Executive readout · one minute
Call research workspace
Read the call alongside every captured source. Audio, transcript, slides and SEC filings stay in one workspace.
Capital Markets Day · 2025-04-28
Executive readout · one minute
Read the call alongside every captured source. Audio, transcript, slides and SEC filings stay in one workspace.
Research coverage
2 live sources
Switch sources without leaving this page or losing your listening position.
Open the source you need; every reader stays inside this workspace.
Listen and read together
The spoken word highlights as audio plays. Select any word to seek to that moment.
Good afternoon, and welcome to the 2025 Profound Investor event. Please take your seats and silence your mobile devices. Our program will begin in two minutes. Good afternoon, and welcome to the 2025 Profound Investor event. Please take your seats and silence your mobile devices. Our program will begin shortly. Please welcome to the stage Profound President, Matthew Burtnick.
Thank you and good afternoon and welcome to Profound's Medicals AUA 2025 investor event. I can't think of a more appropriate time than during the American Urological Association's annual meeting to share with you an update on our progress and some of the exciting developments we have in store for you in 2025. We are at an inflection point of establishing Tulsa as the mainstream treatment option for personalized prostate ablation, malignant or benign, without compromise. First in prostate cancer, we are delighted to have fully and successfully enrolled in our CAPTAIN Level 1 randomized control trial. Following my presentation, Dr. Ram Pathak will come to the podium and share with you his Tulsa experience, outcomes, and efficient interventional MRI workflow. Second, in BPH, where Arun will describe and unveil our new Tulsa AI volume reduction module, which positions Tulsa as a mainstream option for patients with BPH. Following Arun, Dr. Naveen Kela will share his perspective on treating BPH with Tulsa. And finally, Tulsa Plus, where Arun will come back to the podium and describe the evolution of incision-free surgery with complete interventional MRI plus Tulsa solution. And Tom will demonstrate how we're breaking barriers to MRI access with a Tulsa Plus commercial model. Finally, with Dr. Mark Hong, we'll share his vision of Tulsa adoption for mainstream prostate treatment. Before we jump into the CAPTAIN trial, I wanted to take a moment to reflect on why the surgical robot was adopted and how it was driven by patient demand. On the right of the screen, you see a paper by Chang et al., which is probably the highest quality, largest prospective, comparative, non-randomized trial comparing open to robotic prostatectomy. In this study, including the top 11 academic centers in the US. They demonstrated that there was actually no difference in prostate cancer outcomes. There was no difference in health-related quality of life, but robotic surgery did in fact improve the perioperative outcomes for patients. So they improved the patient experience, and this is what drove demand for the surgical robot. They demonstrated less blood flow, sorry, less blood loss, shorter length of stay, less pain, and less pain-related moderate to extreme interference with activity. With the captain perioperative outcomes, we have now completed the established Tulsa Pro clinical evidence of cancer outcomes and favorable quality of life. Via existing evidence of TACT FDA study, real-world usage, and our review articles, we already know the strong prostate cancer five-year outcomes and how they are equivalent to progression-free survival of robotic prostatectomy, but improved health-related quality of life, whether in whole gland or partial gland ablation. With Captain, we are here to present to you today how the patient experience has now been proven in a head-to-head randomized control trial to the gold standard of care of robotic prostatectomy. And so we will show how Tulsa has no blood loss, no overnight stay in hospital, less pain, less interference with activities, mobility, and self-care, and better overall health for the patient. The CAPTAIN trial. So we have already strong data in prostate cancer. Why did we run the CAPTAIN trial? Well, first and foremost, practice guidelines and commercial payers call for level one randomized control trials to really establish ablative therapies as standard of care. So first and foremost, this is a trial for clinical guideline adoption, as well as commercial payers. This was not an easy trial to design and to execute. Past randomized control trials of localized prostate cancer have all failed to recruit due to lack of equipoise between the comparative arms. Patients refuse to be randomized between something like a prostatectomy and the other new modality. CAPTAIN is the first randomized control trial in this space to have successfully randomized to target enrollment. As of January 2025, we had randomized 201 patients, and we continue to enroll patients until 201 patients have been treated due to some of the dropout that we have observed in the trial. To date, we have either treated or scheduled for treatment 194 of the patients, so we're really at the tail end. In the next couple of weeks, we will be completely done with the patient treatments. We have purposefully included in this study principal investigators that include the best academic and private surgeons. And I commend all of the names that you see on this slide for have participated in the study and have helped us successfully enroll this study and demonstrate to you the value of the Tulsa Probe. If you were to take the average number of prostatectomies that these surgeons have done, it is in the multiple thousands. So in a sense, we are comparing relatively initial experience with the Tulsa Pro to highly experienced surgeons. And I think this was one of the keys as to why we were able to successfully enroll in We were able to tell the patient, hey, look, on one hand, you might have a radical prostatectomy. On the other hand, you might get whole gland Tulsa, not just a focal treatment, but really a whole gland treatment. And so that actually provided equipoise for the patient to choose between the two arms. And at the end of the day, the surgeons were able to say, hey, look, if you get randomized to either arm, you're in good hands in my hands. So thank you to all of these investigators, sincerely. All right, let's get into the data. So we have now hard evidence that demonstrates to you without a doubt that Tulsa Pro completely eliminates blood loss and overnight stay for both the patient and the hospital. The graph on the left, you see blood loss with Tulsa at zero and the RP arm with a median of about 100 milliliters. If you were to go back to that Chang et al. paper that I showed you on the first slide, these outcomes are actually better than what that study demonstrated. And I think that's further evidence that we did partner ourselves with the best surgeons so that we can position the data to the clinical community in the best way possible. So from less blood loss to no blood loss. On the right of the screen, you can see the length of stay, and I hesitate to say hospital. Often we say hospital length of stay, but not all the Tulsa patients were treated in hospital, so just length of stay. So from shorter length of stay to no overnight stay, you can see that the RP patients stayed on average about 1.24 days in hospital, and the Tulsa patients stayed 0.29 days in hospital. That's a full 24 hours less in the hospital for the patient. It's not just no overnight. It's a full 24 hours less. And if I can get a little bit cheeky here and just drop a line at when dinner time is, you can see that all the Tulsa patients are either at a restaurant or sitting at home with their family having dinner while the radical prostatectomy patients are eating hospital food laying in a hospital bed. When we look at the post-treatment experience from a pain and quality of life perspective, we can see that now Tulsa Pro has statistically significant less pain during the first week post-treatment. And that is statistically significant for all those points there that you have the star. If you were to look at, these are validated questionnaires, the EQ5D5L health status after treatment, and you were to look at the percentage of patients that report extreme problem or inability with mobility, self-care, usual activities, we cannot demonstrate that Tulsa has statistically significantly improved patient experience in those domains. That means Tulsa patients can have full mobility versus radical prostatectomy patients, or at least 12% of them have extreme problems or inability in this domain within the first month post-treatment. Same with self-care, same with usual activities, less pain. In this case, it wasn't statistically significant, but it was less pain. And finally, if you look at overall health, so this question asked the patient, if you were to rate your overall health, how do you feel today? Zero being the best health you can ever imagine, and 100 being the worst health you can ever imagine. Here we're looking at the change from baseline for both of these arms, and we can see that Tulsa patients have statistically significant better overall health for all 30 days measured after the procedure. These were patient 30-day diaries. So for every single day of that first month, Tulsa patients were in better overall health. If we were to look at sort of the two-week time frame, robotic prostatectomy patients take more than two weeks on average of recovery to feel like a Tulsa patient does the day after their procedure. And by that two-week time point, the Tulsa patients are back to feeling like they were prior to treatment. Moving beyond the CAPTAIN study, this slide here talks about how Tulsa Pro clinical outcomes lead to better patient experience, which leads to high patient satisfaction. And we believe that that high patient satisfaction will drive patient demand and Tulsa Pro adoption. This data here is not part of the CAPTAIN trial. It was collected by Dr. Mang and his colleagues at UT Southwestern in Dallas, Texas, and it shows a 5.2% regret score. This is the lowest regret score that I believe we have ever seen in a prostate cancer treatment. And also importantly, 88.5% of patients would recommend Tulsa to a family member. I think that is absolutely strong data and further evidence of how patients have a positive post-operative experience. And again, we believe that that will help drive adoption of the Tulsa Pro. So we have established improved perioperative outcomes, but we also have established improved efficacy and safety compared to all other ablative modalities. This is a review table that I put together that summarizes all prostate ablation, whether it's HIFU or IRA or Tulsa, with patients from the United States. And you can see that when we compare apples to apples, whole gland to whole gland, or focal to focal, Tulsa wins every time. And finally, Tulsa Pro does provide that unrivaled precision technology and ablation flexibility. I think you're used to seeing Profound show the spectrum of patients from benign to cancer to salvage. These are specific examples that no other technology could do all four of these. And this is due to the fact that this is an intraoperative MRI procedure, as well as a transorethral treatment modality. So in the top left, we have a targeted ablation of an extreme apical lesion that most other ablative devices cannot do. And even in surgery, this can be a very challenging patient to treat without, again, causing that incontinence. If you look at the bottom left, this was a BPH patient, where due to the intraoperative images revealing a lesion in the anterior part of this patient's prostate all the way through to the apex, the physicians decided to extend the ablation further out than the initially planned to completely cover that suspicious area of imaging in the top right a vanilla transition zone ablation for BPH and a large gland and in the bottom a salvage hemi for radio recurrent prostate cancer and with that
I'll thank you for your attention please welcome to the stage associate professor in the department of urology at Mayo Clinic Florida dr. Rom Pathak
All right. Good afternoon. I get to talk about prostate cancer and how I use Tulsa in patients that I see in clinic. And a lot of my talk is going to be about data and outcomes. And while it is really important to know about the data and outcomes, it's really the patient as a whole. Are they getting better? Is their cancer gone? And are they not having any side effects? And that's kind what they care about. We were selected, our patients, sorry, our Tulsa experience was selected as part of the care registry to be a podium presentation at this year's AUA, and I had a chance to present that yesterday, so I'll give an encore presentation today. And let's get started. These are my disclosures. So Matthew did a great job of explaining how Tulsa works. Essentially, it's an incisionless, needleless, needle-free technology that is able to cure prostate cancer in select patients with clinically localized prostate cancer. There's no energy delivered through the rectum and really can treat lesions in any part of the prostate. It is a robotic procedure. It's done with real-time MRI. Again, this is an in-bore procedure. The patient is inside an MRI machine, and I kind of like to think of it as, at least when I talk to my patients, you know, it's imagine treating something in 4K. You know, your TVs nowadays come in 4K, but imagine if you didn't have 4K and you're using ultrasound technology, and to me, that's more like your standard definition, TVs, you know, 20, 30 years ago. So it's really precise and really can provide individualized treatments to patients. Again, Matthew covered this, no blood loss, no overnight stay. Patients are home eating dinner. And the safety is achieved by cooling devices located in the urethra and the rectum. So I'm going to talk a little bit about the pathway. You know, how does this work? How does this process work? Essentially, you know, patients are typically referred either with, you know, a new diagnosis of prostate cancer that we have worked up in our clinic or from the outside. We review the patient's history with particular attention to the patient's MRI, their biopsy, how aggressive that cancer is, and any other staging scans that are available. We review this as part of a multidisciplinary focal therapy team. And if applicable, we perform the Tulsa treatment to these patients. And so we're going to go over all of these in detail. So in terms of workup, who is eligible to receive Tulsa? Well, essentially, it's anyone with kind of grade group one, two, or three disease. So whenever we talk about prostate cancer, we always talk about how aggressive it is, and that's a scale from one to five. Five is very aggressive. One is not aggressive at all. And a majority of these cancers are usually your ones, twos, and threes, and those are the ones that you ideally want to offer Tulsa, especially if the MRI says there's a lesion in a particular area and the biopsy is concordant with that lesion. You can treat select gray group 1 patients, especially in patients who have family history of prostate cancer, high PSA density, or someone having a lot of urinary symptoms. Tulsa can also be used in the salvage setting. So, you know, a patient underwent radiation therapy for their prostate cancer. Unfortunately, there's a recurrence. What do we do? well, we can do Tulsa for those patients as well. Things that Tulsa would not be good for are patients who have locally advanced disease. So that means cancer has already escaped the prostate capsule and is invading surrounding structures. You know, though it's a more advanced disease, it likely needs a more advanced treatment. Also, if the lesion is greater than three centimeters, three and a half centimeters from the target, then we always get CT scans to check for calcifications. So, we always do what's called a shared decision-making with our patients. We offer them all the different modalities, whether it's surgery, radiation, or Tulsa, and we let the patient choose. And basically, the decision is based not only on the cancer cure rates, but also on functional outcomes. So, with surgery, as we know, we're talking about urinary incontinence. We're talking about erection issues after surgery. Radiation, we're talking about fecal urgency, fecal incontinence in some patients. and in Tulsa, generally, the outcomes are very, very favorable, and I'm going to have the opportunity to talk to you about some of that in the next couple of slides, but this slide, and what I want to show you with this slide is really the treatment is individualized, so you see those three different horizontal graphs, and it basically shows, based on where the cancer is that specific patient is how we do the ablation. So on the top one, we're looking at, you know, a left-sided hemiablation. On the middle one, we're looking more of a subtotal ablation, just sparing that left side just a little bit. And then on the top, on the bottom one, we're looking at a completely an anterior hemiablation. So again, you can tailor the treatment according to how the patient presents. You know, surgery is also another good option, but surgery is kind of like and all or none. You take out the whole prostate irrespective of where the cancer is. Here, it's a little bit more specific and precise. This is an example of an interventional of the IMRI suite we have at Mayo Clinic, Florida. And here you'll see how the procedure starts. Essentially, we place a Foley catheter. We put a wire through that Foley catheter. We drain the bladder, and then we remove the Foley, at which point we introduce an ultrasound applicator, which is essentially the device that emits the technology to destroy and sort of cure the patient of their cancer. After we insert the ultrasound applicator over the guide wire, we remove the guide wire and then essentially dock the UA to the Tulsa robot, which then takes care of the rest of the procedure. So what does it look like for me? Well, as you can see, this is kind of, we're sitting by a computer and this is exactly what it looks like. The first step here is contouring the prostate, meaning drawing a line around the capsule of the prostate or the edge of the prostate. This has been sufficiently enhanced by using AI, where you can see that I'm clicking a button to automatically draw that capsule. Makes it a little bit more efficient for us. Once we draw all the surrounding, you know, the edge of the prostate or the capsule of the prostate, that's when we can verify our treatment plan and begin treatment. Treatment can either be clockwise or counterclockwise, and we can really define exactly where kind of on the clock we start the treatment and where we end it. So here's a case example of a patient I did. Again, PSA 7.6. He had gray group 2 disease, and he had an anterior lesion, lesion at essentially the top of the prostate, and it spanned from like kind of the middle of the prostate towards the bladder. He had about a 46 cc gland and calcifications at the bottom of the prostate, but again, not impeding the beam. So we performed a focal anterior ablation. We did two sweeps. We could spare all the nerves that are responsible for erectile function postoperatively. We could spare all the ejaculatory ducts, which are responsible for integrated ejaculation. The UA was placed centrally, again, the target within the distance. And it took about two hours of total MRI room time. 37 minutes was for planning, and 28 minutes for ablation. So what does follow-up look like? So once we finish that treatment, we follow them up like we follow any other prostate cancer patient. Specifically, we take a catheter out in a week, and then we follow up with PSA and validated questionnaires, at least for the first year, if not afterwards. Very little pain in the patients that we treat. You know, you don't need opioids. They can use anti-inflammatories or even Tylenol or Advil. We give antibiotics as part of guideline care, and they have very temporary, if any, stress urinary incontinence. So this is an example of a 76-year-old male we used Tulsa for prostate cancer, but this patient was unique in the sense that he had pre-existing lower urinary tract symptoms, essentially difficulty voiding or troubles urinating. He had an anterior lesion in the transition zone. And what you're seeing here is you're actually seeing the cavity that was created from the Tulsa. And at first glance, it kind of looks like you're already in the bladder upon cystoscopy. But you'll see our cystoscope now traverses the bladder neck. Now you're really in the bladder. So the reason why I like this video is because of two things. Number one, it shows that with Tulsa, you can be very precise. You can spare that bladder neck. You can spare the varro and the sphincter complex. So much so that when you look on Retroflex U, you see that it's just a nice, closed, tight bladder neck. You can imagine, because of that, patients are able to have integrate ejaculation, don't have any leakage of urine, or don't have any issues with continence. Again, this is a grade group three patient that we did, and a whole gland tulsa was performed for combined BPH and prostate cancer. So this is a little bit about the workflow. You know, it takes about an hour for room prep, and then for our part, maybe about two to three hours skin to skin. Most of that time is the ablation. The planning has actually gotten a little quicker than this diagram, given the new AI enhancement software. And the device insertion, especially with more and more experiences, is becoming quicker and quicker. This is an example of our data. Again, total MRI time is improving substantially. Again, it's like anything. The more you do, the more efficient you become. um and you can achieve to about three cases per day especially with uh you know a consistent team including MRI radiologists techs um you know your turnover staff and an anesthesia team that can work in parallel but also as a urologist you know there's a lot of downtime for me that I can you know either catch up on on EMR stuff or even see patients in between cases um and now I get to talk about kind of the outcomes that we found using the care registry. So this was a prospective observational study where patients, you know, consent to be a part of it, and we're able to track their data longitudinally. So these are kind of the real-world outcomes after MRI-guided transurethral ablation. So again, single-arm, multi-center, prospective observational cohort. These are the five institutions that took part in this. And again, most of them were for primary prostate cancer, about 80%. And those that had primary cancer, again, most of them, about 60%, were for grade group Or if you look at both two and three combined, it's over 80%. And the next graph talks about ablation fraction. And I want to spend some time talking about this because there's a lot of misnomers in urology specifically related to focal therapy. So what is focal therapy? Well, according to the care registry for us and for patients treated by Tulsa, what we mean by here is, you know, about 70% of the patients, if not 80% of the patients, were treated with a minimum of a hemiablation, meaning half of their prostate got exposure to treatment. Whereas about 20% were really truly focal, meaning less than 50% of their prostate was treated. Average age, about 70, which is just in line with how prostate cancer works. PSA, about 6.6. The volume was about 40. But again, all those mean that those are just your typical average index prostate cancer patient. And so efficacy outcomes, what did we find? So about 141 patients in the registry reached about one-year follow-up. The PSA decreased by 90%. So not only was that a substantial decline, but it was also very durable. As you can see, 36 months out, that PSA did not budge. 75% had no evidence of disease, or three out of every four, on follow-up MRIs. And at a year, 9% had biopsy-confirmed clinically significant cancer, while 7% had biopsy-confirmed clinically insignificant cancer. 6% required retreatment, of which about 3% required radiation, and another 3% required repeat Tulsa. But really, this is kind of the crux of this, is the safety and function outcomes, and this is why this is different than other treatment modalities. And at one year, most patients, not most, 94% of patients were pad-free, 98% were leak-free. So when you look at the literature and you're looking at these outcomes, especially when you compare them across different treatment modalities, and when we're really looking at robotic prostatectomy, the literature kind of seems to indicate that, you know, incontinence is defined as zero to one pad a day, and that's how people typically report their outcomes. But here we're talking about zero pads a day, and that's 94% of the patients in this study at a year. 77% had preserved erectile function, and 15% reported some degree of erectile dysfunction. 4% had some GU complications that we're going to talk about in just a minute. And these are essentially the conclusions. Again, this is the initial experience at our academic site outside of any clinical trials, demonstrating the benefits of Tulsa. We offer it alongside as one of the options for clinically localized prostate cancer, and outcomes are prospectively tracked, and really profound should be commended on tracking these outcomes longitudinally, not just at a year, but really thereafter. And, you know, we've shown, especially through the care registry, that it's a safe procedure, it's effective in select patients with that grade group 1, grade group 4 prostate cancer. um we just got a nice overview of the captain trial uh and you know in summary i tulsa pro tulsa pro is an mri guided procedure it has you know good surgical workflow that certainly improves over time thanks to a dedicated consistent team and technology improvements
thank you please welcome to the stage profound ceo and chairman arun menawat
All right. Thank you. Amazing data, amazing presentations. We will now move to the next part of the agenda, where we want to talk about the updates that we're doing to our Tulsa AI modules, and these updates will enable physicians to treat patients who have BPH also. So we're going to talk about two big features that were added, but before I go there, let me just talk about the business side of the equation. So these schematics, just to share with you, cancer versus VPH are two very different diseases. So with cancer, it tends to be on the outer edges. It actually sometimes will protrude out and deform the prostate to some extent, and thereby the shape becomes quite unique to each individual, whereas BPH patients is the central part, which is called the transition zone, simply expands, and you can see that. So the way to think about it is cancer is coming from the outside into the prostate, and BPH is caused by inside outgrowth of the prostate. And so we've talked about the fact that about 200,000 patients could qualify to be patients for prostate cancer. And we think, obviously, BPH is a... Several million patients have BPH, but we think that the target for us at this early stage is about 400,000 patients, which effectively means 600 total, and so we see the TAM for the company at about $5 billion, and about 70% of that TAM will be recurring revenue. I think that's part of the value that we bring, but the second part of adding BPH to this portfolio is that now physicians can actually have what I would call a Tulsa day. So they can have all day of prostate cancer patients. Dr. Pathak talked about three. Or they can mix and match. They can have a couple of cancer patients, a couple of BPH patients, which can actually increase the number of total patients they would treat on that day. Or they can have all BPH patients. So adding this new feature set will provide them with the additional patients to be able to become much more efficient and create these days, which we think will help both sides of the equation, both the cancer side as well as the BPH side. So you've heard me talk about TELSA AI. These are intelligent modules. Most of them are software, but some of them are likely to have components of hardware in them as well. And each module has a purpose. So they can be about clinical outcomes or reducing treatment time or improving workflow or adding such that a higher variety of patients can be treated with this. And one of the first modules that we introduced was the thermal boost module, which was highly requested by our physicians. Because as I mentioned, cancer tends to be right at the outer edge. And a number of physicians basically said, you know, we really want to be sure that we have covered the edge. And you can see the image on the top right. We actually go just beyond the boundaries, a millimeter or two, so that the physicians can be sure that they're not leaving any cancerous margins behind. And what we find is that 50% of the patients who are being treated today, thermal boost is used in it. So it's been a very effective program. I can see, because I get reports, we all get reports on the patients that are treated, I can see even some of the teaching hospitals, leading teaching hospitals, are now starting to treat even Gleason grade 9 patients with TELSA, which I would have never guessed they would do, because some of these teaching hospitals tend to really, really be very conservative as they grow new technology programs. So the thermal boost is one of them, the contouring assistant, which Dr. Pathig already mentioned, it automatically provides a recommended treatment design, particularly for whole gland. we have one that aligns the equipment and the images properly very quickly, so it reduces the number of steps they have to do. It's an ease-of-use feature, and the one that we're introducing today is a volume reduction, the idea being that the best way to fix BPH is to really reduce the volume of the prostate and reduce that pressure that's inside that prostate, And that's exactly the purpose of the volume reduction module for us. So, this is how it works. So, on the left, you see the AI module. And with AI, you can see it contours the boundaries of the full prostate. With this, we're actually adding two new features. One is called the volume customizers. So the idea is that, as I mentioned, the transition zone is the real culprit that causes this problem. And so this volume customizer feature allows them to shrink it down so it mostly covers that transition zone. So it's basically trying to figure out where's the cause and how do I really focus on the cause. The second feature is what we're calling a treatment arc. So click a button, an arc will show up, and this arc has these handles, and they can just move those handles up and down, and they can very quickly design what percentage of the prostate, what type of side of prostate they want to move. And that arc can be moved. It can be on the upper end. It can move to the sides and so on. So these are the two technical features that are being added in our software that gives them a lot more flexibility to now effectively and quickly design the treatment that they want to do. Now this arc has another feature, and that feature, as I mentioned, it can also be used with our contouring assistant. So if there is a patient where there is a lesion in one section of the prostate, and they really do want to do, as Dr. Pathak mentioned, focal therapy, they can take that arc, turn it on, and it can be centrally positioned so that the lesion is fully covered and with some extra margins, and they can quickly treat that. So not only these features are designed to improve our ability to do more BPH patients, but also it will give them another tool that will help them more efficiently treat patients with focal therapy. So together, all of these are these features. Here's what this means. So first, you can see the whole gland. We do whole gland treatment. The contouring assistant helps them with that. The second image in the same row, in the cancer row, is the arc that allows them to do a vast majority of the patient's prostate, and they can move the arc and thereby they can pretty quickly make the decision if they're doing subtotal. And then if they're doing a targeted, they can use the arc to really make it targeted to the lesion region and thereby they can do it. But the other thing that we have added with this, just like when you go on Google Maps or any maps and it gives you a target time when you will get there, this will now also, in a very intelligent way, tell them how long will it take to do the ablation. So you can see underneath each of these lines, the ablation time for 70 cc is 55 minutes and so on. And you see the ablation for the targeted 20 cc ablation is 16 minutes of ablation time. Now, if they use that same arc with the new volume customizer tool, then you shrink that region to some extent, and there are ways they can shrink it to whatever they want to do. And then now you have treatment for BPH. You can see that by design, that arc has that triangle in the bottom, and so it automatically saves the Veroot, saves the ejector redux, saves the nerve bundles, and certainly it's safe for the rectal cavity in that region. So it gives you safety very, very quickly. And again, they can do a high-volume reduction If there's a very large prostate, they feel they need to do that. Or medium to minimal is probably where they're going to spend most of the time. And you can see if it's a minimal program, they're treating a 33cc prostate, which is still, quite frankly, a lot of prostate, but that can also be done in about 16 minutes. And one interesting thing on this page is you'll see that actually the cancer patient volume takes a little longer. So it's a 20 cc in 16 minutes, whereas a benign prostate is faster when you're ablating it, so you can actually get to 33 cc in 16 minutes as well. So hopefully you can see the flexibility continues to get better, and it allows them to really be efficient in the design of that treatment, and they have a very good predictability. So it's just a very quick movie of how the product works. You can see it goes from the outside. It quickly shrinks to a smaller size. The treatment arc shows up, and they can move that arc to whatever location they want to do. One of the other things it does is it actually does not heat or blade the slice of the MR that is right next to the sphincter muscles because that then automatically saves those muscles and minimizes the probability of incontinence. So by doing it so efficiently, they can actually do five patients in a day, in fact. And you can see that is in spite of the fact that there is a one-hour gap, and physicians will usually go and do another procedure in between cases, but even in a very comfortable way, Typically, they'll start between 7, 7.30 time frame, and typically they're done by 5 o'clock. And that is the plan that we're going to be working on. And I think that will actually make it a very efficient Tulsa day for that. And so the value that we're creating with this, as I mentioned, is really in volume reduction, and thereby we fully anticipate that the volume reduction module will, in fact, provide a very durable treatment for these patients. So the launch plans, the treatment arc is, this is a new software release that will be out there within the next four weeks. The treatment arc is going to be part of the new release. It will be available pretty much to the whole install base within four weeks. In that first announcement that we're making on that new upgraded software, we've also actually upgraded the contouring assistant. The original contouring assistant that was cleared by the FDA was based upon 54 million parameters. This new one is now based upon 216 parameters, which basically makes it, based upon our internal data, as good as any radiologist, the best of the best. So we feel very comfortable. I think it will continue to provide more confidence to the urology community that this treatment assistant or contouring assistant can be relied upon. For the customizer feature, which will primarily function towards the volume reduction module, we're going to introduce it in another six weeks or so, and we're going to do a soft launch in the third quarter. We anticipate a minimum of five sites. We'll get going with this, and we'll do a full launch by the end of Q3, early Q4 time frame. And all this data that we will be collecting will, in fact, also become part of the care registry, which will also, as Dr. Pathak described, the registry, you'll start to see updates on that for the BPH module as well as we go forward. So this is the bottom line, that we think that we can do rapid ablation of large prostate volumes. You already know about no hospital stay and blood loss, those benefits. No filiguration, meaning that they don't have to go ablate blood vessels at the end of the procedure, which is a big deal for us. That step is not even needed in our case. There are patients who are on blood thinners. Elderly men do tend to get on blood thinners. there won't be a need to even get off of blood thinners. Highly customized, each of those treatment designs has the shape of the prostate change. Longitudinally, the treatment design changes accordingly for them. And then our indication of use, if you look at the description that we submitted originally to the FDA, the indication of use clearly defines that our technology can be used for malignant ablation of malignant tissue or benign tissue or both. And so we feel we are in a very good place with respect to the FDA. So with that, I'm going to turn it over to Dr. Kella.
Please welcome to the stage the founder of the Urology Place and an adjunct assistant professor for the UT Health Science Center, San Antonio, Dr. Naveen Kella.
All right, well, thank you for having me. Good afternoon, everyone. My name is Naveen Kella. disclosures. I'm on the clinical advisory board for Profound, and I'm one of the investigators in the CAPTAIN randomized trial for prostate cancer. So I'm going to be talking to you about BPH as well, kind of dovetailing with Arun's talk. So first of all, BPH. A lot of men in the room, and as we get older, in our 50s, half of us are going to start having symptoms of BPH, and it just continues to progress, and these symptoms can become very irritating. Sometimes you could have BPH as well as prostate cancer, but BPH is a very prevalent condition, and we have a lot of treatment options for BPH. As a urologist, I'll have patients come in. Initially, we may talk about behavioral changes. Then we talk about supplements, medication. Eventually, we get into procedures, and there's a variety of procedures that we can offer our patients. We can do things where we place temporary implants to change the shape of the prostate. We can do permanent implants that can kind of pull the prostate open. As the prostate gets bigger, we can get more invasive with the types of procedures we have for prostates that are from 30 to 80 cc's, which is probably where a lot of our treatments start to take place and where a lot of patients live we can offer treatments that use water vapor laser the terp which is used as an electric or bipolar knife to remove tissue there's a water jet treatment and then as the prostates get even bigger there's overlap but we start getting into other types of options where we use a laser to try to enucleate the entirety of the prostate a very technically challenging procedure we have something that's called pae that we use with their radiology colleagues, where they'll actually embolize the artery that supplies the prostate, causing the prostate to shrink. And robotic-assisted simple prostatectomy, where we actually remove the obstructing part, the part that's creating the resistance to the bladder. We can remove that, but leave the rest of the prostate alone. And then sometimes, as I said, BPH comes with prostate cancer, and we can do combination treatments where, for example, to treat the BPH and the cancer, we could remove the whole prostate using surgery. Some patients who aren't candidates or don't want surgery could do a terp or some sort of procedure prior to getting into radiation. All these treatment options, there's lots of factors to consider in trying to counsel with the patient to figure out what makes sense. I mean, really paramount, obviously, is going to be safety and efficacy. You know, people want things that work, but it has to come with safety. So we discuss how long will this treatment potentially last? Could it last you a few years? Could it last you the rest of your life? We'll talk about the risk of incontinence. Some of these procedures have a significant potential for potentially creating problems with urinary control, ejaculatory function. Patients, even as they get older, want to maintain as much function as possible, including their ejaculation. Some of these procedures can be done in the office. Some of these procedures require hospital stays. Some involve blood loss. So there's lots of things that we talk about as we go into options. So Tulsa. So Tulsa, as you know now in the TAC study, it was able to, when you treat the whole prostate, the prostate could shrink by 90% after one year. So it's able to really create a lot of volume reduction. so the implications to BPH become obvious there. And comparing Tulsa to some of these other treatments that we have right now for BPH that I talked about earlier, well, one thing is that we're using MRI guidance. And with MRI guidance, it can allow us to precisely aim at the areas we want to treat and importantly, avoid the areas that we don't want to treat. And Arun talked about the fact that with this, then you could improve the safety, and improve the chance of avoiding problems with ejaculation, avoiding the nerves that can control erections. Those all should be things with this type of treatment that really shouldn't occur. And then you still have flexibility. So if someone has cancer as well, you could still treat the prostate cancer. One thing also is that Tulsa is a 360-degree treatment inside out, and that's important because a lot of people who have obstruction, A lot of the tissue potentially could be on the top side of the prostate, and that is well within Tulsa's wheelhouse. This procedure doesn't cause really any bleeding, and as you heard, it's safe for patients who are on blood thinners. And all these factors, really, when we're looking at treating patients with BPH, can make Tulsa even safer for this segment of patients than when we're treating for prostate Again, you can see here with the laser, the transitional zone, this is really what the urologists focus on to try to eliminate. That's what's causing this, in the bulk of patients, causing the problems with urination. And then we have nerves that we spare and are well away, usually from the transitional zone. So there should be very little risk of erectile dysfunction. And the rectum is down here, and as you can see, none of the treatment waves are going to be coming close to the rectum, which is also very rare. I think there's been one reported case of rectal injury using Tulsa anyway for prostate cancer, but with this should be even lower risk. So what's some of the evidence? It's early, but this is a prospective study looking at about 30 patients who had obstructive symptoms and went through Tulsa. You can see here the outline. This is done before the contouring assistant, which will make this actually very easy for the urologist to establish. But you just outline the areas that you want to treat. The treatment under, you can see here, this is a temperature of the tissue during treatment. And this is an image of the prostate after contrast is given at the end. And you can see the black areas where really there isn't any more viable prostate tissue this can treat all sorts of different prostates so a big chunky prostate with the heavy transitional zone actually sometimes people have really bad symptoms because the prostate starts to go into the bladder and that's called the median lobe or median protrusion the Tulsa will be able to reach those areas of tissue as well importantly for the surgeon as well as the facility is the time it takes to do the treatments. And you can see here in this study, 30 patients, the ablation time was about 43 minutes. Also, remember, this is back in 2021, 2022, before all these new developments are occurring. And the volume in this study, they looked at prostates that are on average 52 grams in size. You can see most of the patients had prostates in the 48 to 65 cc range in this study. These are results. It looks complicated, but you see some trends that I'll show you. This is called an IPSS symptom score. It's what we as urologists give our patients to see how bad their symptoms are. It goes all the way up to 35. So in this average, it was around 16, 17. After one year, patients reported their symptoms to be around five, and it persisted at two years. Lots of patients also, probably the most important thing I would tell you is the quality of life. It's one question. How do you feel? Are you terrible, which is a six, or are you very pleased, which is pretty much a zero? You can see at the study, they started off as a four. By the time a year rolls around, most patients were reporting a one, and it persisted, and the patients had reported details at two years. Flow rate, you would expect with less resistance, better flow. You can see that the flow rate started around 10 to 12, and by the time a year rolled around, you were close to nearly doubling the flow rate, which is pretty remarkable. And if I were to compare this to other studies, for other modalities, you don't necessarily see flow rates improve like this. And then I'm going to come over here. You can see again, at three months, if we look back, just within three months of treatment, how rapidly Tulsa has been able to improve the quality of life for these patients. Pretty good prostate size reduction. No change in erectile function or urinary continence in these patients. Three of the 30 patients started on medications again in this study. And probably, I think, you know, going back to the safety, there weren't any, there was one grade three. A grade three means a person had to come of the hospital. And it was for an infection, epididymitis, where they had to be treated with antibiotics. That's pretty good, really good, and no grade four, no deaths from this study. Looking at some of these other treatment options as comparisons, looking at this, again, this is IPSS. This is a symptom score. And then again, I think the key thing here is, you know, quality of life. And then we talked about peak flow. But if you look at TURP, which is, again, the electric knife, laser, urolift, water vapor, which is resume, prostate artery embolization, aquablation, which is the water jet. You can see the IPSS symptom score improves with all these procedures as you would expect. You can see with Tulsa in this study, there was a 73% reduction in symptoms on par, if not better than the data that's been reported for other treatment options. Bother scores improved across all treatments, including Tulsa. And again, talked about the flow rate improvement that you see with Tulsa, well in line or better than a lot of these other therapies. This is a patient who actually came to see me for treatment for his BPH. He had done his research, found out that we offered Tulsa for prostate cancer, flew in, came in saying, I don't have cancer. I have an enlarged prostate. I want you to treat it, please. and worked him up and decided that it was a great idea for him. And with this treatment, he had a large prostate, much larger than what you saw in the study earlier. He had a 106 cc gland. He was a young guy, did not want to give up anything for his symptoms, and was very sick of the medications that he was taking for his urinary symptoms. He really wanted to maintain his sexual and ejaculatory function, so he wasn't interested in me performing a robotic removal of the gland, the enlarged gland. Did not want to try aquablation due to risk of being in the hospital and being concerned about potential for bleeding. So we were able to ablate about 60 cc's of his gland in 45 minutes. He's doing great. He's very happy. He said he would do it again. So the sweet spot for Tulsa as a treatment option. You know, this is time on the y-axis, and on the x-axis, you see prostate volume. So as the procedures that we have right now, we talked about, again, robotic, laser nucleation, PAE, aquablation, TURP, you know, some of the smaller prostates are in the wheelhouse with the Resume and Urolift and ITEND, and as you get bigger, aquablation, HOLEP, robotic removal, PAE is what we traditionally use for these bigger prostates, and they usually take more time. Right now, Tulsa Pro, which is what we use for prostate cancer treatment, the procedure duration could be anywhere from two to three hours. But with the AI volume reduction, the treatment time is going to drop. And you can see now it's really right in there with all these other treatment options for larger prostates. So in conclusion, Tulsa Pro can achieve lasting relief. It's getting rid of tissue. That's a big deal. And it can create significant volume reduction to improve quality of life, symptoms, and uroflow improvements, as I showed you in the earlier slides. And what we can do by using these treatment plans where we focus on the area that's enlarged, we're just naturally able to avoid critical structures, the ejaculatory duct, the rectum, nerves. Tulsa has really no bleeding risk, and you avoid the hospital stay. So it's a very safe treatment as far as preserving function and avoiding problems. And if patients have prostate cancer, it's like a Swiss army knife. We can use it to treat both conditions. The goal is to get this to something that's comparable for us as a urologist. I like the slide about being able to do five BPH cases in a day. Hopefully, as the technology improves, doing these procedures in 60 to 90 minutes with the computer doing a lot of the heavy lifting for us will be a great thing. Thank you very much.
Please welcome back to the stage profound CEO and chairman, Arun Menawat.
All right. So thank you, Dr. Keller. Amazing clinical data. Hope you can see the advancements in our AI modules. I want to go up a notch and talk a little bit of high level for you and how Tulsa Plus that we have been talking about for the last four or five months, how this is now starting to catch reality. So to talk about the high level, this is a page that actually when I started the company a long time ago, I used to talk about. So when you think about invasiveness in interventions, That has actually been dropping. So we've gone from open surgery to laparoscopy to robotics. And even on radiation, you see a lot of imaging coming in, but also computerization to improve the accuracy. So precision and invasiveness have been the two, or lowering the invasiveness, have been the two primary drivers towards going there. And I think we're now embarking on the next step, as Matthew said. We are at that inflection point where we think that now the next step is beyond today's robotics towards autonomous robotics. And that means an interventional MR plus Tulsa. So, you know, we've talked a lot about MR. But about six, seven years ago, I also used to say, you know, the urology practice, urology is going to come more towards us rather than us having to go towards them. And today, I can clearly tell you that MR is becoming firmly planted in the minds of the urologists because the societies have talked about this. The fact that there are now guidelines in 2023, AUA provided guidelines that updated and reinforced the use of MRI pre-biopsy. EUA followed that in 2024. And so MRI is now a part of a urologist's thought process, an integral part of their treatment regimen. And then if we talk about robotics, I think what really, you've heard that from Matthew, you've heard it from our physician speakers, what drove robotics was, number one, the demand from the patient. They wanted to have less invasiveness. It was reduction in blood loss. it was really reduction in hospital stay, and that it was applicable in a wide variety of patients, which was, at that time, basically removing the prostate. Well, the same principle, the same rules apply here, except it's quite binary. We're now, you know, we do have a number of patients who are demanding it. You heard that from Dr. Keller. You saw the data that Matthew presented where 88.5% of the patients who have undergone a Tulsa procedure will recommend that to their family. So I think that pull, the demand pull, is indeed in our favor at this point. And as I said, we're moving from today's robotics to autonomous robotics, where you can now go from less blood loss to no blood loss and no hospital stay. And you saw one of the pages that Dr. pathic presented, they already have an interventional MR that they use. And a number of hospitals are now budgeting for it. You're going to hear more and more hospitals that are now recognizing that just like they installed robotic operating rooms, it's now time to install an interventional MR suite as well. And just like for robotics, the first application was prostate, here also the first application is prostate. Isn't it amazing how these things so mesh in the forward direction. And I think that there are two things that I see. One thing is that the interventional MR, as just like the robot has been used now, it is being used in a multitude of different types of applications. I think an interventional MR suite will ultimately be used in multitude of different type of applications. And I won't spend too much time on it because Dr. Hung is going to talk more about it in the future, but certainly you know that we are already doing clinical trials in pancreatic cancer and some of the women's disease like adenomyosis and so on. And there are other companies that are looking at brain and cardiovascular and spine applications, and I think this will democratize the use of the interventional MR over time. But the other way that I think for a urologist, this can become, go from, do I really want an MR or how do I control it to a full control of the use of the MR from the very beginning of the patient, where you can screen the patient population, which a lot of patients want to get screened, to then lesion detection, to the biopsy, and then staging the patient properly, and then of course treating, and then doing follow-ups, and if there's a repeat needed in a small percentage of patients, they can actually repeat that as well. So you can see this is a game-changing idea that it's time for interventional MR to come in and for prostatectomy to take, and urologist to take the lead in driving that revolution. And so with that, I'm going to turn it over to Tom to kind of describe exactly where our program is.
Please welcome to the stage Profound Chief Commercial Officer Tom Tamburino.
All right, good afternoon. To continue the conversation about what is Tulsa Plus, as outlined by Rune, we're going to walk through what we consider a turnkey solution for our target customers to obtain and utilize and adopt the Tulsa Pro technology. One of the major headwinds for the MR space in the urology community has been the number of diagnostic scans required in order to make it a cash flow positive opportunity for them. We'd like to believe through the next few minutes that we're going to demonstrate that Tulsa Pro is the key to unlock that opportunity for the likes of the original equipment manufacturers of MR. So Tulsa Plus is a comprehensive solution. When a urologist says they want to use Tulsa, we come to them with what they need. So if they plan to be operating in an ambulatory surgical center, we'll provide not only the Tulsa, we'll also provide the MR. If there's a need for anesthesia equipment, we'll assist with that. The workflow, as you've heard, is very, very important to the efficiencies of providing Tulsa several times per day, not only for prostate cancer, but also for BPH. And our clinical genius team, which is a team of scientists, has been the backbone of this technology for years now. And we continue to rise above their shoulders to bring us to the next stage of commercialization. They'll be a critical part of that. Patient, physician, and staff education, as well as advocacy for those patients as well, will be a critical component to making sure that Tulsa Plus is successful. And last but certainly not least, as I've come to learn in my six months in the urology space, economics and reimbursement seem to be a very important portion of the equation for the adoption of new technology. All these things combined make Tulsa Plus the IMRI solution of today. We have the privilege of being partnered with Siemens and have the opportunity to present their 0.55 Tesla Magnetone Freemax to the urology call point. And our relationship is being built around the fact that this is the ideal solution for an interventional MRI suite. Why is that the case? Well, it's the largest bore in the world at 80 centimeters. Pretty important for those of us in the United States of America where obesity would require such a large size. The technology does not require a quench pipe. Therefore, a lot of the build-out that's normally required for 1.5 or 3.0 Tesla is not needed. So rather than seeing a crane bring an MR into a hospital or to a new space, you can wheel this in. And it provides a whole host of benefits, which we'll get to in a few slides, from an economical standpoint in terms of the cost of acquisition as well as the continued cost of ownership. Last but certainly not least, it is the most compact MRI available. That also reduces the footprint required for the MR room itself, which again makes it advantageous to enter into other places outside of the hospital, inclusive of ASCs. And last but certainly not least, based on the weight, you can place this at higher levels within a structural building. Most MRs within a hospital, 1.5, 3.0s, right, you'll find them in the basement. With Magnetone, Freemax, you're able to place it at higher levels within a structural building. So this is going to be the opportunity to unlock the urological opportunity for MR manufacturers that they've been pining for for a long time. Let's start talking numbers. So if you compare what the normal cost of ownership would be for a 1.5 or 3.0 Tesla, and you look at what the cost of ownership would be for the Magnetone Freemax, you quickly find out that there's a reduction across every portion of the spend that you would need, right? Number one, the service drops dramatically, and that's because of the fact that this is a much more compact and self-contained unit. As mentioned, no quench pipe, one of the most important factors as it relates to that. Operationally, it also comes down because you're using a lot less of your utility resources, and the product itself in terms of COGS is less and therefore part of that savings is passed on to the consumer. And last but certainly not least, from an installation standpoint, we just talked about the siting where you're able to use a smaller location, not need a crane, and a whole bunch of other considerations to take into place which you'd normally require for a 1.5 or 3.0 Tesla. All these things combined lead us to the opportunity to say, all right, this sounds great for an interventional MRI suite, right? Perfect for Tulsa. However, with AI, Siemens has been able to provide diagnostic-level imaging with a 0.55 Tesla through their Deep Resolve technology. It is our belief in conjunction with Siemens that we can provide the opportunity for urologists to be doing their own diagnostic scans as opposed to referring the patient out. In addition to that, they could use this to do in-board biopsies. We're going to get close to a comprehensive solution that could also be implemented outside the confounds of the building, much like PET-CT has done with some urology practices across the United States. This should look very familiar, as it is one of the PET-CT solutions that you can find in urology practices outside of large urology group practices. This is an on-site solution that we will provide, and we've already tested and validated this model. And what takes place is that through a one-cost operating lease with Profound, we provide the Tulsa Plus, all those items that we mentioned to you. The Magnet, in this case, would be the Siemens 0.55 Magnetone Freemax, along with the Tulsa Pro, along with the necessary anesthesia, the workflow, et cetera. And as you've seen from the slides presented earlier, these patients are always making it home for dinner because there is no hospital stay. So this is an in-and-out procedure same day, which makes this a great solution for those practices that may not have the footprint, square footage, to add this in and not need a renovation or addition. The beautiful part about the reimbursement that came live this year, January 1st, level 7 within the urology space from our friends at CMS, it's now given us the opportunity to look at a whole host of different channels. You saw from the CAPTAIN study that Matthew referenced that we have both academic centers, hospitals, and also private practice physicians. The same holds true for the reimbursement as it relates to the commercialization of the technology is that we have the reimbursement in the hospital setting. We have the reimbursement in the ASC setting. We also have the reimbursement in the OBL setting, a.k.a. the private practice setting. When you compare this to the current reimbursement for prostatectomy, I think this slide clearly demonstrates that there's a host of advantages to Tulsa Pro, and the flexibility of Tulsa Plus allows us to work with the end user to decide where do they want to do this procedure. One quick thing I did want to mention is that the average rate of reimbursement for a Tulsa Pro in an ambulatory surgical center through Medicare is greater than the average rate of reimbursement for a robotic prostatectomy inside of a hospital. Okay, so how do we get there? Well, if we were to do diagnostic scans alone to reach cash flow positive on the acquisition of the Tulsa Plus solution, you would need to do 60 diagnostic scans per week, right? Annualize that out, we're up to almost 3,000 in the first year. Compare that to Tulsa Pro alone, and it only requires two Tulsa procedures per week. Quick math, we're about 100 per year. So the juxtaposition of one or the other to get to cash flow positive suggests that Tulsa clearly has a higher weighting as it relates to the cash flow that the owner can have towards reaching cash flow positive versus if they were doing diagnostic scans alone. So the solution would be somewhere in the middle. And I want to speak to the facts. I didn't mention this last slide. I'll go back for a moment. I apologize. The considerations here is that this is based on an assumption of a 50% Medicare population and a 50% private insurance population, so a 50-50 split. As you can see from the asterisk, this is specific to an ASC in Chicago, Illinois. As I'm sure we're all familiar, there's different rates of reimbursement for Medicare depending on where you are within the country, the United States, the gypsy rates. The Chicago rate is roughly 104% of that average, so it's right there in the bandwidth that you'd expect on the national average, which is a good demonstration that there's a lot of geographic opportunity to present this Tulsa Plus solution across the country. Okay, so now to the feasibility. It is our strong belief, and hopefully you can see that based on the presentations that have been provided by the doctors before me and those to follow, that two to four TALSAs per day is a very reasonable amount of TALSAs, whether that be cancer alone, BPH alone, or some combination thereof. The assumption would be if you did one TALSA per week, one TALSA a day, I apologize, per week, and you did two to four of those, so for an average of three, and you took the other four days of the week, we're not including the weekend, and you simply did seven diagnostic scans with those same assumptions, the 50% to Medicare, the 50% to private insurance still going with the following as it relates to the private insurance assumptions which we believe are moderate Tulsa Pro at 1.5 times the average Medicare rate the diagnostic scans at 2.0 times the Medicare rates that alone would cover the monthly capital costs of the Tulsa Plus solution the construction costs are baked into this assumption as well the service cost, the full-time equivalents, the genius service, assistance with marketing to patients, assistance with marketing to physicians, and the list goes on. So all being told, we're taking what would have been 60 diagnostic scans a week alone. We've dropped it down to a third of that, right? Roughly 21. And the same thing goes with Tulsa Pro, where we were saying that just with two procedures a week to 100 for the year, you're paying for all this in and of itself. You'll load in everything else, right, that comes along with it, and you're cash flow positive with this assumption. We think that's very enticing in and of itself, but there's more, of course, right? This just includes diagnostic scans and Tulsa Pro. Based on the continuum of care that's been presented before me, you can appreciate the fact that there's a lot more that goes into prostate disease care from the PSA all the way through treatment and the surveillance, the management, et cetera, et cetera, and on down the line. We've gotten gold 30 Tulsa Pro cases in the epicenter of this ecosphere that is Tulsa Pro. Also in gold is the 78 MRIs that are associated with these 30 patients. This is real data from a Tulsa Pro program here in the United States, based in Texas. It's their first 30 patients. As you can see, and I'm not going to read all these out in the interest of time. All of these other events are billable medical events, pre and post, because Tulsa has a zero-day global, right? It covers the treatment itself, and that is it. Everything thereafter is also billable. Everything prior to it is billable. So calculating all these things very quickly, you can see that Tulsa is bringing in additional revenue and interventions with that particular patient through their continuum of care. This is the perfect storm for MRI. The convergence of the fact that the urology societies across the world are now suggesting that MR is becoming the gold standard for not only diagnosis, but as we would like to believe for intervention, and then thereafter confirming that they are cancer-free. You mix that in with the fact that we've got advanced platforms such as Siemens Free Max Magnetone, the 0.55 Tesla, and the associated price point, bringing down all those factors, service, installation, cost associated with maintaining that. And then last but certainly not least, the linchpin is the Tulsa reimbursement that went live January 1st of this year. So for us, the killer app to bring MR to urologists and have them control the patient as opposed to referring them out is the Tulsa Plus. That is the Tulsa Plus program in a nutshell. It is a comprehensive solution that can be tailored to the needs of that individual customer, whether that be a hospital, an ASC, or an OBL. We have solutions available to take all of the work that would be associated with bringing this technology to market, we put it on our paper, and we charge one monthly fee for that so we can get off the ground running and remove a lot of the capital considerations that be required through a normal capital budgeting process. The next two slides I've had the privilege to share in previous investor events, but But I'd be remiss not to point out the fact that in my six months here, we've had the ability to build out a world-class commercial organization. This is myopically focused on the U.S.-based sales team, and I'm certain that all the analysts and investors can appreciate that this is a fully baked-out team. You've got a head of sales for the U.S., directors of sales, you have local capital sales executives, you have clinical sales specialists to drive volume, and you have everything else that comes along with it, health economics and market access. So we've begun our march onto the private payers to obtain positive payer policy coverage. We work with individual patients to assist them in obtaining coverage in the meantime. We have a team that works on the economics associated with the cost of acquisitions, the proformas, all the modeling that comes along with it. As we all know, there's a ton of IDNs and GPOs across the country that require a sophistication and a knowledge of how to engage and work with those. We have a team for that. And one of the teams that I'm most excited about is our market development team. They are focused on a number of B2B opportunities, and I'm sure you're familiar with some of these models with LUGPAs, partnering with the likes of interventional radiologists. In particular, there's been an explosion in PAE and that relationship. We are plugged in and speaking with a lot of those entities as to how can we do the same thing with Tulsa Pro and ride on the coattails of those already established relationships. more to come in the future on those opportunities. This will be my final slide. Again, this was shared previously in the public domain, but this is our core four for the commercial team. First things first is awareness. When I came to join the organization, I was told by one investor that we were the best kept secret. Not many people were familiar with Tulsa Pro. We're going to change that. We're going to change it quickly. It's changing here at AUA with a number of presentations from physicians like those we have here on the podium. It's also taking place across the globe through the care registry and our ability to create awareness of the data points on a collective basis of how Tulsa performs. And we're getting ready to make a huge push in the digital marketing arena and really make physicians aware, not only, but most importantly, in my humble opinion, is the patient awareness. We like to think about what took place with LASIK. when Tiger Woods had LASIK everybody else on tour had LASIK and then everybody else who thought they were professional at every country club around the country got LASIK and it just pulled down from there right one person told the other we've had several Tulsa patients who are previous National Football League players who are excited to share their story with others and we'll be leveraging these types of folks who've got name and fame to share their prostate disease journey with other men who are facing it so that they know they too have an option called Tulsa Pro. Access, we've mentioned CMS coverage January 1st of this year was a major, major win. We'll continue to push hard on the private payers to ensure we can get more covered lives in a positive payer coverage. The adoption is arguably one of the most important days on this screen as well. We're not looking to drop off the Tulsa Plus program and walk away. We want to establish a program that is going to be here for many years to come. And our belief that we will become the standard of care for prostate cancer and a formidable component in terms of BPH as well. Advocacy is what comes out of all three of these things combined. You continue this revolution, it feeds itself. We start to get inertia. We start to get momentum. I'll double down on what was shared previously, that my expectation based on where we stand today is that we'll have 70% plus growth compared to what we achieved last year. And as we turn into 2026, that is when we'll hit triple-digit growth and start to work our way up the hockey shaft. That is the growth curve that we would expect with a disruptive technology like this. I appreciate your time, and thank you so much.
Please welcome to the stage founder of Integrative Urology and clinical assistant professor, Dr. Mark Hong.
I'm blacked out. What happened? You doing okay?
All right.
Well, let me just take a drink of water first. Thank you for your time, and I'm honored to be sharing the stage with these distinguished colleagues and closing these excellent presentations with my thoughts on the future of prostate surgery. Disclosures, I am on the Clinical Advisory Board for Profile Medical. I think everyone in this room understands the technology lifecycle, one of, of course, R&D, ascent, maturity, and decline. And, of course, R&D incurs major costs. Therefore, you recoup that in the ascent and maturity phase of a company. But you do need adoption and you need scale in order to recoup those costs. And, therefore, we also all know this technology adoption curve. Basically, new technologies eventually upend the incumbent technology. So, for example, my children can't fathom that I used to carry around data in a five-inch floppy disk, just as their children will not fathom that they used to use virtual cloud storage. Surgery is subject to the same forces, just different. Safety is paramount, while efficacy may not be known for a long time. which may explain why in the world of prostate cancer disruption has been glacial if you look at open surgery where we started and then of course nerve sparing as an evolution and now with modern robotic prostatectomy we as surgeons go for what we call the trifecta it's this elusive concept of cancer care, no incontinence or leakage of urine, and preserved sexual function, erections. That's the trifecta. That's the unicorn. When I did a robotic fellowship almost 20 years ago, the promise of the robot technology was very clear. We were supposed to eradicate incontinence and eradicate erectile dysfunction with the robot. So where are we now? In the robotics era, this is data from our highest American and European journals. If you look at over the last 30 years, clinical outcomes, comparing open versus robotic surgery, basically there's been no meaningful change in incontinence or sexual function over that time, comparing those two. Certainly we lose less blood with robotic surgery. Certainly patients stay less time in the hospital. These are all important things to us as surgeons. But what about the patients? So if you're 55 years old and your cancer's cured, but you're still wearing one to two pads a day, maybe even diapers, and you are unable to get an erection no matter how much Viagra that you take, you're not all that happy. So we've actually seen the pendulum swing. the other way, where now we also watch cancers. We leave them alone. And of course, many patients are actually uneasy with this concept as well, because they're letting cancer grow in their bodies, no matter what we tell them as clinicians that you're safe. And it's well published that with every PSA blood test, with every biopsy result, your anxiety goes through the roof. so there has to be a middle ground and that's where the space for so-called focal therapies or even alternative therapies have come up now with Tulsa Pro in my belief Tulsa actually has a chance of providing that long-term cancer cure without causing those long-term damaging side effects so why is that it's because we actually have the ability to treat in a whole gland fashion, okay? And as you've already seen today, Tulsa is actually quite versatile. You can use it in a focal treatment fashion where you only treat one part of the prostate. You can treat half of the prostate. You can treat 70%, 40%. It's up to you, but it's actually up to the patient and the physician to come up with that treatment plan. If you so choose, then you can actually treat the prostate in a way that replicates what you do with prostatectomy, with taking out the whole prostate. And therefore, you can actually treat cancers that are multifocal, meaning cancers that are present in multiple spots within the prostate. You can maybe even preemptively treat cancers that we kind of know will show up there in the future. And obviously, we can also treat focally. Now, I want you to understand that there is no such thing as a perfect treatment. So in the TAC trial, cancer cure rates were not 100%. But by the way, nor is prostatectomy, and nor is radiation. And of course, you always have to think as a clinician and as a patient, what happens if it does not cure my cancer? Well, your options after robotic prostatectomy or radiation are actually fairly limited, whereas with Tulsa Pro, they are not. so will Tulsa Pro become the future standard care for prostate cancer well I again think that I think it is the most exciting advance in prostate cancer since the da Vinci robot okay but there are barriers to the adoption of the technology number one the MRI MRI is very sophisticated but it's also very expensive. It's not readily available to all surgeons. In order to also build a successful Tulsa program, you've got to have the right team. That means that you've got you, the surgeon, but you've also got anesthesia, you've got nursing, you've got MRI technologists, but also importantly, you have to be motivated. You have to have a mission, in my experience, that every second with a patient under anesthesia counts. I am the only surgeon in the world who has completed five Tulsa procedures in one treatment day. I'm not necessarily proud of the number. I'm proud of the processes and the protocols that we have developed in order to achieve that kind of performance on a routine basis. And I want you to understand that the five cases that we did were actually all whole gland treatments meaning they took longer than even just a limited treatment so we do that by the way the whole gland treatment to try to reproduce again what i would do with a prostatectomy in terms of the cancer outcomes now the key in my institution is that everyone buys into this mission of safety and efficacy there's no time wasted including turnover time time. Now, is this reproducible? Not easily, okay? It requires a high degree of experience, motivation, communication, a fine balance of not rushing your effort, but no wasted effort. Does it need to be this efficient? My answer is yes. This is the only way that Tulsa Pro will scale, will hit that rapid exponential adoption curve. So how are we going to get there? How are we going to achieve scale? Physician awareness, number one, having convincing data. So clearly, with CAPTAIN trial and also the existing literature that's getting added to all the time, I think that there is a very convincing scientific case. Also, marketing to physicians For physician awareness, as we've heard about Patient awareness, which also means Marketing to patients as well Now, interestingly, in my experience Patients get it Once they get in front of a Tulsa message They actually totally get it It's the urologists that they're seeing at that time That may not get it But the patients actually very much Because they're the ones who care about their outcomes They very much care whether they're going to end up and diapers or not. Now, that rising patient demand needs to funnel through the MRI and a surge in availability, right? So that's where one of the bottlenecks is. This is why the Tulsa Plus is so important because with the Tulsa Plus and this incredible interventional magnet that Siemens has developed, you will start to see an easing of the access issue. Also, other indications such as BPH, as we've seen here today, That definitely takes less time to do a procedure, and also operational efficiencies. I presented the artificial intelligence concert AI results at the AUA this year. Clearly, in my belief, will dramatically reduce the treatment time for a relatively inexperienced urologist to be able to do a Tulsa Pro safely without getting into trouble. and it'll take me, or someone like me. A surgeon, a urologist, who has been independently performing over 150 Tulsa cases without a radiologist, who can lower the activation energy of the steep learning curve to teach urologists how to transition from robotic surgery to MRI-guided surgery, to establish MRI-guided surgery centers, and to ensure quality outcomes at scale. To enable that kind of disruption is what Tulsa Pro is meant to be. We need to bridge the gap between what patients desperately want and need and what urologists are currently offering so that we can all achieve that mythical trifecta unicorn at scale. So imagine a future with no incisions And imagine a future with no complications Imagine a future with the cure In every part of the body In every disease state That is our mission And with Tulsa Pro, I plan on achieving that Thank you for your attention And support today and every day
Thank you everyone Thank you to the presenters. This is the formal part of the meeting. I would like to just really thank all the presenters. Amazing. Amazing. Great job. So I know there are some very smart analysts here. I'm happy to have any questions you have. And Steve, if you have questions on the web, please feel free to bring those up as well. So there's a mic in the center. and please feel free to come here or we can bring the mic to you if you like.
So for the doctors in the group, when a patient is informed on Tulsa Pro versus his other options, what percentage of patients accept that and go with that treatment versus something else?
Are we talking prostate cancer patients or BPH?
Well, or BPH patients if you're providing that to them.
So from a prostate cancer side, you know, I would say about 40%, maybe a little higher, are offered Tulsa. Again, we talked a little bit about, you know, where Tulsa is not appropriate in advanced, clinically advanced disease. And, you know, I would say that in the absence of, you know, these calcifications, I would say of those 40%, at a minimum, 20 to 30%, you know, are eligible. for Tulsa. And out of that, I would say a majority of them do choose to do Tulsa. And why? It's because, you know, the side effect profile is much more favorable, right? No urinary incontinence, no erectile dysfunction. I think the biggest issue with Tulsa is, you know, we know exactly who we can offer it to and who we can't. And those who we can offer it to, they gladly jump on it. The problem is there are cases where, you know, cancer is extending past the capsule or the distance between the urethra and the target won't accommodate Tulsa. So really, the short answer to your question is, you know, if they're eligible for it, they jump on it.
How about for the other two?
So I'm in a position where I've done, you know, I was kind of on the wave when the robot first came out, 2005, and then have amassed a pretty large volume of robotic prostatectomies. I've done over 3,000 cases and actively still doing robotic surgery. I think, you know, for me, I have a referral pattern with a lot of outside urologists who'll send the patient to see me for robotic prostatectomy. And so the patient in their mind is already, okay, I'm getting a robotic surgery done. And so sometimes, you know, and I'm an investigator in the CAPTAIN study. So, I've traditionally counseled my patients that I diagnose with cancer about Tulsa, and in that segment, you know, Ron mentioned some of the technical considerations, and I think I guess you guys all know those about the calcifications, the size. So, those, especially for the study, they're, you know, we're strict on the entry criteria. So there's probably, in my estimation, maybe 50% of my patients that I diagnose end up, if they're candidates for surgery and they're a candidate for Tulsa, maybe, not 50%, I would say 75% will say, you know what, the Tulsa sounds a lot better to me. no offense Dr. Kelly I know you've done a lot of robotic cases and then I'll explain to them they're like but you've only done you know 50 60 Tulsa cases what what's the deal there and I'll explain the learning curve for Tulsa is a lot less than the learning curve for robotics was and for the patients that come outside a little bit it's been interesting because they'll see some of the material that we have in the office we have TVs kind of playing talking about the different things we have and a lot of them will be like wait a second doc this what is this Tulsa thing can you explain more about that and so some of them who came in thinking robotic robotic will actually go to Tulsa and then I gotta then I have to call the referring doctor because a lot of times it's like a prescriptive order they're like go see Kella and he'll remove your prostate and then I call the referring doc said well let me explain what's going on so I think awareness will change that. As time goes on, that will definitely change. But again, to answer your question, I think most patients, once they see both options, are really interested in getting Tulsa done. But there's definitely patients who are going to still need robotic surgery in the
future, I think, at this time. How about you, Dr. Hong? Well, I will allow that my practice has evolved such that I think people are now seeking me out primarily for Tulsa, so it's a biased population. But I think what the principles here are, I always ask, as we all do on stage here, what's important to you as a patient, you know, when you get diagnosed, everyone wants to cure their cancer. Absolutely, that's number one. Number two is they want to, you know, not leak urine. That's generally number two. And then number three is sometimes a close third or sometimes a far third is their erectile function. But either way, almost all patients uniformly want the same thing. And when we present their diagnosis and their options, all the options get discussed, including that of radiation and all the subshoots of radiation as well. But at the end of the day, then they also have their own chance of looking at what's out there already about the Tulsa Pro. And what I have generally found is that it's near 100% of the patients who would proceed with a Tulsa Pro with me. Having said that, I think there are other factors, for example, Medicare coverage, this and that, insurance coverage. So those sometimes can affect the decision-making in the end. But in, let's say, a perfect world where insurance were not a consideration, I think it would be very close to, you know, near 100%.
Great. Thank you all for being pioneers.
Excellent. Ben, go ahead with your, as usual, 20 questions.
I guess mainly for Dr. Kella, that slightly presented on BPH with the IPSS score dropping 75% for Tulsa versus, you know, mostly high 60s, mid 60s. yet it was from a lower baseline. What are your thoughts around that? I mean, you would think that a higher baseline could come down more, but any...
So the baseline meaning the IPSS score at the beginning? So, okay, so the care registry is going to... We're still early. I think in that study, the glands were medium-sized glands. The patients, not all of them were necessarily... I think, on medications. And so their IPSS scores did decrease. The percentage was pretty dramatic, I thought. I think my patient, the case study, and I've been only offering it for prostate cancer, sure, you have BPH with it, but this patient who came in strictly for BPH had a much bigger prostate. I've got 106, 108-gram prostate. And he was very frustrated with his quality of life. He had a much higher IPSS score, and he's done great. Now, that's just one patient, and we're early. But to me, the potential of, you know, with BPH, there's less reasons why you can't offer Tulsa. Calcifications don't really matter here, and it's quicker for throughput. What I'm going to try to aspire to, Dr. Hong's five a day, that's really good. But I think you're going to see the results, and you'll probably see the results quickly. my estimation is that it's going to do really well with patients even with high IPSS scores with really bringing it down because the tissue is gone. Yeah makes sense and then on the uh the
docs that are referring into you and you've got the they're expecting patients to go to the robot what's kind of reaction that you get when you call them up and say you know hey the patient asked me
I mean I think so I've been in this area uh in South Texas for 20 years so I have a good relationship with most of them um they just want to make sure their patient does well so i think they're trusting me uh there's a you know but if the patient comes in and they're really okay i'm they're set on getting the robotic done um i mean i think that's going to change as more information comes out because it's so much easier when a patient knows about a treatment before they come in, they've had a chance to do a little bit of research on it. They're perhaps more open to that option. It's different when you as a physician in a busy practice, you're trying to bring up new options for the patient, and the guy's like, well, my surgeon already told me robotic. Dr. Keller, you're the robotic person. But that will change as time goes on, I think. Yeah, I mean, I think with the approval, right, this year, the codes and now facilitating getting MRI centers up and running, I can see that definitely changing.
And also the CAPTAIN trial, right, the results of the CAPTAIN trial would be pivotal for that.
And what do you see?
I mean, it's level one evidence, so, you know, assuming we feel what the CAPTAIN trial will show, I mean, that's argument enough to make a decision.
Makes sense. And then lastly for me, the cost of the practice for the Tulsa Plus, is that something that you're...
What's your question then again?
Like the monthly or quarterly, whatever the fee that kind of wraps it all for Tulsa Plus. And that goes in the numbers that you presented, sorry.
Ben, let me answer that one, if you don't mind. I think that is all changing. You know, particularly Dr. Hong and Dr. Kella relied on cash pay originally, and those practices are continuing. But I think we are in that transition period where now more and more patients are finding out, hey, this is reimbursed. and so I think based upon the fact that it's going to enter that world of comparative, you know, as compared to robotics, what am I getting paid and the hospital administration and Tom talked about that that is now getting engaged to see what's the economics and I think we have pressure tested the economics at a few places and there's no doubt that the economics for Tulsa is superior to that of prostatectomy. Now, I think, Dr. Pathak, you were treating Medicare patients even using the temporary code. Maybe you could talk a little bit about the administrations.
I mean, what I can say about, you know, treatment and payment for Tulsa is that it's significantly gotten better over the last couple of years. Now, I'll be honest, I don't know the exact numbers. I just know how many patients call me back upset with prices, and that was zero. So we haven't had issues.
Thank you. Steve, anything on the web?
Yeah, there's two questions. The first is, have you received any pre-orders for the Tulsa Plus offering?
We have been, you know, Tom and maybe you could talk about the pipeline the pipeline that you built a little bit.
Yeah, happy to. I think one thing that I may have not mentioned during my portion of the presentation is that the expectation around compatibility of Tulsa and the Siemens Freemax Magnatome is in Q3 of this year. So that's an important caveat that we still need to work out on a few things as it relates to that. But we're well on track in terms of bringing those two technologies together. And what I will say in terms of the pipeline is the following, is that we are having conversations with the upper echelons of some of the largest large urology group practice associations in the country related to the Tulsa Plus solution. And we are also having conversations with current users of the technology, Tulsa itself, about adding an additional magnet to increase the capacity that they can offer their Tulsa patients. Some of the top users are booking out five to six months in advance. And if they had a different treatment algorithm in terms of throughput capacity, Another magnet obviously would help with that. There's consideration there as well. So what I'm trying to impress, Rune, is that there's a kind of a plethora of different Tulsa Plus suitors that we're looking with, and the conversations are ongoing. Is that a fair answer?
I think, Steve, we are in discussions, close discussions. The installations of the Tulsa Plus with the Siemens, Magnetron, Freemax most likely is slated for Q4 this year. And we do think that before that, we will have orders on our books.
And the second question is directed at Tom specifically. Tom said there is going to be a huge digital marketing push. What does that look like on the patient side?
Okay to answer? Yeah. Fantastic. So first and foremost, patients talking to patients, right? And patients who are diagnosed, I'm sure the physicians here can speak to this better than I, but when they get the diagnosis, they go right to Dr. Google, right? So search engine optimization is clearly one of the leading ways to get in front of patients who are looking for answers as to what's available to them. That's one avenue. Podcasts, of course, are another major educator, in my humble opinion, of patients, physicians, and consumers alike, regardless of the category. Obviously, we're healthcare-specific here. Our own push from a digital marketing campaign through our increasing interest that we receive from patients directly. I didn't mention this specifically during my portion of the talk, but I'd be remiss not to mention it now, is that we have several nurse educators on staff who take direct questions from interested patients. And then we, of course, refer out in a compliant manner to provide them with access to current Tulsa users. And the list goes on as it relates to the AUA, where we are today, RSNA, EAU, et cetera, and educating physicians. And the physicians then ask us, can you help us educate our patient community so we can do geo-targeting within the community through our clinical sales specialists in a boots-on-the-ground method? And then we juxtapose that also with geo-targeting around those specific Tulsa Pro locations to drive awareness of the technology. And we've got some really nice plans that hopefully we'll be able to talk about in more detail the next time we have an Investor Analyst Day specific to patient ambassadors to build a stable of patients who will be able to speak to one another about their experience facing prostate disease. and not only that but also the mental health aspect and the holistic aspect of a man being comfortable and vulnerable to talk to another man about his health condition and to speak about his prostate disease and share that with other men. So we see an opportunity to do that not only in a digital capacity through podcasts but also in a communal aspect. I'm sure that many of the academic institutions that are represented within the CAPTAIN study have patient education events where they educate the community on what they offer through their men's health campaigns. So it's a multitude of factors that will go into the digital push.
Scott, you're the last word.
Thank you, and it all sounds very exciting. Thanks for taking the questions. I guess for the physicians, one of the things I'm interested in is for your colleagues, are you getting more interest, like people asking you about, hey, I'm hearing about this Tulsa, a, you know, I want to get trained up and kind of asking you about your experience and as part of that expansion of getting more physicians trained to be able to do the procedure.
Dr. Hong?
Yeah, so I actually think that's absolutely crucial to what we are doing and that I'm personally trying to make efforts as well. You know, and I think it has to come from a colleague, you know, another urologist, the urologist. You know, I think the message of what Tulsa is is a little muddy, even in the AUA, and that's what I find to be really interesting is a focal, is a HEMI as a whole, you know, and that may be part of the confusion out there. You have actually very intelligent, well-informed urologists who actually lump the Tulsa into the alphabet soup of HIFU and all the other vocal technologies that are out there. And certainly while Tulsa can be used vocally, it can also shine in a whole gland fashion. So there is a little bit of that, again, activation energy that needs to be lowered. But absolutely, I think that those pathways can be created. There's clearly interest. And, you know, once the results start becoming known, they will, other urologists will really be forced to have to learn about it because otherwise they'll fall behind.
And with the results of CAPTAIN, you know, that, you know, based on some of the data that was already shown, you know, you're at least at academic meetings and specifically at meetings like the AUA. I mean, you're kind of forced to learn when you see level one evidence, you know. And for me, I mean, my practice is very unique. You know, we basically, within the practice, kind of do, you know, our own set of things. So, you know, prostate cancer, someone else is a kidney cancer, someone else is a stone person. But, you know, there is a lot of colleagues here at the AUA that you talk to. And specifically after our podium presentation, a number of them did approach me and ask questions.
I think it reminds me of when we were starting, again, with robotics. There was a small group of surgeons who really started getting things going. Word starts to leak out. Other people want to get involved. I see, you know, I have my referring base, but I haven't, you know, I should, I think now that we have reimbursement and, you know, another piece of this puzzle is access to the MRIs. looks like all these things are kind of getting solved now very hopefully quickly where you'll have the throughput then when all these people want to start doing cases it's uh to me refreshing that the learning curve for tulsa should be a lot less than it was for robotics once you have access also you're not restricted to prostate cancer so like everyone's talked about there's a big market potentially for bph and it looks like those results are going to be good and then again And once we get the CAPTAIN studies pretty much getting wrapped up this year and hopefully start seeing, you know, the data come out to be as promising as what we all think it's going to be. And that's going to make a big difference.
Oh, that's fantastic. And in terms of pipelines or backlog of Tulsa patients, do you have wait lists for patients wanting the procedure? Approximately how long are those? And has that increased since January
with the new Medicare reimbursement? So for me personally, I work with a large hospital that has the system. So now that there's this code since January, I've been focused on the study, but we have a lot more patients who've been asking, okay, there's reimbursement. So So we've been trying to, you know, in the reimbursement with the hospital, so basically we've been trying to get a meeting set up so everyone can be coordinated with the hospital. And we do get a lot of calls. I think some of those patients may be who are insisting on using insurance will be going to, maybe they're going to Houston or Dallas. They're willing to go and find a place where they can get on the schedule. But I think we're going to be, once we get that figured out, I think our wait time will actually go up quite a bit.
And then, I guess, Tom, on the Tulsa Plus side, just lastly, is Siemens helping at all with intros? You know, they obviously have a large commercial presence kind of globally, but I'm sure in the U.S. as well. Or is this really something that you got, they're providing that device and you have that relationship, but really the commercial push is coming primarily from profound.
Yep, great question. And, you know, I often talk about deals in the boardroom and then the percolation of the real world, right? And so the percolation of the real world is happening. So the strategic opportunity that was created in the boardroom level obviously makes sense when you look at the X and O's. And now we're finding that, okay, counterparts are finding counterparts because they're shared information, obviously, from non-disclosure agreements between the two companies to say, all right, here's your opportunity here, right? This is someone who's looking to upgrade to a new magnet. Let's go in there together and present this solution. And, you know, obviously we have a great relationship with Siemens. I want to make sure that it's crystal clear it's not exclusive, right? We are agnostic to the diagnostics. We've got a great working relationship with Philips, great working relationship with GE, and there's several other providers, of course, of magnets out there also. What I love about the B2B aspect of Tulsa Pro is that as a little Canadian company with a market cap under $200 million, right, that's just getting to this point of the chasm to break through to get to mass adoption, folks are coming to us, like, asking how can they work with us because they see the opportunity, as we talked about, to unlock that key of, wait a second, urology can be a call point for us. So, look, are there folks that are doing these procedures that are not urologists? Yes, of course there are. Are there folks that are interventional radiologists doing it? yes we remain agnostic in that respect as well because depending on the country and the region the world even the zip code right it could be a different person who is the favored provider of care in that community so we'd be remiss not to basically acknowledge that and work within those instead of going upstream but you know my firm belief is that this is a urology product in the end these gentlemen right are treating these patients for all kinds of different prostate disease, and they have the opportunity to provide the gamut of all those things that you showed on a slide, right? There's a ton of things they can use in the arsenal, and it's the right treatment for the right patient at the right time. Is it always Tulsa? No. Is it always robotic prostatectomy? No. But the concert of the physician and the patient making that decision, and I'd also be remiss, I didn't mention that within our advocacy programs, we're going to have the partner, right, which could be a spouse, could be a girlfriend, could be a loved one, is a big decision maker in that process, especially when it comes to the erectile function and potency. That's a joint conversation, and it's a very serious one. And so making sure that that education take place is very important. But back to the Siemens conversation, great relationship, not only in the U.S., but also outside the U.S. Those are secondary markets for us, of course. But I can tell you that the smart OEMs are working with us very closely.
Yeah, and the incentives on the ground are kind of aligned where if a Siemens person sees an opportunity, you know, they want to call you guys up and say, hey, let's go in there together. And it's on their radar on the ground.
I think so, right? Because to me, like, you can solve pain or you could also create pain to be solved, right? So some of the pain that's been talked about in the past is, oh, there's not enough magnet time. Well, when the patient starts demanding this technology, you're going to find the magnet time, because if not, they're going to go across the street, right? The Burger King, Wendy's, McDonald's, right? That'll take place in these very dense geographic areas. The first movers will get the advantage. The FOMO will take effect for those that don't have it, and then they'll be racing to get to the answer, and I think that's how we establish a relationship with Siemens, Philips, and GE is that it's an open conversation, and Philips – I apologize. Siemens, obviously, is the first mover, and therefore, they should be rewarded for taking that risk with us.
Thank you all. Brenda, there's just one more question from the web. Can you explain the differences and similarities between the Tulsa and Procept devices, for example, time of procedure, side effects, et cetera?
Maybe I can take that, I guess. So, you know, if you think about the brain or the heart of a person, all of us have about the same size heart, about the same size brain. But when you think about prostate, it actually is quite unique. You can have a person with a 20 cc prostate and another person with a 250 cc prostate. So I think that it translates to the fact that there's no one technology that is going to do it all. You've heard that from our physicians already today, and this is the reason why, you know, when you saw Dr. Keller's slide of how many different technologies are available for BPH treatments, and we already know that there are multiple technologies available for cancer patients. I think the, so I don't see a world where necessarily one is going to be for everything or the other is going to be for everything. I do think that there are going to be sweet spots for these technologies and they're going to do well. From my perspective, obviously I'm biased towards profound, and I think that a large number of patients that have BPH disease, there is a general belief that if their PSA is above 2.6, maybe in the 3.0 range, that there is a 10% or higher risk that there is some cancer hiding behind. And even though if that cancer might be low-grade cancer, patients just don't want it. And so I do think that the fact that we're coming from the cancer side of the equation and are building the level one evidence, I think that is going to be the driving force that will help us drive towards the BPH market. And so to me, I think that the combination of the fact that we have extensive data on cancer and we have extensive data on the fact that we reduced the volume of the prostate to 8% to 10% of the original size, I think that's what's going to drive the adoption of our technology. And I think Procept will have their space as well. So to me, it's great for everybody. Great for the patients to have all this. Yes, of course.
What you're getting from that bin so far and how you're expecting that to change, just maybe in the context of what we've seen before with the adoption of robotic surgery, folks, or at least some folks, get into a comfort zone of routine and workflow, you know awareness of data personal experience with technology to the point where they're more resistant to move and then there's folks who and so wondering if there's if there's aspects of the procedure that you think are making it easier for those folks to get interested are there is there aspects of the procedure like working around the MRI or the automation that maybe will take a little longer for some folks to get pulled over understanding of course the data is going to be a big part of having to move.
Yeah. So it's a great question, for sure, Matt. And I think the way, from a business point of view, that we are looking at it is the first answer to that question is we have Tom Tamberino. Because we have to break walls. And we're going to break these walls. And you remember the early days of Intuitive Surgical, they had to really work hard. It It took a few years before they got there, and I think we have learned from that, we're gonna break these walls much, much faster. The second answer to that is that the key thing that really finally broke those walls for intuitive was the patients demanding it, and if the hospital didn't have it, then the patients were going someplace else, and then the hospitals were facing, Do I shut down my urology program, or do I buy this expensive robot? And I think we're in that inflection point where we're starting to see the early stage of that as well. The third thing is that I think that we have continuously been investing about $15 million a year in R&D and clinical, and our desire to continue to maintain that investment. And so we are very strong in developing the clinical data that allows academic physicians like Dr. Pathak to drive adoption and be able to go to podium presentations. We will continue to do that. And our clinical trials are going to be very, very clinical outcome focused. We're also going to have seen continuously improvement in the technology itself that we will bring more and more AI into this. And I think it will ultimately become cheaper, better, faster, more and more to use. So I don't see this as a one thing that we need to accomplish. We recognize the hard work we have ahead of us. And we have programs in place. And I'm actually very proud of the team. We're going to deliver that for sure. I'm happy to have the physicians.
Yeah, if I may. It kind of goes along what I was talking about. Number one, from a medical perspective, I can tell you that there are definitely things that we as urologists will teach other urologists how to handle themselves, safety, MRI suite, that type of thing, totally foreign environment. Those are teachable things. I'll tell you what is less teachable but skill sets that urologists already have is understanding nerve spurring on a prostatectomy, for example. And how many times have I done a robotic prostatectomy and wish, I wish I had x-ray vision, you know, you can see things directly in the robot, but how do you know where exactly the nerves are? Or to put it a different way, you've done perfect nerve sparing from what you think as a surgeon, technically speaking, yet the patient still has erectile dysfunction a year or two years out. And, you know, after you go through those experiences as a clinician, you start feeling like, what else can I do? You know, I can certainly learn about these new techniques, you know, whatever sparing operations within Da Vinci Theater. At the end of the day, is that going to move the needle? Or when you actually see these patients come through and you are the person who is responsible for that outcome, you see them in the office afterwards and you can see their erections actually very good, but then you don't just, you know, trust their SHIM score or IIEF scores. Then you ask the partner and the partner is nodding her head And you're like, wait, no, no, your erections really aren't that good this early on. And you start getting that feedback loop as a surgeon, and it's very exciting because you actually then are filled with the conviction that what you're doing is the right path clinically for your patient. I think that's where the adoption comes because you have to believe it for yourself. You know, we can look at the trial data and all you want, but actually when you start seeing in your own patients that you see in your office that they're doing remarkably better than what your prostatectomy patients are doing. That's where the adoption will easily happen.
I'm also happiest on my Tulsa days. It's a little bit less stress. Yeah, I was... Compared to my robot prostatectomy. Compared to my robotic prostatectomy. From, you know, just a general stress level, they're very enjoyable days.
I mean, there's no worry about... I mean, we've done a large volume of robotic cases, and, yeah, there's definitely no worry about bleeding you know, what's going to happen. I mean, in bleeding, they don't bleed a lot, but there's a potential, right? It still could be a very traumatic surgery on the urologist and not only the patient. But with Tulsa, definitely, it's, I mean, to me, it's a much more reproducible type of procedure. And, you know, there's just way less risk, no bleeding. So I think that's going to really help as we have the ability to do the procedure with the billing and the MR time.
And by the way, by no means does that mean it's not, we're, Dr. Parthak, Dr. Kel and myself are not fully engaged during the procedure, right? We're not kicking back with our feet up. Having said that, the list of things that can go badly during a Tulsa are nothing compared to the list of things that can go badly during a prostatectomy. So already you have some basis of patient safety built in. And so you're just trying to make sure the procedure is optimal as opposed to avoiding some major disaster. That's a big deal for a surgeon.
Matt, thank you. I think this is very good. I think thank you so much for being here. And thank you for those who are on the website. And again, I would like to particularly thank Dr. Pathik, Dr. Kella, and Dr. Hong to take the time to spend with us and present to our investor community. Thank you so much. We do have a demo here, so those who have a few minutes, please Amanda will present the demo to you, and I also want to thank the Profound team. Amazing collaborative effort, guys. Great job.
Thank you. This concludes our program. Thank you for joining the Profound Investor event.