Profound Medical Corp. (NASDAQ:PROF) Q2 2025 Earnings Call Transcript

Profound Medical Corp. (NASDAQ:PROF) Q2 2025 Earnings Call Transcript August 14, 2025

Profound Medical Corp. misses on earnings expectations. Reported EPS is $-0.52 EPS, expectations were $-0.43.

Operator: Good day, everyone, and thank you for standing by. Welcome to the Profound Medical Second Quarter 2025 Financial Results Conference Call. [Operator Instructions] 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.

Stephen Kilmer: 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 — whether 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.

Rashed Dewan: 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 onetime 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.

Thomas Tamberrino: 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 lend us all 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 is not a statistically significant indicator of success. The intangibles of grit, perseverance and resiliency will more than likely prove out to an R squared equaling 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 3 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.

Mathieu Burtnyk: Thank you, Tom, and good afternoon. During the second quarter of this year, 2 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 CAPTAN randomized controlled trial is decisive and foundational because it is designed to be a key driver towards gaining 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 is 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 2 weeks, almost 3 weeks of recovery on average to feel like a TULSA patient does the very next day after their procedure. TULSA is giving 2 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 2 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.

Arun Swarup Menawat: 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 of these 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?

Q&A Session

Operator: [Operator Instructions] Our first question coming from the line of Rick Wise with Stifel.

John Glenn McAulay: 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, what the — 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?

Arun Swarup Menawat: Yes. Let me just sort of share that a little bit high level and I’ll turn it over to Tom to give you more color. So what I’ve been saying is that we — you heard that in our Q1, we have been switching to this standard, what I call the standard med tech model. And what you will see at the high level is that our next goal is to really increase the number of sites in the United States and capital revenue will more likely dominate the total numbers. Up till now, recurring revenue has been dominating because that’s been the model we’ve been using. And so I think over the next few quarters, you will see that the mix of revenue will switch from recurring revenue to capital revenue. But as the installed base grows, over the long haul, we see ourselves as a recurring revenue dominant company where I think over the long haul, it will still be about 70% recurring revenue and 30% capital revenue.

One more quick color. If you — in our press release, we said we are certainly seeing an increase in same-store procedures or in normal terms, you would call it same-store sales. So between Q1 to Q2, we saw an increase in utilization in the same stores by about 10%, which I’m very happy to see. And at this stage, the whole impact of reimbursement hasn’t really hit. I think we are starting to see it now coming in. But Q2 — Q1, certainly, there wasn’t much. Q2, we were starting to see it, and you can see the increase. But in Q3, Q4, you will see that as well. With that, Tom, you might want to provide a little more color on the capital sales part in particular.

Thomas Tamberrino: 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 of 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.

John Glenn McAulay: 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.

Arun Swarup Menawat: I mean, John, I think with respect to the feedback, we are getting very, very high positive comments that a company like Profound undertook this level of clinical trial. And I think that comes from people who normally don’t like to endorse anything, quite frankly. And so I think that part has not — that has been really, really pleasing to see. The second place we are getting really good feedback is the fact that the trial is now complete. So now it’s like the investment has been made, everything is done. And the reason that is important is because historically, if you go back 15 years or so, there have been attempts to do Level 1 trials in prostate cancer, but those trials have always never — they never completed recruitment and thereby they were all shut down before they completed.

And so I think the fact that we were able to complete the treatments and the recruitment, I think people are finding that patients obviously are interested in doing this as well. The third thing that we are — people do ask things like, well, what do you see? Are you seeing anything that could give us some kind of a preliminary indication on outcomes and so on. And I think that there is certainly a very high level of confidence in our team with respect to the outcomes. And it’s not necessarily divulging any data from the trial, but it’s just thinking about the fact that when we look at the results of the TACT trial, they were better than the trials — any trial in radical prostatectomy. And then since that time, our product has improved, introducing new modules that have improved.

And we have multiple hospitals that have done their own trial and their data is actually even better than the TACT trial data. So I think there is sufficient body of evidence that we feel that if the CAPTAIN results are in the same realm and there is no reason to believe they won’t be that we should be able to demonstrate statistically at least the non-inferior or better outcomes.

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

Michael W. Freeman: I think first, I’d like to ask about the — there were some news about the proposed rule for reimbursement on BPH treatments during the last several weeks. I wonder if you could shed some light on sort of the relative attractiveness of the codes assigned to the TULSA procedure versus what’s currently out there for BPH today.

Arun Swarup Menawat: Sure. Mathieu, you might as well take this since you’re closest to it.

Mathieu Burtnyk: Yes, absolutely. So thank you, Michael, for the question. The proposed CMS proposed rule did come out in July in reference to the proposed facility payments and physician payments starting in 2026. Of course, it’s just a draft guidance until the final rule is out in November. But interestingly, on the BPH side of the equation, there were large adjustments made to the physician RVUs, relative value units, which is the physician payment part of the equation, a downwards adjustment for transurethral resection of the prostate TRP as well as other transurethral resect procedures for BPH. And so from a TULSA perspective, we actually were impacted the least compared to all these other procedures. We maintained our Level 7 facility reimbursement for the hospital, device intensive for the ASCs remain very, very favorable from a facility standpoint.

And from a physician payment standpoint, we were impacted the least compared to all the other procedures. And so when you think about — you can think about these as one BPH procedure versus one TULSA-PRO. And from that perspective, we are quite a bit more favorable than those other procedures. And then on top of that, when you think about it as a per unit time. So per unit time, what are the number of RVUs that the physicians are generating? Well, they’re going to start generating fewer RVUs under the adjusted BPH codes. And then with our TULSA-AI volume reduction software, where the goal of that is to streamline the procedure down to about a 60- to 90-minute skin-to-skin time for the physician. From a per unit time perspective, we continue to maintain a very favorable positioning to other BPH procedures.

So from that perspective, we’re receiving really great feedback from both facilities as well as physicians in that concept that they can now sort of book a full TULSA day, whether it’s once a week or once every 2 weeks and really be able to stack their cases throughout that day and combining both kind of prostate cancer patients as well as BPH patients. So operationally and financially, we’re receiving really great feedback from that perspective.

Arun Swarup Menawat: Michael, we’re — yes, I mean, if you think about specific numbers, I think a lot of people have Aquablation in their mind, so I might as well address it is that indeed, now they are more in the standard category CPT-1 code. And I think as our BPH module with the volume reduction module demonstrates that it can be done in the 60 to 75 minutes that we’ve targeted, I think to Mathieu’s point, we will — in absolute dollars, it will pay higher than what these other procedures pay, and it will be relevant. So having said all that, I mean, it is a proposed rule and things do change. And so please keep that in mind. But yes, I think TULSA came — has effectively come out with no material change in this year’s rules.

Michael W. Freeman: That’s great. I appreciate all of that color. Another question, I think and this is probably going to Tom. I really appreciate you laying out what your sales funnel looks like. And I wonder if you could zoom in a bit on that sort of the final segment of Verify negotiating contracting. Could you describe a little bit more about what — go a little deeper on the definitions of each of these stages? And then specifically on your contracting stage, what would you — how would you describe the average time between — I guess, average time between folks being in the contracting stage to installed and the average conversion rate that you’ve seen historically?

Thomas Tamberrino: 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 time lines 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.

Michael W. Freeman: Okay. All right. I appreciate that. Now one — maybe we can just zoom in on the contracting stage. What — then they might infer some things, but I wonder if you could just go over what exactly the activities are that your targets in that stage are engaged in with you? And as many details as you can.

Arun Swarup Menawat: I can give you a little bit of color. Sure. No, I think — so I think I understand where you — what you’re really asking. At the moment, because of the newness of the fact that these are capital sales, our contracting phase is slightly more complex than once we get established in hospitals figure out how to acquire the TULSA program. It is a little bit more complex from the perspective that multiple departments are involved generally. There’s — certainly, the surgery department is involved always if — since it is a surgical procedure, urology is involved, radiology is involved to some extent, anesthesia might be involved and so on. So I think those lines of communications, how do you streamline that contracting phase is what Tom is referring to.

So it’s definitely not a couple of weeks. It’s probably not more than 90 days or 3 to 4 months. Unfortunately, we cannot give you more color than this at the moment. But what Tom has accomplished is the fact that we are now — we have a very clear idea of what are these departments, how do we go about streamlining them and how do we measure these so that as time goes on, we can contract these time frames. So I think your point is — your thought process is right, why is it taking long? It’s because it is a new process, and it is a little bit more complex than if it was an established product, and we simply had a device that was sold to one department. Is that helpful?

Michael W. Freeman: 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?

Arun Swarup Menawat: Yes. Rashed, you might address that.

Rashed Dewan: 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, that 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’s going to come in, 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.

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

Scott McAuley: I guess 2 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?

Arun Swarup Menawat: So we have about 60 active sites. We’ve added — we’re installing 3 at the moment. We are pretty confident we’ll hit at least 75 by end of this year.

Scott McAuley: 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?

Arun Swarup Menawat: Yes. Scott, that’s a very good question also. We remain very bullish on the TULSA-PLUS model. I think the short-term sales that described are related to using existing MRs in existing sites because that still remains the fastest way to drive installations and top line growth. But there are a couple of really good strategic things that are happening. One of them is that since we talked last, Cook Medical has now announced a whole new division. It’s called IMRI division. So I’m sure you can guess that is for interventional MRs. So they are working closely with Siemens to be able to start installing new interventional MRs at hospitals and the reception seems to be pretty good. We have been also reviewing at number of sites with the economic models and the economics is, frankly, pretty compelling.

So we never thought that it would be a big revenue generator for 2025, as we’ve said before. But we do think that we are likely to have at least one install by end of the year. The product we have is being — we are developing the compatibility with the Siemens interventional magnet, and we are on track to have it completed in mid- to late Q4. So we are still very positive on this. We’re absolutely delighted that Siemens and a big company like Cook will start to get interventional MRs installed. So this whole issue related to the multi-departmental sale and the workflow, all those issues will get resolved as the interventional MRs get installed in the hospital. I can give you a couple of examples. So for example, Johns Hopkins has purchased the TULSA system, and they have purchased an interventional MR.

That system should be running later this year. We have other hospitals that have ordered this and will be running by middle of next year that we know about. And we also know that, for example, Invictus interventional MRs for neurosurgery. We have a couple of sites that are now switching from diagnostic MRs to interventional MRs that are normally designed for neuro can now also be used for urology. So Mayo, Jacksonville is a very good example where they’ve already done that and are very happy with that change. So that transition is most certainly on track, and we’re really thrilled with it.

Scott McAuley: 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?

Arun Swarup Menawat: Scott, we’re — 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.

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

Douglas W. Loe: 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 2 questions.

Arun Swarup Menawat: Okay. Doug, how much time do you have? This is about philosophy. But I’ll try to address them to the best I can. But Mathieu, with respect to clinical trial, maybe you could provide a little bit of color on how many publications we’ve had so far and how many presentations and then just a little more color on the ongoing studies, and then I’ll come back and answer the question on the other — the second part of Doug’s question.

Mathieu Burtnyk: 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?

Douglas W. Loe: Yes.

Arun Swarup Menawat: Yes. With respect to your other second question, Doug, prostate is an incredibly dynamic space right now. And there’s quite a bit of research going on in not only drug development, but also in better diagnostics. And to the point that you made, can we, in fact, diagnose better and earlier and thereby catch these patients while the disease is confined to the prostate, I think there’s quite a bit of work going on. So I’m going to summarize very quickly for you. So number one, on the diagnostics side, the basic conclusion from some of the big studies is if you can visualize the cancer in — through an MRI, you should treat it. If you cannot visualize the cancer, it is not worth treating. And that has been validated quite a bit through genomics testing and so on.

So we’re thrilled with that because that kind of gets us to more MR-centric treatment of prostate and catching the disease when it’s confined, it means more patients for technologies like ours. The second thing that is really, really important is that a lot of these drugs are basically trying to confine or arrest the disease and they go after the cancer stem cells. So I think what we are seeing is that there is a very good likelihood that TULSA and these drug developments are likely to be very complementary, where you might kill anywhere from 50% to 90% of the prostate where the disease is. It is a diffused multifocal disease. And so you could kill the discernible cancer and then supply some disease to make sure that the cancer stem cells that do remain will not leave.

So I’m actually, quite frankly, very bullish about all of this. Hard to talk about it in these forms, but I think that TULSA is going to have a very prominent role as these new technologies come to market.

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

Benjamin Charles Haynor: Just curious on how the soft launch of the volume reduction module for BPH is going. What’s kind of been the initial reaction there? Is there any records you can share in terms of fastest procedure time? Or has anyone beat kind of the leader in the clubhouse of, I think, 5 procedures in a day — TULSA procedures in a day is the highest I’ve heard, has anyone vested that yet?

Thomas Tamberrino: 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 time line 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.

Mathieu Burtnyk: Yes. Thank you, Tom, and thank you, Ben, for the question. We are in a limited — in a pilot launch. And so we have installed the software at about 4 to 5 sites that are participating in this launch so that we can gather the data in time for the full launch. And as Tom mentioned, we are getting a really excellent feedback from the physician users on all the various features, and we are taking that feedback and adjusting our user interface accordingly based upon the feedback from these physicians, and we’ll be able to incorporate that for the full launch towards in the back half of this year. To your question about are we meeting our objectives, certainly, the early data tells us that, yes, we are certainly meeting our objectives of the 60 to 90 minutes.

And if anything, it’s closer to the 60 than to the 90. So we’re delighted to see that. And again, this is with the first version of the software. So I think to give you a comprehensive answer to your question, I’d like to complete the pilot version of the launch and then have our full software released, which will have the full extent of features validated by our clinical users, which should really be the commercial-grade software that we would like to evaluate in market.

Benjamin Charles Haynor: Okay. Very helpful. And then on kind of the next slugs of CAPTAIN data that are coming out, I know there’s been a little bit of discussion here this afternoon. But what beyond — what we’ve already — not beyond what we’ve already talked about, but can you kind of summarize what you expect to see here in a couple of few months here at RSNA and SUO, I mean, subset of the 1-year outcomes potentially. What else do you think will get people excited?

Arun Swarup Menawat: Mathieu, do you want to take that?

Mathieu Burtnyk: Yes, sure. Go ahead and take that. Yes. So 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 we’re 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 — like we’ll have certain elements with a strong enough maturity that 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.

Benjamin Charles Haynor: 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?

Arun Swarup Menawat: Yes, absolutely. I think to a certain point, the no blood loss and no hospital stay, people knew this before going into the trial. And so from like a physician standpoint, they’re not surprised necessarily, but it does give us data to go directly to the patient and do sort of direct-to-patient marketing. And these are also the types of data that are very, very important for kind of hospital administrators as well as payers, right? And so for them to see kind of that 24 hours less length of stay for them that implies very important things from an operational and financial standpoint. So these are certainly things that they look at. The other set of data, the less pain, the patient better overall health, those endpoints actually were not necessarily — I speak to a lot of physicians where they were like, I know the company was telling me these patients weren’t in pain, but we’re still treating their whole prostate.

And so they still had some open questions around some of that post-op patient experience. And so the fact that we’ve been able to demonstrate statistically and clinically significant, less pain for that first week after therapy and better overall health for the full first 30 days after the procedure, that’s actually quite impactful for our physicians and our patients. And I think that does start to influence how they sort of present TULSA to their patients.

Operator: 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.

Arun Swarup Menawat: 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.

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