Lloyd Diamond Presents Pixium Vision at LSI USA '23

Transcription

Lloyd Diamond  0:05  

Pixium Vision we're creating a world of bionic vision for those who have lost their sight. We are a public company, so be mindful of any forward looking statements. So what do we mean by creating a world of bionic vision for those who have lost their sight, our primary target indication is the dry form of age related macular degeneration. And what you see in the image on the left is the typical presentation of a patient at the time they come to us for implantation with our device, they actually maintain peripheral vision, but they lose their central vision. So they can ambulating to space, okay. They can situate themselves, but they're not able to read or recognize faces. Actually, this is a disease of the aging it can be quite debilitating for these patients. after implantation. The image you see on the right is typical of the type of vision that patients will have after treatment with our technology, which is called the premise system. The platform will allow the patient to maintain peripheral vision, but will restore central vision. As you see in the image there. It's an extremely large and fast growing untapped market. Most recently, there was a drug that was approved for in the US for slowing down the progression of the disease. But there is no therapy today that can restore vision once the patient actually loses their central vision. If we look at the potential here, we are concentrating first on Europe, the five large countries in Europe and in the US, there are 64 million people that have both forms of AMD, the wet and the dry form. If you look at late dry stage AMD with geographic atrophy, that's the target patient population. For us, there are roughly a million patients and those that have a visual acuity of 2300 Or worse, which are the patients that would respond to our therapy represent around 250,000 patients 22,000 new patients annually at a target price for the treatment of around $80,000 or euro gives you a market potential of 1.6 billion. Just a brief sort of anatomy lessons, you'll understand how our technology works in dry AMD the photoreceptor cells in the deepest layer of the retina no longer function. Those cells are actually responsible for converting light into an electrical signal that can be interpreted by the visual cortex of the brain, which allows us to actually see in this disease, the photoreceptors cells no longer function. So light comes in, but there's no cell to treat it and so the patient will see a dark spot in their central field. With our technology, we implant a small implant like almost like a solar panel in that layer layer of the retina. And it does exactly what the photoreceptor cells are supposed to do. It will convert light into an electrical signal. Here's a word on the technology itself. There are three communicating components. On the left you see the implant, which goes in the retina, it's in the center of the penny there. I'll talk a little bit about it in a moment. And that implant requires wearables in order for it to work. And so we the patient wears a set of smart glasses with a camera projection module mounted on it and a pocket computer, which are the brains of the operation. Here's the implant itself. It's two by two millimeters in size. It has 378 independent functioning electrodes, there is no battery it communicates wirelessly with the smart glasses. It comes preloaded in a precision implant delivery device that allows for minimally invasive placement of the implant. We have patents protecting both the implant itself and the manufacturing process. We have implant durability testing that we have published that shows 10 plus years of in vitro lifetime. And now we're coming up on 30 years of accelerated aging. So average time of implantation or age of implantation for these patients is around 72. If the implant last 30 years, the implant in most cases will outlast the patient itself. The implant was actually developed by Stanford University and picks him today enjoys a very close research and development collaboration with the University. We licensed all the rights for this implant, both for all indications and all geographies around the world. So now I'm going to explain how the technology works in this in this animation here. Here you can see the retina the photoreceptor cells no longer function, the surgeon creates a small incision and they will inject the implant in the subretinal space. They'll apply silicone oil or gas similar to retinal detachment surgery. The patient will come back four weeks later once the retina heals we put the glasses on the camera on the glasses will capture the image will send it to the pocket computer which will simplify the image and convert it into a light signal which is then transferred back into the implant wirelessly. The implant then will convert that light signal into an electrical signal, which is then perceived by the visual cortex of the brain, and the patient then will see the image we've created for them. So this implant, and wearables the technology is really based on virtual reality or augmented reality algorithms and image simplification. After the implantation, they go for a series of rehabilitation sessions where they learn how to use the system. And they actually learn how to have their visual cortex of the brain perceive the images that we're creating for it. First, the rehabilitation starts in the clinic, and then they're able to continue rehabilitation at home through a remote rehabilitation module that we've incorporated in the system itself. Now, just a few videos of some patients. Here you can see a patient that's been implanted, but they're wearing their regular glasses, they're not actually using our system. And they can see that there's a scribble of letters in front of them, but they're not capable of seeing the word elephant, they actually progress then once they wear the glasses, they're able to identify letters, and then they do more complicated tasks, such as reading train schedules, and then actually reading signs outside of a hospital. Here you see a different patient that's actually reading a magazine here. And again, these patients are legally blind. So they cannot do this without the system. They're here, this patient actually has developed quite fluid reading skills using the system. And here we have a patient in the UK, I believe that's actually playing cards for the first time since they've used the system and capable of doing that without, and they're actually able to identify, identify the numbers, or any letters that are on the card. So they're the patient just saw two, you can see it in the box on the right. And then the next card they'll draw, you will see that it is in fact a a king. So this device allows patients to regain a certain quality of life, which is very important, especially in the aging patient population. So here, you'll see it just in a second you see the K in the black box on the right there. And so they've seen a king. And in fact, in this case, the patient had a better hand than the person they were playing with. So where are we currently in Europe, we are in the final stage observational phase of our final pivotal study. So we've implanted all patients we've enrolled in implanted all of them, we expect to have data at the end of this year, and we will file CE mark in 2024, at which time we believe we'll be the first company to have an on label approval for vision restoration in advanced dry AMD. In the US. We have started our phase two study the FDA now has asked us to progress to our final study and we are in discussions with the FDA we expect to start that study in early 24. And then regulatory submission at the end of 26. We have ongoing future developments as well with Stanford at this point. Now we have a next generation of implant that's been published in animal testing that actually shows a 5x greater resolution than the current implant, which will allow patients to actually recognize people's faces. With zoom, we believe that we can restore vision to near normal 2020 vision. We have five peer reviewed publications and another one expected in 2023. And again, I mentioned previously that our key milestones are data readout in Europe the end of this year CE mark filing early next year. And then in the US beginning our pivotal study early next year. We have an experienced team with a collective knowledge and medical device. We're working with all the top key retinal specialists and hospitals in Europe and the US and the company is currently looking to raise around $20 million or euro I guess it's almost the same to finalize the data read out in Europe and then begin our pivotal study in the US and begin ramping up for commercialization. Thank you