Video Transcription
Amir Arthur 00:02
LuSeed Vascular is a medical device company that's in the clinical phase, and we operate in the neuro domain. So our mission is to provide a safe, effective, and robust solution for the treatment of brain aneurysms. Let me say a few words about this pathology. Brain aneurysms are a result of a local weakening in a blood vessel segment, and it creates what you see here, this bulge. It's evident in roughly one out of 20 people, and 30% of which will experience a hemorrhagic stroke throughout their lifetime unless they're treated. Now, 40% of all the aneurysms are considered wide necks, and they're especially difficult to treat. For this segment, there's a new family of devices called intra-circular flow divertors. Now here there's a major unmet need; using these devices, you have only 58% long-term treatment efficacy, which is roughly like flipping a coin. On top of that, one-fifth of the cases would have to go through re-treatment, either with a stent or a balloon, which makes it super difficult and super risky. On top of this, there is no robust solution for the two main subtypes of aneurysms, bifurcating aneurysms and side wall aneurysms, which leaves 30% of the market untapped. Besides that, there are major usability issues with approved devices in the market, specifically in the US, as they are very difficult to size. The Web device I'll show you later on has 44 sizes, so you can imagine how difficult it is to match the right device to the aneurysm. This is LuSeed's device, and it's a one-and-done device that's able to treat both subtypes of aneurysms, bifurcating and side walls. On top of that, it addresses the main design and usability issues that are presented with the current devices. I'll show you in the upcoming slides exactly how we do it. Now on the left-hand side and then the center side, you can see the Web and the Contour, and you can see the degree of protrusion that they have into the parent artery. This is a major safety risk. By having this protrusion, you're actually blocking the blood flow to adjacent arteries on one hand, and on the other hand, you're increasing the risk of thromboembolic events, blood clots, and stroke. Eventually, on the right-hand side, you can see a clinical image of LuSeed's device, and you can see we have no footprint in the parent artery, which is a major advantage. Now let's take it to the extreme side wall aneurysms. You can see that in the Web on the left-hand side and in the Contour, there's some sort of trade-off; either they protrude too much into the feeding artery, blocking the blood, or the relieving aneurysm is still in need of care, as it's partially exposed. I would say, on the right-hand side, you can see LuSeed's device, which fills the volume of the aneurysm while keeping the blood vessel intact. Now, if we just have a summary of what you have seen, LuSeed is the only device that can successfully treat both types of aneurysms. On top of that, we have a certain design to our proximal face, which is like a Roman arch and can withstand the water hammer effect and post-total pressure much better than other devices. We have only seven sizes, as opposed to 44 with the Web, so it's easier to match the right device to the aneurysm. Our acute blood blockage is better as our device is denser, which makes it more suitable for ruptured cases and acute cases. Our overall market is supposed to be larger because of these extra attributes. A bit about our clinical experience: LuSeed has done seven patients to date, for two of which we have six months of data that shows complete occlusion. On top of that, next month, we're actually starting our EU pilot study of 10 to 15 patients. Here, in the image, you can see one of the cases we've done, a really complex eccentric acorn aneurysm that was treated in 15 minutes. If you look at the competitive landscape and differentiation, LuSeed's device has a really good balance between the number of indications it can address and the ease of use. This enables us not only to compete with our own family of devices, but we can actually lean into flow divertors, which is a new segment of the market. A bit about the overall market: the device market for brain aneurysms is $2.5 billion a year, with a compound annual growth rate of 14.4%, which makes it one of the fastest-growing markets in the medical device domain. The reimbursement for such devices is $17,000 per device in the United States, and we aim to use the same codes. With regard to the market opportunity in 2023, LuSeed Vascular was bought by Stryker for more than half a billion dollars. But what's interesting about this transaction and other transactions in this domain is not the amount, but the phase. All of these companies were bought just after receiving their approval for the pivotal study in the United States. So it shows you how hungry the strategics are, and they have a good reason to be hungry in this domain. The reason for that is Stryker has a $1 billion coil business, and coils have been around for 30 years. You can talk to new interventionists; they're looking for one-and-done devices, and this is exactly what LuSeed is bringing to the market. A bit about our team: as part of the management, we have Mr. Bob Stern, who was the president and COO of Micros. He was also on the board of New Ravi Booth Company, which was sold to J&J. We have Professor El Azar Edelman; I'm sure that some of you know him. He has the Harvard and MIT biomedical engineering department. Professor Vitor Mendes Pereira is one of the top KOLs in our field. On top of that, we have in our board the South Barnea, who is the CEO of Sanara Ventures and Capital, a VC backed by Devon Phillips. Ellie David heads one of the largest private equities on Wall Street these days. Okay, that's about it. Thank you so much. Any questions? Thank you, applause.
