Matt Hedrick, AKICept - Intravascular Treatment Procedures for Acute Kidney Injury | LSI USA '24

Matthew Hedrick  0:03  
I'm the CEO of AKICept Matt Hedrick. Thank you for the introduction. We're an emerging renal intervention company, and I'll explain what that means in a moment. We're starting with a strong management team. Myself, I have experience building a one of the first nanotechnology enabled orthopedic companies, which we recently are actually completing an exit to a very large orthopedic company. Dr. Beck Yao is our scientific inventor, and he's a very accomplished nephrologist with a great deal of experience, excuse me, and Aki and polycystic kidney disease, which I'll talk about more in a moment. And then John Timko is a very experienced commercialization executive and building sales forces in the cardiovascular renal space. I'll highlight also our Scientific Advisory Board. Because of their excitement, the technology we've got a past president of the National Kidney Foundation who's literally written several books on acute kidney injury and is certainly an expert in the space. Dr. Bruce militaris. American site in nephrology past present, Dr. Crowell, past president of society of interventional radiology, which our lead product, which I'll focus on today is a interventional radiology product. We also have very strong distributor coverage, or interest in covering our products already. So for us, it becomes an opportunity to leverage products through this existing distributor sales force. So what are we doing, we're launching a biopsy device in the very short term, I won't spend a lot of time on it, it is differentiated, we're going to use it for cash flow, right, so fun, some of the other technology, so kind of an old school growth strategy. And what I'll focus on today are a couple of interventional cardiology, interventional, interventional or, excuse me, Intro mentioned catheter products for acute kidney injury, whether that's in transplant, which I'll talk about in a moment, or in the ICU. And then over the long term, we've got some very interesting things for polycystic kidney disease that we know we can talk about according to your interest. Right now, this growth strategy is already funded. So it's a lien plan. It's not a lot a waste of capital, and we're very capital efficient, probably a little too capital efficient. So we'll talk about what we'd like to do with this though we'd like to accelerate this plan. But we're building the company for cash flow, and humanitarian and economic impact, which I'll illustrate what we're talking about here. So what happens with hypoperfusion of the kidney is it formed something called acute kidney injury happens from trauma, like a car accident, it's very common case, heart attack, heart surgery, major surgeries, and transplant situations, but red blood cells aggregate in the capillary beds of the kidneys, they slow down perfusion, which reduces filtration, I mean, your kidneys are a filter, it's like a pool filter. If you clog it, the you know, you don't filter your water anymore. reduces energy exchange reduces urine output, current and clearance, measures of kidney function like Camilla, you're gonna regular filtration rate all decline, triggers inflammatory response kills the tissue, scar tissue forms, and it never recovers. So you progressively lose kidney function, depending how much you lose Milla put you on dialysis, and you never recover that function. If you lose too much, it's fatal. So at the bottom here, you can see a picture of kind of these green capillary structures, you can see with basically red blood cells flowing through the normal capillary perfusion image. And you can see some interesting gene delivery things there, which we can talk about, at some point in the future if you're interested. But post this type of injury, you can see these red blood cells are no longer traveling through these capillary beds. So your pool filters clogged, your kidneys aren't working anymore, they repaired to a degree. Right now, there are no treatments for this. So if it happens, you kind of hope it gets better. And if it doesn't, it's just a progressive injury. And what happens causes mortality, increases chronic kidney disease, which can lead dialysis. You know, if you survive, it increases your ICU days, which is very expensive and increases your hospital days in the hospital outside of the ICU, which is also very expensive, increases readmissions. And it's just a very expensive situation that's right now on treatable, but we can treat it in transplant, which hopefully you'll never need one or no one, you know, we'll need one. It's very common that it impairs the recovery of the engrafted kidneys. And right now there's about five to 6000 kidneys that are discarded annually in the US, which is terrible because about 6000 people are succumbing to chronic kidney disease waiting for a transplant kidney, we think we can improve the function of those kidneys, and we think we can save about 2000 of them a year, which each one of those has a high likelihood of being a patient's life. So we think because of the days of stay alone, we can probably justify about a $4,500, ASP, maybe quite a bit higher, because we're think we're going to immediately have an impact here, which I'll show you why, but it's a very large market, multiple billions. You know, it's early, so we don't know for sure. But this is a very common problem, it's global problem. There are no treatments, and everybody has to deal with this issue. So our approach is a device, we go in through the renal vein, deliver a pulse of fluid that clears out the kidneys, if you do this, within 24 hours, you can reverse the kidney injury, we've got strong IP, it's a short procedure, interventional radiologists deliver it, and you do it one time, we've got good data in animals and in humans. So we've improved kidney function with serum creatinine, we've reduced the progression to chronic kidney disease. So short and long term animal data, efficacy, safety, just the types of things you'd expect to see in human kidneys, we've improved perfusion of impaired kidneys. So that's also what you'd expect to see with this type of a mechanism. And, you know, we've got great datasets on this. So we understand the injury, we understand the treatment mechanisms. We've illustrated our treatment effect, and we've had no safety issues in any of these studies. So which is a very important question. So we can perform this procedure safely, we believe we've got a comprehensive data set for those that are interested. So right now we're preparing to launch our biopsy device. For cash flow, we think there's differentiation and a divestiture opportunity there. And we plan to launch transplant in 2026. We plan to launch the ICU indication in 2028. And all that's currently funded. We'd like to accelerate this why because people are succumbing to this disease, which we think we can treat. And of course, there's an economic opportunity as well, we can accelerate it by pulling some of the device development forward and funding a clinical trial sooner. Right now we're going to fund it based off organic growth of our sales plans work. So we'd like to like to move that forward. currently funded plan looks good, kind of a slow build organic growth, we redeploy capital to, you know, fund the ICU indication. But we could also fund that ICU indication very soon. So that's why we're out potentially seeking strategic partners or incremental capital. And we'll use it to do exactly that accelerate the final device development for the ICU indication. And in combination with cash flow, generated from other sales will perform the clinical trial. So that's what we're trying to do. If anyone out there has an interest in not only saving lives, but potentially opening up a very new market that there are no treatments for this right now. We think it's a new procedure. We think it's a pretty hot area. If this continues to work, then I'd ask you to contact me at some point, you know, throughout this process. Thank you. Any questions? Otherwise, I'll turn it to the next speaker. Thanks, everyone.