Hydro, which is another sound-based therapy, this fits really nicely into the focal one ecosystem. And so it is a high priority and we've got the best and brightest working on it. We're excited because of the equity raise. We can fund accelerated growth here and we're gonna continue to make prudent investments in this specific area. So we're excited. Thank you.

Outstanding. Thanks again.

Thank you. And ladies and gentlemen, that's all the time we have for questions this afternoon. Mr. Rhodes, I'd like to turn things back to you, sir, for any closing comments.

Before we conclude today's call, I'd like to underscore the broader significance of the work we are doing in prostate cancer. Prostate cancer remains one of the most commonly diagnosed cancers in men. and its global burden is expected to rise substantially. The Lancet Commission projects annual cases could reach approximately 2.9 million by calendar year 2040, with deaths approaching 700,000 each year. Against that backdrop, we see a meaningful opportunity to advance the standard of care for appropriately selected patients. The growing momentum we are building across our global business reinforces our conviction in that opportunity. As we expand the adoption of VOCA1 and deepen our relationship with physicians, hospitals, and health systems, VOCA1 Robotic HIFU offers a non-invasive, organ-sparing, and function-preserving approach that enables physicians to precisely target cancerous tissue while preserving surrounding healthy tissue. For certain patients, it can provide an alternative to health delay or radical whole gland therapies that carry the risk of greater morbidity and lasting urinary and sexual side effects. As we approach Prostate Cancer Awareness Month in September, we are reminded of the importance of awareness, early detection, education, and access to these important innovative treatment options. At Popul Therix, we remain committed to expanding access to technologies that help physicians treat prostate cancer effectively while preserving quality of life. We are grateful to our employees, physician partners, hospital customers, investors, and other stakeholders who support that mission. Thank you again for joining us today. We appreciate your continued interest in focal tariffs and look forward to updating you on our progress in the coming quarters.

Thank you, Mr. Rhodes. Again, ladies and gentlemen, this does end today's meeting. We do appreciate your time and participation. You may now disconnect.