I think we're going to start the meeting. Good morning, everyone. It's my pleasure to welcome you to our investor event. My name is Reza Zadno. I'm President and CEO at PROCEPT. We are a surgical robotic company with the vision to become the global leader in urology. Please review our Safe Harbor statement. We have a great agenda for you today from the company. We have Kevin Waters, our CFO; Sham Shiblaq, our Chief Commercial Officer; Barry Templin, our Chief Technology Officer. We are very fortunate to be joined by three leading urologists: Dr. Park, Dr. Gale, and Dr. Helfand, who will share their perspective and experiences in care and utilization of aquablation in the treatment of BPH and its potential in the future for the treatment of prostate cancer. We are also very excited that Barry will share data from PRCT-001 and 002 studies on prostate cancer. T hanks to compelling clinical data and support from surgeons and societies, we were able to receive full Medicare coverage with APC level 6 payment in 2021 and launch the product with the goal to become the surgical treatment of choice in BPH in 2021. We have been on a fast curve growing since our IPO in 2021. We continued with clinical data and published five-year Water durability data in 2022 and expanded coverage with commercial payers. For the larger prostates, we published five-year durability data from Water 2, and we received endorsement of NICE on the international front with the standard arrangement in the U.K. for aquablation therapy. We also completed a $150 million equity follow-on to strengthen our balance sheet and also accelerate some of our development programs. We announced prostate cancer initiatives. With that, we received FDA approval to enroll PRCT-002 that were patients with prostate cancer that may or may not have BPH. In 2024, we continued with prostate cancer development and received IDE approval for the first randomized study in the U.S. against the prostatectomy Water 4. We also received FDA clearance of HIDROS and launched HIDROS in 2024. We finished the $175 million equity follow-on to further strengthen our balance sheet. I am happy to say that in 2024, we report a global revenue of $224.5 million. I am very pleased to say we have made good progress in becoming the surgical treatment of choice, and we are on pace to become number two hospital-based, reciting BPH right behind TURP. We are making good progress to close in that gap. A few weeks ago in Madrid, the data on Water 3 were presented. That was a randomized study against enucleation, and the data showed similar efficacy but superior safety to enucleation and also in these large prostates showed 0% transfusion. Happy to say that this year we just guided for $323 million revenue, and we expect the enrollment of majority of Water 4 to be completed. With that, I'm going to ask Kevin to give a financial update. You're not going to come forward. Okay. We're actually going to move right to a commercial update, and we're going to spend more time on prostate cancer today. I'm going to start with a brief commercial update on our BPH business and the progress we're making. Dr. Park will follow me, and then we'll transition to the topic of prostate cancer. Last summer, September of 2024, we received FDA approval and launched the HIDROS robotic system, the next generation system for aquablation therapy. The timing of that release was very intentional as we captured greater than 10% market share of the BPH recitative market in the US in 2024. We're at this pivotal time in the company's future when we need to really accelerate the adoption curve to get to the majority of surgeons. That's where the HIDROS robotic system comes into play. The release during the summer of 2024 was with the intent of bringing the majority of surgeons onto the platform for the coming years. You can see some of the key features, many features, or some of the key features encapsulated in the HIDROS platform. First and foremost, we now deliver AI treatment planning to our surgeons. The confidence of being able to take an ultrasound and not have to manually read it on your own, but you have now AI algorithms that are in place to help guide the surgeon to ensure with confidence that what they're seeing is accurate. We've advanced the imaging on the system as well because that is the foundation of our success is imaging. Now this platform provides advanced imaging. The robotic resection still is the sweet spot, and this is our secret sauce on how we perform our procedure. That robotic resection continues to exist. With the software updates that will be available on HIDROS, we actually expect that to improve over time. Last but not least, the streamlined workflow. When you think about a pragmatic buyer, when you think about the adoption curve of innovations, this is who you're going after with a HIDROS system. They don't want first generation technology. They want advanced technologies that are seamless, that are efficient. That's what the HIDROS platform provides those surgeons. That's why we expect to have great success long term. We're already seeing early results of that with the HIDROS launch. Some of the early learnings on the surgeon side. First, this is our first version of the software for First Assist AI. With more experience, we'll have updates similar to other technologies in your life. We'll update the HIDROS platforms. They'll get better. Right now, we're already having a lot of success with the first edition of First Assist AI. The vast majority of procedures are using AI. The surgeons are relying on it. We're getting a lot of feedback. So far, it's been a great, great experience in the first six months of usage. We're training more surgeons per launch now. This was the goal, bring more surgeons onto the platform. We're starting to see that early success as well with HIDROS. On the hospital side, we now have a single-use cystoscope that goes along with the HIDROS platform. Why is this important? Hospitals spend a lot of money sterilizing scopes. We've now removed that burden with HIDROS. There's no longer that need for additional cost of sterilization with the scope. There's an increased interest now from our IDNs to standardize this platform. They're seeing success with aquablation with all of their last few years of using Aquabeam. Now with HIDROS, they see this opportunity to standardize aquablation as their BPH treatment of choice throughout their hospital system. This adoption we've talked about, we focused initially our strategy on high volume BPH hospitals. It was clear. Our goal is to go cannibalize this high volume recitative surgery market. We saw the unmet need. We believed aquablation could do it. That's what we proved over the last three years is we can go cannibalize business from TURPs, lasers, simple prostatectomies. What we're seeing over the last year, and especially with HIDROS, is our ability to go to low and medium volume hospitals that do. These could be large hospitals, but low and medium volume BPH hospitals and get aquablation in there and increase their volume. Last but not least, the nursing staff benefits. Simpler and quick setup. We have examples of hospitals that have now upgraded to HIDROS. What they are seeing is we are seeing staffs that relied heavily on PROCEPT employees to set up the procedure with Aquabeam that are now doing it independently and doing it from procedure one and procedure two. They are taking ownership of the procedure. When we think about surgeons being independent, it is not surgeons on their own being independent of the technology. There is also the whole operating room feeling comfortable with the technology. That is what HIDROS allows us, that seamless approach to the procedure. We are making great progress there. That all is encompassed in the single tower design where you not only make it simpler for the staff, but also for the surgeon to perform the procedure. Here's the install base. I'll quickly give you an overview of what you're looking at in the bars and the charts. Really, this is a comparison of the end of the first quarter of 2023 versus the end of the first quarter of 2025. What you see is we ended with 192 systems two years ago. We ended this prior quarter with 547 systems. The colors represent the initial starting point. What were these hospitals doing for recitative BPH before aquablation became a part of that hospital system? What you see in yellow are those high volume BPH hospitals. The purple or the dark blue is 172 there, and that is the medium volume. The light blue is the low volume. The strategy has always been to go after the yellow, go after the high volume. Initially, we saw 73% after the first couple of years of launch. We were at 73% penetration of our install base was high volume. What you're seeing now is the shift because the market is shifting. This is what great disruptive technologies do, they shift the way healthcare is treated. What you see is surgeons moving. You see patients moving. You see these hospitals now bringing BPH surgery to the hospital because of aquablation. We are hearing great success stories of not only that aquablation being a benefit to the hospital, but this halo effect. Because of aquablation, a surgeon is moving their procedures to a hospital, and now they are bringing urology procedures with them. Hospital executives love that. That is how you drive growth and you drive programs. That is why aquablation is really one of those technologies which is very enabling for hospitals. I think the key takeaway here is what we're seeing with these low and medium volume BPH hospitals when they adopt aquablation is the majority of them, the vast majority are actually becoming high volume BPH hospitals after they brought aquablation in. It is not a matter of they're low and medium volume and they're staying low and medium volume. They're low and medium volume and they're becoming high volume because of aquablation. Just in summary, the market awareness has been fantastic with HIDROS. Hospitals are really owning this marketing. They're doing a lot of direct to consumer advertising, physician referral education in their local markets. We've got a long runway. As you saw in the last slide, we're just over 500 installs. We're over 20% penetrated in the hospital market. Next year, 2026, we believe we'll also start to receive the benefits of a replacement cycle. Not only will we have greenfields that drive growth for the coming years, we will now start to see replacement cycle tailwinds as well. Momentum with the IDNs has been fantastic. Like I said, these low and medium volume hospitals that are growing into high volume hospitals has been a great success as well. With that, I am going to introduce Dr. Gerald Park. Dr. Park is based in Kansas City Urology, one of the first robotic surgeons in Kansas City 20 years ago, probably a long time ago. 2003. 2003. Over 20 years ago, has now become really a focus on BPH. Started with TURP, became an expert in enucleation, and he'll share his experience now as becoming an expert in aquablation. Thank you. Thank you for having me here. I'm Gerald Park. As introduced, here are some disclosures of mine. Kansas City Urology Care, that's the group I'm with. We're a community-based urology group, 31 of us. A little bit about Kansas City, it's a metropolitan area, about 2 million people. We're famous for barbecue, the almost three peak cheese. And we're also, hopefully after this talk, we'll be famous for BPH. BPH is something that is very common. Our group treats about 22,000 men, but we only treat them surgically about 1,600 people. It's about 7%. Cancer-wise, same thing. We treat about 8,900 men with prostate cancer. But in terms of definitive therapy, that means surgery or radiation about 1,000. It's important for us to understand the mindset of what BPH is to a urologist. I'm going to give you guys a little bit of a history lesson. BPH, as we know, has been around forever. Prior to 1926, it was always done by open surgery. It worked great, but unfortunately, it had a high mortality rate. People actually died from that surgery. When 1926 came around and TURP was introduced, that's been 100 years ago, it really changed the paradigm of BPH. It became the gold standard quickly because people were not dying anymore from BPH surgery. They were doing great. Then something happened along the way. For about 50 years, TURP had a great run. It was really the only show in town, but the morbidity became a bigger issue. A lot of those studies were actually done at the University of Kansas. The leaders of thought then were in the 1970s and 1980s. They showed that the morbidity of TURP was about 30%. They got it down to 18%. That was in the 1980s. This is when medicines were coming on board. No matter how good TURP worked, because of the morbidity with it, it did not take long for it to be knocked off its pedestal. That is where medicines came along. Medicines basically were safer. Because they were safer, urologists as good physicians would always take the Hippocratic Oath seriously, do no harm. We do not want to hurt people. Why are we harming people for a benign disease? Medicines quickly became the first line therapy. TURP was still here and became basically the backup therapy. When people cannot do medicines, then we do surgery. The reality is that medicines do not work that great. We said, you know what, maybe it is safer. It works okay, but at least we are not hurting people, but really not helping them either. This is a prime situation where something can come and take care of this problem. That is where aquablation comes into play because aquablation literally is that safe procedure. It is the effective procedure, and it is a great experience for patient and for surgeon. When I was first learning the DaVinci Robot in 2003, I remember Intuitive always saying, "Hey, we are going to make the average surgeon good and the good surgeon great." What aquablation does, it makes the average surgeon great. I am going to say it makes us superhuman. I will show you how it does later on. No longer do patients have to sacrifice safety and efficacy. We can have both. We can have our cake and get a two. I think that aquablation is really the only modality that's really going to grow the BPH model back to a surgical-based disease like it was in the 1970s, 1980s. The reason I say that it needs to be a surgically-based disease is we understand the anatomy. It's an anatomical disease. It's an overgrowth of the transition zone. That anatomy does not go away with medications. It stays there. Medicines just hide it. Whenever I look at things, I always tell my patients, "Come and see," or I tell my fellow colleagues, "See, SCE. Look at safety, look at efficacy, and look at experience." Safety, we always look at first, do no harm. Efficacy, we want to help people. We also want a great experience for the patient and for the surgeon. TURP was a historical gold standard because it was efficacious. It worked great. Not that great, not that safe, not that great an experience for the patient or a great experience for me either. Medicines came along, knocked it off, became the first line therapy. The thing about medications is as people are living longer and longer, as the Wall Street Journal said last year, this baby boomer generation is healthier and wealthier than ever. Because of that, they want a lifestyle that does not slow them down. Medications slow them down because a lot of them are on polypharmacy. There are multiple medications. We get these interactions. I had a patient the other day who said, "Hey, I fell. Why am I on this Flomax?" Hey, let's stop it. Let's get to definitely take care of this. The other thing is bladder health. Medicines do not protect the bladder. There are two things in the body that pump fluid. The heart pumps blood so you can live, and the bladder pumps your urine out so you're comfortable. We want to do these things to make sure that pump lasts for your lifetime. Aquablation is that new gold standard that I believe can accomplish both for us: safety, efficacy, experience for patient, and experience for the surgeon. I think the data that we're seeing from our group proves it. Here's the data. Here's our group. 2021 was the year prior to aquablation. We're doing about 1,100 cases. Statistically, that's about a 5% conversion rate. We got the robot in 2022, Q4. Really, it's 2023, 2024 when we really adopted aquablation. Started with one surgeon, me, one hospital, one robot. Quickly, within two years, we now have my 31 fellow urologists, 15 of us are doing it. When I was doing enucleation, I was sounding the alarm. This is the greatest surgery ever. Try it, try it, try it. I grew in 10 years from one surgeon, me, to two surgeons in 10 years because the adoption curve is that hard for enucleation. Aquablation, one surgeon, two years later, 15 surgeons. This adoption curve is what enables community urologists like myself who don't have time to do these extended fellowships, take three months off, six months off to learn these new technologies. We can immediately embrace this brand new technology and make us superhuman in how we can treat BPH. I see these recitative therapies as basically going away or being very niche type of procedures. Aquablation is going to be that workhorse of what TURP was in the 1970s and 1980s. Back in the 1970s and 1980s, all old people knew they were going to get cataracts. If they're a woman, they get a hysterectomy. If they're a man, they get a TURP. I think the day is going to come in the very near future as men get older, they realize, "You know what? I get my cataracts done. Now I get my aquablation. It's just part of life." I think that that's the way we're going to see how aquablation is going to change BPH. Now, we'll dial in on my personal practice. I was kind of the enucleationist in our group. I did all the big glands, the hard glands. I was in about 100 cases a year, 70% of it being enucleation. Once I started doing aquablation, I quickly doubled my numbers. I actually grew at 124%. The superhuman part that I'm talking about is I did this in the same timeframe I was doing previous. I wasn't working more hours. I wasn't working more stressful. I was actually, if anything, I was getting home earlier because I'm able to do these surgeries in a superhuman way that I could not have done without the aquablation. When I was doing enucleations, it would easily take me one hour, two hours, sometimes three hours to do surgeries that the aquablation lets me do in like 40, 45 minutes. The question is, how did I get so many people to do surgeries? It wasn't that I got people to do surgeries. I just showed them the problem. Once you show people the problem and show them data, they immediately make the right decision. Before 2020, I was the typical urologist. A patient would come in, "Hey, you doing all right?" "Yeah, I'm okay." "All right. Here's your refill. See me next year." That's all I would do. Next thing you know, we're in that crazy cycle. That's why 97% of people are treated with medications because it's really simple. You say, "You're okay?" "I'm good." You know how guys are. "Are you good?" "Yeah, I'm good." Move on. What I realized is if we show men what's really going on by working them up, and this is something the AUA has given us, these guidelines. They said, "Before you do surgery, you should evaluate them." What I realized is that I changed it not until I already made a decision to do surgery. I said, "You know what? Let's do a workup and then decide if you need surgery." The fact that they show up to the urologist's office means I want help. I want something done. What I did, I started doing pressure studies. I do volume studies. I do a cystoscopy. All of a sudden, we have a nice screen. When patients see their prostates enlarged, they see a median lobe, they see trabeculations, they see bladder damage, they're like, "Whoa, I need something done." They realize, "Hey, it's an anatomical disease. Hey, my prostate's enlarged." I never have to convince anyone that they need surgery. Men are already self-aware that, "Hey, I have a problem. I just don't know what it is." I show them on the screen. They're like, "All right. Let's take care of it." I have to admit, I learned this from my mechanic. My mechanic, every time I go get my oil change, he does that free checkup for me. He usually just says, "Hey, you want your air filter changed? 50 bucks." I'm like, "I'm fine. It doesn't smell in my car. I'm good." Now what he does, he brings the air filter out, shows me this dirty air filter, and says, "Hey, you want to change this?" I go, "Absolutely. Look how nasty that thing is." That is what we're doing for our patients. We're showing, "Look at your prostate. Look at what it's doing to you." They're like, "You know, doc, let's get something done." Once I give them the options and they know that recitative therapy is the 100-year-old proven modality, they want, "I want that tissue removed, but I want the 21st-century way of getting it done. I want the aquablation." Patients are coming to me for it. The secret sauce for me is, we established that as safe, we established that as effective. Now it's the third E for me, the experience. The experience for me is the efficiency. That is what separates this from anything else. You can see these curves on the left side. It's basically these different modalities. As prostate gets bigger, it takes more time. With aquablation, it's relatively flat. These are my numbers on the right. You can see 60 minutes. Pretty much all my cases, no matter how big they are, will be finished in 60 minutes. I love it. My schedule is predictable. I know that I can get to office in time. I can get to that meeting in time. I can get to dinner in time. I can do all these things. I can plan my day and be very efficient with my day. You can see how I can stack cases. I can plan on doing five different cases of all varying sizes from 77 grams to 142 grams. Now I'll be on average about 40 minutes. This is what I say is superhuman. I think as a non-urologist, you see this, "Oh, 142 grams. He did the surgery in 40 minutes." Okay, it's a nice number. The reality is it's something that is literally superhuman. It's like if the Boston Marathon just happened and the winner was in two hours and two minutes. I was like, "Wow, that is amazing. No way I could do it." But if I told you, "Hey, I ran the Boston Marathon in an hour," you're like, "Impossible." I said, "Well, I did use an electric bike." You’re like, "Oh, that's how you did it." You leverage technology. You leverage what's in front of you to accomplish the same goal. That is what aquablation is doing. It lets us be these superhuman surgeons and do things that physically could not be done without this robot. With this excitement that I have about how I've seen the robot take effect with BPH, I'm super excited about Water 4. Can we use this same very safe, very effective technology and use it for cancer? Because for prostate cancer, again, I think we have that same, the SCE, safety. I'm really wanting to know, are we going to do a harm reduction? Are we really going to help these patients in a safe way? I also want to know the efficacy. How is it going to work? What's the retreatment rates? Of course, we don't want to see anyone have an increased risk of metastatic disease, things of that nature. The last E is experience. What's the patient and surgeon experience? Is it going to improve the quality of life of people? Is this something that guys are going to say, "You know what? As you saw from my first graph, we have around 8,900 men with prostate cancer. Only about 1,000 get treated." What's happening with all that 7,000 people? Because prostate cancers, and you'll hear later, it's one of those cancers that's this slow-growing cancer that we don't always have to sound the alarm. At the same time, patients do not quite feel comfortable, "I got cancer, and we're just going to do nothing about it." I think prostate cancer is one of these things where aquablation has a real, real chance of making a real big dent in it. I kind of equate it to what lumpectomy did for women. Back in the day when I was in medical school, I remember there was a lot of controversy. It used to be, "Oh, there's cancer. Radical mastectomy. You got to get rid of it." People started thinking, "Do we have to?" I remember the first people were saying, "Lumpectomy, lumpectomy." They were like, "Boy, I do not know about that." Now it has been proven that for low-stage breast cancer, that is the treatment of choice. Lumpectomy has let women stay women. I think aquablation will let men stay men. Thank you. Thank you, Dr. Park, for that introduction to the prostate cancer section. I'm going to go through a little bit of the why, why is PROCEPT tackling this challenge. I call it a challenge because it is a massive undertaking to change the way we think and ultimately treat men with prostate cancer. I'm going to walk you through that. The journey of a prostate cancer patient, unfortunately, is very different than almost every other cancer that's diagnosed. We are going to talk you through why it's different and how a patient thinks about their treatment options when they're diagnosed with prostate cancer. It's also important to understand that prostate cancer is a multifocal disease. We are going to walk you through why focal treatments for all of the right reasons have been trying to make an impact but are struggling to make an impact. Prostate cancer is a multifocal disease. We're going to talk about that. We'll give an update on the clinical data. We've done some great work in PRCT-001 and PRCT-002. The intent of 001 and the intent of 002 was to prove to ourselves that we could do this. Now we're starting prostate cancer Water 4 Prostate Cancer Study to show that we can actually do this, and we're going to prove it through that study. Last but not least, Dr. Helfand is going to come up and talk about the aquablation therapy cancer technique, very different than the BPH technique. I think there's a lot of confusion out there as to this is not going to work for prostate cancer. You're right if you think the BPH technique is what we're going to do, but we're not going to do the BPH technique. We're going to do a cancer technique, and we're going to talk you through that as well. All right. Let's talk about the incidence rate for prostate cancer in the U.S. Prostate cancer is the most diagnosed cancer for men in the U.S. outside of skin cancer. All right. You see the annual incidence of 300,000 procedures. I've got the blue highlighted because localized cancer is what we're going to focus on. Localized cancer means it hasn't spread outside the prostate. That's what aquablation is going to focus on. It's 70% of diagnoses every year are localized cancer. Think about the risk factor. All right. When you think about all of these cancers that are diagnosed, they get graded into low, intermediate, and high risk. We're focused on the low and intermediate risk patients. There's 76% of cancer that is diagnosed as low and intermediate risk. We'll talk you through what gets done if it's high risk, but our focus is on low and intermediate risk. A large incidence of patients. I think what's really, really interesting is that there are over 3 million men in the U.S. alone that are living with prostate cancer. Let's talk about why that number is so high and why there continues to be an unmet need for these men. Dr. Park just talked about breast cancer. You actually stole my example. That's okay. That's okay. What you see here on your screen is lung cancer. You see colon cancer. You see breast cancer. You see skin cancer. All very highly diagnosed, high incidence rate cancers and all treated with the goal of being able to not have to remove the whole organ. How can you treat this in a way where you do not impact the quality of life? You minimize side effects. You minimize complications. Breast cancer is a great example of that. I want us to think about prostate cancer and the opportunity the same way mastectomy has transferred over to lumpectomy. Mastectomies still happen. If it is a high-grade disease or aggressive cancer, you unfortunately have to get a mastectomy. If you go to a Breast Cancer Society meeting, what you see is the talk has shifted over the last five years. It is not a matter of can we treat the breast cancer. It is a matter of survivorship. How do we treat the cancer and keep the woman whole, improve her quality of life? These are young women. Young men are getting treated or are getting diagnosed with prostate cancer. There is an unmet need there. The question, we've all had loved ones. Maybe some of us have been diagnosed with cancer. And when you get diagnosed with cancer, what's the first question you deal with is, "How do I get it out? When do I schedule surgery? How do we treat this?" That's the first question. It is different for prostate cancer. Unfortunately, it is different for all those millions of men. The reality is the question, if you have lower intermediate cancer, is not a matter of, "How do I get it out?" Because when you're provided the options, the trade-offs are massive. Impotence and incontinence for a young man is massive for any man of any age. That is the trade-offs you have to talk about. Now you start thinking about, not do I treat it? How long am I willing to monitor the cancer progression? Because now it's a matter of watching the cancer progress. And do I catch it fast enough to treat it? And what am I willing to give up? Because if I'm going to treat the cancer, I know I'm giving something up to my lifestyle. Something has to give. That's what you have to think about if you're a prostate cancer patient today with the options that are available to you. What's the goal? I'm now a prostate cancer patient. I go through this journey. I'm speaking to one of these surgeons on the stage here. The goal is, how do we have your lower intermediate risk? The conversation is, how do we avoid this cancer from progressing? If it does, how do we safely intervene early in this progression? Okay. I am an initial diagnosis and the patient. We have this thought process. I have these risks that far outweigh the benefits at this stage because I have lower intermediate-grade cancer. I'm told we have this ability to go on active surveillance. Active surveillance doesn't mean you don't do anything. You come back, whether it's MRIs or biopsies or PSA checks or different things in different time frames that you have to have happen to become an active surveillance patient. The surgeons also have to consider, is this patient reliable? Is this somebody who's going to come back and be treated? What if they move? They have to find a new surgeon. There's a lot of thought process that has to go into being in this active surveillance protocol. Really the goal here is we're going to avoid over-treatment because over-treatment means we lose those benefits and it becomes a risk. Here's what happens. At first follow-up, typically about one year, a third of those patients, that cancer isn't the same condition as when it started. It's already gotten aggressive. 30% at first follow-up, the cancer has progressed. Now I'm a patient and I'm like, "All right. I've now made this trade-off. I'm going to live with cancer, but I think I can do this." Within one year, roughly at the first follow-up, 30% of those men are already now saying, "Oh, no. What am I going to do?" Now you have this decision you have to make. You need to consider intervention. Do I want these trade-offs? Because the benefits, meaning I'm able to survive potentially because this could now take my life, do they outweigh the risks, which are erectile dysfunction and incontinence is the two primary risks that go along with prostate cancer surgery? Now you have this decision you have to make. And then when you start thinking about the decision process, you say, "Well, what happens? What happens if I continue to surveil this cancer?" Now what we know is that when you begin active surveillance, 60% of these patients will eventually move to radical surgery. The majority of them end up getting surgery. And I'm talking about radical surgery, meaning radical prostatectomy or radiation. That's where these massive risks come into play. The question isn't whether or not that radical surgery is on the table for you. It's a matter of for most men, is it when is it going to happen? That's what goes through the mind of these men when they're going through this process of having prostate cancer and the journey they go through. I'm going to take you a step back and tell you about PROCEPT and why we're on this journey and what we're trying to achieve. This is our avocado slide we show for BPH. Many, many years ago, we started this journey on BPH. Why did we start this journey? Because in the world of BPH, there was an unmet need. Resective surgeries have been around. Dr. Park has talked about it. TURP has been around for almost 100 years. What we know about resective surgery has been proven time and time again, whether it's a laser procedure, whether it's TURP, whether it's simple prostatectomy as it works. It's effective. It's durable. There's a trade-off in the form of ejaculatory dysfunction, in the form of continence. You have to consider that this is an elective procedure. Because of that, non-resective surgeries for over 25 years, there's been a whole host of them and more coming out. How do we fill this void, the void of safety? What they've been able to do is provide an option which is safe. Unfortunately, there continues to be this trade-off. If you choose safety, you're giving up what? You're giving up efficacy and durability. That's what aquablation has done. We've come to market. We've bridged that gap. That's why we're having the success we're having. Dr. Park just talked about it. You can now have a conversation with a patient for an elective procedure and be able to have a conversation about not having to give up necessarily safety for efficacy and durability. Now think about prostate cancer. The story is not that different. It's a very different disease. We're talking about cancer now, but the story, the unmet need is still very similar. Now instead of size of prostate or shape of prostate, we're going to talk about progression, progression of prostate cancer. What you see here is grade group one to grade group three represented. As the cancer gets more aggressive from low risk to favorable intermediate risk to unfavorable intermediate risk, the options begin to change and the conversation changes with the surgeon and the patient. When you think about low risk, you may think active surveillance. What we actually see is many of these patients actually get prostatectomies. They're getting radical prostatectomy in their low-risk patients because they don't want to live with cancer. When you start to move to favorable intermediate and unfavorable intermediate, you're starting to see radiation and prostatectomy start to step in, and that becomes the primary option for those patients. What are we trying to do here with aquablation? It's the same story. When you get radical therapy, you know you're treating the cancer. You're getting the cancer out. That's the goal. Erectile function and continence becomes the trade-off. On the other side, you have active surveillance. What's active surveillance trying to do? It's not treating the cancer. You're surveilling it. You're watching it. You're monitoring it. You're prioritizing the quality of life, sexual function, and continence. That's the current paradigm. That's what's going on with the world of prostate cancer. When you think about aquablation, you think about our ability to prioritize both safety and our ability to treat cancer. That's what we're trying to achieve. This has been going on for many years in the world of prostate cancer. You think about focal treatments. You think about what they're trying to do. It's the same story what they're trying to do, but how they go about it is not how we go about it. Focal treatment is very different. We're going to create a new category of surgery in prostate cancer. Think about focal treatment. This right here is an MRI with a visible lesion. Your yellow is your visible lesion you found on MRI. For the layperson, great. MRI is like that's what you use. We saw it. Let's treat it. Okay. Here's what we know. What we know is when you see it and you treat it with prostate cancer, it doesn't mean that's the only cancer that exists. In fact, UCLA did a study. What they showed was that focal disease, prostate cancer is not a focal disease. Forty percent of these men that had grade group two cancer, when the pathology was taken after the lesion was removed, they found cancer on the other side of the prostate. Cancer that was missed by MRI, cancer that was missed by biopsy, but it was there. When you think about focal disease and you think about focal treatment, there's a reason why it continues to struggle to have the success it needs to have is because prostate cancer is not a focal disease. When you look at the studies of focal therapy, many times what they're doing is they're measuring their success of treating the lesion. Look at that yellow, the yellow circle. These studies show my success in treating the yellow circle. When you think about the patient, you're not treating the whole gland. You may still have cancer. When we think about our results for PROCEPT and when we think about aquablation is going to report out, it's not apples to apples. We're talking about success of cancer-free patient, not success in treating one lesion. Very, very different. The other question I think we need to understand is the difference between BPH and the difference between cancer. This is the transition zone of the prostate. When you're treating BPH, what are we trying to do? We're trying to put a big old tunnel right in the middle of the transition zone. We're just putting a big old chunk of tissue. We're taking it out and we're basically allowing the bladder to empty. That's all we're trying to do. That's the most important thing is emptying the bladder. All right? This is very different. When we think about cancer, you need to treat the peripheral zone. Most cancers exist in the peripheral zone. What we're going to show you today is that we can do that. Okay? We haven't had to try to do it. We didn't want to do it with BPH. Okay? Being able to do it versus the desire to do it are very different. With cancer, we'll treat the peripheral zone as well. In conclusion, prostate cancer is a multifocal disease. It requires a whole gland treatment, and that's what we're going to show you today. Based off our PRCT-001 and PRCT-002, we have strong confidence in the design and the assumptions we've made in Water 4. We're excited to continue enrolling these patients and show you data on that. Aquablation therapy can treat the peripheral zone. We'll talk about that. 60% of these patients on active surveillance will progress to radical treatment. That's a really, really important takeaway. We're the first company ever. We're very proud of this, and we hold ourselves to a very high bar. This company is built on level one clinical data. We're going to do it again with Water 4 PCA. We're the first company ever to receive an FDA IDE approval to enroll this randomized trial comparing our therapy versus radical prostatectomy. There are other studies out there, but they're not FDA studies. We're holding ourselves to the highest bar possible, and that's really, really important to differentiate as well. We're going to pursue a specific treatment indication. That's a long-term. There are other things we can do in the intermediate, but we're going to go after a treatment indication as well for prostate cancer. With that, I have the pleasure of introducing Dr. Indy Gill. Dr. Gill, I crossed paths with him 20+ years ago when I was a sales rep. He was at Cleveland Clinic. He was running circles around people, being an early adopter at that time. He hasn't slowed down at all. He's now the chair of urology at USC, and I have the pleasure of having him as our primary investigator for Water 4. Thank you. Appreciate it. it. Thanks. Great job. Thank you. You laid it out beautifully, Sham. Thank you. Just as a start, I'm not a paid consultant for PROCEPT. The two conflicts of interest listed here are companies that are startup companies that we've done, but I'm not a paid consultant. When we talk about prostate cancer, you'll often hear the word over-treatment. You will also hear that low and sometimes intermediate-risk prostate cancer does not need to be treated. These are generally accurate comments, but there are nuances. What is over-treatment? Over-treatment more reflects the nature of the treatment rather than the nature of the disease. If treatment were as simple as just scraping off a mole or taking a little polyp on colonoscopy, we would not be talking about over-treatment. The problem is for low and intermediate-risk prostate cancer, the treatments that we have are somewhat heavy-handed and have sequelae, lifetime sequelae that decrease their appeal to men with low and intermediate-risk prostate cancer. What is low and intermediate-risk prostate cancer? It is dependent upon the amount of cancer in the prostate. It is dependent on whether the cancer has spread outside the prostate and what is the cellular level aggressiveness of that cancer. These three things determine the low, intermediate, high-risk scenario. Essentially, the intermediate risk is divided into favorable intermediate risk and unfavorable intermediate risk. How do we assess stage? We assess stage by figuring out whether the cancer has spread outside the prostate. How do we assess grade? Grade is looking under the microscope at the cells and assessing their level of aggressiveness. The least aggressive is grade group one. The most aggressive high-risk is grade group five. PSA is a surrogate for the aggressiveness of the cancer. That's how we figure out whether cancer is low, intermediate, or high-risk. Going on to treatment, looking at the low-risk cancer, grade group one, it is very straightforward: active surveillance. Looking at the high-risk group, grade group four or five, it's very straightforward. This is coming at us. We are going to throw treatments at it, i.e., radical prostatectomy, radiation, etc., to neutralize this. It's the vast intermediate part that is grade group two, grade group three, where the conundrum lies. I mentioned active surveillance for low risk. What does active surveillance mean? Active surveillance means that we are not going to do any active treatment right away. It doesn't mean we are not going to do active treatment at all. It just means that we are not going to do it right away. Active surveillance, we are not taking any anti-cancer steps right away. The game plan here is the man has been diagnosed with low or intermediate-risk disease. We are going to continue to do PSA checks every so often, let's say every six months or so. We are going to do MRI, and then we are going to do maybe a biopsy at a year or two or something like that. That is how we follow patients along on active surveillance. In this continued surveillance, if the cancer takes a leap, if it goes from low to intermediate risk, then our thinking changes. The man could say, "I'm stressed with the fact that we are just following cancer. I want to do something about it." When that switch occurs is when the dam bursts. That is when we go from having a good lifestyle now to having active treatment, which is radical prostatectomy or surgery. That is where then the sequelae of these treatments, which is essentially urinary incontinence or issues with that and erectile dysfunction, they kick in. For intermediate-risk disease, the guidelines do not give a preference between active surveillance or radiation or surgery. The overall message here is we do not have enough prospective randomized data to be able to guide you strongly one way or another. For intermediate-risk disease, it is between the patient and the physician as to which way to go: active surveillance, radiation, or surgery. How do we figure out which way to go? One of the best trials is the PROTECT trial. This is from the United Kingdom, run by Oxford. This randomized about 1,600 men equally into active surveillance, into radical prostatectomy, and radiation therapy. The data were actually quite stunning to guys like me. Okay? A major finding was that at 15 years, if you just did active surveillance for men with low and intermediate-risk disease, their chances of dying from prostate cancer are really not a whole lot different than if you actually did surgery or radiation. Meaning the difference in prostate cancer-specific mortality in low and intermediate-risk men undergoing active surveillance and followed for 15 years, the difference in cancer-specific mortality was less than 1%, 0.9%, compared to if you did surgery or radiation right away. Boy, that sounds pretty amazing, right? I mean, all we are doing is doing surveillance, and the patient is having an excellent mortality outcome. It is obviously not as simple as that. There are nuances, as is often the case in this. In this trial, men on active surveillance initially did not have surgery or radiation, but as they were followed, then cancer progressed, then they moved on to getting the radical treatment. That is when the sequelae of the radical prostatectomy or radiation kicked in. In this instance, at 15 years, 60% of men, 60%, had switched over to active treatment. The excellent cancer-specific outcomes were reliant on this conversion to radical surgery. Ideally, for active surveillance, it would be that the man is on active surveillance and does not have to have any treatment and would die from a non-prostate cancer cause. That would be a home run. That occurred only in 15% of men at 15 years. The vast majority had to have either active treatment or died from other causes. As I'm saying, these men who are now going to go to active intervention, that is a heavy-handed approach. These men with low to intermediate-risk disease are now going to have sequelae of treatment, which is incontinence and erectile dysfunction. A kinder, gentler, softer approach is what is needed. Aquablation, I believe, is that approach wherein the goal is to go in from inside the prostate and to be able to shell out the entire prostate, not just the obstructive tissue, but the entire transitional and peripheral zone, and be able to thereby eliminate the prostate cancer without hurting the neurovascular bundle that runs outside the prostate or the sphincter that is outside the prostate. Without harming these two critical structures, we are thereby able to take care of the cancer while minimizing the downside, the morbidity. There is diagnostic uncertainty of prostate cancer, and this is substantial. Firstly, as Sham already said, prostate cancer is multifocal. All residents learn it literally in their first year of training that 80% of men with prostate cancer are going to have multiple spots within the prostate of cancer and typically two to three spots. Okay? That is a multifocal disease, which we are now trying to take care of with focal therapy. There is an inherent contradiction there. 40% of men diagnosed with grade group two disease on one side actually have disease on the other side as well, unbeknownst to us. Active surveillance studies show that if a man has had his first prostate biopsy, we want to typically reconfirm it. If we are going to do active surveillance or focal therapy, the guy has a first biopsy, then we reconfirm it with the second biopsy. The second biopsy increases, upgrades the disease in 30% of men. It does not inspire confidence in the biopsy itself. Focal studies have shown for intermediate-risk disease about a 30% consistent failure rate, either in-field recurrence or out-of-field recurrence. It is this diagnostic uncertainty that supports whole-gland treatments, but the problem is the whole-gland treatments have high morbidity. We feel that, or I feel that aquablation has a niche that it could fulfill, which is currently lacking. Focal treatments currently are thermal. Okay? There are sequelae from thermal treatments. Aquablation has the potential, and because they are thermal, therefore they can hurt the neurovascular bundle, which is outside the prostate. Therefore we typically restrict thermal treatments only to one lobe of the prostate. We do not do bilobar. If you do not do bilobar, you are going to leave disease behind, as we are showing here. Therefore, aquablation, which is athermal and can take care of both lobes from the inside of the prostate, is therefore appealing. We are embarking on the WaterForce study. This, I personally feel, is going to be a game changer. Never before in the United States has a new treatment been compared to an established standard in a prospective randomized manner. Never before. It has been really my privilege to have been involved in the design of this study. I'm eagerly looking forward to it. I feel that aquablation has the potential to be able to address the issue without causing sequelae, without nuking the entire neighborhood. As important as it is to show the efficacy of aquablation, equally important, and I cannot stress this enough, equally important is it to show it in the setting of a prospective randomized trial. If it is just a single-arm pilot study, it's not going to carry the day. It is just not going to get into guidelines. It is not going to be recognized by payers, and therefore will not impact urologists like me who are looking to that level of acceptance in the guidelines, etc. The trial that we've designed, I feel, is innovative. FDA has blessed it, and we are already underway. We feel that we will not only get this done for the first time in the United States, a prospective randomized trial comparing a novel treatment to established standard, but we'll get it done in record time. We are holding ourselves to it. We are already underway. It's 280 patients randomized, 3 as to 1, and we hope to be able to conclude this trial. I'm told not to give the number, but I'm trying to hold back. We're going to get this done in short order. Thank you. Thank you, Dr. Gill. Always a pleasure to hear you speak. Okay. I'm going to get into the data from the '01 and '02 study. To be clear, this is not data from the WaterForce trial. This study is undergoing with enrollment right now. We've used the last couple of years to really hone in our understanding of our data, how the procedures evolve to treat prostate cancer. Dr. Helfand's going to go into that. I'm going to show for the first time our outcomes data from the patients that we've studied to date, and then we'll get into how we and what we've learned about the procedure. PRCT-001, it's a global trial, single-arm. We've enrolled about half of that study to date. It's still ongoing right now, included men in grade group one, two, and three. The PRCT-002, remember, was a small US feasibility trial that completed last summer with 22 patients. We are combining them and pulling this analysis because we now have 88 patients treated, 65 with three-month follow-up, and 47 at six-month follow-up to give the full picture of data that we have. If you look at the demographics, typical localized prostate cancer, men average age 67, three-quarters of the men were enrolled in the United States centers across the two different studies. 70% had intermediate risk, with the vast majority of those being grade group two disease. We've kind of moved down the table there. 80% of men had an MR visible lesion, so that means about 20% were just detected on systematic biopsy. The group had moderate BPH, which you can see there is an average score of 16. As a reference point, a typical BPH trial will be 21-22 points at baseline. Some LUTs, but this is not a BPH trial per se. When you get into the anatomical details, the average prostate size was 61 grams. The largest size we treated was 133. Prostate cancer tends to be smaller glands than what we see in BPH. BPH, we've treated a gland over 1,000 grams. Cancer, they're going to be smaller. Where the cancer was located, as both Sham and Dr. Gill noted, three-quarters was in the peripheral zone. You can see here there was transition zone only in a quarter. There was transition zone and peripheral zone, and then peripheral zone only. Moving down to the procedure details, the procedure just took over an hour of time. Length of stay was a day and a half. The surgeons have not been rushing for day case surgery. It is something that is feasible, but that is not a priority of this study. Catheter duration about two and a half days. And probably most importantly, there were no transfusions reported in these first 88 cases, even with the more aggressive removal of tissue in the gland. Okay. As we've touched on the design of the trial and reference points, these are for the most contemporary, probably credible publications in the field of oncology, prostate oncology today. And we've used this data to help create the assumptions for the statistical design of the WaterForce trial. We're also using these as a reference point to compare the data of our data today as we walk through this. To start, this is the radical prostatectomy arm of the PROTECT study. It's roughly 500 patients. This measurement is something called the SHIM score. This is a patient-reported outcome tool, meaning they have five questions to answer. The maximum score is 25, and they have great erectile function. If you have zero, you have very poor erectile function. The group on average had an average score of 16 at baseline. At six months, the group on average dropped to just over 4, and there was a bit of recovery at 12 months at 5.5. How does this measure up to the scale? Somebody is considered to have severe ED with a 7-point or less SHIM score. You can see the population ended up at six months in the severe category. There is a band from roughly 8-11 for moderate ED. A second study, the AFU study, a large study done in France, reported just baseline and 12 months in their data. You can see similar numbers here, the average starting at 19 and the resulting number at 6 at 12 months. You are again in that severe ED category. Now, the aquablation data. Our combined data started at 17.5, and we went to 17.1 at six months. There is no change. We are not reporting 12-month data today because we do not have it yet today. The population needs to age as we follow these patients over time. Remember, our first regulatory endpoint is around erectile function. Our comparator arm is the radical prostatectomy arm. This is a clear indicator as to how we have designed our study, excuse me, and what we have modeled in. These numbers are in very good alignment with what we've assumed for the radical arm, obviously from published data, and now what we've assumed for the aquablation arm, which is stability in erectile function. Our other second main regulatory endpoint at six months is around pad use incontinence. This is any pad use is collected. Again, we're starting with the radical prostatectomy arm of the PROTECT study. 2% of the men at baseline were already using pads. That had no bearing because it wasn't caused by the surgery. However, at six months, you can see it almost bumped up to near 50% of the population. There was a bit of recovery where only about one in four men were using a pad at 12 months. If you look at the Bridge et al. Paper here in the middle, again, they only reported baseline and 12 months. You can see a similar fact there where 4% were on pads entering the trial, and you had about one in three still using a pad at 12 months. When you compare this to the data that we have now seen, we started with 3%, so very in line with the other studies that you've noted there, and we had a bump up to 8% at six months. Longer-term data will be reported later on. Again, as our second co-primary endpoint around pad use incontinence, these assumptions, obviously the published data we're already aware of, but our data is panning out as expected and very consistent with what we see in the BPH world. Okay. Now we get into kind of the oncologic control aspect of our data. So as Sham and Dr. Gill have touched on, which is cancer is a progressive disease. Here are two very good sources as to monitoring active surveillance patients and progression at their kind of first checkpoint, if you will. The number of 30% has been used. This was a study at UCL in London, and you can see it's about one in three men. The other paper from Case Western from the United States is around 46%. Our data, which is a protocol-driven biopsy across all patients, was 10% in the study here. We're noting this is an important fact as Dr. Helfand is going to show in some of his data. He's looked at this data out to five years in his own population and seen a lack of progression after a man has undergone aquablation. More to that later on in the talk. This all combines to these diagnostic measures, meaning you look at MRI, you look at PSA, you look at grade group under biopsy, and all those factors into a decision between a patient and a surgeon as to, "Okay, do I need another treatment? Is it time that I need something else done?" This is what's called often a salvage treatment. You have your first treatment, your primary treatment, and then how often do you need something else? These first two examples are both focused on radical prostatectomy from two different studies. You can see at about one year, 6-7% of men will need an additional treatment following their index radical prostatectomy. It's typically radiation therapy. They're doing this because they're watching a PSA rise, etc., as the patient moves on. Again, we just have six-month data today. As expected in this field, this is why we're running a 10-year WaterForce study. We have to have long-term data. The data we have sitting on today, there has not been any salvage treatments up to the six-month time point with our patient group today. As we know, kind of the best of the best as far as treatment is radical prostatectomy, and it's close to perfect. This is the bar that we are aiming at. We are on our first six months off to a great start. I think from our approach of being a whole-gland treatment, we have strong belief that our long-term durability, meaning lack of salvage treatment, is going to hold up in the long term. That is why we're happy to start the WaterForce study that is ultimately going to have a 10-year follow-up. In conclusion, our data is encouraging. It further supports the design of the WaterForce randomized study that we're doing. We are seeing a material stop or delay of progression of cancer. We are seeing significantly reduced rates of unnecessary morbidity from the index procedure. As the aquablation arm, we have an even greater confidence today in the assumptions that we've made in the design of that trial. At this point, I'm going to turn it over to Dr. Brian Helfand. I have my notes here. I could start this, and then there's a lot more. A urologic oncologist who's the division chief of urology at Endeavor Health. He's also a professor at the University of Chicago and most recently named chief scientific officer at Endeavor Health. Brian, I will turn it over to you. Thank you, Barry. Certainly, thank you again for the opportunity to speak here. I actually had the opportunity last year as well. I think the point is that I'm getting more and more excited by the data that we're seeing. Certainly, as a urologic oncologist, using a water jet to treat cancer initially was really kind of an absurdity. The fact that it's a reality today is really, really exciting, and the journey continues to get better and better. Certainly, what I'd like to really go through today and show you and give you some insights into is how we can use the aquablation system and how safe it can be in terms of cancer control. Again, a lot of the questions that we're really asked or I'm asked all the time is, "Does aquablation spread cancer? We're using a high-pressure powered water jet, and you're going against a tumor. Is that going to spread that throughout the body? Can you really use the Aquabeam to get to all parts of the prostate? We know that prostates are varying sizes and shapes, but can you actually use that to get into the peripheral zone, the very outmost reaches of that prostate? Is Is it, again, does it really truly have that superior safety profile? I think Barry gave you a little insight. It does, but we'll go through some of that. Certainly, does that have any impact importantly on the oncologic outcomes? Does it change the cancer progression? Again, this is very different. Aquablation is not a focal therapy. We've already reviewed, and Dr. Gill did an awesome job of that, of showing that it is a multifocal disease. There are many tumors for most patients that exist in the prostate at any given time. Just going after one bit of it really is a failure for most of those patients. Ultimately, many of those patients who receive classic focal therapies will need other radical therapies to get them across that clear line. We know that when you look at MRIs, they are not, even though they've moved the bar in terms of our diagnostic capabilities, they're still not perfect, and we can't see most tumors. Most of these multifocal disease is actually quite invisible. Aquablation opens that opportunity because it can do a near total resection. We don't really know what to call it, but this is a radical aquablation, but it's a near total resection of that prostate from the inside out, starting from the urethra and really going to the very outmost reaches of that prostate. Again, can it access the transition and peripheral zone? The answer is yes, it can get out there. Again, this is very different. There is no other BPH technology. Even back to open surgery, if you did an open simple prostatectomy, if you're going to go into that peripheral zone, you are doing a radical surgery. Really, even the whole app, all of that can't get to the peripheral zone. Because it's going from the inside out, it has that ability to get there in a safe fashion. It's athermal. Again, we can resect with this more than 95% of all prostate tissue. At least that's what we've estimated based on the current experience. Again, it's a near total resection, but it leaves the important parts of the prostate, including those nerves that reside right outside, intact. Again, it's an athermal type of technology, so we don't have to worry about spread to those nerves. Certainly, at the bladder neck, we're not using the ability to destroy that, so we don't have the incontinence rates. Even if HoLEP, as an example, can do that, you would be causing incontinence in the same mechanism. Again, aquablation is really positioned in such a unique fashion to treat prostate cancer. What we did is throughout the years, and we started our program back in 2018. Since that time, we have treated many men on active surveillance, meaning these men had prostate tumors. They were low risk or they were lower volume favorable intermediate risk, but they also had concomitant urinary symptoms. We wanted to say, "Well, they needed an outlet procedure because of their urinary symptoms. I really wasn't impressed with their cancer." Historically, I said, "Well, just leave them alone, but we're going to use aquablation because it would help alleviate their urinary symptoms." What we did was we compared the groups of these. We looked at men who underwent aquablation only. These men we identified just had urinary symptoms. They did not have cancer. We compared them to our active surveillance group of men who had also concomitant BPH or urinary symptoms. We wanted to know, is there a difference in outcomes? Number one is, do we improve their urinary symptoms? Are we changing any erectile function or anything with that? We also made a comparison because we took that same group of men who had enlarged prostates and prostate cancer and compared them to a group just on active surveillance and wanted to ask the question of, "Is this changing their oncologic outcomes? Are we making their cancer worse over time? Are we changing it at all? Or are these men with the aquablation actually doing better?" Here is just a baseline clinical characteristic comparison between all three of those groups. Group one was the BPH only who underwent aquablation. Group two was the BPH and prostate cancer who underwent aquablation. Group three was the active surveillance only, no treatment as well. These are average 70-year-old men. Men on active surveillance alone were slightly younger. The ones who underwent surgery, aquablation, had enlarged prostates. Actually, most of them were about 100 grams. They, as expected, those who underwent aquablation had significantly worse LUTS at baseline urinary symptoms as measured by the IPSS and quality of life scores compared to those who just are on standard active surveillance. Again, when you look and you say, "Well, is this safe? Do men who undergo aquablation, do we improve their urinary symptoms?" It is no surprise that there is no difference whether they had cancer or not in terms of symptom control. Everyone had significant improvements in urinary symptoms. Certainly, this is showing out to six months. We have the five-year data on this. At five years, these men are doing excellent and continue to void without complaints. If we look at quality of life there, which I'm not showing here, or I am showing here, they have significant improvements in quality of life. Again, it doesn't make a difference what criteria you're using, whether you're using PBR, whether you're using max urinary flow. Again, these differences and improvements they have after aquablation are sustained, and they have significant improvements. No surprise, aquablation works. We've showed this now for years in terms of urinary symptom improvements. The question is, is this safe? There is a question that patients ask me. There's a question that I get from other physicians. When you're taking this water jet and blasting away men with tumors, is this going to spread? I always then reflect on the fact that I love what I do, and I treat men with prostate cancer. The reason why I love this type of tumor is that it is so different than other tumor types. It is what I refer to as the lame, the nice, the snail of tumors. It takes years to develop, years to spread. I did a lot of basic science research back in the day where I would actually take prostate cancer cells and try to grow them in mice and stuff. It is very hard to, even if you take the cells and sprinkle them in mice, it's hard to get them to stick around or grow. Certainly, things that we've done over time is we do prostate biopsies over time. We perturb the tumors in these men. It has never been shown that prostate biopsies spread cancer. Certainly, it has never been shown, even when you have men with really bad metastatic disease and locally advanced disease causing urinary symptoms, that the tumor is so bad in the prostate that these men can't pee. We've historically done channel TURPs. Again, no evidence that when we've done a TURP on these patients, that there has been any type of spread. In fact, a lot of BPH procedures we do also are on men we don't know, but they have cancer, and there's no evidence that there's any exacerbation. We had to ask the question is to say, "Is there a surrogate can we use to say if we look at circulating tumor cells, is that exacerbated? Are the numbers of these tumor cells that float throughout the blood, are these increased or changed if you do aquablation?" Again, it's a very odd circuit because circulating tumor cells as an outcome, and particularly in prostate cancer, actually have very little prognostic value. There are some smaller studies that would suggest that if you do surgery, you may have a transient increased spike in the circulating tumor cells. I think one study may have implied that it has a higher chance if you have really high numbers that it can associate with the chance of recurrence. My guess is when you factor in that, it's just the aggressiveness of the overall disease and the overall stage of that patient that is a higher indicating rather than circulating tumor cells. Ultimately, I kind of think that this question is a moot point. We did the initial study as part of the PRCT-001 to say, "Is there a change in circulating tumor cells among men who are undergoing aquablation?" The answer is yes, there is a transient spike, what I would call an insignificant increase in the number of circulating tumor cells that happens with aquablation. It quickly goes back down to a baseline very low number. I think the point here is I think it's a silly question because there really is no evidence in all of the historic things that we've done to prostate cancer and how we perturb it during surgery or even radiation really has never shown to spread it. It's not really something that I'm really focused on or worried about. When we've looked then and said, "Forget Brian, what you believe and all that data, what happens to these patients that you've done aquablation on?" Now referring back to those two cohorts, cohort two, which is the BPH and prostate cancer, as well as cohort three, which is the active surveillance only, we look at their cancer outcomes over time. How many of these patients had worse cancers diagnosed that ultimately needed treatment over time? Again, this is a five-year follow-up. As you can see here, that top line, the blue line is the aquablation arm, that cohort two. The, I think it's red arm or purple arm there is the active surveillance only. In a five-year period, about half of those patients who are on active surveillance only were treated with radical therapy, whether that was surgery or radiation. Comparatively, only 20% of men in that aquablation arm were treated. Again, a significant reduction. When you look at a hazard ratio, that's a 58% reduction. If you compare the overall value, that's a 30% difference there. This is a very short-term follow-up. I also want to emphasize that these men were not treated with the standard protocol that we have developed for cancer control now with Aquabeam. These were generally using the BPH procedures, often got into that peripheral zone, but we were not really intending to treat the cancer. We were really intending to just treat their urinary symptoms. I think the point here is it is a very safe procedure, and I am really impressed and actually quite surprised that these men, from an oncologic perspective, are doing so much better. The question is, why not? Again, they have better urinary symptoms. Worst-case scenario, we are improving their urinary symptoms. We have no real change in sexual function. Finally, if we can change their cancer outcome, even if you have low-risk cancer, why would we not use aquablation therapy? Again, we have to recognize that the Aquabeam is a tool. Sometimes we get that tool and we develop a protocol and we become so married to using that machine or technology in a certain way. The BPH way, if you will, or the standard way that we use Aquabeam is we do two passes with the water jet and we create that central defect, which is largely focused in on the transition zone. We create that hole throughout the prostate, which makes men urinate significantly better. Again, when you look at that defect there, you can clearly see that there's a hole there. This is from the Water 3 trial, which was the most recent results released comparing the aquablation to HoLEP. Again, that defect is very similar whether you're using the aquablation or the holmium laser to create it. This is now different. We want to get rid of all of the tissue. We want to do the aquablation cancer or the radical aquablation or the subtotal or whatever we're ultimately going to call it. I think that anyone in this room can really see if you look at that far right picture, this defect is quite impressive. We are getting to the outmost reaches of the prostate to the true capsule. There is very little, if any, tissue that's really left there. Really, really impressive that we can use that tool, but use it in a novel way. I want to next go through how we think differently about using the aquablation system in this. Again, this is really just emphasizing the fact that the traditional aquablation BPH procedure is really just going after that transition zone and making a big hole in it. Here we're actually getting way into that peripheral zone. That question that I get from patients or from other clinicians to say, "Brian, can you really get into the peripheral zone?" The answer is yes. Again, we use very different passes. I think that this was the thing that has taken the longest to really kind of think about and develop. Again, we become so married to a concept where we're going to use a tool in the same way over and over. The aquablation system has so many cool things that you can do. Again, this is now when I do this, not that the normal one was boring, but now a BPH case is almost kind of run-of-the-mill roach. When you get into the cancer, it is truly becoming a little bit more artistic. Again, the aquablation system democratizes it so anyone can do it. You have the ability to then look at your prostate. In this case, you can kind of see there that there are two yellow dots on that 3D model. Those represent where the cancer locations are that we've biopsied or shown up on the MRI. We come up with subsequent plans. You can use the aquablation computerized system and even ultimately the AI technology to really help you slice and dice that prostate in a really sick way. I just described it, but cut it up into so many different pieces. Ultimately, the goal is all the same. Get rid of all of that tissue. We know we can do that in an athermal and very safe manner. Again, this is really just how we do it is that this is the ultimate image. I look at it and I say, "Hey, we want to get rid of the anterior tissue as much as we can." Then we want to go after and deep into the periphery as we can. Again, the standard BPH procedure uses two passes. For the cancer cases, we're doing anywhere to three to four, sometimes even five or more, just to really cover all of that tissue that we can and use the AquaBeam to its utmost potential. This is just the case in particular that we did is that we did that first cut. We went all the way, used that arc as high as we can in our planning to get as much of that anterior tissue. Again, our purpose here isn't death. For this case, we're really just getting into the transition zone. Remember again that most prostate cancer patients are really 40 grams or less. This really has an ease at getting into all of that peripheral zone. Even on the 130-gram cases, there are ways that you can then subsequently get deep into that prostate tissue. We then make two additional plans. This is the second pass where we are going to depth, and we are going to then maximize to the really peripheral zones. Here is the third pass in that same way. Ultimately, we just want to make sure that we clean up. What we have learned for hemostasis from the BPH experience was that we use a bipolar cautery or monopolar cautery device, and we usually do focal bladder neck cautery. We did that initially because we were saying, "Hey, we want to decrease any risk of any transfusion or significant bleeding." We now use that, but we also use that in novel ways. We do the focal bladder neck cautery. Then we go, and while we're actually using the ultrasound and live imaging, we use that resectoscope and then clean up any tissue that is there. This additional cleanup is about an additional 15-20 minutes. This is not adding significant length onto the procedure. The average length of this is about a 60-minute procedure versus a 40-minute procedure. When you talk about this in the grand scheme, it is about half of what it takes or even a third of what it takes to do a radical prostatectomy. Again, when you look at this, I'm so excited because we really have shown that, number one, this is safe. It doesn't spread cancer. All of those skeptics saying that a high-pressure water jet is going to spread this to people's heads, it doesn't appear to spread, and that is no surprise there. If you look at circulating tumor cells as a surrogate, it really is no evidence that this is exacerbating cancer. We have reduced grade group progression, meaning that these men who receive it, even if you're not doing a full cancer template aquablation therapy, they're doing better from a cancer control. Awesome to actually see and a very pleasant surprise that even using that, we can actually alter in such positive ways their cancer outcomes. Again, we've evolved it. Now we really are going after all of that tissue and doing a subtotal radical surgery, if you will, to get rid of that and not only eliminate that, but to really hopefully cure them. Again, a very different idea. These patients, I should say, and we're not showing their data, really have no difference in terms of urinary symptom control, in terms of erectile function, etc. It does get to that peripheral zone access because, again, you can use that water jet in so many novel ways. With that, I am so excited to see how Water 4 goes. Certainly, not to ruin any surprise, other surgeons besides myself have started this journey. When you look and see that they have easily adapted the techniques that we've developed. The learning curve on this, even the radical surgery, is actually quite low. It's really cool to have seen these other surgeons start the journey. Thank you, guys. Thank you, Dr. Helfand, Dr. Gill, Dr. Park. I'm going to wrap up with some closing statements, and then we'll open up with Q&A. I first just want to commend the three of you and everybody else in the Water 4 study. Challenging the standard of care in healthcare and medicine takes a certain breed of surgeon confidence in what you're doing. Going back to the 1990s, I mean, when laparoscopy started and challenged open surgery, these surgeons were called criminals. Surgeons were called criminals for doing laparoscopy in the 1990s. It wasn't that long ago. Now it's like, why would you do open surgery if laparoscopy is available? When you think about just in the 2000s and the introduction of robotic surgery, the challenge to these surgeons to try to advance surgery and saying, "What are you doing?" You think about all the evolutions and what we are doing with aquablation. For thought leaders, Dr. Gill is a world-renowned thought leader in the field of robotic prostatectomy. To sit here and to say, "We need to do better." There is nothing wrong with robotic prostatectomy, but there is an opportunity to improve the care for prostate cancer patients. To sit here and to say, "Let's do better," is really why we thank you for that. We thank you to all the Water 4 investigators because we can do better, and we hope to prove that. When you think about what we have prided ourselves on at PROCEPT, it is to take on this challenge. We're actually built for this. This is what we do. We don't go do 15 things. We do one thing, and we do it really, really well. When we go do the next challenge, the reason why we're standing in front of you and talking today is we have confidence we're going to do it really, really well. We've built the success of this company on the level one clinical data that we have with BPH. Nobody else did this. How many therapies are out there for BPH? How many have done a randomized study against TURP? We built this company on level one clinical data because we have confidence the technology works. We proved superior safety. We proved against the gold standard the efficacy results. You see the success we've had just over the last three years. We just got reimbursement a few years ago. We have already built the success with the BPH world. We plan to do the same thing now with prostate cancer. When you look at the BPH world, just in a few short years, there are over 150 peer-reviewed journals, all in the foundation of the Water 1 study, which was that randomized study. That is our goal with prostate cancer. That is why we are starting the Water 4 Prostate Cancer Study. We are building the level one evidence, doing something nobody has ever done. We are doing it because we have confidence that we can help patients and we can change the way prostate cancer is treated forever. Ultimately, the goal of Water 4 is to provide men with a frontline treatment option for prostate cancer that is localized. Thank you, and I will open up the Q&A.