Savas Komban Presents Smartlens at LSI USA '23

Transcription

Hello, my name is Savas Komban, I'm CEO and Co-Founder of Smartlens. Today I will also talk about glaucoma. And I'm sure you, you know about glaucoma by now. So we are trying to solve an important problem in this space. And just some brief information about the space again, is, as you know, it's the leading cause of irreversible blindness and they're around more than 140 million people suffering from glaucoma worldwide. This number is expected to be more than 370 million in the next two decades, is a chronic and progressive disease. And it's bringing a huge burden on lives and economies all around the world. When we look at some numbers, even in the United States, more than 50% of the patients are still undiagnosed. And among among those who are diagnosed 20% of tomorrow, excuse stage with the highest score permanent lines and for another 50% with the disease is worsening every 12 months, and the progression cannot be stopped. And other number from Europe is 38% of patients are losing their vision irreversibly. So the question here is what is missing and what can be done going forward with glaucoma. So the primary risk factor and only treatable risk factor for glaucoma is high IOP. And all of the decision all of the all of the treatments, it's either medications or surgical procedures, they're all focusing on reducing the IOP. And the problem is starting there because IOP like the blood pressure fluctuates for everyone throughout today. And we are trying to measure IOP with just one single measurement every three to six months when the patient is in the clinic. And that's the best case. All of the decisions, all of the clinical decisions that take into consideration IOP assessment and these are all of the decisions about glaucoma treatments, they have to be made based on based on that limited snapshot. For doctors, it's like getting to see a single frame from a movie and trying to figure out the whole story. technology hasn't changed since the 1950s. And we do not know the real efficacy of the treatments over 24 hours. And there is also no way to to monitor and improve compliance as well. Our solution for this problem is my lens. It's a non invasive device. It's the smallest available microfluidic device on Earth, and it comes in a soft contact lens format is going to be prescribed for up to 24 hours by the doctors based on the disease state. And based on the clinical decision the doctor is making doctors are defining the frequency of the usage. We have strong clinical data showing one to two millimeter mercury accuracy to Goldman and the device itself is Electronics Free. There are no chips or batteries inside. And it's an easy to use uncomfortable device. The person is just wearing the lens and taking the pictures of the lie with a portable camera or with the regular smartphone camera. This is a video from our clinical trials. And you can see our lens on the human eye and that this red.is being placed by our software by our image recognition software. And we are tracking the innermost channel in our device. And that shows us the IOP level. Each tick mark on the scale is corresponding to a certain millimeter mercury level at Coleman. And as you can see from the video as well. All of the features of the sensor system is on the periphery and Milans is not obstructing vision, patients can just continue with their daily lives daily routines. We have strong clinical data and for and that we publish our preclinical in Nature Medicine and in other peer reviewed journals. It's a classical device regulatory pathway is 510 K. And we have just presented our clinical results at the American glaucoma Society meeting earlier this month. In this trial, for example, the patient is taking up reducing medication at the second hour. And you can see my last measure was in blue and golden measurements in red. You can only take a few golden measurements from a patient per day and that's what we could take in this trial. So Milan said a significant strong correlation to both Goldman and rebound tonometry. Based on our clinical results. We have been very proactive in our IP strategy. As a spinoff from Stanford University. We made an exclusive licensing agreement with the University and you also find our own IP. Our technology has received wide recognition in academia and media. We have learned patterns six off tomorrow, the granted and five are pending. They are calling more than 40 countries. There are some existing devices in the market but they are far from being an ideal solution. The first one is a handheld portable device. It relies on the patient's own ability to measure they in their own eye okay, like a doctor, and it doesn't provide clinical relevance. results. The second one is an implantable device patients need to undergo surgery. It's an electronic space device. And it's an invasive device as well. So Milans being a non invasive and Electronics Free device that's easy to use comfortable and has significant correlation with Coleman can provide clinically relevant results. It doesn't require any additional training and it will be an easily accessible device bringing a high market potential. We have two large markets. The first one is patients suffering from glaucoma, it will be used for patients suffering from all types of glaucoma. And the second big market is glaucoma suspects only in the United States that around 8 million people ocular hypertensives that needs to be regularly monitored. Based on our surveys with doctors we see quick adoption, especially with patients with severe stage it serious Stage patients with worsening disease patients have borderline pressures patients with normal tension glaucoma and before and after retinal surgeries as well. Doctors want to monitor IOP in order to make sure that there are no complications. My last view will be available through all these NMDs through physicians and optometrists, me the subscription model, the usage frequency will be defined by the doctor based on the clinical decision and based on the disease state and progression of the patient. It's going to be an affordable and easily accessible device around $100 per day, and it's going to be reimbursable through the existing CPT codes. And it's bringing a high mark market potential not just for glaucoma patients but also people that use for the device for for glaucoma. Our second device in the pipeline is turmeric and it's a programmable device based on doctor's prescription is being programmed and it gives the medication directly on to the eye based on the prescription. With turmeric in place, there will be a big difference because doctors will be able to get understanding they will be able to monitor efficacy and get feedback on treatment efficacy in a few weeks without waiting six months to see the patient. Again back in the clinic. With my lesson place, turmeric will provide us the full full feedback loop so that we will be able to offer personalized treatments for each and every patient. It can work with all types of glaucoma medications. And other important benefit is it gives medication in microdose. So it can so it helps me minimize all the side effects and drug tolerance over time. And it also helps improve patient compliance because patients will not need to worry about when and how to take their medication and which medications at what time. So we have been quite capital efficient. I think we are a unique company because of that. And we just raised 3 million up to now and we have multiple of Ophthalmology VCs, as our investors, key opinion leaders, doctors and the pharma company, we are only raising 3 million right now because that's that will be sufficient for us to get the FDA clearance next year. And we have already signed a term sheet due diligence has finished and this has been oversubscribed around for us. In five years, we are going to have to have more than $200 million in revenues with 6% of the patients in the United States and point 5% worldwide we have high gross margin and we have already established our manufacturing line in the United States. We will have multiple commercial partners in several geographies. I have the privilege of working with an experienced and accomplished in ophthalmology, medical devices micro fluidics and regulatory clearance and we are going to start onboarding our commercial team next year. We have world renowned glaucoma experts and presidents form presence of American glaucoma Society president of New York pioneer founders of large optometry experts in the United States and and former CEO of two publicly traded ophthalmology companies. So in summary, Smartlens is offering a unique opportunity with our novel clinical stage products that address unmet needs in ophthalmology. We have an expert team in place and we are on track to launch in six months, 16 months next year. We have a capital efficient business model that has been proven and this is going to be a high return on investments. Thank you.