Wearable Artificial Organs | Victor Gura, CEO

Victor Gura  0:01  

Thank you all for coming to listen to my talk. I'm a physician, and the founder of Wearable Artificial Organs. I also practice medicine, I'm not going to be the business CEO of this enterprise, we have somebody younger, that has more business skills than I. In the former life. I also wore a uniform and I was a military doctor for many years, with a lot of unfortunately, large Battlefield, real experience. We're going to talk about a breakthrough technology that will disrupt $200 billion dialysis industry, we have a robust pipeline of IP. We are done with bench animal in three human trials that have all been successful and published in top journals like the Lancet, our first product is 18 months from funding. And it is a portable renal replacement therapy that is intended for B for use in intensive care units. And in the military, in the battlefield or in disaster areas. We're trying to raise $8.5 million for our next steps to manufacture and take to market our device for the ICU and military application devices. Our regulatory pathway is a 510 K with one more clinical trial for that particular application that we plan to conduct at Cedars Sinai Hospital where I work today. We have breakthrough status for our technology. We were fortunate to win a innovation 2.0 award from FDA and we were issued a letter of support from the agency. As I mentioned, three human trials already done. And we already sold to the US Army, two prototypes of our military application for $3.7 million. For the ICU application, hospitalized patients are at significant risk of acute kidney injury due to medical procedure, the catastrophe that brings them to the ICU in the first place. And heavy medications are 60% of patients that go to the ICU will have kidney injury. About 5 million people in the US go to ICU every year. And 357,000 of those end up on continuous renal replacement therapy. That stands for a dialysis therapy that filters the blood 24/7. When you have two normal kidneys, they filter the blood 24/7 for 24 hours a day, seven days a week. So that's 168 hours a week of blood filtration. In dialysis. you filter the blood for nine to 12 hours a week. No wonder that it doesn't work too well and the outcomes are not that great. In the ICU for CRT. We have a continuous renal therapy that dialysis 24 hours a day, seven days a week. It's complex, it requires a lot of expertise. It's expensive, and the run between three and $10,000 a day easy. These are some of the machines in the market today from Baxter next stage now for Zee News, brown, etc. Those costs about 40,000 per machine $200 A day in disposables, 70 litres of sterile fluid a day that costs a lot of money. So that's an expensive proposition.

So we came up with a CRT device that gives us a 300% Excess margin with a cost of $7,000. $200 a day is the cash flow of disposables. When instead of 70 litres a day, we use only .3 liters a day. It's has a rechargeable battery, no need to hook it up to any outlet. It weighs only 20 pounds. And what you see here is a ruggedized device for military use. So it has to go in a helicopter or an aircraft or in the battlefield. So that's the way it would look in the battlefield. It's easier to operate it requires less manpower of nurses, which is also very expensive. And the main difference is because it's battery operated in a very small amount of fluid, you can transport the patient while receiving treatment. So you can use this in a helicopter, in an airplane, in an ambulance, or even in the ICU, you cannot take the patient on CRT to a CAT scan. Because you cannot move the machine. This you can put in a stretcher and keep treating while moving the patient from place to place. In the battlefield there is what do we call the golden hour from time of injury of casualty until you can render care, there is an hour in which if you succeed in rendering care, there is a much higher survival. So the helicopter played a big role. And when you could transport very quickly, the casualty to a center of care that translated in much less mortality. I know that for a fact, because I spent about five years of my life flying in those helicopters in the battlefield, in another side of the world. To do care in an aircraft is not easy. So the army had a need for something that does not use 70 gallons of fluid. And that works on a battery. And it's cordless. And you can use it anywhere, anytime. In the battlefield, you have a helicopter coming to take casualty from the battlefield. But if you have a anti aircraft missiles flying around like today, it may take you a day or two until you clean the hills around then you can come in with a helicopter. So what the Army wanted is the boats that can do dialysis or CRT until the helicopter come in. And that's why they took on took us on on the right lower panel you can see what looks more or less like an ICU flying in a in an aircraft, what he does not have yet and that's where we're coming in is the CRT and or dialysis device. And the pandemic created a major need and demand for CRT devices. And we are geared to meet that unmet need of CRT devices, that does not exist today. And that creates a market for the stockpile that the governments of the world need to create. So we're one trial away to be conducted in cedars for the 510 K approval of our CRT device. We have a family of patents that have been issued and other families, family and other patterns coming up. Let's talk a little bit about how does this make money. The total addressable market of the dialysis field is huge is hundreds of billions of dollars. They there are about 13.3 million people a year that have acute kidney injury in the world. And there are about 5 million people in the world today that are on chronic dialysis. 700,000 of those in the US 360,000 In Japan, etc. The cost is humongous. The margins of any dialysis device like ours is about 70%. The only comp that we can find of an exit of a machine recent

that comes close doesn't even come close to what we do. Is the sale for $2 billion of a company that had about 1% of this market in the US alone, and it's sold for $2 billion. Do we get paid for this? Yes. Medicare by standards reimburses dialysis. And in the ICU, we don't depend on a insurance company approving or not approving our use and our device. And do we have it by a pipeline? Yes, we do. Many applications chronic dialysis, pediatrics, disaster relief, cardiac products, just to mention a few. The assumptions here are difficult to read. This is too busy slide. But if you look to the bottom, the bottom line is we think that our EBITDA on the second year of being in the market would be in the area of the $30 million a year. In the pipeline, we have a wearable artificial kidney. What you see on your left is the prototype two, in the prototype two of the wearable kidney human trial you see that dancing lady, that picture came out in Lancet, I took it. And that is our prototype two that weighs only 11 pounds instead of a regular dialysis machine. Our model three is there, it's what's coming now and it will be two pounds device. Dialysis is very difficult. On your left upper side you see a dialysis unit that I designed and I still work there from time to time. Patients are hooked up to a machine for a long period of time. And we are going to get that down to a two pound device that people can walk around go to the supermarket and go to work every day. We have an experienced team. I will not dwell on that. But this all work has not been done in the air. We have a great CEO coming that has a lot of experience in the in the space the CFO. We have a bar none Scientific Advisory Council with people from Harvard, London, Vanderbilt, University of Connecticut, NYU, UCLA and West Virginia University. This has been the product of many people. Times we had 22 engineers working for us. At times we have fives it depends on the needs. So we don't have to financially meet all those things. And thank you so much for your attention.