Tim Moran 0:00
Good morning, everyone. It's great to be here. My name is Tim Moran, I'm the CEO of Motus Gi. And Motus Gi is a publicly traded company. We trade on NASDAQ under mo Ts. And our focus. And what I'm going to talk to you about for the next couple of minutes is all around GI and really providing innovative technologies. Starting with our peer review system. We are addressing arguably one of the largest unmet needs in health care, and that's associated bowel, insufficient bowel prep prior to colonoscopy. What you'll hear today is that we're playing in a very large multibillion dollar addressable market. We've supported our technology, both efficacy and safety data through four clinical studies to date, three of which are peer reviewed. One is out for peer review. We have a large multicenter randomized control trial that we'll initiate later this year, really centered around reimbursement. We have patented first mover advantage, so we have over 30 granted patents on our technology, we have more than 30 pending patents. And there's no competition in this space today. In addition to our current focus, which you'll hear is in the hospital market, we see significant follow on opportunities both through expansion geographically but also indication expansion. And then finally, our team is led by an experienced medical device leadership team with many years in both large multinational medical device companies and small startups. So if you've had a colonoscopy, you know that the procedure itself is not all that difficult, but getting your bowells clear and ready for that colonoscopy is the difficult part. In terms of the unmet need, there are more than 50 million colonoscopies done each year on a global basis. And 20 million of those are done here in the United States. The issue is, a study was done by Cleveland Clinic just a few years ago, it was a very large study looking at this problem. Specifically, they looked at 9000 patients over a four year period. And what they did was they tracked the patient when they were admitted into the hospital to have a colonoscopy administered their bowel prep, which is typically a 24 hour process, and found that more than half 51% of the patients within their institution stayed for at least one additional night, sitting in a nursing bed or ICU bed, doing bowel prep, so they could have their colonoscopy done. Obviously, you know, that's a very costly issue for the healthcare system. Because most of these procedures are reimbursed through a DRG, you know, a single bundled payment that is looking at the entire episode of care. So when a patient's stay is an extra night or two, it's hard to recoup those costs, but also from a patient satisfaction and a clinical perspective, you know, these delays lead to aborted procedures, the need for repeat procedures. And then of course, when you don't have visualization during a colonoscopy, the biggest issue is Miss pathology. So let me let me dive a little bit deeper. So this is kind of the patient journey, if you will. And what I'm talking about in this piece here are patients that need an emergent colonoscopy. So these are not the patients like URI who may have to go for a screening colonoscopy, every you know, three to five years. These are patients that have an issue such as a lower GI bleed, or some other problem where they find themselves going to the hospital into the emergency room. And they ultimately get admitted needing a colonoscopy done. And you can see as I outlined earlier, the first thing that's done after their workup is they're put into either a nursing bed, or they're putting into an ICU depending on the degree of their bleed. They're administered that normal prep process. So they're put on 24 hour of clear liquid. And typically in the hospital, they're given a product called Golightly. So it's four liters of purgative that's very difficult to drink. Particularly, if you have other medical conditions comorbidity, these patients oftentimes can't even lift the glass up to drink eight ounces, no less four liters in a 24 hour period, which is all playing the role in this pain point of them not being ready to have their colonoscopy done on time. That's where we come in. And that's where we believe that we can disrupt this significant unmet need. So we have a product called Pure view. And I'm happy to say that about four weeks ago, we received FDA clearance of our third generation of this system, Pure View EBS. You see the picture here on the left side of the slide. It's driven. It's a razor razor blade model, it's driven by a small piece of capital equipment that really drives all of the pump technology. And then on the other side of the screen, we have a single use disposable sleeve. This sleeve fits over the kaleidoscopes that are used in the market. So Olympus obviously a very large player in that space Pentax and Fuji kind of round out that market. Regardless of which column Kaleidoscope you're using our single use disposable sleeve fits over that and really gives the physician then the power to complete their exam, you see that there's five water jets that are at the head of our the distal tip of our sleeve, and then a very large suction channel that allows them to pull debris out of the colon, I'm going to show you a few pictures in a moment. What's really nice about this device, and the way we've designed it is it doesn't interrupt the traditional workflow. So the physician is doing their normal colonoscopy now just having the power to clean and evacuate debris from the colon. But also it doesn't interfere with the working channel, the scope, you see in the center of that black section of the picture, the working channel is obviously where the physician would want to use tools to go down and do polypectomy and other procedures. So we're not interfering with any of that, where as a matter of fact, we're giving them the visualization and allowing them to do their work at the same time. So I talked about the technology. So it's very simple, yet sophisticated, right? You have to be very careful when you're cleaning the colon that you don't cause any damage to the mucosa abrupt the colon wall. So some of the things that we built into this technology that allow us to do this both quickly and safely, or pulse vortex irrigation. So you see a picture there, we're basically taking a mixture of water and air and pulsing it into the colon when the physician steps on the foot pedal, allowing them to clean about 15 centimeters of the colon at a time. So they're able to do this very quickly. And it almost creates a washing machine effect where it's scrubbing the wall of the colon, getting it here in films off the wall of the colon and then providing kind of pristine visualization of the of the colon wall where they can then identify Is there a polyp, a flat sessile polyp that oftentimes can be very difficult to identify if there's any type of debris covering it. On the other side of the slide, you see our smart said suction. So not only are we providing them with significant suction capacity, but also we've built smart sensor into this suction capability. So as the system is pulling debris out of the colon, if it senses that a clog is forming, it'll automatically purge itself back out into the pulse vortex irrigation, breaking up that debris further and then simultaneously sucking out of the colon. So this is all happening seamlessly without any intervention from the physician or from the technician. You still have dirty ears and clean ears. Now you get to see dirty colons and clean colons. So you're happy you chose track to today. But you know, at the end of the day, this is all about it's not about cleaning colons. It's about providing visualization, so on demand visualization, to disrupt a problem that has existed for the you know, since colonoscopy was started, right. And these are real long reaching issues. If you think about Miss pathology, because the physician can't see all three segments of the colon. How we price our system today is the capital equipment is sold at $75,000. We don't view ourselves as a capital company. We're all about driving this procedure and the uptake of our disposable sleeve. So we have various programs. In order to acquire the capital, of course, an outright purchase. We have a leasing partner, we also do bundled agreements and rental programs, the sleeve sells a list price of around $1,100, we have been on the market under a soft launch over the last year during this COVID period. We're commanding an ASP of around $975 per procedure. In the US, we talked about on that first slide the 20 million colonoscopies that are done each year. If you segment that down further, the urgent colonoscopy, so the patients that arrive at a hospital and have to have this done, there's about one and a half million procedures done each year in the US. So if you look at a pricing of our system, and you think about that type of volume, you know, we believe that initially here in the hospital market, we can build a very compelling company with significant revenue growth over the next few years. So in terms of upcoming catalysts, now that we have this recent FDA clearance behind us, we are launching the product. So within weeks of the clearance, we already started to ship our system, we have seven systems out in the market under evaluation. Obviously existing customers that were on our previous generation are the first that we've upgraded. But the feedback has been tremendous, really what we've done from our gen two device to the current pure view EBVs has all been around ease of use. So how can we make the device simpler for the physician in terms of navigating through the colon? And we did that on a redesign of this disposable sleeve? And how can we make the device easy to get set up and ready to use prior to the case for the techs and the nurses that are involved with that. And I think we've really hit the mark with this new design. Obviously, during COVID We had to navigate through the stops and starts in the market, right access issues to hospitals. We believe now that the path ahead is clearing. We've already doubled the size of our sales force. So we've had three salespeople over the last 18 months. We already now have six reps and we'll continue to grow as we see the leading indicator He's come in this year with uptake of the device. I mentioned an upcoming clinical study that we will provide more context to over the next few quarters. This is a multicenter randomized control trial that's really looking at not the studies that we've done to date, which show our device works and provides a high level of visualization compared to the current standard. But when you get that visualization, what does that then enable, can the physician detect more adenomas or lesions compared to the standard of care today? That is the data that in working with CMS, we will need to unlock the next phase of growth for the company, which is the outpatient market. So for the you know, the regular routine colorectal cancer screening, outpatient requires reimbursement to kind of fit into that market. And that's something that we're undergoing now, and hopefully in the next couple of years becomes a nice follow on growth opportunity for the company. And then finally, I mentioned opportunities for expansion. I mean, clearly, we're focused today as a smaller company on the United States as our beachhead. Clearly this geographic expansion, we're having dialogue with other strategics in terms of, you know, how do we attack Europe and Asia. As a small company, we don't have the resources to do that today. But there are others where this product we think, fits nicely into their engine. But also from an indication expansion. We received an FDA approval this past year with our gen two device for using this product in upper GI applications. So not for the colon but for upper GI bleeding, which is also a significant issue, a very high mortality rate with that procedure. And that same, same problem all around visualization. So the physician has blood and clots in their field of view, they can't find out where that bleed is coming from and treat it. So we are planning to submit our next gen peer view EDS for the upper GI indication later this year. And we believe that's going to be a very exciting and compelling market but also provide more utility to the existing capital equipment that's in the market today. So again, it's great to be here in person this year. I will go to the breakout room if anyone has more specific questions and I appreciate you joining the session today.