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Zachary Klaassen: Hi. My name is Zach Klaassen. I'm a urologic oncologist at the Georgia Cancer Center in Augusta, Georgia. I'm really happy to be joined on UroToday by Dr. Jim Wysock, who is an assistant professor in the Department of Urology at NYU up in New York. Jim, thanks so much for joining us on UroToday.

James Wysock: Thanks for having me. Happy to be here.

Zachary Klaassen: So we're going to talk about improving prostate tissue collection. And really, I like the title of your slides-- the details are in the core. And you've had a lot of experience with some of the new technology to try to improve, basically, tissue acquisition. So why don't you pull up your slides and roll through some of those for our listeners?

James Wysock: All right. Thanks. What I wanted to highlight with this is some of my early experience with a novel prostate biopsy gun. And I think that this really is a missing piece in our prostate cancer diagnostics where we could make some significant improvements. And this gun actually offers what I think are some real, tangible benefits over our existing guns, which we use probably every day or every at least every week, and are used across the country at a very high volume, but maybe actually impairing some of our ability to do accurate diagnoses. So this is just a few quick slides to highlight some aspects of this. I did call it Improving Prostate Tissue Collection because really, that's the core of prostate cancer diagnosis.

And so to get into that, we really drive the diagnosis of prostate cancer by taking a needle core biopsy. And there's some critical parameters that we get off of those cores that really determine what the prostate cancer diagnosis is and, ultimately, what we may be offering a man for treatment for that prostate cancer. And specifically, what we're really looking at is things such as total length of cancer on a core, how much of the core is involved with cancer, the number of positive cores or the percentage of total cores involved. There's also some evidence that says, look, the quantification of the cancer that we find on these cores predicts outcomes and predicts results of our treatments. So this is actually a very important part of the diagnostic pathway.

And while we have a lot of great progress in using biomarkers and MRI to try and improve how we do prostate cancer diagnosis, when ultimately, it comes down to the biopsy needle, which is something that has not really received a lot of attention, I think we really should look at opportunities to improve that step in the diagnostic pathway, because this really does impact the diagnostic accuracy. One of the critical components to the diagnostic accuracy that many of the viewers probably have some experience with is fragmentation of the core. And that, in this one study that I referenced here, was as high as 30% of standard biopsy cores. Up to a third of the cores that you send are fragmented.

And the problems with fragmented cores are shown on this slide. You see these cores, and they can come back to the pathologist in a variety of, essentially, messes. And I've seen this on my own patients because I've done a lot of work with targeted biopsy, systematic sampling. And a lot of it is towards identifying prostate cancer mapping for focal therapy. And what I found by taking more and more cores and really looking at the tissue that I'm obtaining with the standard biopsy is you get a lot of partial cores. You get a lot of cores that don't come off the needle in a normal way. They aren't being fully cut by the needle.

And then you're looking for these to really give you reliable understanding of the cancer in terms of its length, in terms of its orientation, in terms of the overall diagnosis and volume. And there's a lot of areas that, I think if you really look at what we're sending, could be improved upon.

So the SUREcore® needle that is developed by URO-1 Medical, I first encountered it at one of the Focal Therapy Society meetings. And it's a very different design. And this image shows what the standard biopsy needle looks like when it's deployed into tissue versus what the SureCore needle would look like when it's deployed into tissue. And I'm going to show a quick video on the next slide which really highlights this, but the design of the needle is pretty unique.

What you can see here in this image is that there are teeth along the needle, and it has, in essence, a curved body within the core. And the combination of those two teeth and the structure of the needle itself allow it to not be as easily deflected, as I show in this image, and also allow the tissue to recoil via a different mechanism when we're sending that needle into tissue to improve our core.

This is a nice video to highlight that, and so I'm just going to let this play. It takes about a minute, first starting with the standard biopsy needle. The notch in there is not designed to not allow that actual collection canister to bend, and it will absolutely bend when it's deployed into the tissue. And so you can see on the SUREcore® needle there's a recoil that allows and keeps that chamber linear. And this allows you to then ultimately shear off and cut the tissue more accurately. So the standard biopsy and the novel biopsy gun, the SUREcore® gun here are shown as how they're very different in terms of what they're actually able to obtain.

You can see here that the cross-section in the cannula is also an important piece that the SUREcore® gun can help improve. So it's a wider cross-section in their body. And by having a little bit more structure with those teeth, you, in essence, are grabbing the tissue a little bit more accurately. And I think this slide really points out that bend that you see in the chamber, that's happening on many of our cores. We don't see that under ultrasound.

But when you pull back your biopsy and you're getting these fragmented cores, or even sometimes get just a small amount of tissue, think about what's happening there. And as you take 12, 16, 18-- and if you're doing saturation biopsies, 20, 30 cores-- with the same needle, think about how that degrades over time. And I've gone through biopsies where I'll go through three or four guns because as I'm taking cores, I can even hear the spring is weakening, and the tissue coming off of the core is very poor quality. And so I think there's a lot of room for improvement in this step.

Great. That's all great. What do we know about whether this biopsy needle actually is better? There are some very preliminary studies to show that it is improving the amount of tissue that is obtained per core in these pilot studies. They also showed that the percentage of high-quality cores was significantly improved over the standard of care needle. They actually showed reduced detection of atypical small acinar proliferation rates.

And ultimately, and I think probably the most important component here, is that the tissue volume is improved with this versus the standard core. And this was also shown in both approach, transrectal as well as transperineal. As we move a lot more of our biopsies to the transperineal approach, this biopsy needle would work just as well in that scenario, so I don't think there's any limitations. When you summarize these early data, I think they're very encouraging that the engineering of this needle will give us better cores.

So at the end of the day, prostate cancer diagnosis still relies upon the prostate biopsy, which still relies upon these needles. We need to be paying a little bit of attention to this. As we're moving towards more active surveillance, more partial gland ablation focal therapy, we really need to have a man's diagnostic biopsy be as accurate as possible. One of the weak links could be these biopsy needles not giving us good diagnoses. If we have a better biopsy, it would really, I think, serve to improve this.

So where are we going with this? I think that we're developing as an ongoing multicenter validation prospectively. I think that will help give us more information and more data on this. And then I think we could expect that this would have a broader clinical implementation over time based on those results.

So take-home message-- I think prostate cancer needle core quality is critical to the prostate cancer diagnostic pathway. And the SUREcore® URO-1 is a tool to help improve that quality. Thank you.

Zachary Klaassen: Jim, fantastic presentation. I think that video was absolutely brilliant, just to really show what we can't see under ultrasound. And we do see that tissue fragmentation. I've had some experience with SUREcore® myself, and not only is the tissue intact, it's longer, it's a little bit wider. And I think that really gives the pathologist not just the amount of tissue, but the quality and the integrity that we're looking for. So I really appreciate you showing that, and especially the video I thought was really, really great.

URO-1 one also has the coreCARE® touch and go tissue transfer technology. Maybe just touch a bit on that. And this is really the transportation, the removing the tissue from the needle to the pathology lab.

James Wysock: Yeah, I think that's another very important piece to this. Even if you get a great core, how do you get it to the pathologist? A lot of us put those cores either on Telfa or some sort of foam pad and then put it into a formalin jar. And in fact, that's the mechanism that I typically use.

But I've gotten actually a lot of negative feedback from our pathology department when I put it on something like a Telfa because it can break apart in the formalin jars, and then they're picking out the fragments of tissue, trying to differentiate that from some of these other materials. And what the rest of the URO-1 device would do is you can then apply the core to a membrane which will hold it in place. Put that into the formalin jar and send it as you usually would, but the product that then gets handled and delivered to the pathologist is pretty consistent with how you obtained it.

That also opens doors for better orientation of your cores if you wanted to mark an end of your core to say this is the base end or whatnot, you could then be more confident that what you send is what is going to be interpreted correctly. So I think that is another potential major advantage with this approach.

Zachary Klaassen: Yeah, great summary. You teased a little bit the multi-center validation, so I may probe a little deeper. How many centers? How many patients? How far along is this study when maybe we will see results from the multi-center validation?

James Wysock: So right now, we're in the IRB process. We're looking at, right now, three sites. Here at NYU, we are in the late stages of our IRB application. I anticipate we'll be up and running relatively soon. We're looking to do 50 patients at our site.
The number of patients is actually an interesting concept here because what we're going to do is a core-by-core analysis. So each patient may get anywhere from 12 to 20 cores, but when you're doing core to core, 50 patients is be a much larger number of points to evaluate. So 50 patients at three sites, looking anywhere from 150 to 200 patients, but there's going to be a lot of core point analyses. And that's going to be powered, then, to really identify differences in those key diagnostic parameters between the SUREcore® and the standard of care gun.

Zachary Klaassen: Outstanding. That'll be great. I know you gave us some take-home messages already in your slides, but maybe just a couple of concluding remarks. It's been a great discussion.

James Wysock: Look, ultimately, we can put a lot of weight on improving prostate cancer diagnosis in a number of ways. We can get MRIs. We can get better biomarkers. We can select the men for the biopsy. But at this time, we still rely on a good biopsy. We need to make sure that that biopsy is as high quality as possible. A better biopsy needle like the SUREcore® appears to be giving us better tissue that we can then get more reliable diagnostic accuracy. I think it's a tool that we should really be looking at more carefully, and hopefully in the future, be utilizing more readily.

Zachary Klaassen: Wonderful. And we'll look forward to the results of your study, Jim. Thanks so much for joining us on UroToday and for your time this evening.

James Wysock: All right. Hey, thanks so much for having me.