Read the Full Video Transcript

Diane Newman: Welcome. I'm Diane Newman. I'm an adult nurse practitioner at the University of Pennsylvania in Philadelphia. I'm also adjunct professor of Urology and Surgery at Penn. I'm really excited today because I have a guest who's going to talk to us a little bit about his company, BrightUro™. His name is Derek Herrera. I want to talk with him because he's got some new technology in the area of lower urinary tract dysfunction. Individuals who have incontinence, overactive bladder, urinary retention, we do diagnostics on them to determine what is that bladder function? I'm excited because, Derek, you have some new technology. I want you to talk a little bit about your company and what you really are developing in this space.

Derek Herrera: Yeah, pleasure to be here. Thanks for having me. I'm the founder and CEO of BrightUro™, and we started BrightUro™ about a year-and-a-half ago to commercialize technology that's been development by leading research at the Cleveland Clinic for over a decade, primarily Dr. Margot Damaser and Dr. Howard Goldman and a lot of others have been working, and what they've been working on is trying to develop a miniature sensor that can be inserted completely in the bladder to record pressure and volume data for wireless, catheter-free urodynamic monitoring. And so, what we're doing is we're creating and commercializing the Glean Urodynamic System, which will be the first wireless, catheter-free method of urodynamic monitoring.

Diane Newman: Yeah, that's really exciting because many of my patients don't undergo urodynamics, catheters are put in, several catheters, they're like, "This is going to be painful," and a lot of them don't want to do it. And then in the past, there's been quite a bit of technology advancement in ambulatory urodynamics. Where do you think your product's going to fit? Because I'm kind of excited that it's wireless, so it's going to have the newest technology, or are you going to use catheters with testing?

Derek Herrera: No, so it's catheter-free, and we use that term to basically describe the way that we can do it. And so what we've done is we've created, at the heart of our system, is a miniature sensor that can be delivered transurethrally into the bladder. Once it's in the bladder, it can record data. And then we use a small removal string, almost like a double J-stent, where you can just pull the string out after that period of monitoring and download that data. It's a relatively simple proposition, but what that means is that you no longer have to fill the bladder in 10 minutes.

Diane Newman: Oh, really?

Derek Herrera: You no longer have to have catheters hanging from your body, laying from the table while people are watching you and they're asking you to void. Suffice it to say that the catheter-based technology, even though it's the best thing we currently have, that's not the most overly physiologic representation of bladder function and lower urinary tract function. And so the thing that we offer is privacy, comfort, the patient, once it's inserted, they can get up and leave the room and go be monitored either in clinic, or eventually with the next-generation technology, at home, for some period of time, and then come back, download the data. That's the major shift that we have. There's no catheters, no people watching you when you're urinating.

Diane Newman: Well, and you're bringing up a really good point because we bring them into the urodynamic room and we expect to replicate their symptoms that they have when they're at home, at work, and they're on the exam table, legs are up, catheters are in them. That's not their normal, when they have their symptoms with their bladder symptoms. So the way we're doing it is, really, how can we reproduce exactly what they're reporting to us that occurs when they're on their daily routine? So in a way, this is kind of other kind of areas like holter monitoring, where we monitor the heart when they're out there in their normal lives. Is that what you're talking about?

Derek Herrera: Exactly. Yeah. What I would say is holter monitoring in 2012 is like urodynamics is today. Holter monitoring, previously you have to go into a clinic, you would get hooked up to 12 different leads, it was cumbersome, it was awkward, and that test only replicated symptoms 23% of the time. A company launched a product called iRhythm and others have entered the space with a wearable technology that has only two leads. You can wear it, you can shower, you can go about your day, and wear it for between 7 to 14 days. And that had 99% plus symptom replication.

And so when we look in the field for urodynamics, because the artificial nature of the environment, the catheters, the artificial bladder filling, the people watching you when they tell you to void, all of those things, they lead to a pretty high level of failure to replicate symptoms. And the whole goal of urodynamics from a clinical perspective is to understand what's happening in the bladder when those symptoms are experienced. So imagine you undergo this invasive, somewhat awkward and embarrassing test only to find at the end that a clinician says, "Hey, we tried really hard, but we didn't get the information needed." And that's what we're trying to solve, is re-envisioning that entire method from the ground up in a more physiologic, more efficient, more comfortable manner, and thereby improving diagnostic yield and accuracy.

Diane Newman: Now, is the testing been done in both men and women, all ages? What type of diagnosis? Who really qualifies for this?

Derek Herrera: The beauty of urodynamics is that it can be utilized across the entire range of the patient population, men, women, pediatric patients. For us right now, the initial data has been in females. The Cleveland Clinic is publishing, and that should be publishing any day now in the Journal of Urology, but they're publishing some of the first-in-human studies they've done, particularly 11 adult women with overactive bladder. We've already got additional clinical studies lined up now where we're going to expand on those results and also expand to the male population. And so we've designed a tool that we've done a lot of testing on for men that enables transurethral delivery for those patients.

The one patient population that we can't get to just yet is the pediatric population, and that's just due to the size and the limitations of the technology. Because with our technology, what we've done is, it sounds simple, but only until recently has this been feasible, and what we've done is we've taken the entire console that used for urodynamics, the laptop, the printer, the pump, all of the capital expenditure and the equipment that's needed and gotten rid of all of it because we put miniature electronics that can perform the same functions into a miniature flexible circuit board that can be delivered in the bladder. So we're talking 5 millimeters or less. The entire sensor itself, the outer diameter is 15 French.

Diane Newman: Oh, wow.

Derek Herrera: Inside of that we have a battery, a microprocessor, flash memory storage, a Bluetooth antenna, a pressure sensor, all of these advanced electronics, and it's also in a cost-effective and efficient way because those components are cheap now because of proliferation of smartphones and other technology. So we offer a single-use disposable device.

And so now when you think about that from a business perspective, I no longer have to pay $100,000 for that machine. And then because that machine costs $100,000, I have to turn the room in an hour because I got to use it a lot, I got to get patients. That's where the 10-minute artificial bladder-filling period came from. We eliminate all of that, and so any nurse or NA can insert this in a matter of minutes in any exam room. And because it's not expensive, because there's no CapEx or disposable devices, now instead of having one specialized clinic, you can put it in the dozen other clinics that don't currently have urodynamics. And so, with that, that's really the business and the clinical practice efficiency innovations that we're offering, is improved efficiency, reduced CapEx, simplified training, and so any nurse in any exam room can utilize this. And we really want to improve access to care because of that.

Diane Newman: Well, that's really good, because you are right. There's only certain places that can really offer urodynamics. It is a big expenditure for that practice. So anyway we can get such technology out to where we need it. And you brought up a really good point too about men, men do not want those catheters. Urodynamics is very traumatic for them, so the fact that you're eliminating it. Now, when do you think this will be available?

Derek Herrera: The goal is to have the first-generation product available in Q2 of next year.

Diane Newman: Oh, wow.

Derek Herrera: We're working very quickly. We've got a phenomenal team, we have great investors, and we've been very fortunate to have support from so many people coming together to make this a reality. And we also leverage over a decade of hard work and effort and diligence, dedication from the entire Cleveland Clinic team. But that's the goal. Our gen-one product will be on the market in Q2 of 24, and that product will be limited to in-clinic use for up to 24 hours of monitoring and not pediatric patients. So any adult male, any adult female in need of urodynamics can utilize that device.

And then the next one we're working on, which we're very excited, which we think is going to transform the field even more is, instead of limiting it to in-clinic use, they'll come into clinic and then we'll be able to send them home for up to 3 days of monitoring before they return to clinic and we download that data. And so, we're taking a step-wise approach, and we'll be running studies this year starting very shortly to demonstrate that safety and efficacy for that 72-hour, potentially, home-monitoring period.

Diane Newman: Well, and we talk about urology, but another big group where this is going to be really helpful is the rehabilitation setting, where we have a population of individuals who have neurologic lower urinary tract dysfunction, either from stroke, MS, Parkinson's, spinal cord injury, and urodynamic testing, understanding what's going on in that bladder is so very important. That's really quite a market for urodynamics, so I would think that this is really going to be placed really well with that population also. Have you been studying that population, or where have you been really placing this device at the current time in the research?

Derek Herrera: Yeah, the neurological lower urinary tract dysfunction is a smaller population than some of the bigger populations like BPH and OAB, but it's a really high-risk and important value proposition that we can offer for those patients specifically. And so, because they're at high risk, they're the ones that get your urodynamics a lot of times because you want to make sure there's no DSD or vesicular ureteral reflux, all those things in enabling safe urinary management. And so, video urodynamics is great. It's a great tool, it's the gold standard for diagnosing all these things. But even that, you're still in a somewhat artificial environment, and the premise of the entire evaluation, filling the bladder in 10 minutes or 20 minutes, it may be leaving some things behind.

So for those patients, eventually what we would expect is that if they're at high risk and coming in every year for video urodynamics for 10 minutes of observation, you also want to know what happens when they go home? And if our device is able to provide evidence to show that, yeah, this patient is having significant overactivity on a chronic basis, every few hours their bladder is going nuts, which is putting them at high risk for these types of conditions, that's valuable data and clinicians should want to know that. So for that population, we think eventually this will be a supplementary approach or even just a different modality or alternative option.

Diane Newman: No, I have to tell you that this is a really exciting product because you're exactly right. We test individuals in the office. We can't replicate exactly what they're doing. They have these complaints and we can't say it's because of this. So the fact that you're going to be able to monitor them when they're in their normal daily routine is a huge advancement in this field. So I really thank you. It's really exciting that you've really developed this technology. Sounds like you're doing a lot of research on it. I'm sure we're all going to wait to see when it's going to become available, so thanks.

Derek Herrera: Thank you so much for the opportunity. Yeah, pleasure to be here and we're very excited to bring this to market.

Diane Newman: Great.