Lloyd Diamond Presents Pixium Vision at LSI Europe '23

Transcription

Lloyd Diamond  0:05  
So at Pixium Vision we're creating a world of bionic vision for those who've lost their sight. We are a publicly traded company in Europe, so be mindful of any forward looking statements. Our first target indication is a dry age related macular degeneration, which is a disease which affects the photoreceptors cells of the retina. These cells are responsible for converting incoming light into an electrical signal that then can be interpreted by the visual cortex of the brain. In this disease, these cells begin to degenerate and die. So light comes in. But there's no cells to convert the light to an electrical signal. So the patient essentially sees, like in the image you see on the left a blind spot in their central vision. With our premier platform, I'll explain in a moment and our implant, we actually restore their central visual field, while at the same time preserving their natural peripheral vision that they retain, even throughout the course of their disease. So this is the prima system. It is actually a combination between a retinal implant, which I'll describe in a little bit more detail on the next slide and a pair of wearables, which consists of a set of augmented reality glasses and a camera projection module that actually beams the image onto the implant. A word about this marvel of technology, you can see here, the size of the implant on the center of the US Penny, it's two by two millimeters in size, and it's thinner than a human hair. It has 378 independent electrodes on it, and the material is what we call a photovoltaic material. So it actually is like a solar panel, it converts light energy into an electrical signal, which is what the photoreceptor cells are supposed to do. The implant was developed at Stanford University and picks him licensed the rights for all indications and all geographies for the implant. It comes preloaded in a surgical injection device that you see in the bottom left box, which allows for minimally invasive placement of the implant. And actually on the next slide, I'll show a video that describes in greater detail how the surgery is done. It does partially replace the function of the central photoreceptor cells, it is fully wireless. So it communicates wirelessly with the camera projection module. And the implant has been tested, we have published a 10 plus years of lifetime performance of the implant. And now we have in vitro data that goes up to 30 years. So if you think about the average age of implantation of these patients is around 72 years of age, the implant will most likely outlast the patient. It is patent protected, both on the implant, the wearables and the manufacturing process. So here's a brief video to sort of demonstrate how this works. There you can see the retina the photoreceptor cells have degenerated, the surgeon creates an incision, and then they'll inject the implant in the subretinal space, they'll then apply silicone oil or gas to reattach the retina. And four weeks later, once the retina is healed, the patient will come back we'll place the glasses on them. And then the glasses when we switch them on will, the camera will capture the surrounding image, it will simplify that image converted into light and then translate that light and transfer it from the camera through the pupil onto the implant. The implant then will receive that light image, convert it into an electrical signal and send it to the visual cortex of the brain where the patient will perceive the image that we've actually created for them. After the surgery, the patient goes through a rehabilitation process where they actually learn how to use the the device and they're actually retraining the visual cortex of their brain to see again and interpret the images that we create for them. That's usually done in clinic for several months. And then after the patient can continue the rehabilitation process through the comfort of their own home through a remote rehabilitation platform that we've put in place that allows the clinician to monitor the progress of the patient from the comfort of their own home. We actually started with in the lab setting with trying to understand the limitations and the capabilities of our technology. And what we've noticed is that over time as the patient becomes familiar with the use of the technology, they're actually able to progress in their visual restoration performance. So usually they'll start in a very static setting learning how to recognize letters again and read and then eventually they'll actually use the system in ambient light conditions. outside in. In daily activities, as you can see this patient, they are on the right in the hospital setting, trying to find where a specific department is at a hospital. So, we have our first generation technology, which is actually in the end of its clinical trial, Pivotal clinical trial in Europe. And we already have in our pipeline, the second generation technology under development, which you can see on the right side of the screen, which will incorporate most of the characteristics of the glasses into the glasses themselves, as well as an implant that has up to 10,000 pixels, which should be able to restore near 20 20 vision when using the zoom function. Today, we have excellent vision restoration with respect to reading. And we're now just starting the process of facial recognition in our next generation technology, the patients should actually be able to see people's faces. So we are targeting with our first generation technology 245,000 patients in Europe in the US, which can lead potentially to a $1.7 billion market. The average price of this implant with the wearables will be around $80,000 or euros per patient treated, which pales in comparison to the cost of blindness in this aging population. We are the only technology company today that will be able to claim vision restoration. There are some drugs that have been put on the market that actually have been recently approved, that demonstrate the slowdown of the progression of the disease. But nothing today is able to restore vision once lost. Primo will be the first technology that will be able to claim that we have 16 patent families with Project protection in all major geographies. And currently, as I mentioned previously, we have a we're in the observational phase of our European pivotal study. So all of our patients have been implanted, we expect to see the data at the end of December and then we'll present top line data sometime in q1 of next year, at which time we will file for CE mark. In the US we receive breakthrough device designation and we're currently negotiating our final clinical trial with the FDA. We have five publications in peer reviewed journals, we will we have just submitted a six now, which we hope will publish next year as well all demonstrating safety and efficacy of the technology. To date, we've implanted just under 50 patients in Europe and the US. We expect to file for CE mark in the middle of next year. And then we will begin commercialization sometime in early 2025. We're raising $20 million to continue our clinical trial work in the US and to begin to prepare commercialization in Europe. We have a very experienced management team that has come from both large and small medical device and has experience in bringing disruptive technologies through regulatory approval and into market. And we are working with the top experts in the field of retinal degenerative disease, geographic and geographic atrophy. So in summary, we are a breakthrough technology with that has demonstrated clinical success. We have a large untapped market that we're actually targeting. We also have a clear path to market. We are now pursuing reimbursement to support the health economic outcome and price of our technology and we are working with a top tier team. Thank you very much