Kristen Comstock: Hi, my name is Kristen Comstock and I work with the BrightUro team. And we were delighted to be invited by UroToday to give an overview of the Glean Urodynamic System today. And so I've invited two experts in urodynamics to guide the conversation and share their perspectives.

So we have Dr. Jason Kim from Stony Brook Medicine in New York. He is the director of urogynecology at Stony Brook, and he also participated in the clinical study for MUSE that recently concluded. And so he can share his firsthand, hands-on experience from that clinical study.

We also have Doctor Scott MacDiarmid here. He is at Allyant Urology in North Carolina. And he is also a well-recognized expert in urodynamics and is the chief medical officer for BrightUro. So we're very lucky to have both of you here today.

For our first question, I'm going to start with Dr. MacDiarmid. And I'd like to ask if you could describe the Glean Urodynamic System. Just give people an overview of what that is if they're not familiar and how it compares to their conventional urodynamics. How is it the same and different?

Scott MacDiarmid: Great question. Again, I want to reiterate this is an exciting time that Glean just got FDA approval last month. And what great timing to bring, I think, a wonderful technology to the AUA in Las Vegas. And just knowing that it's going to help us diagnose and treat our patients with lower urinary tract symptoms better.

Your question is: Glean is a wireless, catheter-free, ambulatory urodynamic system. It has three components. There's this wonderfully designed pressure sensor that's placed into the bladder. There's a urine flow meter. And then there's a patient-physician app, and they all basically talk to one another via Bluetooth, through the cloud.

And like conventional urodynamics, they measure bladder pressure during bladder filling and emptying. But what Jason and I are going to talk about, what's unique is because its physiologic bladder filling is done in privacy, not in a lab, and it's hopefully during even your activities of daily living, it's going to really open the door to us better understanding, from a pathophysiologic standpoint, what's going on with the bladder and lower urinary tract so we can help these patients better.

Jason M. Kim: Yeah, I think traditionally urodynamics often is uncomfortable for patients and we're force filling the bladder. And a lot of times, we don't get the results we expect. It's a nonphysiologic fill. So I think really one of the strengths of the system is it allows for a physiologic fill that's probably better able to replicate a patient's symptoms.

Kristen Comstock: Now, Dr. Kim, you've used Glean in a clinical setting in a study that was recently concluded. And so could you talk a little bit about your experience with that and what you foresee as the clinical impact that Glean will have?

Jason M. Kim: Sure. So as part of the trial, I inserted a few of these devices and actually, it was quite easy to insert. I think in our clinical trial, the average time for insertion was about 30 seconds. And it's almost like putting in a coudé catheter. And essentially anyone in your practice who could put in a catheter can put in a Glean.

And I think this will be a paradigm-shifting device because traditional urodynamics requires you to have a urodynamics room, an expensive setup, high capital costs for your urodynamics machine, and usually a dedicated staff member to run the tests all day. So it hogs up time, space. It's a resource hog.

With Glean, like I said, the average time to insertion is about 30 seconds—anyone who could put a catheter in. So I envision it changing how we do this. I think what we'll do is we'll probably start in the mornings, maybe put in a few back-to-back in different patients, ask them to either wait in the office or go get a coffee, or walk around, and then come back to our office when they're ready to urinate, and they urinate into the Uroflow and the data are uploaded to the app.

And where I think the strength is, a lot of practices, like our practice, we have seven or eight different clinical sites. However, we only offer urodynamics in two of the sites because of the high capital costs and resources that I talked about. And I think this allows us to bring urodynamics to all the sites. We don't need the setup, and I think it'll really transform how we do things.

Scott MacDiarmid: I would call it the octopus model. Right now, if you look at large urology group practices or just large groups that are hospital-employed, we have many satellites. It's just part of expanding health-care system campuses, really—you're going to the customer.

And we have a wonderful video urodynamics room and nurse. But the satellites, especially, they are referring people but not—they're really dramatically underutilizing urodynamics. Now you're able to take that to the tentacles of the head of—and then if they need to send someone to the head of the octopus, that's fine. But there's no question it's going to really improve the diagnostic capability across the entire model.

Jason M. Kim: In a more efficient—

Scott MacDiarmid: Yes, more—

Jason M. Kim: More efficient manner.

Kristen Comstock: Yeah, great. I like that. Can you speak to the patient experience for Glean and how that is different than the patient experience for conventional?

Jason M. Kim: Sure, we're presenting actually an abstract on that this Monday. We looked at the differences between conventional urodynamics and the Glean System. And what we found is the patients actually thought that doing urodynamics with Glean better reproduced their symptoms, and the physiologic fill was more comfortable.

And I don't want to get too technical, but there was a metric called net promoter score. And basically, what it showed was that patients found the experience with Glean to be good, whereas they rated conventional urodynamics as needs improvement. And so it tells us patients are more comfortable with this ambulatory urodynamic system.

Kristen Comstock: Every single technology that's out there has a lot of strengths, and it also has some limitations in terms of who you use that for. In what situations do you use that technology? Can you speak a little bit to what you might call limitations of Glean?

Jason M. Kim: Well, I think one thing people may notice is in this iteration of the Glean System, there's no abdominal pressure tracing. And for, I guess, urodynamic purists who are used to this, they may view this as a problem. I can tell you, as someone who's been part of the clinical trials and viewed the tracings, that for the vast majority of the cases, it's not necessary.

If you're experienced reading urodynamic tracings, you can tell what's going on without an abdominal pressure. But that being said, there are a certain subset of cases where abdominal pressure is important, and perhaps those patients would be better served by conventional urodynamics.

Scott MacDiarmid: Yeah. Kristen, you really think about it: the majority of information that we get from urodynamics now, which has the bladder, abdominal, and then the subtracted detrusor pressure, the majority of the information is gotten just by having a single catheter.

I mean, you think about all the data we get from free urine flow. In the filling phase, we get bladder capacity, sensation, compliance. Ambulatory urodynamics has taught us that detrusor activity—to detect that—is actually more sensitive than a lab setting. And during the pressure-flow voiding phase, the flow and the PVR, again, doesn't need a subtracted detrusor pressure.

It's really going to be the voiding phase in men—do you need an abdominal pressure line to get a subtracted detrusor pressure? I think Glean has come up with a great way to minimize any potential false negatives or false positives. But the good news is, in the next many months, we're going to have an abdominal pressure sensor.

And I think that will be an important addition. That's the whole idea of bringing this technology to make it better and better. And importantly, this is not to replace my wonderful urodynamics lab and my Jamie—this is my nurse—this is additive. This is a synergistic approach just to make us better at driving excellence for our patients.

Kristen Comstock: You talked a little bit about the MUSE study and what's going to be presented on Monday. Is there anything—like can you give just a bigger-picture explanation of what is the MUSE study?

Jason M. Kim: Sure.

Kristen Comstock: What was it intended to learn?

Jason M. Kim: OK. So the MUSE study, it stands for Modern Urodynamic System Efficacy. And what we looked at was the feasibility of using the system, the efficacy, and adverse events. And what we found on feasibility is that the vast majority of patients—actually, I think 97% of patients that we attempted to put it in—were successfully deployed. And as I mentioned, the average time was about 30 seconds.

So it really is easy to do. And then we found that the safety profile was excellent. There were some minor adverse events; however, there were no major adverse events, and the kind of events that we had are similar to things we would expect from conventional urodynamics like transient hematuria or maybe dysuria. So I think it shows that it can be performed quite easily in the office setting. And I think I mentioned it before, but I truly believe anyone who could put in a catheter can deploy this system.

Kristen Comstock: I know one of the challenges with conventional urodynamics is the ability to recreate the symptoms that brought the patient there because of the nature of the test, and sometimes they can't even void. So can you speak to that a little bit, what some of those challenges are and what the expectation would be for Glean in contrast to that?

Jason M. Kim: Sure. Actually, I think this is one of the strengths of Glean. When you have a patient undergoing conventional urodynamics, often the Uroflow is an intubated Uroflow. And oftentimes, in the beginning, we'll get a Uroflow and it shows that they can urinate, but with a catheter in place they can't. And you know they're not in retention.

Actually, interestingly enough, in the MUSE study there were a decent number of patients who could not urinate in a conventional urodynamics that were able to urinate with the Glean system in place, and I think that's one of the strengths.

Scott MacDiarmid: It's interesting. I remember pulling out ambulatory urodynamics in 1992, in England with my friend Derek Rosario and Chris Chappel. And ambulatory urodynamics, over the last 20, 30 years, has taught us a lot. And you know that monitoring—as the literature will support—is more sensitive in picking up detrusor overactivity and quantitating it.

It's more sensitive in picking up stress urinary incontinence because it's reproducing the event that does it. It's actually a wonderful way to do voiding because you can often get multiple voids; it's done in privacy.

And Jason is exactly right. What almost makes me reflect over my lifetime of telling people they have—men—they have an acontractile bladder, and the TURP isn't going to work. When you do an ambulatory, they actually do generate a contraction. I think another very excellent one, especially in the neurogenic patients that develop high bladder pressure that could harm their kidneys, this is monitoring pressure 24/7, as opposed to a 20-minute snapshot that can have a lot of maybe false positives because of the rapid filling phase of what I do today in my video lab.

So really, when you take those—and also the literature would say that people, which is the bottom line, when they did conventional on ambulatory—this is now wireless ambulatory—and then did ambulatory, it did change your treatment algorithm in many patients. So I think it's going to be wide open on what this opens the door to us helping our patients again.

Kristen Comstock: That was great. We learned a lot about Glean, so thank you for that. In summary, I was just going to ask both of you to share your overview of Glean and a key takeaway for people who are watching.

Jason M. Kim: I'm really excited to be able to start using Glean because I think there are multiple benefits for our patients, for our practice, for our system. Our patients will benefit from more efficient care, and probably the physiologic fill will allow us to get better information. For our practice we will be able to offer it to more patients, and we'll probably be able to save money because we don't have to invest the resources for conventional urodynamics.

Scott MacDiarmid: Just for myself, it's just an honor and privilege to be asked to be part of the BrightUro team. And I've had a lifelong passion of hoping that my colleagues would see the benefit of using urodynamics to help diagnose their LUTS patients—men and women—just to make them better. And I'm proud, again, to be a part of it.

Kristen Comstock: Well, I want to thank you both today for making time to come and share your experience with Glean and also your perspectives on how you foresee Glean impacting the landscape of urodynamics going forward. It'll be really interesting to see how it all plays out.

I also want to, on behalf of BrightUro, thank the UroToday team again for giving us this opportunity. This is such a milestone for our company, to have FDA clearance a month ago, and so it's really a great time to come back and give an update. So thank you for that. If anybody wants to learn more you go to GleanUDS.com and you can learn all you want and more about Glean. So thank you.