Phil Marron Presents Sharpview Ophthalmology at LSI Europe '23

Transcription

Phil Marron  0:05  
Good morning. I'm Phil Marron, COO, from Sharpview Ophthalmology. Who Sharpview? Sharpview is an organization that is commercializing and intraocular lens, specifically to patients with AMD Cataract. So what's a cataract? Top left you'll see vision with a cataract. Cataracts are one of the most common operations in the world, very, very treatable. But what is AMD? AMD is where your vision declines irreversibly over time. It's a macular disease. Currently, there's no cure for it. Sharpview is a joint venture between SeeYourself and Three Hill Partners. We have some active directors and Ally Max and Mark and the COO and we have a country manager Bernardo. So the market in the product, AMD is massive. If you look at AMD worldwide, it's most common cause of irreversible blindness in adults over 60 years old. The prevalence is rising cataracts. Again, we'll all get cataracts, if we live long enough, but it is treatable. It's treatable with a standard IOL. So what is the Eyemax Mono? The Eyemax Mono, for all intents and purposes looks like a standard IOL. It acts like a standard IOL. But what it also does is it acts on the AMD and uniquely is specifically designed to allow the brain to use the non disease part of the macular in order to create vision for the patient. And this is vision that lasts longer. The Eyemax Mono does not have an impact on AMD, because AMD is an irreversible disease. But it does allow the patient to allow the patients to see their family to read to have a better quality of life for a lot longer. How does it work? The Eyemax Mono works by focusing the light at 10 degrees around the macula. So in the center, you see a little circle. If you have a cataract, you get given a standard IOL that focuses the light to five degrees. When the macular disease as a ticket as far as affected that area then the vision goes the Eyemax Mono allows a four times larger area the macula to be used, and the brain can then create a focal point and allows better vision. So this means that the Eyemax Mono will act for a lot longer than standard monofocal. So who is it for them. So the base mark of the Eyemax Mono is at the top, the segments at the very top there. The Eyemax Mono for patients who have not yet had a cataract. So a patient will go to see will notice they've got AMD, they'll go to retina ologists and this is the patient for the Eyemax Mono. If the patient had a cataract, the MX one can't be used. However, if a patient has no cataract, but AMD with more exciting results showing that the Eyemax is really for treating AMD it's not a cataract lens is for treating AMD. In the middle we've got the future of product and this is for an Eyemax focus lens with more which I mentioned later. So the Eyemax Mono is CE marked in Europe. It's manufactured by car group and in India. It's used around the EU, but we're specifically picked Spain and Italy because they're early adopters in technology. The Eyemax Mono has also been launched the next EU countries Turkey, Argentina, I mean us the far afield as Hong Kong and South Africa. We've initially focused as a small team, we've initially focused on KOLs to generate peer reviewed publications to generate the interest and high profile ophthalmologists. But at the moment now we're in the point where need to sort of broaden our commercial reach. So what's the evidence? So we've got clinical experience, the Eyemax Mono has been used to 1000s of eyes so far, and it's used regularly in dozens of clinics. We've got peer reviewed publications of over 300 eyes, or more on the way more publications coming on the way and with new data that's been recently presented as recently as two weeks ago at the European Society for cataract and refractive surgeons. We have four abstracts, but significant data on 170 eyes presented by Dr. Adela. We've also got new clinical studies underway to prove the efficacy, the Eyemax Mono when used in patients with AMD. And we've got another study in Italy looking at rehabilitation. So these are just some examples of some of the peer reviewed studies we have at this moment in time. Just to show that and show that Eyemax Mono is out there. It's being used and it's being used successfully. Two weeks ago, we attended a conference in Vienna, and there were four presentations around the Eyemax Mono. The one in particular interest is by Professor Federico Basara Dr. Federico by the law of Milan, Italy. He looked at 170 eyes and under 170 Eyes 56 Eyes gained more than two lines of visual acuity, and over three quarters of the eyes gained more than one line of visual acuity. There's no complications, intro or postoperative because this is a standard cataract procedure to insert the Eyemax Mono. But it also gave positive results in patients with other macular conditions like macular hole, potentially Ayurvedic, which is a disease of the back of the eye. And significantly, the majority of these patients were patients who had very insignificant cataracts just to show that the Eyemax Mono works on the AMD and he's not working on the cataract itself or alone. These two clinical studies underway. Principal Investigator Dr. Donati and Madrid and that's a head to head with an Eyemax Mono compared to a standard IOL. Then this other study is by Professor retos team in Italy. And that's to evaluate whether or not helping the patient rehabilitate after increases the speed at which a patient makes use of the Eyemax Mono. So where are we going with this company, we need to invest in commercial reach, we need to expand our KOLs, we need to give ourselves a bigger footprint across European territories. And we'd like to employ product specialists to go out and support our distribution partners across Europe. Our big work is on patient access and reimbursement in all our key territories. Currently, we are going for a new visa in Germany, which is a reimbursement process. And we've got tenders, which we've won easily. Then we need to invest outside the EU, where we got to get local approval we have a CE mark but often they're they have their own registration requirements as well. I think mainly to evaluate our path to FDA approval. Every week, I get lots of inquiries from America, asking me when will this lens be available, we need to invest to get that available to America. Investment in further educate it further, sorry, further indications I've mentioned that we've used it in macular holes and in other maculopathy ease. So we've got doctors who are now wanting to run their own studies looking at into in other indications. And we'll we'll explore this collaboratively with them. And then finally investment to the launch of his focus lens. Previously, I mentioned the Eyemax mono can be only be put in in a patient who hasn't had a previous IOL. The sulcus lens is a lens that will sit in front of a standard IOL and allow the same Eyemax monovision the same effect on the retina. And they will in patients who've got a cataract who've had an operation will then be able to gain the benefits of greater vision for a longer time. And this as you can imagine there's a huge marketplace, because most patients who have a cataract in AMD, will have had the standard IOL at first. So what you want the investment for were a unique intraocular lens with absolutely no direct competition. There are other lenses that have an effect. But there's nothing that does what the Eyemax Mono does, which is allow the patient to see better for longer. It see marked in Europe. It's available for use outside Europe. And we've got opportunities to know the macula conditions. We have a very small, lean operational team in place. Part of the investment is to expand this team and have a more permanent formalized structure. And we've got the product in clinics and it's widely used. And the pipeline is the new indications that we're seeking. We're looking at detached retina, we're looking at ADD we're looking at other maculopathy is where the outside of the retina still has active areas where the where you can, you can help the patient gain vision. And we've got the new product which is the sulcus lens. For that reason for patients who've had cataract surgery, it's already CE marked. We've already been doing some tests on it. And we're looking to potentially roll this out in the coming 12 months. We're looking for eight to 10 million euros. We need to drive our commercial efforts. We're a small team, we need to put more footprints on the ground and a broader reach. We need to develop new indications and bring the lens to market. Thank you very much for your time. Thank you