Scott Roth 0:00
Scott. My name is Dr Scott Roth, and I'm a non invasive cardiologist, essentially an echo guy. I used to run the echo lab at LIJ in New York, and this company largely grew out of that clinical experience. So question is, why am I here talking about intensive care units and ICU patients and and things like that. And essentially, think about it, right? Why do we build ICUs and staff from 24/7 there's only one reason that we have intensive care units, and that is to maintain organ function while whatever therapy has a chance to work. That's the only reason we spend that effort. Okay? The way organ function works. We have to get perfusion, oxygenated, blood flow to the organs. And as you know, picture on the left is the heart. Think about it like a pump, right? So a balloon that's going to fill and squeeze create blood flow and pressure and perfuse your organs. That's what the game is about. The problem lies largely to the nurses, okay, how are they going to manage these patients and maintain organ perfusion? Very important problem, because organ failure is the number one cause of death in ICUs in the United States and around the world. The problem that they have is that the information that they're using to manage these patients largely doesn't tell them what's happening with the pump, only with the output of the pump. Okay? So if you look at the bottom, what we've had for 50 years is hemodynamic monitoring, monitoring blood pressure and blood flow. That's fine. Tells you that there's a problem, but it doesn't tell you exactly what to do, okay, when the patient has a problem. In contrast, if you ask me a cardiologist to come to the bedside and help them. I can use cardiac ultrasound and look at filling in function and tell you what to do, but that's not available as a monitoring tool in the ICU. It's certainly not available as a tool for the nurses. So either cardiologist or someone with that expertise is not going to stand at the bedside for 24 hours, 12 hours, or even an hour, okay, and you won't be able to use it to see the dynamic changes. So what that leads to is that the nurses and the teams in the ICU are typically guessing trial and error. If you've ever heard of a fluid challenge, that's trial and error. So what we did is we created essentially a new category, using ultrasound, in particular, transesophageal echo as a monitoring tool in places like the ICU. Took a lot of technology to accomplish that, but it creates a new category that's, we think, over a billion dollar category. So let me show you what that's about. Okay, the product then consists of, focus on the first three components, right? There's a disposable probe is a transesophageal echo probe that's single use. FDA cleared to stay in for up to 72 hours. There's now a handheld ultrasound system that that connects to and the image is transmitted wirelessly to an iPad or a tablet. The next step is that we've created machine learning algorithms to automatically measure and help interpret the image for the nursing crowd, to a large extent. So now, when you put that all together as a package, what you have is Te monitoring for nurses to maintain organ function in the ICU. We already know that the probe works, because we've seen that in over 20,000 patients, and it changes what they do easily 70% of the time. Crazy consistent. You can go into any ICU in the world and see this happen in real time. Give you a quick example. So here's a patient who came out of the noncardiac or had sepsis, septic shock, ends up in the ICU, but still unstable, still hypotensive. Given a lot of fluid, a lot of pressures, you look at the numbers, low blood pressure, low flow, but it doesn't tell you exactly what to do. Should I give more fluid? Should I do something else? In contrast, you put the probe in, you get an image. You're looking at a short axis, or cross sectional view of the main pumping chamber, the left ventricle. And what you see is that, by both the picture and the numbers, that the left ventricle is actually filled appropriately. Okay, so I don't need to give him any more fluids, but what you'll notice is that a young patient like this, who's dying from septic shock should be squeezing every last drop of blood out of the ventricle with every beat, and he's clearly not right. This is a weakened pump, so what they should do is completely change course, back off. Don't give more fluid. Add an inotrope. Make this pump stronger. Okay? And they were able to wean them off. Pressers by the next morning, we think that this preload, contractility will essentially become new vital signs in the ICU that said, we've been had the opportunity to develop a very good IP portfolio, especially around the probe and the unique things here some new ones pending every everything you see on the left is already FDA cleared and currently in use in a small number of reference sites. Yes, and what we're doing today is, on the right, we have developed the machine learning algorithms to automatically measure and interpret the image, and now we're performing final validation, if you will, and therefore we expect FDA clearance before the end of the year. So put that together as a package, and it's a very low risk regulatory path at this point, no miracles, no outcome studies, just validation on the on the images that are being collected. These are the types of sites that we've been working with around the country, and you'll notice some of the biggest hospitals in the country. Essentially, we've been very fortunate to be able to do that. I also mentioned that we've seen the probe in over 20,000 patients, zero complications. It's very small, thin, flexible, like an NG tube, okay, no issues. The business model is also very compelling in that it's a razor razor blade model. So what you get is the probe itself is Single use, disposable, sells for about $1,500 and we expect that a large hospital system would be then using that in multiple departments, multiple ICUs, multiple hospitals within their system. And that rolls up to close to a million dollars a year in a large hospital at the same time, high margin business. So essentially, it's a recurring revenue high margin business. And the capital component here, the handheld is very small by comparison experience group. We're very realistic. Okay, we know there's over 4000 hospitals in the United States that could use it. We're targeting 453 because we know they have the multiple departments, and this can help them at the same time, what that rolls up to is a very realistic plan, okay, for the next five years. So with an initial investment of $5 million and then a subsequent follow on to scale, what you see is revenue of about $100 million at five years. What I want you to notice is that only takes 172 out of the 453 hospitals. Okay, so these are hospitals that we know will adopt. We're not talking about spreading it widely, obviously, with a strategic or a partner that could be much bigger, much faster. This is our go it alone plan, if you will. So presently, we're asking for $5 million to complete the path to this next regulatory approval. We're open small company, and we're certainly open to different ways to accomplish that at the beginning, and like I said, We'd then be planning on an additional raise to really, truly scale once the one touch hemodynamic software is on the market for the nurses, and my nine minutes is up, I think so I'll stop there. You.
Scott Roth 0:00
Scott. My name is Dr Scott Roth, and I'm a non invasive cardiologist, essentially an echo guy. I used to run the echo lab at LIJ in New York, and this company largely grew out of that clinical experience. So question is, why am I here talking about intensive care units and ICU patients and and things like that. And essentially, think about it, right? Why do we build ICUs and staff from 24/7 there's only one reason that we have intensive care units, and that is to maintain organ function while whatever therapy has a chance to work. That's the only reason we spend that effort. Okay? The way organ function works. We have to get perfusion, oxygenated, blood flow to the organs. And as you know, picture on the left is the heart. Think about it like a pump, right? So a balloon that's going to fill and squeeze create blood flow and pressure and perfuse your organs. That's what the game is about. The problem lies largely to the nurses, okay, how are they going to manage these patients and maintain organ perfusion? Very important problem, because organ failure is the number one cause of death in ICUs in the United States and around the world. The problem that they have is that the information that they're using to manage these patients largely doesn't tell them what's happening with the pump, only with the output of the pump. Okay? So if you look at the bottom, what we've had for 50 years is hemodynamic monitoring, monitoring blood pressure and blood flow. That's fine. Tells you that there's a problem, but it doesn't tell you exactly what to do, okay, when the patient has a problem. In contrast, if you ask me a cardiologist to come to the bedside and help them. I can use cardiac ultrasound and look at filling in function and tell you what to do, but that's not available as a monitoring tool in the ICU. It's certainly not available as a tool for the nurses. So either cardiologist or someone with that expertise is not going to stand at the bedside for 24 hours, 12 hours, or even an hour, okay, and you won't be able to use it to see the dynamic changes. So what that leads to is that the nurses and the teams in the ICU are typically guessing trial and error. If you've ever heard of a fluid challenge, that's trial and error. So what we did is we created essentially a new category, using ultrasound, in particular, transesophageal echo as a monitoring tool in places like the ICU. Took a lot of technology to accomplish that, but it creates a new category that's, we think, over a billion dollar category. So let me show you what that's about. Okay, the product then consists of, focus on the first three components, right? There's a disposable probe is a transesophageal echo probe that's single use. FDA cleared to stay in for up to 72 hours. There's now a handheld ultrasound system that that connects to and the image is transmitted wirelessly to an iPad or a tablet. The next step is that we've created machine learning algorithms to automatically measure and help interpret the image for the nursing crowd, to a large extent. So now, when you put that all together as a package, what you have is Te monitoring for nurses to maintain organ function in the ICU. We already know that the probe works, because we've seen that in over 20,000 patients, and it changes what they do easily 70% of the time. Crazy consistent. You can go into any ICU in the world and see this happen in real time. Give you a quick example. So here's a patient who came out of the noncardiac or had sepsis, septic shock, ends up in the ICU, but still unstable, still hypotensive. Given a lot of fluid, a lot of pressures, you look at the numbers, low blood pressure, low flow, but it doesn't tell you exactly what to do. Should I give more fluid? Should I do something else? In contrast, you put the probe in, you get an image. You're looking at a short axis, or cross sectional view of the main pumping chamber, the left ventricle. And what you see is that, by both the picture and the numbers, that the left ventricle is actually filled appropriately. Okay, so I don't need to give him any more fluids, but what you'll notice is that a young patient like this, who's dying from septic shock should be squeezing every last drop of blood out of the ventricle with every beat, and he's clearly not right. This is a weakened pump, so what they should do is completely change course, back off. Don't give more fluid. Add an inotrope. Make this pump stronger. Okay? And they were able to wean them off. Pressers by the next morning, we think that this preload, contractility will essentially become new vital signs in the ICU that said, we've been had the opportunity to develop a very good IP portfolio, especially around the probe and the unique things here some new ones pending every everything you see on the left is already FDA cleared and currently in use in a small number of reference sites. Yes, and what we're doing today is, on the right, we have developed the machine learning algorithms to automatically measure and interpret the image, and now we're performing final validation, if you will, and therefore we expect FDA clearance before the end of the year. So put that together as a package, and it's a very low risk regulatory path at this point, no miracles, no outcome studies, just validation on the on the images that are being collected. These are the types of sites that we've been working with around the country, and you'll notice some of the biggest hospitals in the country. Essentially, we've been very fortunate to be able to do that. I also mentioned that we've seen the probe in over 20,000 patients, zero complications. It's very small, thin, flexible, like an NG tube, okay, no issues. The business model is also very compelling in that it's a razor razor blade model. So what you get is the probe itself is Single use, disposable, sells for about $1,500 and we expect that a large hospital system would be then using that in multiple departments, multiple ICUs, multiple hospitals within their system. And that rolls up to close to a million dollars a year in a large hospital at the same time, high margin business. So essentially, it's a recurring revenue high margin business. And the capital component here, the handheld is very small by comparison experience group. We're very realistic. Okay, we know there's over 4000 hospitals in the United States that could use it. We're targeting 453 because we know they have the multiple departments, and this can help them at the same time, what that rolls up to is a very realistic plan, okay, for the next five years. So with an initial investment of $5 million and then a subsequent follow on to scale, what you see is revenue of about $100 million at five years. What I want you to notice is that only takes 172 out of the 453 hospitals. Okay, so these are hospitals that we know will adopt. We're not talking about spreading it widely, obviously, with a strategic or a partner that could be much bigger, much faster. This is our go it alone plan, if you will. So presently, we're asking for $5 million to complete the path to this next regulatory approval. We're open small company, and we're certainly open to different ways to accomplish that at the beginning, and like I said, We'd then be planning on an additional raise to really, truly scale once the one touch hemodynamic software is on the market for the nurses, and my nine minutes is up, I think so I'll stop there. You.
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