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Steven Kaplan: My name's Steve Kaplan, and I'll give you about 15 minutes of everything you need to know about BPH, which is impossible. But I will tell you some highlights, some things that you should be at least aware of, and I'll tease you a little bit as well about some new data.

So the title is, Deobstructing Mouse Traps. These are my disclosures.

You kind of know, there's a lot of options out there. There are surgical options, minimally invasive options. The bottom line is, is that we're looking for things that are easy to do, and being on the business side as well, reimbursed well. And that's going to be part of the way some of these technologies actually look for that. Science is one thing, but money's another, and that actually drives a lot of the engine here.

In addition, we also know that patients eventually kind of wear off on medications. And I don't know how many of you are on BPH medications, but do you really want to be on a BPH medication for five years, 10 years, 15 years, 20 years? And it's kind of ironic, having been literally involved in virtually every clinical trial in BPH on medical side, I'm wondering, because now, I'm of that age, fortunately not symptomatic, would I want to be on an alpha blocker, or on a 5-ARI for the next 15 or 20 years of my life?

The other piece is, is that we don't really do a good job of defining retreatment. And the bottom line is, much of the data that I'll show you, don't believe it. And what I mean by that, it's not real world data it's regulatory data, that's as good as you're going to get. And your experiences are actually more important in terms of assessing things.

How have the guidelines changed? I've been on the guidelines panel for about 15 years. This is the major change is that, you should guide therapy by, minimally invasive therapy, certainly by prostate size, and one would argue, the presence of an intravesical lobe.

These are a lot of the therapies that are out there. You're aware of them, many of you actually do them. Aquablation is a new one, and I'll share our experience, which is now the largest experience in the world. I don't have PAE, only because on the surgical side, and we'll hear from the next speaker where that kind of fits in.

Now we talk about large prostates. Here's some data about it. In the real world how many patients actually have a large prostate? And you can see, that about anywhere from eight to 10% of men have prostates over 100 grams. And that's the sweet spot for some of the newer technologies. But where do these all fit? And everybody's trying to fit, retrofit, anti-fit, in terms of where some of these technologies fit with regard to prostate size.

This is the UroLift data. And basically just remember, that this is regulatory data. And what I mean is, these are the responders. Unlike a medical therapy, where everybody in is analyzed out on medication, with these technologies, it's only the people who are followed. What happens to the people who are not followed? Well, we'll show you some real world data and tell you the truth. It's not so much misleading. It's not the requirement by the FDA to mandate that everybody gets followed with the technology. So this is the best of the best.

And if you look, and this is the Rezum five year data, and it's very similar. And if you look at minimally invasive data, pretty much all of them look alike.

So let me go now to another technology aquablation. The reason I bring it up is only to show you some of the newer thoughts of it. How many of you have done ablation? Show of hands. Okay. So if you look to your right, you look at this newer hemostatic methods, which actually look pretty good, but those are self-reported. What I mean is, is that, when the transfusion rates, which are much lower than they used to be by cauterizing the bladder neck, when they say that's 0.6% transfusion rate, that's self-reported. Docs tell them that I transfused that patient. So that's not actually the number of patients who were transfused, it's higher. But it's nowhere near what it was before we were doing cauterization. Sorry that the slides flipped.

So for those of you who have done it, it's a very cool technique. It has a handpiece, and it has a transrectal ultrasound. So you see it from the inside, you see it from the outside. I kind of call it a three-dimensional TUR. And it's very fast. I mean, that is clear, in terms of just the timing of it and you certainly can do larger prostates. But I'll give you kind of my thoughts about down in terms of volumes, which would be the lower end of it, and whether it's worth doing.

This is kind of the imaging, won't get too much into it just simply because of timing. But if you're good at ultrasound, it's really a cool technique to do. And in fact, I do my other techniques now under ultrasound and I've learned. I've done over 4,000 TURs, and I've learned some tricks by just putting an ultrasound program. It's kind of cool in terms of figuring that out.

So you kind of measure things out, you measure the landmarks, both from an intravesical lobe, and I'll make some comments about the intravesical lobe in just a second. And it's kind of hard once you set it up, the algorithms are actually quite good, but nevertheless, it's not just setting and forget. It doesn't, it's not one of those technologies. I actually have to monitor this and go from there. And like any picture, and I could show you a picture of UroLift, and Rezum, and TURP, and HoLEP, and it's all going to look like that. I wonder if it's the same picture actually, from different technology. Everything looks great at the beginning. It's kind of wide open.

And there have been various clinical trials, WATER, the WATER study which was in prostate, small, relatively actually more typical prostates. WATER II, which were in larger prostates. The open WATER study. There's now a WATER III study, which is being done through Europe. And I think I've shown that slide.

So let me just show you my own experience, and actually, we're up to 190 patients, but at the time that we put these slides in, it was 182, retention of 93 patients, one to 36 month follow up. So this is the largest data set in the world with aquablation, a real world data experience. Prostate sizes, you could see were all over the place. Most of the patients were able to void, were in retention, and virtually everybody had antegraded ejaculation. Not immediately, right after, or during, but certainly, the first time that they actually tried.

This is kind of the background of these patients. Some of them had failed TUR, Rezum, UroLift. 17 on PAE in it. And I'll be interested later when we have the session. All of these patients who had PAE had significant prostate shrinkage, but they had significant intravesical lobes, at least in the sets that we actually saw. We've done actually, a combo with our colleague at Mount Sinai, who had a 300 some odd gram prostate, and he had both a PAE, which shrunk the prostate, and a successful aquablation afterwards.

So this is the data and it's kind of TURish in terms of both symptoms and flow. Right now, we actually have about 11 patients at three years. The data is pretty good. And this is everybody and anybody who I have. We didn't censor any of the data, we threw it into the blender, and that's actually what it is.

As we get more and more data, when we get our 200th patient, we're going to publish this and see where this all goes. And it'll be curious to see your own experiences. And frankly, am I better at 190 than I was at five? Sure, but there's still kind of nuances that you need to learn about it.

Complications. We had two patients who I had to bring back for post-op bleeding. The two smallest patients, that two smallest prostate volumes, 38 and 42, figure that one out, too smallest volumes.

Undermining the bladder neck. We can talk about it during the panel. It's a real phenomena. You've got to be careful, because you really got to get that ultrasound image. It's happened, and I'm aware of this around the country as well, undermining the bladder neck ain't a joke. And this patient required a suprapubic tube. Fortunately, that was it. But you got to be very mindful of that. Three patients were transfused, none in the last 90.

So it's quick. The average time of the aquablation itself, there's wheels up and wheels down as you know, and that takes a little bit longer. Prostate size is not a barrier, I would argue. I'm not sure I want to do it for smaller prostates. I mean, I don't have ADD, I have S-T-U-P-I-D, and I really lose things very quickly. So if I can do it in half an hour, I'm doing it in a half an hour. And I can do probably, a 50, 50 some odd gram TURP in half an hour. So it's for me in my head, it's 15 and above, but that's very individual.

These are some of the issues where it fits. We'll see. I think a lot of it will have to do with reimbursement. One thing for everybody to know, Medicare used to cover it for everybody. They do not cover this procedure for men 81 and above. I don't know if you're aware of it. Kind of a new stupid aging thing. And they're appealing it, but just be aware, it's not covered any longer by Medicare in men 81 and above.

This is the iTind device.

Here's some nice data. My colleague Bilal, one of my kids, Bilal Chughtai and his group have really been leading in this, and you can see kind of the data. Here's the data. I'm going to predict something for you. They just got a level six reimbursement. This is going to be a hell of a lot more iTinds being done. Did the data change? That's the data. The only thing that's going to really change is the reimbursement. And now at a level six, more and more people are going to do this. So we'll see what the data actually shows.

Just going to go quickly through this. The Optilume, a balloon, I'm the PI on this. This uses actually, an anterior commissurotomy, paclitaxel, which is kind of a dual type of therapy. We presented this data here in Amsterdam at the EAU. It's pretty good. If you look at minimal clinically important differences, it's in the 80%, which is pretty high.

This is the flow rate through three years. And we've just completed our pivotal trial called the PINNACLE trial. The data has been unblinded, I just saw it last week. And I'll just tease you and say, we've never seen data like this. It's like, blows everything else out of the water. I can't tell you how, except that it does. We'll see. And it's now at the FDA, it will be submitted to the FDA for approval. So it will be another technology for you guys to think about. In terms of comps, these are historical comps. Once you see the PINNACLE data, which is the Phase III data, it'll be much better.

I'm going very quickly, because I just want to pinpoint some highlights. This represents the amount of patients who after we do all these therapies are still on medical therapy, and it's not insignificant.

And you can see here, these are the men, this is their alpha blocker use, and 5-ARI use prior to surgery. This is continued usage. It's not insignificant. A lot of men stay on medical therapy. A lot of them afterwards, the most common ones that are the relatively newer ones, are either alpha blockers or OAB agents, particularly the beta-3s. As of interest, the new beta-3 potentially vibegron, or Gemtesa, is being used a lot in men. They're really exploding in terms of using them in men.

This is the de novo usage. And again, you can see the use of OAB agents. So it's evolving. Take home message is, patients are still on medical therapy even after procedures.

This is a study regarding retreatment. And I think we have to be honest with ourselves, the retreatment rate is higher than what's reported in the literature. It just is. And there's a lot of reasons for that, which we won't get into, but I'm going to show you some of the numbers which are actually impressive.

Retreatment is defined very simply. Another BPH procedure. Can't make it any more simple than that. This is analysis in more than 50,000 men. It's uncensored, this is it. Everybody in the blender. And you can see that the retreatment rate is significant even for TURP and GreenLight. Now we're following this data at two and three years to see where it lands. But I think it's important to manage expectations regarding retreatment. Because at least with the surgical side and the minimally invasive side, it is much higher than we actually thought.

So with all of that, I know I threw a lot at you, but the point that I'm trying to make is A, there are new technologies. We still got a lot to learn. Retreatment rates are higher than we think. And we should actually do a better job of actually defining that.

In the hands of people who do a lot of them. It kind of works. I'm sure you all have had your own good experiences with UroLift, and with Rezums, and you'll have them with aquablation, but it doesn't work in everybody. It's not for everybody, and the retreatment will be a little higher than we actually think.

These energy-based techniques, you do have to learn how to do. Even aquablation, which is relatively quicker, because it's a pre-programmed algorithm, is not a home run or a gimme. You've really got to be careful, particularly at the bladder neck. You got to be really get good imaging at the bladder neck, or as you can blow right through it. And it can be a complication that requires a super pubic tube if you kind of lose the bottom of the bladder neck.

So I'll leave with this. Thank you.