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Good afternoon. Thank you for joining us for the FocalTherics 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 31, 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 FocalTherics, debuting 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. Additionally, this quarter, we moved our ESWL and distribution businesses to discontinued operations to further establish clarity in our financial reporting in alignment with our strategic priorities.

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 to date, and we are even more excited by the large global opportunity that lies ahead for FocalTherics. 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 HIFU capital system 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 SUO-approved fellowship programs. Adoption at leading academic institutions such as these allows the next generation of urologists to gain hands-on training and exposure with Focal One 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.

Of note, Imperial College London in the U.K., one of the pioneering and most highly published focal therapy programs in the world, has converted their HIFU activity from a competitive HIFU technology to Focal One. Reinforcing the growing preference of our technology platform amongst some of Europe's most established focal 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. Focal One procedure volumes increased 47% year-over-year, demonstrating strong usage by existing programs, as well as the impact of new Focal One 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 programs. In July, we submitted a 510(k) application to the FDA for Focal Connect, our proprietary remote connectivity technology. Focal 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 mi 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 Focal One as the core foundation of a world-class focal 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 orifice approach and direct access to the prostate without an incision or blood loss, the Focal One 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 at Mount Sinai in New York. The first BPH patients in the U.S. are planned for treatment with Focal One later this year in New York. As for indication 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 U.K., 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 to expand utilization for use of Focal One. 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, FocalTherics is now fully aligned to capture the high-growth opportunity in front of us.

Going forward, we will remain focused on the disciplined 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 HIFU 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 HIFU'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 in 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. As a reminder, 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 nine capital system sales in the prior year period, as well as a 38% increase in Focal One treatment-driven revenue. As mentioned earlier, Focal One 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 EUR 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 a decrease in shareholders' equity of approximately $9 million since the first drawdown of the credit facility.

As mentioned above, our recent equity raise 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-core 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 HIFU 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 $50 million-$54 million.

I would now like to turn the call back to Ryan for closing comments.

Thanks, Ken. As we look to 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 FocalTherics 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?

Thank you very much, Mr. Rhodes. Ladies and gentlemen, at this time, if you do have any questions or comments, simply press star one. If you do find your question has been addressed, you may remove yourself from the queue by pressing star two. 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 will go first this afternoon to Anthony Petrone with Mizuho.

Hey there. Thanks, guys. Congrats on the quarter. You have Brad on for Anthony today. Maybe the first one, just wanted to talk about box orders, some promising systems getting their second incremental boxes. Just maybe wanted to refresh us on what a mature department looks like, and then also 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. Our pipeline remains extremely strong. As we shown at in the Investor Day event, 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, demonstrated. I think the other comment around this is that we now have 13 centers that have two or more Focal One machines. They've invested to grow their capacity, typically in other hospital sites. An example, of course, is Cleveland Clinic, and as stated, Cleveland Clinic now has six sites operating with Focal One. Again, we continue to focus and execute, and we're excited about the momentum building. 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. Maybe just one, you touched on utilization, but just you've had some strong placements over the last few quarters, three straight quarters and over 10 systems placed. Imagine that the procedure utilization kind of ramps. Maybe just a reminder on when these boxes placed can get to full capacity and kind of how we should think about, I guess specifically the number you give, the U.S. HIFU procedures number, in the back half of this year. Thank you.

We get better all the time onboarding and building programs. In many hospitals, especially in the U.S., we typically see patients already booked in advance of them receiving their Focal One machine. That is a positive sign. That means there is 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. Some will ramp faster than others, but typically, we have gotten better at our metrics in terms of the onboarding process. I think that theme will continue to grow and evolve as we sell more centers. Again, there are some hospitals that have invested in the technology because they do not want to lose those patients to a neighboring hospital. I think most would understand the value and utility of focal therapy is real, and you have got to answer to that.

I think as we have demonstrated, Focal One is the top priority when you look at capital purchases supporting their Focal One HIFU program or Focal One program in prostate cancer.

Thank you. We will go next now to Jason Bednar of Piper Sandler.

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 Focal One as a platform across multiple indications and the resourcing that is necessary to accomplish this as you aim for that 40% growth profile? What kind of additional sales resources should we be thinking about? Also, how are you planning for incremental R&D spend to advance this multi-indication approach?

Yeah. We've socialized. The equity raise really supports three buckets of growth. The first is commercial, accelerated commercial growth. 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 at our Investor Day, we've already filed some very important patents, and we want to accelerate that development process as well.

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 could double-click and come back just to follow up on specifically the sales resources and the R&D spend. 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? 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. I'll answer the first question. 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. I think that's a good way of looking at as you're building your models for R&D and SG&A. R&D will ramp down a little bit, and then SG&A, 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.

I would also mention, with BPH, we're already in the urology call point. We're in those hospitals already. We're working with typically the same urologist or the same urology team. 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. Sorry, just a volume growth question relative to the capital growth question.

Yeah. Again, the way I would look at it is obviously, we're growing in both categories. 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. But we're 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 business. But in the near term, obviously, capital equipment is going to be the bigger driver, but we will see the 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 per an account?

We've spent more time training incremental doctors where appropriate. I would say we've come up in the number of physicians who are accessing or using the technology at a site. Some of our busiest sites, it's commonly 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 ranges by institution. But I'd say if I was going to average it out, I'd say the number would be somewhere probably around 2.5 and trending upward. Some of our busiest sites, 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. Then if you truncate down into kind of a middle group, you could have that number, somewhere around that.

It takes time to launch and build a program, but we've gotten better at that onboarding process. We typically see, as I mentioned earlier, a faster ramping coming because more hospitals today have a bolus or backlog of patients who are already requesting the Focal One treatment. We're excited for the momentum we're building. There is additional requests for training new doctors, and we answer to that request. 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. We've been very conservative in some of our models, just because we want to be accurate in terms of what the impact would be at the time of launching, say, BPH or in the limited launch we have going on with endometriosis. 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. Just second question. I think in mid-June you announced an agreement with MellingMedical to expand access for veterans. 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? When you mentioned that 300 system number for the qualified leads, how much of that is in VA hospitals? Thank you.

Yeah. 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. Typically there's a VA hospital in close proximity. Right now I can actively say that the engagement with MellingMedical allows us to look deeper at government accounts, VA, and even military accounts. I can tell you where we have three we're working on in our immediate near term VA hospitals, and I think we've got good progress coming together there. The doctors who will come over there in some cases have already been exposed to Focal One because the academic center is likely in very close proximity to that VA hospital.

That works out really well for us, and what I like about it is it exposes both residents and fellows to Focal One robotic HIFU, which they can learn there and then adopt and maybe practice or implement clinically at that VA site. 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 some are counted in that number. Not all of them, but some. 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 H.C. Wainwright.

Hey. Good afternoon, Ryan, Ken, and thanks for taking our question. I just have one on the gross margin. It is 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. There are several things that are attributed to our strong gross margin increase. Notably, we finished the year last year, 48% HIFU gross margin. Q1, we finished 51%, and Q2, 55%. The things attributed, number one, really a global disciplined pricing strategy. We implemented our Focal One i system at the end of last year, and we are seeing the good, strong pricing with that product. We worked on lowering our BOM cost reductions with certain materials. As a result of our increase in demand, we are also seeing good, strong factory absorption. When you layer in the increase in consumables and the growth rates of that is also attributing to strong gross margins to date.

As we move forward, we are going to continue to focus strategically on further BOM cost reductions, and we will also see as procedure volumes continue to grow, that is a very accretive margin to our total gross margins. Those are the main factors that will contribute to the gross margin improvement today and in the future. I would also say real quick that notably, the proposed rule came out from CMS, and it is calling for an 11.6% increase in reimbursement. As Ken referenced, we are 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. That is important because it allows us to revisit our pricing models, which will play accordingly in the improvement of gross margin. Again, I think there are three areas that we can continue to focus on.

We are excited about the direction we are going and we are excited about continuous upside in terms of margin improvement.

Got it. That's very helpful, and thanks again for the continued question.

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

All right, great. Good afternoon, everyone. Can you speak to the upcoming clinical data that we need to watch out for? The one in particular that I'm watching for is the HIFUSSA study. Anything else we should be watching? Also on the HIFUSSA study, when could we see a readout for that? Just maybe speak to how important that one could be.

Yeah. Great question, Alex. The HIFUSSA 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 in some form factor or maybe the beginning of next year. It is an important study because it is looking at active surveillance. 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. 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 we're excited because we know that it will likely be favorable to the story. The story today about use of focal therapy amongst a patient population to include low to intermediate risk.

Yep, absolutely. Good to hear. 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? It might be a little premature, but any update on the regulatory strategy for the U.S. market there?

Yeah. 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 University Hospital 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. 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 will start playing out more next year in 2027, when we really start ramping up things. I'm excited about this because I think, 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 Focal One in the U.S.

We are awaiting that publication to come out.

All right. Excellent. Well, appreciate the update. Thank you.

Thank you.

We will go next now to Josh Jennings with TD Cowen.

Hi. Good afternoon, Ryan, Ken. Thanks for taking the questions, and it is great to see continuing momentum here. Wanted to just circle up on one of the standouts at the Investor Day, and I think you mentioned earlier in the call, Ryan, on the histotripsy development program, with the new capital, you are going to be able to fund that development more fully.

It seems like the team is very confident that this development program will be successful and then ultimately you will have a combo HIFU histotripsy technology offering that could be super differentiated. Maybe just help us frame up just, and I know it is 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? 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 am glad you brought it up. I think it is an important discussion. As referenced, we have been in sound-based therapy for well over 30 years. Sound-based therapy is in our DNA, and of course, our history in lithotripsy for treating kidney stones naturally sets us up well for adding new technologies to our platform. We have got a full development team in place. We filed a couple patents, as we referenced on June 1st. If I had to point out to a timeline, I would say it is more in the one to two year range. Now, again, we have got critical milestones to hit, and we are working on some of these in the near term, but we have others in front of us. It is a high focus for us.

I think because of our background and work in lithotripsy and, of course, in HIFU, which is another sound-based therapy, this fits really nicely into the Focal One ecosystem. It is a high priority, and we have got the best and brightest working on it. We are excited because of the equity raise. We can fund accelerated growth here, and we are going to continue to make prudent investments in this specific area. We are excited. Thank you.

Outstanding. Thanks again.

Thank you. 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 Focal One and deepen our relationship with physicians, hospitals, and health systems. Focal One 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 help delay more 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 FocalTherics, 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 FocalTherics 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.

Welcome to the EDAP TMS First Quarter 2026 conference call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Louisa Smith from Gilmartin Group. Please go ahead.

Good morning. Thank you for joining us for the EDAP TMS First Quarter 2026 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting 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 31, 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.

Thank you, Louisa, and good morning, everyone. As announced this morning, we delivered a strong first quarter. We reported record first quarter total revenue for the company of $17.8 million, led by record first quarter Focal One robotic HIFU revenue of $11.6 million, further reinforcing the momentum we highlighted on our previous fourth quarter call. Today, I will provide additional color on new system placements, growing utilization trends, and our ongoing indication expansion efforts before turning the call over to Ken to review our financial results. Before discussing the quarter in more detail, I would like to remind everyone that effective January first of this year, EDAP becomes a U.S. domestic issuer. As a result, beginning this quarter, we will report all financial results in U.S. dollars on a go-forward basis. Now, turning to our first quarter results.

Our HIFU business continues to demonstrate strong and sustained momentum. We have now delivered seven consecutive quarters of year-over-year growth in the segment, reflecting increasing physician adoption, expanding utilization, and growing global demand for Focal One robotic HIFU technology. We delivered record revenue across our core HIFU business, driven by strong growth in both system placements and procedure volumes across U.S. and international markets. During the quarter, we recorded 11 capital sales and 10 total net placements, further reinforcing the strength in growing visibility of our Focal One pipeline. In the quarter, we continued to expand adoption across many of the most prestigious academic cancer centers in the United States. As noted, University of Pittsburgh Medical Center, UPMC, converted to a cash sale, and Moffitt Cancer Center became the 10th Focal One system installed in the state of Florida.

These placements further validate Focal One's emergence as a leading robotic focal therapy platform being adopted and utilized by top-ranked institutions nationwide. We also placed a second Focal One system within the Mass General Brigham healthcare network. With this addition, 11 U.S. hospital and health networks have now invested in and launched two or more Focal One robotic HIFU programs, underscoring the growing utilization, confidence, and long-term commitment we are seeing from major healthcare systems. Internationally, we achieved a record six capital sales in the first quarter, reflecting the continued expansion of our global commercial reach, supported by our established and growing sales channel infrastructure. Performance in Europe was particularly strong. In France, we completed our first cash sale following the French National Health Insurance's decision to provide universal coverage for the Focal One HIFU procedure.

As a reminder, this coverage decision was supported by results from the landmark HIFI study, a large prospective comparative trial that demonstrated positive efficacy outcomes for Focal One robotic HIFU as compared with radical prostatectomy in the treatment of prostate cancer. This quarter also marked the first time our Focal One capital sales were driven by demand across two clinical indications: prostate cancer and deep infiltrating endometriosis. Further highlighting the value of Focal One as both a multi-specialty and multi-indication treatment platform. In the U.K., Cleveland Clinic London converted to a cash sale supported by strong engagement from global thought leaders in both urology and gynecology departments, which plan to utilize Focal One robotic HIFU for the treatment of both prostate cancer and endometriosis.

In Eastern Europe, we achieved our first Focal One cash sale in Hungary, driven by the hospital's strategic initiative to expand treatment capabilities for both prostate cancer and endometriosis. These placements are important as they recognize Focal One robotic HIFU as the only multi-indication focal therapy platform to deliver broad clinical utility across both men's and women's health. In the Americas, we delivered our first Focal One system in Mexico, further expanding our growing clinical regional footprint, which now includes Brazil, Argentina, Chile, Panama, and Mexico. This is a result of our growing and expanding sales channel throughout this region. Turning to utilization, U.S. procedure volumes increased 53% year-over-year. This significant growth was driven by physicians and hospital systems that increasingly recognize the importance of offering Focal One as a cornerstone focal therapy treatment within a comprehensive prostate cancer program.

As we continue to expand the clinical applications of Focal One robotic HIFU and bring meaningful value to a broader population of prostate cancer patients, we also remain focused on the significant unmet need in patients who experience recurrence following failed radiation therapy. Radiation therapy failure rates reported in the clinical literature remain significant, and treatment options for these patients are extremely limited, often consisting primarily of hormone deprivation therapy, which can carry debilitating, long-lasting side effects that materially impact a patient's quality of life. Our recent announcement regarding the peer-reviewed publication of the HIFI-2 study further strengthens our global leadership position in focal therapy. This study is significant for several reasons. First, it represents the largest prospective study ever conducted, enrolling more than 500 patients evaluating salvage treatment following recurrence after failed radiation therapy.

HIFI-2 is the largest prospective study assessing the use of Focal One robotic HIFU within this important patient population. Importantly, the study demonstrated clinically meaningful oncologic control with 71% of the overall patient population avoiding hormone deprivation therapy at 30 months. Additionally, in a rigorously selected subgroup of patients, 84% avoided hormone deprivation therapy within the same follow-up time period. These positive results show promise for use of Focal One HIFU as a breakthrough treatment for this important population of men who have previously been left with limited options that result in negative, long-lasting side effects. It is also important to note that the National Comprehensive Cancer Network guidelines already recommend HIFU as a treatment option for patients with prostate cancer recurrence following failed radiation therapy, and both Medicare and commercial payers currently provide reimbursement coverage for the use of Focal One robotic HIFU in this clinical setting.

In summary, the publication of the HIFI-2 study further reinforces Focal One's unique position as a non-invasive, organ-sparing, and function-preserving treatment option for a patient population that has historically faced limited therapeutic alternatives beyond palliative care. In urology and moving beyond prostate cancer, we continue to invest in expanded clinical indications for Focal One. We are currently accelerating clinical studies evaluating the use of Focal One for the treatment of benign prostatic hyperplasia, or BPH. In early March, our clinical team collaborated with urologists from the Icahn School of Medicine at Mount Sinai to treat patients in Chile as part of an ongoing clinical research study. Based on encouraging early outcomes, the trial will continue with plans to enroll and to treat a second cohort of patients over the coming months.

In addition, a separate IRB-approved study will be conducted at Mount Sinai in New York following patient evaluations from the Chile study. Together, these initiatives reflect our broader strategy to expand the clinical utility of Focal One and to further strengthen the body of evidence supporting its expanded use across additional urologic applications. Within gynecology, our commercial rollout in endometriosis continues to gain momentum across Europe. As mentioned earlier, multiple hospitals have now invested in Focal One robotic HIFU to support the treatment of both prostate cancer and endometriosis, reinforcing the platform's growing multi-specialty clinical utility. During the quarter, we actively participated in two major scientific meetings: the European Endometriosis Congress and the British Society for Gynaecological Endoscopy annual scientific meeting.

Our Focal One sponsor symposium at the European Endometriosis Congress in Bologna, Italy, attracted more than 400 attendees and generated strong engagement from leading clinicians and specialists across key international markets. On the clinical front, Hôpital Edouard Herriot in Lyon, France remains central to our expansion strategy, serving both as a high-volume treatment center and as our primary physician training hub for endometriosis. In parallel, Focal One robotic HIFU endometriosis programs are beginning to launch and enroll patients. We are pleased to confirm that first patient treatments at several newly established clinical centers are expected to begin in the coming weeks, representing an important milestone as these programs transition from physician training into active clinical adoption. At these recent scientific meetings, investigators also presented positive long-term follow-up data from the phase II and phase III randomized controlled trial, demonstrating effective and durable outcomes that remained consistent across all patient cohorts.

These findings further reinforce our confidence in the long-term clinical value of this treatment approach. Importantly, we believe the growing body of clinical evidence establishes a strong foundation to support the advancement along the regulatory pathway. Collectively, these commercial and clinical developments further strengthen our conviction that endometriosis represents a significant long-term growth opportunity for Focal One. As we mentioned on our last call in March, we collaborated with the leadership team from the NYU Langone Health Department of Urology to host the inaugural international symposium on robotic focal therapy in New York City. This event attracted physicians from both the U.S. and international markets who are either developing or actively evaluating focal therapy programs centered around Focal One robotic HIFU. The strong attendance and overall success of this educational program further highlights the growing momentum we continue to see throughout the global urology community.

Building on the success of the NYU symposium and in response to increasing demand from urologists seeking to integrate Focal One technology into their practices, we will be sponsoring a CME-accredited physician training course at Memorial Sloan Kettering Cancer Center on Thursday, May 14th. MSKC is ranked as the leading urology-focused comprehensive cancer center in the United States and is a leading and highly experienced user of Focal One robotic HIFU globally. Looking ahead, we will deliver a strong presence at the upcoming annual meeting of the American Urological Association in Washington, D.C. starting on May 15th. The AUA meeting represents the largest global gathering of urologists and serves as a premier forum where the latest advances in urology are presented and translated into clinical practice.

Throughout the conference, we will host multiple educational and clinical engagement activities, including booth presentations, semi-live Focal One procedures, panel discussions, and hands-on Focal One simulation sessions led by key clinical thought leaders. In addition, we will be hosting numerous analyst and investor meetings throughout the scientific program. Finally, we are excited to announce that we will host an investor day on June 1st at the Nasdaq market site in New York City. During this event, we will provide important updates on our commercial growth strategy, clinical indication expansion, and product innovation roadmap as we continue to build increased momentum across our business. We believe the opportunity ahead of us has never been greater, and we look forward to sharing our vision for the next phase of growth. We hope you will join us in New York.

With that, I would now like to turn the call over to Ken to review our financial results.

Thank you, Ryan. Good morning, everyone. As a reminder, all figures will now be reported in U.S. dollars. As Ryan mentioned earlier, our record revenue performance for the first quarter of 2026 was driven by continued strength in our core HIFU business, which grew 78% compared to the first quarter of 2025. Growth in our HIFU business was partially offset by expected continued decline in our non-core distribution and ESWL businesses, which declined by 20% in Q1 2026 versus Q1 2025. Total company-wide revenue for the first quarter was $17.8 million, an increase of 25% as compared to total revenue of $14.3 million for the same period in 2025. Total HIFU revenue for the first quarter was $11.6 million as compared to $6.5 million for the first quarter of 2025.

The 78% year-over-year increase in HIFU revenue was driven by 11 Focal One capital sales in the first quarter of 2026 versus six capital sales in the prior year period, as well as a 30% year-over-year increase in Focal One treatment-driven revenue. As mentioned earlier, Focal One procedures in the U.S. grew 53% year-over-year. Gross profit for the first quarter was $8.1 million compared to $6 million for the prior year period. Gross margin was 45.7% in the first quarter compared to 42% for the first quarter of 2025.

The 370 basis points increase in gross margin year-over-year was primarily due to the strategic shift to our higher margin HIFU business segment, which had gross margins of 51.4% for the first quarter compared to 48.6% for the first quarter of 2025. Operating expenses were $15.5 million for the first quarter compared to $12.3 million for the same period in 2025. The increase in operating expenses was driven by higher sales expense related to increased system sales as well as incremental costs associated with our transition to a U.S. domestic filer. Operating loss for the first quarter was $7.4 million as compared to $6.3 million in the first quarter of 2025.

Net loss for the first quarter was $9.1 million or $0.24 per share as compared to a net loss of $7.4 million or $0.20 per share in the prior year period. The increase in net loss was driven by incremental operating loss of $1.1 million as well as a $1.7 million non-cash charge related to warrants and interest expense on the European Investment Bank tranche A drawdown. This was partially offset by $1.1 million positive currency impact versus the prior year period. Turning to the balance sheet, inventory increased $13.3 million at the end of the first quarter as compared to $12.8 million at the end of Q4 2025.

This sequential increase in inventory was due to a higher level of HIFU-related inventory to meet the increased demand for Focal One systems as our business momentum continues to grow. Cash and cash equivalents at the end of the first quarter were $15 million compared to $20.5 million at the end of Q4 2025. This sequential decrease was driven primarily by cash used in operating activities to support our strategic investments in accelerating HIFU growth. Subsequent to the end of the first quarter, on April 20th, we received the second tranche from the European Investment Bank credit facility totaling approximately $14 million, which will further strengthen our balance sheet and will be reflected in our Q2 financial statements. The tariff impact on the first quarter P&L and balance sheet was approximately $400,000. We are reiterating our full year 2026 guidance.

We continue to expect core HIFU revenue in the range of $50 million-$54 million, representing 34%-45% growth over 2025, and combined non-core revenue in the range of $22 million-$26 million. I will now turn it back to Ryan for closing remarks. Ryan?

Thanks, Ken. As we execute through 2026, our priorities remain clear. Commercial execution and continuing to deepen penetration across leading centers, indication expansion and advancing our endometriosis and BPH programs. Technology and innovation, positioning Focal One as a leader in the space with the most advanced robotic focal therapy platform. Q1 was a great start. We are confident in our ability to deliver on our 2026 priorities. Operator, please open the line for questions.

Thank you. At this time, if you would like to ask a question, please press the star and one on your telephone keypad. To leave the queue at any time, press star two. Once again, that is star and one if you would like to ask a question. We'll take our first question from Michael Sarcone with Jefferies. Please go ahead. Your line is now open.

Good morning, thanks for taking our questions. Just to start, the U.S. HIFU procedure growth, 53%, really impressive and that's a nice acceleration. Maybe you can just talk a little bit more about what you're seeing in terms of utilization and what's driving that growth. I guess secondly, how sustainable is that level of growth in your opinion?

Yeah, Michael. First off, yeah, we had good procedure growth and again, on a quarter-over-quarter basis, double-digit growth. Again, we're seeing increased demand for non-radical treatments, obviously focal therapy being the discussion point. We see a couple things. One is our install base customers continue to evolve with their programs. We've expanded training to additional doctors, so that has a direct input to increased volume of procedures. Also, we're getting better at ramping programs, obviously selling more capital creates more capacity to treat more patients. I think it's really a culmination of a number of things. I think, you know, the patient audience, as we know, prostate cancer is a heterogeneous cancer, so patients are now doing more research. They're really looking at their options closely.

If they're really not a candidate for radical treatments, they should, you know, ideally be on active surveillance, or they should be a target for focal therapy. We see very good engagement from the centers that have our technology and certainly more centers looking to adopt it. Again, I would You know, we have a dedicated sales force on the clinical side that's doing an excellent job of advancing the programs. Again, we sell and build a program. We feel very confident that we'll continue to grow our procedures. It's a very important metric for us. Of course, it's important to driving increased margin as well as, you know, overall revenue.

That's helpful. Thanks, Ryan. I guess just to follow up on that, when you think about your U.S. accounts in particular for Focal One, I mean, can you give us some sense of, you know, what's the average number of surgeons, you know, using the system at accounts today? Maybe talk about how that's evolved over the, you know, the past few quarters.

Yeah. A very good question. You know, some of our earlier programs, we had individual surgeons or urologists that drove deals. Of course, as we described it as a program, a program may involve a number of urologists. We've moved from kind of that, you know, 1.5 number of trained doctors to nearly two per site, two or more. We have some sites where we have as many as six urologists trained to access Focal One and more in the queue to be trained in coming quarters and including weeks. We're a little more prescriptive now as we've matured in our business. We wanna train more urologists. It really depends, you know, it varies by institution, you know, academic centers versus community hospitals.

We're, you know, we're in that kinda 2% or more range, is our goal. Certainly, in some instances, as I referenced, we have up to 6% or 7% urologists trained and now starting to access Focal One. That's really positive for us. We'll continue to focus on that as we launch new programs.

All right. And if I could just squeeze in one more, just, you know, on the endometriosis side. Sounds like some really solid momentum overseas. I guess just a two-parter here. How are you thinking about financial contribution as you start to see, you know, endometriosis application grow? Secondly here, you know, any update on what's going on with your U.S. efforts in endometriosis? Thank you.

As we talked about, we had some great wins in the quarter with gynecologists weighing in on endometriosis. Again, bringing in a second specialty, you know, we're not only a urology company in men's health, but we're also becoming a women's health company. I think what you're seeing there is certainly more activity on the capital sales side. In the short term, we'll see that. I think we'll see more of that coming because we can do more procedures on the same platform, Focal One. It may be too early to say in our models. We'll have more that we can share in future updates of how that may play into the overall revenue number, including recurring revenue, right? On disposables or consumables.

As far as the U.S., we, as noted, we're still waiting for published data from the randomized control trial that has now follow-up out to 24 months, coming up on 24 months. There was a subset of patients who are part of the sham arm who were treated and were coming up to 12 months follow-up. We're expecting that data to be published likely sometime this year. That data will be very important for us to revisit our strategy with the FDA in the U.S. The good news is some of this data has been recently discussed and presented at the two meetings I referenced in Europe. There seems to be very good engagement from the thought leaders who specialize in endometriosis.

When the new data is presented, I think that'll be an opportunity again to take that, and that will play directly back into the conversations that we'll have with the FDA.

Great. Thanks, Ryan.

Thank you.

Thank you. We'll take our next question from Jason Bednar with Piper Sandler. Please go ahead.

Hey, guys. Good morning. Thanks for taking the questions, and congrats on the quarter here. Wanted to start on the HIFU business here in the U.S. Your placements are doing well globally. That's obvious. You put up really good growth here in the quarter. A lot of that, though, can be attributed to this international expansion that you're touching on. I know we're a few years into this more focused commercial initiative around HIFU in the U.S. as well, though. Can you take us around, you know, through how you're thinking about the U.S. market? What does that runway look like in the U.S.? When we think about opportunities in HIFU, are they just simply greater now outside the U.S. and that's why we're seeing, you know, more emphasis in growth from, again, from kind of your ex-U.S. markets?

Again, we sell what we believe, and clearly have demonstrated, a clinically necessary strategic revenue-enhancing service line in the number one diagnosed cancer in men. Prostate cancer obviously is an anchor point in men's health. Looking at the system sales, we have a strong pipeline, and that pipeline is building. I think hospitals are also starting to recognize the need to answer to the call of offering focal therapy. Focal therapy is emerging as a treatment category as we know, but it is a necessity to be a comprehensive offering in a hospital. We are, you know, looking at our system sales, we're really early in this adoption life cycle.

I mean, we're growing here, but the upside is significant for the company in looking at total numbers of potential sales for the future, and I'm talking about the U.S. Again, we continue to focus on building our active pipelines. As you can see, we continue to sell in academic centers, but also growing more rapidly in community hospitals. That's important, and we had some notable wins as we look across our install base. In the outside U.S., I think the important thing to understand is our legacy history in urology as a company in Extracorporeal Shock Wave Lithotripsy, we already have an established sales channel. Now we're fully activating on that sales channel.

A number of us came from Intuitive Surgical, and we know the playbook, and we're applying that playbook like we did back in the early days of radical prostatectomy. I think we're seeing those results play out now. The outside U.S. market continues to gain traction as we continue to move the U.S. market.

To add to that, as we look at our mix for the year, it will still be predominantly in the U.S. when it comes to unit sales. As a reminder, we sell direct in the U.S., so we can demand a higher ASP both on our system and on our consumable products.

Okay. Just to clarify, Ken, you're saying that, you know, embedded in the guidance for the rest of this year, what's implied is that U.S. accounts for a disproportionate amount of the mix of system sales?

Correct.

Okay, perfect. Maybe next one on, you know, you obviously have the biggest conference coming up here with AUA. Is there anything quantitative you're prepared to talk about in terms of sessions, meetings, exposure? I know, Ryan, you mentioned a lot of those that you have planned, but how this year's conference compares to the last few years as you look to broaden your exposure and deepen your relationships?

Yeah. A couple of good things for this year. The meeting is in Washington, D.C. next week, and as communicated on the call, we have a course going on with Memorial Sloan Kettering Cancer Center. That's on the front end of AUA the day before, and then we're gonna be directly in Washington, D.C. with the scientific program of AUA. As we look at it, we will have a very strong showing at this meeting, a lot of busy activity at our booth. We have presentations, we have the ability to do case simulations, which are really important for new customers that get to get on the Focal One platform and go through an actual treatment. They see how easy it is to set up the treatment and what the robotic platform can do for them.

Beyond that, I would just say there are a scattering of different scientific presentations throughout the meeting, abstracts either presented orally or in some of the poster sessions, or even some discussion on the growth of focal therapy. I think the biggest thing that we see is focal therapy is becoming more of a household word in the treatment category of prostate cancer. As it continues to evolve, we're in a new era of treatment. We'll see some of that going on out in the scientific sessions. We have a number of presentations from key thought leaders at our booth. We'll have a dinner event that's already sold out, and we're excited about that. That'll be on Saturday night.

We'll have a lot of great activity, and of course, we have a very large booth in the main focused area of the exhibit hall. While we're there, we're entertaining a number of discussions with key investors and key analysts. We believe we're a breakout story, we want to have those conversations and continue the momentum we're building.

All right, very good. Last one from me. Maybe just shortly after AUA, you've got your Investor Day coming up. Should we be prepared for a long-range plan at the Investor Day? Is that something you're gonna be prepared to discuss?

At our Investor Day, really, we're really at an inflection point of our business. We want to provide a number of key updates. There will be some updates on our financial models. We'll be talking about kind of the wrap around our commercial strategy. Of course, we'll be talking about some of the new indications and what we're focusing on there. I think there'll be a technology element, something we haven't discussed or shown before, that will be of interest to all attendees. We're investing in some new innovations as it relates to Focal One, but even beyond Focal One. I think there'll be a lot there for people to learn and understand and we look forward to sharing those updates accordingly.

All right. Thank you very much.

Thank you.

Thank you. At this time, there are no further questions. I will now turn the meeting back to Ryan Rhodes.

As discussed on this quarter's call, Focal One robotic HIFU continues to emerge as a market-leading focal therapy technology being adopted by more and more physicians in hospitals around the world. Focal One requires no surgery, cutting or use of radiation, thus allowing physicians to perform a non-invasive, precise robotic targeted ablation that treats only the intended disease areas while preserving the patient's healthy tissue. Its focus as an organ-sparing, function-preserving treatment aligns with the direction of modern medicine. Importantly, Focal One is not just a device, it's a foundation of program building within healthcare institutions. We believe this multi-specialty, multi-indication strategy positions us well for sustained growth and long-term value creation. I wanna thank everyone for joining us on today's call.

We look forward to seeing you at the upcoming annual meeting of the American Urological Association next week and at our Investor Day and the Jefferies Healthcare Conference, both taking place in New York City in early June. Thank you.

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.