Kathy Magliato, Cordex Systems - Studio Interview | LSI USA ‘24

Kathy Magliato  0:00  
Thank you. So I'm Dr Kathy Magliato, and I'm a cardiothoracic surgeon. I actually specialize in heart and lung transplantation, but I'm here today as the founder, CEO and Chief Medical Officer of Cordex systems. And at cortex systems, we've developed a technology that can actually measure the earliest, earliest warning sign of the development of heart disease, and that's important, because heart disease is pretty much preventable, right? It's about 80% preventable, and yet it's the number one killer of men and women in the world. So having a technology that could diagnose it early could be really, really helpful. Turns out that you have about 60,000 miles of blood vessels in your body. If I were to sew them together end to end, they would literally wrap around the world TWICE, TWICE, which is extraordinary. And every millimeter of every mile of those blood vessels is coated with this beautiful single cell lining called the endothelium. This endothelium, think about it like Teflon coating right inside your arteries. When that lining is healthy, you don't develop heart disease, but when that lining starts to break down, that sets the stage for plaque to develop inside your arteries and clog them. That happens inside your heart, you get a heart attack. Inside the neck vessels, the carotids, you get a stroke. And so what our technology does is essentially, basically it will assess the health of the lining of the arteries. Because what we actually have found is that the earliest sign that that lining is starting to break down is you lose compliance, meaning the arteries start to stiffen. And that's essentially what our cuff as a sensor can pick up. So when you start to think about, you know, what market would that be? Well, it turns out that every risk factor for heart disease has only one thing in common. They all destroy that lining, right? And what's crazy is you think about how we treat heart disease right now. You know, we give you pills to treat your blood pressure, your cholesterol, to treat your you know, hypertension, we also tell you to lose weight, eat, right? You know, decrease your stress, exercise. But at no point in time are we actually measuring a metric of your cardiovascular health. So we call our device a smart cuff, and that's because it's based on the principle of an ordinary blood pressure cuff. So the way we develop the technology is the following, I actually figured out pretty quickly I wasn't going to solve the issue of heart disease from inside of an operating room, right? So I went back to school and I got an MBA at UCLA Anderson, where I met this incredible PhD bioengineer named Dr Michael Witt. And Dr Michael Witt came up to me the very first day of class and said, Oh my gosh, you're a heart surgeon. You know, I'm a bioengineer, and I have this incredible idea. His incredible idea was to take the one tool that every doctor uses just about every day on every patient, which is an ordinary blood pressure cuff, which we've had since 1881 and using a proprietary mathematical algorithm, we can turn an ordinary blood pressure cuff into a linear sensor that can biohack your pulse at about 200 data points per second to create a measurement of vascular health. So essentially, the technology is built on the platform of a blood pressure cuff, but a blood pressure cuff on steroids, because we gather so much more information than a standard cuff, and we call the technology the smart cuff. And we started the company on grant money. We applied for several grants. We won every grant we applied to to the tune of about $700,000 then we took the company through two different rounds of capital, and I actually raised all the money for my company without using an outside person or placement agent. And we raised about in total, almost $12 million so right now the company is actually raising our third round, which we're considering sort of a late seed round, and that's a $5 million round of capital, and our milestones for that round are going to be FDA approval here in the US and CE marking in Europe. So we need to do some clinical studies to achieve a 510, K de novo approval process on a monitoring claim. So again, about a $5 million round of funding, and that should take us, you know, hopefully, two to three years to accomplish. I'm really proud of the fact that we've tested, actually over 700 patients with our technology. So you know, remember, you're starting with something on paper, right? And then the first thing you got to do is lock down all the intellectual property. So currently, we have about 34 patents in 17 countries, and we've kept part of the algorithm as a trade secret, then we had to do all the clinical testing. So all of our clinical testing is about, you know, all in a little over 700 patients. Most of our testing was done at Johns Hopkins University. So we went to, you know, the number one ranked hospital for 21 consecutive years. Excellent team, and did our. You know, most of our clinical testing there. With all of that data, we were able to publish several peer reviewed papers, and we also were able to present at the American College of Cardiology meeting and the American College of Sports Medicine with our data. So let's talk for a minute about how the device works. So it's it's so simple, we actually designed it so that it wouldn't even be needed to, you know, a physician, to even use so anybody who can take vital signs in a doctor's office can, frankly, use our device. So what we do is this, we put a cuff on your arm, and we can use any blood pressure cuff on the market. We put a pulse oximeter on your finger. The technology itself, the device, you just simply hit a start button on the device. You never touch the technology again. But now I have a way to quantify your vascular health so that I can really look at it over time, and you really serve as your own baseline, because everybody you know has some level of vascular endothelial dysfunction just by being a human on this planet and being exposed to, you know, pathogens on the planet, we can actually find endothelial dysfunction in children as young as eight years of age. So what we want to do is measure your vascular health, then we want to intervene with medication or lifestyle changes, and then we want to measure it and see how your vascular health changes over time. So having a precision health metric unique to you is a very, very powerful tool in medicine. I.