Pixium Vision | Lloyd Diamond, CEO

(Transcription)

Llyod Diamond  0:03  

Pixium Vision is a public company, so be mindful of any forward looking statements. Our mission is to create a world of bionic vision for those who have lost their sight and mission we take very seriously. Maybe a brief anatomy lesson first thing in the morning to get everybody make sure everybody's awake. But our primary indication for this technology is the dry form of age related macular degeneration. And for those of you that aren't familiar with the disease, this is a neurodegenerative disease that actually affects the photoreceptor cells in the deepest layer of the retina. The photoreceptor cells are normally responsible for taking incoming light from the pupil, through the pupil and then translating that light into an electrical signal which is then sent to the optic nerve to the visual cortex of the brain, where the patient will actually see what the eye is looking at. In these patients, unfortunately, the photoreceptor cells no longer function. And so our technology platform prima actually takes the place of these photoreceptor cells, and I'll explain the technology in a moment. What you should know is that the time of presentation, our patients the average, I guess, onset of the disease is 60 years of age. By the time they progress to the legal flump form of blindness, on average, it's about 72 to 73 years of age. And so the patients at the time of presentation that we treat with our technology have a similar vision, as you see on the left side of the screen. They maintain some level of peripheral vision, but they have lost their central detailed vision postimplantation with the premier technology, we actually complement the remaining peripheral vision with a bionic form or a virtual reality form of the central vision. And so you can see in the image on the right, we actually are able to create an environment where they can see letters and start putting together sequence of letters and words. I'll talk a little bit about the clinical results in a moment. When we first started the journey at Pygeum, we in licensed the technology from Stanford University, and there had been other technologies in the space targeting orphan forms of retinal degenerative diseases such as retinitis pigmentosa, the the furthest those technologies had ever been able to go is just giving some form of light perception to patients. And so we didn't know what to expect when we first implanted our original patients in France 48 months ago. And actually, with some good scientific development, and I think maybe a bit of luck, we actually progressed with our patients over time. And we were able to allow them to recognize letters words, and now we are focusing on activities of daily living, where they can recognize train schedules, and even navigate through a hospital, a being able to read signs in a hospital and find what floor a specific department is on. I want to talk about the the target patient population. So you know, for those of you that have been around in the device and drug world, you probably know that age related macular degeneration, at least the dry form is sort of the holy grail of posterior segment disease. And today, there really isn't any option for these patients, at least where restorative vision is concerned. So remember, these patients that were targeted or legally blind may have the advanced form or what we call geographic atrophy. And so you imagine 160 million patients worldwide that have some form of dry AMD, as compared to about 40 million that have the wet form, the wet form being a different disease. However, today there are treatments, drug injection treatments, interview atrial injections for these patients. So the large majority goes untreated. And so if you think about our primary geographies we are we are targeting commercialization being the US and the large, five large European geographies. All cases of AMD represent about 64 million patients that's wet and dry, of which the late stage of the disease so those that are progressing to legal blindness are roughly 5 million patients. Now those that have AMD the dry form with geographic atrophy, which is really the primary target patient population for us in those same geographies represent about a million patients of which about 245,000 have severe enough disease where they could actually benefit from the pre med implant. That's 245,000 patients with about 22,000 incidents every year coming into the potential treatable pool. So maybe I'll just walk you through the technology briefly. Um, it's a very cool technology actually, that the company spent many years developing. It combines neuromodulation brain machine interface, and artificial intelligence to create this virtual world for these blind patients. There are three communicating components and implant, which you see on the left. And I'll talk a little bit more about that in the next slide, as well as a pair of accessories or wearables that consists of smart glasses and a pocket processor. And I'll walk you through the mechanism of action in a moment. So a word about the implant itself, two by two millimeters, it's thinner than a human hair. It's made out of a photovoltaic material, which converts light to an electrical signal, again, which is what the photoreceptor cells are supposed to do if they were functioning normally. It has 378, independent functioning electrodes. There's no battery or anything like that. It's completely activated by the wearables that the patient wears. And it's implanted in a minimally invasive fashion, with a high precision implant delivery device. And I'll show you an animation in a moment about what I'm describing now. It also is quite durable. We have published in an engineering publication that we have in vitro 10 years, plus a lifespan and accelerated aging shows 20 years. Again, the average age of implantation of these patients today in our clinical work is around 78 years of age. So the implant should last for the duration of the patient's remaining life. As far as the glasses in the pocket computer are concerned, the miniature there's a miniaturized camera, which is mounted on the lens. And these are corrective lenses, usually, because the patients, as I said, do maintain some form of peripheral vision. So we provide corrective lenses to enhance their peripheral vision, we mount the camera on the lens on the side of the eye where we've implanted the patient, the camera then captures an image of the surrounding environment. And then that image is sent in a streaming fashion to the pocket processor with a pocket processor, a pocket computer will actually simplify the image, convert it to an infrared signal, which is then sent back through the camera to a projection module on the backside of the camera, through the pupil onto the implant with the implant, then we'll convert that signal into an electrical stimulus, which is sent to the optic nerve in the visual cortex of the brain where the patient will perceive the image we've created for them. So it's not exactly they're not exactly seen. For instance, in this case, if they're trying to read a label on a pill bottle, they're not seeing exactly what's on that label. But they're seeing the recreation of the letters that we have a processed and created for them. So here's a brief animation of what I just presented. Here you can see the deepest layer of the retina, the photoreceptor cells are gone, the surgeon creates a minimally invasive incision through a rat anatomy, they inject the implant in the subretinal space, gas or oil is applied, no sutures are needed. The patient comes back four weeks later, after the retina has healed for switch on we capture the image, send it to the pocket processor, which then converts the image to the signal onto the implant and then to the visual cortex of the brain where the patient perceives what we've seen for them, what we've created for them. So a word on our clinical progress. We have are now coming up on 48 months of our first inhuman French feasibility study, we've actually generated three publications based on this data which show a durable safety and efficacy profile. I'll talk about that on the next slide. And we have started our final pivotal study in Europe called primavera, which I will talk a little bit about in a moment. In the US, we began, we began a US feasibility study, and we're expecting to read out of that data sometime the second half of 2023. And we have ongoing discussions now concerning our regulatory program and pathway with the US. So what is the publication show? And what clinical results have we gotten today? Our 24 month data shows that we have had improvement of visual acuity of up to nine lines on an etdrs chart, with the average being five lines. And just to put this in context. I mean, you know, what does that mean? In order to show clinical significance and visual acuity improvement, patients must demonstrate at least two lines of improvement on an etdrs chart. And so we've gone well beyond the expectation there. And it's based on these clinical results that we received approval from the European competent authorities to begin our pivotal study in Europe. A word about the study, we are actively enrolling in 15 centers in the five major geographies plus, plus the Netherlands This will include 38 patients who have a visual acuity of 2300. Or worse, the primary endpoint is etdrs, as I said, and we will measure the outcomes at 12 months. Again, this has been the subject of several publications. We are now working through our pipeline to generate a second generation of implants with Stanford University, which will allow us more pixels which ultimately will create better detailed vision for our patients. We expect European commercial launch sometime at the end of 2024, after we complete the data readout of our pivotal study, so just as a summary, we have a state of the art technology to address the most common debilitating economic condition in patients older than 60 years. We have an ongoing pivotal study in Europe with an expected readout in late 2023, early 2024. We're targeting a very large potential patient population. We have robust IP around our technology, and we're now ongoing, strengthening presence in in our key markets, including the US. Thank you