Kick off our program today. Let us start by pointing out that this event will include forward-looking statements within the meaning of applicable securities laws in the United States and Canada. All forward-looking statements are based on Profound's current beliefs, assumptions, and expectations, and relate to, among other things, expectations regarding the efficacy of the company's treatment technologies, results of future clinical trials, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance, and future commitments. Such statements involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this analyst and investor day event.
Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
Good afternoon, and thank you for joining us. My name is Derek Bower, and I'm the Vice President of Marketing here at Profound Medical. It is our pleasure to welcome you to our 2023 Analyst and Investor Day. This program will feature presentations on TULSA-PRO and its unrivaled flexibility to treat a wide variety of prostate disease patients. You will hear from key opinion leaders in the United States who have gained firsthand experience with the technology. You will also hear testimonials from several prostate disease patients that have undergone the TULSA procedure. Lastly, members of Profound's management team will provide financial, commercial, clinical, and corporate updates with a focus on the future of TULSA-PRO. All questions will be held to the end of the program.
We encourage you to enter your name and institution into the Q&A area so that you can be called upon to ask your question directly. To kick off our event, we are very excited to share with you and our global audience a short message that demonstrates the impact that our company is making on not only this disease state, but in patients' lives around the world. This video showcases a leap forward, an evolution that patients have demanded. We heard them, and we responded. Profound Medical is defining a new category: incision-free surgery.
In life, there are moments that test our strength, moments that bring sorrow and uncertainty. A prostate diagnosis can bring a flood of questions. Does your life have to change? Does it have to affect your continence, your intimacy? Do you have to stop living? No, because this procedure was meant for you. It's for you, the hard worker. It's for you, the party starter, and you, a father and now a grandfather. It's for men who want to play with their grandkids, for husbands who want to dance with their spouse, for those who want to bring back the little things in life and to make memories, small in size, but great in heart. It's for all of you. Don't just survive, live! one in seven men experience prostate disease every year in the United States and Europe. Now, these men have another option.
The TULSA-PRO was designed to treat the disease and maintain the man, to allow them not only to survive, but live. The TULSA-PRO is moving an entire disease state into a new revolutionary category of incision-free surgery, focusing on what is important to men while maintaining oncological control. The transurethral ultrasound ablation procedure, or TULSA-PRO, is performed in an MRI scanner, providing the treating physician with the precision of real-time MRI to visualize the anatomy and confidently deliver the treatment of the prostate and its surrounding structures. The TULSA-PRO keeps the urethra and the rectum safe by keeping both at natural body temperature. The surgeon uses real-time MRI images to prescribe the margins of the prostate tissue that they intend to ablate or kill.
The real-time, precise treatment planning gives the surgeon phenomenal ability to customize the treatment to fit the goals and needs of each individual patient, unlike any other available technology. This is autonomous robotics. Once the surgeon tells the robot the boundaries of the abnormal tissue, the robot measures the tissue temperature using the MRI data and sends sound waves into the prostate tissue to gently heat it to temperatures that kill the targeted tissue and no more, without causing any boiling or charring. The result is that the abnormal or diseased tissue is dead, and the vital organs and structures around the prostate that are critical to normal functions are safe. This is TULSA. Real-time imaging, precision, gentle heating of a surgeon-prescribed region of tissue, no more and no less.
TULSA is a game-changing technology that empowers the surgeon to customize the treatment of every individual to preserve urinary and sexual function. TULSA-PRO, built for real patients with real-time precision and real-world results. Don't just survive, live.
Derek, thank you. It does really make you think about it from a man's perspective. Good afternoon. My name is Adam Milligan. I'm the Vice President of Business Development. So let's switch gears a bit to the other side of the equation. We have three U.S.-based physicians presenting three different perspectives regarding their experience with the disease state and with the technology. First, I would like to introduce Dr. Mark Hong. Dr. Hong is a board-certified urologist with Integrative Urology. He trained at Stanford University School of Medicine, Brigham and Women's Hospital, and Harvard Medical School. He is fellowship-trained in robotic prostatectomy. Dr. Hong, thank you for being here.
Thank you for having me. My name is Dr. Mark Hong. I'm a urologist in Phoenix, Arizona, with Integrative Urology, and today we're talking about the contemporary management of prostate cancer. If you actually think about prostate cancer as an evolution of therapies, we, of course, have the two major treatments for prostate cancer, which have been around for decades. That's namely that of surgery or removal of the prostate, also called prostatectomy, and radiation therapy. Radiation, of course, involves a different kind of treatment altogether that's non-surgical. There's been an evolution in both sides. Certainly, for us as surgeons, we started out taking out the whole prostate through an incision. Then we moved to the laparoscopic era, and now the robotic era, where we take out the prostate through small incisions.
But you're still taking out the whole prostate. On the radiation side, there's been some evolution, brachytherapy seeds, MRI guidance, but there's a recognition that both of these treatments, while good at curing cancer, can cause significant side effects, impacts on your quality of life. Therefore, a third option, called active surveillance, has really become very popular because of the perceived harms of these treatments, of surgery or radiation. And let's just be honest, you know, I will say that most guys who are choosing these treatments are not excited about having these treatments done. Meaning that nobody that I know in my practice wants to have a prostatectomy, okay, or even wants to undergo radiation. It's just that they feel like they're forced to do so because of the nature of their cancer.
That's also why they choose active surveillance, is they're fearing the complications or other problems that can occur from these treatments. So what you would ideally want to have is a treatment that actually cures the cancer without causing side effects. And, really, that would be the holy grail. Well, I can tell you that such a thing actually exists, and that's called the TULSA-PRO, which is actually a customizable treatment for prostate cancer that's also incision-free, but it's also surgical. So it's sort of a one and done, and then, you move on with your life. We're gonna go into specifics. In the robotic era, though, I think if we really look honestly at our data and what we've done, we have clearly been good at curing prostate cancer.
This is well-published in our literature, the urological literature, of what the outcomes are after prostatectomy. On a long-term basis, prostatectomy, quite good at curing cancer, but not so good at preserving your continence and erections. So what I mean is, being able to not leak urine, that's continence, and, of course, have an erection enough to perform, and that's erectile dysfunction. Well, if you look at the slide here, the two curves that you'll see, the first one on the left and the one on the right. The one on the left is for incontinence, leakage of urine, the one on the right is for erections. Of course, if you start on the left side of the graph, you'll see that people start off pretty good, obviously, before surgery.
Immediately after surgery, you see a very dramatic worsening of both the incontinence, the leakage of urine, and erections. Now, over time, you do see that that function comes back slowly, but you'll see that those curves never get back to where they were before the surgery, both for incontinence and for erectile dysfunction. And by the way, this is the same whether you had it done open or robotically. So I think it's just fair to say from our published literature that the clinical outcomes of prostatectomy surgery have not really improved significantly in the last 30 years. Certainly, in the robotic era, we've achieved significant improvement in blood loss and length of stay in the hospital.
But in terms of the things that really matter to patients long term, which is, curing your cancer, but also not wearing a diaper or being able to perform sexually, it's a, it's a debate that robotics has really changed that, that nature. Of course, you should also know that in the robotic era, there have been, some safety issues, in terms of equipment malfunctioning that have actually led to injury or death. This, of course, could happen to any equipment, but it's also the complexity of the equipment. I personally trained, on the very first da Vinci robot, and I can personally attest to, or troubleshoot a piece of equipment, sometimes, having lengthy delays in the operating room because of that.
So I think, I think it's just fair to say that as a surgeon, you always have to be carefully monitoring the safety of the device. In this case, the arcing of instruments electrically, that can actually lead to a serious internal burn. There's just a lot of things that have to be considered. And really, the sophistication on the simplicity of the device really matters. So therefore, what you'd like to have is a surgical treatment that cures cancer but also is quite safe, and is reliable, and it does not cause the collateral damage that leads to incontinence or erectile dysfunction and other side effects of surgery. Well, that actually is why the TULSA-PRO is emerging as a significant alternative option to those standard surgery or radiation.
And that's because it is safe, it's incision-free, there's virtually no blood loss, there's no hospital stay. The actual recovery is fairly minimal because you made no incisions. Therefore, people are back to work fairly quickly. But also you're able to customize treatment to where the cancer is. You could choose to treat just a small part of the prostate or choose to treat all of it if the cancer requires that. And also, we can treat the entire gland without causing the significant side effects of surgery, incontinence and erectile dysfunction. Finally, the MRI guidance for the treatment is quite important. It gives you very accurate information as you treat it, so therefore, you know when you're damaging collateral structures and therefore leading to a worse outcome. The MRI thermometry, therefore, really matters when it comes to the TULSA-PRO.
By the way, you should also know that there's just an advancing pathway of how we diagnose prostate cancer and how we treat it as technology gets better, and namely, that we're really using MRI much more than we ever did before. And MRI is incorporated into the diagnostic pathway so that we can actually target biopsies and know what's going on in a much more targeted fashion. By the way, also, you should just know that, you know, what happens if cancer is not fully treated with the current methods? For example, with radiation, well-publicized rates of 20%-40% recurrence after radiation therapy. Well, what do you do in those guys? It actually can be quite dangerous to try to take out a prostate after radiation.
Therefore, actually, the TULSA-PRO is a safe and effective way to treat guys who have failed after radiation. Again, on this cancer pathway, you should know that in the past, you know, we, of course, diagnosed prostate cancer through the PSA blood test, which in and of itself is controversial, but, getting a PSA, doing a proper rectal exam, to check for cancer on that, and then, of course, that leads to a biopsy. Even a biopsy in the old pathway is just a bit of a buckshot approach, where you're taking multiple samples from all over, but not particularly in a targeted way, therefore potentially missing cancers. Nowadays, we're, of course, still using PSA blood tests and the prostate exam, but we've incorporated multiparametric MRI into that pathway that allows us to see the prostate.
And if you can see the prostate very well, and if you, if you can see the cancer, you can actually biopsy it and prove what's going on, and there. That can then lead to more targeted therapy, such as the TULSA-PRO, and this is all backed up with clinical trial data. I want to tell you about one of my patients, a 76-year-old male with a PSA of 14. Just so you know, that is definitely not normal. It is quite elevated. But he had already come to me with a diagnosis of what we call clinically insignificant cancer, meaning that, it was a tiny spot of cancer found on just one sample on the biopsy. And, that's the kind of cancer that, likely will never cause a problem in the future.
Therefore, rightfully, he was told to be on active surveillance, watch the cancer, and not try to do any radical treatment. However, his urination was definitely getting worse, and he had been on medication for that, but he was also trapping quite a urine behind after he peed because of this BPH or benign prostate enlargement issue. Because of that, we actually treated that, which we did that with a standard BPH treatment, the GreenLight laser , and he was quite happy with that. However, we didn't want to lose track of his cancer, so while on active surveillance, I actually felt a nodule again, a potential worsening of the cancer.
His PSA, while it had gone down after the laser procedure, as we would expect, I ended up getting an MRI and clearly showed something of major concern, really on the top portion of the prostate, that probably was not gonna get sampled very easily with a standard biopsy. Also, his PSA density is elevated. That means that per unit volume of his prostate, it was pumping out more PSA. That was also of concern. So we did an MRI fusion biopsy. That's called a-- It's a targeted biopsy of the areas of concern, and we could clearly see that in the targeted samples, in that area that lit up on MRI, his cancer was more aggressive than what we found if we just did the standard biopsies from all over the prostate.
Now, at this point, the patient still has significant concerns about his future continence. Of course, why wouldn't you? I don't want to wear pads in the future. And also, his erections. Therefore, the traditional methods of treating this, he wasn't that interested in, so therefore, he underwent a TULSA-PRO procedure. And of course, in this situation, we were fairly aggressive with the area that we could see on the MRI, but we also ended up treating his entire prostate as well. On the slide, then you can see the actual treatment images from this patient. The images from the top line are the before images, and then during the treatment are the second and third lines, and then the after images are on the fourth line.
You can kind of just take it from me that there's just a big, gaping hole, in the middle of the prostate where you see the black space on that fourth line. That means that even before he has woken up from anesthesia, I already know that I treated his cancer. Well, guess what? Afterwards, zero incontinence, not wearing pads, even from the beginning. He even had erections preserved, from the beginning, and his, first PSA after the, TULSA-PRO procedure was at 0.3. Keep in mind, it was 12 before that. Well, I can tell you, over a year and a half later, I just saw him back in my office.
He's still doing great, super happy with his results, and in a way, very grateful because his other options, had he gone to another urologist, would have been prostatectomy or radiation. Both options that he did not want to have. By the way, this is another patient of mine, just to kind of illustrate that cancer can grow outside the prostate, and when you start having something suspicious for what we call extraprostatic extension, that means the cancer is creeping and trying to get its way out. Well, by the way, that probably accounts for the publicized rates of about 20% recurrence after prostatectomy. That means that... Think about this. If you take the whole prostate out, about one in five guys still have prostate cancer coming back.
Well, why would that ever happen if you took, took the whole thing out? Well, listen, if you have microscopic cancer outside the prostate, beyond where you cut, that's gonna grow back over time. Well, you can almost imagine that on a TULSA-PRO, if we already can see that on the imaging, then we go aggressively in the area and let that beam of energy really destroy even the microscopic stuff that's beyond the prostate. So in, in that kind of situation, you can almost imagine that cure rates of the TULSA-PRO might actually exceed that of the prostatectomy because you already know that you need to treat aggressively in that area beyond the prostate.
And by the way, there's new features with the TULSA-PRO called Thermal Boost, that actually will help us treat way beyond the current zone that allows us to get into areas that we want to get into beyond the prostate. I also will illustrate on this particular patient, that he had multiple challenges from a hip implant that he had placed and some other anatomical issues. We were able to overcome those and cure his cancer without causing him significant side effects. So in conclusion, I can tell you that there's just a sea change happening right now in the field of prostate cancer, both in terms of diagnosis, incorporating MRI, but also then allowing MRI-guided surgical treatments like TULSA-PRO, to really become quite prominent. So the paradigm clearly is shifting then.
If you're just being told that you should take it out or get radiation or watch it, really, you're not having proper informed consent. You actually should be aware that there actually is a treatment available for you surgically that can cure your cancer without the side effects, and actually, that's been well published. We'll also, of course, get results of the CAPTAIN trial. Very exciting to see a head-to-head comparison of prostatectomy and TULSA-PRO, but I can already tell you from my own practice what the results are gonna be. You're gonna see very good results on the cancer side, but much superior results on the incontinence, sexual dysfunction, and side effect side. So I thank you for your attention, and I look forward to your questions in the question and answer session.
Dr. Hong, wow! Thank you for sharing the true benefits of TULSA-PRO and how it fits into the contemporary treatment of prostate disease. Next, it's my pleasure to introduce my good friend, Dr. Joe Busch. Dr. Busch is a board-certified radiologist at The Busch Center. He trained at the University of Tennessee, USPHS Hospital, and Baptist Memorial Hospital. Dr. Busch has over 50 years in diagnostic radiology, has performed over 20,000 prostate MRI scans, over 2,000 MRI in-bore biopsies, and is one of the earliest adopters of TULSA-PRO. Dr. Busch, we're so glad you're here with us today.
Hi, I'm Dr. Joe Busch, talking to you from The Busch Center, which, as you can see, is a new paradigm in screening, diagnosing, and treating prostate cancer using strictly an MRI and incision-free treatment with TULSA-PRO. In our approach, with screening, we screen with a non-contrast biparametric MRI, relying heavily on the diffusion-weighted imaging, which can actually tell you, indicate which level of prostate cancer we're dealing with. And then we follow that up with the targeted diagnostic biopsy, which I believe in the future, will become more important as genomics enter the scene of the Gleason score. And then, this is followed, if it's an appropriate case, we'll treat the patient with MRI-guided ablation or with the TULSA-PRO, and of course, part of this is IV contrast injection to evaluate the ablation zone.
In our experience, this has been our patient distribution. I love the fact that we are doing what I call near whole gland or prostatectomy-type studies, and 67% of our cases have been whole gland, 20% less than whole gland, but still greater than hemi, and then the 13% goes along with maybe 25%-30% ablation of the prostate gland. I really feel that physicians that are doing this for the first time will notice a couple of things. They'll notice that there'll be a very interesting increase in accuracy in what they're looking at. So, they'll be able to pick up the prostate gland very easily on the first cases.
There are differences in the MRIs that are used, but still, you're gonna see the prostate and the disease and the structures better with MR than you do with ultrasound. As you gain experience with this technology, as we have here at The Busch Center, we've optimized our treatment plan to the point that we started branching out with instead of just doing the whole gland therapy or the near whole gland therapy, we started to attack the apical sphincter. We treated glands that are greater than 90 ccs, and we've actually done now at least seven patients who have salvage radiation therapy failures and also laser failures. We've seen any HIFU failures, which we've treated.
It's very exciting, and one thing about Profound, I like the idea that we're moving into 3rd -generation robotic technology, and they continue to improve the technology. As a physician who first saw TULSA back in 2018, I tell some of my people that, you know, it's really changed dramatically, in my opinion, with increasing accuracy and precision. Going back to this apex, which I'm really interested in, is that because no matter what technology you choose to treat men with apical lesions, you have the problem of incontinence.
Because you're down there on the pelvic floor, you're on the external sphincter, you're on the four muscles that form the pelvic floor, and so there's a big problem with urinary incontinence, erectile dysfunction, and of course, complications of the procedure, which can usually be a urethral stricture. In at least 1/3 of the patients, usually the cancers are in the apex, and I think that TULSA-PRO is uniquely suited for this, because you can precisely plan around those structures, and then you can precisely treat with the high frequency, so ultrasound ablator. At the same time, we're cooling the urethra, and we're cooling the rectum at the same time. You have very good immediate feedback of exactly where you're treating the patient.
Again, at the apex, this is a nice example of how I draw out the apical lesion, looking at all the structures around the apex. Here's the cancer right here. We're one of the first ones in the world to use the ADC mapping and the DWI mapping simultaneously with the traditional T2 mapping of the cancer. And then, you can see how we treated this cancer, very tight margins and very a lot of precision, avoiding ablation of the muscular structures and avoiding ablation of the majority of the sphincter. In my opinion, there's no other technology that can do it this way. Again, at the apex, we have a paper which has been accepted for presentation at the international meeting coming up in Chicago in November of 2023.
This is gonna be the paper that is presented. As you can see, there's a lot of data on this, but the bottom line is, in my opinion, I've got nobody on diapers and nobody on pads. We're maintaining 82% erection sufficiency and again, 4.8% requiring intervention for urinary retention. That's two patients, and of course, excellent results with only two patients requiring retreatment. It's very interesting about this retreatment business. I've now retreated eight TULSA patients. They're not all my patients. Only four of them are my patients. But they all demanded to be retreated with TULSA. They didn't want anything else. They thought that their first TULSA treatment was so smooth, so fast. They were all still dry. They were still getting erections. They wanted to repeat the process.
All the more reason for the insurance industry to start taking a hard look at this technology because it's gonna play a bigger role than just the initial treatment. I think it's gonna be a very key technology for retreatment of disease from other procedures. Now, BPH, we attempted to start doing this, these large glands, the taco glands of 90 cc's. We have done this. You can see 34 patients with BPH. All the glands were 90 cc's. A normal gland is 30-40, so these glands are all twice normal. And of course, we even treated a beautiful case that was at 275. That gentleman got excellent results. I'm very proud of the fact in this group, plus two additional patients, I've now gotten seven patients off of catheters.
In other words, they came to me wearing a catheter from anywhere from two months to six months. I actually had one patient that was a BPH patient, that was catheterizing himself for seven years. He is now five months post TULSA, and he's peeing normally. He's not had to use any catheters whatsoever. And as you can see on this treatment that we're showing here, on these BPH patients, we have the ability to spare the ejaculatory duct. In cancer patients, I feel a little bit differently. There's too much of a chance if the cancer is that close to the ejaculatory duct; I don't believe that should be spared.
So in conclusion, I see this technology as excellent oncological control, similar to surgery, similar to radiation, only with a lot less complications, a lot, lot, lot, lot less pain and discomfort and morbidity for the patient. I think that the MRI, to begin with, is the accurate way to stage. I think most good physicians will not operate or irradiate without having an excellent MR to see where they're going and what they're doing, so that you can accurately see where the sphincter is, where the nerves, the bladder neck, and the capsule are, and what is the relationship. In other words, when you're dealing with cancer of the prostate, it is location, location, location. What structures is it near that could cause harm to the patient?
TULSA can save these structures, and I think we've clearly shown that in our practice. I think all patients seeking treatment for organ-confined disease, regardless of the grade, and I plan on publishing what I've done with the Gleason 8s and the Gleason 9s, should consider TULSA therapy. Because I think you're gonna get the same results, although you will not have to deal with hormone deprivation and all the complications of other procedures. You can... So I think TULSA is going to enter the mainstream. It just takes time for people to see this.
In my experience, my urologists that have worked with me really see the difference in this technology, and it's all because we're using the MRI, which has a lot of advantages for temperature control and also accuracy in the anatomy and the physiology of what's going on in the gland and the structures around the gland. I guess with more and more experiences, what's happened with us, you can broaden your uses of TULSA technology ablation. I look forward to even advancing the field even more with the new improvements that the Profound Medical Corporation has made with this technology. I thank you for this time, and I look forward to answering any questions in the future, if necessary. Thank you.
Really great stuff, Dr. Busch. Thank you for sharing your experience with TULSA-PRO and how you have integrated it into your practice. Now it is my pleasure to introduce Dr. Kelly Stratton. Dr. Stratton is a fellowship-trained urologist in the University of Oklahoma Health System. He trained at Oklahoma University, Vanderbilt, and Memorial Sloan Kettering. Dr. Stratton is experienced in robotic prostatectomy, MR fusion biopsy, HIFU, and cryoablation. Dr. Stratton, it's so good to have you here.
Thank you for that introduction. I am Kelly Stratton, I'm a urologist, as mentioned, and I'll be talking about a urologist-administered TULSA-PRO program, my adoption, and then also my learning curve. I treat patients here at the University of Oklahoma, where I'm an Assistant Professor of Urologic Oncology, and I work at the Stephenson Cancer Center. So just to give a little bit of background of my personal experience, I really started by trying to move into focal therapy as a way to offer patients a minimally invasive treatment for their prostate cancer. Thankfully, I've had this opportunity to expand my practice into TULSA-PRO.
There are many reasons for this, and it could be thought of as a shift to incision-free surgery, because as a urologist, I am a surgeon, and one of the things that I've offered many patients would be prostate removal. The problem with prostate removal is the impact on quality of life, and this is very detrimental to men who experience urinary incontinence or changes in erection. The benefits to TULSA is that we can offer a treatment that's ablative in nature and focal in the ability to provide treatment, but it's to a much broader spectrum of patients. So in reality, TULSA is not a focal-only procedure, and that's a huge advantage. So in my practice, I treat patients, as I mentioned, with prostatectomy, but also with things like cryotherapy or HIFU.
Typically, we think of cryotherapy or HIFU as just focal treatments, where we see an MRI lesion, and we're going to target them with either a destructive thermal injury like cryotherapy or an ablative treatment like HIFU. But there are many patients who don't really have just one area, or they have areas very next to critical structures like the neurovascular bundles. That's the real advantage to TULSA: we can customize that treatment to the patient's disease and not try and fit this ablative treatment onto what the patient has. In particular, my enthusiasm for TULSA was really led by patients who came to me asking and wanting incision-free surgery that maintained quality of life.
So really, the patients really pushed me into this as something that I can expand as an option for them. When you think of TULSA-PRO and you compare it to other treatments, in particular, radical prostatectomy, TULSA-PRO has a much less risk of urinary or sexual complications. Again, it has that broader ability to treat than HIFU or cryotherapy. You can really tailor the treatment to the entire prostate and not have to focus on just one area or an index lesion. The other nice thing is that during the treatment, you have continuous monitoring of your treatment delivery and also the impact of the treatment, which is completely unique to the ablative approaches.
With HIFU and cryotherapy, there's really nothing that tells you that you've achieved a successful treatment until the patient has recovered, and you've seen them later and down the road.... So when we think of our learning curve, if you consider robotic surgery as kind of the historical learning curve surgery, it really takes many, many cases to develop competency. Some people even say hundreds of cases. And it's true that many residents get those number of cases, but when you think of transitioning from robotic training to robotic practice, it does take a high volume of surgeries in order to maintain that competency and really have expertise in doing robotic prostatectomy. There's also limitations to access to the robot.
You know, something like TULSA-PRO may provide a new opportunity for urologists in that the delivery of the treatment can be achieved at a very proficient level with much less experience. The confidence in your delivery is really, you know, indicated by the imaging and the thermometry, which happens in real time. You can certainly start at the sweet spot of patients. We would consider those with low-intermediate, like Gleason grade group 2 disease, or even those with high volume Gleason grade group 1 disease, and then expand as you become more experienced with TULSA-PRO treatments and you gain more experience with other patients.
Again, this thought that you would have to have a large volume of patients in order to gain proficiency is just not as, as not as consistent in the ablative treatments. You can get very good very quickly. Here's one of our, one of our treatments. In fact, I believe this is my first patient. Really looking through the treatment planning, each individual imaging slice, you're able to create an individualized and specified treatment region for that area of the prostate. This really helps us control the treatment and allows us to customize the plan. The way that we're looking at the prostate here is very intuitive to anyone who's doing MRI-guided fusion biopsies or monitoring patients who have prostate cancer using MRI.
So this is a very familiar workflow to the general urologist who may be doing fusion biopsies or those who are following patients who have prostate cancer with MRI imaging. So really, we're taking what is familiar to the urologist and moving it into a treatment planning, ablative treatment like TULSA. Here, here's a framework for patient selection, looking at that sweet spot of patients. Histologically, those with low-intermediate risk disease, like Grade Group 2 disease, also those with high volume Grade Group 1 disease, and then the treatment planning, looking at sub-total versus whole gland. You know, I feel like one of the benefits to TULSA is that I can treat the patient bilaterally and not worry about a decline in quality of life.
When you think of patients who undergo focal therapy, really, focal therapy is trying to not treat as much of the prostate as possible to prevent the side effects, like an impact on quality of life, such as erectile dysfunction or urinary control. That really leaves untreated gland that can later cause rises in PSA or harbor cancer themselves. So we are now seeing, with focal therapy, the limitations over time, that men have a great ablation in a small area, but then subsequently have a rise in the PSA or a new area in the contralateral gland, and we didn't treat that area. We strategically avoided it to try to avoid side effects. That's really the long-term durability issue with focal therapy.
TULSA overcomes that by providing men with a greater degree of treatment and yet still controlling the treatment in a way that prevents the side effects. So we can treat sub-total or even whole gland, maintain continence, maintain potency. Also, there's a wide spectrum of prostate volume. So whereas some of the ablative treatments have limited prostate volume range, with TULSA, we can expand that to even larger prostates. Obviously, when we're first starting, it's nice to have that middle ground, 30 g-50 g. But as you continue to increase in increase your experience, you can increase the size of the treatment volume as well. So in conclusion, TULSA-PRO has some important advantages over prostatectomy. It's incision-free, minimally invasive. It's an ablative treatment that preserves quality of life.
It's able to ablate enough of the prostate that we're achieving PSA response levels that are much like having a prostatectomy. The patients who come back to me, their PSA levels are almost zero. In fact, sometimes they're hard to detect. That's very different than our experience with other ablative treatments. And finally, TULSA-PRO, we can customize that treatment to the patient's specific anatomy. In fact, we can change it throughout the prostate so that we're ablating exactly the areas that we want to. Many urologists, even general urologists, routinely perform fusion biopsies. So the technology of TULSA-PRO meshes with and is familiar to these urologists, who are oftentimes looking at MRIs and doing targeted biopsies. The operative experience is the same as the clinic experience with an MRI.
The need to create this long training program is not as concerning when patients or surgeons are undergoing TULSA training, because we do this routinely for many different patients. The procedure time is also comparable to having a prostatectomy, and in some cases, it's even faster. In my experience, we were able to get it under three hours within my first five cases. The short learning time is short. I see patients every day who have prostate MRIs. TULSA-PRO works off of that same imaging in the same way. The familiarity with that anatomy and that view and tailoring the treatment to what I see in clinic is a great way to really expedite the training for TULSA.
So literally, I can sit in clinic, show patients their MRI and describe to them exactly where we're going to ablate their prostate, and I can take that directly into the operating room, do that for patients with MRI guidance, continuous monitoring of the treatment, and assurance at the end of the surgery that, "Hey, we ablated exactly what we had discussed in clinic. The treatment was a success.
We expect your PSA to go down, and we expect you won't need any other treatment in the future." In conclusion, I think that TULSA is going to be a bridge in the gap between focal therapy and radical prostatectomy, that's gonna take urologists to the next level as far as offering whole-gland or nearly whole-gland treatment that's ablative, that offers complete cancer control and offers preservation of urinary and sexual function. Thank you for the opportunity to talk to you about my experience with TULSA-PRO.
That was awesome. Thank you, Dr. Stratton, for providing your insight and experience into what it's like for a new user to adopt TULSA-PRO, and we look forward to the continued partnership. Truly great perspectives from each of the physicians that presented today. The work, the hours, the commitment is all about our patients. At Profound, we are not only dedicated to commercializing the best product and treatment, but we are dedicated to the positive impact this has on patients around the world. Please join us over the next few minutes to hear from three patients as they share their story, from diagnosis through treatment and recovery, and the impact it has made on their lives.
My dad had passed away of prostate cancer, so it's always something that I've been actively monitoring.
I had been having regular exams by a urologist for many years, and my PSA kept increasing, and that's what triggered the concern of the urologist.
We were on the golf course. We were chipping and putting. We were just out practicing, and he had gone to the doctor that day, and we were just waiting for his call back.
The doctor called me, and my urologist gave me the news. I was just dumbfounded.
We had probably the worst news we could ever have.
The most difficult part of the journey was the unknown. I've never had cancer before. I've been very healthy, and to hear the diagnosis of cancer is worrisome.
Our doctor told Tommy that he needed to have it out immediately, that surgery was gonna be his best option because he was young, and he was healthy, and he had an opportunity to get over the side effects better. For us, it just sounded extremely barbaric.
I wanted to preserve the quality of life that I had, but at the same time, had to make sure I was gonna be here for a while. We looked at a lot of options. We looked at surgery, we looked at radiation, we looked at active surveillance, we looked at hormone treatments. Then through additional research, we found TULSA-PRO, and it offered the longevity I was looking for. It offered the quality of life I was used to.
The idea that with some of the other procedures that you might have incontinence, you might have an inability to perform the way you're used to in the bedroom. These things are things that are real to men, and they mean a lot. But when you mention prostate cancer, people kind of shuffle it off, but it's a real level of anxiety that I think people overlook. The TULSA procedure seems to be inherently sympathetic to that emotional part, and the fact that it's done so efficiently and with very little to no side effects, is exactly what I think most men would want in having to go through any kind of procedure of this nature.
Another great aspect I love about the procedure, TULSA-PRO, is if it doesn't work the first time and there is some residual that does show up in the future, you can go back and have a second procedure. You don't go back after surgery, and you don't go back after radiation. TULSA-PRO allows you to go back and have a second treatment, third treatment, if necessary.
I opted for TULSA because I wanted to stay away from any adverse side effects. It was an in-office procedure. I didn't have to stay overnight at a hospital, and I could go home. My doctor said it's likely to be a one-time procedure in your life, and I like that. I just wanted to get it fixed and move on with life.
The more I thought about it, and the more I looked into TULSA procedure,... Those other options just didn't make any sense to me anymore.
The procedure was so easy, plus it was successful.
It was pretty seamless. Got to the hospital, and everything went real smooth. Recovery was the most surprising thing.
I had the procedure and went home two hours later and didn't hurt anywhere. Didn't even know it, what I'd had done, so it was really a kind of a non-event for the procedure.
I was on my way to recovery without having to do anything else. No hormonal therapy, no pills, no nothing.
Literally, the next day, he was working. He walked 1.5 mi.
I was back in the gym in 10 days, had a great rest of the summer, was on vacation two weeks later with my children and the rest of my family, and enjoy a very active lifestyle.
After the procedure, I had absolutely no side effects at all, and I am happy I had the TULSA done.
I would have wanted to know about TULSA from the start. The therapies that were presented to me seem antiquated now that I've been through this and learned more about TULSA.
I think everybody needs to know about TULSA-PRO. I feel like it's going to be a first-line treatment for men with prostate cancer.
If I could go back and do it again, I wouldn't change a thing with TULSA-PRO, Profound. It was... I think it's the exact results I was looking for and the recovery time. I wouldn't change anything.
Wow! Just such very impactful stories. We want to thank you, Bob, Don, Tommy, and Autumn, as well as your families, for courageously sharing your stories with us. Truly a moment to pause and realize the impact that TULSA-PRO is having. To bring that impact to more men, it is important to have partners that drive the mission forward. So we will now hear from a few of our partners in this endeavor. Sally from Philips, Elisa from Siemens, and lastly, Dr. Robert Princenthal, aka MRI Bob from RadNet. Of special note, GE is also a valued partner and represents approximately 25% of our install base. As they're a publicly traded company and in a quiet period, they are unable to join us today.
Hello, everyone. This is Sally Lin, Head of Product Management for Systems and Solutions of MR Businesses at Philips. Today, I'm very happy to be here and talk about how Philips team up with Profound to improve the lives of prostate cancer patients. First, it's important for us to recognize that the purpose of Philips is to improve people's health and well-being through meaningful innovation, and we have set out an ambitious target to improve the lives of 2.5 billion people per year by 2030. When it comes to prostate cancer, it is one of the top strategic clinical program that we focus on, with one in six men in U.S. and Europe are diagnosed with prostate cancer and about 1 million more new cases each year. The demand to have proper prostate cancer diagnosis, treatment, and palliative care is becoming ever more pressing.
Of course, with the technology advancements in place, the picture is not so gloomy. About 70% of prostate cancer cases were diagnosed at a localized stage, where MR-guided ultrasound ablation treatment can really bring value, and the majority of patients have more than 80% survival rate after five years of diagnosis. With a high occurrence and growth rate in mind, that what I just mentioned, the prostate cancer care is bringing heavy financial burdens to the U.S. health systems. At Philips, we take a holistic approach towards prostate cancer care to address this problem. Here, you can see that from prevention, screening, to diagnosis and staging, to therapy and treatment follow-up, Philips has a wide range of solutions to address the need of prostate cancer care.
To give you a few examples, we have Dyna-CAD that provides advanced visualization for prostate MRI analysis, digital pathology to better understand the prostate cancer type. Needless to say, for MR, the business I'm part of, can be utilized for screening, diagnosis, provide image guidance for therapy, and for response, assessment, and follow-up. Specifically for therapy, we team up with companies like Profound to provide incision-free MR-guided ultrasound ablation for localized prostate cancer, which enables rapid patient recovery and reduces side effects. Philips, together with Profound, we team up to deliver a high quality and high clinical impact solution to prostate cancer care and to improve the lives of our patients. Thank you.
Hi, everyone. My name is Elisa Roccia. I'm the Global Clinical Marketing Manager for MR Oncology at Siemens Healthineers. First of all, thank you to Profound for inviting us to participate in this event. Prostate cancer is a topic we all care a lot about. Thinking that one in eight men will develop this disease in their lifetime is really sad and impressive. There is a lot of work that we have been doing and that we can do to address this very important healthcare challenge, especially developing MRI technology that can support prostate cancer care from screening to diagnosis, therapy, and follow-up. Because there is clear evidence that MRI in the prostate cancer patient pathway can really bring clinical value. At Siemens Healthineers, we offer a comprehensive portfolio of MRI systems that can really serve a global market, starting from first-time users up to advanced researchers.
We have prostate covered at every field strength. Now, with increased availability of MRI systems and with increased requests for prostate MR exams, there are some challenges that we need to address. For example, the need for shorter scan slots and increased throughput. Here, artificial intelligence can help. Solutions like deep learning image reconstruction can really help to deliver high-quality MR images with a greatly reduced acquisition time. For example, what we see now on the slide, it's a standard multiparametric prostate MR exam that takes about 15 minutes. Now, if we use deep learning reconstruction for this case, the scan time goes down to eight minutes. What this means is that we can have a full multiparametric prostate MR exam that fits into a 15-minute slot, which can be seamlessly integrated into routine workflow.
Now, with the increased number of MRI scans, this comes hand in hand with also an increased workload in reading and interpretation of these exams. And again, here, artificial intelligence can come and help. Solutions for AI-based lesion detection and classification can help to speed up the reading times, but also reducing the variability between readers. And the radiologists can use this information coming from these tools to communicate with clinicians and support diagnosis and therapy decisions. Indeed, we know that for prostate cancer, there are a number of treatment options that are available, and it's extremely important to find the right solutions, the right treatment for each patient. And here again, MRI plays a pivotal role. For example, in radiation therapy. In radiation therapy, MRI can play a very important role in planning, but also to add valuable information about the tissue and the tumor biology.
In recent years, there have been several success stories that have shown how MRI can be integrated into the MRI radiotherapy planning workshop. For example, in radiation therapy, MRI can play a very important role in planning the therapy, but also to add valuable information about the tumor biology. In the past years, there have been several success stories that have shown how MRI can be integrated into the radiotherapy workflow. Let's take ablative therapy now. Profound TULSA-PRO solutions brought ablation therapy to a whole new level. Indeed, it delivers very specific advantages for certain patient groups. For example, for those patients who are not eligible for radiation therapy. Profound TULSA-PRO solution and MR temperature control can really individualize the therapy delivery for each individual patient, which greatly improves treatment outcomes.
We are very proud to have been partners with Profound since 2016, and that this great partnership continues strong to constantly deliver advanced therapy for prostate cancer patients. Thank you very much.
Hello, I'm Dr. Robert Princenthal. I'm a board-certified radiologist who's been in practice for more than 30 years, and I'm currently the medical director for RadNet's prostate imaging program. I attended medical school at Penn State College of Medicine in Hershey, Pennsylvania. I did my internship at Hartford Hospital in Connecticut. I did a full diagnostic radiology residency at Yale University and did a fellowship in body imaging and interventional radiology at the University of California, San Diego. I'm proud to be part of RadNet, Leading Radiology Forward. RadNet is one of the largest outpatient operators of imaging centers with over 290 centers across the country. I'm happy to talk about men's health and how imaging can really assist men for appropriate detection of prostate cancer.
There is a lot of controversy about the role of PSA screening, and because of that, the United States Preventive Task Force guidelines in 2008 recommended that PSA screening shouldn't be done. The challenge was, prostate was the only organ in the body where targeted biopsies didn't exist. Anytime a man had a PSA of greater than four, urologists would stick 12 needles into the gland with poor guidance, and they would either miss a cancer, which would be up here. They would find an incidental baby cancer that didn't need to be treated and miss the, the killer cancer, or they would get a low-grade cancer and misgrade the higher Gleason score or the more significant cancer. Now, how can we improve PSA screening?
Radiogenomics, which is integrating liquid biomarkers, imaging tools, and cancer genetic profiling, is the future of precision care for prostate cancer. We need to do better.... And now with the role of MRI, we can triage men who would benefit from a biopsy, and we can reduce a significant number of men to avoid a biopsy and reduce the harms. So there was a false negative biopsy rate with the standard old way of 26%. MR only has an 11% false negative rate, but now we can really improve the benefit of biopsy, find more clinically significant cancers with fewer needles and fewer harms.
Where we're going with this is we want to utilize faster MR techniques, and RadNet is leading the field in creating a MANogram, which is a low-cost, ten-minute screening exam without IV contrast, in conjunction with RadNet's artificial intelligence program with Quantib, to allow us to most accurately identify men at risk for prostate cancer. This allows men to have targeted biopsy and accurate pathology correlation, which then opens the role for incision-free treatment with TULSA-PRO. And we need to use genomics to figure out which man may have a higher risk factor. Women have been a much greater advocate for their own health care. In the fifties and sixties, there was no mammography, and a woman would present to their surgeon with a big breast mass, and they would have a radical mastectomy. Without image guidance, there was complications of lymphedema.
But finally, as women pushed imaging and doctors to evolve, we have mammography, we have needle biopsies, and now we have breast conservation. We can do the same benefit for men at risk for prostate cancer. The pathway should be PSA screening, prostate MR, targeted biopsy, and then for about a third of men, they would be candidates for less invasive treatment rather than surgery or radiation. And this opens the door for targeted therapy with TULSA-PRO, which allows men to be treated and ablate their cancer with very minimum side effects of erectile function and bladder control. So RadNet is proud to be working with our partner, TULSA-PRO. We want to have a comprehensive radiology solution. We want to have multiple TULSA-PRO centers to provide this at all of our locations with our urology partners.
We believe that radiology and urology working together will allow a greater access of this exciting technology to men moving forward. We're very excited and pleased to be working with TULSA. We feel they're the leader in ablative energies, and in our experience, we've had excellent results and excellent outcomes. Thank you very much.
To all of our partners, thank you. It is now our privilege to introduce the rest of our management team. Today, you will hear from our Chief Financial Officer, Rashed Dewan, Chief Commercial Officer, Abbey Goodman, Senior Vice President, Product Leader, Mathieu Burtnyk, and our Chief Executive Officer, Arun Menawat. Rashed, the floor is yours.
Thank you, Adam. Good afternoon. I'm Rashed Dewan, CFO of Profound Medical. Over the next few minutes, I'll provide you with business update from the finance perspective. To start with, I want to provide you with the opportunity side for Profound Medical. As you have heard from the physicians, with the flexibility of the technology and the variety of patients that could be treated with TULSA-PRO, we believe TULSA-PRO could be used to treat 600,000 patients per year who are diagnosed with prostate cancer and hybrid BPH in the U.S.. With the ASP of $8,000, the total addressable market for Profound in the U.S. is $4.8 billion. So how are we addressing this market? In the US, we have deployed a very efficient business model. We do not charge any upfront capital cost to our customer.
We place our capital equipment at the customer site for free. We charge the customer $8,000, approximately, per patient procedure. The price includes the treatment kit, the right to use the capital equipment, GENIUS Services, treatment support, hardware warranty, and software upgrade. The model is very efficient for both the customer and Profound. From customer side, they do not have to invest a significant capital upfront, which also reduces their per-patient cost. From Profound side, it reduces the entry barrier, but at the same time, with our engagement through the GENIUS support services, to deliver the best outcome for our patients. Our cost of the capital is about $50,000-$60,000. We recover the cost over the 12 to15 procedures. We only place to the customer side the capital equipment, who has visibility of that kind of a volume.
In fact, we have recovered or on the way to recover most of our capital placement costs in the near term.... Even though the customer does not have to pay any upfront capital costs for TULSA, they do have some cost commitment to implement a TULSA program. The MRI-compatible anesthesia machine is a requirement. Most hospitals have it, but if they don't, the cost of acquiring some machine is about $75,000. There could be a possible MRI software upgrade that will be required. Most of the hospitals have service agreement with their MRI vendors, which includes the software upgrade. But if they don't, the cost could be upward of $50,000. There needs to be minor modification to the MRI cage, which allows the TULSA-PRO to connect to the MRI. The cost is between $5,000-$10,000.
With this kind of cost commitment, it gives us the comfort that the customers are as committed to the TULSA-PRO program as we are. In this slide, we're showing you what we have done so far and the progress we made. As you can see from the bar graph on the left, we have continuously added more and more sites to the TULSA program, and we are working hard to achieve the 50 sites by end of the year. Our recurring revenue is also progressing well. As you can see, over the last three quarters, consecutively, on average, we have grown over 15%. Most of our revenues are going to be tilting towards recurring revenue in the future, as the overall U.S. market is also implementing the recurring revenue model. Over time, we expect majority of our revenue will be recurring revenue.
With a lot of focus on the cost containment and the cost down, along with the manufacturing efficiency, we have stabilized our gross margin above 60%, which is visible in the gross margin chart. As you can see, also, with all the increased focus in our operation, we have built in additional capacity and also stabilized our inventory level at around $ 8 million. We expect as the volume increases over the near term, we are confident we should be able to use existing capacity and the inventory to fulfill those without a significant investment. In my last slide, I want to show you how we are utilizing the cash part. As you can see from the GNS slide, that we have been continuously cutting the cost and stabilized around $ 2 million in the last three quarters.
We are and will continuously invest in selling and distribution and strategically invest in R&D. Profound Medical is committed to innovation, and we will continue to invest in R&D and clinical to add new features and enhance our offering. Some of them, you'll hear about it today, and some of them will come in the future. With that, I will turn the podium over to Abbey Goodman, Chief Commercial Officer, to discuss our commercial activities. Thank you.
Thank you, Rashed, and it's nice to be here. So I'm gonna talk to you guys about our commercial strategy and what we're doing to see and believe why TULSA is the next mainstream technology. The evolution is here. We are demonstrating our recurring revenue business model, our strategy within the sales channel, including our GENIUS Services strategy, our reimbursement strategy, and our marketing strategy. We've achieved many milestones to date, and we're looking forward to many more. The momentum is continuing to create significant value for our partners and our patients that are demanding access to TULSA-PRO. Our initial approach was to focus on leading hospitals, and today, we have some of the most impactful cancer programs as TULSA partners. With the clinical benefits and results, our partners are choosing to reinvest in TULSA by adding more locations within the U.S.
The corporate partnerships that we have, like RadNet, like Mayo, will allow the continued adoption and growth of TULSA-PRO across North America. TULSA-PRO is giving our partners the confidence they need to treat a variety of prostate diseases with precision, flexibility, and durability. No other established or emerging technology can safely and effectively prescribe treatment plans and treat the disease like we do. So our business model you heard about earlier, we are a pay-per-procedure. We place the capital equipment, but with that is so much more. We include our clinical GENIUS S ervices that provide continuous clinical support and feedback to ensure efficiencies, and that we have the best workflow possible at each one of our programs. Additionally, we provide software and hardware updates because we believe every patient and every program should have the latest and greatest.... Reimbursement.
Today, most patients are cash pay, and a temporary C code is available to hospitals, C9734. The Medicare national average for that payment is a little over $13,000. That C code reimbursement is 3.6% higher than last year and about 20% higher than any other prostate surgical procedure. But what's coming is our permanent CPT codes. Those were established in June 2023, and they'll be effective in January 2025. So today, when that C code is used, our physicians are billing an unlisted C code, but with this dedicated CPT code, we will be able to recognize every participant within that procedure. So what are the catalysts, right? People. Our organizational design has evolved to focus on driving utilization, and as a result, we've recognized the specific skill sets needed to propel the organization forward.
We've grown our account management team and our account executive team. The account management team was built to support the growth of our existing partners through continuing education and market access activities. This role has resulted in procedural volume increase, which is reflected in the recurring revenue growth. Our account executive team is growing also, with a strong focus on new programs and additionally, the expansion of our corporate partners. We continue to overcome hurdles, find solutions, build out pathways, so that we can ensure our partners have a program of the highest quality. Our clinical GENIUS team, they are a step above and beyond what you would consider clinical support today. Our PhDs, scientists, experts, work with every program to ensure that they are the best that they can be.
They continue to educate on patient eligibility, they expand disease states, they lead launches of our AI modules, Thermal Boost being the first of those modules, I'm sure some of you know about, and they perform clinical reviews to drive workflow efficiencies. Our channel strategy. Our imaging centers and hospitals have been a focus. Imaging centers have been successful with the cash pay model, being supported by independent urologists and radiologists, where MR time can more readily be available. Hospitals have been successful with the C code. Our early adopters started slow and controlled. In the last six months, the feedback that we've received is that the results have shown patients are satisfied, they're happy, and the clinical outcomes are as good as, if not better, than our results from our TACT clinical trial.
Thereby, the learning curve is established, and as the C code becomes effective, these sites will be able to come online quicker. Marketing. What we've got here today, what a team! We've seen exponential growth year-over-year in our website presence, an average of over 16,000 new users every month, and a 295% increase in users visiting Find a Center. What a great job. So what's changed? What's changed that's going to impact 2024 and into 2025? Well, our CPT codes are one, effective January 2025, targeted with our first publication of our CAPTAIN trial early that year as well. But what we've seen is urology is adopting the contemporary care pathway for prostate disease, from screening to diagnosis to treatment and to follow-up with MRI.
But the patient has also evolved, which means they're demanding a treatment that has also evolved. We've gone from open to minimally invasive to now incision-free. With the level one evidence, along with patient demand and quality of life expectations, this will drive more adoption. We'll continue to support the change in that paradigm and focus on our hospitals, which will include top cancer centers, teaching hospitals, and community hospitals, along with ASCs, urologists, and imaging centers. We believe that TULSA is the emerging technology with the potential to become the next mainstream alternative to current treatment options. So where can TULSA be used? Everywhere, because our CPT code will be applicable in all of these locations. There is no other technology that can be used in all of these places of service.
We have experience using TULSA within a mobile MRI unit, which can be placed at any of these locations to increase capacity and provide TULSA as a new point of service. So what about the patient? You've heard that it's versatile, but what does that mean? It means 98% of the patients that we treated today are prostate cancer patients, and of those, 15% of those patients have low-grade prostate cancer and BPH, that hybrid patient. About 60% of the ablations are whole glands, providing flexibility to treat subtotal or focal. Prostates treated as small as 20 cc all the way to 250 cc. You heard me correctly, 250. There is no other technology that can do that. All grades of disease treated, including high risk, grade group five, and even palliative patients have been treated. So in conclusion, the evolution is here.
We have unstoppable growth in our sales team, number of sites, patients awareness, and the patients being treated. The permanent codes are on the horizon. TULSA can be used in all of these locations of services. A variety of patients can be treated, aligning with the message that you heard earlier regarding our total addressable market. Our corporate partnerships are strong and aligned. So join us. Get on the bus. Join us for the evolution. Thank you for the opportunity to be here, and I'm going to turn it over to my peer and my friend, Mathieu Burtnyk, Senior VP.
Thank you, Abbey. The TULSA-PRO combines three powerful technologies to provide precision, flexibility, and durability like none other. First, real-time MRI guidance for ablation that uses true intraoperative real-time MRI images for the most accurate planning and thermometry. Second, transurethral directional thermal ultrasound for heating of the prostate from the inside out. Third, autonomous robotics, and this is really one of the main ingredients of the TULSA secret sauce. Using real-time MRI thermometry, the TULSA-PRO uses a proprietary closed loop temperature feedback control algorithm to adjust the ultrasound delivery with unrivaled precision. These three combined powerful technologies mean the following: precision that matters for better outcomes with the MRI, flexibility from transurethral ultrasound to customize to nearly all patient anatomy and disease, and durability from clinical evidence of treatment effects without significant adverse effects. Precision, flexibility, and durability means incision-free surgery.
Without cutting the skin, surgeons insert catheters into the patient and map out precisely the edges of what they want to ablate, what they want to treat. Here in oncology, every millimeter matters. Every pixel matters. This is not just focal therapy. This is customized, targeted treatment tailored to each individual's anatomy and disease. Overtreat by millimeter here, add a safety margin with a few millimeters there. This is true incision-free, customized surgery, in this case, ablating a 44 cc prostate in 38 minutes with no change in urinary or erectile function and prostatectomy like PSA response sustained for years. TULSA has the flexibility to treat all parts of the gland, large or small. This is an important because no two patients are the same. Prostate cancer can grow in any zone of the prostate.
More often, there are multiple areas of the prostate, or actually, cancer that is completely diffused throughout the prostate. This publication by Ganzer et al. showed that each posterior, anterior, and apical targets were best suited by a different technology. But the reality is, is that tumors are large and can extend from posterolateral corners all the way to the anterior or to the apex. And as presented by Dr. Busch, apical tumors pose a significant challenge for all other ablative devices. With TULSA, surgeons can focus on designing the best, most effective, and safe treatment plan without having to worry about how to fit their patient's disease into their device's treatment box. The fact that TULSA has the unique customizability to tailor ablation for different types of patients is not just colorful images and diagrams.
The TULSA-PRO has validated its flexibility and customizability through high-quality, peer-reviewed clinical publications across a spectrum of prostate disease states. Over the next few slides, I will briefly summarize some of the seminal studies and publications that demonstrate this flexibility. Let's start with what is considered the gold standard of treatment effect studies. TULSA-PRO has provided the most comprehensive set of acute and chronic treatment effect studies validating the technology. Nearly 40 preclinical canine subjects and 20 clinical patients first underwent treatment with TULSA-PRO, followed by radical prostatectomy, either on the same day or at a later time point, as long as three weeks for clinical patients. This undoubtedly shows the temperature cell kill relationship between the MRI and histology, and proves that what you see during the treatment actually happens to the patient at the cellular level.
Finally, in the clinical treatment effect studies, it was demonstrated that the ablative temperatures are indiscriminate of tissue type, benign or malignant, or grade of cancer. Completed ablation of all index tumors to the prostate capsule was not only measured on MRI, but was observed and validated on gold standard histology. Whole-gland ablation of prostate cancer in the TACT trial. This is certainly a seminal study of the TULSA-PRO, forming the FDA pivotal study of a single whole-gland TULSA sparing the urethra and apical sphincter. The TACT pivotal study of TULSA has reached the end of the five-year follow-up duration, making TACT the largest single study of TULSA reporting long-term outcomes. You've seen this data before, so I won't describe the outcomes in detail, but they demonstrate the durability and stability of efficacy and safety outcomes.
Prostate cancer with concurrent BPH is, however, new, and we are seeing this as our increasing number of patients in this category seeking treatment with TULSA.... In this retrospective clinical service evaluation of lesion-targeted TULSA, individualized ablation plans in prostate cancer patients with or without concurrent BPH are reported. What is impressive here is that in the real-world setting with individualized treatment plans, we actually see outcomes that are better than TACT. Salvage TULSA in men with radio-recurrent prostate cancer is a in this prospective phase I, II study, which was expanded to include 40 patients. Here, the investigators performed vigorous screening of these patients using PSMA PET imaging and also used that same imaging technology after the procedure to verify complete eradication of the disease. This patient population with radio-recurrent prostate cancer is a particularly difficult disease state to treat.
Surgeons hesitate to perform radical prostatectomies, as they will undoubtedly leave the patient with permanent morbidity. With the TULSA-PRO, with an inside-out approach to ablation of the prostate, we're able to treat these patients without that significant morbidity, as we can see in these astounding results. Now, this study I'm really excited about, TULSA-PRO for men with BPH and release-- and relief of LUTS. This is the first prospective study treating BPH with TULSA-PRO, showing safety, effective, and durable symptom relief. The study is nearly complete recruitment and has already one-year outcomes from the first 16 patients. All measures of efficacy, uroflowmetry, and patient quality of life have improved. Specifically, IPSS and IPSS quality of life have both reduced by over 75%. This is better or on par with all other modern BPH surgical procedures.
There were no grade four adverse events or higher, no hospital stay, and no blood loss, including patients who did not have to discontinue their anticoagulant therapy. Stay tuned for updated outcomes as this study completes enrollment and follow-up on all patients. Finally, the CAPTAIN RCT, the first multicenter level one trial comparing ablative treatment randomized to radical prostatectomy. Other randomized trials have failed to recruit patients, and I'm proud to say that we are successfully recruiting at multiple sites in the United States, as well as two sites in Canada and 1 in Finland. The study is recruiting because of some very practical components that we've included by design: the two to one randomization, the inclusion of high-volume surgery centers. But I wanted to highlight one subtle yet important point.
The inclusion criteria are organ-confined, intermediate risk, grade group two and three prostate cancer patients with no limits on prostate or cancer volume. These are real-life prostate cancer patients. Patients that are not only pure focal candidates with limited tumor volume, but real patients with real disease that is often multifocal, bilateral, or diffused throughout the gland, patients that would otherwise be surgical candidates. With that, we look forward to expand our participating treatment centers and complete recruitment of the target enrollment. TULSA patient segmentation has been demonstrated by real-world usage of the product, as we have heard from our distinguished surgeons today, and also vigorously validated through peer-reviewed clinical publications. Whether it's localized prostate cancer in intermediate-risk patients, select grade group four and five patients, select grade group one patients who will likely fail active surveillance with concurrent BPH or even radio-recurrent salvage patients.
TULSA-PRO is becoming mainstream in these disease states due to its unrivaled precision planning and treatment for any prostate. The intraoperative MR imaging, fundamentally without any registration errors, provides the clearest and most precise view of the prostate, prostate disease, internal structures to the prostate, as well as the detailed and intricate important anatomy surrounding the prostate. Real-time thermometry, a direct measure of the temperature cell kill effect, is visualized by the surgeon throughout the ablation and is adjusted via autonomous robotics to deliver the most accurate and precise ablation. These features are distinct and exclusive to the TULSA-PRO. Other ablative devices do not have this level of visualization and control of the therapy.
These technologies can be appropriate in some patients, but given their technical device characteristics, limiting access to the prostate or volume of ablation, they are typically limited to patients with a particular disease subset, small unifocal cancers exclusive to a single portion of the prostate. These other ablative devices are not just limited in prostate volume, disease location, and tumor burden due to their technical characteristics. They're also limited by clinical evidence. This slide summarizes a review of all prostate ultrasound ablation publications originating from groups in the United States. In the case of whole-gland ablation, it is clear that HIFU has high morbidity. On the other hand, in the case of partial gland ablation in the U.S. real world and FDA studies, we can see that HIFU leaves too much clinically significant disease behind. With TULSA-PRO, I'm proud that we're investing in R&D.
We are constantly innovating to expand patient eligibility, and these are innovations that we can provide to our customers in real time without having it to sell to them. Here, I'm showing you just two recent examples. The first is a hardware improvement, the PS+ , which we just released this month. This new robotic arm has a number of features, with one of them allows an extra degree of freedom of lateral motions, which surgeons can use to further customize their ablative treatments.... The second here is a software module, Thermal Boost, which Arun will speak to, but is a feature which allows surgeons an additional degree of freedom to customize in real time, ablation temperature, and more confidently achieve desired thermal margins.
Thermal Boost was cleared by the FDA about one month ago, and we have already rolled it out to select centers in the United States with really amazing customer feedback. Here, I have included two notes from treating physicians. The first is from Dr. Ghanouni at Stanford. He mentioned that Thermal Boost allowed them to obtain the desired treatment margin around the tumor more efficiently, and with this feature, they expect to expand their confidence in patient selection. The second is from Dr. Steiner, from WellSpan York Hospital in Pennsylvania. He echoed similar feelings from Dr. Ghanouni and mentioned that this is actually what he calls safe technology. S for safety, improved prediction of disease ablation. A for anesthesia time reduction, estimated 30% decrease in procedure time. F for fractional tumor ablation coverage, only boost tumor volume and avoid critical structures.
And finally, E, extended coverage for large glands, which means more patients qualify. In summary, the TULSA-PRO offers incision-free surgery with the unique flexibility to tailor ablation for different types of prostate patients. Through careful device design, combining three powerful technologies to first-hand surgeon experience, comprehensive clinical publications, ongoing clinical trials, and product innovation that really matters, TULSA is used confidently in a variety of disease states. Surgeons can start with the sweet spot, and with experience, expand their confidence and advance precision to offer TULSA-PRO for very unique and challenging cases. The TULSA-PRO evolution is here. Thank you. Without further ado, I have the pleasure to pass the podium to Dr. Arun Menawat, CEO of Profound.
Thank you so much, Mathieu, and I hope that every one of you has enjoyed these presentations just as much as I have. So, you know, at this point, I feel like we have checked most of the boxes. And the first one, you know, I talk about the unmet need. You know, five years ago, when we began talking with urologists, the initial responses that we used to get was, "Well, you know, when you talk about these side effects, that's some other guy. You know, my outcomes are better." Or we would hear, "Look, the patients just want the robot." The other responses that we would hear used to be, "Well, urology is never gonna do use an MR.
We are surgeons. Well, you know, now that we have produced a technology that has clearly demonstrated significant benefits with respect to side effects and recovery, that message has completely changed. They can actually hardly wait to tell you how many different issues that exist with today's technologies and how much improvement, in fact, TULSA has the potential to provide. With respect to the MRI, you know, today, compared to five years ago, when MRI was barely used, today, about 70% of the patients who are treated with prostate cancer undergo at least one MRI. MRI is here, and TULSA is here, and that's why the evolution is here. The second thing I wanted to discuss, particularly, is the robot. TULSA-PRO is really autonomous robotics, and some people have framed it as the third-generation robotics, but really, it's not about the robotics.
It's really about the value that robotics provides. And I think clearly, with autonomous robotics, we have seen we can now move to the next platform, the next wave, where we can think about incision-free procedures, where we can think about no radiation, when we can treat patients who may have comorbidities and cannot afford to have blood loss, or we can treat patients who cannot be in a hospital, and we can reduce overall cost. So this is real value, and that is the value that Profound's autonomous robotics actually means. And one of the third questions that has come up frequently has been about imaging's role in interventions or surgical procedures. A number of questions have been related to, well, you know, MR is used for diagnostics, you know, what about its use in intervention?
You know, the reality is that when we think about reimbursement, the payment is based upon time or effort, and the effort or the risk involved with the procedure that is done. So if you look at universally, a payment for a diagnostic imaging versus similar diagnostic imaging, but moves to an intervention or surgery, you would typically find significantly higher reimbursement for those procedures. So in fact, even if a hospital or a clinic would have limited MRI, it's better for them to move diagnostics to a lower cost center and really utilize their MR for the higher value technologies, such as TULSA-PRO. And so these have been some of the early adopter, early when you are talking about game-changing technologies, these are some of the things that we had to overcome, and we're really pleased to see that these things are now behind us.
Today, as you heard from Mathieu, we have significant clinical data. You heard from Rashed, our TAM is far greater than what we thought when we started, and that's the nature of game-changing technologies. You learn as you go. You heard from Abbey, we already have leading hospitals using our technology. By the way, the patients love TULSA. They are already asking about TULSA. Thank you. As you know, AMA has already established the CPT codes that will be available as of January 2025. You know, most of the time, when you are talking about such game-changing technologies, it takes seven, maybe 10 years before a Category I code is established. We were there in five years.
Abbey talked about that we are now building a world-class sales team, and we have already established gross margins, and we have a very effective R&D team. This is just an example of the demand that patients are beginning to indicate. You know, a year ago, compared to this last month, we can see a fivefold increase in the number of hits to our TULSAprocedure.com website, which is specifically designed for patients. So Dr. Hong talked about this publication that describes the state-of-the-art today, particularly in prostatectomies. And this publication is really credible because it uses about a 1,000-patient population. Half of them are robotically done prostatectomies, the other half is open surgeries. And the publication primarily talks about the benefits of robotic surgery, which is lower blood loss and less hospital stay, incrementally better in both of those.
But TULSA, really using the same measure, moves to a discrete next level, no blood loss and no hospital stay. But then TULSA is going one step beyond, significantly reducing the risk of side effects and enabling the treatment of a wide variety of patient population. In fact, you can treat PPA patients with BPH, and you can treat patients with, with cancer. There is no other technology that has such wide variety. And you get a confirmatory analysis at the end of the procedure, which really helps with the communication with the patients. But the question that I asked our urology community, "Well, what is the difference between robotic surgery versus non-robotic surgery?" Because when you really look at these charts, really there is no difference. And from a scientific perspective, what that says is we're kind of stuck.
For the last 40 years, we have 20% redos or repeat surgeries, and we have about 20% incontinence and about 50% erectile dysfunction. So we really haven't changed anything in the last 40 years. Well, that's not good enough. And this is where this whole idea of an MR-centric strategy makes a lot of sense. We can do far better screening using MRI. We can do far better diagnosis. We are already now mostly doing MR-guided biopsy, and Profound is now completing that image by bringing an MR-guided treatment procedure with TULSA, and certainly follow-ups can take place. And this is why our TULSA- AI initiative is really critical.... And as time goes on, we will continue to describe more and more about why this is a very important initiative for Profound.
We have already publicly talked about two of these, the Contouring Assistant, which is with the FDA at this point, and in our clinical. We still continue to expect that by the first half of next year we will get clearance for this. The Thermal Boost, which we recently received clearance for, is already receiving some rave reviews from our early users.
So Thermal Boost gives them the ability to really see the margins, guesstimate if, if they think that there is a problem, and be able to really address the margins, or in some cases, it just gives them confidence that if they see cancer, they can just take care of with some extra blast of energy, have some better assurance that they have actually taken care of the cancer. And when you look at the, the next one, which is the Contouring Assistant, which, which you may have already heard about also, is to be able to use the knowledge of the current procedures of successful patients and be able to use that information and thereby suggest a treatment plan, which gives them, a new urologist in particular, confidence in the treatment designs.
At the same time, it helps them make adjustments to their own liking, and thereby they can get up the learning curve and have the customization, the way they see it, the right way. But when you really look at what is our FDA clearance, you know, it is for the ablation of prostate tissue, and in the description, benign and malignant. So we have a broad FDA clearance, and we should be able to treat patients who have cancer disease or BPH disease, which is why we are also announcing today that we will have a TULSA for BPH. This will be a takeoff from our Automatic Contouring Assistant. The idea is to be able to very quickly provide a BPH design that will still be customized to the shape and size of each prostate.
And it will automatically then present the treatment plan and ablation protocol and allow physicians to quickly treat patients who may only have BPH. And, you know, Mathieu went through some of that data with you, and more data, more trials are already underway, and more and more data will be coming in the next few months. But this is, again, a very small snippet of the comparison of a small data set for TULSA, but the initial data is actually quite impressive. The IPSS score, the lower the better, and really, TULSA brings the score down to a level of people who are in their mid-thirties. And so we are quite excited to be able to expand the potential of TULSA and bring it to the patients who have BPH.
And finally, you know, I mentioned to you this idea of 20% redos or such high incontinence so on is not good enough. So we will be announcing initiatives where the TULSA- AI will continue to become a learning system, and we will be collecting the data, the databases that you get from all of these different procedures in the new patient pathway, which will then allow us to really detect better and thereby ultimately break that barrier of the 20% redos that the industry is actually settled on at the moment. So this is my final presentation. I'm proud of the team. You've seen the team today, and I think you can expect continued evolvement as we go forward.
My message to you is, you know, what we are doing is really amazing for the patients. It is amazing new technology. It will ultimately help healthcare in terms of reducing costs of those redos, reducing costs of the total workflow at the same time. So get involved with us, you know, be part of the change. Thank you. So let's switch to question and answers at this point. And so I'm gonna turn it over to our team. We're gonna take a very short break and come back for Q&A. Thank you.
As a reminder, if you have a question, be sure to enter your name and institution into the Q&A, so that we can call upon you to ask your question live. And our first question comes from Josh Jennings of TD Cowen. Go ahead and ask your question, Josh. Josh, can you unmute and ask your question? No. Okay, Josh seems to be having some technical issues, so he emailed me the question, so I'm gonna read it for him, if that's okay. TULSA-PRO appears to be extremely well positioned for the future of MR-centric management of prostate disease. Can you talk about where the clinical community is today in terms of progressing to an MR-centric approach? Are there centers who have moved forward already, and what steps are required to make an MR-centric approach become mainstream?
I think that the concept of this MR-centric strategy is definitely resonating everywhere. You heard from our partners that is a strategy for them. You heard from RadNet, our partner, RadNet, they are actually looking forward to this MR-centric strategy. They have already started certain programs where they can do early detection with their screening applications and their own AI initiative. So I think that we are in the early innings, but we are certainly starting to see that I would say a few of these centers have adopted it and are beginning to build these databases. The second point I wanted to make is that the MR-centric, I think, is definitely the longer term strategy, but even today, you know, using TULSA as part of the workflow is still going on.
And so I think the idea is that the first step towards getting to the MR-centric strategy is really getting TULSA to many, many sites. And I think once we get TULSA to many, many sites, then I think moving into these AI initiatives and these MR-centric strategies is gonna be the actually the second step for us. But I would say certainly, this year, by end of this year, you will begin to see a few of these centers, you know, adopting these strategies on a routine basis.
I would just even take that one step further to say, you know, we've seen MRI explode from a diagnosis perspective. We're using MRI to guide our biopsies and our evaluation of patients clinically, where the prostate cancer is. Then we move that MRI into a focal form of treatment, and then TULSA will allow us to move MRI into treating focally or whole gland, much the way that we had used prostatectomy or radiation therapy as an option for patients who need a whole gland strategy. So really, we see TULSA as a way to expand MRI even more into a treatment modality that could be used either focally or in a more broad application.
Thank you, Dr. Stratton. Excellent.
Yeah, if I can add something there, you know, just knowing what I see in my community, you know, I think there's a wide variation where I still think we're in our infancy. MRI itself has been around for a long time, but you're actually starting to see the rapid adoption in the urology community, that I'm still kind of seeing, for example, urologists who are primarily oncology-based, that are not necessarily getting MRIs or MRI guided biopsies. So I think we're actually relatively in our infancy, and certainly part of our awareness and guidelines now, but the actual adoption is still yet to come on a larger scale.
Just to illustrate this point, I recently saw a patient who had been biopsied by a different urologist for evaluation of TULSA-PRO, and he had had an MRI done after the biopsy, which normally is not useful because of the hemorrhage and other, you know, things that mask a cancer to be seen. I'm actually bringing up the point because I could actually see where the biopsies had been taken on the standard non-MRI approach, and I can tell you that where the biopsies actually were taken versus what the pathology results said they were taken from, I'm talking about anatomically within the prostate, they were widely different. It kind of points to how, you know, we're still in our infancy.
You know, what we think we're biopsying when we do an ultrasound guided biopsy alone may wildly differ in terms of what the actual location of the cancer are, is, and therefore, the, that MRI piece is a very crucial part of the technology.
Thank you, Dr. Hong. Excellent. Steve, let's move to the-
Thank you. Our next question comes from Rahul Sarugaser from Raymond James.
Thanks. Can you hear me okay?
Yes, Rahul, go ahead.
Great. Thanks, Arun. To everyone, thank you so much. It's been a great presentation today and excellent to see all the progress, specifically in the prostate cancer. My question, however, is gonna focus on your announcement today on moving into BPH, specifically. Which is great to hear because we've always thought that TULSA was very applicable in BPH, given its label. So, perhaps for the doctors on the call, Dr. Hong, what's... And apologies, Kelly, I think your first name. You know, we'd be grateful to hear your thoughts on the applicability of TULSA for just BPH-only patients.
And then, Arun and team, we'd be grateful to hear about how you plan to leverage the TULSA system in the nearer term for treatment of BPH only, of only, of BPH-only patients. Thank you.
Yeah.
Yes, I understand the question. My brief comment on that is, I definitely see a future for that. As we all know, BPH is much more prevalent, and therefore a treatable state than even prostate cancer for men. The key to the technology will continue to be the same metrics that determines the success of any BPH procedure, whether it's TULSA or otherwise. That is, namely that of symptomatic improvement and objective improvement, which we know how to measure. Already, Arun did show some of those results. I think they will be borne out, 'cause I've already seen that in my patients who have been treated for prostate cancer, but also had concurrent BPH.
We've seen some pretty dramatic improvement in flow rates, and, you know, other measures. Now, in order for that to be widely adopted, we're gonna get even more efficient, therefore, the AI tools are important. Also, just being able to have a, you know, very efficient processes set up so that, you know, if it's taking three hours to do one BPH patient, that clearly doesn't compete with the existing technologies. Yet, I can definitely tell you that it is possible to use the TULSA to efficiently treat a BPH patient.
Thank you, Dr. Hong. Rahul, let me sort of describe a little bit of this. So what we announced today is really the first step that we're taking towards BPH. And as Dr. Hong mentioned, the first idea is to use our AI capability that we have incorporated in the Contouring Assistant, to be able to then design the treatment for BPH. And the value of this is clearly, number one, we anticipate and we've got a lot of work to do, but we anticipate that it will be much faster way to design, to do the treatment plan. But at the same time, it will be far more customized to each shape and size of the prostate. And so that capability that we have already built in our company, we're using it to expand as our first step.
We're very aware of the fact that, you know, we cannot have a three-hour procedure, even though, to be very honest, we... When we talk to some of the patients, you know, the time is actually turning out to be less important to them as compared to the durability aspect of this, because, as you know, our prostates shrink, you know, over time. And so as they shrink, it actually, theoretically, would remove the symptoms, you know, for good. I think what you will see is sort of an evolution of our BPH strategy, where we're going to use our first AI-based treatment design, which will help us make it faster.
I think that there are certain things, if we do that, we anticipate we will be able to do also in the way we provide the ultrasound, thermal ultrasound as the heating source. So altogether, we think that using the same hardware, we should be able to provide a far more efficient and still maintain that customization capability, to do so. And then we're not prepared to talk about beyond that today, but what we are saying is that we are quite serious about entering the BPH space over the long haul.
... Sorry, let me just make one. I didn't mean to imply a BPH procedure will routinely take three hours for the TULSA-PRO. Actually, if you think about an apples-to-apples comparison, when we do a TURP or a, you know, laser TURP, we're not actually trying to remove all the prostate tissue endoscopically. Therefore, if we actually just look at the volume of tissue that we normally would remove with a standard, you know, resection TURP, and do the same thing on a TULSA-PRO, I can pretty much tell you without a doubt that you can do it under an hour. So I think already the ability and technology exists to be able to do BPH at scale, but of course, the AI tools and other things would be even more helpful.
Yeah. Yeah. Thank you. Excellent. Next question, please.
Our next question comes from Frank Takkinen at Lake Street Capital Markets.
Yeah, great. Thanks for taking my questions. Can you hear me all right?
Yeah, Frank. Good, good afternoon.
Perfect. Thank you. So the question we have received over time is just the dynamic between a urologist and a radiologist when it comes time to do a TULSA-PRO procedure, given the MRI piece of the equation, as well as the urologist piece of the equation. So I was curious if the two physicians on the line could comment on that and explain how you feel that that's gonna play out over a number of years, and how the radiology department could work with the urology department over time.
Yeah, I'd be happy to go over that. So, you know, in many of these technologies that are image-based or multidisciplinary, here we have urologists working with radiologists. The initial learning curve is kind of defined by whoever has access to the technology. So we've had radiologists, interventional radiologists, working with TULSA to date, but now we start to see that adoption by urologists, and certainly we'll need access to the MRI. But you can see, for instance, like in rectal spacing, that started very heavily with the radiation oncologist performing those procedures, and now it's the momentum has shifted to where urologists are primarily placing those devices.
So I think in TULSA, we had radiologists with the initial access to the MRI, but we see the benefit of having urologist involvement and how that's going to increase the uptake of TULSA. Really, what is gonna be the motivating force is the outcomes, and that's what we see that's amazingly different than the other treatments that we offer patients. The improvement in lower urinary tract symptoms, the effect of our treatment, and the control, the limitation of impact on the neurovascular bundles and critical structures. These are all things that are very important to urologists, and we're gonna be champions of this technology. And so working together with our radiology colleagues, I can see how this will fit together very nicely. We needed their help to get this technology started.
We needed to work closely with the radiologists. There'll be groups that have urologists work independent, depending upon how they have access to the MRI. That's how I had done my cases without a radiologist present. But there are plenty of groups that will have colleagues that are interested in working together, and that's no different than radiation treatments or other multidisciplinary treatments that we have already.
Yes, I would echo those comments, Dr. Stratton. I would agree. I think it's a collaborative approach, even before you step into TULSA, having excellent radiology for the MRI reading, that's incredibly crucial. And, you know, I think this whole effort has been always a collaborative one with radiology. You know, Dr. Busch, I would let him do my TULSA-PRO, and, you know, I do them independently, but I work very closely with Dr. Princenthal at RadNet initially for these, and we've had excellent results. I think it's local to your environment.
If you have access to MRI, you have a team that is, you know, adept at wanting to do this, then you work together, and in other places, it's gonna be more of an independent model.
Thank you.
Our next question comes from Michael Sarcone, Jefferies.
Thank you. Can you hear me okay?
Yes, Michael, go ahead.
Great. Well, thank you, Arun and team, for hosting this. This has been great, and thanks, Doctors Hong and Stratton, for your presentations today. Just to follow up on that, again, this is a question about, you know, TULSA adoption, for prostate cancer. I guess for the doctors, you know, how would you characterize the level of provider awareness of TULSA today? You know, Dr. Stratton, you just mentioned, you know, it's all about these outcomes that are so good, low adverse event rates. You know, do you view increasing provider awareness as a lever to drive, you know, meaningful increase in TULSA utilization? Or are there other factors that would be more important in the near term to driving broader use or uptake of the system procedure?
Yeah. The kind of widespread knowledge of TULSA is growing based off of our access with the technology. And so as we continue to expand access, we're going to see providers' interest really expand, I think. The MRI and its impact on prostate cancer treatment and even BPH treatment is, like what we had said, still growing. And so what we're seeing is really a trickle-down from the early adopters to kind of the people who are in the trenches every day. And then now we're starting to educate residents and fellows in how to read MRI and to use it to guide treatment.
You will quickly see the growing number of new urologists come out with a functional understanding of MRI, of prostate MRI, a functional understanding of robotic surgery, focal therapy, and image-guided therapy, and how that kind of interplays with the landscape of prostate cancer treatment. Patient interest is really what will motivate the providers to refer to a TULSA Center. As we kind of grow this number of patients who have such a positive experience, their momentum will capture that wave, and it's going to expand. That's my impression, and that's how it's worked in my experience, is that these patients ask for it, they seek it out, and that will only continue to grow as we open more centers.
Yeah, I would agree with that. If we look at 10, 15 years ago, we were doing open prostatectomies, and then suddenly we started doing robotic prostatectomies. As Dr. Stratton mentioned, the learning curve for robotic prostatectomy is incredibly difficult. Yet it was widely adopted. You know, I still clearly can remember what all those conversations were. But actually, while the debate for open versus robotic was going on, patients were asking for this. And of course, you know, it drove the adoption of the da Vinci robot. So I think, you know, we're totally in our infancy right now in the TULSA Pro. It's a foreign concept for a urologist like myself, a surgeon, to think about surgery as an image-guided surgery rather than physically removing or getting my hands involved.
But at the same time, the results are actually gonna drive the adoption. The patients themselves, who don't want to be impotent, they don't want to be wearing a diaper, they will eventually learn about these things because, look, this is well-published in our literature for many years, so there's no excuse for us as urologists to say, "Well, it's not published." Actually, it is. But what will drive it is the actual results, which, in my practice, have been excellent.
Thank you. Michael, let me just also turn this over to Abbey. Because I think we do have some experience that is starting to build, and I think as Dr. Hong said, we're very early stage there. But, Abbey, I know you have some experience.
I think, I think I can get this one to work, so I'm pretty loud. Thank you, though. I think what's interesting from what you've heard today is that we have patients that are advocates, physicians that are advocates, and as we increase usage and drive the adoption of TULSA, we are also being discussed at a carrier level. So those insurance carriers who have typically denied newer technologies, our patients, our physicians, our partners are advocating and educating others about TULSA and what it can do. So there's an example where we had a patient that was denied TULSA, but because of the support from the physician, he got on, did a peer-to-peer consult, and had that denial overturned.
I think what's important to note is that our partners are strong, and we've got the data that can support the reimbursement and coverage for our patients, and that's really when we're gonna see that futuristic growth that we've discussed today as well.
Mathieu, the CAPTAIN trial will be a pretty big-
Yeah, absolutely.
Yeah.
I mean, as we generate that level of evidence in grade group two and grade group three men, comparing head-to-head TULSA-PRO and radical prostatectomy, we are investing to build that foundation of clinical evidence to help, you know, physicians and help patients choose which treatment is really best for their disease. And so by investing in this clinical data, we will lay the foundation for, you know, the tools that you need in order to make the best decisions for your patients.
Yeah. Michael, there is no other company that is doing a level one study, right? CAPTAIN. And so I think insurance companies, and rightly so, they're looking for strong clinical evidence. And Mathieu described quite a bit of it today, and the continued work that we're doing. I think with all this and strong support from our patients and our physicians and our partners, I think we are, you know, in the early stages, as Dr. Hong said, but we have all of the ingredients to be able to get the payments.
Thank you so much, everyone. If I can just throw another quick follow-up in there. Just given all that you have so many of these boxes checked, and what Doctors Hong and Stratton said, you know, is the logical next step then to invest in a comprehensive direct-to-patient campaign to really ramp that patient awareness and get those referrals going?
So that's a great question. Thank you for that. We are very excited about our marketing team, as you heard earlier, and the direct-to-consumer campaign, we are building those out as we speak. We have tested a few of them this year, and I think that's—I believe that's also one of the ingredients that has caused such an uptick in the education of patients and the demand of patients. So we will continue to invest in that and continue to educate patients and drive access and awareness every day.
Great. Thank you.
Yeah, great, great point.
... We have a follow-up question or questions from Rahul at Raymond James.
Thanks, Steve. Thanks so much for taking my follow-up question. So this question is very specifically for Dr. Hong and Dr. Stratton. So following on from Michael's question around patients being advocates and driving interest among docs, but at the end of the day, it's gonna be data and people in your seats that are going to drive utilization of TULSA. And so, you know, beyond the patient advocacy among themselves and with their docs, how do you see broader dissemination of awareness, but also broader dissemination of utility, utilization among your peers? And also leaning specifically into, you know, what your opinions will be on the evolution of the CAPTAIN data that, you know, I think Matt Doherty started previewing some of how he thinks about that.
If you can maybe talk about physician adoption and also specifically how data is driving that going forward?
Dr. Stratton, do you want to take that first?
Sure. So, you know, we have a level of evidence supporting the treatment with TULSA that is going to continue to grow. And as was mentioned, you know, no one has really tried to compare level in a level one evidence way, two treatment modalities. So we've never pitted radiation therapy versus radical prostatectomy. This CAPTAIN trial is going to be really a foundational change in how we look at surgical management of prostate cancer. And I think that just indicates to me how impressive the results are.
And whenever I first started to work with Profound and started to consider TULSA as an option, there was some skepticism on my part, particularly related to this trial and the potential that the treatment may be beneficial to some patients, but may not result in a positive outcome. Just knowing and understanding ablative treatments, because, you know, in my practice, I started with cryotherapy, moved to HIFU, then moved to TULSA. Seeing those stepwise progressions and understanding the benefits for select patients, you know, I just can't help but believe that TULSA is going to offer something that is beyond what we've seen yet and will compete with radical prostatectomy for outcomes, both as a quality of life outcome and then also as a cancer control outcome.
Together, that's kind of the trifecta that we talk about, having a patient be able to maintain continence, erectile function, and gain cancer control. So, you know, I think that there's going to be a growing level of data with this trial. There's also groups that are reporting their own results. So recently, at our regional meeting, the South Central meeting, I presented results from my series, but also UT Southwestern presented some very impressive results in a larger group of patients. So the data is being generated right now by the early adopters, and I think it's just gonna continue to grow.
Yeah, totally. And I think the data, of course, will drive the adoption in the urology community. And then also, I think, we're already kind of refining protocols. I think at some point then we'll actually have a much more efficient pathway. So, you know, we're still in our infancy on all the processes that it takes to be able to do this well, but all things that we had to figure out with da Vinci as well and any new technology that we pick up. So the concept of the image-guided surgery is something that will be a new thing, but certainly the newer generation of urologists is already getting comfortable with imaging.
So, you know, people like myself can come up with sort of training methods and other things to help our peers to go through the transition that might otherwise be fairly painful, but actually, it's really not once you commit to it. So I think that will also drive the adoption.
Excellent. Thank you.
Our last question comes from Chris Potter.
Hi. Thanks for the great presentations. My question's on reimbursement. Once the permanent CPT code goes into effect in 2025, can you talk about what the out-of-pocket expense will be for a Medicare patient or a traditional insurance patient? I know you don't know the exact numbers, but I think you suggested that it would be similar to the temporary reimbursement. And if that's the case, does that mean that the out-of-pocket expense will continue to be over $20,000 for someone having this procedure?
Chris, thank you for the question. So once we get the Medicare or the CPT code goes into effect, it will be just like any other procedure. There's a certain percentage that is always patient pay, and majority of the payment will be covered by either Medicare or the private insurance company of the patient. So, as you said, we don't have exact numbers today, but our expectation is that the payments that the patients will make once the permanent CPT code is in place are going to be in the same ballpark as what they pay for a robotic prostatectomy or any other prostate treatment procedure. So they're gonna be all in the same ballpark. So, during the private pay, usually this is kind of historical.
Usually, private pay, it's new technology and so on, it usually starts out higher, but once the permanent codes are in place, they all settle into the right place, for the patient. With respect to the, you know, what we've talked about, the payments and then Abbey mentioned the current C code. You know, I think what we're really saying is that these numbers come from actual patient treatments and actual costs, and the type of analysis that they do to develop the number for the C code is fairly similar to what they will do to develop the number for CPT. So that's all we really know today.
But bottom line, our expectation is that the patients will be able to choose, work with their physicians, obviously, and be able to pick the treatment, and that the out-of-pocket costs will be, you know, insignificantly different from any procedure.
Okay. If I could just follow up. Will the total cost in an ambulatory surgical center be less than a hospital setting?
Chris, that is typically what happens. Certainly that is what our expectations are, is that because it's a day procedure, ASCs will be able to do this quite, as a routine. Normally the costs at ASCs are less, which is why typical payments are less, which also means, again, on average, the out-of-pocket cost for the patient will also be less. You're exactly right.
Thank you. Just one last follow-up. If we assume that the permanent code will enable a similar reimbursement of $13,000, can the... Maybe I don't understand how the insurance system works, but can the patient expect to have more reimbursement than the $13,000 on a thirty-some-odd thousand dollar procedure?
No. As I said, the $30,000 is a cash pay model. That model is a concierge practice model, and those physicians who do not accept any insurance or Medicare, they can essentially design their own charges and so on. But for most people who are insured or supported by Medicare, for them, whatever that new number will be, is what the charge will be. So, so I think you really... Those two things, numbers are completely disconnected. And as I said, once the permanent codes are in place, then the way you might think about this is really it's gonna be the same, same as that for other procedures. So I don't know if I've completely helped you with that.
Yes. Thank you for explaining it twice. Sometimes I need to hear an explanation twice. I understand.
No, I'm just saying that I realize these are complicated things, and I think as our doctors have described, this is game-changing technology and, you know, getting to new codes and getting to all this clinical data, that's sort of normal. And during that time, you know, the services, the facilities that provide the services typically charge whatever they want to charge. And then once the reimbursements are in place, then they get back—they sort of get into the normal charges. That's very routine, and that's why I was describing for you.
Thank you, Arun. I understand.
Thank you.
If I can just maybe add something, take that another step further. Make some assumptions that the, you know, whatever Medicare comes back with is something that makes it reasonable for a facility and physician to want to offer to their patients. Let's just kind of make that assumption. Then, then you're talking basically your options are coverage of a prostatectomy under Medicare, coverage of radiation under Medicare, or TULSA-PRO under Medicare. You know if you're a patient and you're now having that coverage, you can just imagine how that's going to explode the demand. Because, again, just what patient really, really wants to have prostatectomy or radiation if there is a viable alternative under Medicare and other insurers? So, yes, I, I think, you know, those, of course, have to be worked out.
They're getting worked out, but there is a reasonable assumption that it will be worked out.
Excellent.
Thank you.
All right. I think our time is up. On behalf of the Profound team, I want to thank our doctors first, most. We're proud to partner with you, and we are obviously here for you, as we all together grow and bring this new technology to the mainstream. I also would like to thank our partners, Philips, Siemens, RadNet, who took the time to present at our conference, and most certainly our patients, who were able to take the time to describe their experience. I'm very proud of my team. Thank you so much, everyone, and certainly everyone who really worked so hard to put up this production. Amazing job. Thank you.
Yeah.