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Roger Dmochowski: Good day. I'm Roger Dmochowski. I am a urologist in Nashville, Tennessee at Vanderbilt University Medical Center. It is a great pleasure to be joining you today with two esteemed colleagues, Dr. David Chaikin from New Jersey and Dr. Vijay Goli from Las Vegas, Nevada, as we discuss the use and indications for a new endoscopic system in urology.

Thank you, Doctors Chaikin and Goli for joining me today to discuss the recent FDA cleared single-use disposable UroViu cystoscopic platform and to share your experiences with the device, as well as the economic implications for urology and urogynecology practices.

As you know, I'm very much involved in both clinical as well as operational duties at my hospital, and in my operational role, I oversee the costs and utilization of surgical supplies for our operating rooms. A major concern for us is the tremendous ongoing costs associated with reusable instruments, in particular, reusable cystoscopes. The costs associated with cleaning, reprocessing, maintenance, and repair are staggering and also impact the efficiency of our surgical teams and surgical throughput. I personally believe that there is a tsunami of change coming and coming rapidly with the transition to single-use instrumentation, as we saw in the uptake and utilization of disposable ureter scopes and that cystoscopy will soon follow.

In addition to convenience and projected cost savings, concerns about cross-contamination are now front and center in patient safety circles. The availability of a single-use, self-contained cystoscopic system or platform that eliminates large capital investment, additionally provides high-quality images and image capture capabilities, and that can be imported into the EMR associated with the safety and convenience of single-use, allowing each patient to be examined with a factory sterile device with rapid market adoption really is very intriguing.

David, let me first turn to you. Could you please describe your practice and your clinical experience with a single-use UroViu disposable cystoscope?

David Chaikin: Thank you, Dr. Dmochowski. Garden State Urology is a large single-specialty LUGPA-affiliated urology practice. My particular area of special interest and expertise is in female urology with a focus on voiding dysfunction, incontinence, and pelvic reconstruction.

I was fortunate to be one of the investigators in the early IRB-approved clinical trials with the UroViu single-use cystoscope, and have continued to use the system following FDA clearance. As most of my practice is female urology, most of my experience is with the UroViu female diagnostic scope and the Uro-N injection scope optimized for intravesical BOTOX administration.

One of the features of the UroViu platform that is particularly appealing to me is that it is a very flexible platform with a number of cannulas or sheaths that are optimized for specific procedures or indications. The female diagnostic scope is optimized for the female anatomy and female diagnostic examinations. It is 12 french, which is very well tolerated by the patients, and it has a hydrophilic coating that does not require any lubricating gels and has the widest field of view of any scope on the market today, which is about 140 degrees.

The cannula itself has a slight coude tip, and the combinations of the coude deflection with the wide field of view allow for easy, rapid systematic visualization of the entire bladder. Since there is not a need for a tower, an external monitor, and a dedicated room, I no longer have to schedule cystoscopic procedures or reserve the cysto suite. I can perform cystoscopy in any room at any time. This flexibility has allowed me to perform cystoscopy on first patient visits for my patients with recurrent UTIs, hematuria, or voiding complaints, and has had a tremendous impact on the quality of my patient care.

Patients always want to know the underlying cause, and instead of telling them that I will have a better idea when they come back for cystoscopy in two or three weeks, I can now provide a diagnosis at the first visit, which is generally a huge relief for them. For many of my new patients, cystoscopy with the UroViu system is now part of my initial comprehensive visit and has a very positive effect, not just on my patient care, but on my office efficiency and patient put through.

The Uro-N is also a game-changer, as it allows for a single operator procedure without the need to rely on an assistant. The injection needle is integrated into the sheath. It is always at six o'clock in my field of view, and the needle itself does not wander. I believe it has simplified the injection process for me, and patients tolerate the 14 french hydrophilic coated sheath much better than our current rigid instruments.

I will say one other aspect of the UroViu platform that I found to be very impactful is that every time I open a new disposable scope, not only is it sterile, but I'm working with a brand new instrument with a brand new camera sensor that provides superior images.

Roger Dmochowski: Thank you, David. Dr. Goli, you have been an investigator and also an early adopter of the UroViu single-use platform. In addition, I understand that you have completed a detailed analysis of the expected financial implications and impact of transitioning to the UroViu single-use disposable system from standard systems. I wonder if you could share your findings with the audience and also the implications for your practice.

Vijay Goli: Thanks Dr. Dmochowski. Like Dr. Chaikin, I'm also part of the largest urology group in Las Vegas, Nevada, and also was fortunate enough to be involved in the initial clinical trials, which allowed us to get FDA approval of the Uro-V and Uro-N scopes.

From the initial time forward, we have always been interested in a safer approach for our patients' safety, especially when you consider the fact that I think we all agree that reusable scopes are maybe not completely 100% sterilized. This also allowed me to investigate switching over or transitioning from a reusable scope to the first approach of a disposable system, which is the EndoSheath system. At the time, my manager and I had to not only convince my partners of transitioning to a new type of system, both for the safety concerns for our patients but also we had to find a cost solution. When we did this, what we found was that by utilization of an EndoSheath system, the cost savings was approximately $50 per patient.

Now, in order to get to that, we had to identify where the cost savings were, which were, each reusable system you had to buy an actual scope as well as a video tower, a dedicated room, sterilization processing systems, as well as sterilization solutions. And then also the staff time. My manager did an in-depth analysis of the costs associated with the reusable system and found that it approximately cost about $198 per patient. Just switching over to the EndoSheath system, which still has a large initial cost as well, as you have to buy a scope itself as well as also clean that scope, but at least it allows for less time and utilization of the staff, as the sheath which touches the patient is actually disposable. So that actually allowed for a savings of approximately $50 compared to the reusable scope.

In order to transition my group of 15 providers to a reusable system such as that, we had to create a pro forma and when we did, we found that the largest utilizer of the cystoscopes had a $50,000 savings per year. Even the provider that utilized the least amount of cystoscopy in the group still saved $10,000 per year. So, at that point, it was an easy solution to switch.

Now, moving on into the completely disposable system, which is the Uro-V and Uro-N systems, which similar to Dr. Chaikin, I also perform female cystoscopies now that it's been FDA approved with the Uro-V scope as well as perform BOTOX injections with the Uro-N scope. We found that there is actually a further reduction of 40% cost savings between the EndoSheath system and the completely disposable system.

As a side note, one of my partners actually questioned, "Why switch?" I said, "That is fine. I'll give you a simple example." I said, "I'm going to perform a cystoscopy using a reusable scope on one of your patients that has life-altering diseases, such as HIV or hepatitis. I will give that scope to your staff to clean. Then I will use that scope on you to perform a cystoscopy." I said, "Are you okay with that? If you have the alternative to use a completely disposable system where each cannula which is utilized in the UroViu system is a brand new scope." I always tell my patients.  Now when I perform the procedures, I always tell them, "This cannula has your name on it because that is the only cannula that I am going to use for you and no one else. And I throw it away at the end of the procedure." Having said that, my partner was convinced that yes, a completely disposable system is the way to go.

Having said all of this, the cost savings of course were tremendous. But now, when I transitioned into a telemedicine platform last year during the pandemic, it really allowed me to utilize my office more efficiently. Now that I perform utilization of telemedicine for seeing patients and follow up, I have only patients come to the office for exams as well as procedures. Not being limited to a room that is dedicated to procedures using the Uro-V system, I am able to utilize my other exam rooms on a back-to-back basis for cystoscopy. In fact, I've been able to go from room to room and perform cystoscopies.

My staff actually are the ones that are the most excited about using the disposable system because of the fact that there is no extra work for them. They just have to have the patient go into the room, prep the patient themselves, and then open the sheath on a sterile field and get the cannula prepared. That's it. So having said all this, I believe that this system is the only way that I can see the future of urology. Thank you.

Roger Dmochowski: Thank you, Dr. Goli. Dr. Chaikin, you highlighted some very interesting attributes of this system in your discussion. From your standpoint, can you compare and contrast your experience with sort of standard scopes and also the patient comfort issues associated with this versus rigid endoscopy?

David Chaikin: So Roger, I would say to you the most amazing part that I have seen in using these reusable scopes, particularly this one because it comes on its own video platform, is there is no setup. So when I see a woman as a new patient, as part of their examination, albeit with complaints of urgency, frequency ... A lot of times the complaint may be a recurrent urinary tract infection, but really when you get down to it, their complaints are urgency and frequency ... I can do a cystoscope as part of the initial physical examination. I can rule out things like urethral obstruction, I can look in the bladder, I can rule out carcinoma in situ and other bladder cancer problems. And that alone has really changed for me because it has now become part of a physical examination. It's very easy.

There are a lot of patients who you may put off doing a cystoscope for a long time just because of the hassle of scheduling and so forth. I do it right in the room. There is really no setup. The nurses are used to it. Really, all they do is hand me a line for the fluid, and that's it. As far as comfort is concerned, the sheath is very small. It's about 12 french, and I really haven't had any patients complain of pain associated with it. Just as if when I use a rigid instrument, there is almost always initial discomfort, although that goes away with time. So, in terms of patient comfort, I think that it is an improvement, and in terms of efficiency in the office, it is a major improvement.

Roger Dmochowski: Thank you so much. Dr. Goli, you really highlighted on some very interesting and thought-provoking data that you have regarding cost savings. As we all know, our practices are increasingly being subjected to really circumferential pressure to maintain and decrease costs, spending really at every possible intersection of practice. You mentioned, though, something that I think is also very important, and that was the throughput in your office, especially the acceptability of your support staff. Can you talk a little bit more about how you guys have optimized that and also how your staff and employees have viewed the acquisition of this system?

Vijay Goli: Absolutely. Thank you, Dr. Dmochowski. Right. So one thing is for sure. I think everyone that switches to a single-use disposable system will find that their staff is just as happy as your patients are. First, as Dr. Chaikin reported, the scope is actually very much more tolerable for a patient's feeling of discomfort. That is for sure. Also, staff now does not have to spend time, several hours a day just cleaning scopes in between patients. They love it because it frees up their time to do other things and also not be just basically like a worker bee. All they have to do, that's what my medical assistant said to me, one day said, "Doctor, when is this scope going to be available," prior to being able to go to market. Because she said that, "Listen, I love that scope. It's so great to be able to just open a disposable system and then just throw it away and get the next patient." They really will get involved with this rapidly. Human beings are naturally lazy. So we promote that by allowing them to get a disposable system.

One thing though, that I would like to say as an alternative, I know Dr. Chaikin mainly uses this for females, but since my practice is both male and female, I found that I can actually utilize the Uro-V and/or the Uro-N scope for males as well to evaluate their urethra. I've had several patients come in with urinary retention emergently, and instead of sending the patient to the emergency room and potentially having to go to the operating room, which would just ruin your whole day, as well as the poor patient's, I have them come to the office and I perform a urethroscope using the Uro-V scope immediately and I can assess whether they have a stricture and evaluate their anatomy immediately.

As Dr. Chaikin said, I can actually do the procedure on the first time that I see the patient and also be able to have more confidence in either advancing a catheter into the bladder more easily if there is a large obstructive prostate versus a stricture, which then I can pass a glide wire and dilate over safely. And that is where I started discussions with the team at UroViu that we should consider utilizing this in the emergency room so that we could prevent the injuries caused by nursing staff blindly passing catheters into a male patient's urethra when they come in with retention and not knowing the anatomy. Either we or the ER physician, with our training can perform a urethroscope right then and there and evaluate the urethra, which will make a huge difference.

Also, I've used the Uro-N scope on males when I had a patient come in who had a catheter that would not release the balloon fluid. I was able to place the scope adjacent to the catheter, go up to the balloon and pierce the balloon using my needle from the Uro-N scope. So this is all so much easier to perform in the office setting as well. The patients were extremely satisfied with this type of treatment as well as ourselves because now we don't have to rush to the emergency room or the operating room to perform these same procedures.

Roger Dmochowski: Thank you very much. You touched on some very important things. From a health systems standpoint, both the ability to impact the length of stay or avoid the length of stay is going to be critical to our hospital partners. But the other thing is the patient safety aspect, which is obviously an area that is associated with significant litigation is catheter-related trauma to the urethra, especially in males in the acute hospital setting. So something that can be done to lessen that and potentially mitigate the financial risk associated with medical-legal implications of catheter traumas is a really critical and potentially significant benefit for the care of patients.

As you've heard today, this is a fascinating addition to our armamentarium. You've heard from two very busy urologists, their experience and their very high approbation of their contact and experience with this device and the many attributes that really do potentially make this device the next really revolution in the endoscopic evaluation and potentially also endoscopic manipulation. Plus, you heard some very interesting implications from the standpoint of not only diagnosis but also treatment, especially related to BOTOX administration. And also from a standpoint of avoiding trauma and other issues associated with difficult catheterization.

I want to thank you today for your attendance and listening to this very interesting discussion. There is more data being accrued clinically, and we are very excited about the potential for this in the future for the care of our urologic patients. Thank you very much.