André Burch Presents Sedivention at LSI Europe '23

Transcription

André Burch  0:05  
Obesity is the new pandemic in seven years from now. 1.5 billion people on our planet will be obese. And it's not a question of appearance and how they feel. Obesity comes with diabetes, myocardial infraction, hypertension, and cancer. Every year more than 400,000 people die in the United States because of obesity. Why do people they are obese, eat so much, even if they know they shouldn't. It because they are feeling all day long, I'm hungry. And one of the reason is because they have a disturbed regulation of they're hungry and satiety feeling. And it comes from the vagus nerve you see here. So the stomach signals all the time to the brain, you should eat you're hungry. Sometimes I have the same feeling after a long working day, when I come home, open the fridge and I'm hungry, then I eat as much as I can. And that's the vagus nerve that tells the brain and that's how we attack the problem. So you see the vagus nerve is on the outside of the stomach wall. And with our catheter, we're gonna freeze the vagus nerve, we're gonna ablate the vagus nerve. So actually we've developed a very simple cryo catheter that long, it will be inserted through the mouth through the esophagus into the stomach, position it and inflate it with the gas that cools down the stomach. And within three minutes, the vagus nerve sees a temperature of -22 degrees and will be ablated. That's the sad dimension cry a catheter afterwards it will be retrieved and the whole procedure takes about 20 minutes. It's like going to the dentist or doing a gastroscopy. cryoablation is safe. It's done daily in large hospitals for the treatment of AFib in the heart, and it's really works very well and it's also done in treatment of other organs. What treatment options do obese people have these days there are mainly two. One of them is taking drugs. So the drugs they are in the press. Now the semaglutide, the Elon Musk and Kardashian drugs. They inject every week, the drug into the below the the injected every every week once they lose weight about 15 kilogram per year, but it's a lifelong therapy. They have to be strictly compliant when taking the drug. Otherwise they gain weight again, they're mostly digestive disorders or side effects and currently the EMA is investigating suicide and hydroseed cancer rates cost at 13,000 US dollar a year. Bariatric surgery is very effective. patients lose weight up to 35 kilograms a year but a lot. They don't want to do it. Because it's really, really, a erasable irreversible treatment, complication of surgery or the risk of surgery are included. About 20% of the patients that have lifelong side effects cost 15 to 23,000k. There is another treatment is called gastric balloons. They swallow a balloon the patient's it stays there for six months, it's an implant and has to be withdrawn after six months because of the acid in the stomach. Afterwards they see the yo-yo effect. Our treatment with the cryo catheter is different. It's easily done as our already described, we expect that 15 kilogram per year can be reduced or within a year. It's one time it's minimally invasive, and it's no implant. We expect minor side effects like nausea and delayed gastric emptying the cost will be around $1,000 for the whole procedure. What we do is called macatomy and that's not new. It's still done already. When patient do bariatric surgery, then the stomach will be reduced to the size of an orange and the vagus nerve is cut as well. That's one of the reasons why patients are less hungry, they lose their hungry feeling. B Block it's an implant that signal to the brain will be interrupted. It works and studies are done with the needle with a cryo needle where physicians insert from the back to the vagus nerve, a needle and to cryoablation. This works very well in patients. But all All these treatments are not scalable. And that's the problem. Although of all patients lose weight, one patient three to three, the cryo needle said, I'm not the slave of my hunger feelings anymore. That's important. I'm not the slave of the hunger feeling anymore. And that's how we want to help those patients. Our therapy is highly scalable. It's no implant cost effective. And gastroenterologist can do it. 9500 in the United States, they do 7 million gastro copies per year, so they know the patient's it's minimally invasive office space, no radiation. So how can we as a start up in the future, help this 1.5 potential patients. We're going to develop the product, we run the clinical trials, we get the products approved in the markets, we are also able then to manufacture the product, at least for the first 100,000 units. And we will be responsible for the global marketing that every patient gets the same message and the latest information about the treatment, we will not build a sales force, it will be too cost intensive. But we will work with global sales partners we already have contact with. They have the distribution channel to the customers. It's a it's a disposable product, and they have access to the hospitals. Marketing is very important in this area, not only for getting access to the customers, but also getting access to the patient. It's even better. Some patients potential patients already contacted us after they have heard about our treatment, and wanted to try it out, be part of his study. But we only have a prototype now. So it works through obesity societies and social media. Our team is quite strong. I think it's really strong. So the physician, the founder of the company she sees patient every week potential patients that can be treated. Our colleague Stephan myself, we have more than 28 years experience in the med tech field in multinational companies and in startups from the beginning to the exit. And we work with KOLs in Europe and in the United States. Professor Prologo in the middle, he is the person who made the treatment with the cryo needle. He's a fan. He supports us and will support us in the United States once we are ready to go there. Diaper situations very robust. We have three international patents and one patents already granted in Germany in the United States. That's the prototype on the left hand side in the middle. From in vitro test, you see how the stomach of a pig is frozen. On the right hand side you see a cryoballoon after after the acute animal trials how its positioned in the stomach. The journey we have ahead of us is pretty clear. It's a medical device. The next step is we are going to do the product development proof of concept is completed successfully completed. We are seeking now in the seed round 2 million euro to get the product developed first in human studies planned in year three in Europe. It's also a CE marking study based on the clinical results. We're gonna run a global trial in the United States to get reimbursement and access to the US market. Potential exits we see after the first clinical trial. And prior to the global market entry. So far, we financed the whole project by ourself. We won some prize money, half a million euro was invested. So until now, we have a term sheet from the high tech during the fall after a letter of intent and have submitted a 2 million non dilutive grant in Germany. We won this year several awards where we are very happy to have this one. And if you have questions about Sedivention you'd like to get know to know more about it. Please contact me anytime. Thank you