Lloyd Diamond, Pixium Vision - Bionic Vision | LSI Europe '22

Transcription

Lloyd Diamond  0:03  

Thanks for the introduction. So as we said, Pixum Vision is creating a world of bionic vision for those who have lost their sight. We are a publicly traded company. So please be mindful of any forward looking statements. or worried about dry age related macular degeneration, which is the primary indication or target for our technology. You can see the image on the left that is typical of the presentation of a patient when they come for implantation for the premier system, which is our technology. And I'll explain that in just a moment. So they lose their central vision, but they maintain peripheral vision. So peripheral vision is what's responsible for situational vision in a space. So they can kind of see where they're on a specific space, but they can't read recognize faces or use any detailed vision. And then on the right postimplantation with our technology is exactly the results that we get by where we maintain their natural peripheral vision, but we enhance their loss central vision with what we call, bionic vision that we create for them. So what I wanted to do is just show you a real life experience here of a patient, that 12 months post implantation actually was undergoing a reading test by where we don't allow them to use our system. And they're just simply using their corrective lenses that they were for their peripheral vision enhancement, we asked them if they can recognize the letters or word on a page. And then we allow them to use our system, we changed the page with a different word, and we see if they can recognize those letters and state the word. So here you can see the word elephant, he's not wearing our glasses or anything just his own. And he cannot see any of the letters he says he just sees scribbles. So he's about the distance that we would typically be from a computer screen. And then here, you can see that he's wearing these other funky glasses, those are ours, He's scanning CV can see the letters. And this is a display that the rehabilitation specialist has in front of them by where they actually can see what the camera is viewing and then what the implant in the back of the eye that we pose is actually receiving. And you can see that he's actually quite able to see the letters, he states, each one of them and then he and then he states the word. And this is very typical of the patients that we've implanted, and that we track post implant, post implantation.

Unknown Speaker  2:34  

And then in addition, as they progress, we'll do other tasks such as reading train schedules, and then taking them outside in the hospital setting and asking them if they can actually find their way through a hospital without any assistance. So the point that I want to make here is that for dry age related macular degeneration in the advanced stage of the disease, these patients are completely dependent on others. What I would say is the average age of onset of dry AMD is around 60 years old. And by the time the patients are in their 70s, if they're going to progress to blindness, that's usually at the stage that it occurs. I want to talk a little bit about our target market. In the US and Europe, which are the first markets we're targeting there are about 64 million patients that have all forms of AMD, there's a dry form and a wet form. The wet form represents about 20% of the patient population, there today are treatments for those patients, they receive intravitreal injections, and that's about a $10 billion market. Of those 64 million, there are about 5 million who have a late stage form of both wet and dry, and then about a million have dry in the late stage with geographic atrophy. And that's the sweet spot of our indication of those million, 250,000 have a visual acuity of about 2300 or worse. And that visual acuity is the point at which we can intervene and give some meaningful vision back. It represents to us about a $20 billion target accessible market. And if you look at incident rates of about 22,000 patients per year coming into the pool, it's roughly a $1.6 billion market today for which there is absolutely no therapy. I want to make you know just the mention about the technology itself. The system is a small microchip that you see on the left that's the prima implant and it communicates with wearables are accessories that the patient has to wear. I'm going to talk a little bit in more detail about each of the components. The implant itself as you can see in the zoomed in version is two by two millimeters it has 378 independent functioning electrodes. It was developed at Stanford University and the company today pixum owns all the rights for all indications and geographies for the implant. It is thinner than a human hair and it actually is injected Sabra only with a proprietary injection device, which allows the surgery to be done minimally invasively inpatient outpatient under General or local anesthesia, the average operating time is about an hour and a half. The in vitro Testing has shown 10 year lifetime of the implant and in accelerated aging where at about 20 years, average age of implantation of these patients is 72 years old. So the implant is then surgically implanted. And then four weeks later, the patient comes back after the retina is healed. And we then put these wearables on them these glasses at with a pocket computer that actually communicate with the implant. So what happens is, patient comes back we put the glasses on, we have a camera that we mount mount in front of the pupil where the implant was placed, switch the system on the camera captures the environment, sends that image to the pocket computer, which processes and simplifies the image, and then sends back that image in the form of infrared light through the pupil to the implant where it'll stimulate the individual cells on the implant, the implant converts that light into an electrical signal which is sent to the visual cortex of the brain, where the patient will perceive the image that we've created for them virtually, we usually start with shapes and then eventually we progress to more complicated tasks like reading. So here's just a brief animation of what I just described, you can see the retina there, those are the cells that no longer function, where we place our implant, we create a small incision, the surgeon will inject the implant in the subretinal space, they will apply gas or oil to reattach the retina four weeks later, once the retinas healed, patient comes back, we put the glasses on, and then the edge the rehabilitation process starts where they learn to use the system. And they can begin to perceive the images and letters and numbers etc, that we create for them. So typically, after the implantation is done, patients will come to clinic for about three months where they're learning to use the system and then we send them home and through a remote rehabilitation process, where the rehab expert is in clinic and the patient is at home, we can monitor progress, we can actually have them do exercises to begin to improve their visual acuity and use of the system and we can collect information on how their visual acuity is improving over time from the comfort of their own home. We are currently in Europe. In our final clinical phase, we have our phase three study where we just announced we completed our target enrollment, we expect to get 12 month data sometime toward the end of next year, at which point we will then file for CE mark, and we believe we'll have the first on label indication for vision restoration in advanced dry AMD. In the US we have a phase two study ongoing and we're in discussions with the FDA on the US regulatory pathway. Our pivotal study is 38 patients in six countries in Europe and our primary endpoint is improvement of visual acuity by etdrs, which is how many lines better they can read on a letter reading chart. And as I mentioned, the primary data readout is 12 months post implantation. We do have publications to where we've published our phase two data in both the Journal of ophthalmology and nature where we've shown in a phase two in Europe, a visual acuity improvement of an average of seven lines on an etdrs chart in our patient population, which is actually meaningful. In order to show statistically significant improvement in visual acuity, you should show a minimum of two lines. So we've gone well beyond that. As I mentioned, European commercial launches anticipated sometime towards the end of 2024 depending on how long it takes for the competent authority to regulate our dossier. Thank you very much