Transcription
Laurence Marsteller 0:05
I want to compliment the organizers at LSI. They've just done a great job we've seen now, this be the fourth ophthalmology company, and why ophthalmology this is an area of we've seen great innovation and great exits, various therapeutics saving patients from blindness. I'm Laurence Marsteller, CEO at Radiance Therapeutics is an atomic medical device that is already in the clinic saving patients from blindness. Just up front of some of our value proposition and recent milestones. We were very pleased that during JP Morgan week, we heard from the FDA that we are 510 K had been cleared. We've also recently received USPTO Notice of Allowance with strong claims on our patent. We have manufactured devices. And for early sales introduction we have existing CPT codes that can be used. This is an area of active acquisitions, and we'll speak about that in a bit. So this innovation addresses the unmet need. Glaucoma is the leading cause of irreversible blindness. Glaucoma has high interocular pressure. In the spectrum of disease for patients with mild to moderate disease, they may often be managed with eyedrops if they fail eyedrops. There's laser interventions. And then there's this new area of great economic activity called minimally invasive glaucoma surgery devices or MiGs. But for patients with moderate severe disease, and these are the patients who are actively losing vision, the therapy is missing. These patients need a one and done surgery which does exist and that's drainage surgery. Unfortunately, 50% of patients undergoing the surgery will suffer post operative scarring and fail their surgery. And this is the leading cause of blindness. In this paper, the BMJ we see that patients starting on day one with the surgery, this is yours going out this is four year data, we see that by year three, approximately 50% of the patients have had progressive scarring and progressive vision loss. Because of this large failure rate, there is a current standard of care, which is a device and see it's a oncology drug ported over and its uses to down regulate the fibroblasts that cause scarring. But even with my demise and see postoperative scarring and still 50% That's we're very pleased to be commercializing the clinically proven solution. This is the radiance TX atomic applicator. The mechanism of action is beta radiation, which is well documented antimetabolite to downregulate. The fibroblast that are resident in teens capsule essentially puts the scar tissue to sleep like Sleeping Beauty. Reasonably this innovation comes from University College London, one of the top five research universities and our two innovators serpin QA and Mr. Ian Murdock, both knighted by Queen Elizabeth and recognition and part of this innovation. What also distinguishes us as a mid stage company is the randomized controlled trial data proving efficacy that this company already possesses. And this comes from underwriting by the Wellcome Trust which funded these studies. And the studies have been published in the British Medical Journal. For randomized controlled trials powered for efficacy and proving superiority have already been completed and published. This is we think you really unique in Early Stage Company. In this study by criminate, all this was 320 patients undergoing drainage surgery that were enrolled, and the half received placebo and the other half beta therapy. And we see that by year three, in the beta therapy intervention arm the red line 90% efficacy rate compared to 50%. This is a massive increase in efficacy that is rarely seen in medicine, and really set the world on fire in glaucoma. And a follow up study cook at all another randomized control trial powered for efficacy and proving superiority. 117 patients were enrolled at time of drainage surgery, and they either receive the current standard of care that might have mice and C or beta therapy alone, it will be find is that the odds ratio at one year beta therapy is 3.2 times more likely have a functioning drainage reservoir without scar and the 5.6 times will likely have a lower intraocular pressure. All told four randomized controlled trials have been published. And this allows us to make the bold but well stated scientific evidence. This is a major therapy advance saving patients for blindness. The world's leading cause of blindness now has a treatable intervention. The company has strong IO IP. We've just received notice of allowance with strong claims. We are celebrating our 510 K and our first devices have been manufacture on yourself. The glaucoma market is a 5 billion to $6 billion enterprise. And because of these device interventions, it's growing at 40% annually. It's also an area of consolidation with early acquisitions by number of the leading players. Our checklist for success. This therapy solves a significant medical problem. And I make that statement with four randomized controlled trials powered for efficacy and published in peer reviewed journals. It's a big market. We have strong IP protection. We've received the first 510 K to validate a manufacturing supply chain and we're in an industry with active m&a. Thank you so much.
© 2024 Life Science Intelligence, Inc., All Rights Reserved. | Privacy Policy
