Video Transcription
Lloyd Diamond 00:02
Steve So at Nitinotes, we've developed a technology called EndoZip, and we have developed the world's first automated endoscopic treatment of obesity. And I'll explain what that means here in a moment. But first, let me explain the technology itself. It is an automated suturing system designed for endoscopic sleeve gastroplasty, otherwise known as ESG. And many of you have probably heard of this procedure. Apollo sort of coined it, and Boston just acquired that company, and it's a very simple procedure to understand. There's basically four steps. First, we insert a tube orally into the stomach. You see in the second image here, there's an articulated head that allows easy positioning within the stomach. Then we push a button, and within 60 seconds, the Singer sewing machine, or automatic stitching device, takes over, and it actually approximates two sides of the tissue, creating, if you will, a compressed area within the stomach. And then you extract the tube, you put another one down, and you could repeat that three to five times to get the desired outcome. So I'll show a quick video here that hopefully the sound works. If not, I can narrate it.
Lloyd Diamond 01:20
Nitinotes presents EndoZip, automated endoscopic suturing for stomach restriction. EndoZip is a fully automated, easy-to-use, operator-independent system, starting with a minimally invasive oral approach. EndoZip is inserted through an overtube, together with a standard pediatric scope. An articulating head allows easy positioning in any anatomy. Suction is then applied to collapse the stomach around the suturing head, drawing the stomach walls into designated stitching ports that enable reproducible, full-thickness suturing with the press of a button. Automated stitching is initiated through an activation of a helical needle that connects the anterior and posterior walls. The stitches are automatically tightened and secured, allowing quick extraction of the device. A new device is inserted, and
Lloyd Diamond 02:12
then you just simply repeat the procedure to the desired outcome. Now that might seem trivial what I just showed, and of course, for a very well-experienced surgeon, hand suturing endoscopically is something that they learn over time. It probably takes them about 30 to 40 cases and maybe a year, and after one or two cases with this, as long as you can navigate into the desired anatomy, you can do endoscopic suturing. So it is a huge advance in this space. So let's talk about the market opportunity today. We estimate that for EndoZip, it's about a three and a half billion dollar market, about 630,000 procedures, and that's coming principally from two areas. First is all of the work that Apollo did, and now Boston, in sort of developing that market, about 30,000 procedures a year, and we believe that we can capture part of that market. And then there's a huge white space, as well as endoscopic suturing starts taking up in the clinical setting. Those are procedures today that aren't done where we believe we can capture them. So where does ESG fit in all of the different therapies? First, everybody probably knows, from morbidly obese people, bariatric surgery, that's a very long, complicated procedure with high morbidity rates and high risk. Then you have intragastric balloons. So that's a temporary solution, where they'll insert a balloon, leave it in for a few months. In some cases, it has to be extracted. There's maybe a balloon that also will self-dissolve, but it's only a four to 12 month solution, and then you have to put the balloon back in again. Then, of course, the hot topic now is injectable GLP-1 drugs such as Ozempic and others, and a lot of off-label prescription here. The problem is, it requires chronic use, or you gain back the weight, and there are many side effects and high costs associated with it. In fact, they estimate that about 50% of patients at six months become non-compliant, and they quit their therapy. The minute you stop taking the drug, you gain the weight back. And then there's ESG, which is where we come in, and that will give you similar outcomes, which I'll discuss in a minute, as far as percentage total body weight loss to drugs, but it's a more durable and cost-effective solution. So maybe just one point again I want to make about the drugs is they've kind of paved the way to open the market. I think the important point here is, if you look at the bottom right of the slide, is that we know that there's been a study that shows over five years, ESG achieved greater weight loss than GLP-1. And from the cost-effectiveness perspective, you would actually have to decrease the drug therapy today by 74% to have a similar health economic outcome. I don't know many drug companies that are willing to start dropping their prices; I guess maybe one day, if they become more generic. But it's still a chronic therapy in order to maintain the weight loss. We know that ESG has been clinically validated and safe. There have been over 50,000 cases done with endoscopic sutures, over 200 publications, less than 2% complication rates, and we know that Apollo received the first FDA-cleared device in ESG for the treatment of obesity. There's a lot of validation in this space. Every year now, since 2022, there have been exits. And there you can see the exit value at the time that the companies were acquired. There is an ecosystem of companies that are either in this space or looking to get into this space as well, again, more validation for the uptake of these therapies. If we look at the clinical results, Nitinotes has conducted three different trials over six sites and then just under 100 patients with an average percentage total body weight loss, which is equivalent to that of Apollo or drugs. So the endpoint was met from an efficacy and safety standpoint, and this data has been used to support our CE mark filing, and I'll talk about where we are in the process in a moment. We also know that through the clinical trial, EndoZip showed that it was easy to use, it was fast and efficient therapy, and today, in the world, especially of obesity, it's very important that you can treat patients quickly in a cost-effective manner and improve patient flow throughput. In the operating setting, there's also reimbursement in place, so we do not have to pave the way from a market access perspective. On average, reimbursement in the US is around $10,000, and then in the UK, similar in price. And then there are codes in place in Italy and Germany. And then there are more now being developed, and a lot of that market access work is also being driven by Boston. So if I talk about where we are in the process today, we have already filed the CE mark. We are in the question and answer phase. We expect approval end of Q1 early Q2 of next year, at which point we will begin commercialization. And at the same time now, we're negotiating our 510(k) pathway with the FDA, where we expect to launch in the US in the middle of or early Q3 2027 or late Q2 2027. We also have a staged launch plan in Europe, so we can show proof of concept. And of course, then the primary focus will be the US market. We're seeking $22 million in a Series C round to commercialize EndoZip and to support our US regulatory strategy. So in summary, in the last minute, what can we say about our technology and Nitinotes? We know that GLP-1 drugs are actually paving the way for the market, but they have a less than 50% adherence rate. There's unmet demand, which creates an opportunity for ESG procedures, as I showed you, the continuum of therapy. Boston has just done an acquisition of Apollo, and there is an ecosystem of potential acquirers and strategics that are interested in this area. We offer a more minimally invasive, cost-effective, and efficient solution. We have a de-risked commercialization path because market access has already been done for us, and we are seeking a $22 million Series C to fund FDA and commercialization. Thank you. Applause.
