Carlos Leal Presents Kneevoice at LSI USA '23

Transcription

Carlos Leal  0:05  

Carl's Leal, an orthopedic and knee surgeon, co founder and chief scientific officer of Kneevoice. And what I will show you today is a device that analyzes the sound of the knee to determine cartilage damage. And why the knee because it's the largest Z saw the largest bone, the largest cartilage, the largest loads that you can imagine. And the numbers are also large in terms of disease, about 100 million Americans, according to the CDC have suffered from knee pain. And out of those about 33 million are suffering promotes arthritis, it's a second most common cause of chronic pain, which is interesting. But for anterior knee pain, and for cartilage damage, we really do not have a lot of diagnostic options. The ones that are out there are expensive or time consuming, and they're not always very precise. So we've been searching for this. And I've been searching for this for more than 25 years, more than two decades trying to find a good medical biomarker for cartilage damage, especially in this patellofemoral joint. And at least until 10 years from before, we were not able to understand how much cartilage damage you really have, using the regular images that we have. So we know that X rays really show static images, they're good for alignment, they show the joint space as well as the CT scans, they may show us lateral displacement to tilt the joint space, but they don't show us the cartilage actually, if you want to see the cartilage, you have to go for an MRI. And the MRIs. The conventional MRIs are good, but they're not really, they don't have a very good specificity or sensitivity for early or mild patellofemoral osteoarthritis, if you want to see the real cartilage you have to go for cardiogram. And this requires a very special type of MRI or sometimes even conscious media, which is invasive. So the literature is full of this reports that it's not that great to determine how the cartilage is doing. So we believe that people suffering from knee pain deserve something better. We believe really, that we need to listen to the body, and we just don't have the wisdom or the tools to do that. So that's why we created the the Kneevoice. Out of a very simple fact. healthy cartilage generates little friction. And that generates very little noise. But in your cartilage produces more friction and a greater noise. And as you can see from mild, moderate and severe cartilage damage, then you have more noise that can actually be from this simple fact turned into a simple hypothesis. You will check on the patella femoral contact that generates audible emissions, something that we can really measure and we can acquire before us as knee surgeons, we just put our hands on the on the on the kneecap of the patient, and then just try to understand what's going on there. But the noise. And many times the noise comes before pain when it's painful, it's usually too late and you require surgery. So this is a device it's a new voice devices composed of an external audio and vibration sensor. It is attached with an adhesive patch and has a little gyroscope on the side. So you can monitor the flexion and extension. And it goes to this very nice iPad looking touchscreen, that will give you a score from zero to 100. Zero being horrible and 100 being perfect. This will give you a swell, a scale of excellent and good, fair or poor in those four degrees, and it will show in colors and as a very good experience for the patients because it has a speaker so you can actually listen to the knee and watch the graph. Or you have what's going on. This is how it looks like it's a final product. It's not a prototype anymore. It's ready to market. It's ready to scale. These are this is the way the microphone or the sensor looks like the gyroscope looks like and the patients really love it. I mean, you go and it's actually something that we do not have in many of our practice offices. You don't see anything and an orthopedic office. You just see the hands of the doctor and he's telling you things and asking for some kind of test that has to go somewhere else. We just said the patient in a high stretcher on a high chair and then just do eight flexion and extension takes seven minutes to do and then we'll get up very easy data that we can move with. We have to prove it. The evidence is out there. Where we submitted to arthroscopy this study 120 Knees, we compared MRIs with Kneevoice scores in patients that go to surgery out of those 120 Knees As we compare two MRIs, with knee voice and arthroscopy to see if what we hear is what we get. And we found very interesting data were 30% more accurate than MRI, in low, mild or moderate and 15%, even in severe osteoarthritis, which means that what you hear is what again, and means as well that you can avoid MRIs, in many patients, at least for follow ups. And if it's a mechanical problem, you can go for a mechanical type of exam or image. But if you want to do something metabolic and see how the cartilage is doing, actually, there's nothing but this. How can we use this? Well, for us in the medical use, it's very good for treatment indication based upon dynamic data of cartilage damage, not just images, not just details, or the motion or where the patient is telling you. This is great for monitoring and particular interventions, when you have knee pain, and the world is divided in those who have knee pain, and those who will. You go to the doctor and he will tell you probably 90% of the people will not have surgery will be intervened with physical therapy, medication, injections, orthobiologics, hyaluronic acid, how do you monitor that pain? Pain is an emotion, it's subjective, I need a number. And it's something that really tells me that this person is getting better or not. And I'm not going to do an MRI every three months. It's expensive. It's time consuming. It's not the way to go. We can prescribe very good physical therapy protocols, we can prescribe exercise in a better way, we can tell people this is what you do, this is what you shouldn't do, with a very precise way of doing it. And in the future, we're gonna have a wearable that will provide a dynamic non invasive and precise health and wellness biomarker. And in sports, we can really work on this for performance and for joint damage prevention. The other benefits is that we will have with our neural network of huge database and population already have more than 10,000 data there that is useful for medical and pharmacological or surgical analysis. Where are we now, we've already done all the heavy lifting, even though we're a very small company based in Santa Monica here in California. But the device is ready to mark is ready to scale horizontally machine learning with the software, we have done a pre submission as a de novo. And actually, we have a very nice IP with patents from the UK to South Korea, all over the world. Our go to market and revenue strategy has changed a little bit. Now we prefer to give the user a physician, physical therapist, insurance company hospital a group, we will give them at no cost this device, and then they can charge here the states with their current CPT codes from 35 to $120 per exam per test, we will charge $15 To the one who's using this device with a minimum of 25 a month, which means that the doctor will make money from day zero, the company will make money from day zero, and then we can have a better strategy for making this a real gold standard. We do need a specific CPT. But that needs a lot of work that needs a lot of time. But so far, we're the ones that are existing now we can work on. The next step is that the knees not the only one. The only joint one would be listen to, we're going to work on different joints specifically. And ATM joint, we're already have a very good development. So far, we have raised $2 million from founders and seed rounds and we're seeking for a series a 5 million for FDA clearance in the mass market, Kneevoice's production. And that's what we're looking for. I'm very proud to be part of this management team and founders but also with this scientific advisory board with the best knee doctors in America and in the world. And we're very proud of having also an Executive Advisory Board with people coming from companies like, Zimmer Smith and Nepean Oracle and a scientific advisory board with the leaders of past presidents of the arthroscopy Association of North America like Dr. Rob Hunter, or Jack Barrett, plus the Olympic doctor from Germany, the doctor from Barcelona football team or the president of the International Society for Thrace copies that calls doctors brigade. We understand that medicine is realizing that the body holds the answers and we just need to give it a voice and our little contribution is that everybody has the right to move with confidence pain free and that is what we want to bring them. Thank you