Carlos Leal, Kneevoice - Spotlight Interview | LSI USA ‘23

Transcription

Nick Talamantes  0:14  
Dr. Leal thank you for joining me in the LSI Studio today.

Carlos Leal  0:17  
Thanks, Nick, it's great to be here.

Nick Talamantes  0:18  
Tell me a little bit about the work you're doing at Kneevoice. 

Carlos Leal  0:22  
Basically, we've been working on a diagnostic device that analyzes the sound of the knee to, to obtain a data that gives us a very precise diagnosis of cartilage damage, something that we didn't have before, something that is pretty revolutionary. It's the leading edge of diagnostic devices. It's an easy, non invasive machine that you can actually have like a little sexy iPad at the doctor's office. It's actually one of the only things if not the only one that we have as orthopedic surgeons in our offices, because basically, we have our hands, and we order exams, and then we make decisions. Now we do have something that is a real experience of patients, that creates a new data that is valuable to determine treatments, follow up and monitor what we're doing.

Nick Talamantes  1:16  
Why don't you tell me a little bit about the technology and how it works. 

Carlos Leal  1:21  
Basically, we've been working on this, you don't imagine how much for almost myself about three decades, I mean, this company is like now 7-8 years old. And in all those years have tried to use microphones. I've tried to use sensors, I've tried to use even the iPad, or your iPhone, putting the iPhone on the microphone and getting the the images that you get with sound and trying to make it a number. So that technology has evolved, after in this past five years, to a very sophisticated medical engineering and sound engineering sensor that you place on the kneecap with a gyroscope on the lateral side of your knee. And they after eight repetitions from zero to 90 degrees, you get the information that you want. So this is basically in a very simple words, a high tech type of microphone, that gives me a number, a score from zero to 100, being zero, horrible and 100. Perfect. And you can divide that in for like, low, mild, moderate or severe damage comes with a color, the patient can listen to the knee can see actually the graph. So it's not only a good experience for the patient, a great aid for the doctor, but also very good technology.

Nick Talamantes  2:40  
What is the current standard of care then for sort of monitoring and understanding knee health right now, you mentioned that there's nothing in the clinicians office today they have to send out for an exam. So what does that look like? How is it patient managed?

Carlos Leal  2:57  
Well, the world is divided two, those who have knee pain and those who will. So actually, you go to the doctor, only if you have pain, actually, right. Most of the people go to the general doctor or the Orthopedic Surgeon General. And say if you want to go to the knee guy, you have to have an MRI, you have to have an x-ray, and then they will go there. The standard of care right now, if you have anterior knee pain, which is our main problem is that 90% of the people don't require surgery. So some of them end up in unnecessary surgeries. Some of them definitely require surgery 10 to 15%. And that 85 90% are treated with physical therapy, load control, medications or injections. And that standard of care ends there. You cannot have anything to follow up and see what you did is actually something good. Because you have to rely on pain and pain is an emotion is like love, you cannot measure it. And then you cannot have a follow up having an MRI every three months, it's too expensive, and it's not a great experience. So in the beginning, the knee voice will allow people to have a marker before you need an MRI or an x ray to go to the knee doctor. That's one thing that the insurance companies love. The other thing is that once you started treatment, which usually is not surgical, not even at the beginning, then you can tell the patient you know what, we'll see how your cartilage is doing. And then next follow ups. And every time the patient comes, you can have a test, it takes seven minutes. It's in the office. It's like taking a blood pressure. It's really easy. It's not expensive. And it really adds a lot to the to the whole pathway of the therapeutic process.

Nick Talamantes  4:50  
So then, is this a new tool in the toolbox so to say or does it take something out? Does it completely replace the need for imaging or using them as complementing technologies?

Carlos Leal  5:02  
That's a good question because it's a totally new technology. Nobody knows about it. Everybody knows how to put your hand on the knee and test and say, Hey, this doesn't sound good, sounds good or sounds really bad or okay, you're fine. But this is a new technology, we're evolving into something totally different from images, which are shadows from X-rays, or magnetic resonance, or bone scanning, invasive procedures, this is totally new, we're basing, we're working on a new diagnosis with a new technology of sound engineering. So it's, it's very hard to get into the medical community. But as soon as you bring in this to the specialists, and the guys, the key opinion leaders have knee surgery in this country and all over the world, they say, Hey, I need this, I would love to tell my patient, you know what, I think that you're not that great, but I'm going to need a number for that. So if you have this or that or that, then we go for an injection, maybe we'll go just for medication, maybe you're going to need surgery before, maybe you're not going to need surgery at all. Because you know, if you if you take x-rays or MRIs or CT scans, you may have a terrible dislocation of your patella or you may have dysplasia or just the shape or your bones are not right. But those are your bones. It's like having a big nose or a small ear, or a blonde hair. It's not a disease. It's an anatomical condition. And in many ways, many doctors all over the world treat that as if it was a disease. And the frustrating thing is that when you take a new exam after years months, it doesn't change that much. So it's frustrating, the patient comes to you and says, Doc, my CT scan is exactly the same as you had before surgery. They have to say, well, it doesn't change much. So what did you do? And then you have the knee will say this is what I did. The cartilage looks better.

Nick Talamantes  6:59  
So you mentioned that the clinicians you're speaking with currently the knee doctors, they are interested in this technology when you're introducing them to it. Are you guys currently in the market?

Carlos Leal  7:11  
We're starting to get in the market because we're in the final phase of approving, we could have had to two pathways. I mean, we could go to an infomercial and sell this. Like with no science. We took it the hard way we wanted to go through the FDA, which at the moment is like 3400 pages just in hardware. But that's what we want to have. And we want to we want a serious medical device getting involved with the key opinion leaders. So we're getting into market but we're in the process of doing the the FDA pre submission that was already done. They asked us for more patients in the states already done 120 patients and guess what we are 30% more accurate than MRI. If you compare MRI, Kneevoice and the findings in surgery 30% In mild, moderate or severe osteoarthritis, even 15% is severe. So if you want to go to the market, you need a final device, we already have the final device, we already have it ready to scale. We already have a beautiful IP, patents from the UK to China or South America Europe in the US. We are in the regulatory process. And now we have also seen CPT codes that can actually work. So if it if it already has the another specific CPT codes, but we have more than 10 CPT codes that can can be used for this device. Well, doctors are just waiting for for that. Because actually the model that our business model is pretty straightforward. I'll give the doctor a device at no cost. They can charge for the current CPTs from 35 to $100. And they will pay is about $15 per test. So they make money from Day Zero. They help the patient the patient is happy, we're happy. And they have to do at least 25 a month. So with this business model, we're able to interest the industry interest insurance companies interest people who work in medical devices, pharmacy, pharmaceutical companies that work with hyaluronic acid, ortho biologics, they want to know what's going on with my injection that work. So doctors if you use my injection, take this device for free. And will will pay for the basics and then you just charge for whatever you need to it's a very nice model that we have changed and then go to market. So we're like this, we just need the final push. Seriously that we're requiring them right now to complete FDA start mass production and give this to the doctors that are waiting for

Speaker 1  9:50  
it. Is that what brings you then to LSI this year you're looking to find investors and make be other strategic partners that can help you guys get over that finish line. 

Carlos Leal  10:00  
Definitely, absolutely, I mean, there's there's three things that we require. Because this is just the beginning. I mean, this is the knee, but we're going for the jaw, we're going for other joints, we can listen actually to every joint. So we're going for a wearable. So those three things are basically all the regulatory processes, the production of the device, the go to market strategy. And obviously, like every startup we need money, we need money to get things together and and go further with the production so we can we can go finally to sell the product when it's working and when the doctors have it. So we pretend to have a lot of these devices moving around. And I am absolutely sure we are absolutely sure that this will become a gold standard and medical care for knee surgery.

Nick Talamantes  10:52  
Dr. Leal I want to wish you the best of luck and to use a maybe poor metaphor running this race. I believe that you guys are just about there. And I hope that you guys are able to find the get that second wind to cross the finish line here. Thank you so much for stopping by the studio and telling me about your story and the work you're doing at Kneevoice.

Carlos Leal  11:15  
Thank you. Thank you. We can test your knee anytime.

Nick Talamantes  11:17  
I probably need it