Mike Karim, Oxford Endovascular - Flow-Diverter Using Origami Engineering | LSI USA '24

Mike Karim  0:04  
My name is Mike Karim. I'm the CEO of Oxford Endovascular, we're a spin out from Oxford University and we are developing origami engineering to treat brain aneurysms. I'm going to show you a short video to bring this to life. The Japanese art of origami is evolving to save lives. One in 50 People have brain aneurysms that can rupture causing death and disability flow diverters or stents, then treat brain aneurysms, but placements can fail through device deformation. World leaders at Oxford University have combined medicine and space Tech with origami engineering to develop poxy flow and next generation flow divert a laser cut from a unique alloy. Oxford, Endovascular elite engineers have refined oxygen flow to allow it to open accurately first time every time. It overcomes the problem in the market growing to over $3 billion. Support saving lives joining our Origami mission to treat brain aneurysms. Thank you for listening to that. Many people are really surprised how common brain aneurysms are, they affect one in 50 people. And if somebody has a rupture, they have about a 50% chance of survival. And the ones who survived 50% of those have serious brain damage. Treatments evolved over the years open surgery is still done. Endovascular, became coiling about 20 years or so ago. But neither of these actually cure the aneurysm itself. And this is where flow divert has come in. So in 2009, the first flow divert has got approval, and they're basically a highly modified stent that lies across the neck of the aneurysm causing it to shrink, heal and disappear. But that's if you can get the device in the right position. And to open. This is FDA data that shows that 35% of procedures have placement failures where the device often fails to open fails to get in the right position. For migrates, and activation failure, the failure of the device to open affects about 50% of those failures. And these can all lead to serious adverse events. And the reason for these challenges is the design of current technologies, which are made of braided woven mesh devices with strands of metal literally knitted together. The market is growing because of obviously the aging population, increased cardiovascular disease, and more and more doctors around the world learning how to place these types of devices. It's a very exciting space, you can see the acquisitions that have taken place over time, and increasing in their value. We have a great team Oxford Endovascular, we have fantastic engineers on the ground, that in the leadership, we have a combination of medical engineering, and business people who've taken technologies to market over the years and have worked with a lot of the large companies. So Oxford flow is origami engineering for the brain. What distinguishes the design of this technology is that we don't take a series of strands of metal and knit them together, we take a chip of nature and all with a unique design and you need that unique design. It's programmed into a laser cutting machine. And the technology is cut all in one piece. It's overlaid with a special sleeve which deals with the flow diversion. And what this is designed to do is optimize the radial force along the device into whatever shape of vessel that it's put into. So that opens accurately first time, every time. And the great thing is it doesn't require any new technique, or any new equipment will actually save money to healthcare services around the world. This just gives you an idea of how that origami concept works. Folding structures where a lot of the inspiration came from the European satellite program, one of our engineers worked on that. I'm just going to run these these videos the the lower technology in this model aneurysm is a standard flow diver to that represents the market and in the top is our technology. I'll run them together so that you can see the difference. So you can see the lower device what's on the market at the moment is challenged first of all getting in the right position and opening up it's having to be recaptured several times and you can see on the top our device is nearly already open in the right position. Now a device is fully open. But the competitive device is still having to go through a series of recaptures. And those recaptures actually damage the structure of the device. And often during the procedure, there'll be recaptured and thrown away. That $16,000 of device just wasted straightaway as well as the extra time and money that goes into keeping that patient on the table at more risk, etc. Even when the devices are actually in place, and the doctors managed to do that. Often what they'll do is do another procedure following it, they'll put a balloon inside to try and force the device. So why should adopt I have to go through that when we show these videos? The first thing they say is how have you got this technology to do what I wanted to do as a doctor. The second thing they ask is when you're doing your clinical studies, and can I be involved, because I believe there would be immediate benefit to patients. During the pandemic, our engineers had nothing better to do they were locked away in their kitchens where they'd moved the the technology as they were developing it. And they found a way not only to address all of those issues, but actually to increase the flow diversion capability of the device. So it's now around 98% flow reduction compared to what you see 9394 with current devices. So that's an extra bonus on what we're able to develop. And this just shows you adopters I view of the technology. This is in one of our animal studies, we've done a number of rabbit animal studies, which are standard for neurovascular. And what they're looking for is to see that the device is actually fully open and conforming to the vessel. Often with competitive devices. They'll describe it as sailing blind, or they're not sure whether it has actually opened or not. And then they'll display they'll often put a balloon. And this just shows you the device. So the image on the left is a cross section through the subclavian artery in the rabbit aneurysm model. And you can see the dark purple dotted areas that's a cross section through the structure of our device. And this is 30 days after placement. Showing it's nicely endothelial as you've got tissue regrowth over the device. And across the neck of the aneurysm The neck has actually healed off on the right, that's basically showing at a cellular level, there's no untoward effects, or inflammation on the cells, basically showing that the device is safe, as well as being affected. Now all the way through the development process. We've involved key opinion lead adopters, to give us feedback, critical feedback on the design of the technology to make sure that it meets the needs of the end users expense occur at the top. He was the principal investigator for the CE mark of the first technology that came to market, Dr. Sam lemon, another key opinion leader who's involved in development, and he's done a lot of our animal placements. Now these doctors don't give compliments away lightly. So first inhuman for us is about 12 months away, we're working through our design verification, validation testing, not only will be looking at the safety of the device, but we'll be looking at all of those key factors placement, accuracy, opening resistance to migration, etc of tangible things we can record. This is our timeline, we're going through our D V and V at the moment, heading towards first in human. We've engaged with FDA all the way through the last few years and we're coming up to our third priests have been very good at helping us get alignment with what they would like to see before we go into our pivotal clinical trial. In the last few weeks, we've closed a round of about $10 million. We've got a little bit more to come in. We'll be raising 40 million in a year, year and a half. So we'd love you to join us anyone who's interested. Please come and see me afterwards and support origami engineering to treat brain aneurysms. Thank you