My name is Rick Wise, and I'm delighted to welcome Arun Menawat, Chairman and Chief Executive of Profound Medical, and I have to say, Arun, I've known each other for many years now. I picked up coverage of Profound late last year, and in my mind, the company's made significant regulatory and significant positive regulatory and innovation progress since that point. Just recently, CMS announced that the company's minimally invasive TULSA-PRO prostate ablation technology will receive Level 7 facility payment reimbursement. That's higher than the competing surgical procedures' Level 6 payment. With CMS reimbursement in hand, the company's cleared a significant and major and critical adoption hurdle. Today, Arun, I hope to hear more about what that all means and what's next and your top 2025 priorities as well.
Fantastic.
Thank you for being here.
Thank you so much, Rick. It is actually great to be here. And you're right, I've been to these conferences that you've hosted for many years, and it really, I'm particularly happy about this company, Profound, and the stage we're at today. So Profound is about TULSA. And TULSA is an entirely new way of treating diseases of the prostate, whether it's malignant or benign. We introduced the product in January 2020, and it is a new technology. So most of the patients we've treated so far have been cash patients. And as Rick said, starting January 2025, reimbursement will take effect. So we are a company that is at the moment in that transition zone where we'll be switching from cash pay model to a reimbursement model. Excuse me. So let's talk about prostate cancer first. There are about 300,000 patients who are diagnosed with cancer.
And the way they are treated is you can either remove the prostate robotically or you radiate the prostate in its place. And if you look at the clinical data on these technologies, the bottom line is 20% of the patients who undergo the treatment become incontinent, and over 50% have erectile dysfunction. And so you ask the question, why is that, even though these technologies that are being used today tend to be among the best technologies? And the reality is that if you look at the schematic, the nerve bundles that control these functions are right underneath the prostate, and the sphincter muscle that controls the incontinence function is right at the apex edge of the prostate. And so when you remove it, you kind of tend to kill the nerve bundles, or you stretch the sphincter muscles and altogether, that causes these problems.
And so there are inherent in the procedures that we undergo today. So this is why our procedure is entirely different. We actually treat the patient inside an MRI. So if you look at the image, we actually place the patient in the bore, and then the surgeon, instead of having knives and cutting or robotic tools to cut, they sit in front of a screen. And if you look at the image at the bottom in the middle, they basically can draw the boundaries of the prostate right there. So they see the boundaries, they know where the nerve bundles are, they know where the sphincter muscles are, they can just draw and tell the computer anything inside of this needs to be killed. Now, we also insert a catheter, and that you see in the inset image on the bottom left.
And this catheter goes through the urethra straight in the center of the prostate. And that yellow blade-like structure that you see is really what it supplies very different sounds and different frequencies. And that sound then gets absorbed by that tissue, and that absorption heats the tissue one degree at a time. And not only that, from that MRI, we get these images, but we also get a temperature map in real time. So you have this blade coming. The computer software knows where the boundaries are that the surgeon has already told the software. And that blade then just gets rotated, and it heats tissue to kill temperature. It doesn't overheat, it doesn't underheat. And all of this is quite heavily driven through our AI technology that I'm going to show it to you. So you see the entirely new way of killing the prostate in its place.
No radiation, no blood loss. It's just very gentle heating, and the tissue gets reabsorbed by the body over time. And so the prostate just shrinks down to the urethra. So here's the movie you can see. The patient is in the bore. The catheter is placed right into the center of that prostate. So here comes the catheter. And these cross-sectional images are taken by the MRI to see the images at the bottom of the whole prostate. On every image, the surgeon has drawn those boundaries that I showed you. And then they press another button, and it just starts gently heating the tissue. The yellow color is the kill temperature. And so we killed about one cc per minute, so 40 cc is the average size. 40 minutes, the whole prostate is effectively dead. Minimal side effects because we know where the nerve bundles are.
We have no blood loss whatsoever. Recovery is typically a few hours. Most people will go home and they'll go out to dinner that same day. There's no hospital stay for this procedure. So as I said, this is an entirely new way of treating, and it's quite in terms of invasiveness, it's pretty benign. So that portion that I talked to you about, the design of the prostate itself, this is now AI-based, and it's been approved since May of 2024. And basically, when the images show up, the surgeon presses a button, and a treatment proposed design shows up on the screen. You can see that treatment design showing up right now on every slice.
So it used to be they would draw it by hand, but today they just see it, and they verify, and they say, yep, I accept it, or they can make some minor modification. So not only that, this is AI-based, and thereby it learns and it gets better and better over time, but it saves a significant amount of time also. And I think even in the beginning, from the very start, most surgeons are saying it will save maybe about 20 minutes or so. But I think over time, as they become more and more comfortable, it will save even more time to the point that you can actually treat at least one more patient in the same day. And this is the second part, which is that treatment part that I talked to you about. And again, this is the actual screen that the surgeon is watching.
They're not doing anything. They're just watching that screen. And you can see the yellow color effectively getting painted in the middle. So the top row are the boundaries that the surgeon has accepted. The middle is the treatment. And the bottom, you can see the dead tissue. You can see the dark tissue right in the bottom. And if there's something that didn't go right, the software will stop, or the surgeon can stop it. They can restart and so on. There's plenty of flexibility for them to do this. So what are we getting with this? Amazing amount of precision, MR quality precision. We're getting amazing flexibility. You can treat whatever type of prostate you want, large, small, half of it, all of it. And we have killed it.
They can see it at the end of the procedure, and that dead tissue gets reabsorbed because we're not boiling or charring that tissue, and so the body doesn't really respond by creating any fibrotic tissue or anything else, so we've learned a lot from this technology also because it is so unique and so new, and at this point, one of the things I'm really proud of is we have 67 peer-reviewed publications now. We have over 200 conference presentations, so this product is being used. It's been a subject of phenomenal types of clinical trials, and not only that, there's plenty of clinical data now. It's in various segments, so for BPH and benign, we already have two published articles. In hybrid cases where you have BPH as well as cancer, we have three publications.
The workhorse is really either treating half of the prostate or, in fact, the majority of our patients are in whole gland treatments where you can see we have 16 publications. And then it's turning out to be one of the better ways of treating patients who fail radiation. So all in all, really a fantastic body of clinical evidence. And we continue to add to it because one of the things that we have sponsored is a first Level 1 randomized trial called CAPTAIN against robotic prostatectomy. So we will continue to develop the technology, but part of our objective is to develop it in various segments so that it gives the surgeons all of the data they need to be able to use the full capability of this technology.
So I'm just going to share with you a couple of key publications just so you can see the data. This first one is whole gland prostate cancer, five-year outcomes. And what it shows is very stable PSAs. About 20% of patients needed a secondary treatment post TULSA, which is statistically similar to what you get from robotic prostatectomy or radiation. So we're in the same range as what anybody else is. But what you really see is really 97% of patients were continent during this treatment, and 13% of patients had erectile dysfunction, but it was considered to be low grade to the point where they would respond to drug treatment. Severe ED, which is what typically you get from those other treatments, really was 0%. And this is just think about this.
This is the first generation of our technology when they had no idea how to use it, including us. We were learning as well. Now, with the latest data, it's even better because they can control it even better than they used to. The same thing on the BPH side, what you see is the way to measure is IPSS score. We see unbelievable, incredible improvements when TULSA is used for BPH. You see in the insert screen those two pictures where there's a whole prostate, and then a year later, that whole prostate is basically down from 58 cc to half a cc in size. Not only that, you have eliminated this majority of this prostate, you've eliminated the possibility of that disease, which is why I really talk about the durability potential of this technology. What's the real world?
That's the most important question is all this converting into real world? And I think this is one of my favorite pages, and we talk about it quite a bit. If you look at the bar at the bottom, what type of cancer is being used? This technology is being used on Grade Group 1, which is low-grade cancer. The majority of our patients are then in the intermediate group two and three, but we are treating Grade Group 4 and 5, which is high-risk patients, which is something that our surgeons on their own decided that the technology was good enough to start and try. And then they even have treated palliative cases to debulk these prostates. So we're really pleased with the fact that full range of different grades of cancers are being treated with our technology.
The second point being the size of the prostate matters when you're picking the technology, and so in our case, because of the fact that we use the MRI and we go from the center out, our surgeons actually don't care that much. They just draw the boundaries. If it's a large prostate, 200 cc. We've treated prostate so far, I think, is the largest we've treated, 283 cc. That's about as large as it gets, and 20 cc or smaller, we treat those all the time, so that flexibility in the range is really important, and then the other thing we find is this flexibility of how much you're ablating, how much are you killing. Over 50% of our patients are treated whole gland.
But what we find that I particularly find interesting is about 20% or 25% of the patients are being treated 50%-99% of the prostate. And then there are about 20% that get what they call less than 50% or focal type treatment. So for the first time, it gives the surgeon that flexibility to decide, do I want to treat the whole thing, or is the disease really confined that I can really treat less of it, which means even less possibility of any side effects? And then at the top bar, you can see the full indication. About 75% of the patients are cancer patients, but the portion of the population that is growing is that patient population that has both cancer and BPH combined, which is a unique population.
And I don't believe that there are any other technology that can take care of that patient population like we can. So because of the fact that it is being used so flexibly around in different types of cases, one of the things we heard from our surgeons was, "Hey, you know when I'm treating these high-risk patients, I find that the margins, I just want to be sure that the prostate margins that I can kill that comfortably." So it's a software-driven company. It's a software. And we simply provided the software called Thermal Boost. And this software just goes to the edge of those boundaries that they've drawn, which gives them comfort that the boundaries are going to be cancer-free. And over 50% of the patients that we treat today are using this technology.
And I think one of the things about our company is you will see these types of modules will come up so that we can really, really take care of these patients and make sure that the uniqueness of their prostates is reflected in the uniqueness of the technology that we develop. So the market for prostate cancer is about 300,000. As I said, that's the diagnosed patient. We think we can treat at least 200,000 of those. Typically, regardless of what business model we use, it's about $8,000 per patient. And that gives us a very nice TAM. And I think in the insert image, you can see the cancer typically is in the peripheral zone or the outer zones of the prostate. And having that flexibility to treat the whole gland and be able to go to that outer edge is a critical part of our technology.
So we're pleased with what we have shown so far, and we think this TAM is very, very real. Now, as we went into the cancer side, a number of surgeons actually said, hey, it's also a very good application for BPH. And so last year, we talked about taking the same AI technology that's already FDA-cleared for the boundaries of the prostate. We're using the same technology, and we're developing a specialized, faster way of ablating using that technology, but for patients who have BPH. So the idea here is that these are two diseases of the prostate, but they're actually very different diseases. The BPH comes more from the transition zone of the prostate, which is inside, and that zone becomes big.
But given that, again, we are in the MRI, we can actually visualize where is the abnormality, and they can literally design the treatment to take care of that abnormality, which we think is one of the reasons why the results in our clinical trials are so strong because of that ability to literally customize that treatment. So if the transition zone has really grown, we can ablate more. If it hasn't grown too much, we can ablate less, and that affects the time and how quickly the patient can recover as well. So this is just a schematic of that transition zone of the prostate that has grown in this patient.
And if we just look at the patients that we consider to be those patients who have the most severe form of disease, because this is such a big disease, there are over 12 million patients, and there are going to be multiple solutions that will be available for the different grades of this disease. We're focused on that patient that has the most severe form of the disease, and that patient may also have some cancer. And if we just look at that segment, we think that's about 400,000, which effectively triples our TAM. And so we're quite excited about the possibility of advancing our software. So same hardware, same regulatory approvals, same use of reimbursement codes, except the software is going to be designed more for treating the patients for BPH. So let's talk about the business side. So as I mentioned, we started in January 2020.
The first couple of years were related to the COVID, so it did hinder us a little bit. But we're really proud of the fact that even though 75% of our patient population was cash pay, we were paying over $30,000. And quite frankly, when you have patients who are willing to pay over $30,000 when they could get a prostatectomy or radiation for almost nothing, it was quite amazing to watch this also. And patients never, like those who could afford it, they never said, many patients have said, I'll pay more for something like this. And so we have treated over 3,000 patients during that time. We are in over 50 hospitals. So when I look at this period when we're in this cash pay model, we think benchmarking against new technologies, we've done actually quite well in that space.
And then, as Rick said at the beginning, we're thrilled with the way CMS and AMA worked towards getting a permanent code. So the Level 7 , I'm going to describe it in a second, is the highest level code, quite frankly, not just in urology, in any space, is the highest ablative code they've ever approved, which is pretty interesting in itself. But the second part that's even more interesting, I think, is that the codes are going to be applicable in almost any delivery setting, which means that if you have, for example, a robotic prostatectomy, it can be done in a hospital. CMS will not pay for it even in ASC.
But because our procedure is incision-free, radiation-free, no blood loss, and no hospital stay, they have approved the use, and almost tomorrow a doctor can buy an MRI, and they can do the TULSA procedure, patients will go home, and they'll get fully reimbursed for the whole thing. There is no other procedure where that is true. And so these are two very big things that have gotten us quite excited about 2025 and beyond. And the fact that we have already covered leading hospitals in the United States that are already using the technology. We think that also bodes well in the perspective that we can provide very strong references to the new hospitals that will want to be adopting this technology. Now, the codes that have been approved, in fact, are also quite unique in the sense that it's not just one code. There are two scenarios.
If there are two physicians who want to use this technology, let's say there is a resident and a urologist, they can divide it up, and they can only be visible when they need to do their part, so one can manage the device management of insertion of the catheter and taking care of the patient after the procedure. The main physician surgeon can come in and just focus on the treatment part, which might take an hour or so and then leave, and they can then bill using their own codes and get paid for their time, and in another setting where there's one physician who is doing the whole thing, they can use the 55882 code, and they can then bill for the whole thing.
So again, we started with the theme of flexibility, and that theme of flexibility shows up in the way the codes have been approved also, which again, we're really proud of. And that second point that I made already is this is the only technology, TULSA is the only technology that is now approved for use in hospitals, ambulatory centers, imaging centers, physicians' offices, or large practices. So in that section, in that part, the non-facility, so called non-facility, it's like our domain. No other technology can even be used in that domain. And then the codes, the Level 7 code for TULSA in a hospital setting, the national geometric mean will be almost $13,000. And when you compare that to even robotic prostatectomy at $10,400, that difference is fairly significant. All these other technologies are typically in the $9,200 range.
Robotic prostatectomy is just over $10,000, but TULSA will be at $13,000. What's even more interesting, as I was talking about the fact that we can be using this technology in ASCs, the payment for TULSA at ASCs at $10,700 + is higher than payment for robotic prostatectomy in a hospital setting. So we think that this is another key for us to help drive adoption. When you think about the physician payment, these numbers are very interesting because at the high level, you would say, well, you know the robotic surgeon is making it about $1,150. A TULSA might make $918, so there's some disadvantage. But the reality is that on a per-hour basis, it is the same because TULSA is a faster procedure.
So when CMS or RUC committees did their analysis, they basically recorded how much time the surgeon said it took to do the procedure, and that payment is based upon that, which is why we typically talk about the fact that if you're doing two robotic prostatectomies in a day, you could literally do three with TULSA. Or if you're doing three prostatectomies, you could do four in a day because it is actually a little bit faster procedure. So from that perspective, when you have discrete increases in the number of procedures you can do in a day, the reality is you could actually do financially even better. So I've also talked about the fact that we have a CAPTAIN trial that is coming up. It is the first Level 1 study, 201 patients randomized two to one against radical prostatectomy. And we are on track to complete treatment.
The first set of perioperative data we are looking to be announcing at the AUA or American Urological Meeting in 2025, which is at the end of April next year. So we're quite excited that this will not only give strong evidence, but it will also provide the data that we need to get the insurance companies as well to start paying for that procedure. One of the questions that comes up is, well, what about MRI, availability of the MRI? So we took all the MRIs available in the United States. We looked at which brands we're compatible with. That number is about 14,000 MRIs, which means over 64 million hours per year is available. Now, if all 200,000 TULSA procedures are done every year, that adds 500,000. That's less than 1% of the available capacity of the MRI. So this is sort of like a non-issue.
Now, it can be issues in certain situations like a community hospital where they may not have a number of MRIs, but the reality is the majority of the TULSA procedures will be done either in these imaging centers or they'll be done in hospital settings, and there's no issue with respect to that. Now, lastly, the most exciting thing to me is Siemens has recognized the need for an interventional MRI, and we have a relationship with them already in place. We're continuing to strengthen that relationship, and as we go in the future, we'll be able to provide a hospital or an ASC or a doctor's office with both an interventional MRI, which is much easier to use, designed for something like this, and combine them all together into one fully operational solution, so that's part of our approach as we go forward.
That's my final comment, Rick. Please feel free to ask any questions. We have about three minutes.
Just to dive in, you obviously spent a great deal of time on the new CMS reimbursement. Talk to us about the early interactions with physicians and hospitals following that announcement. What kind of reaction? Have you gotten new leads, or have you opened new centers, or sold new systems? However you want to characterize it.
I mean, I think there is no doubt that they are very quickly coming up to speed on the reimbursement story. A number of them we have called, but quite frankly, in the last week or so, we're starting to get incoming calls from them after they've read the regs on their own. I do think that the reaction is quite positive.
I think that the whole idea of combining the MRI with the TULSA is actually resonating. And obviously, we're operators, and there's good and bad and everything. And I think that our strategy is to get them started with the existing MRIs, but ultimately, I think the idea of TULSA Plus, where they can get their own MRI and have full control of everything, is where it seems like that's where it's going.
Another important step, Arun, you hired a gentleman named Tom D'Ambra to be your Chief Commercial Officer. I know you worked with Tom at Novadaq, and this was a very important hire from multiple perspectives for you, and you worked hard to make it happen, I know. Why is this so important, and what are Tom's marching orders, and when can we start to hold him accountable for whatever that is?
To answer your last question, Tom holds himself more accountable than anyone can ever hold him accountable for. And so this is actually why I brought him. The reality is that I think all of my life, and you know this, I've spent my life building game-changing technologies and bringing them. And that's not an easy task. And so in the last company, Tom led the company from a sales and marketing perspective. It was a hard product to sell. It was hard to go sell to a surgeon who is already doing surgery and saying, "Hey, if we give you visualization, you can do better." Versus here, I actually think that this is once this reimbursement code, they're all in place, and some of these sites are running and using, so on, I actually think this is going to be a far, far easier proposition.
So bringing Tom was the first step. I think we're bringing some of our old sales team back that really did produce quite well. And that was one of the main reasons for doing so. And again, to come back to accountability, hold him accountable in this quarter because he definitely is there.
And looking ahead to the next one or two years, what are the major milestones that you'd have us focus on and think about from your perspective?
I think in terms of milestones, how well we can get going with the reimbursement news and so on is obviously one. The CAPTAIN trial results will be another one. I think that the TULSA Plus model, how does that go and how does that affect ASCs?
Because a number of ASCs have already wanted an MRI for their orthopedic work, and I think this could become another argument for them to get one. I think that will be another big milestone because if that door opens the way we think it will, I think it will be a game changer for a lot of things. And then finally, I do think that this is a platform. This is the next generation of robotics, Chris, Rick because the robotics of today is over 20 years old. This is the robotics of tomorrow where there is no incision and no hospital stay. So it's just the beginning to me.
Great. Thank you so much, Arun. As always, you made a complex topic very clear. Thank you, and congratulations on all the progress so far. Thank you so much.