Mike Karim Presents Oxford Endovascular at LSI Europe '23

Transcription

Mike Karim  0:04  
Good morning, everybody. My name is Mike Karim. I'm the CEO of Oxford Endovascular, and we've been developing origami engineering to treat brain aneurysms. Were a spin out from Oxford University. I'm going to show you a very short one minute video. To bring this technology 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 divert, as are stents that 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 oxy flow and next generation flow divert a laser cut from a unique aloe, Oxford endovascularly. Elite engineers have refined oxygen flow to allow it to open accurately first time every time. It overcomes the problem in a market growing to over $3 billion. Support saving lives joining our Origami mission to treat brain aneurysms. Well, brain aneurysms are surprisingly common they affect one in 50 people. And if a brain aneurysm ruptures, patients have a 50% chance of dying and of the ones who survive over 66% will have permanent brain damage. Every year, there are three quarters of a million people who have ruptures, it's really important that the intervention takes place effectively to treat these. Now the market for disposable devices that are being used to treat brain aneurysms is currently over a billion dollars, but it's rapidly growing over the next few years to over 3 billion. And this is because more doctors are doing these endovascular techniques. There are better imaging equipment that's available and more countries are getting involved in the treatments. And this just gives you an idea of some of the acquisitions that have been taking place in the space. So the early flow diverter from a startup chestnut medical got acquired is now part of Medtronic portfolio. And in the last year, there was an even larger acquisition of around 540 million US dollars for 'metoo' technology. Now flow divert has got established in around 2009 and a flow divert or is essentially a woven mesh stent that reduces the blood flow into the aneurysms. But all the existing devices have challenges because of their woven mesh design. They can't conform accurately to the shapes of the arteries can't open effectively, often. And this is some of the data that the FDA collects on flow diverter related failures. And these occur in 35% of procedures. And you'll see that the really big one nearly 50% of the failure modes is actually failure of the device to open. And when these happen they lead to adverse events, such as a decreased therapeutic response, intracranial hemorrhage, thrombosis, neurological deficit, etc. Our technology is focused on overcoming these issues. I've spent over 30 years in medical device development taking new technologies to the market. I co founded the company along with Professor James burn one of the godfathers of neuro vascular who helped to develop the coiling procedure and many other technologies. He got together with Professor Zhang Yu, who is the expert in origami folding structures did a lot of work on the European Space project on satellites. On our found, our Chairman Charles Taylor has exited three vascular companies. So Oxford flow is origami engineering for the brain, it moves away from the mobile woven mesh structure. It uses a laser cut all in one piece, unique design nitinol structure as an inner skeleton. This allows the technology to conform to whatever shape that it's put into. And as we were developing the technology, the doctors asked us to make a device that places and opens accurately first time every time resists migration, and avoids having to use more than one device. This means that not only is it a safer technology, but They will also save time, and also save cost. But the cost of production of the device is very similar to existing devices on the market. It will go in using existing equipment and under existing reimbursement codes, and the doctors asked us to make it easier than existing devices. And that's what we've done. The image below is a model aneurysm with a micro catheter in place, and the main competitor device is about to be deployed. And you'll see the challenges that doctors have trying to get a device to actually open immediately, you can see those delayed opening here. So the device is having to be recaptured, which actually distorts the device and reduces its flow diversion capabilities. Even when it's open, there's still a gap with the vessel wall. And this is an area where blood clots can form the micro amberlite. This opening issue is challenged all the way along the device, so the doctors having to recapture the device and manipulate it. And this pushes the delivery wire further and further up the vessel, which runs the risk of a puncture. As we were developing our device, doctors asked us if we could avoid that issue, as well. You see the last part of the device that manipulation going on again, often at this stage, they'll remove the device completely and get out a new device at huge cost and putting more risk for the patient. You'll see the final part of it, the doctor just about manages to get the device in place. And that's typical of the placement. And at this stage, they'll often do another procedure put a balloon inside the device to force the device open. So these are the typical challenges that are in in the marketplace with all the existing devices. The oxygen flow device by comparison lands in the right position, it opens immediately due to that unique design that we have with the laser cut frame. The rest of the device lays down proportionally with optimized radial force on the final part of it pops open. And this is what we've seen all the way through the animal work that we've done. During the pandemic, we also worked out a way to get even greater flow reduction. So we see a 98% flow reduction compared to about 93 94. With the other devices. Our aim was to get equivalents, but we were able to supersede that. And this is showing you a doctor's iView of how the device shows up under Live X-ray. This is from one of our animal studies. And the doctor is looking to see that the device the margins of the device are clearly focused and open. Often they cannot even see the edges of the existing technologies on the market. This is an independent pathologist report at 30 Day follow up showing good aneurysm healing and endothelial activation of the device and at a cellular level, no untoward effects. And we've had some great feedback from World key opinion leaders who've looked at the device and given advice all the way through the development program. So we've really tried to listen to their needs. We're going through our V and V and heading towards the first in human clinical study, which will be that key value, inflection point. And we're about 12 months away from that we're doing a fundraiser at the moment, which is a 6 million pound fundraise designed to get us to the end of first inhuman, got a lot of doctors interested to be involved in were narrowing down the sites to be involved. We will then go on to a pivotal clinical study we've done two FDA pre subs and the FDA have been extremely helpful in guiding us through our development program. So we're really excited about how this is going. The doctors are really excited. And if anybody wants to join us, we have a lead investor already in the round with a sign term sheet. So please join us and help us solve this issue with origami engineering for the brain. Thank you.