PROCEPT BioRobotics Corporation (PRCT) Earnings Call Transcript & Summary

May 13, 2022

NASDAQ US Health Care Health Care Equipment and Supplies conference_presentation 82 min

Earnings Call Speaker Segments

Reza Zadno

executive
#1

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 and 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 our population, 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 #1 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 10 years. More color on that population, 12 million of those men are actively managed for BPH. 4.3 million are watchful waiter, 6.7 million are on pharmaceutical, 1.1 million have failed to medication. And in 2019, 400,000 of them had looked for some intervention. This is a massive opportunity, a very large market. The technology our population from PROCEPT integrates image guidance, customized treatment planning, consistent robotic surgery and during resection, it doesn't use heat and the combination of these features allow this technology to be used on small prostate as well as very large prostate and everything in between in 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 publications. 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, understood market and the customer base is well defined, that has allowed us to have a very efficient commercial organization. With that introduction, I'm going to let Barry talk about the clinical results. Thank you.

Barry Templin

executive
#2

Thank you, Reza. Good morning. So I'm going to briefly go over our clinical data and some of this will be mentioned that's going to be shown this weekend here at AUA. So first as a backdrop, which is what is the clinical unmet need that we've embarked on with the technology to try to solve. So first, you have to understand prostates come in various sizes and shapes. You can see here depicted by our fruit slide. That could be as small as 30 ml or 40 ml in range in excess of 150 ml. Currently, there are 2 broad categories of treatment options. First is a resective option, meaning that the removing obstructive tissue at the time of the procedure, most notably known as the TURP procedure. It's been around for nearly 100 years, PVP, Enucleation and Simple. And 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 in continence. The other primary category is the non-resective category. And again, limited primarily by size, typically up to 80 ml or 100 ml in prostate size. They have a very strong safety profile. However, they don't have the same efficacy outcomes as the resected category. So 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 in non-resective-like safety outcomes? So the clinical evidence that we've built behind Aquablation is driven by 3 primary clinical studies. The WATER study was a randomized study and prostates up to 80 ml against the TURP control arm. We showed superiority and safety. We also showed superiority and symptom relief and prostates larger than 50. We conducted a second FDA study. This was a single-arm study in prostates ranging from 80 ml to 150 ml. So this is the larger category. And again, demonstrated similar clinical outcomes as we saw in the smaller prostates of less than 80. And lastly, we ran an all-comers study called OPEN WATER, more complex patient set, broad range of sizes 20 ml 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. So when you look at the safety profile, again, this table shows the prostate side, the average prostate sizes treated, the percentage of obstructive median lobes. You can see as it increases as prostate size increase. And 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 of the patients started roughly in a 20 to 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 5-year data from the WATER study, which is the teal line and the red line represents the TURP arm. And then this weekend, we'll be releasing our 4-year WATER II study, which is the large prostate study. Again, very consistent results, as you can see, are maintained out through 5 years. Going on to durability of the treatment, meaning men who don't have to undergo another surgical or an intervention for lots 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 Rezum 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, and you can see we're at 9%, and we've only reported 4-year data, which will be shown this weekend. 5-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, rectal 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. And lastly, I'll conclude with the 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, so 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 up to 150 grams and our surgeon advisers here can further comment on this when they get into their presentation. So at this point, I will turn it over to Kevin for the financial review. Kevin?

Kevin Waters

executive
#3

Great. Thanks, Barry, and good morning to everyone, both live and on the web. I have quickly 2 slides just to go over our financial performance in the first quarter and a couple of comments on our fiscal 2022 guidance. You could see here in the first quarter, we produced revenue of $14.2 million, $12.6 million of that is in the U.S. 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 3 quarters at $350,000. And 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, 3 and 4 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 U.S. You'll see here our accounts of the U.S. on average perform about 5.6 procedures per month. And 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 in our earnings call last week. We raised our revenue guidance. Previously, we're at $54 million to $58 million. We have raised this guidance to now $58 million to $62 million. This does represent 80% year-over-year growth at the high end of our guidance. And again, while not on this 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, so 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% to 49%. And 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 going to turn it over to Sham here to go through a few of the commercial metrics before we get to the surgeons. Thank you.

Sham Shiblaq

executive
#4

Good morning. So 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, BPH is a large disease states, the #1 reason that a man visits the urologists, 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 and actually perform. That means either they're on BPH drugs, they fail BPH drugs or they receive a surgical option. And it's a lot of patients to go after and a strategy standpoint. So we 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 of 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. So the reason why we made that midterm opportunity is, these are our current customers. The urologists are current customers. These patients are talking to these same surgeons every day. And so the next step would be to focus on those patients that are failing drugs or are currently on drugs. And then the long-term opportunity was also a large -- which is a large TAM of $10 billion or the 3.9 million men that are on drugs or failed drugs, but these patients are in the care of a primary care physician. And so that's a different type of execution for us to educate the community in large scale. So 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. And so 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 does more than 100 resective surgeries in a year. And 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. So as a company, we're focused on 30% of hospitals that generate 70% of resective BPH procedures. That's the immediate strategy. So 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 is -- continues to be the focus on resective surgeries, but we're hyper-focused on this -- on the prostate sizes, about 50 to 100 grams, and I'll explain the rationale behind the 50 to 100 grams and how we see the data playing out over the last 1.5 years. We believe we're the obvious choice for large prostates. But when you look at the average sized prostate, there's a bit of a misnomer that the small to average-sized prostates are easy to treat. But as Barry showed in the WATER data, the WATER data, as you recall, is 30 to 80 grams. We did a randomized trial with TURP and with Aquablation. And in both arms, the over 50% of patients had an obstructive median low. So when we think about size and shape as the decision-makers typically why a surgeon decides what therapy to choose to their patients, it's not just size, also the complexity of the anatomy. So when you have these smaller to average-sized prostates with complex anatomy, there's very few choices that are shown to be effective in treating those men. So that's what we're focused on is average-sized gland because we believe our technology can be superior in this area. And the data is proving out that way, the surgeons are actually following suit. As you can see by the histogram, the number of patients that are treated in the 60 to 80 gram category is our largest segment of patients treated and the vast majority of our procedures are between 40 and 100 grams. So 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 3 of these gentlemen who joined 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 to 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 and genetics and he uses genetics to actually help him guide and the right treatment for patients on prostate surgery as well. And 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 private practice. So with that, I'm going to pass it over to Dr. Elterman. Thank you.

Dean Elterman;University of Toronto;Urologist

attendee
#5

Thank you. Thanks, Sham. It's a pleasure to join you all today. So these are my disclosures. So I'm going to 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 4 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. So 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. So 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. So this waterjet, along with the treatment plan, will result in a very standardized outcome and operative experience. And then lastly, this is heat-free waterjet 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. And so 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. But by adding the transrectal ultrasound, and you can see, again, the prostate in multidimensions, 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. And so we can see here using the ultrasound, what prostate tissue needs to be removed, what tissue would like to preserve and allow for the planning to be individualized to each individual patient. So 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 1 denotes different median lobes. These are 4 different prostates. We want to remove a median lobe because that causes a lot of obstruction. And so we can resect the median lobe. Number 2, 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. So the contouring software allows us to preserve the bladder neck, you see that green area. And so we actually reduce the amount of power of the waterjet there and preserve the bladder neck. Number 3 is the bulk of the prostate. Those are the lateral lobes. And of course, we want to entirely resect those. And so 3 is really where the full power of the waterjet is able to ablate and remove tissue in a very precise, but also quick fashion. Number 4 is the verumontanum. This is a key area of structure where the ejaculatory ducts are. And so by us being able to both identify it, but also preserve this area, we're allowed to reduce the rates of retrograde loss of ejaculation. In resective technologies, those rates are as high as 50% to 100% essentially. With Aquablation, the numbers are essentially around 10%, and it's going down even further as we refine the technique. And lastly, number 5 is the external sphincter, of course, you want to identify and preserve this sphincter because that's what's for continence. And 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 waterjet does not go beyond where we want to treat. And so these are 4 personalized plans for 4 different men, 4 different prostates, and 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, this area may affect erections. And so 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. 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. And so 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 to their camera, you're seeing the end of the prostate, those 2 lobes and the sphincter is going to come into view and sort of close around, and then I'm going to move forward so that I know I'm for sure, in front of the sphincter. And so I conceal the ultrasound, but I can also see in real time the ability to identify critical landmarks in order to preserve continents as well as ejaculatory function. And so we're able to see very well, very carefully importing key structures to preserve continents. 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. And so 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. And so 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 waterjet 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. And by doing this, we're able to actually protect these critical areas and preserve ejaculation. And so you can see in the yellow, that's exactly what the Veru protection zone is. You program into the software, the waterjet so that it doesn't go through those key areas. So this is an example in real time where you see us only doing the left-hand side of the screen, patient is right. And then it actually will automatically when that side is done, move and to do the opposite contralateral side. And so this is all planned into the software. So at ahead of time, exactly what you're keeping and exactly what you're taking away, resulting in, of course, very low rates of ejaculatory dysfunction. And 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 have done some research looking at the images and how they correlate to outcomes. So we now have a better appreciation of how deep the waterjet needs to go to preserve ejaculation, and this has allowed for improved treatment planning and even lower rates of ejaculatory dysfunction. So being able to critically analyze the images and look at outcomes, we've actually gotten better at refining the technique. And 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. And you can see that in 2015, 2016, they were really looking at only prostates between 20 to 80 milliliters, and they use the waterjet followed by a little bit of electrocautery. And the rate of 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. And in fact, these large vascular prostates were attempted to stop leaning using a catheter, so a balloon to tamponade any bleeding. And we found higher rates of transfusion around 6%. And so there was this idea that, well, maybe that's not the best method we need to go back to doing something else. And so 2018, 2019 OPEN WATER study commercialization, larger range of prostates being done 20 all the way up to 280, a little bit of a nonspecific cautery was used, and we saw those rates go much, much lower, less than around 3%. And then there was this notion of doing something called focal bladder neck cautery, which was identifying the key areas that caused bleeding at the bladder neck and applying a just a little bit of electrocautery to ensure that significant areas do not bleed. And with the advent and adoption of focal bladder neck cautery, both in commercial -- 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. And so in 2,000 consecutive cases, we've been able to identify this optimal method and it's actually gotten better. And we're doing even bigger prostates all the way up to 500 gram like monster prostates. And so hemostasis just really isn't an issue because the technique is really being refined. And now I'll hand it over to Dr. Helfand.

Brian Helfand;NorthShore University;Urology Specialist

attendee
#6

Thank you. So good morning, and thank you guys for coming this morning. Again, here are my disclosures. So I think, as Sham previously mentioned, I have a relatively unique role within my hospital system and that I have a large interest in genetics, which kind of trusted me into the role of Head of Personalized Medicine. And as such, many years ago, had to come up with an algorithm for the treatment of BPH that really was designed to get the right treatment for the right patient. And certainly, if you guys are familiar with the marketplace right now, there are many different technologies that are out there. And 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. And then certainly, the WATER studies came out and started to work with PROCEPT and say, hey, maybe that there is an 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, our personalized surgical planning for that treatment, which really can answer all those patient needs. And so again, it's been compared to an iPhone. So before the iPhone, you had the actual phone that called patients, you had a separate camera, you had a calendar. And certainly, the iPhone came up and were like, why would you need that? And now it's one device and it's considered standard. And 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. And 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. So for patients who are concerned with sexual function. And when we talk about sexual function, as you hear, we are 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. We -- most goals, we want to get them off of their medications. The medication compliance is very low anyways. But if they're on it, they really want to 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. So if we can speed that up, that kind of helps. And certainly, no man or woman for that matter, really enjoys having a catheter in, so the shorter duration, we can have that. And certainly, why we're doing this is we want to ultimately improve their urinary symptoms. And really, when we talk about that, this technology meets all of that. And that really captures almost every single patient that we see in the office. I think Dean just referred to the evolution of the PROCEPT technology And certainly, when you saw that this was initially a concern that there was a higher bleeding rate. And 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% to 0.8%. So with that and certainly with the coincidence of COVID, there was a question is can we do this as an outpatient procedure? Because at that time, we were not allowed to admit patients in the hospital. And my thought there was, 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. And so during COVID, we really started a protocol, which is now quite established. And the large patients of our -- or large population percentage will actually choose to go home that same day. And so 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. And certainly, this is the initial experience. This has been now expanded to almost triple these numbers. But really, 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 100-plus gram prostates that I can do this too. So this is really a forward part of this technology that we can do this as an outpatient. And with this, I will pass this on to Dr. Desai.

Pratik Desai;Potomac Urology;Urologist

attendee
#7

Thank you for having me. So I'm offering a slightly different perspective than my 2 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 urologists. We see a lot of large prostates, man who come in with voiding dysfunction. And so 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. So when we look at what we've done historically, we've -- as people have said, it's been essentially a resective treatment of BPH. And in the last decade, there has been an explosion of less invasive, less dangerous and less more bit of treatment options available to our patients. And what we've seen in private practice is this group of patients were undermanaged with medication and that when they progressed, they were reluctant to have any treatments done because of the morbidity associated with that. So 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're treated personally, they have options in radiation, surgery, et cetera. And 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 want to be on medication, there are non-resective options that are done outside the OR. But in a significant percentage of those patients that want resective options, we stratify them to have them offer both office space, minimally invasive options as well as resective, more permanent options depending on their disease progression and what their appetite for treatment is. And so 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 lows for resective techniques versus small glands with non-median lows for non-resective techniques. And we've seen a tremendous increase in the number of our resective options. As far as symptoms go, we want to identify these patients earlier. We were obviously starting with medication, they have AUA symptom scores. All of the patients received the standard work up 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, clearly, there is a genetic component to BPH. And several of these patients have a history where they know their fathers, brothers, et cetera, have had treatments for the enlarged prostate. So we have the standard work up after the identification that involves a cystoscopy, a transrectal ultrasound and some sort of pressure flow study, whether it's a noninvasive pressure flow study in some cases and been with retention, a TRUS Urodynamic study. And we do this across the board for all surgeons, whether they are Aquablation surgeons or not. And what we've seen is that beyond just discussing medications and treatment options, we're navigating those patients to experts in these treatment plans. So 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. And as this field expands, what we're seeing is our resective opportunities to treat patients in a more appropriate manner has been increasing. So 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 2 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 to 70 patients based on OR time. So 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, collabs, et cetera. But our experience has been tremendous with this technique form multiple things. I mean, it's standardization. So we have OR times that are reproducible. We have days where instead of just doing 5 cases a month, we're doing 7 to 8 cases in a day. And we're able to stay on time, have the OR allow us to book that next day with 7 to 8 cases. We're able to get about half to 2/3 of our patients out the same day depending on the size of the gland, whether they were on anticoagulation or not, et cetera. And so 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.

Unknown Analyst

analyst
#8

Thank you. On the behalf of the surgeons, I'm going to moderate [indiscernible] process all the question. So everybody can hear us watching us via web and then we will [indiscernible] so on the 5-year data [indiscernible] your thoughts on why they've been the way they are and then real world [indiscernible] potentially they could improve or how do you see that right now?

Dean Elterman;University of Toronto;Urologist

attendee
#9

So they are 100% reflective of real-world experience. And 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 is that these great TURP resection is really thought they were doing a great job. And all we did was put an ultrasound in at the end of the procedure. And they actually did not do a great of a resection as they actually initially thought. So I think that the visual images actually confirm that you are actually doing what you think you are. And certainly, that leads to increased durability. One of the other things that's reflective, you brought up Rezum and the retreatment rates is that a lot of that is actually the recovery experience, okay? And you have really one chance to get this right for most patients. So patients are miserable. They always think that there's going to 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 same medicines being used. They're very comfortable, and they see immediate kind of improvements as reflected in the data in their symptoms. So they're not looking for that retreatment, they're not looking for kind of issues there. So I do think that the experience in itself in that perioperative period leads to decreased retreatments as well.

Brian Helfand;NorthShore University;Urology Specialist

attendee
#10

I'll add that, that 6% at 5 years is excellent far better than any other surgical medical therapy combination, right. So if you look at Rezum, it's going to be like 15%, UroLift is like 30%, probably maybe 50%. And the other thing is, 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've never done a single case, but they've been doing TURPs for 10, 20, 30 years. And you were able to see a group of novices get equivalent and better outcomes than the standard of care that they're really good at doing. And so to your point, that it's going to actually get better, I would agree. When I first did my first case is in the WATER II study, I was included, I've never done a single case. And those patients are now 4 years out, and they're still doing great. And with more experience, I've gotten better and my patients will do better. So I actually think that these numbers are excellent, and I would anticipate even real world, they will remain very, very low.

Dean Elterman;University of Toronto;Urologist

attendee
#11

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 the GreenLights and the UroLifts, the market leaders essentially in BPH are not nearly as personal and the differences in shape and volume of prostates.

Unknown Analyst

analyst
#12

A quick follow-up. Just on the same question, but for the adverse event rates in terms of sexual dysfunction, urinary continence should come -- 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 integrated ejaculation rate.

Dean Elterman;University of Toronto;Urologist

attendee
#13

Yes. I mean, I think, first of all, the current functional outcomes are excellent. So regardless of where the prostates are bigger than 100 or lower than 100 grams, whether they have a middle or they don't, you have a reproducible outcome resulting in very low erection, ejaculation and incontinence rates, things that matter to men, right? And what's really needed is you're able to do playbacks. You can look at your case, companies can look at cases and we can examine what techniques, what ways of contouring are going to result in different outcomes. And so I anticipate that those ejaculation rates, which are really good for a receptive technology. Remember, compared to like 50% to 100% loss down to 10%. That's going to drop down. I think it's probably 8%, and it's going to get down to 5.3%. And that's going head-to-head with non-receptive 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.

Brian Helfand;NorthShore University;Urology Specialist

attendee
#14

I mean, I wholeheartedly agree with that. I mean, again, I think reflected on the fact that most of the real-world data has really started with novices. And so in the worst-case scenario, we're talking about 10 to 15 kind of percent ejaculatory dysfunction rates, which is crushes anything that's currently out there. And I think that's only going to get better with better experience and improved experience. And the other part about that is when you look at really, again, the prostate size of shapes, the different morphologies that are out there, typically, we have the biggest problems historically with the largest prostates, retreatment rate sexual dysfunction, et cetera. And again, this is just so different. But even in the novice hands really makes it so easy to do and preserve all those things that matter.

Pratik Desai;Potomac Urology;Urologist

attendee
#15

It's interesting because even medication-based therapies, it shouldn't be overlooked to have this ejaculatory dysfunction. And so a lot of these men have had adverse events from medication, and that's one of the reasons why they're pursuing something more. This is going to get better. This is a tremendous improvement in what we've offered from a whole up, which has close to 100% or a simple prostatectomy has 100% for these guys who have 80-plus gram glands, they were resigned to ejaculatory dysfunction. That's not the case. And 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 it's not versus the likelihood that it's going to happen and their reluctance to then do a medically needed procedure diminishes.

Unknown Analyst

analyst
#16

Sorry. One last question. Just on -- I think I heard today that within the water studies or maybe one of the water studies that 50% of the patients had median lobe involvement. And just wanted to understand better why other -- the non-resective approaches may be vulnerable in terms of not having great outcomes when there was median lobe involvement. And -- what are you in your practice for the, I guess, normal, not normal size, but the 60 to 80 middle range or even higher, even lower, patients that have median lobe involvement is Aquablation therapy, the right choice for these patients.

Brian Helfand;NorthShore University;Urology Specialist

attendee
#17

Yes. So median lobes are my favorite because those are the patients that -- most of the time, when you have a median lobe are really going to cause your obstructive symptoms. So we extreme, they can't empty their bladder completely, et cetera. And so getting rid of that and sometimes almost just that alone can actually really improve that patient's quality of life in 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 orifice is where the kidneys kind of plug in or the rectum below. So Aquablation is really designed not only to get rid of that tissue, open that up nicely, but there's really 0 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.

Craig Bijou

analyst
#18

Craig Bijou from Bank of America. Thanks again for doing the panel, everyone. I want to talk about patient selection. Obviously, you guys -- it seems quickly evolved your algorithms to have Aquablation as a significant portion of your resective procedures at least. But maybe just talk about how quickly you kind of came to that conclusion. I'm sure you guys as kind of the KOLs for Aquablation, get the question from your colleagues all the time. And maybe just talk about your own experience and then kind of what the feedback or questions you're getting from your colleagues on Aquablation, specifically?

Pratik Desai;Potomac Urology;Urologist

attendee
#19

Yes. 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. And so 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. And what we found is that, again, tailoring this for men with median lobes, tailoring this for men who want a more permanent outcome, tailoring this for men who don't mind having a general anesthesia, et cetera, has expanded the discussion of Aquablation within our treatment algorithm. But also it's interesting now we are getting referrals for patients directly for Aquablation from their physicians who have now been patients for Aquablation. And 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. So I think that when you look at both the patient itself, themselves in talking about what options there are, that algorithm is very important, but it has to be personalized. And then when you look at the word getting out about this technology, not amongst just urologists, but in the local community because the results are immediate because the side effect profile is so good. I think there is a more of an interest even from specialties outside of urology for this technology.

Dean Elterman;University of Toronto;Urologist

attendee
#20

I think that histogram that Sham showed is really telling because you would think that 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 if I can't do a TURP or I can't do a UroLift, I'm going to do Aquablation. You can see this migration where now the majority of these cases are 40 to 100 gram prostates. The average TURP in the United States is probably like 50 grams. So it's really filling in to do every prostate that sort of comes in the door. And I think that as surgeons adopt it, they realize very quickly, it's not just for these patients. It's actually going to be for essentially all my patients.

Brian Helfand;NorthShore University;Urology Specialist

attendee
#21

And I would say is, again, I think data is always great to go behind it. And so our hospital system is a very large system. There's 9 hospitals in the system. And the interesting thing is I keep track of patients and new patients who are coming in from outside of the system as a marker for growth. And so specifically, in the area of BPH, there has been an influx of patients coming in specifically for Aquablation over the past 3 years. That is very [ tell-tale-ings ] saying, "Hey, there's something here and people even from outside this large entrapment area are coming in. And 2 is that we have a very large medical group of urologists, but we also have many private urologists that participate and operate in the system. And the adoption of Aquablation for their patients is 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. And I use that as a positive signal because again, I didn't bring this in with any kind of real intention [ of that to say ], "Hey, let's try this out and see how it works in the personalized medicine space. But seeing the growth of every other urologists who treats BPH really emphasizes the universality of this procedure.

Craig Bijou

analyst
#22

Great. Maybe following up on that. I mean is there -- are there a group of patients that you wouldn't do Aquablation on? And obviously, the transfusion rates look great, what you've seen. But is there a sub-segment of patients that you don't think Aquablation would be a good procedure for?

Brian Helfand;NorthShore University;Urology Specialist

attendee
#23

There's 2 patient segments that at least in my practice, I've seen is that those patients who are so sick, they can't understand any kind of -- with standard kind of general anesthetic and 2 of 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 kind of [ contra ], but that's a very small segment of that population.

Dean Elterman;University of Toronto;Urologist

attendee
#24

Those are patient factors. They're really not prostate factors, right? And so much of the decision-making of all these modalities is really dependent on prostate factors.

Craig Bijou

analyst
#25

One other one. Just obviously, drug dropout or even just drug use or medication use for prostates is obviously the first line of treatment. But what are you guys seeing in terms of when you bring an intervention to a patient? Is Aquablation bringing that earlier? Are you deciding to choose an innovation, intervention earlier for you? Or are patients actually because of how you present Aquablation, are they more willing or to do it faster than they normally would?

Brian Helfand;NorthShore University;Urology Specialist

attendee
#26

So very, I guess, sensitive subject in any ways kind of close to what I believe in is that sometimes, even though the algorithms are all suggestive because we always want to start off minimally invasive. They're just not suffice. And when you look at the real-world data, 60% of them will not be compliant with their medications within 1 year that's astonishing. And then those -- a lot of those men say, "Well, this is just the way it's supposed to be. So 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 going to get patients on the right track. So certainly -- and I'd 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, we want to be more aggressive there.

Pratik Desai;Potomac Urology;Urologist

attendee
#27

We've seen a huge increase in that. And 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. And that has been eye-opening because we used to have patients on medication for a long time and that thought was when you fail medications, we'll do a surgery. But having that barrier of failure really undertreat maybe 30% of men who are under -- that are not happy with their symptoms, but they're not in retention, they're not having incontinence. Their objective measures of failure, maybe not what we want to strive to treat.

Unknown Analyst

analyst
#28

I've heard Dr. Desai about your robust waiting list. I was just wondering if -- it sounds like there's patients the doctor have health that 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 and Aquablation procedure because what they learned online or from any marketing that the company has done.

Pratik Desai;Potomac Urology;Urologist

attendee
#29

So we've had a few of these transitions. Initially, it was insurance coverage, right? So we have a treatment option, not covered by insurance, a patient would want to wait to have something done, see if it's going to get covered in the near future. And so there were patients on sort of a waiting list for that. But with COVID, the availability in our ore just plummeted. And much like what Dr. Helfand said that we have about, again, 2/3 of our patients now outpatient because of that reason. And that opened up a lot of availability. But now what we're finding is we're still dealing with nursing shortages, we have still OR time issues, et cetera. And so it is something that we're working very carefully for, 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. So 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. And working with the system, we're doing a lot more per day than we did before, and that's driving it down. But 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-plus patients.

Brian Helfand;NorthShore University;Urology Specialist

attendee
#30

Similar experience. It was exciting, I suppose, to see that initially, patients were paying out a pocket for this, which I was feel bad 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 kind of the flood gates. Our average waiting list is really between 2 to 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. And certainly, it's not like these patients are staying in the hospital or anything like that. But on the other hand, is even with these innovations, it's still a backup in terms of procedures.

Dean Elterman;University of Toronto;Urologist

attendee
#31

I'll just comment on patient awareness, different country health care system. But I will say that uniquely to Aquablation, I get people from West Coast, British Columbia all the way to East Coast and everywhere in between. And 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 watch TURPs. He's watch Greenlights. He knows exactly what's up. And he's like, "I want to go to get an Aquablation." And so 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 his property. So I've experienced that, and I've heard it across the states as well.

Pratik Desai;Potomac Urology;Urologist

attendee
#32

So I mean, the market is growing fast enough that we do cover more than 1 hospital. We're approaching our second and third hospitals for purchase of the robot for availability.

Craig Bijou

analyst
#33

Maybe if I can ask on kind of following up on the same-day procedure. Dr. Desai, I think you were at 50% to 2/3, a little bit less than Dr. Helfand, who's 85%, 90%. So just the considerations, and I mean, Dr. Desai, how does that move towards a much higher percentage. It seems like it is evolving that way, but -- and maybe patient selection is also a part of that, but just love the year.

Pratik Desai;Potomac Urology;Urologist

attendee
#34

Yes. 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 are some patients that want to stay in the hospital. And as some of the availability of hospital rooms and admissions changes, there are some patients now let's say I want to stay overnight. From a safety perspective, the robust bleeding that you would expect to see that would be dangerous to prevent this from being an ambulatory procedure is very, very slight. I mean it's -- I think, one of these procedures where, yes, you could go home and at the worst situation have a [indiscernible] catheter, have to come to the ER, it's very different than, say, going home and then returning emergently to the OR. That's not what we're seeing. And so that gives you a lot of leeway to offer this to the patient as motivated. You do teaching for 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. And in a motivated patient, we've had no issues with that. So I think that what's interesting is a lot of what drives and prevents things from being an ambulatory setting or outpatient completed 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.

Brian Helfand;NorthShore University;Urology Specialist

attendee
#35

Yes. I mean I think the difference is also potentially related to populations. I live in a very kind of higher maintenance, if you will, population on the north side of Chicago. And even despite the fact that safety and is saying, hey, pre-operating expectations, a lot of men, and I'll even say they're significant others say, "Hey, just stay in the hospital. I can't really get around that. It's not wrong, but 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. There's only so much -- again, we're doing this as a quality of life procedure. So we don't want to disrupt that quality of life in that process.

Unknown Analyst

analyst
#36

One more round. Just saw some data today about -- on at least Rezum on larger prostates, and it seemed to be -- it was interesting, but I think it was 50% of patients stayed on medical therapy. And -- but I just wanted to better understand non-resective use in larger prostates and the efficacy that the urology community believes that those interventions have and just the frequency of using non-resective and prostates over 80 milliliters.

Pratik Desai;Potomac Urology;Urologist

attendee
#37

We used a substantial amount of UroLift, a substantial amount of Rezum in our practice. But 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 10, 12 treatments with Rezum. These guys have a protracted recovery course, often with catheters, dysuria, urgency frequency, retention, et cetera, that we just don't see with Aquablation. So in patients that have a contraindication to general anesthesia perhaps, I could see why that is. But most people, we counsel them that while this may be more involved with general anesthesia and operating them upfront, the recovery process is very different in these larger brands. The retreatment rate for those patients that you're trying to do the Rezums, the UroLifts at the upper limit of what the norm is, I would say, or the averages is very high. And the satisfaction is not the same as a 30-gram land that has no median lobe. And so when we offer all of these things, like I said, in multi-disciplinary fashion, we obviously have patients that would prefer a non-operative technique if they're appropriate. But 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.

Dean Elterman;University of Toronto;Urologist

attendee
#38

But much of that [indiscernible] speak to it. So first of all, UroLift has absolute issues because the actual length of the implant, that -- the suture is not going to reach the capsule of very large plans. So it's really not practical for anything really over sort of between 80 to 100 grams. It just won't work mechanistically, okay? And then, of course, you're going to have to be putting in many of these implants, which has its own issues in terms of is it going to be efficacious? Is it really practical to put in 14 UroLift implants. You're going to certainly maybe start to lose money, the reimbursement. So that's UroLift. Rezum is interesting. I mean, first of all, the on-label indication is 30% to 80%. I think that it can work in larger glands. However, as we said, catheter is going to be in for much longer, much rockier period of time. It's nice that it ablates tissue. But remember, that tissue has to go somewhere, has to necrose and there can be issues with that necrotic tissue getting stuck in the prostate or having to sluff out or get obstructed. And so I don't think Rezum is great for everybody, and there are issues around it. And then I think there's just less predictability. Just where the steam goes, who knows? It's funny. I do any number of things. But when it comes to like it was my dad or no, I'm being honest now. I treated the parents of my friends. And they said, well, what do you want to do? And then it's like personal, right? And when it becomes personal, I do Aquablation, because I know that I'm going to get a result that I can see, I can visualize, it's reproducible. I know exactly what is going to happen in the operating room. I know exactly what's going to happen to them postoperatively their course, and I know what their outcome is going to be reliably every time. And I do hundreds of Rezum cases. But when it comes to someone who's like family to me, I pick Aquablation as an anecdote.

Unknown Analyst

analyst
#39

Do you mind just talking a little bit more granularly about the catheterization rate of Aquablation versus Rezum versus other resective procedures and also the discharge protocols, like what percent go home same day with these other resective procedures?

Brian Helfand;NorthShore University;Urology Specialist

attendee
#40

And so when you look at catheter rates, and again, there's going to be some variability across the board and certainly talking to urologists across the country based on the type of procedure, you're going to get slight differences. But in general, Rezum is going to be a lot longer catheter anywhere 3 to 5 days, again, based on that surgeon and patient 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 in drilling 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. The experience or patient recovery is also very different across the board. And again, a lot of that has to do with the type of energy utilized to ablate that tissue. So you get varying degrees of really kind of dysuria pain. You get varying degrees of irritative symptoms, I got to go to bathroom, I got to go now urgency, frequency, et cetera. And different degrees of hematuria. And 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. So 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. So 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 avoid. And so to deal with that, we really give him Advil. So that's the whole key to this operation is Advil, really 2 weeks scheduled, 2 tablets in the morning, 2 tablets before they go to sleep, that really covers 98% of patients. The need for re-catheterization meaning, hey, we did the procedure. There may be some type of prosthetic swelling or edema that really kind of constricts that passes that you just opened up temporarily. And so we would have to put a catheter back in just so you can avoid until that swelling goes down. He's 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. So again, we try to take out the cat, the next day. It's a little disappointing when patients come in and say, "I just have this procedure. You're going to put a catheter back and now I'm awake when this happens, not so pleasant. So 20% in that way is kind of unacceptable, if you will. Certainly, there's a higher risk as well for Rezum. We've had a lot of kind of failures, if you will, of de-catheterizing just because, again, there's so much slough tissue as well as edema, inflammation, et cetera. We need to re-catheterize those patients. I think really a lot of that from a practical standpoint has really motivated a lot of the urologists. I can do this procedure, it opens it up. I'm not getting those calls. I love it.

Pratik Desai;Potomac Urology;Urologist

attendee
#41

Yes. It's interesting. The purpose of the catheter, all these procedures are somewhat different. And the Rezum, it's because if you didn't have the catheter, they would be in retention. And most of the resective techniques, the purpose of the catheter is to prevent bleeding blood clots, clot retention. And so that's a relatively perioperative phase. And so that catheterization, you can tell reliably you're going to get this out within 24 hours. Again, minimal dysuria, but your expected outcome is almost immediate. And that's something that's been striking with this and is from a physician very comforting to tell the patient, they're going to see that difference within the perioperative period, not 3 weeks out, not 4 weeks out, not 8 weeks out. And it's interesting the difference is so striking more than any other resective technique that I've seen is 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. So 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 going to have that outcome in a very short period of time. And their postoperative expectations are going to be met sooner than some of these other techniques.

Unknown Analyst

analyst
#42

So when urologists adopt the procedure, do they intend to shift most of their BPH procedure to this relatively quickly, i.e., do they look at it as standard of care?

Brian Helfand;NorthShore University;Urology Specialist

attendee
#43

We've seen in real time that shift. And just looking at the benchmarking by just the number and types of cases that are being done. And we know that it's not -- it's hard, especially if you start looking at a lot of the private practice groups that are in our system kind of know what's happening in the office. But certainly in the operating room, the type of procedures, sector procedures that are being done have all shifted.

Pratik Desai;Potomac Urology;Urologist

attendee
#44

In our practice, it's shifted drastically. And again, the only limiting factor was insurance coverage. And as that shifted, it's made it much more available.

Dean Elterman;University of Toronto;Urologist

attendee
#45

There's definitely practices that have adopted wholeheartedly to just sort of shifted. It's not just starts with one surgeon [indiscernible] plenty of cases, and then they like go over almost 100. And then it's like 5 and 10 and 20, like Atlanta is a great example of a big group where they're virtually doing everything with Aquablation.

Craig Bijou

analyst
#46

Just want to follow up, and I think you guys have talked about it a little bit, but maybe just asking more directly, what percentage of your potential patients would you consider a non-resective and Aquablation. So is there a -- I know Dr. Desai, you said there's not really much overlap. So I just want to understand kind of directly asking the question, is there an overlap between non-resective or during an Aquablation?

Brian Helfand;NorthShore University;Urology Specialist

attendee
#47

I'm so biased in this way. So 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 going to start talking really about non-resective with the exception of Rezum type of procedures. On the other hand is, when you really kind of lay out the data and you say, well, look at the actual degree of symptom improvement, why are we doing this? Again, I think the slide shown is that medications get part of the way non-resective procedures get you a little bit more than this, but a resective procedure is going to get really there. So if you have a one-shot opportunity to do this, do it right, do a complete, do a durable procedure that's going to last. So I think when you put it or laid out like that, most patients can, I'm not saying we convinced, because I think it's the right thing to do of a more invasive procedure. But again, individual preference there may sometimes in a very small percentage of my personal practice, leads you to a non-resective-type procedure.

Pratik Desai;Potomac Urology;Urologist

attendee
#48

This is a quality of life issue, right? So 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 want to go to the hospital. And even though you say, look, the durability of this may be limited 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 treatment. And I bet that drives a lot of the [ Rezums ], right?

Dean Elterman;University of Toronto;Urologist

attendee
#49

Yes. I mean unless some patients previously [ noted that they ] want something. And I think that's actually the minority. And those people [ like a blood pump ] takes me what are my options? And it's interesting, I've seen a very interesting evolution where previously, I would have a council patients. I'd say you have an option of Greenlight, Rezum, UroLift, PAE, and all these things. And they have to take time. Can I get back to you? Can I research it? I'll talk you in 2 weeks. Soon as I've introduced Aquablation into this discussion, they always pick Aquablation. So when you empower patients, its -- ultimately it's a shared decision-making process, and you need to empower them to educate them so they make their own decision. But 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. And when you add an Aquablation, they no longer have to grapple with what trade-off am I going to be willing to take. And so they pick Aquablation.

Unknown Analyst

analyst
#50

Quick one. Just when -- 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 wanting -- I was surprised, I'm sorry, it was the wrong slide. And just a follow-up, just, I mean, how big are you guys going today? And I mean, are you -- did you see Aquablation encroaching on kind of those prostatectomy cases as well?

Brian Helfand;NorthShore University;Urology Specialist

attendee
#51

Yes. I mean I think even a robotic simple prostatectomy, would have been really challenging with the size. So the -- if you can envision the prostate itself extended to the level of the belly button. So, so much so that when -- if you did an ultrasound to look at a residual volume in that patient, they were coming up with about 35 milliliters. And 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 a leader in half that was sitting in as bladder because he couldn't pay. And so 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 want to go into if you didn't have to robotically. And I said, 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. And then 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 4 passes done. It was under 20 minutes in that kind of portion of the case. We -- ultimately, he is voiding spontaneously now. He has a low residual volume for him, which is really less than 200 millimeters down from 1.5 liter already. We call that a total success. His overall happiness is ecstatic. He comes and think he's like the world's champion into our clinic. He knows everyone. But it really has shown that this can handle the monsters and has convinced me but many other people that it should be done for those [ usual guys ] as well.

Dean Elterman;University of Toronto;Urologist

attendee
#52

[indiscernible] skill limitations like I can't do a robotic prostatectomy, because that's just not in my skill set. I don't have that. But 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 in a nucleation. 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. So I think that's a key point.

Pratik Desai;Potomac Urology;Urologist

attendee
#53

So this is a fairly small group of patients, right. Even then, we've seen an evolution. We do -- historically, we've done a fair number of simple prostatectomies. We have a partner of mine who does very large glands with HoLEPs. And there is an evolution. I mean that's gotten -- those have gotten less and less. I think last year, we did 2 simple prostatectomies. He did 400 or 500 gram HoLEP. As -- again, this becomes more the common thing. We'll push those outliers as part of our treatment plan, but the vast majority of guys are less than 180, 200 HoLEPs. I mean, overwhelming.

Kevin Waters

executive
#54

Great. So [ we're going to closing -- we've been ] closing. I want to thank 3 physicians who joined our panel, I really appreciate it, insightful and helpful. Thank you for coming. To all investors and audience, I 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. And we encourage you to come visit our booth at AUA. We have a lot of exciting things going on. And just again, thank you for your participation and support. Thanks, everybody.

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