Laurence Marsteller Presents Radiance Therapeutics at LSI Europe '23

Transcription

Laurence Marsteller  0:05  
This is Radiance Therapeutics saving patients from blindness. I'm Laurence Marsteller. Its CEO. This is a handheld ophthalmic medical device that is saving patients from blindness or therapy is already being used at our collaborating hospitals. Just a quick review of our value proposition summary. Last year, I was delighted to introduce this company at this LSI conference in London. That was a great conference. And this seems to be just as good and I'm really excited to be here. Since that time, we've had a tremendous year, we've received our FDA 510K clearance, and we received our USPTO patent for our core patent. We have extensive patent portfolio consisting of 12 patent families filed as PCT throughout the world, which we're actively prosecuting. We have proven out the manufacturing supply chain and there's existing CPT codes for reimbursement. This innovation addresses the unmet need. Glaucoma is the leading cause of blindness worldwide. Glaucoma has high intraocular pressure for patients with mild to moderate disease and we're going from left to right on this compound on the screen here. From mild to moderate disease, those patients may be well treated with eyedrops, should patients feel eyedrops their laser interventions and there's been a lot of economic activity in the newly innovations of minimally invasive glaucoma surgery devices or MiGs. But for patients with moderate to severe disease, those are the patients who are actively losing vision. A therapy is missing here. These patients required drainage surgery. This is a definitive one and done surgery that solves the problem. But it has a horrendous failure rate 50% of patients undergoing the surgery will fail from post operative scarring. This is the leading cause of blindness worldwide. This article which is peer reviewed for the British Medical Journal shows that starting day one, you go out four years between three and four years 50% of the patients have failed the surgery recognize what this means in human terms. Everyone above that dotted line has had vision loss. Because of this problem, there has been an innovation developed by our co founder earlier serpin. Ca and that is using a oncology drug and antimetabolite known as Mitamisin C, which down regulates the activity of fibroblasts, the cell line required for scarring. But even with this intervention, they're still in the real world data, a 50% post operative scarring rate by three years. This data from market scope. That's we're delighted to be commercializing the clinically proven solution, we're introducing the radiance of Thalmic applicator. This is an application of beta therapy. And well regulated as a device it has a drug mechanism of action that is well understood that downregulates fibroblast via the cell cycle controller p 53. This innovation comes from University College London and more fields I hospital. Together, they're the world's most successful partnership in ophthalmology innovation. The clinical studies which I'm going to show you have already been completed. These were funded in part by the Wellcome Trust, and they've been peer reviewed and published in leading journals, including the British Medical Journal. All totally have extensive clinical experience for randomized controlled trials, powered for efficacy and proving superiority have been completed. These are equivalent to phase three and phase four studies. In the BMJ criminal study, this was a large randomized controlled trial powered for efficacy. 320 patients followed for over four years. Those patients in the placebo arm had a failure rate of surgery between three and four years of almost 50%. Those in the intervention arm of beta therapy had a success rate at four years of 90%. Recognize everyone above the blue line and under the red line, representing about 30% of patients treated, these patients would have been blind except for the intervention of beta therapy. In a second randomized controlled trial powered for efficacy and proving superiority, cook at all 117 patients were enrolled at the time of surgery to either the current standard of care might have mitamisan C or to beta therapy, the odds ratio at one year, beta therapy is at 3.2 times more likely success rate, not having scarring. And beta therapy eyes had a 5.6 times more likely to have an inter ocular pressure less than 60 millimeters of mercury. All told for randomised controlled trials have been completed and published in peer reviewed journals. That allows us to make the outstanding statement that this is a major therapeutic advance, saving patients from blindness. As I previously summarized, we have very strong IP 12 patent families and we are delighted that the USPTO has recently issued our patent for a core patent with extensive claims. We have also received our 510K from the US FDA, and we have supply secured and proven out our manufacturing supply chain. Within ophthalmology, glaucoma is where all the innovation is coming right now. It's a big and growing market. It has a 40% annual growth rate. Our market and these are using very conservative reimbursement estimates is approximately $500 million. The current standard of care might have mice and see has 100% market penetrance no doctor is not going to use a antimetabolite. Knowing that half their patient is going to fail. The clinical data already shows extensive clinical data already shows that we're superior to the standard of care, and thus we expect it to be the next standard of care. This is an area of billion dollar exits of ophthalmology and specifically glaucoma and the mid space minimally invasive glaucoma surgery space has had rather active m&a is with big exits. Our checklist for success, this therapy solves a significant medical problem. randomized control trials have already been done and published. This is a big market. We have issued patents and a more extensive patent portfolio that is being prosecuted worldwide under the PCT. And in other countries such as China. We have the FDA 510K clearance. We have validated our manufacturing supply chain and there's an active m&a with big exits in this area. Thank you so much