Victor Gura, Wearable Artificial Organs - Artificial Kidney & CRRT System | LSI USA '24

Victor Gura  0:04  
I'm a physician and an inventor, and I take care of dialysis patients. I'm also the founder of the company. The impetus to develop this technology was that the outcomes of dialysis are awful. The quality of life is poor, mortality is high, and the costs are astronomics, and the only way to improve that was to come up with better technology. When your kidneys don't work, you filter your blood only with dialysis for three four hours, three times a week. That's 12 hours a week of blood filtration. Your native kidneys, when they're healthy, filter your blood 24 hours a day, seven days a week. So in fact, we're replacing with 12 hours of blood filtration on dialysis a week, 168 hours of blood filtration with normal kidneys, no wonder things don't work well. So we had to figure out a way to miniaturize a dialysis device to the point that it will work 24 hours a day like a normal kidney does. And we did. Our company is a breakthrough technology addressing a very large market. We have a robust patent library. We have three human trials done around the globe. We made this thing work in Italy, in London and in Seattle, and the data published in the likes of Lancet. So if it worked in Italy, it worked in London and it worked in Seattle, technology works. We have an application for military medicine. So if you figure out the field hospital that cannot offer dialysis and cannot evacuate the patients. We have the solution for that, and we got support from the DOD for the military application. We will have a 510, K application for the wearable for chronic patients. It will be a PMA. However, the PMA has been very supportive. We have breakthrough status with the agency, and the agency also issued a letter of support for our project from FDA. Medicare reimbursement is guaranteed by statute, because they reimburse dialysis. And we've been to FDA, and they really, I'm sorry, to Medicare, and CMS really likes it, and they said there will be no problem with reimbursement. We're raising now 10 million after we got about eight and a half million in non diluting funds from DOD and NIH. So we're going to move into the next one. We do have a pipeline, not only in the military application, but pediatrics, intensive care, disaster relief and cardiac i The business model. How does this make money? Well, we know how much Medicare pays for something like this, and it's a razor and blades model where the device itself would sell for 20, $30,000 but the or lease, but the money is in the consumables, but the margins are about 70% we're profitable with point 2% of the market share. And we're going to disrupt a major sclerosis infrastructure of dialysis clinics that will no longer be necessary would become obsolete, as I mentioned, when you do dialysis three times a week. In the left upper corner here, you see a dialysis unit where people are sitting tied down for hours on end the patients say they're doing time they have to remove, to remove about a gallon of water. In four hours, when you have normal kidney function, you pee about a liter and a half a day. So in two days, you do about a gallon. Imagine taking that gallon in four hours instead of 48 hours. That's one of the many reasons why people on dialysis don't do very well, and there, because of time, I could talk about breakfast tomorrow, about the misery of being on dialysis. That everybody knows that with a wearable device that weighs only two pounds and people can walk around with it and filters the blood. 24/7 you wouldn't go to the clinic, you would be able to work. 95% of patients on dialysis today are disabled. Patients would have the ability to hold the job and go to do your chores and move around. This is pictures of our beginning where we reduced a large machine into a miniaturized device, and I on the upper right corner you see our first pig animal trial was done in situ, Sinai. And then the next to the right is our trial in Italy, where a patient that is in the middle there, between me and Professor Ronco from Italy, is having dialysis as he walks in the park. The dancing lady up in the right is a lady undergoing dialysis. The picture shows in the bottom, blood running through the device. This is our model two. This picture was published in Lancet. In the bottom left, we have other pictures of our model, two on patients undergoing dialysis in Seattle and in London. But patients said it's too heavy and too big. They don't want to walk around with this large belt, so we had to please the patient, who is the ultimate client. And the client, as you know, is always right. So we came up with a different way of miniaturizing further. And to the bottom right, you see our next model, and I think we can make it a little even less than that. It's only two pounds, and it works 24/7, and it goes in a discrete way to walk around anywhere. We have a team with a CEO that is younger and more business oriented than me, a CFO VP of regulatory and quality business people and JD that is also manages a lot of our projects. Our Scientific Advisory Board is a WHO IS WHO of the field of nephrology in the United States and in the globe. Our next two trials. Last of those two is going to be a pivotal trial, after which we expect to go to market. That's going to be done in Boston, in the Brigham, under the collaboration with Dr boventry in who's a chief there, but we have a really stellar group of people from around the globe that has been supporting us for the last few years. We collaborated with a lot of people around and we've been written up in all kinds of places, including the economies, the LA Times, the Figaro, you name it, we built our devices in North San Diego County, Here with DNK engineering, only 700 engineers there. They work by contract with us, and I think that I reached to the end of my time without having to be kicked out of here. And if anybody wants to hear more, I look forward to hear from you. If you have any questions, please, you.