Good day, everyone, and thank you for standing by. Welcome to the Profound Medical Second Quarter 2025 Financial Results Conference Call. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Stephen Kilmer, Head of Investor Relations. Please go ahead.

Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws in the United States and Canada. All forward-looking statements are based on Profound's current beliefs, assumptions, and expectations and relate to, among other things, any expressed or implied statements regarding future financial performance and position and expectations regarding the efficacy of Profound's technologies in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment, and osteoid osteoma. Such statements involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Profound undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events, or otherwise, other than as required by law. Representing the company today are Dr. Arun Menawat, Profound's Chief Executive Officer; Rashed Dewan, the company's Chief Financial Officer; Dr. Mathieu Burtnyk, Profound's President; and Tom Tamberrino, our Chief Commercial Officer. With that said, I'll now turn the call over to Rashed.

Good afternoon, everyone, and welcome to our second quarter 2025 conference call. On behalf of the management team and everyone at Profound, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Tom in a moment to provide commercial updates. However, before I do, I would like to provide a brief summary of our second quarter 2025 financial results. To streamline things, all of the numbers I will refer to have been rounded, so they are approximate. For the 3-month period ended June 30, 2025, the company received total orders of over $3 million and recorded revenue of $2.2 million, with $1.6 million coming from recurring revenue and $650,000 from a one-time sale of capital equipment. Second quarter 2025 revenue was essentially unchanged from the same period in 2024. Gross margin in Q2 2025 was 73% compared to 64% in Q2 2024. Total operating expenses in the 2025 second quarter, which consists of R&D and SG&A expenses, were $15.4 million compared with $9.3 million in the second quarter of 2024. Overall, the company recorded a second quarter 2025 net loss of $15.7 million or $0.52 per common share compared to a net loss of $6.9 million or $0.28 per common share for the same 3-month period in 2024. As of June 30, 2025, Profound had cash of $35.2 million. With that, I will now turn the call over to Tom.

Thank you, Rashed. There is no sugarcoating the fact that while the orders that we received are up, the final Q2 revenues were below our expectations. The shortfall was largely due to what we believe are short-term delays in completing a few TULSA-PRO capital sales, and we continue to believe we will be able to deliver 70% to 75% growth in 2025 compared to 2024. As I said on our last call, the transition from a placement model, which was the focus through the end of 2024, to a capital model here in 2025 would lead us to know that it's going to be a back-end loaded operation. Let me provide some color on our pipeline to help illustrate that. Today, at the top of the TULSA-PRO sales funnel, there are close to 500 prospects sitting in the targeting stage. Of those 500, there are 100-plus leads in the engaged stage. And of those 100-plus leads, so far, 80 have been qualified. By that, I mean they are within the verify, negotiate, and contracting stages. Digging a bit deeper still, 39 are in verify, 27 in negotiate, and 14 in contracting. While we obviously can't guarantee all the qualified leads, even those at the last contracting stage will result in final installs before the end of the year, reasonable assumptions and basic math drive our confidence that the second half of the year will be significantly and materially better than the first. We aren't relying on hope and probability models. We are proactively refining our sales team and processes as we grow. A few updates on our sales organization since our last call. This is an organizational sale to organizational buyers, in particular in the U.S., where our immediate target customers are corporatized bureaucratic hospitals. We have learned that capital reps with experience are not statistically significant indicators of success. The intangibles of grit, perseverance, and resiliency will more than likely prove out to an R squared equating to one as it relates to success in sales, business development, or any other role here at Profound for that matter. With that in mind, the U.S. sales team has been streamlined. The director sales level was eliminated, and the regional business director team and capital sales executive team were honed to create a tight-knit team for the aforementioned intangible attributes. There are three regional business directors who report directly to the Vice President of Sales. Each regional business director has a team of 3 to 4 capital sales executives. The clinical and service teams play an integral role in the sales process, and we are now offloading items that were previously bucketed for sales to organize, coordinate and execute onto these teams to free up the sales team to build a bigger funnel. Profound organizational leverage is required as this is an organizational sale and an organizational purchase across several specialties and administrative verticals. Thank you for your time. I will now turn the call over to Mathieu.

Thank you, Tom, and good afternoon. During the second quarter of this year, two important company objectives were achieved. We believe these milestones are catalysts that will drive adoption and utilization of the TULSA procedure in the United States and also globally. The first of these achievements is the CAPTAIN trial is fully recruited and all patient treatments are complete. The CAPTAIN randomized controlled trial is decisive and foundational because it is designed to be a key driver towards gaining a favorable recommendation from the relevant professional society treatment guidelines and ultimately to positive reimbursement coverage from private payers. Inclusion in society guidelines means eligible prostate cancer patients will have to be presented TULSA as a treatment option. Compare that to today, where most patients who are treated with TULSA are those who either asked for it directly by name or ask for alternatives to today's standards, robotic surgery or radiation. And we know that once patients are presented TULSA as a treatment option, they choose TULSA. The CAPTAIN trial initial target enrollment of 201 patients was surpassed with a total of 212 patients treated. The reason for this increase was to compensate for patients who dropped out of the study disproportionately after being randomized to robotic radical prostatectomy. Already, the initial perioperative outcomes demonstrate conclusively that TULSA provides a superior patient experience compared to robotic surgery. These outcomes were presented during this year's AUA Annual Meeting or that of the American Urological Association, which was at the end of April in Las Vegas. These outcomes were summarized during our last quarter's investor call. Briefly, TULSA provides patients, surgeons, and hospitals with no procedural blood loss and no overnight stay, nearly a full 24 hours less than robotic surgery. Compared to robotic surgery, patients treated with TULSA have statistically and clinically significant less pain during the first week after the procedure, and they're in better overall health every day for the first 30 days of their recovery. To put this into context, robotic prostatectomy patients take more than two weeks, almost three weeks of recovery on average to feel like a TULSA patient does the very next day after their procedure. TULSA is giving two weeks back to the patient. These perioperative outcomes are meaningful beyond what they mean clinically and operationally for patients, surgeons, hospitals, and also payers. They are a window into what we might expect through additional short, medium, and long-term study endpoints. In essence, superior perioperative outcomes provide us with the confidence that CAPTAIN will continue to demonstrate favorable TULSA outcomes via its primary endpoints of safety at 1 year and efficacy at 3 years. The final preoperative results are on track to be announced at this year's Annual Meeting of the RSNA or the Radiological Society of North America as well as at the SUO or the Society of Urological Oncology, both in early December. We also expect that the data will be mature enough to provide the first subset of 1-year outcome data at these two meetings before announcing more complete results at AUA in 2026. The second seminal achievement this quarter is the pilot release of the new TULSA-AI volume reduction software. Using the same TULSA hardware, the same indication for use, and the same reimbursement codes, the new software module designed for BPH procedures offers fast intelligent workflows that will provide surgeons with an estimated total procedure time of 60 to 90 minutes regardless of prostate shape or size. The first commercial BPH procedure with the new TULSA-AI volume reduction software was performed in June, and we remain on track with the full commercial launch in the back half of this year. We believe this new software will help move TULSA from niche to mainstream within the BPH treatment options. Whether prostate cancer, BPH, or patients with both cancer and BPH, surgeons and facilities will be able to stack cases, creating predictable and efficient TULSA dates, all with no overnight stay, no blood loss, no fulguration, no Grade 4 adverse events, and no need for patients to discontinue their anticoagulant therapy. Coinciding with the TULSA-AI volume reduction pilot release was the publication of 12-month outcomes from a Phase II trial evaluating TULSA for the treatment of men with BPH. The prospective 30-patient study by Dr. Viitala and his team at Turku University Hospital in Finland was published in BJU International. The study demonstrates significant BPH symptoms relief on par or better than modern treatment. The IPSS or International Prostate Symptom Score decreased 76% from 17 to 4. After TULSA, all quality of life measures improved, urine incontinence scores improved, even sexual function scores remained stable or improved in all patients. 96% of patients discontinued their BPH medication, and none of the patients had to discontinue or bridge their anticoagulant therapy. These outstanding clinical results speak to the precision achieved using state-of-the-art real-time MRI and true personalized treatment plans offered by AI-powered TULSA-PRO. With that, I'll now turn the call over to Arun.

Thanks, Mathieu, and good afternoon, everyone. To summarize what you just heard, our sales team has been stabilized. That, combined with our large and growing TULSA-PRO pipeline, continues to drive our confidence in our ability to deliver full-year revenue growth of approximately 70% to 75% in 2025 over 2024. The new TULSA-AI volume reduction module to treat patients with BPH symptoms is significantly reducing the procedure time, making it very competitive with other BPH treatment technologies. Adding the BPH module also enables physicians to create a full TULSA day during which both prostate cancer and/or BPH patients can be treated. From the perspective of ease of scheduling and creating a TULSA program, this ability is important. And finally, the initial clinical outcomes data from CAPTAIN will be presented in December. We continue to believe that as more data is published, it will most likely lead to new guidelines from relevant cancer societies that will effectively require that patients be made aware of TULSA as an option along with radical prostatectomy and radiation therapy. This ends our prepared remarks for today. With that, we're happy to take any questions you might have. Operator?

Our first question comes from Rick Wise with Stifel.

This is John on for Rick. Just wanted to start off with the guidance. Good to hear that you're reiterating the prior range. Just want to get a better understanding of the ramp. And then within that, how to think about the sales contribution from a recurring and capital perspective. So if you could just offer some color on how that builds throughout the third and fourth quarter and whether this mix of 80 systems in the pipeline fits more into the capital structure or more into the prior pay-per-use structure that you were using?

Yes. I want to provide a high-level overview before handing it over to Tom for more details. In our Q1, we transitioned to what I refer to as the standard med tech model. Our main objective moving forward is to expand the number of locations in the United States, with capital revenue expected to play a larger role in our overall figures. Previously, recurring revenue has been the primary contributor as that was the model we followed. In the upcoming quarters, we anticipate a shift in the revenue mix from recurring revenue to capital revenue. However, as our installed base increases, we envision becoming a company that mainly relies on recurring revenue, aiming for around 70% recurring and 30% capital revenue in the long term. Additionally, we noted in our press release that we've observed an increase in same-store procedures, comparable to same-store sales. From Q1 to Q2, utilization in these locations rose by about 10%, which I find encouraging. The full effect of reimbursement has not yet been felt, but we are beginning to witness its impact, especially moving into Q2, and we expect to see it more prominently in Q3 and Q4. Tom, please go ahead and elaborate on the capital sales aspect.

Yes, happy to, and thank you for the question, John. So building off Arun's statements and your preliminary question specific to the 80 systems that we've referenced, the capital model is obviously our preferred methodology to introduce the technology into the commercial realm now that Medicare reimbursement is live as of January 1 this year. So there's a mixture of new capital. There's still some remaining placements from the previous model prior to reimbursement being live on January 1. So converting those placements is absolutely part of the strategy. And then last but certainly not least, capital cycles can be quite interesting given the bureaucratic corporatized nature of American healthcare at this stage of the game. So if it's required to do a placement agreement to stay outside of the capital cycle leading into years from now, in order to get new sites, we are willing to work with customers to do a placement agreement with a significant commitment in terms of the number of cases that they will complete. And there's a delta between the cost per procedure under that model versus the capital model, and it's strategically done so that the capital model is absolutely more attractive in the long run for the hospital. Hopefully, that provides a little bit more color to the question that you asked.

Yes, that's helpful. And just in terms of the CAPTAIN data, I wanted to hear any feedback you're getting from physicians in the field. Is this inspiring greater adoption? Is this helping the pipeline? Just any commentary on CAPTAIN would be helpful.

I think we are receiving a lot of positive feedback regarding the clinical trials initiated by our company, Profound. This enthusiasm comes even from individuals who typically refrain from endorsing initiatives. It's been very encouraging to see that response. Additionally, receiving good feedback about the completion of the trial is significant because, historically, many Level 1 trials in prostate cancer have failed to complete their recruitment, resulting in shutdowns. Our ability to finish both treatments and recruitment suggests that patients are genuinely interested in participating. People often inquire about preliminary insights on outcomes, and there is considerable confidence within our team about the results. While we can't disclose trial data, it's important to note that the outcomes from the TACT trial exceeded any previous radical prostatectomy trials. Furthermore, we have improved our product with new modules, and several hospitals have conducted their trials with results that surpass those from the TACT trial. Therefore, we believe that if the CAPTAIN results align with these trends, we will demonstrate statistically non-inferior or even better outcomes.

Our next question coming from the line of Michael Freeman with Raymond James.

I would like to ask about the recent news regarding the proposed rule for reimbursement on BPH treatments. Could you provide some insight into how the codes assigned to the TULSA procedure compare to the existing options for BPH treatments?

Sure. Mathieu, you might as well take this since you're closest to it.

Thank you, Michael, for the question. The proposed CMS rule was released in July regarding facility and physician payments starting in 2026. It is draft guidance until the final rule is published in November. On the BPH side, there were significant downward adjustments made to the physician relative value units for transurethral resection of the prostate and other related procedures. Fortunately, our TULSA procedure was impacted the least among these. We retained our Level 7 facility reimbursement for hospitals, and the reimbursement for ASCs remains very favorable. Even in terms of physician payments, we were less affected compared to other procedures. When comparing a BPH procedure to a TULSA-PRO, our positioning is much more advantageous. Additionally, when looking at the per-unit time for RVUs generated, physicians will generate fewer RVUs under the adjusted BPH codes. However, with our TULSA-AI volume reduction software, we aim to streamline the procedure to about a 60- to 90-minute skin-to-skin time for the physician. From this perspective, we maintain a favorable position compared to other BPH procedures. We are receiving excellent feedback from both facilities and physicians, who appreciate being able to schedule a full TULSA day and effectively manage cases of both prostate cancer and BPH patients throughout the day. Overall, we are getting strong operational and financial responses.

Michael, if we consider the specific numbers, many people are thinking about Aquablation, so I’ll address it. It is now more aligned with the standard CPT-1 code. Our BPH module, with the volume reduction component, shows that the procedure can be completed in the targeted time of 60 to 75 minutes. To build on Mathieu's point, it will generate more revenue than other procedures, and it will be significant. However, it’s important to note that this is a proposed rule, and changes may occur. Additionally, TULSA has emerged with no significant alterations in this year's regulations.

That's great. I appreciate all of that information. I have another question, and I think this one is probably for Tom. I really value your explanation of the sales funnel. Could you elaborate a bit on the last segment of Verify, specifically the negotiating and contracting process? I would like more details about the definitions of each of these stages. Additionally, regarding your contracting stage, could you share the average time it typically takes for individuals to move from the contracting stage to installation, as well as the average historical conversion rate you've observed?

Michael, thanks for the question. And oh man, do I wish I had very analytical answers to it at this stage of the game. We're working towards that, right, because we just switched to the capital model at the beginning this year. So the point being is that the definition of these stages is to enable us to be able to do just that, right? What is the average time to go from one stage to the next, et cetera, et cetera, so that we can be much more predictive and reliable in our forecasting as an organization. What I can tell you is that we check all the boxes, right, the clinical value with patients, the clinical value as seen by the physicians. And as you just asked a great question specific to the economics, we check the box there as well. So really, what we've learned how to do is organizational selling. And what do I mean by that is, we've done a much better job here of honing the process such that we include our clinical team for the clinical sale, our health economics and market access team for the economic sale, and working very closely, and this is getting back to your original question, with our service team and our engineers as it relates to verifying and confirming magnet compatibility and any potential remediation that may need to take place in order to launch a TULSA program such that we can leverage the other departments outside of sales to work in parallel to the sales process so that we're not doing things in just a 1 block, 2 block, 3-block fashion, but trying to get each of those pathways started and running in parallel as much as humanly possible to compress the timelines of a normal capital sale. So part of the verification is exactly as I just described, specific to confirming magnet compatibility, any potential remediation that needs to take place to launch a TULSA program from a workflow standpoint, and the list goes on. So we are doing a much better job of ensuring that we are setting up new site launches such that by the time the PO is issued, we've already got a good portion of the launch under our belts so we can get to treating patients faster, which is obviously the goal of everything that we're doing here in the first place.

I appreciate that. Now, could we focus on the contracting stage? What specific activities are your targets in that stage involved in with you? Please provide as many details as you can.

I can provide some insight. I understand your question. Currently, due to the novelty of these capital sales, our contracting process is a bit more complicated until we establish ourselves in hospitals and learn how to implement the TULSA program. This complexity arises because multiple departments are typically involved. The surgery department is always engaged since it’s a surgical procedure, and there are also inputs from urology, radiology, anesthesia, among others. Tom is addressing how to improve the efficiency of this contracting phase. This process is definitely not a matter of just a couple of weeks; it usually takes around 90 days or 3 to 4 months. At this time, I can’t provide further details. However, what Tom has achieved is a clear understanding of the involved departments, how to streamline interactions, and how to measure these processes so we can shorten these timelines in the future. Your reasoning is correct, and the reason for the delays is because this is a new and more intricate process compared to an established product where we would typically be selling a device to just one department. I hope that clarifies things.

Yes. I understand that. Very last question here. You described some streamlining in your sales force. I wonder if that might translate to a reduction in burn going forward?

Yes. Rashed, you might address that.

Sure. So thanks, Michael. So definitely, like I mean, we initially had said, remember last year when we had the analyst call that we'll have a little bit higher cash burn in the Q1 and Q2. And as Tom said, we already did make the necessary adjustment in the sales team. Also, if you look at our working capital, we have also increased our inventory a little bit to fulfill the orders that are going to come in the future. Also, please note that our gross margin has been staying very strong. We've been in the 70-plus percent, right? So in the second half, as the order comes in and we convert the working capital into cash, then we expect that our cash burn in the second half is going to be much lower compared to the first half.

Our next question coming from the line of Scott McAuley with Paradigm Capital.

I guess two for me. One, maybe I missed it, but kind of what's the current number of active TULSA placements in the U.S.? And how many have been added kind of since our last update?

We currently have around 60 active sites and are in the process of installing three more. We are optimistic that we will reach at least 75 by the end of this year.

That's great. And on the TULSA-PLUS, that was kind of highlighted as part of that investor event during AUA and seemed like an interesting opportunity. Any updates there or any of those numbers that you had highlighted in the pipeline for TULSA-PLUS? Or are you treating that kind of separately?

Yes, that's a very good question. We remain optimistic about the TULSA-PLUS model. The short-term sales relate to the use of existing MRs at current sites, which is still the quickest way to drive installations and revenue growth. However, there are some significant strategic developments. Since our last discussion, Cook Medical has launched a new division called the IMRI division, focusing on interventional MRs. They are collaborating closely with Siemens to begin the installation of new interventional MRs in hospitals, and the response has been quite positive. We have also been reviewing several sites with economic models, and the economics look quite promising. We never anticipated it would generate considerable revenue in 2025, as we previously mentioned, but we do expect to have at least one installation by the year's end. We are currently developing compatibility with the Siemens interventional magnet and expect to complete that by mid to late Q4. We are still very optimistic. We are pleased that a major company like Cook is starting to get interventional MRs installed. The multi-departmental sale and workflow issues will be resolved as these interventional MRs are installed in hospitals. For example, Johns Hopkins has acquired the TULSA system and an interventional MR, which should be operational later this year. Other hospitals have placed orders that will be operational by the middle of next year. We know Invictus interventional MRs for neurosurgery are transitioning from diagnostic to interventional MRs that can now also be used for urology. Mayo in Jacksonville is a prime example of this transition, and they are very satisfied with the change. Overall, this transition is indeed progressing well, and we are very excited about it.

That's great. Very interesting color there. And sorry, one last one for me. I know the past few months has been some new marketing initiatives, hiring the spokesperson, I think kind of increased activity on social media and elsewhere. Are you happy with the results of those initiatives, kind of planned expansion of those for the balance of the year to help get the word out both kind of directly to patients as well as to new physicians?

Scott, I'm personally very, very happy with the team that we have. We did make some adjustments in that team also because when you hire all these new people, you have to look at what fits and what doesn't. But at this point, I'm thrilled with where we are. And yes, we are really, really grateful and excited about Leonard joining as our spokesperson. And yes, you will see significant presence as the top line grows; you will see significant presence in the social media from us.

Our next question coming from the line of Doug Loe with Leede Financial.

I appreciate all the color on all the blocking and tackling you're doing to drive TULSA-PRO adoption. There's no substitute for this more blocking and tackling on that theme. But just a couple of related questions, if I may. Arun, maybe just with regard to the 60 existing TULSA-PRO active sites that you referred to. Just wondering if you are aware of any longitudinal studies or localized clinical trials that might be relevant in the peer-reviewed medical literature that could sort of drive awareness of TULSA-PRO's utility just from a clinical collaborator perspective? So that's the first question. And then, second of all, I was just wondering the number of the systemic therapies for targeting prostate cancer that used to target castrate-resistant disease are moving downstream into localized disease, ZYTIGA and XTANDI, specifically the cytochrome inhibitors. I was just wondering if in your discussions with potential customers, if there's any sort of pushback on perhaps some bias toward continuing to use systemic therapies in comparison to a localized ablation therapy like TULSA-PRO, if that's at all relevant to adoption. And I'll leave it with those two questions.

Okay, Doug, how much time do you have? This is about philosophy. I'll do my best to address your questions. Mathieu, could you provide some details on the number of publications we have had so far and the number of presentations, as well as some information on the ongoing studies? After that, I'll come back to answer the second part of Doug's question.

Yes, for sure. Thank you, Doug. Of course, Profound has our sponsored studies, CAPTAIN, obviously big news through to the completion of all patient treatments, and we move through into the data readout, which we believe will be important for professional society guidelines, which will be impactful for utilization. But in addition to that, there are a number of other initiatives, both kind of from Profound's perspective and many from the sites themselves. So we do have an international registry. So this is a Profound-sponsored registry. It's called the CARE Registry, and it's international, and we invite every TULSA site into this registry. And the protocol is designed such that any patient treated with TULSA-PRO can be put into the registry. So whether they have cancer, whether they have BPH, or whether they have certain specific things about their condition, they can all be included in the registry, and then we can do some subgroup analysis after the fact. So that is certainly a growing body of evidence, and we've done a number of conference presentations through that. There's a number of important U.S. sites in this registry, and we've also expanded it to a few important sites outside the U.S. So that's ongoing, and we plan to have that as regular updates throughout the year as the years progress. And I think that will provide a lot of real-world evidence as to what kind of patients are treated with TULSA as well as clinical outcomes, which will then again help drive adoption as well as payer coverage. As Arun was sort of alluding to, many of the sites like to revalidate their clinical outcomes once they acquire the TULSA-PRO. So they read about our clinical studies, TACT trial, et cetera. They acquire the device, especially academic hospitals. They like to sort of revalidate in their own hands what kind of outcomes are they getting. And so they do their own sort of studies on their own. And as Arun mentioned in his comments, what we see from those studies actually is the outcomes there are actually better than TACT more often than not as they sort of get to use the product without tight clinical trial restrictions, if you want to call them that. So there, we've certainly seen these sites present their data through the conference circuit. Sometimes we even include them in some of our press releases. They include major academic sites in the U.S. We mentioned Mayo, Florida, UT Southwestern. And I can tell you that sort of so far this year, we've had at least 12 presentations at major society meetings that featured CAPTAIN data, our CARE Registry data, real-world usage of the contouring assistant, AI feature, dose escalation protocols, and so on. So I don't know, it's a bit of a long-winded answer to your question, but do you find that helpful?

Yes. Regarding your second question, the prostate space is very dynamic right now, with significant ongoing research in both drug development and improved diagnostics. To address your point about better and earlier diagnosis, there’s considerable effort in this area. To summarize quickly, the key takeaway from major studies on diagnostics is that if cancer can be visualized through an MRI, it should be treated; if it cannot, it is not worth treating. This has been supported by genomic testing. We are excited about this as it leads to more MR-centric treatment for prostate cancer, allowing us to catch the disease early, which means more patients for technologies like ours. Additionally, many of these drugs aim to contain or halt the disease by targeting cancer stem cells. There’s a strong possibility that TULSA and these drug developments will complement each other, as they could potentially eliminate 50% to 90% of the prostate affected by the disease, which is diffused and multifocal. Thus, it’s feasible to remove the visible cancer and address any remaining cancer stem cells. Overall, I’m quite optimistic about this development. Although it’s challenging to discuss in this format, I believe TULSA will play a significant role as new technologies emerge.

Our next question coming from the line of Ben Haynor with Lake Street Capital Markets.

I'm interested in how the soft launch of the volume reduction module for BPH is progressing. What has been the initial feedback? Can you share any records regarding the fastest procedure times? Has anyone surpassed the current record of five TULSA procedures in a single day?

Ben, thanks very much for the question. I'll take a stab at it to start, and I'd really like Mathieu to chime in as well as he's very close to the launch with his clinical team also. Thus far, the feedback has been great, and we're excited for the full launch coming up in Q4 of that particular software module and upgrade. The whole point of that is to make sure that we streamline a few different things, in particular, the procedure time, as you're alluding to. And so we're looking to get that procedure time in the range of 60 to 90 minutes, of course, depending on the size of the prostate and any other concomitant factors that go into that. But on average, 60 to 90 minutes, which is obviously quite different than our current timeline as it relates to prostate cancer, where many times it's a whole gland ablation, which, of course, takes more time than just removing a segment of the tissue as you would do in BPH procedures. So very excited about that and very excited about the full launch coming up. And I'll let Mathieu chime in as well on anything I may have missed.

Thank you, Tom and Ben, for your question. We are currently in a pilot launch and have installed the software at about four to five sites involved in this initiative to collect data for the full launch. As Tom mentioned, we are receiving excellent feedback from physician users regarding various features, and we are using that feedback to improve our user interface. We plan to incorporate these adjustments for the full launch later this year. In terms of meeting our objectives, early data indicates that we are achieving our goal of 60 to 90 minutes, leaning closer to 60 minutes. We are pleased with this progress, especially considering this is only the first version of the software. To provide a comprehensive response to your question, I would like to finish the pilot launch before releasing the full software, which will include a complete set of features validated by our clinical users, representing the commercial-grade software we aim to evaluate in the market.

Okay. Very helpful. Regarding the upcoming CAPTAIN data releases, I know there has been some discussion this afternoon. Can you summarize what you expect to see in the next couple of months at RSNA and SUO? I'm referring to the subset of the 1-year outcomes and what additional information might generate excitement.

Mathieu, do you want to take that?

Yes, sure. I think first and foremost, I mean, not to minimize it, but having the complete data set of the perioperative outcomes will be important because it will sort of be the final data set of those outcomes, and that will also be what we will be publishing in peer-reviewed publications, which is then what professional societies and payers look at. They tend to look at the full peer-reviewed publication rather than sort of conference presentations. So I think that's not to be minimized that at RSNA and SUO we'll have that in place. We'll have that in the literature, and that will really enable us to start some of these conversations with professional societies who we know are already supportive of the procedure, right? The professional societies are the ones that sort of took the TULSA procedure to the CPT panel for the CPT Category 1 code. So we already know that there's support of the procedure now with sort of peer-reviewed publications in that randomized context, Level 1 data, it will give us more interactions with them as well as with payers. In addition to that, we will have to check how mature the data set is with respect to all the other either primary or secondary outcomes. We do expect that by then, we'll be able to start to give kind of interim looks at that, whether it's 1-year sort of safety outcomes, 1-year quality of life outcomes, urinary incontinence, erectile dysfunction, and then maybe even some early efficacy outcomes. It's difficult for me to give you exact targets right now because it will depend on the maturity of that data, but that would be sort of what we'd be considering at that point in time, some PSAs, potentially even some histological comparisons of biopsy outcomes to positive surgical margins on the surgery side.

Okay, so still quite a bit to see there, obviously. And then you mentioned the conversations with the professional societies of the CAPTAIN data. Any more color you can shine on the conversations with payers on that front?

Yes, absolutely. I think to some extent, the absence of blood loss and hospital stays was already known before the trial began. From a physician's perspective, this isn’t necessarily surprising, but it does provide us with data that can be used for direct-to-patient marketing. This information is also crucial for hospital administrators and payers, as a 24-hour reduction in length of stay has significant operational and financial implications for them. Additionally, they pay attention to data showing less pain and better overall patient health. Many physicians I’ve spoken to acknowledged that while the company had mentioned patients were not in pain, they were still conducting extensive treatments on the prostate, leaving some questions about the post-operative experience. Therefore, the fact that we have shown statistically and clinically significant reductions in pain during the first week after therapy and improvements in overall health for the first 30 days post-procedure is quite impactful for both our physicians and patients. This will likely influence how they present TULSA to their patients.

And there are no further questions in the queue at this time. I will now turn the call back over to Dr. Menawat for any closing remarks.

Thank you so much for the colorful questions. We're looking forward to updating you in the Q3 analyst call. Thank you. Have a wonderful day.

This concludes today's conference call. Thank you for your participation, and you may now disconnect.