Victor Gura Presents Wearable Artificial Organs at LSI USA '23

Transcription

Thank you so much. It's a pleasure to be here. I want to talk to you about the only dialysis device that uses the kidney 24/7 and blood 24/7. Your God given kidneys works 24 hours a day, seven days a week. That's 168 hours of filtration. No wonder that if you filter the blood only 12 hours a week like we do in the regular dialysis clinics, the the outcomes are poor, they're poor in terms of the misery of the patients their complications, hospitalizations and quality of life. We miniaturised the device to develop a wearable, we have several patterns. We also have data. We have bench, animal and human data that have been published in peer reviewed papers. So I'm proud to say I have a paper in Lancet with my own data on a human trial. We did a human trial in Italy, we did the human trial, in London, we did another human trial in Seattle. And the technology worked and if it worked in Italy, and the UK, and here, the technology works, we're trying to develop two applications with the same components. One is a a therapy for critically ill patients in the battlefield, where you have to provide renal replacement to critically ill patients that have been injured and cannot easily be inadequate. And we got funding from the US Army to do that. And we have a that will be a 510 K hour wearable product has been the winner of an award by FDA for innovation. And we also got a letter of support from the FDA for our project. We expect to do the trial for the military application in Cedar Sinai. And we will do the next two trials in humans in the United States, in Vanderbilt, and in the Brigham in Harvard, Boston. The Medicare reimbursement is guaranteed by law, we're trying to raise $10 million. The cost of dialysis enormous the it's about $88,000 per patient per year, if you do the math, our economic impact to Medicare will be enormous in the fact that if you develop a molecule a device, you don't know if Medicare is going to pay for it, we met with Medicare, they will pay for it in they may even pay more than what they would pay for regular dialysis technologies today. The margins we show up this time are about 70%. And we do have a pipeline product in pediatrics, military, intensive care and cardiac. The business model is razor and blades. Of course, the Medicare reimbursement covers both the consumables and the in the device itself. And it will disrupt mature markets that have been basically doing the same thing. With stationary machines. For about five or six decades, it's time to come up with a better thing. As you can see in the upper in the upper left level here we have what the dialysis looks today, and the patients are tethered to the machine and they want freedom. So when you filter the blood 24/7 You remove enough fluid from the patient to allow them to eat and drink what they want. Our human data indicates that indicate that we also remove enough salt to allow patients to eat salt normally which patients on dialysis cannot do today. The savings in drugs that our data already support that will be in Medicare reimbursement of drugs is enormous. We make for it Since one drug obsolete, it's phosphate binders. And if we make that drug obsolete, the savings to the taxpayer are in the order of the $6 billion a year, which is what we pay today for phosphate binders alone. There's many more advantages in quality of life mortality to the patients with our device. Typically, when you dialyze with current machines, you require about 40 gallons of fresh water per treatment, we use only 300 CC's. You dialyze continuously, which is the only way to remove enough toxins that accumulate in renal failure and make patients very ill. If you continue dialyze in only a few hours a week those toxins are not removed. And they have very deleterious effects on the patients themselves. This slide basically indicates that we miniaturised the dialysis device very much like computers were media to rise to a phone today. We started with the first trial in Cedars Sinai in pigs. Then, we did our first trial in Italy, with Professor Ronco, well known famous guy, the lady on the right upper quadrant that is dancing is wearing the device. This picture was published in Lancet. And why do I say that because we underwent data scrutiny of our trial in the Lancet, kidney, international JCI and a few others. And we did also a trial in London with Professor Davenport that you see some pictures of that in the lower slide our device model tree, it will look something like the pictures there. You can wash and shower with it. And you can walk around with it. We have an experience theme. We manufacture our devices in a large FDA certified facility for medical devices in San Diego. We have an excellent group of a advisors from Harvard, London, Royal Free Hospital, Vanderbilt, University of Connecticut, Beth Israel, UCLA and University of Virginia. I hope that people are awake at the end of my discussion, and I would love to have questions if somebody has some. Hearing none, our collaborators are several all over the place. And I'm done, thank you so much.