Robert Neusner presented BMI Organ Bank at LSI USA '24

Robert Neusner  0:00  
Bob, good afternoon. I'm Bob Neusner. I hope you had a good lunch. So we talked about Kilimanjaro. Now I'm going to talk about why I'm here today. In September of 2022 I got a phone call. It was the phone call that No parent wants to get it. Was from my 26 year old daughter, and she said, Dad, I got some not so good news today. They told me I've got something called polycystic kidney disease, and they think I'm going to need a kidney transplant someday. So I did what every good parent would do. I went to the internet and I went down the rabbit hole. First I was concerned, and then I was frustrated, and then I was a bit angry. So what I'm going to do in the next eight minutes and one second is share with you what the problem is and what we're doing to make it go away. Thank you for your time. So if you have chronic kidney disease, which you can get from high blood pressure, type two diabetes or polycystic kidney disease, among others, your kidney eventually stops working to stay alive, you must have dialysis or a kidney transplant. The good news is, if you can get a kidney transplant, your odds are very good. The 10 year survival rate is about 80% if you're one of the many people who cannot get a kidney transplant, that's a difficult situation, with a 10 year survival rate of about 12% in the last decade, over 70,000 people have died in the US while on the wait list. And the frustrating reality is, many viable kidneys are discarded today when they could save a life. It's not just a clinical challenge, though there are economic issues as well, dialysis cost $114,000 a year for 130 and that's for life, right? For $133,000 you can do a kidney transplant and then have relatively small anti rejection medication cost for the rest of life. So a kidney transplant pays for itself in less than two years. So you may ask, why is this challenge here? When there are so many good reasons to do transplant, there are solutions today to preserve kidneys as they go from a donor that's given the gift of life to a recipient. You see them up here on the slide. The first one bucket of ice, double bag the kidney, put in Saline solution and throw it in the beer cooler. The second one was approved by the FDA over 20 years ago with a fairly similar strategy of keeping that kidney cold. And what kidney, excuse me, what transplant surgeons have told us is to use more kidneys. They need tools that would help them evaluate kidneys so they can decide that they're safe to use. And they need ways to preserve that kidney over longer distances. We're here in Dana Point if that kidney is in New Jersey, near where I live, it can't get here in time to survive that journey. Whoops. Sorry, wrong direction. Before I talk about how we're solving the problem, I do want to point out this is a very large opportunity with a very high unmet need. The available market for organ transplantation is $6.4 billion almost 5 billion of that is for kidneys. We have unique approaches that would meet that unmet need. Let's talk about what's different about BMI organbank, the devices that I showed you essentially chill the organ. They use a hibernation strategy. If you can get the kidney cold enough, you can reduce the amount of oxygen and nutrients it needs, but you can't turn it off. Those kidneys eventually suffocate and starve. We at BMI organbank are taking the opposite approach. We're keeping kidneys warm, and I'll show you in the next slide. But the idea is we are keeping that kidney fully functioning so that you can measure how well it works, and so that you can keep it alive and cells replicating, and our initial preclinical studies have shown 24 hours and more of kidney preservation, which is an unprecedented result. We take our inspiration from mother nature rather than fighting Mother Nature. So this is a little cartoon diagram. But what you would see inside our microwave size device is a cassette highly engineered to maintain kidney sterility. We have a proprietary solution we licensed exclusively from Duke University. We circulate that solution of nutrients and electrolytes through the kidney. We have an oxygenator that breathes for the kidney by providing oxygen, and we have a patented pump that simulates the beating of the heart. So just like you've got going here in this room, you've got blood, you've got lungs and you've got heart. Now I want to show you some of the data from our device. This was created last year, generated last year. On the left, you see a kidney. This is what left for you. On the left, you see a kidney. This is a kidney that was declined for transplant, and you can see that modeled look kind of looks like it got beat up. Now you can see, as you move right over time, the kidney cleared after five minutes. And that's not unusual. Other devices can do that. What's unusual, though, is this kidney still looks great after 24 hours, and the way we simulate transplantation is to pump whole blood into that kidney. And you can see the quote from the transplant surgeon we were working with. He said, I would have declined that kidney before he did decline it. Now I would transplant that. What you see on that page that's our life saved. This is our flagship device, the first device will launch Organ Bank transport for kidneys. You can see our proprietary solution license from Duke. We have a pipeline with unique capabilities to be applied to livers, lungs, limb transplants and several undisclosed opportunities as well. The last thing I'm going to say before I talk about the investment opportunity itself is to let you know I was the head of reimbursement for a large swath of J and J at one time. This is a situation with very favorable us reimbursement. If you don't have that almost nothing will get you adoption. So Medicare has dialysis spending that's out of control. They pay dollar for dollar for organ preservation cost, including devices like ours, and they do it today. So when we launch this device, customers don't have to do anything different than they're doing today. They can just use our device and gain the benefits we're having a good year so far, and I'd like to highlight a few of those things. Our preclinical data was just accepted in transplantation direct that's very well known journal in the field. Should drop any day. We were informed by the North Carolina Biotechnology Center where we're based, they'll match up to $500,000 in angel funding. We reached an agreement with the flagship hospital of atrium healthcare, part of the fifth largest integrated delivery network in the US to pilot our device based on their need for it. And if you know what the SBIR at the National Institutes of Health, we had a score of 18 in our recent grant proposal that would likely be in the top 5% we're waiting our funding, but that's 100% non dilutive funding. With the $5 million seed round we're doing today, we'll be ready for clinical trials, and then we'll raise our Series A of about $25 million we're doing that through convertible convertible notes, with evaluation cap, and I'm done with one second. Thank you for your time. You.