Video Transcription
Giorgio Castagneto Gissey 00:02
What if we could deliver the unmatched efficacy of Metabolic Surgery without requiring a single incision? We're talking about a full reversal of obesity, type two diabetes, Nash, which is inflammatory liver disease, and liver fibrosis. This could well be possible in the future, thanks to our technology called Four Pass. I'm Giorgio Castagneto Gissey, and I'm the CEO of Keyron. Keyron is a medical technology company focused on producing highly effective medical devices to replicate different types of metabolic surgeries to solve the problem of severe obesity. So what are the challenges in severe obesity treatment? So mainly, there are two types of treatments: Metabolic Surgery and pharmaceuticals. Pharmaceuticals are simply inadequate for this patient population, which requires at least 15% weight loss. Metabolic Surgery, on the other hand, is incredibly effective. It leads to at least 40-45% weight loss in at least 90% of patients; it fully reverses diabetes and Nash. However, it's invasive and expensive, and access is limited to only 1% of eligible patients. On the other hand, pharmaceuticals just don't work for this patient population. Consider that a blockbuster drug like Ozempic, which is the compound behind semaglutide, leads to only 8% of semaglutide patients achieving 15% weight loss. They also do not reverse liver fibrosis and do not tackle the root causes. So we need something like Metabolic Surgery, but something that can be taken up, something that is non-surgical. In fact, there are 22 million people just in the US and Europe that have severe obesity and diabetes. The first line of action is lifestyle change. Most patients, at least 90%, do not succeed. Drugs are dropped within six months, with the latest drugs being more effective but also producing more adverse events. As for surgery, 99% of patients refuse surgery altogether. No one really wants to undergo a surgical procedure. So 22 million patients are affected by a lifelong chronic condition, which is severe obesity and diabetes or Nash, but they have no valid treatment until Four Pass comes in. We have a treatment that is an endoscopically implantable device that replaces Metabolic Surgery. It restricts the stomach, just like Metabolic Surgery, and allows a bypass of the small intestine, which is where most of the nutrients are absorbed. So we combine the synergistic effect of restriction of the stomach with the malabsorption in the small intestine, which is unheard of in the space. This is a device called Four Pass, which combines a channel gastric balloon with an intestinal sleeve. It brings food from the upper stomach to the small intestine, and it basically replicates the same functions of Metabolic Surgery, but without a single incision, both externally to the abdomen and also internally to any part of the digestive tract. This is a device that stays in place for a period between six and 12 months. It's not just an idea; it's a fully developed implant on delivery system, which is made of silicon, nitinol, ePTFE, and fee. It's also not just a device; it's a technology platform able to replicate all of the most common types of bariatric Metabolic Surgery procedures, from gastric bypass to biliopancreatic diversion and sleeve gastrectomy. These are 1 million procedures that are performed per year, with only 1% of patients opting for it. So we can also open the market to the other 99% of patients who avoid surgery in the first place. We've completed 1020 studies. We've demonstrated an extremely safe and tolerable device. We've shown safe deployment and retrieval, very smooth procedures. We're already able to complete these in less than 30 minutes, both for delivery and retrieval, and we've shown incredibly high efficacy on weight loss and insulin resistance, better than gastric bypass for insulin resistance and better for weight loss than semaglutide. But most importantly, from a safety perspective, we've shown extremely high tolerability and an extremely good safety profile. This is what the pylorus and the stomach looks like after one month of the device sitting in there. You cannot really notice the device was actually there. So excellent safety. Deliverability from an efficacy standpoint, this is where things get really interesting: nearly two times better, one and a half times better efficacy on insulin resistance relative to gastric bypass. We completely avoid the massive peak in blood glucose. So you can see with gastric bypass and also the reversal down to hypoglycemia that makes gastric bypass patients tired for the rest of their lives. We can avoid that while reversing diabetes. Also, plasma insulin is a fraction of that with gastric bypass; we also lower weight gain. These are growing pigs, so they were not weight loss models, but weight gain reduction models. We lower weight gain compared to semaglutide, a blockbuster drug already making billions of dollars a year, by nearly three times. We've seen an incredible 80% reduction in weight gain relative to controls and dramatic effects on insulin resistance, which are consistent with a reversal of type two diabetes and Nash. We've published this study in the highest-ranked journal in the world for gastroenterology. So what we do is we combine the well-known safety of gastro balloons with the amount of efficacy on weight loss and insulin resistance of surgery. This is a completely new combination that liners, which are primary competitors, the technologies that try to replicate Metabolic Surgery without the surgery, with a medical device that these technologies simply do not offer. They are not really safe; they all perforate the digestive tract in one way or another, and also they don't have a gastric component, so they are not highly effective as Metabolic Surgery. In our case, we truly replicate the efficacy of Metabolic Surgery without making a single incision, externally or internally to the digestive tract. We have an amazing team, including people who have sold their businesses for multiple billions of dollars in this weight loss device space, people who've raised hundreds of millions of dollars, two of the most well-known scientists in the space, an amazing technical team, including people from two of the largest companies in the space, and one of the strongest medical device developers in the US, with 12 plus engineers and a matched advisory board with the world leaders in obesity, Metabolic Surgery, gastroenterology, and regulatory affairs. We also have a remarkable IP portfolio with three patent families and 23 total patent applications. Most of these have been granted in the US and the EU, and there are also three additional patent families in the works. So we have a Series A round to bring us past first in human studies. We expect, within 18 months, to obtain human safety and efficacy data with our first in human study of 20 patients. After that, a multi-center study of 300 patients in the US and Europe, with FDA approval in 2029. We've raised $3.2 million so far, and we've done a whole lot with that. In fact, we're ready for first in human trials, a ten million round, and most of that is already committed. That will bring us past first in human with a little bit of proprietary work and low-risk proprietary work. Tuesday, the ten million round, we already have $3 million committed by shareholders alone, and $5 million pre-committed by external investors. We aim for a targeted completion by April 1, 2025, so very soon. So it's time to change the script for the severe obesity patients who really don't have a valid treatment for what is a lifelong chronic condition. This is a device that can truly reverse obesity, type two diabetes, and liver fibrosis, the first device that is able to do that. We can truly replicate the effects of Metabolic Surgery, but without a single incision. Thank you very much. Applause.
