Laurence Marsteller, Radiance Therapeutics - Beta Ophthalmic Applicator | LSI Europe '22
Laurence Marsteller 0:05
Hello, I'm Lawrence Marsteller, CEO of radiance therapeutics, saving patients from blindness. Our technology is an atomic medical device that is already in hospitals saving patients from blindness. This innovation addresses the unmet need in glaucoma, in ophthalmology, and arguably as leading cause of blindness now solved. It is the unmet need in medicine. Glaucoma is high intraocular pressure and leads to blindness. For patients with mild to moderate disease, they can often be maintained on eyedrops. For patients who failed their eyedrops they can be augmented with lasers. And there's a new class of intervention called minimally invasive glaucoma surgical devices, that has had quite a bit of economic activity with billion dollar exits just in the last couple of years. But for patients with moderate severe glaucoma, therapy is missing. And these are the patients who are actively losing vision and going blind. And that is the unmet need in glaucoma, ophthalmology and medicine. What they need is a definitive one and done surgery which does exist. That's called drainage surgery. Unfortunately, 50% of patients undergoing the surgery fail the surgery from post operative scarring in the subsequent three years. This is an outsize failure rate that we haven't seen since oncology surgeries in the 1940s 50%. Arguably for this leading cause of blindness, no one should be blind unless they fail this surgery. And this data from the British Medical Journal, a criminate, all showing that starting at the day of surgery, then going out for four years, by three years, half the patients have failed their surgery, everybody, all those patients subjects above that blue dotted line are now blind. Because of this problem, there is a current standard of care, which is ported over from oncology treatment using the anti metabolite drug might have mice and C to downregulate the fibroblasts, and while this was an innovation in its time, even with this intervention, it still fails by 50%. By three years this from a gold standard ophthalmology, market scope data. That's I'm particularly delighted to be here in the outskirts of London to announce this innovation from University College London and more fields I hospital. Addressing this unmet need radiance is commercializing the clinically proven solution, which is the radiance of dynamic applicator, read the mechanism of action is a downregulation of fibroblasts. They're resonant in the conjunctiva through the SoulCycle controller p 53. Reasons to Believe this innovation comes from serpin HCA who was knighted by the late Queen Elizabeth, for his innovations in glaucoma surgery, and by University College London. Together they are the world's most successful hospital university partnership in ophthalmology innovation. What we think is really outstanding and notable for a early stage commercialization effort is a large clinical data set that already exists. These clinical studies were funded in part by the Wellcome Trust, and it provided a rich and detailed set of of clinical trials for randomized controlled trials, powered for efficacy, and proving superiority to the current standard of care have already been completed. With that out to seven years. So back to the British Medical Journal. This is a peer reviewed article on the seminal study. This study enrolled 320 patients undergoing drainage surgery, they randomized either to placebo or to beta therapy at the time of surgery. And what we see is that out at three to four years, the placebo arm has a 50% failure rate, recognize everyone again above that dotted line had gone blind in that arm. But with the application of 30 seconds of beta therapy, we see that in the red intervention arm, that there's now a 90% success rate the surgery, this is an 80% increase in efficacy, resulting in a 90% success rate for this notable surgery. In a second study, this is Cooke at all, they randomized 117 patients undergoing brain surgery to either the current standard of care might have mice and C or beta therapy alone. And the results are again and outstanding. At one year, the odds ratio for the beta therapy arms are 3.2 times more likely not to have the scaring and 5.6 times more likely to have a lower intraocular pressure. The these randomized control trials these gold standard studies that have already been peer reviewed and published allow us to make the outstanding claim that this made this is a major therapeutic advance saving patients from blindness. This disease is now treatable. Going forward from the introduction of this disease, glaucoma should no longer be the leading cause of blindness. This therapy is protected by strong IP. In the United States. It's a traditional 510 K regulatory pathway. Our supply chain is locked in we already have first last release of our product. training a little bit to ophthalmology in the market. The glaucoma market is worth four and a half billion a year. Within ophthalmology. Most of the growth in the market is actually within glaucoma. A few years ago, it was retina and before then it was lasix but we see this 40% year on year growth in glaucoma devices driven by the innovations and then the invasive glaucoma surgery. Our own market, we're estimating greater than half a billion dollars a year in revenues, using both conservative numbers and the number of patients that need to be treated and a conservative numbers for reimbursement. We've not done medical Medicare reimbursement of work. This is an area of active m&a. There's been a number of quote billion dollar exits just in the last couple of years. Notably Alcon acquiring a vantus scent 10 acquiring in focus, Alcon acquiring, transcend, and Allegan acquiring Aqua sis for a little less than $4 billion in transactions just in the last couple of years. So our checklist for success. This therapy solves a major medical problem. And I make that statement with the unprecedented for a startup company of four randomized controlled trials powered for efficacy proving superiority to the current standard of care. It's a big market. We have strong IP claims. We have a validated near term regulatory pathway 510 K in the United States. In Europe we are a class to be CE mark. We are currently ISO 1345 compliant and will be undergoing our audit soon. We have the manufacturing supply chain locked in and we have first lot release and this is an area of active m&a markets. Thank you
