Thank you, and good afternoon, and welcome to Profound Medical's 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, where we are delighted to have fully and successfully enrolled in our CAPTAIN Level 1 randomized controlled 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 Kella will share his perspective on treating BPH with TULSA. 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. 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 U.S. they demonstrated that there was actually no difference in prostate cancer outcomes. There was no difference in health-related quality of life. Robotic surgery did, in fact, improve the perioperative outcomes for patients. They improved the patient experience, and this is what drove demand for the surgical robot. They demonstrated 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 and 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 controlled trial to the gold standard standard of care of robotic prostatectomy. 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. We have already strong data in prostate cancer. Why did we run the CAPTAIN trial?
First and foremost, practice guidelines and commercial payers call for Level 1 randomized controlled trials to really establish ablative therapies as standard of care. 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 controlled 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 controlled 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 purposely included in this study principal investigators that include the best academic and private surgeons. I commend all of the names that you see on this slide for having participated in the study and have helped us successfully enroll the study and demonstrate to you the value of the TULSA-PRO. If you were to take the average number of prostatectomies that these surgeons have done, it is in the multiple thousands. In a sense, we are comparing relatively initial experience with the TULSA-PRO to highly experienced surgeons. I think this was one of the keys as to why we were able to successfully enroll in this study.
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." That actually provided equipoise for the patient to choose between the two arms. 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." Thank you to all of these investigators, sincerely. All right, let's get into the data. 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 ml. 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. 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. 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. Just length of stay.
From shorter length of stay to no overnight stay, you can see that the RP patient stayed on average about 1.24 days in hospital, and the TULSA patient 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. 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.
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 EQ-5D-5L 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, where 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 was not statistically significant, but it was less pain.
Finally, if you look at overall health, 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. 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 timeframe, robotic prostatectomy patients take more than two weeks on average of recovery to feel like a TULSA patient does the day after their procedure.
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. 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. Meng 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. 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.
We believe that that will help drive adoption of the TULSA-PRO. 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 IRE or TULSA, with patients from the United States. You can see that when we compare apples to apples, whole gland to whole gland, or focal to focal, TULSA wins every time. 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.
This is due to the fact that this is an intraoperative MRI procedure as well as a transurethral treatment modality. In the top left, we have a target ablation of an extreme apical lesion that most other ablative devices cannot do. 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 they 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 radial recurrent prostate cancer.
Thank you for your attention.
Please welcome to the stage Associate Professor in the Department of Urology at Mayo Clinic, Florida, Dr. Ram Pathak.
All right, good afternoon. I get to talk about prostate cancer and how I use TULSA in patients that I see in clinic. A lot of my talk is going to be about data and outcomes. 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? Are they not having any side effects? That's kind of what they care about. Our TULSA experience was selected as part of the CARE Registry to be a podium presentation at this year's AUA. I had a chance to present that yesterday, so I'll give an encore presentation today. Let's get started. These are my disclosures. Mathieu 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. 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. To me, that's more like your standard definition TVs 20, 30 years ago. It's really precise and really can provide individualized treatments to patients. Again, Mathieu covered this, no blood loss, no overnight stay. Patients are home eating dinner.
The safety is achieved by cooling devices located in the urethra and the rectum. 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 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. If applicable, we perform the TULSA treatment to these patients. We're going to go over all of these in detail. In terms of workup, who is eligible to receive TULSA? Essentially, it's anyone with kind of Grade Group one, two, or three disease.
Whenever we talk about prostate cancer, we always talk about how aggressive it is. That's a scale from one to five. Five is very aggressive. One is not aggressive at all. A majority of these cancers are usually your ones, twos, and threes. 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 Grade Group one 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. A patient underwent radiation therapy for their prostate cancer. Unfortunately, there's a recurrence. What do we do? We can do TULSA for those patients as well.
Things that TULSA would not be good for are patients who have locally advanced disease. That means cancer has already escaped the prostate capsule and is invading surrounding structures. That's a more advanced disease, likely needs a more advanced treatment. Also, if the lesion is greater than 3 cm, 3.5 cm from the target, and we always get CT scans to check for calcifications. 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. Basically, the decision is based not only on the cancer cure rates, but also on functional outcomes. 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.
In TULSA, generally, the outcomes are very, very favorable. I'm going to be able to, I'm going to have the opportunity to talk to you about some of that in the next couple of slides. This slide, and what I want to show you with this slide, is really the treatment is individualized. You see those three different horizontal graphs, and it basically shows, based on where the cancer is in that specific patient, is how we do the ablation. On the top one, we're looking at a left-sided hemi-ablation. On the middle one, we're looking more of a subtotal ablation, just sparing that left side just a little bit. On the bottom one, we're looking at completely an anterior hemi-ablation. Again, you can tailor the treatment according to how the patient presents.
Surgery is also another good option, but surgery is kind of like an 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. 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 guidewire, we remove the guidewire and then essentially dock the UA to the TULSA robot, which then takes care of the rest of the procedure.
What does it look like for me? 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. It makes it a little bit more efficient for us. Once we draw all the surrounding, 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.
Here's a case example of a patient I did. Again, PSA 7.6. He had Grade Group 2 disease, and he had an anterior lesion, a lesion at essentially the top of the prostate. It spanned from 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. 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 antegrade ejaculation. The UA was placed centrally, again, the target within the distance. It took about two hours of total MRI room time. Thirty-seven minutes was for planning and 28 minutes for ablation. What does follow-up look like?
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 do not need opioids. They can use anti-inflammatories or even Tylenol or Advil. We give antibiotics as part of guideline care. They have very temporary, if any, stress urinary incontinence. This is an example of a 76-year-old male we treated. We used TULSA for prostate cancer. 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.
What you're seeing here is you're actually seeing the cavity that was created from the TULSA. At first glance, it kind of looks like you're already in the bladder upon cystoscopy. You'll see our cystoscope now traverses the bladder neck. Now you're really in the bladder. 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 verumontanum and the sphincter complex. So much so that when you look on Retroflex , you see that it's just a nice closed, tight bladder neck. You can imagine, because of that, patients are able to have antegrade ejaculation, don't have any leakage of urine, or don't have any issues with continence. Again, this is a Grade Group 3 patient that we did.
A whole gland TULSA was performed for combined BPH and prostate cancer. This is a little bit about the workflow. It takes about an hour for room prep. 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. The device insertion, especially with more and more experience, is becoming quicker and quicker. This is an example of our data. Again, total MRI time is improving substantially. It is like anything, the more you do, the more efficient you become. You can achieve about three cases per day, especially with a consistent team, including MRI radiologists, techs, your turnover staff, and an anesthesia team that can work in parallel.
Also, as a urologist, there's a lot of downtime for me that I can either catch up on EMR stuff or even see patients in between cases. Now I get to talk about kind of the outcomes that we found using the CARE Registry. This was a prospective observational study where patients consent to be a part of it, and we're able to track their data longitudinally. These are kind of the real-world outcomes after MRI-guided transurethral ablation. Again, single-arm, multi-center prospective observational cohort. These are the five institutions that took part in this. Most of them were for primary prostate cancer, about 80%. Those that had primary cancer, again, most of them, about 60%, were Grade Group 2. If you look at both two and three combined, it's over 80%. The next graph talks about ablation fraction.
I want to spend some time talking about this because there's a lot of misnomers in urology, specifically related to focal therapy. What is focal therapy? According to the CARE Registry for us and for patients treated by TULSA, what we mean here is about 70% of the patients, if not 80% of the patients, were treated with a minimum of a hemi-ablation, 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. Again, all those mean that this is just your typical average index prostate cancer patient. Efficacy outcomes, what did we find? About 141 patients in the registry reached about one-year follow-up.
The PSA decreased by 90%. 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. 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. Really, this is kind of the crux of this, is the safety and functional outcomes. This is why this is different than other treatment modalities. At one year, most patients, not most, 94% of patients were PAD-free, 98% were leak-free.
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 incontinence is defined as zero to one PAD a day. That's how people typically report their outcomes. Here, we're talking about zero PADs a day. 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. 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. Outcomes are prospectively tracked.
Profound should be commended on tracking these outcomes longitudinally, not just at a year, but really thereafter. We have shown, especially through the CARE Registry, that it is a safe procedure. It is effective in select patients with that Grade Group 1, Grade Group 4 prostate cancer. We just got a nice overview of the CAPTAIN trial. In summary, TULSA-PRO is an MRI-guided procedure. It has good surgical workflow. It 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 are doing to our TULSA- AI modules. These updates will enable physicians to treat patients who have BPH also.
We're going to talk about two big features that were added. Before I go there, let me just talk about the business side of the equation. These schematics, just to share with you, cancer versus BPH are two very different diseases. With cancer, it tends to be on the outer edges. It actually sometimes will protrude out and deform the prostate to some extent. Thereby, the shape becomes quite unique to each individual. Whereas BPH patients, it is the central part, which is called a transition zone, that simply expands. You can see that. 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. We've talked about the fact that about 200,000 patients could qualify to be patients for prostate cancer.
We think, obviously, BPH is 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. 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. The second part of adding BPH to this portfolio is that now physicians can actually have what I would call a TULSA day. They can have all day of prostate cancer patients. Dr. Pathak talked about three. 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. They can have all BPH patients.
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. You've heard me talk about TULSA- 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. Each module has a purpose. 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. 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.
A number of physicians basically said, "We really want to be sure that we have covered the edge." 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. What we find is that 50% of the patients who are being treated today, thermal boost is used in it. 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 leading teaching hospitals are now starting to treat even Gleason grade 9 patients with TULSA, which I would have never guessed they would do. Some of these teaching hospitals tend to really, really be very conservative as they grow new technology programs.
The thermal boost is one of them. The contouring assistant, which Dr. Pathak 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. It reduces the number of steps they have to do. It's an ease-of-use feature. 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. That's exactly the purpose of the volume reduction module for us. This is how it works. On the left, you see the AI module. 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.
The idea is that, as I mentioned, the transition zone is the real culprit that causes this problem. This volume customizer feature allows them to shrink it down so it mostly covers that transition zone. It is basically trying to figure out where is the cause and how do I really focus on the cause. The second feature is what we're calling a treatment arc. Click a button, an arc will show up. This arc has these handles, and they can just move those handles up and down. They can very quickly design what percentage of the prostate, what type of side of prostate they want to move. That arc can be moved. It can be on the upper end. It can move to the sides and so on.
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. That feature, as I mentioned, it can also be used with our contouring assistant. 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.
Not only are these features designed to improve our ability to do more of BPH patients, but also it will give them another tool that will help them more efficiently treat patients with focal therapy. Together, all of these features, here's what this means. 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. They can move the arc. Thereby, they can pretty quickly make the decision if they're doing subtotal. If they're doing a targeted, they can use the arc to really make it targeted to the lesion region. Thereby, they can do it.
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 it will take to do the ablation. You can see underneath each of these lines, the ablation time for 70 cc is 55 minutes and so on. You see the ablation for the targeted 20 cc ablation is 16 minutes of ablation time. If they use that same arc with the new volume customizer tool, then you shrink that region to some extent. There are ways they can shrink it to whatever they want to do. Now you have treatment for BPH. You can see that by design, that arc has that triangle in the bottom.
It automatically saves the veru, saves the ejacular reducts, saves the nerve bundles, and certainly is not, it's safe for the rectal cavity in that region. It gives you safety very, very quickly. 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. You can see if it's a minimal program, they're treating a 33 cc prostate, which is still, quite frankly, a lot of prostate, but that can also be done in about 16 minutes. One interesting thing on this page is you'll see that actually the cancer patient volume takes a little longer. It's a 20 cc in 16 minutes, whereas a benign prostate is faster when you're ablating it.
You can actually get to 33 cc in 16 minutes as well. Hopefully, you can see the flexibility continues to get better. It allows them to really be efficient in the design of that treatment. They have a very good predictability. It is 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. 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 ablate 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. By doing it so efficiently, they can actually do five patients in a day, in fact.
You can see that is in spite of the fact that there is a one-hour gap. Physicians will usually go and do another procedure in between cases. Even in a very comfortable way, typically, they'll start between 7:00, 7:30 time frame. Typically, they're done by 5:00 . That is the plan that we're going to be working on. I think that will actually make it a very efficient TULSA day for them. The value that we're creating with this, as I mentioned, is really in volume reduction. We fully anticipate that the volume reduction module will, in fact, provide a very durable treatment for these patients. The launch plans, the treatment arc, 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 million parameters, which basically makes it, based upon our internal data, as good as any radiologist, the best of the best. 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.
We are going to do a soft launch in the third quarter. We anticipate a minimum of five sites will get going with this. We will do a full launch by the end of Q3, early Q4 time frame. 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. 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 fulguration, 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 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 will not be a need to even get off of blood thinners. Highly customized, each of those treatment designs as the shape of the prostate change. Longitudinally, the treatment design changes accordingly for them. 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 ablation of malignant tissue or benign tissue or both. We feel we are in a very good place with respect to the FDA. With that, I am going to turn it over to Dr. Kella.
Please welcome to the stage the Founder of Urology Place and an Adjunct Assistant Professor for the UT Health Science Center, San Antonio, Dr. Naveen Kella.
All right. Thank you for having me. Good afternoon, everyone. My name is Naveen Kella. Disclosures, I'm on the clinical advisory board for Profound. I'm one of the investigators in the CAPTAIN randomized trial for prostate cancer. I'm going to be talking to you about BPH as well, kind of dovetailing with Arun's talk. First of all, BPH, a lot of men in the room. As we get older, in our 50s, half of us are going to start having symptoms of BPH. It just continues to progress. These symptoms can become very irritating. Sometimes you could have BPH as well as prostate cancer. BPH is a very prevalent condition. 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. 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 cc-80 cc, 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 TURP, which uses an electric or bipolar knife to remove tissue. There's a water jet treatment. As the prostates get even bigger, there's overlap.
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 our 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. Sometimes, as I said, BPH comes with prostate cancer. 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 TURP 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. People want things that work. But it has to come with safety. 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. There's lots of things that we talk about as we go into options.
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. It is able to really create a lot of volume reduction. The implications to BPH become obvious there. Comparing Tulsa to some of these other treatments that we have right now for BPH that I talked about earlier, one thing is that we are using MRI guidance. With MRI guidance, it can allow us to precisely aim at the areas we want to treat and, importantly, avoid the areas that we do not want to treat. Arun talked about the fact that with this, you could improve the safety, 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 should not occur. You still have flexibility. 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. That is important because a lot of people who have obstruction, a lot of the tissue potentially could be on the top side of the prostate. That is well within TULSA's wheelhouse. This procedure does not cause really any bleeding. As you heard, it is safe for patients who are on blood thinners. All these factors, really, when we are looking at treating patients with BPH, can make TULSA even safer for this segment of patients than when we are treating for prostate cancer.
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. We have nerves that we spare and are well away, usually from the transitional zone. There should be very little risk of erectile dysfunction. The rectum is down here. 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. With this, it should be even lower risk. What's some of the evidence? It's early. 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. You just outline the areas that you want to treat. You can see here, this is a temperature of the tissue during treatment. This is an image of the prostate after contrast is given at the end. You can see the black areas is where, really, there isn't any more viable prostate tissue. This can treat all sorts of different prostates. A big chunky prostate with a heavy transitional zone. Actually, sometimes people have really bad symptoms because the prostate starts to go into the bladder. That is called a 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. 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. The volume in this study, they looked at prostates that were on average 52 g in size. You can see most of the patients had prostates in the 48 cc-65 cc range in this study. These are results. It looks complicated. You see some trends that I'll show you where this is called an IPSS . It's what we, as urologists, give our patients to see how bad their symptoms are. It goes all the way up to 35. In this average, it was around 16, 17.
After one year, patients reported their symptoms to be around five. 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 6, or are you very pleased, which is pretty much a zerofour You can see at the study, they started off as a 4. By the time a year rolls around, most patients were reporting a one. It persisted. The patients have reported details at two years. Flow rate, you would expect with less resistance, better flow. You can see that the flow rate started around 10-12. By the time a year rolled around, you were close to nearly doubling the flow rate, which is pretty remarkable.
I would compare this to other studies for other modalities. You don't necessarily see flow rates improve like this. 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. Probably, I think going back to the safety, there was one Grade 3. A Grade 3 means the person had to come to the hospital. It was for an infection, epididymitis, where they had to be treated with antibiotics. That's pretty good, really good. No Grade 4, 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. I think the key thing here is quality of life. We talked about peak flow. If you look at TURP, which is, again, the electric knife, laser, Urolith, water vapor, which is Rezum, 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. I 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." I worked him up and decided that it was a great idea for him. 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. 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. We were able to ablate about 60 cc of his gland in 45 minutes. He's doing great. He's very happy. He said he would do it again. The sweet spot for TULSA as a treatment option, this is time on the Y- axis. On the X- axis, you see prostate volume. As the procedures that we have right now, we talked about, again, Robotic, Laser Enucleation, PAE, Aquablation, TURP. Some of the smaller prostates are in the wheelhouse with Rezum and UroLift and iTind. As you get bigger, Aquablation, HoLEP, Robotic removal, PAE is what we traditionally use for these bigger prostates. 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. With the AI volume reduction, the treatment time is going to drop. You can see now it is really right in there with all these other treatment options for larger prostates. In conclusion, TULSA-PRO can achieve lasting relief. It is getting rid of tissue. That is a big deal. It can create significant volume reduction to improve quality of life, symptoms, and uroflow improvements, as I showed you in the earlier slides. What we can do by using these treatment plans, where we focus on the area that is enlarged, we are just naturally able to avoid critical structures, the ejaculatory duct, the rectum, nerves. TULSA has really no bleeding risk, and as you avoid the hospital stay.
It is a very safe treatment as far as preserving function and avoiding problems. If patients have prostate cancer, it is like a Swiss Army knife. We can use it to treat both conditions. The goal is to get this to something that is 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 minutes-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. Thank you, Dr. Kella. 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. 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. When you think about invasiveness in interventions, that has actually been dropping. We have gone from open surgery to laparoscopy to robotics. Even on radiation, you see a lot of imaging coming in, but also computerization to improve the accuracy. Precision and invasiveness have been the two, or lack of lowering the invasiveness have been the two primary drivers towards going there. I think we are now embarking on the next step.
As Mathieu said, we are at that inflection point where we think that now the next step is beyond today's robotics towards autonomous robotics. That means an interventional MR plus TULSA. We have talked a lot about MR. 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. 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 they are now guidelines. In 2023, AUA provided guidelines that updated and reinforced the use of MRI pre-biopsy. EUA followed that in 2024. MRI is now a part of a urologist's thought process, an integral part of their treatment regimen.
If we talk about robotics, I think what really, you have heard that from Mathieu. You have 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. It was applicable in a wide variety of patients, which was, at that time, basically removing the prostate. The same principle, the same rules apply here, except it is quite binary. We do have a number of patients who are demanding it. You heard that from Dr. Kella. You saw the data that Mathieu presented where 88.5% of the patients who have undergone a TULSA procedure will recommend that to their family. I think that pull, the demand pull, is indeed in our favor at this point.
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. You saw one of the pages that Dr. Pathak presented. They already have an interventional MR that they use. 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. 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 now? I think that there are two things that I see.
One thing is that the interventional MR, just like the robot has been used now, is being used in a multitude of different types of applications. I think an interventional MR Suite will ultimately be used in a multitude of different types of applications. I won't spend too much time on it because Dr. Hong is going to talk more about it in the future. Certainly, you know that we are already doing clinical trials in pancreatic cancer and some of the women's diseases like adenomyosis and so on. There are other companies that are looking at brain and cardiovascular and spine applications. I think this will democratize the use of the interventional MR over time.
The other way that I think for a urologist, this can become go from, do I really want an MRI, or how do I control it, to a full control of the use of the MRI 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. If there is a repeat needed in a small percentage of patients, they can actually repeat that as well. 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 urologists to take the lead in driving that revolution.
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 Tamberrino.
All right, good afternoon. To continue the conversation about what is TULSA Plus, as outlined by Arun, 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 MRI 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 MRI. TULSA Plus is a comprehensive solution.
When a urologist says they want to use TULSA, we come to them with what they need. If they plan to be operating in an ambulatory surgical center, we will provide not only the TULSA, we will also provide the MR. If there is need for anesthesia equipment, we will assist with that. The workflow, as you have heard, is very, very important to the efficiencies of providing TULSA several times per day, not only for prostate cancer, but also for BPH. Our clinical genius team, which is a team of scientists, has been the backbone of this technology for years now. We continue to rise above their shoulders to bring us to the next stage of commercialization. They will 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.
Last but certainly not least, as I've come to learn in my six months in the urology space, economics and reimbursements 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 MAGNETOM Free.Max to the urology call points. Our relationship is being built around the fact that this is the ideal solution for an interventional MRI Suite. Why is that the case? It is the largest bore in the world at 80 cm. Pretty important for those of us in the U.S. 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 a 1.5 or a 3.0 Tesla is not needed. Rather than seeing a crane bring in an MR into a hospital or to a new space, you can wheel this in. 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. 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, you'll find them in the basement. With MAGNETOM Free.Max, you're able to place it at higher levels within a structural building. 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. 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 MAGNETOM Free.Max, you quickly find out that there's a reduction across every portion of the spend that you would need. Number one, the service drops dramatically. 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. The product itself, in terms of COGS, is less. Therefore, part of that savings is passed on to the consumer. 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 more biopsies. We are going to get close to a comprehensive solution that could also be implemented outside the confines of the building, much like PET/CT has done with some urology practices across the U.S. 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. We have already tested and validated this model. 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 MAGNETOM Free.Max, along with the TULSA-PRO, along with the necessary anesthesia, the workflow, etc. As you have seen from the slides presented earlier, these patients are always making it home for dinner because there is no hospital stay. This is an in-and-out procedure same day, which makes this a great solution for those practices that may not have the 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 seven within the urology space from our friends at CMS, it has now given us the opportunity to look at a whole host of different channels. You saw from the CAPTAIN study that Mathieu 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?
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. 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. 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. The solution would be somewhere in the middle. I want to speak to the facts I did not mention this last slide. I'll go back for one 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 U.S. , 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 gives us 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 Tulsas per day is a very reasonable amount of Tulsas, whether that be cancer alone, BPH alone, or some combination thereof. The assumption would be if you did one Tulsa per week, one Tulsa 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 rate. That alone would cover the monthly capital cost of the TULSA Plus solution. The construction costs are baked into this assumption as well. The service cost, the full-time equivalence, the Genius service, assistance with marketing to patients, assistance with marketing to physicians, and the list goes on. 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, roughly 21. 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 load in everything else 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. 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, etc., etc., and on down the line. We've got in 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. It covers the treatment itself, and that is it. Everything thereafter is also billable. Everything prior to it is billable. 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 MAGNETOM Free.Max, the 0.55 Tesla, and the associated price point, bringing down all those factors, service, installation cost associated with maintaining that. Last but certainly not least, the linchpin is the TULSA reimbursement that went live January 1st of this year. 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. 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 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 US-based sales team. 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 Ssales Specialists to drive volume, and they have everything else that comes along with it, health economics and market access.
We have 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 pro formas, all the modeling that comes along with it. As we all know, there is a ton of IDNs and GPOs across the country that require sophistication and knowledge of how to engage and work with those. We have a team for that. One of the teams that I am most excited about is our market development team. They are focused on a number of B2B opportunities. I am sure you are familiar with some of these models with LUGPA's partnering with the likes of interventional radiologists. In particular, there has 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. 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'd like to think about what took place with LASIK when Tiger Woods had LASIK. Everybody else on tour had LASIK. Then everybody else who thought they were professional at every country club around the country got LASIK. It just pulled down from there. 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.
We will 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 and 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 in our belief that we will become the standard of care for prostate cancer and a formal 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%+ growth compared to what we achieved last year. 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.
Blacked out. What happened? Okay. You do okay?
All right. 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 Profound Medical. I think everyone in this room understands the technology lifecycle, one of, of course, R&D, ascent, maturity, and decline. R&D incurs major costs. Therefore, you recoup that in the ascent and maturity phase of a company. You do need adoption, and you need scale in order to recoup those costs. We also all know this technology adoption curve. Basically, new technologies eventually upend the incumbent technology. 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. What about the patients? 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. We've actually seen the pendulum swing the other way, where now we also watch cancers. We leave them alone.
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. It is well published that with every PSA blood test, with every biopsy result, your anxiety goes through the roof. 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. Why is that? It's because we actually have the ability to treat in a whole gland fashion. 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. It is actually up to the patient and the physician to come up with that treatment plan. If you so choose, you can actually treat the prostate in a way that replicates what you do with prostatectomy, with taking out the whole prostate. 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. Obviously, we can also treat focally. I want you to understand that there is no such thing as a perfect treatment. In the TAT trial, cancer cure rates were not 100%. By the way, nor is prostatectomy, and nor is radiation.
Of course, you always have to think as a clinician and as a patient, what happens if it does not cure my cancer? Your options after robotic prostatectomy or radiation are actually fairly limited, whereas with TULSA-PRO, they are not. Will TULSA-PRO become the future standard of care for prostate cancer? I again think that I think it is the most exciting advance in prostate cancer since the Da Vinci robot. There are barriers to the adoption of the technology. Number one, the MRI. MRI is very sophisticated, but it is also very expensive. It is not readily available to all surgeons. In order to also build a successful TULSA program, you have got to have the right team. That means that you have got you, the surgeon, but you have also got anesthesia, you have got nursing, you got MRI Technologists. 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. 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. 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.
Now, is this reproducible? Not easily. It requires a high degree of experience, motivation, communication, a fine balance of rushed effort. I'm sorry, 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. How are we going to get there? How are we going to achieve scale? Physician awareness, number one, having convincing data. 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. Interestingly, in my experience, patients get it.
Once they get in front of a TULSA message, they actually totally get it. It's the urologist that they're seeing at that time that may not get it. 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 in diapers or not. Now, that rising patient demand needs to funnel through the MRI and a surgeon availability. 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. Also, operational efficiencies.
I presented the artificial intelligence, Contour 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. It will 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.
Imagine a future with no incisions. Imagine a future with no complications. Imagine a future with the cure in every part of the body and 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. All right.
I said done, Dr. Holmes.
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. I know there are some very smart analysts here. 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. There is a mic in the center. Please feel free to come here, or we can bring the mic to you if you like.
Please, someone go grab it.
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?
Or BPH patients if you're providing that to them.
From a prostate cancer side, I would say about 40%, maybe a little higher, are offered TULSA. Again, we talked a little bit about where TULSA is not appropriate in advanced, clinically advanced disease. I would say that in the absence of these calcifications, I would say of those 40%, at a minimum, 20%-30% are eligible for TULSA. Out of that, I would say a majority of them do choose to do TULSA. Why? It's because the side effect profile is much more favorable. No urinary incontinence, no erectile dysfunction. I think the biggest issue with TULSA is we know exactly who we can offer it to and who we can't. Those who we can offer it to, they gladly jump on it.
The problem is there are cases where cancer is extending past the capsule or the distance between the urethra and the target won't accommodate TULSA. So really, a short answer to your question is if they're eligible for it, they jump on it.
How about for the other two?
Right. I am in a position where I've done, 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 for me, I have a referral pattern with a lot of outside urologists who will send the patient to see me for robotic prostatectomy. The patient in their mind is already, OK, I'm getting a robotic surgery done. Sometimes, and I'm an investigator in the CAPTAIN study. I've traditionally counseled my patients that I diagnosed with cancer about TULSA. In that segment, Ron mentioned some of the technical considerations. I think, I guess you guys all know those about the calcifications, the size. Those, especially for the study, they're very strict on the entry criteria.
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. [Kella], I know you've done a lot of robotic cases. I explain to them, they're like, but you've only done 50, 60 TULSA cases. What's the deal there? I explain the learning curve for TULSA is a lot less than the learning curve for robotics was. 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.
A lot of them will be like, wait a second, doc, what is this TULSA thing? Can you explain more about that? Some of them who came in thinking robotic, robotic will actually go to TULSA. 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. I call the referring doctor and say, let me explain what's going on. I think awareness will change that. As time goes on, that will definitely change. To answer your question, I think most patients, once they see both options, are really interested in getting TULSA done. There are definitely patients who are going to still need robotic surgery in the future, I think, at this time.
How about you, Dr. Hong?
I will allow that my practice has evolved such that I think people are now seeking me out primarily for TULSA. It is a biased population. What the principles here are, I always ask, as we all do on stage here, what's important to you as a patient when you get diagnosed? Everyone wants to cure their cancer. Absolutely, that's number one. Number two is they want to not leak urine. That is generally number two. Number three is sometimes a close third or sometimes a far third, is their erectile function. Either way, almost all patients uniformly want the same thing. When we present their diagnosis and their options, all the options get discussed, including that of radiation and all the substitutes of radiation as well.
At the end of the day, they also have their own chance of looking at what's out there already about the TULSA-PRO. 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 covers this and that, insurance coverage. Those sometimes can affect the decision-making in the end. In, let's say, a perfect world where insurance were not a consideration, I think it would be very close to 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, on that slide that you presented on BPH with the IPSS score dropping 75% for TULSA versus mostly high 60s, mid 60s, yet it was from a lower baseline.
10, right.
What are your thoughts around that? I mean, you would think that a higher baseline could come down more, but any.
Right.
The baseline, meaning the IPSS score at the beginning?
Correct.
Right. OK, 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. 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. This patient who came in strictly for BPH had a much bigger prostate. I've got 106 g, 108 g prostate. He was very frustrated with his quality of life. He had a much higher IPSS score. He's done great. Now, that's just one patient. We're early. To me, the potential with BPH, there's less reasons why you can't offer TULSA. Calcifications don't really matter here. It's quicker for throughput.
I'm going to try to aspire to Dr. Hong's five a day. That's really good. I think you're going to see the results. 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. On the docs that are referring in to you and you've got the, they're expecting their patients to go to the robot. What's kind of the reaction that you get when you call them up and say, hey, the patient asked me about this and maybe we'll go on this route?
I mean, I think so I've been in this area in South Texas for 20 years. I have a good relationship with most of them. They just want to make sure their patient does well. I think they're trusting me. If the patient comes in and they're really, OK, they're set on getting the robotic done, I think that's going to change as more information comes out. 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. The guy's like, well, my surgeon already told me robotic. Dr. Kella, you're the robotic person.
That will change as time goes on, I think.
Once we get these NFL players out there saying TULSA.
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.
Also the CAPTAIN trial, right?
The results of the CAPTAIN trial would be pivotal for that.
What are you guys' thoughts on how those are going to be received by the guideline authors?
I mean, it's level 1 evidence. Assuming we feel what the CAPTAIN trial will show, I mean, that's argument enough to make a decision.
Makes sense. Lastly, for me, the cost of the practice for the TULSA Plus, is that something that you're comfortable with sharing?
What's your question, Ben, again?
Like the monthly or quarterly, whatever the fee that kind of wraps it all for TULSA Plus and what you're offering economically. That goes into the numbers that you presented, sorry.
Yeah. Ben, let me answer that one, if you don't mind. I think that is all changing. Particularly, Dr. Hong and Dr. Kella relied on cash pay originally. Those practices are continuing. I think we are in that transition period where now more and more patients are finding out, hey, this is reimbursed. I think based upon the fact that it's going to enter that world of comparative, as compared to robotics, what am I getting paid? The hospital administration, and Tom talked about that, is now getting engaged to see what's the economics. I think we have pressure tested the economics at a few places. There's no doubt that the economics for TULSA is superior to that of prostatectomy. 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 treatment and payment for TULSA is that it has 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.
Great. Thanks for taking the question, gentlemen.
Thank you. Steve, anything on the web? We're good?
Yep, there's two questions.
Yeah.
The first is, have you received any pre-orders for the TULSA Plus offering?
We have been. Tom, maybe you could talk about 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 MAGNETOM Free.Max is in Q3 of this year. That's an important caveat that we still need to work out on a few things as it relates to that. We are well on track in terms of bringing those two technologies together. What I will say in terms of the pipeline is the following: 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. 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. If they had a different treatment algorithm in terms of throughput capacity, another magnet obviously would help with that. There is consideration there as well. What I am trying to impress, Arun, is that there is a kind of a plethora of different TULSA Plus suitors that we are looking with. The conversations are ongoing. Is that a fair answer?
Yeah. I think, Steve, we are in discussions, close discussions. The installations of the TULSA Plus with the Siemens MAGNETOM Free.Max most likely is slated for Q4 this year. We do think that before that, we will have orders on our books.
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?
OK, to answer?
Yeah.
Fantastic. First and foremost, patients talking to patients, right? 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? 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 health care specific here. Our own push from a digital marketing campaign through our increasing interest that we receive from patients directly.
I did not mention this specifically during my portion of the talk, but I would be remiss not to mention it now is that we have several nurse educators on staff who take direct questions from interested patients. We, of course, refer out in a compliant manner to provide them with access to current TULSA users. The list goes on as it relates to the AUA, where we are today, RSNA, EAU, et cetera, and educating physicians. The physicians then ask us, can you help us educate our patient community so we can do geotargeting within the community through our clinical sales specialists in a boots-on-the-ground method. We juxtapose that also with geotargeting around those specific TULSA-PRO locations to drive awareness of the technology.
We have 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. 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. 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 trial have patient education events where they educate the community on what they offer through their men's health campaigns.
It is a multitude of factors that will go into the digital push.
Scott, you're the last word.
Thank you, Arun. 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, I want to get trained up, and kind of asking you about your experience as part of that expansion of getting more physicians trained to be able to do the procedure?
Dr. Hong?
Yeah. I actually think that's absolutely crucial to what we are doing and that I'm personally trying to make efforts as well. I think it has to come from a colleague, another urologist, urologist. I think the message of what TULSA is is a little muddy, even in the AUA. That's what I find to be really interesting is the focal, is hemi as a whole. 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 focal technologies that are out there. Certainly, while TULSA can be used focally, it can also shine in a whole gland fashion. There is a little bit of that, again, activation energy that needs to be lowered. Absolutely, I think that those pathways can be created.
There's clearly interest. Once the results are becoming known, other urologists will really be forced to have to learn about it because otherwise they'll fall behind.
With the results of CAPTAIN, based on some of the data that was already shown, 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 1 evidence. And for me, I mean, my practice is very unique. We basically, within the practice, kind of do our own set of things. So prostate cancer, someone else's kidney cancer, someone else's stone person. There is a lot of colleagues here at the AUA that you talk to. Specifically, after our podium presentation, a number of them did approach me and ask questions.
Yeah. I think it reminds me of when we were starting, again, with robotics. There is a small group of surgeons who really started getting things going where it starts to leak out. Other people want to get involved. I see I have my referring base, but I haven't—I think now that we have reimbursement and another piece of this puzzle is access to the MRIs. It looks like all these things are kind of getting solved now, hopefully quickly, where you'll have the throughput then when all these people want to start doing cases. It's, 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. Like everyone's talked about, there's a big market potentially for BPH. It looks like those results are going to be good.
Once we get the CAPTAIN studies pretty much getting wrapped up this year, and hopefully start seeing the data come out to be as promising as what we all think it's going to be. That's going to make a big difference.
Oh, that's fantastic. In terms of kind of pipelines or backlog of TULSA patients, do you have waitlists for patients wanting the procedure? Approximately how long are those? Has that increased since January with the new Medicare reimbursement?
For me personally, I work with a large hospital that has the system. Now that there's this code since January, I've been focused on the study. We have a lot more patients who've been asking, OK, there's reimbursement. We've been trying to get the reimbursement with the hospital. Basically, we've been trying to get a meeting set up so everyone can be coordinated with the hospital. We do get a lot of calls. I think some of those patients, maybe 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. 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.
That's great. I guess, Tom, on the TULSA Plus side, just lastly, is Siemens helping at all with intros? They obviously have a large commercial presence kind of globally, but I'm sure in the U.S. as well. Is this really something that you got, they're providing that device, and you have that relationship? Really, the commercial push is coming primarily from Profound.
Yep, great question. I often talk about deals in the boardroom and then the percolation of the real world, right? The percolation of the real world is happening. The strategic opportunity that was created at the boardroom level obviously makes sense when you look at the X and O's. Now we're finding that, OK, counterparts are finding counterparts because they're sharing 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. 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.
There are 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 the mass adoption, folks are coming to us 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. 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 and the world, even the zip code, right, it could be a different person who is the favored provider of care in that community. We would be remiss not to basically acknowledge that and work within those instead of going upstream. 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. They have the opportunity to provide the gamut of all those things that you showed on a slide, right? There is a ton of things they can use in the arsenal. It is the right treatment for the right patient at the right time. Is it always TULSA? No. Is it always robotic prostatectomy? No.
The concert of the physician and the patient making that decision, and I'd also be remiss if 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 is a joint conversation. It is a very serious one. Making sure that education takes place is very important. 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. I can tell you that the smart OEMs are working with us very closely.
Yeah. The incentives on the ground are kind of aligned where if a Siemens person sees an opportunity, they want to call you guys up and say, hey, let's go in there together. It's on their radar on the ground.
I think so, right? Because to me, you can solve pain, or you could also create pain to be solved, right? Some of the pain that's been talked about in the past is, oh, there's not enough magnet time. When the patient starts demanding this technology, you're going to find the magnet time. 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. They'll be racing to get to the answer. I think that's how we establish a relationship with Siemens, Philips, and GE is that it's an open conversation. Philips, I apologize, Siemens obviously is the first mover.
Therefore, they should be rewarded for taking that risk with us.
Excellent. Thank you all.
All right.
Arun, this is 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?
Yeah. Maybe I can take that, I guess. 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. 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. I think that it translates to the fact that there is no one technology that is going to do it all. You've heard that from our physicians already today. This is the reason why when you saw Dr. Kella'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.
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. 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 reduce the volume of the prostate to 8%-10% of the original size, I think that's what's going to drive the adoption of our technology. I think Procept will have their space as well. To me, it's great for everybody, great for the patients to have all this. Yes, of course. Please.
That's awesome. OK.
Just follow up on some of the interest that you're getting from colleagues, how that's been 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 and awareness of data and personal experience with the technology to the point where they're more resistant to move. Then there's folks who, and so wondering if there's aspects of the procedure that you think are making it easier for those folks to get interested. Are 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. It is a great question for sure, Matt. 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 Tamberrino now. Because we have to break walls. We are going to break these walls. You remember the early days of Intuitive Surgical. They had to really work hard. It took a few years before they got there. I think we have learned from that. We are going to 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. If the hospital did not have it, then the patients were going some place else.
The hospitals were facing, do I shut down my urology program, or do I buy this expensive robot? 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. 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. Our clinical trials are going to be very, very clinical outcome focused. We're also going to, you've seen, continuously improvement in the technology itself that we will bring more and more AI into this.
I think it will ultimately become cheaper, better, faster, more and more to use. I do not see this as a one thing that we need to accomplish. We recognize the hard work we have ahead of us. We have programs in place. I am actually very proud of the team. We are going to deliver that for sure. I am happy to have the physicians.
Oh, yeah, if I may, because it kind of goes along with 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 a foreign environment. Those are teachable things. I'll tell you what is less teachable, but skill sets that urologists already have is understanding nerve sparing on a prostatectomy, for example. How many times have I done a robotic prostatectomy and wish I had X-ray vision? You can see things directly in the robot, but how do you know where exactly the nerves are? 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.
After you go through those experiences as a clinician, you start feeling like, what else can I do? I can certainly learn about these new techniques, whatever sparing operations within Da Vinci system. At the end of the day, is that going to move the needle? 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 do not just trust their [Schoen] score or IIEF scores. You ask the partner, and the partner's nodding her head. You are like, wait, no, no, your erections really are not that good this early on.
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. 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 happy on my TULSA days. It's a little bit less stress.
Yeah.
Compared to my robotic prostatectomy.
I mean, yeah, compared to my robotic prostatectomy. I mean, from just a general stress level, they're very enjoyable days.
Yeah. The prophylaxis is good for stress, I guess.
I mean, there's no worry about, I mean, we've done a large volume of robotic cases. Yeah, there's definitely no worry about bleeding, 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. With TULSA, definitely, I mean, to me, it's a much more reproducible type of procedure. There's just way less risk, no bleeding. I think that's going to really help as we have the ability to do the procedure with the billing and the MR time.
By the way, by no means does that mean Dr. Arun, Kella, 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. Already, you have some basis of patient safety built in. You are just trying to make sure the procedure is optimal as opposed to avoiding some major disaster. That is a big deal for a surgeon.
Great. Thanks so much.
Matt, thank you. I think this is, we're good. I think, thank you so much for being here.
Blood pressure.
Thank you for those who are on the website. Again, I would like to particularly thank Dr. Pathak, Dr. Kella, and Dr. Hong for taking the time to spend with us and present to our investor community. Thank you so much. Excellent. We do have a demo here. Those who have a few minutes, please, Amanda will present the demo to you. I also want to thank the Profound team, amazing collaborative effort, guys. Great job. Thank you.
This concludes our program.