We can start. Good morning, everyone. Sorry, there were some delays for internet. Welcome to PROCEPT Investor event. We are thrilled to have this meeting here during AUA in New Orleans. It's great to see everyone, and those of you on Zoom or phone, thanks for joining us, and I hope you can hear me well. Please review our safe harbor statement. My name is Reza Zadno, I'm President & CEO at PROCEPT. Today with me, we have Kevin Waters, our Chief Financial Officer, Sham Shiblaq, our Chief Commercial Officer, and Barry Templin, our Senior Vice President of Clinical and Medical Affairs. Sham will introduce the surgeons who will speak later.
The agenda for today is the management team will make an introduction to the company on the clinical, financial, and commercial strategy, and then physicians will talk about their experience with Aquablation, and there will be time for Q&A at the end, so please hold your questions for the end of the meeting. BPH is the number one reason men see a urologist. About 50% of men between the age of 51 and 60 have BPH, and almost all of them, 99%, complain about the impact of the disease on their quality of life. In the U.S., there are 40 million men with BPH, and the number of men above the age of 65 is expected to double in the next ten years. More color on that population. 12 million of those men are actively managed for BPH. 4.3 million are watchful waiters.
6.7 million are on pharmaceuticals. 1.1 million have failed medication. In 2019, 400,000 of them had looked for some intervention. This is a massive opportunity, a very large market. The technology Aquablation from PROCEPT integrates image guidance, customized treatment planning, consistent robotic surgery, and during resection, it doesn't use heat. The combination of these features allow this technology to be used on small prostates as well as very large prostates and everything in between in the hands of all surgeons. The safety and efficacy of our product have been evidenced with compelling clinical results and data with the only FDA randomized study against TURP, and these clinical have resulted in multiple publication.
The combination of the clinical data and support from physicians and societies have allowed us to increase market access with full Medicare coverage and few commercial payers covering the procedure. This is a well-understood disease, market, and the customer base is well defined. That has allowed us to have a very efficient commercial organization. With that introduction, I'm gonna let Barry talk about the clinical results. Thank you.
Thank you, Reza. Good morning. I'm gonna briefly go over our clinical data. Some of this will be new information that's gonna be shown this weekend here at AUA. First is a backdrop, which is what is the clinical unmet need that we've embarked on with the technology to try to solve. First, you have to understand prostates come in various sizes and shapes. You can see here depicted by our fruit slide. They could be as small as 30 or 40 mL and range in excess of 150 mL. Currently, there are two broad categories of treatment options. First is a resective option, meaning that they're removing obstructive tissue at the time of the procedure. Most notably known is the TURP procedure. It's been around for nearly 100 years, PVP, enucleation, and simple.
As you can see, they break at different size points across the spectrum. These are all very good procedures when it comes to efficacy outcomes. However, they do come with a higher risk profile when it comes to sexual dysfunction and incontinence. The other primary category is the non-resective category, and again, limited primarily by size, typically up to 80 or 100 mL in prostate size. They have a very strong safety profile. However, they don't have the same efficacy outcomes as the resective category. The unmet need here is described as could a technology come to market that could treat any size prostate, any shape prostate, and get resective-like efficacy outcomes and non-resective-like safety outcomes. The clinical evidence that we've built behind Aquablation is driven by three primary clinical studies.
The WATER study was a randomized study in prostates up to 80 mL against the TURP control arm. We showed superiority in safety. We also showed superiority in symptom relief in prostates larger than 50. We conducted a second FDA study. This was a single-arm study in prostates ranging from 80 to 150 mL, so this is the larger category. We again demonstrated similar clinical outcomes as we saw in the smaller prostates of less than 80. Lastly, we ran an all-comer study called OPEN WATER. More complex patient set, broad range of sizes, 20 to 150 mL. All of these have comprised and helped us get on many of the guidelines. You can see here AUA, EAU, Canadian guidelines as well as NICE at the bottom of the screen.
When you look at the safety profile, again, this table shows the average prostate sizes treated, the percentage of obstructive median lobes. You can see as it increases, as prostate size increased. In the blue box, you can see a low rate regardless of size and regardless of clinical study we've conducted of these irreversible complications of incontinence, erectile dysfunction, and ejaculatory dysfunction. When you look at symptom improvement, here you can see in the various color lines, all the patients started roughly in a 20-25 point IPSS baseline score, averaging approximately a severe condition. You can see an abrupt or an immediate improvement, and it's sustained. We're now reporting five-year data from the WATER study, which is the teal line, and the red line represents the TURP arm.
This weekend we'll be releasing our four-year WATER II study, which is the large prostate study. Again, very consistent results as you can see are maintained out through five years. Going on to durability of the treatment, meaning men who don't have to undergo another surgical or an intervention for LUTS or being put back on BPH meds. From the WATER study, you can see a very favorable rate of Aquablation of only 6% of men required another intervention or were back on meds. The TURP arm of the WATER study was 12.3%. Looking at other contemporary FDA clinical studies that have recently been reported, you have the Rezūm study at 15.5%, and you have the UroLift L.I.F.T. study at 33.6%. These were all studies done in prostates less than 80.
When you look at the category above 80, as we sit here today, Aquablation is the only study to run an FDA study in this size category. You can see we're at 9% and we've only reported four-year data, which will be shown this weekend. Five-year data will come out next spring. Just a reminder, when you look at our risk profile table here, this is a table I showed before, but looking at the OPEN WATER data as a backdrop of very low rates of incontinence, erectile dysfunction, and ejaculatory dysfunction, and you compare that to the published rates of real world outcomes of TURP, PVP, enucleation, simple prostatectomy, you can see here they all work in different size ranges of prostates, however, they all have relatively higher rates of incontinence, ED, and ejaculatory dysfunction compared to what I just showed you with Aquablation.
Lastly, I'll conclude with this slide, which is how are we capable of treating any size or shape prostate, and that's the robotic execution of tissue removal. You can see the blue dots here represent the time spent resecting. We've been able to standardize room setup, planning for the surgeon, and now with the robotic execution, we can remove tissue from any size gland, and you can see approximately 6 minutes as shown by the graph on the screen, and this data runs all the way out to 150 grams. Our surgeon advisors here can further comment on this when they get into their presentation. At this point, I will turn it over to Kevin for the financial review. Kevin?
Great. Thanks, Barry, and good morning to everyone, both live and on the web. I have quickly two slides just to go over our financial performance in the first quarter and a couple comments on our fiscal 2022 guidance. You can see here in the first quarter, we produced revenue of $14.2 million. $12.6 million of that is in the US. The remaining $1.6 million would be attributable to our international business. That is robust, 97% year-over-year growth, and that growth was driven by both new system sales and also our single-use disposable handpiece sales, both performing above our own internal expectations. Starting with systems, we sold 22 systems in the U.S.. We now have an installed base of 93 AquaBeam systems in the U.S.
You can see our pricing has been relatively constant over the previous three quarters at $350,000. We are excited about the fact that most all of those sales in the first quarter were to new greenfield hospital customers, and we have a robust pipeline as we head into Q2, Q3, and Q4 for the remainder of 2022. On handpieces sold, we sold approximately 1,425 handpieces. While not on the slide, this is 130% growth year-over-year in units over Q1 of 2021 in the US. You'll see here our accounts in the U.S. on average perform about 5.6 procedures per month. Lastly, we now have, with the recent addition of Aetna, 175 million covered lives in the U.S.
We believe this represents about 75% of all covered lives in the U.S., and we do believe this will be a nice growth driver for us as we move throughout 2022 and head into next year as well. The next slide is a summary of our 2022 financial guidance that we went over on our earnings call last week. We raised our revenue guidance. Previously, we were at $54 million-$58 million. We have raised this guidance to now $58 million-$62 million. This does represent 80% year-over-year growth at the high end of our guidance. Again, while not on the slide, the high end of our guidance would imply that our installed base of AquaBeam robots in the U.S. will grow 100% year-over-year compared to 2021. Very nice growth for the company with our installed base.
If you go down and look at margins and our adjusted EBITDA, we did reiterate those metrics, although we did say on gross margins, we now anticipate being at the higher end of the 47%-49%. Just lastly, touching on cash in this market, cash is king, and we have $284.3 million of cash. We do believe the cash on the balance sheet will be sufficient to meet our near term and longer term growth objectives and get us to profitability where we wouldn't have a need to go back and tap the public markets, and quite pleased with our cash balance today at $284 million. A quick summary on the financials.
I'm gonna turn it over to Sham here, to go through a few of the commercial metrics before we get to the surgeons. Thank you.
Thanks, Kevin.
Good morning. I'll do a pretty high-level summary of the commercial strategy.
For PROCEPT, and the data we'll share is primarily focused on the U.S. market today, as that's where the majority of our commercial execution is currently taking place. As Reza mentioned, you know, BPH is a large disease state. It's the number one reason that a man visits the urologist, which provides us an opportunity to treat a lot of patients in the U.S. There's 8.2 million patients every year that see a physician for BPH and are treated in some shape or form. That means either they're on BPH drugs, they fail BPH drugs, or they receive a surgical option. It's a lot of patients to go after from a strategy standpoint.
We've decided to segment our base into an immediate, midterm, and long-term opportunity, and I'll walk you through how we think about our business. The immediate opportunity, as you can see, is a $1 billion TAM, and that's the current surgical market. The non-resective and resective market, as Reza discussed, comprises those 400,000 procedures, and 290,000 of them are the existing surgical market, and we're hyper-focused on converting the existing resective surgical market. The midterm opportunity is about $10 billion. Those are men that are on drugs or have failed drugs, but the important part about this category is these are patients that are in the care of a urologist. The reason why we've made that a midterm opportunity is these are our current customers.
The urologists are our current customers. These patients are talking to these same surgeons every day. The next step would be to focus on those patients that are failing drugs or are currently on drugs. The long-term opportunity is also a large TAM of $10 billion, the 3.9 million men that are on drugs or have failed drugs, but these patients are in the care of a primary care physician. That's a different type of execution for us to educate the community in large scale. When you think about a large scale direct to consumer campaign and educating the whole world about Aquablation, that's more of a long-term opportunity for us.
If we're hyper-focused on the urology community in the short term, as we're in those offices today, there's different types of advertising we do in the local market to get those patients educated. That's the strategy between the long-term and immediate opportunity that we have. When you look at the segmentation of our customers, and specifically on the hospital side, there are 2,700 hospitals in the U.S. that do resective surgery. We talk about low volume hospitals and high volume hospitals. We define a high volume hospital as any hospital that does more than 100 resective surgeries in a year. It's about 32% of the total hospitals are high volume hospitals, which equates to 860 hospitals in the U.S. that are high volume.
When you look at the number of total procedures that are coming from that segment, you see there are 250,000 procedures in the U.S. that are hospital-based resective procedures, and those 32% of hospitals actually do 71% of those procedures. As a company, we're focused on 30% of the hospitals that generate 70% of resective BPH procedures. That's the immediate strategy.
With all of the success we've now had in getting insurance and with Medicare starting over a year ago and now with the commercial payers following suit, our strategy continues to be to focus on resective surgeries, but we're hyper-focused on the prostate sizes about 50-100 grams, and I'll explain the rationale behind the 50-100 grams and how we see the data playing out over the last year and a half. We believe we're the obvious choice for large prostates, but when you look at the average size prostate, there's a bit of a misnomer that the small to average size prostates are easy to treat. As Barry showed in the WATER data, if you recall, is 30-80 grams.
We did a randomized trial with TURP and with Aquablation, and in both arms, there were over 50% of patients had an obstructive median lobe. When we think about size and shape as the decision makers, typically why a surgeon decides what therapy to choose for their patient, it's not just size, also the complexity of the anatomy. When you have these smaller to average size prostates with complex anatomy, there's very few choices that are shown to be effective in treating those men. That's why we're focused on this average size gland because we believe our technology can be superior in this area. The data's proving out that way. The surgeons are actually following suit.
As you can see by this histogram, the number of patients that are treated in the 60-80 gram category is our largest segment of patients treated, and the vast majority of our procedures are between 40 and 100 grams. With that being said, I'm going to pass it over to our surgeon panel. Let me do some quick introductions. It is my pleasure to introduce the three of these gentlemen to join us today. Dr. Dean Elterman joins us from the University of Toronto. Dean specializes in functional urology, a global thought leader, well-published. In fact, he was a few minutes late because he was moderating a session over at the AUA next door and so he joins us today. Dr. Brian Helfand from Chicago, Illinois, with NorthShore University. Dr.
Helfand focuses on all things prostate, including cancer, also has a large percentage of his practice in genetics and he uses genetics to actually help him guide him and provide treatment for patients on prostate surgery as well. Dr. Pratik Desai next to me from Alexandria, Virginia. Dr. Desai is part of a 12-person urology practice, Potomac Urology, multiple surgeons in the practice performing Aquablation, and Dr. Desai will speak to us today about how they view BPH and how they view the growth of BPH procedures in a private practice. With that, I'm gonna pass it over to Dr. Elterman.
Thank you.
Thank you.
Thanks, Sham. It's a pleasure to join you all, today. These are my disclosures. I'm gonna go over a little bit in terms of an introduction to the technology so that we're all on the same page in terms of what this Aquablation system can really do. This is the only image-guided, heat-free, and automated robotic therapy for BPH. It has four key components which really differentiate it from anything else that any of us here on the stage do for BPH. Number one is that it utilizes real-time image guidance. There's an intraoperative ultrasound which is used in combination with cystoscopic visualization, and this provides a multidimensional view of the treatment area.
Unlike most surgeries where we're only seeing a small window on the cystoscopy in front of us, we can actually see the entire prostate using real-time ultrasound imaging. The second key feature is that we're able to do personalized treatment planning. This advanced planning software allows us surgeons to actually map out the treatment contour to identify the tissue both to preserve as well as resect. When you're doing a regular operation, you're kind of just seeing what is the next thing in front of you, whereas here you're actually able to see the entire prostate and decide ahead of time what needs to be left behind and what we want to remove. The third is the automated robotic execution. This water jet, along with the treatment plan, will result in a very standardized outcome and operative experience.
Lastly, this is heat-free water jet resection, and this removes a precise amount of prostate tissue and really minimizes any thermal damage to surrounding tissue that we see with other technologies, electrovaporization, laser therapies. When you put these all together, it really does have a unique ability to treat prostates with imaging precisely in a heat-free fashion. In terms of real-time imaging, this is essentially a schematic of what we, the surgeons, are able to see. On the left-hand side is what would be your standard view during an operation, which is the cystoscopic or endoscopic view. You can see with your scope kind of what's in front of you.
By adding the transrectal ultrasound, and you can see again the prostate in multi-dimensions, you're able to have this view of the treatment area and allow you to plan out probably more precisely and more accurately, but also more completely, the amount of tissue that needs to be removed. Here's an example of a treatment area. We can see here, using the ultrasound, what prostate tissue needs to be removed, what tissue we'd like to preserve, and allow for the planning to be individualized to each individual patient. In terms of this idea of personalized treatment planning, what it allows us to do is identify the critical anatomy so that, for example, a median lobe, and you can see the number one denotes different median lobes. These are four different prostates. We want to remove a median lobe.
That causes a lot of obstruction. We can resect the median lobe. Number two you're seeing is the bladder neck. The bladder neck is a key area. There's blood vessels there. It's important for other reasons, and we want to preserve the bladder neck. The contouring software allows us to preserve the bladder neck. You see that green area. We actually reduce the amount of power of the water jet there and preserve the bladder neck. Number three is the bulk of the prostate. Those are the lateral lobes, and of course, we want to entirely resect those. Three is really where the full power of the water jet is able to ablate and remove tissue in a very precise but also quick fashion. Number four is the verumontanum. This is a key area of structure where the ejaculatory ducts are.
By us being able to both identify it, but also preserve this area, we're allowed to reduce the rates of retrograde or loss of ejaculation. In resective technologies, those rates are as high as 50%-100% essentially. With Aquablation, the numbers are essentially around 10%, and it's going down even further as we refine the technique. Lastly, number five is the external sphincter. Of course, we want to identify and preserve the sphincter because that's what's for continence. We've seen in the previous studies that there's really no risk of incontinence because we're able to both see the sphincter with our lens and also mark it out so that the water jet does not go beyond where we want to treat. These are four personalized plans for four different men, four different prostates.
The software takes you through it, and it's the surgeon who actually makes fine-tune adjustments, moving these numbers 1, 2, 3, 4, 5 around to create that individual treatment plan. Heat-free, I think, is something that's underappreciated. With transurethral resection, bipolar, monopolar laser, there is this heat that transmits into the deeper tissue. It may cause additional urinary symptoms, dysuria, may affect erections. There's high variability in terms of the depth of penetration with heat. We do see necrosis that goes much deeper into the cavity of the prostate than is appreciated at the time of surgery. There's certainly the risk of potential capsular perforation causing damage and bleeding, risk to the neurovascular bundle, which can impact erections, and of course, delayed healing.
You know, when men come in for a laser or a TURP, we're telling them 6-8 weeks of recovery, and of course, that's much shortened because of the Aquablation technology. Here's a quick example of the sphincter protection. What we're seeing on the left-hand side is the surgeon moving back their camera. You're seeing the end of the prostate, those two lobes, and the sphincter is going to come into view and sort of close around, and then I'm gonna move forward so that I know I'm for sure in front of the sphincter. I can see on the ultrasound, but I can also see in real time the ability to identify critical landmarks in order to preserve continence as well as ejaculatory function. We're able to see very well, very carefully, important key structures to preserve continence.
The next is this, unique feature, which is the veru protection zone for ejaculation. It's believed that if you, resect and remove the ejaculatory ducts around the verumontanum, which is an anatomic structure, as well as the end of the apical tissue, it, will result in loss of ejaculation. You really want to preserve and protect these critical areas by not touching them, not having any heat or energy go there, and not actually removing that tissue. This technology, essentially at the end, you can see the yellow, zone with the yellow circle around it. That's essentially the veru protection zone where the water jet does not sweep down to the bottom. In fact, it looks like a snow angel. It only does the sides and doesn't sweep down to the floor at the critical structures.
By doing this, we're able to actually protect these critical areas and preserve ejaculation. You can see in the yellow, that's exactly what the veru protection zone is. You program into the software the water jet so that it doesn't go through those key areas. This is an example in real time where you see us only doing the left-hand side of the screen, patient's right, and then it actually will automatically, when that side is done, move and to do the opposite contralateral side. This is all planned into the software, so ahead of time, you know exactly what you're keeping and exactly what you're taking away, resulting in, of course, very low rates of ejaculatory dysfunction. At the end, you can see that that structure is preserved.
That's an after image, and you can see those key structures are not touched. We've done some research looking at the images and how they correlate to outcomes. We now have a better appreciation of how deep the water jet needs to go to preserve ejaculation, and this has allowed for improved treatment planning and even lower rates of ejaculatory dysfunction. Being able to critically analyze the images and look at outcomes, we've actually gotten better at refining the technique. I anticipate it will actually get better and better so that the rates of ejaculatory dysfunction will be in the single digits essentially. There has been an evolution of hemostasis, so this is the ability to control bleeding.
The prostate is a very vascular organ, gland in fact, and there has been an evolution from the very early first-in-man studies all the way to today. You can see that in 2015, 2016, they were really looking at only prostates between 20-80 milliliters. They used the water jet followed by a little bit of electrocautery, and the rate of a transfusion was less than 1%. It was actually really quite good. Moving on to about 2017 when they did the larger gland study, WATER II, it was decided that they would do no cautery whatsoever. In fact, these large vascular prostates were attempted to stop bleeding using a catheter, so a balloon to tamponade any bleeding. We found higher rates of transfusion around 6%.
There was this idea that, well, maybe that's not the best method, we need to go back to doing something else. 2018, 2019, OPEN WATER study commercialization, larger range of prostates being done, 20 all the way up to 280. A little bit of nonspecific cautery was used, and we saw those rates go much lower, less than around 3%. There was this notion of doing something called focal bladder neck cautery, which was identifying the key areas that cause bleeding at the bladder neck and applying just a little bit of electrocautery to ensure that significant areas do not bleed.
With the advent and adoption of focal bladder neck cautery, both in commercialization, this rate has dropped down well below 1% at 0.8%, which in fact is not only excellent for Aquablation but excellent for any BPH technology. The rate of bleeding for TURP and bipolar GreenLight is actually higher. In 2,000 consecutive cases, we've been able to identify this optimal method, and it's actually gotten better. We're doing even bigger prostates all the way up to 500-gram, like monster prostates. You know, hemostasis just really isn't an issue because the technique has really been refined. I'll hand it over to Dr. Helfand.
Thank you. Good morning, and thank you guys for coming this morning. Again, here are my disclosures. I think, as Sham previously mentioned, I have a relatively unique role within my hospital system, in that I have a large interest in genetics which kinda thrusted me into the role of head of personalized medicine. As such, many years ago, I had to come up with a algorithm for the treatment of BPH, that really was designed to get the right treatment for the right patient. Certainly, if you guys are familiar with the marketplace right now, there are many different technologies that are out there.
We were coming up with an algorithm based on the size, shape, need for anticoagulation, type of symptoms that the patient presented with that would match that patient up. Certainly the WATER studies came out, and started to work with PROCEPT and say, "Hey, maybe that there is a important, one-size-fits-all technology, that we don't need any of these other, technologies because we can provide that personalized medicine, if you will, or personalized surgical planning for that treatment, which really can answer all, those patient needs." Again, it's been compared to, an iPhone. Before the iPhone, you had a, the actual phone that called patients. You had a separate camera. You had, a calendar.
Certainly, the iPhone came up, and we were like, "Why would you need that?" Now it's one device, and it's considered standard. That's really what PROCEPT and Aquablation has provided. We don't really need that treatment algorithm because it really does allow all of this. When you talk to patients, how do we choose patients that are appropriate for Aquablation? Really, almost every patient really qualifies for this because it really is designed to personalize not only that treatment plan but really answer that patient need.
For patients who are concerned with sexual function, and when we talk about sexual function, as you hear, we're concerned about that ability to maintain that ejaculation, that fluid, at the time of orgasm that comes out, which we wouldn't think is important to most men, but it is actually one of the primary complaints, that they have after standard historic procedures. Most goals, we wanna get them off of their medications. The medication compliance is very low anyways. If they're on it, they really wanna get off of it. Certainly the speed to recovery. No one wants a long drawn-out recovery, which many of the minimally invasive therapies have. If we can speed that up, that kinda helps. Certainly, no man or woman for that matter, really enjoys having a catheter in.
The shorter duration, we can have that. Certainly why we're doing this is we wanna ultimately improve their urinary symptoms. Really when we talk about that, this technology meets all of that. That really captures almost every single patient that we see in the office. You know, I think Dean just referred to the evolution of the PROCEPT technology. Certainly, when you saw that this was initially concerned that there was a higher bleeding rate. Certainly with the evolution of this technology, we have really refined that protocol, and the rates of bleeding are really in the real world between 0.3%-0.8%.
With that and certainly with the coincidence of COVID, there was a question: can we do this as an outpatient procedure? Because at that time, we were not allowed to admit patients in the hospital. My thought there was, "Well, why not try?" Because worst cases, they end up back having a problem, they're in the ER, and then we have to admit them to the hospital anyway, so what's the harm of trying? During COVID, we really started a protocol which is now quite established, and a large percentage of our patient population will actually choose to go home that same day. Really, we came up with this algorithm based on ultimately the color of the urine afterwards, whether we keep them based on the prostate size.
Certainly, this is the initial experience. This has been now expanded to almost triple these numbers. But really 80% to 85% to 90% of patients who we offer outpatient surgery to can go home that same day. None have ever shown up back in the emergency room. We have really refined that and we're not talking about guys who have small little glands that, "Hey, we can get them home the same day." These are men who have, you know, 100+ gram prostates that we can do this to. This is really a forward part of this technology that we can do this as an outpatient. With this, I will pass this on to Dr. Desai.
Thank you for having me. I'm offering a slightly different perspective than my two colleagues here. We're in a private practice group, and as you've seen, this is a huge part of our practice. Of any really general practicing urologist, we see a lot of enlarged prostates, men who come in with voiding dysfunction. My perspective on how we've grown our Aquablation program and our BPH program in general has been remarkable to the growth of our practice and also the treatment options that we can offer our patients. These are my disclosures. When we look at what we've done historically, we've as people have said, it's been essentially a resective treatment of BPH.
In the last decade, there has been an explosion of less invasive, less dangerous, and less morbid treatment options available to our patients. What we've seen in private practice is this group of patients were under-managed with medication, and that when they progressed, they were reluctant to have any treatments done because of the morbidity associated with that. In order to keep current with what's offered to patients across the board, we have several different treatment algorithms in our practice. Generally speaking, when we look at prostate cancer, et cetera, patients have a multidisciplinary approach to their disease. They treat it personally. They have options in radiation, surgery, et cetera. What we see in BPH is this has essentially mimicked what we offer our patients.
In patients who are progressing on medication or may not wanna be on medication, there are non-resective options that are done outside the OR. In a significant percentage of those patients that want resective options, we stratify them to have them offered, both office-based, minimally invasive options as well as resective, more permanent options, depending on their disease progression and what their appetite for treatment is. As you see in this large group of our patients, we have now standardized the treatment algorithm utilizing pressure flow studies, cystoscopy and ultrasound, and essentially tailoring treatment options even for small glands with median lobes for resective techniques versus small glands with non-median lobes for non-resective techniques. We've seen a tremendous increase in the number of our resective options.
As far as symptoms go, you know, we want to identify these patients earlier. We're obviously starting with medication. They have AUA symptom scores. All of the patients receive the standard workup from the beginning and a discussion of not just are you okay on what you're on, but is there room for improvement in your treatment plan. Also, you know, clearly there is a genetic component to BPH, and several of these patients have a history where they know their fathers, brothers, etc., have had treatments for their enlarged prostate. We have the standard workup after the identification that involves a cystoscopy, a transrectal ultrasound, and some sort of pressure flow study, whether it's a non-invasive pressure flow study, in some cases in men with retention, a true urodynamic study.
We do this across the board for all surgeons, whether they are Aquablation surgeons or not. What we've seen is that beyond just discussing medications and treatment options, we're navigating those patients to experts in these treatment plans. You know, when we identify a patient with a median lobe and a smaller prostate, they see someone who is appropriate for that surgical treatment, not just a general urologist. As this field expands, what we're seeing is our resective opportunities to treat patients in a more appropriate manner has been increasing. This is what we've seen in our practice. I mean, clearly, early adoption, there were multiple hurdles, not just a technique, but in reimbursement in the private practice setting.
We're in a part of the country where our two largest primary insurance plans did accept this early on, and you've seen our volume as a result really go through the roof. Even at this pace, we have a waiting list currently of 50-70 patients based on OR time. This is clearly across the board as we have less invasive techniques also exploding in our practice. This has become our resective technique of choice. Just in follow-up, we also offer some of the other ones, HoLEPs, et cetera, but our experience has been tremendous with
This technique forms multiple things. I mean, it's standardization. We have OR times that are reproducible. We have days where instead of just doing 5 cases a month, we're doing 7-8 cases in a day. We're able to stay on time, have the OR allow us to book that next day with 7-8 cases. We're able to get about half to two-thirds of our patients out the same day, depending on the size of the gland, whether they were on anticoagulation or not, et cetera. Stratifying a lot of this, it's an evolution in private practice and what we have to offer, but it's become the cornerstone of resection in our practice.
Thank you. On behalf of the surgeons, I'm gonna moderate, and then, as a matter of kind of process, I'll repeat the question so everybody can hear it that's watching it via web, and then we will have our surgeons answer questions. Please.
Hi, Josh Shainhouse. Thanks so much for hosting this event and to the surgeons for spending time with us this morning. Just to start on just the durability data, those 5-6% in 5 years and those 35 patients, 12.3% going back to surgery, again, similar treatment. It seems pretty clear to us about the mechanism driving that durability delta. Just wanted to get your view. The real-time imaging you're seeing, the tissue way that you're getting complete resection, potentially revolutionary. Just wanted to confirm that for one. Just the discussion earlier today, you know, the people in the third just got up and talked about re-op rates for Rezūm in the real world versus the clinical data being much higher.
It seems to me that as the technique for ablation is improving, that real-world durability could actually get better, perhaps with improved healing as well. I know that's been well followed.
I'll summarize. I think I heard the whole question. I'll summarize. On the five-year data, your treatment rates, your thoughts on why they've been the way they are. Then, real world, do you think that potentially they could improve or how do you see that playing out?
They are 100% reflective of real-world experience. I think one of the advantages and coolest parts, if you will, of PROCEPT and AquaBeam is that you have an image, and you have the ultrasound, and you can see exactly what's being resected. One of the most interesting things is that historically, and I say historically because a lot of these urologists have now switched over to the AquaBeam, these great TURP resectionists really thought they were doing a great job, and all we did was put an ultrasound in at the end of the procedure. They actually did not do as great of a resection as they actually initially thought.
I think that the visual images actually confirm that you are actually doing what you think you are. Certainly, that leads to increased durability. One of the other things that's reflective, you brought up Rezūm and the retreatment rates, is that a lot of that is actually the recovery experience, okay? You have really one chance to get this right for most patients. If patients are miserable, they always think that there's gonna be a problem and something should be done. Aquablation itself really doesn't have that same recovery experience. Patients are pretty happy in that recovery. There's not a lot of pain medicines being used. They're very comfortable. They see immediate kind of improvements, as reflected in the data and their symptoms. They're not looking for that retreatment. They're not looking for, you know, kind of issues there.
I do think that the experience in itself and that perioperative period leads to decreased retreatments as well.
I'll add that, you know, I think the 6% at 5 years is excellent. Far better than any other surgical medical therapy combination, right? If you look at Rezūm, it's gonna be like 15%. You look at UroLift, it's like 30, probably maybe 50%. The other thing is, you know, this is the WATER study where we're getting a lot of this data, so it's 5-year data now matured. 14 of the 17 centers had no prior Aquablation experience. They were novices. They'd never done a single case. But they'd been doing TURPs for 10, 20, 30 years. You're able to see a group of novices get equivalent and better outcomes than the standard of care that they're really good at doing. To your point that it's gonna actually get better, I would agree.
You know, when I first did my first cases in the WATER II study, I was included. I'd never done a single case. Those patients are now four years out, and they're still doing great. With more experience, I'd gotten better, and my patients will do better. I actually think that these numbers are excellent. I would anticipate even real world, they will remain very, very low. One of the biggest differences with those other technologies is there's an incredible variety of morphology and shape of prostate disease. I mean, you don't have the ability to tailor the treatment the same way you do under ultrasound guidance with even TURP or, you know, the GreenLight and the UroLift.
The market leaders essentially in BPH are not nearly as personalized in the differences in shape and volume of prostates.
Let me just ask a quick follow-up. It's just on the same question, but for the adverse event rates in terms of sexual dysfunction, urinary incontinence. I mean, should those rates also get better as user experience grows and you refine the technique? I think, Dr. Elterman, you described how you were improving the one approach to reduce or improve the antegrade ejaculation rate.
Yeah. I mean, I think first of all, the current functional outcomes are excellent. Regardless of whether prostates are bigger than 100 or lower than 100 grams, whether they have a middle lobe or don't, you have a reproducible outcome resulting in very low.
Erection, ejaculation, incontinence rates. Things that matter to men, right? You know, what's really neat is you're able to do playbacks. You can look at your case, companies can look at cases, and we can examine, you know, what techniques, ways of contouring are gonna result in different outcomes. I anticipate that those ejaculation rates, which are really good for a resective technology, remember, compared to like 50%-100% loss down to 10%, that's gonna drop down. I think it's probably 8%, and it's gonna get down to 5-3%. That's going head-to-head with non-resective, but clearly, they don't have the durability, they don't have the ability to do various morphologies, and so you're kind of getting the best of both worlds.
I mean, I wholeheartedly agree with that. I mean, again, I think reflected on the fact that most of the real-world data is really started with novices. In the worst-case scenario, we're talking about 10%-15%, you know, kind of, ejaculatory dysfunction rates, which crushes anything that's currently out there. I think that's only going to get better with better experience and improved experience. The other part about that is, when you look at really again, the prostate sizes, shapes, the different morphologies that are out there, you know, typically, we have the biggest problems historically with the largest prostates, retreatment rates, sexual dysfunction, et cetera. Again, this is just, so different, that even in the novice hands, really makes it so easy to do and preserve all those things that matter.
It's interesting because even medication-based therapies, it shouldn't be overlooked, have this ejaculatory dysfunction. A lot of these men have had, you know, adverse events from medication, and that's one of the reasons why they're pursuing something more. This is gonna get better. This is a tremendous improvement in what we've offered from a HoLEP, which has close to 100% or a simple prostatectomy has 100% for these guys who have 80+ gram glands. They were resigned to ejaculatory dysfunction. That's not the case. I think that's, when we counsel a patient, a very powerful piece of information that says, "Look, it's a possibility, but the likelihood is that it's not versus the likelihood that it's going to happen," and their reluctance to then do a medically needed procedure diminishes.
Sorry. One last question just on. I think I've heard today that within the WATER studies or maybe one of the WATER studies, that 50% of the patients had median lobe.
Yeah.
Involvement. Just wanted to understand better why the non-resective approach is maybe vulnerable in terms of not having great outcomes when it's medial lobe involvement and, or what do you in your practice for the, I guess, normal, not normal size, but the 60-80 ml range or even higher, even lower patients that have medial lobe involvement, is Aquablation therapy the right choice for these patients? Thanks a lot.
Yeah. Median lobes are my favorite, because those are the patients that most of the time, when you have a median lobe, are really gonna cause your obstructive symptoms. A weak stream, they can't empty their bladder completely, et cetera. Getting rid of that, and sometimes almost just that alone can actually really improve that patient's quality of life and urinary symptoms. Unfortunately, many of the minimally invasive therapies were designed so much that they either couldn't address it because it's extending into the bladder and so you couldn't really eliminate that, or there was a concern that if you did get rid of it, that there would be injury to adjacent structures, the ureteral orifices where the kidneys kinda plug in or the rectum below.
Aquablation is really designed not only to get rid of that tissue, open that up nicely, but there's really zero concern period that there would be any injury to the associated structures. Certainly, in the thousands of cases that have been performed worldwide, there have been no injury to any of those associated structures.
Hi, Craig Bijou from Bank of America. Thanks again for doing the panel, everyone. Wanna talk about patient selection. Obviously, you guys, it seems quickly evolved your algorithms to have Aquablation, you know, a significant portion of your resective procedures at least. Maybe just talk about how quickly you kinda came to that conclusion. I'm sure you guys as, you know, kinda the KOLs for Aquablation, get the question from your colleagues all the time and, maybe just talk about your own experience and then kinda what the feedback or questions you're getting from your colleagues on Aquablation specifically.
Yeah. What's interesting is that this disease process is largely driven by quality of life. It's not, in most cases, not an emergent procedure or urgent procedure. This is more of a chronic procedure that the patients have dealt with for a long time. When we start talking about intervention, recognizing, having that conversation about what they want for their disease process, et cetera, is a very important interaction. What we found is that, again, tailoring this for men with median lobes, tailoring this for men who want a more permanent outcome, tailoring it for men who don't mind having a general anesthesia, et cetera, has expanded the discussion of Aquablation within our treatment algorithm. It's interesting now, we are getting referrals for patients directly for Aquablation from their physicians who have now been patients for Aquablation.
The reason that's interesting is these are primary care doctors likely that have given out Flomax, alfuzosin for years and years, and they are now saying, "Look, come and get something done earlier," because they've seen the results. I think that when you look at both the patient itself, themselves in talking about what options there are, the algorithm is very important, but it has to be personalized. Then when you look at the word getting out about this technology, not among just urologists, but in the local community, because the results are immediate, because the side effect profile is so good, I think there is more of an interest even from specialties outside of urology, for this technology.
I think that histogram that Sham showed is really telling because you would think that.
You know, some people are trying to find a niche for this, but in fact, in reality, it's treating the average prostates that are coming into U.S. operating rooms, and that's where the majority of these cases are being done. This is not some niche thing where, oh, if I can't do a TURP or I can't do a UroLift, I'm gonna do Aquablation. You can see this migration where now the majority of these cases are 40- to 100-gram prostates. The average TURP done in the United States is probably like 50 grams. You know, it's really filling in to do every prostate that sort of comes in the door. I think that as surgeons adopt it, they realize very quickly it's not just for these patients. It's actually gonna be for essentially all my patients.
I would say, again, I think data is always great to go behind it. Our hospital system is a very large system. There's nine hospitals in the system. The interesting thing is they keep track of, you know, patients and new patients who are coming in from outside the system as a marker for growth. Specifically in the area of BPH, there has been an influx of patients coming in specifically for Aquablation over the past three years, that is very telling, saying, "Hey, there's something here," and people even from outside this large catchment area are coming in. Too, we have a very large medical group of urologists, but we also have many private urologists that participate and operate in the system.
The adoption of Aquablation for their patients has really increased in a very similar type of graph to what Dr. Desai showed, is that the growth has happened. It's not just a trend, but it's actually taking the place of many of the other procedures that historically were offered. I use that as a positive signal, because again, you know, I didn't bring this in, you know, with any kind of real intention other than say, "Hey, let's try this out and see how it works in the personalized medicine space." But seeing the growth of every other urologist who treats BPH really emphasizes the universality of this procedure.
Great. All helpful. Maybe following up on that, I mean, are there a group of patients that you wouldn't do Aquablation on? Obviously the transfusion rates look great, you know, what you've seen, but, you know, is there a subsegment of patients that you don't think Aquablation would be a good procedure for?
There are two patient segments that at least in my practice I've seen is that those patients who are so sick they can't withstand any kind of general anesthetic, and two, those patients who had a recent cardiac event who cannot stop any kind of major anticoagulation. In our experience, aspirin, baby aspirin is totally fine, but anything more than that, if you can't stop it, we really, that's kinda contra. That's a very small segment of that population.
Those are patient factors. They're really not prostate factors, right? Much of the decision-making of all these modalities is really dependent on prostate factors.
One other one. Just obviously drug dropout or even just drug use, or medication use for prostates, is obviously the first line of treatment. What are you guys seeing in terms of when you bring an intervention to a patient? You know, is Aquablation bringing that earlier? Are you deciding to choose an intervention earlier for you or, you know, are patients actually, you know, because of how you present Aquablation, are they more willing or to do it faster than they normally would?
Very, I guess, sensitive subject in many ways are kinda close to what I believe in is that sometimes even though the algorithms are all suggestive because we always wanna start off minimally invasive, they're just not sufficient. When you look at the real-world data, 60% of men will not be compliant with their medications within one year. That's astonishing. Then a lot of those men say, "Well, this is just the way it's supposed to be." The more aggressive we can be, and certainly I believe the earlier age you are to kind of remove, open up that, improve their quality of life, is gonna get patients on the right track.
Certainly, and I like to hopefully think that I'm free of the surgeon bias here, but I do think in real world is that when we look at the degree of improvement of symptoms and the kind of durable procedure you can offer a patient to improve them for the rest of their life, it we wanna be more aggressive there.
We've seen a huge increase in that. I think that one of the eye-opening things is when we have this discussion with the patient who's been on alpha blockers for a long time, and we are not using standardized scores, we're not having that discussion of overall happiness, consistency, compliance with medication, et cetera, there's a huge opportunity there to treat the patient better, right? And having a treatment that doesn't have the morbidity associated with the traditional treatments allows us as a physician to feel more comfortable offering that earlier in the disease process. That has, you know, been eye-opening because we used to have patients on medication for a long time, and the thought was, when you fail medications, we'll do a surgery.
Having that barrier of failure really undertreats 30% of men who are under, you know, not happy with their symptoms, but they're not in retention, they're not having incontinence. Their objective measures of failure may not be what we want to strive to treat.
Any additional questions?
I heard Dr. Desai about your robust waiting list, and I was just wondering if it sounds like there's patients. You Dr. Helfand, patients are coming to your hospital system from outside, and you guys are capturing that, driving a lot of growth. I just was wondering if you guys could all just talk about your waiting lists for Aquablation and that element of patients coming to your practice that you wouldn't normally recruit BPH patients that are the patient demand factor coming seeking out an Aquablation procedure 'cause what they've either learned online or from any marketing that the company's done.
We've had a few of these transitions. Initially, it was insurance coverage, right? We'd have a treatment option not covered by insurance. The patient would wanna wait to have something done, see if it's gonna get covered in the near future. There were patients on sort of a waiting list for that. With COVID, the availability in our OR just plummeted. Much like what Dr. Helfand said with that we had about, again, two-thirds of our patients now outpatient because of that reason. That opened up a lot of availability. Now what we're finding is we're still dealing with nursing shortages, we're still OR time issues, et cetera.
It is something that we're working very carefully for increasing the number of cases we can do per day, our internal efficiencies, so that we're able to have a standardized flow of the OR that day. Again, even looking at our fastest resective techniques, these weren't reliable because of the size and shape of the prostate. Now with this, it is reliable. Working with the system, we're doing a lot more per day than we did before, and that's driving it down. Clearly, this is a market that's undertreated. As we're offering this, I can tell you that we consistently have a waiting list of 50+ patients.
Similar experience. It was exciting, I suppose, to see that initially patients were paying out of pocket for this, which I always feel bad at in today's era. It's probably normal in Canada, but it just really showed the patient motivation to undergo this procedure. Thankfully, most patients are now covered by insurance, and that has really opened up the, you know, kind of the floodgates. Our average waiting list is really between 2-3 months to really get on schedule, and again, reflective of the same type of experience, that this has allowed many, many more procedures in a day. Certainly, it's not like these patients are staying in the hospital or anything like that.
On the other hand, even with these innovations, it's still a backup in terms of procedures.
W- I'll just comment on patient awareness, different country healthcare system, but I will say that uniquely to Aquablation, I get people from West Coast, you know, British Columbia, all the way to East Coast and everywhere in between. A lot of them are physicians, a lot of them are professionals. They're in the operating room. I had an anesthesiologist from another city. He's watched TURPs, he's watched GreenLight. He knows exactly what's up. He's like, "I wanna go to get an Aquablation." I think this is. I've heard obviously anecdotally from many other U.S. centers, where patients are not just looking for a TURP alternative, they're asking for Aquablation uniquely because of its property. I've experienced that, and I've heard it across the States as well.
I mean, the market is growing fast enough that we do cover more than one hospital. We're approaching our second and third hospitals for purchase of the robot for availability.
Maybe if I could ask on kind of following up on the same-day procedure. Dr. Desai, I think you were at 50% to two-thirds, a little bit less than Dr. Helfand, who's 85%-90%. You know, just the considerations and, I mean, you know, Dr. Desai, how does that move towards, you know-
Yeah
a much higher percentage? It seems like it is evolving that way, but and maybe patient selection is also part of that. Would just love to hear.
Yeah. COVID has changed a lot of things for us. I mean, when we weren't able to admit the patient, we were much more aggressive in pushing ambulatory treatments. What's interesting is some of it's patient expectation. There's some patients that want to stay in the hospital, and as you know, some of the availability of hospital rooms and admissions changes, there are some patients now that say, "I wanna stay overnight." From a safety perspective, you know, the robust bleeding that you would expect to see that would be dangerous to prevent this from being an ambulatory procedure is very slight.
I mean, it's I think, you know, one of these procedures where, yeah, you could go home and at the worst situation, have a clot clog up your catheter, have to come to the ER. It's very different than saying, going home and then returning emergently to the OR. That's not what we're seeing. That gives you a lot of leeway to offer this to the patient who's motivated. You do teaching for, you know, home irrigation, if that's there. If you think they're a little red, they go home with irrigation kit. Our nurse practitioner does teaching in the recovery room. In a motivated patient, we've had no issues with that.
I think that what's interesting is a lot of what drives and prevents things from being an ambulatory setting or an outpatient completed at a surgery center is safety. I don't know that that's the hurdle here. It's more workflows, reimbursement, and some patient education expectation.
Yeah. I mean, I think the difference is also potentially related to populations. I live in a very kinda higher maintenance, if you will, population on the north side of Chicago. Even despite the fact of safety and you're saying, "Hey, preoperative expectations," a lot of men, and I'll even say their significant others say, "Hey, just stay in the hospital." Can't really get around that. It's not wrong. We do try to even set the expectations in the office and, "Hey, I think we can get you home that same day. Plan on that." It
Again, we're doing this as a quality of life procedure, so we don't wanna disrupt that quality of life in that process.
One more round. Just saw some data today about at least Rezūm on larger prostates, and it seemed to be. It was interesting, but I think it was 50% of patients stayed on medical therapy, but just wanted to better understand non-resective use of in larger prostates and the efficacy that the urology community believes that those interventions have. Just the frequency of using non-resective in prostates over 80 milliliters.
We use a substantial amount of UroLift, a substantial amount of Rezūm in our practice. I don't know that there's overlap. These large glands, when you look at the recovery process that's involved with guys who are getting, you know, 10, 12 treatments with Rezūm, these guys have a protracted recovery course, often with catheters, dysuria, urgency, frequency, retention, et cetera, that we just don't see with Aquablation. In patients that have a contraindication to general anesthesia, perhaps I could see why that is. In most people, we counsel them that while this may be more involved with general anesthesia and operating room up front, the recovery process is very different in these larger glands.
The retreatment rate for those patients that you're trying to do the Rezūm, the UroLift at the upper limit of what the norm is, I would say, or the average is very high. The satisfaction is not the same as a 30-gram gland that has no median lobe. When we offer all of these things, like I said, in multidisciplinary fashion, we obviously have patients that would prefer a non-operative technique if they're appropriate. In the workup, understanding that their recovery and overall outcome may not be the same, it makes it seem like you're trying to shoehorn a treatment that may not be the best thing for the patient.
Much of that reason is mine, so I can speak to it. You know, first of all, UroLift has absolute, you know, issues because the actual length of the implant, the suture is not going to reach the capsule of very large glands. So, you know, it's really not practical for anything really over sort of between 80-100 grams. It just won't work mechanistically, okay? Then, of course, you're gonna have to be putting in many of these implants, which has its own issues in terms of, you know, is it gonna be efficacious? Is it really practical to put in 14 UroLift implants? You're gonna certainly maybe start to lose money, the reimbursement. So that's UroLift. Rezūm is interesting. I mean, first of all, the on-label indication is 30-80.
You know, I think that it can work in larger glands. However, as was said, catheter is gonna be in for much longer, a much rockier period of time. It's nice that it ablates tissue, but remember, that tissue has to go somewhere. It has to necrose, and there can be issues with that necrotic tissue getting stuck in the prostate or having to slough out or get obstructed. I don't think Rezūm is great for everybody, and there are issues around it. I think there's just less predictability. You know, just where the steam goes, who knows? You know, it's funny, I do any number of things, but when it comes to, like, if it was my dad or. No, I'm being honest now.
I treated the parents of my friends, and they say, "Well, what do you wanna do?" Then it's, like, personal, right? When it becomes personal, I do Aquablation because I know that I'm gonna get a result that I can see, I can visualize. It's reproducible. I know exactly what is gonna happen in the operating room. I know exactly what's gonna happen to them post-operatively, their course, and I know what their outcome's gonna be reliably every time. I do hundreds of Rezūm cases. When it comes to someone who's like family to me, I pick Aquablation as an option.
Please.
Do you mind just talking a little bit more granularly about the catheterization rate of Aquablation versus Rezūm versus other resective procedures and also the discharge protocols, like what % go home same day with these other resective procedures?
When we look at catheter rates, and again, there's gonna be some variability across the board and certainly talking to urologists across the country based on the type of procedure you're gonna get slight differences. In general, Rezūm is going to be a lot longer catheter anywhere 3-5 days, again based on that surgeon and patient, you know, kind of preference. If you do a GreenLight, a lot of times you just send them home with a catheter. Catheter can come out the next day. If you do a TURP, same similar type of protocol. Aquablation itself is a 24-hour catheter indwelling time, at least according to what we do. Again, there's variability across the country, but most urologists are leaning more toward the 24-hour mark.
Um, the-
Experience or patient recovery is also very different across the board. Again, a lot of that has to do with the type of energy utilized to ablate or that tissue. You get varying degrees of really kind of dysuria pain. You get varying degrees of irritative symptoms. I gotta go to the bathroom. I gotta go now, urgency, frequency, et cetera, and different degrees of hematuria. I call all of those kind of stuff potential opportunities for pink slips that the patient would call your office and need to talk to a nurse or something like this. In comparison, Aquablation has the lowest pink slip rate because of the actual recovery experience is the easiest, decreased catheter need, and decreased kind of irritative symptoms.
There is some kind of mild dysuria. Really most patients will say is, "Hey, for several weeks, actually, when I pee, there's some pain at the tip of my penis that are awareness when I void." To deal with that, we really give them Advil. That's the whole key to this operation is Advil, really two weeks scheduled, two tablets in the morning, two tablets before they go to sleep. That really covers 98% of patients. The need for recatheterization, meaning, hey, we did the procedure, there may be some type of prostatic swelling or edema that really kind of constricts the passages that you just opened up temporarily.
We'd have to put a catheter back in just so you can void until that swelling goes down is actually extremely low. In our hospital system, there's a 3% need for those patients who stay, and we can kind of really keep in as well as in the office need for a catheter to go back in compared to things like GreenLight, which is actually about 20% in our experience. Again, we try to take out the catheter next day. It's a little disappointing when patients come in, they say, "I just had this procedure. You're gonna put a catheter back in. Now I'm awake when this happens." Not so pleasant. 20% in that way is, you know, kind of, you know, unacceptable, if you will.
Certainly, there's a higher risk as well for Rezūm. We've had a lot of kind of failures, if you will, of decatheterizing just because again, there's so much soft tissue, swells up, edema, inflammation, et cetera. We need to recatheterize those patients. I think really a lot of that from a practical standpoint has really motivated a lot of urologists to be like, "Hey, I can do this procedure. It opens it up. I'm not getting those calls. I love it.
Yes. It's interesting. The purpose of the catheter in all these procedures is somewhat different. In the Rezūm, it's because if you didn't have the catheter, they would be in retention. In most of the resective techniques, the purpose of the catheter is to prevent, you know, bleeding, blood clots, clot retention. That's a relatively perioperative phase. You know, that catheterization, you can tell reliably you're gonna get this out within 24 hours. Again, minimal dysuria, but your expected outcome is almost immediate. That's something that's been striking with this and is, from a physician, very comforting to tell the patient they're gonna see that difference within the perioperative period, not three weeks out, not four weeks out, not eight weeks out.
You know, it's interesting, the difference is so striking more than any other resective technique that I've seen. Some of the patients come in complaining that the stream is too strong, that they're having trouble just because it's coming out completely and forcefully. They're adjusting going back to the way they used to urinate, just physically not making a mess in the restroom. It is a very, again, going back as a physician suggesting these options, it reinforces the comfort when you counsel a patient about this option that they're gonna have that outcome in a very short period of time, and their post-operative expectations are gonna be met sooner than some of these other techniques.
Um.
When urologists adopt a procedure, do they tend to shift most of their BPH procedure to this relatively quickly? i.e., do they look at it as standard of care?
We've seen in real time that shift and just looking at the benchmarking by just the number of and types of cases that are being done. We know that it's hard, especially if you start looking at, you know, a lot of the private practice groups that are in our system to kind of know what's happening in the office. Certainly in the operating room, the type of resective procedures that are being done have all shifted.
In our practice, it's shifted drastically. Again, the only limiting factor was insurance coverage. As that shifted, it's made it much more available.
There's definitely practices that have adopted it wholeheartedly, and they've just sort of shifted. It starts with one surgeon doing like 2, 3 cases, and then they, like, go over almost 100, and then it's like 5 and 10 and 20. Like, Atlanta's a great example of a big group where they're virtually doing everything with Aquablation.
Thanks. Just wanted to follow up, and I think you guys have talked about it a little bit, but maybe just asking more directly, you know, what percentage of your potential patients, you know, would you consider a non-resective and, you know, an Aquablation? I know, Dr. Desai, you said there's not really much overlap, so just wanna understand kinda directly asking the question, you know, is there an overlap between non-resective or doing an Aquablation?
I'm so biased in this way. It's again some of the times of how we present it to the patient. If the patient is so insistent on having an outpatient, I mean, in-the-office type procedure, then yes, we're gonna start talking really about non-resective with the exception of Rezūm type of procedures. On the other hand is when you really kinda lay out the data and you say, "Well, look at the actual degree of symptom improvement. Why are we doing this?" You know, again, I think the slide shown is that medications get you know, part of the way. Non-resective procedures get you a little bit more than this, but a resective procedure is gonna get you really there.
If you have a one-shot opportunity to do this, do it right, do it complete, do a durable procedure that's gonna last. I think when you put it or lay it out like that, most patients can. I don't wanna say be convinced, because I think it's the right thing to do, of a more invasive procedure. Again, individual preference there may sometimes, in a very small percentage of my personal practice, lead you to a non-resective type procedure.
This is a quality-of-life issue, right? When you have these discussions with the patient, a lot of it depends on the patient bias. There are men who don't want general anesthesia. They don't wanna go to the hospital. Even though you say, "Look, the durability of this may be limited," they because the majority of these have little serious morbidity associated with the procedures, there's still a place where from a patient preference standpoint that they want the less invasive office-based treatments. I bet that drives a lot of the Rezūm, right?
Yeah. I mean, unless some patient's preconceived notion that they want something, and I think that's actually the minority. Most people are like, "I've got a problem. Fix me. What are my options?" It's interesting. I've seen a very interesting evolution where previously I would counsel patients and say, "You have an option of GreenLight, Rezūm, UroLift, PAE, you know, all these things." They would take time. Like, "Can I get back to you? Can I research it? I'll talk to you in two weeks." As soon as I've introduced Aquablation into this discussion, they always pick Aquablation. When you empower patients, it's ultimately a shared decision-making process, and you need to empower them to educate them so they make their own decision.
It's been very interesting, at least in my opinion, that when you have all these other options, it's very confusing because they're all about pluses and minuses, pros and cons, trade-offs. When you add in Aquablation, they no longer have to grapple with what trade-off am I gonna be willing to take. They pick Aquablation.
Quick one. Just on, I saw the slide where you did a monster prostatic 500-gram with Aquablation. Just wanted to better understand, I mean, how big are you guys willing. Oh, it was a prostate. I'm sorry. That was the wrong slide.
I'm still wearing that metal clear now.
Just to follow up, I mean, how big are you guys going today? I mean, do you see Aquablation encroaching on kind of those, you know, prostatectomy cases as well? Thanks.
I mean, I think even a robotic simple prostatectomy would have been really challenging with the size. If you can envision the prostate itself extended to the level of the belly button. So much so that if you did an ultrasound to look at a residual volume in that patient, they were coming up with about 35 ml. You actually, in order to see that he was actually in retention and this patient presented couldn't pee, you actually had to scan above his belly button to actually get that where they saw there was 1.5 L that was sitting in his bladder 'cause he couldn't pee. My thought process was, is that he just actually had colon cancer surgery previous to this.
He really didn't want any more open surgery. It was a kind of an abdomen that you didn't really wanna go into if you didn't have to robotically. I said, "You know, what is the harm here?" Thought process is, if this doesn't work, what have we lost? We've lost absolutely nothing. It's minimally invasive. It will give him the best shot to kind of go in. If that fails, then we'll start talking about a more invasive type procedure. The nice thing is it really worked.
So, the only additional thing that I had, and again, just because I didn't know from that size perspective, what we're really dealing with is that I said, "Hey, let's have a long kind of resectoscope loop in just in case if there was any kind of issues there." Actually, this was a very non-bloody case at all. The actual Aquablation procedure, there was four passes done. It was under 20 minutes in that, you know, kind of portion of the case. Ultimately, he is voiding spontaneously now. He has a low residual volume for him, which is really less than 200 milliliters down from a liter and a half already. We call that a total success. His overall happiness is ecstatic. He comes in thinking he's like the world's champion into our clinic.
He knows everyone. It really is shown that this can handle the monsters, and has convinced me, but many other people that it should be done for those huge glands as well.
Surgeons have skill limitations. Like, I can't do a robotic simple prostatectomy 'cause that's just not in my skill set. I don't have that. As surgeons adopt it, and we're not talking KOLs at big academic centers, we're talking private practice, small communities, they don't have to farm out these tough prostates. They don't have to send it to the university to get a simple prostatectomy or a enucleation. They keep it in their practice, and by having the skills to do Aquablation, they're able to do a much wider swath of patients presenting to them. I think that's a key point.
This is a fairly small group of patients, right?
Right. Right.
Even then, we've seen evolution. Historically, we've done a fair number of simple prostatectomies. We have a partner of mine who does very large huge glands with HoLEPs. There is an evolution. I mean, those have gotten less and less. I think last year we did two simple prostatectomies. He did 400- and 500-gram HoLEP. As again, this becomes more the common thing, we'll push those outliers as part of our treatment plan. The vast majority of guys are less than 180-200 grams. I mean, overwhelmingly.
Thanks so much.
Great. We're gonna close. I'm just in closing. I want to thank the three physicians that joined our panel. Really appreciate it. Insightful and helpful. Thank you for coming. To all investors, audience, really appreciate you coming. I hope you were able to learn a little bit more about PROCEPT and the trajectory of Aquablation. The management team and our employees are super excited about our future and what we heard here today. We encourage you to come visit our booth at AUA. We have a lot of exciting things going on. Just again, thank you for your participation and support. Thanks everybody.
Sorry, Bart. You can go.
I didn't-