Lloyd Mencinger, Aqua Medical - Vapor-Based Endoscopic Ablation | LSI USA '24

Lloyd Mencinger  0:00  
So a bit about what we're doing at Aqua Medical. So our target is type two diabetes. And you know, I picked this out infographic of the ADEA website, because I thought the notion staggering cost really captured it. You know, the only problem with all the numbers are on because they're all increasing so fast. So here it's showing 34 million with type two diabetes in the US, it's already 38 million, it says 88 million with pre diabetes, it's already 98 million, so more than one in three adults. And with over 50 pharmacologic out there in use, including the new ones, most patients are not well managed. And of course, you have the host of complications, side effects. So true epidemic, enormous spending and not really changing the underlying course of the disease. Okay, so what are we doing at Aqua so our goal is to change the course of the disease and part of that minimize and potentially eliminate injectables and certain cohorts of patients. And we have a device based approach to this. It's a 30 minute outpatient procedure and we use hot water vapor ablation in the GI tract. And here's what it looks like. It's it garden variety upper endoscopy procedure. So here's an endoscope goes to the esophagus or the stomach and enters this 10 inch or so section called duodenum or do Edina. And you can see our blue catheter exiting the scope. And what we do is we deploy these two self expanding discs and they create a neat little treatment chamber. And from the center shaft to the chamber we precisely dose hot water vapor. And water vapor is the perfect ablation agent because it has high energy, it can get uniform coverage into the irregularities. And then it ablates to a nice controlled depth into the mucosa and produces what we call this beautiful we call it the box effect. Okay, so a question comes up here. How does this treat Type two diabetes? And the answer is, it's actually not surprising at all, because there's decades of experience with bariatric surgical procedures for obesity. So like gastric bypass and ruin y, which have in common that they exclude the duodenal. So in those procedures, patients lose weight over weeks and months, but almost immediately type two diabetes is result even the next day. So then a company had a actually a clever idea. They said, Well, if that's the key What if we make a tube or sleeve that covers to do a Dana fix it to the lower stomach, the food will bypass. And they did and actually they showed similar results that over weeks and months, the patient's lost weight and almost immediate dramatic improvement in diabetes. Now, the company had a problem keeping the device in place. But that's not funny, but notwithstanding, they validated the principle. And in the meantime, so a number of companies have pursued endoscopic approaches to ablate to do a dnm with some really impressive results. Now here's an extract from one of the studies from one company, you can see impressive reduction hemoglobin a one C. But even more impressive, you're seeing durability out to 24 months, which I think is quite impressive. Now, look at the product. On the left you see there's a big endoscope and there's a large catheter bigger than the endoscope. So picture the Physician He has to navigate to devices through the patient's mouth all the way through to the do Danum. To perform that it's cumbersome, it's time consuming. It's it's really a super experts task. Okay, so that's a constrained market. If you look at ours, you saw how easy it is right through the scope, pretty much any Gian Daskalakis can perform our procedure. And so that makes it you know, enormously expands the potential for commercialization. By the way, this company has IPO, they raised over $400 million, we've gotten to this point with less than $20 million. So the big news for us is we've completed a 27 patient clinical trial. And of course, when you do a first inhuman everybody in hospital shows up wants to see what's going on. But the results have been fantastic. So first, this is patient fingerstick glucose. So the blue is basically the run in period. So before the procedure, the patients are doing their finger sticks every day, and that's their glucose level C key some you know, some trend, but then we do the procedure and immediate dramatic improvement reduction in glucose. But the gold standard for diabetes is really hemoglobin a one C. So if you look at this chart, you can see the run in period. So that's again the month prior the procedure relatively flat, and you see a a super acute improvement in hemoglobin a one C we've actually had three months reduced it down a point and a half as the mean. Now if we compare it to others that are out there, we you can see where the blue bars we have a much more acute, you know improvement reduction and hemoglobin anyone see and at the same point in time at three months, we're showing superiority. So we're thrilled with these. We're thrilled with these results. Of course, and now these are principal investigators. So these are top key opinion leaders, they, you know, they, they're familiar with bariatric metabolics, and to scopic approaches, surgical approaches, and been involved in the study and all the results. And here's just a subset of some of the comments they had afterwards. Game changer, really, really impressive, incredibly easy to use. But the big one, the punch line, here is the last one, you have a 20 minute procedure here, where there are others, you're talking minimum hours, several hours. What that does, that puts it into ASCs, which is the profit zone for gi physicians. So this is a big commercialization opportunity. Now if we look at all the advantages we have to the others. So first procedure time usability learning curve, no one is in the same universe as us because they're double devices. Okay, if you look at fluoroscopy well, because of the complexity the others with two devices, they need x ray, and we do not need it. And actually it is a constraint because only certain endo Suites have fluoroscopy capability. anesthesia, we're conscious sedation, it's a normal gi procedure, propofol, they need general sedation because again, the complexity the guide were the other catheters, we have a cost of goods advantage. And we safety tolerability, no essays in the study and pain scores close to zero outcomes I put equivalent, but it looks like we may have an advantage there too. So. And also, let me tell you about the regulatory we're pretty happy about this regulatory as a company, we already have three 510 ks clear. Now, we don't have a diabetes specific indication yet, but that red, that red box allows us to ablate as an ablation tool anywhere throughout the GI tract. So that means that any doctor in the US can ablate to do a dino them. And then we can fast track into a diabetes indication. So we're happy about this. And finally, we think we have a great team. This is Greg Barrett, he's he actually he created the ablation market for the esophagus, esophagus. Barracks, medical and barracks was basically sold. He sold it to Covidien for 425 million. He's done a lot of deals we work together every every week. He's our chairman. And this, you guys may know Bill Starling. He's kind of a legend. I tried to put his resume on one page, but it's impossible. I put his IPOs on one page. And it's funny because the companies he started and the products are selling over $4 billion out there. So a great, wonderful guy to work with just just real pleasure to be on our board. This is the late Pete Nicholas. He founded Boston Scientific. He invested in us from the beginning and every round. And to show you how noble this guy was. He actually passed the baton before he before he passed. He passed the baton to his son, Ithaca partners, and they continue to fund us all the way through but the amazing we're so blessed to have him be a part of aqua all the way through and you probably know William de Xiang Bay, I think, I think they're rated like the four years in a row like the most active venture venture capital funds. So he's a great partner with us. And VK Sharma, he's our chief medical officer. He's ex Mayo Clinic director and serial entrepreneur and you can see that I've been around the block here before and so we're raising a 15 million Series B. And if this fits in the thesis of anyone's fun, we are always happy to talk about money. Thanks