Ash Attia Presents Bionic Vision Technologies at LSI USA ‘23

Transcription

Ash Attia  0:05  

I want to thank you very much for taking interest and staying until four o'clock on a Thursday evening. What I'm about to show you is a revolution that was once considered to be science fiction. But now it is a reality. And it's the first in the world. People who are born through a genetic condition with any one of over 360 plus genes are hit with a retinal disease called retinitis pigmentosa they are born they can see. But then as they approach their 20s or 30s they lose their sight completely, and they become blind. So I'm going to start with the end in mind. What do these people say? That we have implanted our system in after they receive it?

Video playing  1:08  

Scott Nixon's eyesight started to fade when he was just a baby. And he was declared legally blind before he turned 21.

I can't even tell you something like, you know, how many fingers am I holding up let alone anyone else.

He is one of four participants trialing a bionic eye, which helps people with retinitis pigmentosa navigate the world.

Speaker 4  1:27  

So these patients start with vision in early life, but progressively lose vision.

Speaker 5  1:35  

The cutting edge surgical technique involves placing an implant on the skull, which attaches via a lead to electrodes within the back of the eye. The glasses have two cameras capturing footage that sent to this unit, which converts the video into an electrical impulse that then passes back to the skull onto the device in the eye, which stimulates existing tissue helping wearers see. Great Grandmother Colleen Knowles is one of millions robbed of this site due to a genetic condition of the retina,

Video playing  2:08  

sometimes a little bit, even though it's not your fault, there's still a bit of guilt that, you know, they've picked up this genetic condition from me. And I see that down the track being a relief for parents and that as well, to know that something can be done live on, for sure. I can look at over the bay and know whether there's any boats out there on the bay. With without advice, some I don't even know there's technically I know that's water and sand, but I wouldn't be able to tell you,

Colleen still vividly remembers her switch on day,

probably the first seven or eight times nine times. Maybe that's it? Can you see anything? No, no, no, no. And then all of a sudden, oh, and my family were in another room watching it through CCTV. So it was exciting for them as well, is history making that's gonna change the lives of visually impaired people.

Ash Attia  3:12  

That's what it does to somebody who lost their vision. And now they have a vision that they can function with. So what is this disease? In very simple terms, you are born with this inherited disease, as I mentioned, you are born with one gene out of possibly 360 Plus individual genes that will cause you to completely lose your sight because it destroys the cells in the back of the retina, that in you and I and all of us, it turns light into vision. So once you destroy that, you have no sight any longer. Actually, the incidence of this disease is a lot more than what a lot of people think. In the Western world like the United States and Europe. It's about one in 4000 People born with this in India and China, it is one in 750 people, or one to 1000 people born are affected by this disease. And there is absolutely no viable option that exists today in our world. Gene therapy will never do it because gene therapy will perhaps look at a gene or two or three, but they could be born with as I mentioned 360 Plus genes, stem cells will not will not do it. And it's very, very early on. So really no viable alternative until you come to the bionic eye which would provide the only alternative how does the system work very quickly. After the video it's an implant very similar to the cochlear implant for the profound depth, and it's implanted right under the skull and a lead or an electrode is placed in a very safe space behind the retina. So you can go in and out of that space fairly safely without damaging any cells or causing any problem to the patient. Then there are the externals, and what are the externals pair of glasses like mine, but they are very cool glasses, they are basically embedded with video cameras, and for red detectors, etc, that captures the scene of whatever it is in real life that the that the wearer is looking at. It sends it to a microprocessor that you saw the picture, it's no bigger than an iPhone. And it's charges just like any mobile phone, that is the super duper computer, that signal processes, everything that it looks at, and also provides the power and sends it back to the stimulator that then stimulates the back of the retina in a certain pattern, very high technology and very, you know much and a pattern that style that between that then and the brain, the vision of the people come back in a way that allows them to do so many things that you and I take for granted, they can recognize the loved ones for the first time, they can find the empty chairs recognize street signs, and traffic lights, and folder washing and socialize with people. That is something that of course they have missed for so long. And the tragedy is they know what it is like to see because when they were born, they saw it very well. What makes this extremely unique is that it is basically the very first implant that would be in a safe space called the colloidal space. It's very safe surgery, it's simple done by any retinal surgeon. Basically, it doesn't damage any remaining healthy cells that the patient has. And if the hardware was to be basically upgraded, you can remove it quite easily and insert another set of hardware. And it doesn't exclude those patients. For example, if gene gene therapy was to be really advanced, or stem cell therapy, it doesn't exclude them from that because it doesn't destroy or damage any remaining cells. We are getting ready to go into the pivotal trial. We have already done two clinical trial first in men in 2012. And followed those patients for over two years. There are, by the way, still all alive today in 2023. And we did a feasibility study with four patients in 2017. And we have followed them up and it is very safe and very effective to the point that the FDA have granted us at the end of 2021 a breakthrough indication the last trial that stands in our way to go and obtain commercial approval in the United States, Europe, Australia, China etc. is the pivotal trial, which we are going to go into with a device that is much much easier to upgrade, much thinner externals and very thinner implants. So that it's very, it's minimal surgery. Out of the development 3d of the bionic eye, we came up with a non implant product that uses everything that the bionic eye does except the implant, but it's not for retinitis pigmentosa. It's not for those people. It's for those who use white cane, for example or guide dogs. So it's a consumable product that uses everything that the bionic eye system does use the glasses the externals, purchases no implant, but instead of the implant it uses a belt that you wear. And on the in the back of this belt. There are 100 vibrators those 100 vibrators basically allows those people who need vision aid to navigate know how far are obstacles from them, where are where is the obstacle and whether they're getting closer or further etc. It actually does provide an excellent you know, navigation and safety for those visual aid also, nothing exists like it. There are of course readers but that is not for these people. There are a The white cane as I mentioned, but the white cane only senses the ground and white dogs and not white dogs, but the guide dogs rather, basically their vision is the height of the dog. This, of course captured the entire view. And it's, we've done a clinical trial and the results have been published and it is excellent. This is a consumable product that we can very quickly release to the market within about 12 to 18 months. Of course, nothing happens without a very competent and experienced team. I take myself out of that sentence. But my team are extremely experienced in the research, development and commercialization of implantable devices and such as, for example, cochlear implants as this technology, kind of similar to what cochlear does for the Deaf. This does it for the blind. We work of course with the who's who. And our Medical Advisory Board, the who's who in the retinal surgery work world. And if you mentioned any of these names, they will tell you they are the number one leaders in retinal surgery in the United States, Europe, and in Australia. Huge market absolutely huge. The viral site, which is a consumable product is about a $1.2 billion market just for the white cane users. But it extends to nearly a $14 billion market if you include people legally blind. Now the bionic eye, which is the implantable system for retinitis pigmentosa, we currently focus on the late stage. So that is the stage that is they have gone completely blind. And that is a fairly extensive market 3.4 billion. And we will never stop there, of course, and we will start looking at early stages. We are forecasted to achieve significant revenues. And that's actually quite conservative. So we will start by launching the cycle the consumable product with early revenue in 2026. calendar year, and we expect in on launching the bionic eye. And we are looking into becoming over $100 million company by calendar year 30. We are seeking 20 million, what is that going to do? We are going to basically get into the pivotal trial and completed because it's the last trial we require before the FDA and the European and basically the global commercial approval. And in summary, we have something that's really groundbreaking. We will be the first in market, we will drive this market, we will be on monopoly for some time until someone comes. There's no one right now anywhere near where we are. It's been clinically validated. We have many publications for those two clinical trial. We have a very clear strategy in place to gain commercial approval and we have a very strong patent portfolio. And as you as I have mentioned, the market opportunity is quite significant. And again, nothing happens without experienced people behind it. And we believe we do have that and I thank you very much for your attention.