Teleflex Incorporated (TFX) Earnings Call Transcript & Summary

My name is Matt Ashley, Associate Medical Director at Teleflex Interventional Urology and a practicing urologist in Bend, Oregon. I'm excited to bring the urologic community together today to discuss BPH care, the current procedural landscape and how we are harnessing large health care databases to better inform our patients as they navigate their BPH journey. Sharing the stage with me today will be Dr. Steven Kaplan, Professor of Urology at Mount Sinai School of Medicine and Director of the Mount Sinai Men's Wellness Program. He's an internationally renowned authority and thought leader in all aspects of BPH with over 1,000 publications to his name, including numerous landmark studies within the field. I will also be joined by Dr. Raj Shinghal, the Chairman of Urology at Palo Alto Medical Foundation. He completed his residency at Standard University, where he has also served his teaching faculty. Raj practices general urology with a focus on BPH and stone disease and has participated in several clinical trials for novel BPH and stone treatments along with his leading research and large health care databases. BPH is a complex disease, and we continue to uncover new facets. It's not just dealing with prostate obstruction, but the consequences that has on the bladder the role of the nervous system, the impact of numerous other medical conditions and patient behaviors that ultimately manifest themselves as the patient's lower urinary tract symptoms. However, even with all this new understanding of the disease complexity, we are still generally using a very narrow definition of success. And what's more, we'll see how that narrow definition tends to poorly fit our patients' goals and expectations. We all strive to deliver on our patient's goals, but we first need to ask ourselves how well do we understand what they actually want. The slide in front of you shows 2 separate studies that were done, one among patients and one of the physicians. On the left side, you see a study of 1,000 men with symptomatic BPH who were considering treatment and were asked to list their top priorities in BPH treatment. You can see their top 4 answers here included minimal downtime, minimal discomfort, no catheter and preservation of sexual function. A very similar study was done among 200 urologists who were asked to list their top priorities when offering BPH treatment. Their top 4 responses were durability, improvement of flow rate and emptying, improved irritative symptoms and minimize variability in outcomes. So you can see here that in both of these surveys, the top 4 outcomes have no crossover whatsoever. So with that, the next question for us to ask ourselves is where does this disparity come from in patient and physician goals? Much of it comes from the way that BPH surgery has been developed. And the fact that for decades, there was really just one transurethral option. It's understandable that our goals and priorities would be set with that one procedure in mind. However, now that treatment options have expanded significantly, we have not seen the expansion in understanding patient priorities and goals that one would expect with the increased options. We now have the technology to deliver patient-centered treatment. We just need to start offering it. In this new BPH landscape, where we have the opportunity to present diverse options for BPH treatment, you can see an expanded list of the men's health survey on the left. So this expands on the patient's priorities that you saw on the previous slide. These are the same values with which the UroLift system was originally developed and the fundamental vision that UroLift strives to keep at the forefront of its current mission and continued innovation. We, as physicians face the challenge of balancing these priorities, along with procedural risks and all in the context of the need for bladder protection. It's a complex discussion and one that our presentations this evening will help inform. We have seen some encouraging evolution in the AUA Guidelines on BPH over the past few years with the recognition of the risks of medical treatment, the importance of discussing sexual side effects of treatment and the need for anatomical evaluation with cystoscopy and prostate sizing. However, these do not go far enough. We still have work to do in order to fully align patient and physician priorities into the new paradigm of BPH care. I'd now like to welcome our 2 speakers first, Dr. Shinghal, who will be speaking on understanding BPH treatment, device safety in the FDA's MAUDE Database; followed by Dr. Kaplan, who will be discussing retreatment rates and post procedural complications after BPH surgery, a U.S. health care claims and utilization study.

Hey. Thank you, Matt, for the introduction. And thank you, Teleflex, for this opportunity to speak to the urology community. Most importantly, thank you all for taking your own precious time to learn a little bit more about minimally invasive treatment options for BPH and their safety profile. My name is Raj Shinghal. I'm a urologist practicing in Northern California at an organization called Palo Alto Medical Foundation. I'm in clinically active practice and take care of a variety of different issues, including BPH. My talk today is going to focus on understanding BPH treatment device safety in the FDA's MAUDE database. Over the years, we've looked at minimally invasive treatments for BPH from different perspectives, one of them being safety. Safety is paramount, "do no harm," as a surgeon and as a physician. The FDA's MAUDE database as a collection of malfunctions and injuries submitted to the FDA by both mandatory as well as voluntary reporters. The database is a valuable source of real-world information regarding patient experience and device safety. Now people have used the MAUDE database in a variety of analyses, in the most recent analyses that have been published and even got some attention at the AUA. They looked at the raw number of events that were reported in the MAUDE database. Well, sure, you can do that. But if you don't understand the context of how often a particular procedure is performed, it really gives you a flawed picture. And the fundamental flaw of all these analyses is that they never accounted for the rate of complications or reports that were reported to the database. So the analysis I'm going to present today looks at the number and severity of these BPH treatment medical device reports or let's call them adverse events that are reported in MAUDE. This is the first such analysis to place these entries in the context of total procedures performed annually. To do this, we performed a search of the MAUDE database. You can log in and check the MAUDE database out if you're really board. You can use the terms UroLift, Rez?m and AquaBeam for the entries between 2019 and 2022. The entries were then adjudicated by yours truly, where we looked at event timing and severity. We then decided if these were intraoperative events and use something called the [ Gupta Scale ], which I'll review with you to adjudicate them in terms of severity. And then postoperative events were used -- were adjudicated using something called the Clavien-Dindo scale, which I'm sure you're familiar with. We eliminated any duplicate or irrelevant entries. And the unique part of this analysis was that we created a market model to understand how often these procedures were being performed using both Medicare data as well as CPT codes between the period of 2019 and 2022. The [ Gupta ] scale, which is on the left, is used for intraoperative events. Mild events are things that wouldn't cause any significant deviation from the planned procedure, perhaps a device that didn't initially work and you were able to get it to work or something like that. Moving on to a life-threatening event where a device called serious harm, let's say, laser misfiring and causing an operative fire or something like that. The Clavien-Dindo scale is, on the other hand, a classification tool used in medicine to understand postoperative complications. And I think you're well familiar with this. Again, complications can be very mild, where you had to give some Tylenol for a fever or something like that, all the way to life-threatening complications or even things that lead to patient death in Grade 4 or Grade 5. There are even sub classifications within Clavien-Dindo, but we try to keep it simple and just use grades 1 through 5. So I want to look at our market model and look at the number of procedures performed and the number of adverse events that were reported in MAUDE. Let's look at the bottom table first. This looks at how often each procedure was performed in the periods between 2019 and 2022. You can see that consistently that our UroLift system was performed 4x more often than the Rez?m procedure and 8x more often than Aquablation over the period that we analyzed. Consistently, 60,000 to 70,000 of UroLift procedures are performed annually in the United States. Aquablation did have an increase in the number of procedures from 2019 through to 2022. And I think you're probably seeing that more machines are being deployed in different areas and a whole lot of marketing around that. Now let's look at the figure in the upper right corner that looks at the number of adverse events or MDR submitted between -- in this period of time. You can see that in general, there has been a trend up in terms of the number of medical device reports. Although the UroLift numbers have stayed relatively stable, we do see a higher number of Rez?m and a higher number of Aquablation numbers overall. Let's talk a little bit about that market model that gave you those numbers you saw on the last slide. This is something that we designed and we wanted to validate it. So first of all, how did we get the numbers for the market model? For UroLift procedures, we got those from Teleflex. For Aquablation, we actually got those numbers from the PROCEPT analysts and the securities reports that are publicly available between 2020 and 2022. For the small number of procedures performed in 2019, those were imputed from a random sample of Medicare and commercial claims from Symphony Health. Rez?m was a bit more challenging, but we were able to get those numbers, again, from a U.S. Medicare and commercial claims database and be able to impute those numbers into our model. To validate this, we actually compared this to externally validated databases that have been published. Some of you may be familiar with, including [ NSQIP ], the Definitive Health database and TriNet. Now 2/3 of the BPH procedures performed in the United States are TURPs, still ends up being a popular procedure. But 1/3 of all procedures for BPH are UroLift procedures. You can see there's still a very small number of Rez?m and Aquablation procedures relative to UroLift overall. It was nice to see that the model we created really paralleled what you could see in these 3 independent databases. So let's turn to the results from our analysis. What did we find when we actually look at the rates of complications? Well, let's start with the intraoperative events, the [ Gupta ] mild moderate events. And what you can see is that UroLift outperforms Rez?m and Aquablation by an order of magnitude with only 8 events per 10,000 procedures in 2019 and 5 of events for 10,000 procedures in 2022. Aquablation, in the other hand, is quite different with 4% complication -- intraoperative complication rates in 2019 and 1% or 1 per 100 in 2022, a very different type of procedure. Let's talk a little bit about the more severe events, the Grade 3 or Grade 4 events that could occur intraoperatively. Again, we see that Aquablation performs quite differently compared to procedures like UroLift, or in this case, Rez?m. No severe or life-threatening intraoperative events were reported with UroLift or with Rez?m versus Aquablation, you can see that there were some high-grade events that did occur that potentially could be life-threatening. Now to be fair, Aquablation is a maximally invasive procedure for the prostate. This is not a minimally invasive procedure. But let's not kid ourselves, although it really sounds nice when you're using a water jet to shave out the prostate, this is still a surgical procedure that potentially can have some complications. How about postoperative events? So looking at the mild Clavien-Dindo events, using this scale, we can see that the rate of mild to moderate events for UroLift was stable over the period that we analyzed and was lower for UroLift again, compared to resume or Aquablation. The UroLift rate of events was 2 per 10,000 events from 2019 and continue that way all the way through 2022. In fact, the rate went down a little bit, which may speak to more familiarity and more expertise across the community in doing UroLift procedures. I think we just get better at it as we've continued to do UroLift procedures. Rez?m, on the other hand, you see 4 events approximately per 1,000 procedures. So an order of magnitude higher. In Aquablation as well, you're seeing about 4 events per 100 procedures initially when they weren't doing bladder neck cautery, and now 4 events per 1,000 procedures in 2022. Aquablation, in its defense, has gotten safer now that we are integrating focal bladder neck cautery, you are seeing less bleeding compared to the days when we just use traction. What about the more serious Grade 3 plus events. Again, here, we're seeing the difference between the maximally invasive procedure versus minimally invasive procedures like UroLift. 15% of the patients experienced a serious postoperative event, reoperation, hemorrhage, transfusions, things like that. Those occurred in Aquablation, 15% of the reported procedures in 2019. In 2022, again, due to advances in technique, we're seeing that, that number improved, but it's nowhere near what you're going to be seeing for something like UroLift or even Rez?m. Again, maximally invasive versus a minimally invasive procedure. So what can we learn from this analysis? When you factor in procedure volume, UroLift has the lowest rate of mild, moderate and severe complications in both the intraoperative setting as well as the postoperative setting. And I just want to emphasize how important it is to look at the rates of complications. I mentioned how the MAUDE database and analysis over the last couple of AUAs had been published and even made the late-breaking session. Those are looking at raw numbers and they threw some really flawed conclusions. If you look at things in the context of how many UroLift procedures were performed or how many Rez?m procedures were -- are performed, UroLift clearly has the best safety profile. Aquablation has improved over time, but it is a maximally invasive procedure that has more significant moderate and severe events compared to the minimally invasive procedures that we've mentioned today. I want to thank you for your time. And to continue on the theme of safety, Dr. Kaplan, who's going to go ahead and deliver his talk. Thank you very much.

Thank you to the Teleflex group and my fellow speakers to be able to have this opportunity to share some, I think, important information and an important way of looking at the way we look at various types of therapies for lower urinary tract symptoms secondary to BPH. So one of the things that patients always kind of ask us is what the retreatment rates are going to be and what the likelihood of I'm going to need something else done. And we thought it's important to be able to share real-world experiences, because ultimately, that's going to determine and really dictate the information that we actually get. So we worked together with Teleflex over the last couple of years and have presented some of the initial data and subsequent data to various meetings, the AUA, EAU. And I'm kind of very happy to share some of this data with you. It was just published in Prostate Cancer and Prostatic Diseases. And it represents, to date, the largest real-world experience with these various procedures. And again, I'm going to say this over and over again. It's important, with respect to sharing this information, with regards to expectations, because most of what we share and we're good at sharing what the patient can expect on the day of the procedure, what's going to happen probably for the first day or 2 and maybe even the first month. But long-term data is really based on registration data, and that's the best of the best. And ultimately, we kind of have all learned that what happens in the real world doesn't always reflect that. So we wanted to get a true reflection of what's actually going on in the real world and being able to present that to your patients as well. So a huge database was examined, and this represents all Medicare and commercial plans. We didn't pull out and push out. It's everybody, all comers between 2015 and 2021. So everybody got thrown into the blender as the case maybe. We looked at outpatient claims and then met them with a BPH diagnosis. And we looked at both invasive surgical procedures, and we looked at specifically TURP and GreenLight and also minimally invasive therapies, and we looked at prostatic urethral lift and water vapor thermal therapy. And these are the main ones that we actually looked at. But in addition, what we wanted to do is to make sure that -- because the potential critique of this analysis would be, well, maybe you kind of took different populations. Maybe one group was more likely to have sicker patients or different morbidities. So we did what we term hazard model risks to determine whether or not that was a factor in the data, and I'll share all this data with you shortly. So this represents, again, the largest real-world data experience with invasive surgery and minimally invasive surgery for BPH or lower urinary tract symptoms secondary to BPH. So here is the first big piece of data and this represents the rate of procedural complications through 90 days and 365 days for the 4 procedures, and 90-day and 365 days. And you can see that the cumulative 1-year rate is much higher in the Rez?m water vapor thermal therapy, then followed by GreenLight, TURP and UroLift prostatic urethral lift. And it's interesting, and as you absorb this data in terms of your own experiences, whether this kind of fits. Now one of the critiques potentially is that, well, 90-day, it may be post-procedural right away what's occurring, catheters can come in, catheters can come out, irrigating a foley catheter. Okay, that would be fine. One could argue that, that would happen probably within the first 30 days, but let's just say that for a moment that, that is true. We did 365 days. And there's no way that we can say that it was the day of the procedure and immediate complications that occur right afterwards. And that 365 days is stunning, stunning with respect to the differences between the various procedures and significantly higher in Rez?m, water vapor thermal therapy. So that's the first thing that kind of blasted out at us, is like, wow, more than I thought, higher than I thought. We also looked at the risk of enduring these procedural -- enduring procedural complications. And specifically, as I alluded to before, we did this hazard model risk ratio. To look at whether or not there were other factors that could have swayed the data in a way that biased it one way or other. In other words, was there more morbidity in one patient, whether more diabetic patients, more obese patients, more hypertensive patients, age all of that. All of that was kind of analyzed, but we wanted to make sure that we weren't biasing the data even inappropriately or inadvertently towards one or the other. And you can see here that the data pretty much stayed the same. So specifically, you can see these comparisons, and we did, in the first, you can see GreenLight versus TUR, Rez?m versus GreenLight, et cetera. So I'm going to pull out some statistically significant major data points. One, it was 23% higher in TURP versus UroLift, prostatic urethral lift. It was 33% higher for GreenLight versus prostatic urethral lift, but it was 63% higher in Rez?m, water vapor therapy versus UroLift, prostatic urethral lift. And this is kind of across the board. So no matter how we slice and dice the data, no matter how we looked at it and tried to really almost put an arm behind our back to try to see that, but not missing something in doing that, the data clearly demonstrates a significant differences between the 3 other procedures versus prostatic urethral lift. Those are the numbers, and I'll let it sit there for you to absorb it. And this was highly significant -- statistically significant. So this is real and it demonstrates that, at least with these 4 procedures, that prostatic urethral lift has a lower risk of encountering a procedural complication compared to the other 4. So what is -- one can argue, what is really the best way of retreatment. And we can have this debate over and over again because some people will say, well, if you're on a medication after a therapy, is that a retreatment? Good argument. If you have to have procedures afterwards, whether it's another catheterization, catheter irrigation, intravenous antibiotic after a procedure, anything, you could say, well, that could be part of the equation. But one thing you can't argue about is if you need something else done, another surgery. I mean, that is as clean a definition as you can do. I mean, you cannot debate that. You can't argue that. I don't think anybody would argue that. So if you look at the numbers, and this to me was also fairly stunning, is what the rates of surgical retreatments were for the first year. And remember, this is everybody is in here. We didn't pull out some, we didn't delete others. This is every patient who had Rez?m water vapor thermal therapy, GreenLight, TURP and prostatic urethral lift. And if you look at the rate of surgical retreatment, you can see that it's highest in the Rez?m water vapor thermal therapy. But look at the chart and the GreenLight. And I would bet that you would be surprised at that number. I was a little surprised. But the more you think about it, it actually maybe is not surprising in terms of what those numbers actually are. And it gives you a good table setting for how minimally invasive therapy, as a whole, should be used to be viewed. I mean, the class of minimal invasive therapies as you looked at the surgical retreatment for Rez?m water vapor thermal therapy and in UroLift, but also surgery. I mean, surgery has a pretty significant retreatment rate in the first year. And I think that's kind of important to know and maybe some folks didn't actually think about that or realize that. So I think, for me, that was kind of the stunning kind of take-home points. Now this is 5-year data. So we didn't want to just look at 1 year, but we looked at -- wanted to look at 5-year. And one of the critiques could be, well, why didn't you put it in Rez?m water vapor thermal therapy, and we specifically did it because we didn't want to bias the data against Rez?m water vapor thermal therapy because it just wasn't enough clean data for 5 years because it came out later than prostatic urethral lift, and certainly TURP and GreenLight. So we purposely did not want to bias it particularly if we couldn't be confident in the number of patients that we could actually have. And therefore, we took that out of the mix in this analysis at 5 years, not 1 year, but at 5 years because we didn't want to introduce a sampling bias. So look at the radiosurgical retreatment. So for TUR, it's about 7%; for GreenLight, about 9%; and for prostatic urethral lift, slightly higher at 11.6%. So a lot of messaging here. One is, at least when I was training, and I'm teaching, I thought that the surgical retreatment rate for TURP is about 1% per year. And you can see a lot of that is in the first year, maybe related to the need to go back in and re-TUR the patient. But you can see, in 5 years, it's about 7%. So it's a little bit higher. It's about 1.2%, 1.4% per year. GreenLight is more, again, not terribly surprising, because probably your own experiences, you may have had to do more retreatments if you've seen -- one of the operations that I do a fair amount of is in patients who have failed GreenLight prostatic vaporization. And prostatic urethral lift, a minimally invasive device, a minimally invasive procedure is not that much higher. I mean, it's only about 11%. And again, that's fairly consistent with what we've seen with the registration data. So a, that kind of gives confidence about the registration data, because if you look at the random control trials, it was 13.6%, and the real world was actually better. And maybe it has to do with more people doing it and doing more of them and there's an experience and a training. And over time, certainly, I do them differently than I did with my first, having done hundreds of these now, and I do them differently. So I learned and maybe got -- like, any other procedure, I got better at it as time went on. But those are the real numbers. And now you can tell a patient with confidence that, that's the likelihood that you're going to need something else done and particularly here with prostatic urethral lift. I think it has to be defined as we get more data in the future for Rez?m water vapor thermal therapy. And obviously, there are other things coming out like iTind and Optilume. We'll see what the real world is. But what's nice, at least here, is that at 5 years, the registration data, the published registration data and real-world data kind of lined up, so that was kind of a nice thing to see. But again, remember, the 1-year and the 5-year data and remember some of the highlights and the data that we talked about before. So what's kind of the takeaways and the take-home message is not just for you, but to be able to share with your patients as well. Within 1 year of BPH surgery, about 1 in 20 patients may require a retreatment. Whether they've receive any of the 4 procedures that were analyzed. So that's important to know. From my perspective, that, to me, is something that I think patients would accept and would find reasonable. But now you can have real data to show that. One year, the surgical retreatment rate is not statistically different between the therapies. You saw the numbers before. But nevertheless, there are some slight differences, but not statistically significant. At 5 years, the retreatment rate for prostatic urethral lift is comparable to the published registration trials. While the 5-year retreatment rates for TURP and GreenLight, I think, are a little higher than expected based on traditional teaching. And I think that's important to know as well as you put this into the armamentarium for choices. And for some technologies, as we saw here, particularly the Rez?m water vapor thermal therapy, as many as 1 in 4 may require procedural retreatment for a complication within the first year. So those are real numbers that I think will help you, not just in terms of yourself, how you align all these procedures. But for the first time, we really had -- I mean, it's not a small database. This is a everybody database. Everything is thrown into here between the assigned times. And again, we wanted to make sure that we had enough numbers to be able to make reasonable analyses, which is why we didn't look at, as I said, Rez?m water vapor thermal therapy at 5 years because we didn't have enough numbers. We didn't look at Aquablation, obviously, it wasn't around. We didn't look at [ holmium ] because it's just a number of numbers. and we wanted to have enough numbers to be able to make reasonable assessments and conclusions. So again, thank you very much for your time and listening. And I hope this data is helpful as you put this all together. And you're going to see more and more real-world data. And I think that's where, if you will, the money is, because that's what you'll be able to share with your patients and be able to use this in your own conversations as you think about what treatments you want to use in the future. And I hope you find these types of analyses, helpful to you in your practice. Again, thank you very much for your time.

Thank you, Dr. Kaplan and Dr. Shinghal for sharing your research and insights. Before we go into questions from the audience, I'd like to make a few closing remarks. These 2 studies provided fascinating insights into the postoperative experience of patients undergoing various BPH treatments. When we think about the disconnect between patients and physicians, this is where we find some of the biggest differences and priorities. I use this data routinely in my own practice when explaining various procedural options in order to empower my patients to make decisions that fit their own unique values and priorities. It's not my job to decide what is important to any given patient, but it is my responsibility to communicate the most accurate picture of risks and benefits so they can choose what's right for them, so understanding the reality of the post-op experience and complication rates in a real-world -setting is crucial to that task. In my pre-procedural discussion, I try to focus on issues that are important to the patient and we can see from the large-scale surveys that this is often speed of recovery, avoiding sexual side effects, avoiding catheters and overall level of discomfort. Of course, this is always balanced with an emphasis on preservation of bladder health and data-driven assessments of procedural retreatment rates in the context of both controlled and real-world data sets, a better recognizing our patients' concerns and providing realistic explanations of outcomes. We will move closer to bridging the gap between patient and physician priorities and move a step closer to the new paradigm in BPH care. We will now open up the presentation to questions from the audience.

Great. Well, thank you, Dr. Kaplan and Dr. Shinghal. I'd like to start with a question for Dr. Kaplan. You alluded to, as we were going through the initial parts of your data, was the surprise with some of those rates of complications and some of those rates of retreatment. And I wanted to get your opinion on where --- why the surprise? This is the real world. Why does it seem so surprising to many of us? Where do you think the discordance in our own perceptions or even in some of the pivotal studies of the modalities aside from UroLift that give us this idea that, that retreatment rates, the complications are not what they seem to be in these large real-world sets? So you can unmute yourself there.

Yes. Well, there are a couple of things. One is there's the classical teaching certainly on the surgical side, like TUR and I don't know, folks in the audience, what you were trained -- usually, it's supposed to be a 1% failure rate per year or so, and that's clearly not true, and certainly not in the first year. And the other thing is that when you do registration studies, you're doing the best of the best. So there are 2 pieces the wider disconnect. In registration studies, you get committed people who want to do this and do this well, obviously. But the other thing is, is that when you look at these analyses, it's only patients who stay in the study that are analyzed. Patients who are lost in the study, in other words, they may have had whatever therapy, they may have had a UroLift, they may have had a Rez?m, and they don't do as well as they'd like and then they go to another doctor and they have their TURP or whatever. That's not counted in the study because it's not -- these are not intent-to-treat analysis. And that's not a BPH thing. That's not a BPH technical thing. That's an FDA thing and that's just the way they mandate things. So you're getting, essentially, people who presumably were happy and stayed in the study. You don't get the patients who were lost and just threw that out, who were lost to follow up. This registration trial -- of this health care analysis, excuse me, is everybody. So if they fail -- they didn't like their Rez?m or their UroLift in a clinical trial and they went down the street to some other urologists to have their TURP, we're going to see that. So that's kind of the difference. And it's not surprising. We see this for everything. Historically, there's not a correlation between some of these things, so.

No, I think I totally agree. The benefits of this is you really see the effect of loss to follow-up in control trial. I think it's a really nice observation of that. Dr. Shinghal, the MAUDE database, so that's something that's been used more widely in other specialties. That's relatively new in urology. And we're not -- many of us are not used to kind of thinking about the actual device safety. So after going through this and seeing these results, how has that changed what -- the way that you talk to your patients in these procedures that involve devices?

Yes. Thanks for the question, Matt. It is interesting to kind of produce the MAUDE database. And again, as I mentioned, if you're bored, you can look up any device from a laser fiber for a holmium laser to any BPH-related device and see what complications are being reported both from manufacturers, but also from end users as well. The quality of the MAUDE database is it's the full bell curve. You're going to have things from social media that could put in there all the way to case reports. I think from a safety standpoint, it's something that I want to factor in my counseling. And when you look at, for instance, the Rez?m complications, you certainly do see complications even reported in MAUDE that are device failures. There's a high rate of generator failures that reported some of the higher rate of intraoperative complications. And then postoperative irritative symptoms or pain experiences that patients have reported are even in that database. For Aquablation, it was quite enlightening in that there are complications that I hadn't even thought of, rectal injuries from the transrectal ultrasound probe. There are 4 or 5 of those in the MAUDE database, too. So it is enlightening when you're looking at these different techniques and if you're integrating them, relatively new into your practice, to peruse those. That's what we tried to do with this analysis and to put it in context of the number of procedures performed. There has been some flawed analysis out there that looked at raw numbers. But when you look at it as a percentage of number of procedures performed, the UroLift procedure performs very, very well from the safety standpoint, both in intraoperative complications and then in post-operative complications.

Dr. Kaplan, we have a couple of questions here regarding the rates of early and late complications with Rez?m that just seems so much higher than many of us would have expected. Can you talk a little bit more about what those complications were? What you think was driving those numbers?

Well, at least initially, with post procedural complications, it's retention, catheterizations and cystoscopies. And part of it had to do with patients going back into retention, because there's a lot more edema and then you have to be cystoscope-d, hematuria, things like that. So those are the most common things. And one could argue that, that's tried and that's expected with the procedure. But when you're a patient, you don't want that. It may be tried and expected to a urologist, that they think it's going to happen, but it's another one for the patient to undergo them, to have catheters put in, to have -- to be cystoscope-d, so that's one aspect. But I think the cleanest -- the one that's not arguable, the one that's not debatable is needing another BPH treatment. And that to me was like, whoa. Because that -- no matter what language you speak, no matter where you come from, you're a Rez?m person, you're a UroLift person, whatever person you are, residual retreatment, everybody can define as that's a treatment value. I mean, you need something else with -- for BPH. You can't argue that. You can argue with the other stuff whatever you want to argue. But -- and I would -- from my perspective, I think sometimes we look at data and we forget there's someone at the other end of this. It's not just us reporting the data. There's a patient and the patient has to undergo this and they have to come back and get their catheters irrigated or the catheter change. They come back to the office. That's a pain in the -- in certain parts of your body. And I think we sometimes forget that, that's there's a consumer, a person at the end of this. And they're not happy. I mean, I'm not even talking about going back on medication, which is a whole different can of worms that we're going to be looking at and talking about in the future. So I think when you do a procedure and you got to do a lot of stuff afterwards, people should note that. It's only the right way to be fair with patients and to remember that. But the surgical retreatment is clean. I mean, we can't make a cleaner diagnosis of that.

No, no absolutely. I'll give you a quick follow-up that's come up in different ways from a few people here, and that's in those in -- whether it's with complication data or with retreatment, was there anything in that analysis that can tell you about predictors? And if not, is there anything in your experience that would suggest that this is a factor that's going to make someone more likely for either one of those issues?

In general, probably bigger prostates, and again, we didn't look at it. I think sometimes -- maybe very big and very small, because very small may have different reasons why they have their symptoms and very big is because it just can't treat everything. So I think that's part of it. In terms of TUR, it's an interesting question. I don't know why. Why, if you're removing tissue, because you have a higher -- now maybe for TUR, it's just bleeding. They go back and it's coded, back as another TUR when they have to coagulate, then it's a second TUR, which would be interesting to see in terms of the why. For GreenLight, it maybe bleeding and they go back and they have the TUR tissue, I guess. So there are not a lot of entry points in there. I don't know what their symptom score was. I don't know if they had big middle lobes or no middle lobes, and there are a lot of other factors. But just logically, why that would happen, you would think -- and a lot of it has to do with coding probably. But at the end of the day, code here, code there, there's a patient who has to have a rigid system still put inside of them and they're not going to be very happy about it.

Raj, we have a couple of questions about other parameters and whether they're included in the MAUDE database. These are typically -- most of the questions are relating to when you're talking about adverse events, and you're talking about, in particular, Aquablation, these are often bigger prostates. And so was there any sort of preoperative patient data in there. And whether there was or not, how do you personally talk to patients about risk when you are dealing with small versus large prostates in that treatment discussion?

Yes. Great question in the chat. And that's fair. The MAUDE database does not necessarily provide that data. Occasionally, you'll have some inklings about that, but for the most part, it's not going to provide the data regarding prostate size or IPSS or anything like that. It's primarily going to be talking about complication. In reference to something that Dr. Kaplan mentioned, for Aquablation and we can use that as a surrogate for TURP, no question that when we looked at those severe Clavien-Dindo events postoperatively, a large number of those were bleeding and/or transfusion events. No question about it. And as I mentioned, we've seen those numbers come down as there are more Aquablations being done. People are broadening the number of the size of prostates with which they do Aquablation. But most importantly, we've integrated bladder neck cautery in for Aquablation. But in fairness to the question that was in the chat, Aquablation is a procedure that's used for larger prostates. You're right. You're absolutely right. However, I do think that the way Aquablation is being put into the market to say that, oh, it's a minimally invasive procedure. I don't think that we can equate Aquablation to UroLift or even Rez?m. These are different procedures. That is an extirpative procedure that is similar to a TURP and it's going to bleed more, and the MAUDE database shows that. The severity of those complications is there. In terms of counseling, I think that's -- we're looking at efficacy. We're looking at safety for patients. There are patients who would prefer a procedure that's going to meet some of their own personal goals, and you outlined those really well. We make a lot of assumptions as an urologist that, like, I need to make the biggest possible channel. That's going to make you happy, but your ejaculation is going to be affected or you're going to have a catheter in for 2 days or you're going to have hematuria for weeks. Did I factor that in as your urologist? Maybe I didn't. And so your point about factoring in patient preferences is a really good one and something that I -- I've been in practice 21 years, I'm continuing to evolve and get a little bit better about that. Regarding large and small prostate, yes, Aquablading a 40-gram prostate doesn't make a lot of sense to me. I think a lot of the minimally invasive procedures are a much better choice. Trying to do a UroLift in a 150-gram prostate, everyone on this call is going to tell you that's really not a good idea either, and so getting the preoperative data, cystoscopy, uroflow study, a prostate ultrasound, for me, I need all that information to help counsel a patient.

Yes. I think the underlying important point in that question is that these are -- these kind of database studies, these large views of what's happening is really not saying these complications are higher, so this procedure is better or worse. It's really just, this is reality. This is what's happening, and then we can use that to help educate our patients. I think we have time for maybe 1 or 2 more. Dr. Kaplan, we have a question for you. You alluded to the evolution of your UroLift technique as the years have gone on. People want a glimpse into the current Kaplan technique. What are you doing now that's different? How have you evolved over time?

I just sing different songs, I suppose. That's what we're doing. I just want to make a quick point about the Aquablation. So we've just reviewed our own data in over 275 men. The average-sized prostate, the average-sized prostate was 106 grams. So the average-sized prostate we do is probably not the ideal candidate for a minimally invasive procedure. And I also think -- and as I've gotten older, and fortunately, I don't have symptoms, at least not yet. I don't understand using medical therapy. I mean, to me, this is where the UroLifts, the Rez?m the minimally invasive class and maybe some of the flexible cystoscopic procedures are where we should be thinking of it as opposed to delaying. I think we use medical therapy -- the patients -- and I'm sure in your own practices, you'll have 1, 2 and 3 medications for urinating problems. That's insanity. I mean, it's insanity to do that and to put them on for 5, 10 and 15 years. That's nuts. And if I needed something for urinating problem, depending on my size prostate, which I don't know, I would have some procedure. I'm not taking medications for 20 years so I urinate a little bit better. That's insanity. But to answer the technique, well, a lot of it has to do with -- we used to just do it the way you plug them in, you do whatever how many you're going to be doing. But what I've done is I kind of go into the bladder. And this is not my own technique. It was actually Peter Chan, who kind of did this. He's out in Australia. I kind of go in, start at the top and then instead of going upwards and pushing, I go from down -- from 12:00 and push that way, and I find that I can get the tissue better. It's easier to push downwards than upwards. And then I also always will put in one -- I go right at the veru, plug it in at that point because I know that I'm going to be fine because I have a distance between the veru and where the implant is going to go. So that's been the major change. I mean, this is variation, there's not much pressure and somebody is don't press too hard, there's somebody else is I'm not pressing hard enough. And that's always an issue. But just in terms of geographically, I find it going this way as opposed to going upwards, it's just an easier technique.

Yes. I think that sculpting of the anterior channel is a great way to go there. So we're coming close to the end of time here. I just wanted to thank Dr. Kaplan and Dr. Shinghal for all of their insight here. These are 2 really interesting studies. And to that, at least just speaking for myself, have really had a real impact in the way I talk to patients, getting an idea of what is really happening out there that helps us inform people and, really, the goal of letting our patients make these decisions for themselves. So we'll come to an end now. I appreciate everyone's participation. Everyone watching around the world here, these studies, some are ready for distribution, some are not quite ready. If you have questions about getting copies of them, you can always go to your urology consultant. They can help update you and get you materials when they become available. But again, I wanted to thank everyone involved. This is a really interesting evening, and we look forward to seeing you again at the next one.

Thank you, Matt.