Elad Sapir 0:03
My name is Elad Sapir. I'm from Israel. I'm a Cuspa CEO. My background is mechanical engineer. And the last one two years I was involved in various of r&d projects and the medical startups. Most recently before cast by lead another startup in the structure heart field and Cuspa is also in that field. So we are a startup based in Israel. We have been founded about three in something used a years ago. We are in our r&d predicting preclinical stage, we are focused on structural heart a OTech Varvatos implant, our regulatory pass is a PMA Class V device and we are expecting to have a first human in the first half of next year. So, aortic valve disease are divided into basically two segments. The aortic stenosis, which is a little bit more known in the industry and the ODK, regurgitation, or TK stenosis is patients suffering from classification in the valve and the notic. regurgitation, you do not have classification the valve is deform and there is a leakage. Today, there are trans Arctic a repaired a replacement devices, which are focused on a Arctic stenosis. They Arctic stenosis patients have classification, the device is the classification to position themselves and maintain contact. And without classification, it's a contraindication to the current transcatheter devices. This leads to a absence of transcatheter treatments for article rotation patient. Our solution is the CASPER it's a transcatheter repair device, that is a position in one of the costs of the of the valve. In this movie, you can see the cost per device being delivered through a delivery system to the IoT valve, the physician is loading the device on the catheter and delivered that over a wire to the valve once in the position. To the expected landing zone the catheter is a stable and you can navigate to the desired CUSP location are routinely the A there are three costs but maybe more a less than this. You divide you decide which one you would like to position the device onto and once you're in the desired location. You release the implant by clipping it to the cusp. detaching the, the catheter the delivery system from the implant is very easy. And once the implant is in the location, it's instantly effective and preventing leakage. This is the customer. It's my nitinol frame clip with a biological material, a conical sleeve that is the main aspect of the Casper. Here we can see an animal valve in a simulator, where the one of our models is positioned and affecting as we expected. In the following movie we can see before and after evolve with them a setup of regurgitation and evolve where the implant is positioned. Our clinical experience was published in the human intervention and one the best flush while I Fleshlight was the last day you will PCR here we can see it before and after an animal with the Casper and without today we have already 30 to 90 days follow ups with animals and we have no we have no way from balik event and we see good performance of the implant interposition in the in the animals there is increase interest in Article rotation in academia. These are slides that were presented in TCT by Professor Marty Leon focused on the recent development in analysis of who is the patient while the patient population and how they are treated, treated. Compare comparing them to the aortic stenosis patient and also dealing with how we identify the patient how to treatment, most of the guidelines in the formation and Based on the technologies and data that was exists 30 or 40 years ago, we estimate that the total addressable market in the US is over a 1.5 billion and can reach up to over four and a half globally. As I mentioned, there is no transcatheter treatment to a our patient. However, there are a couple of players that are now developing replacement solutions, we are dealing with repair and comparing to the coming technologies that are now in processing the FDA, or in early clinical evaluation, we can say that our device have a less limitation in anatomical constraints. And more importantly, once you've been using it, it still leaves all options for future treatment, whether it's surgical treatment to the patient, or in the future, translate all tick replacement devices over our a repair device. We have a IP coverage for core technology, both in the US and globally and we have more patents in process. Today, we are in the completion of the development and design phase. We're about to start the validation with the our main target is to reach to first inhuman with the five patients in the first half of next year. Following that we will continue to a clinical study here in the US to reach out to FDA approval. Our team is highly experienced in innovation, a research and development, financing and managing structure startups and medical innovation from other projects. And we are raising now $8 million in two tranches of 4 million and another 4 million and the first four tranche will lead will lead us to the first milestone of reaching for the first Newman. Thank you everyone and feel free to feel free to reach out afterwards. Thank you
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