Savas Komban, Smartlens - Measuring Intraocular Eye Pressure | LSI USA '24

Savas Komban  0:03  
My name is Savas Komban. I am the CEO and co founder of smart lens. We are solving an important problem in ophthalmology, and it's about glaucoma. Glaucoma is the leading cause of irreversible blindness, and it's a chronic and progressive disease, and bringing a huge burden on lives and economies all around the world. Currently, there are around 140 million patients suffering from glaucoma worldwide, and this number is expected to raise to more than 370 million in the next two decades. Let's look at some numbers in glaucoma. Even in the US, more than 50% of the patients are still undiagnosed, and 20% are at severe stage with a high risk of irreversible blindness. And another number from Europe is 38% of patients are losing their vision at least in one eye over years. And the question is, what is missing? What is the current challenging limitation in treating glaucoma? The primary and only treatable risk factor of glaucoma is elevated IOP. And our challenge is uncertainty, because IOP fluctuates throughout the day, and currently we can only get a glimpse of IOP when the patient is in the clinic. So this is, in the best case, a few IOP measurements per patient per year, and all of the clinical decisions have to be made with that limited understanding. So for doctors, it's like seeing only one single frame from a movie and trying to understand the whole story. Because of that, glaucoma becomes a very difficult condition to diagnose and treat, and our solution for that is my lens for IOP monitoring. It's a non invasive device, the smallest variable microfluidic device in the world, and it's built in the form of a soft contact lens. And the good thing about the technology is it's Electronics Free. There are no chips or batteries inside the device, making it a comfortable device to wear, even for older patients. With my lens, we are moving beyond the glimpse of IOP, and it's going to be prescribed for certain days based on the disease state and disease progression prescribed by the doctors. So it's going to be the halter monitor for the ophthalmologist and optometrist. The device is very thin. Its thinness is similar to daily contact lenses, and it can have any kind of optical correction. Using my lens is simple. Patients are wearing it on those days, prescribed by the doctor, and they are using their own smartphones to just take a photo of their eyes. All they need to do is to launch the app, and the app itself captures the photos. It recognizes myelins on the eye, and it captures the IOP readings. Then it processes the readings, and then it sends back to the doctor. This is a video of myelins from the clinical trials. And microfluidic sensing system is on the periphery, and the system is capturing the changes, tiny changes, in the cornea based on the change in the IOP, and it has the ability to filter out the noise, like blinking, coughing or sneezing. As a result, doctor gets to see all the measurements in this dashboard, and they are able to compare the target IOP and with the actual diurnal IOP values for their patients. They choose how frequent do they want to see data from each and every patient, and further statistical analysis will also be available. How accurate are these measurements based on the clinical data that we have published, clinical study done by Dr spina kinavi and Dr James Tsai, the my Lance measurements were within two millimeter mercury of Goldman measurements, and Goldman itself has this two millimeter mercury error range, and there was a significant and strong correlation between my lens and and Goldman. According to blend and Altman plots, there was no significant bias between my lens and Goldman, so the mean bias was point 007, millimeter mercury, and the device was safe to safe to be worn for every patient. So there was no major adverse events reported. There have been some previous devices, and there are some existing devices in the market, mainly for research purposes. The first device is an electronic based contact lens whose measurements do not correlate with with the Goldman measurements, but still, as a research product, it was used in more than 100 different clinical studies. The second device is a portable tonometry the patient needs to use it themselves and to measure their own IOP. And the device is being widely sold in the US and globally. The third device is an implantable device that requires sophisticated eye surgeries, and there are multiple other technologies, implantable technologies that are currently being developed. So the unique advantage of my lens is it's a variable device. It comes in the form of a non invasive variable device. It's easy to wear, easy to use, and can provide clinically relevant data. And bringing a huge market potential. We have 19 patents, seven of them are already granted, and 12 are pending. They are covering more than 40 countries. Our initial study was featured in Nature Medicine and our technologies have been widely recognized worldwide regarding the clinical use of mylans based on our surveys with the doctors, they are saying that they are going to use mylans throughout the whole treatment lifecycle for glaucoma, starting from diagnostics and intervention decisions, whether to treat the patient or not, defining the right target pressure for each and every patient, choosing the right therapies, medications, surgeries or their combinations, monitoring efficacy, treatment efficacy and disease progression, monitoring, patient compliance, which is also a big issue in eye care, and based on all those results, optimizing the treatments. So between so with these additional measurements between office visits, we are going to have much quicker feedback on treatment efficacy. It will enable personalized treatments, and it will also help improve patient engagement. Additionally, it will also pave the way for a new generation of therapies. Myelins will be used for patients from suffering, for patients suffering from all types of glaucoma. And our primary markers are the US, Europe, Japan and China. Based on the feedback from doctors, we are expecting a quick adoption, especially with patients at severe stage and patients with worsening disease. Our go to market model is through physicians and optometrists. There are around 20,000 MDS in the US and more than 40,000 ODS, and they are going to prescribe the device based on the disease state and progression of of their patients, we expect the average user usage will be around a few times a year than if several times, several times a month, and reimbursement will be available for more frequent usage. Another independent research that verifies our our go to market model, and the need is there has been just a recent research from an independent market research company. And based on the results, 77% of the doctors are saying that they are going to integrate IOP monitoring as soon as it becomes available. Our commercial launch is going to be next year. We are currently in the FDA process. We have done multiple presales with the FDA. The road, the 510, K pad has been confirmed. And right now we are finishing a 7070, subject pivotal study to get through the FDA clearance. And beginning of next year, q1 next year, we plan to be in the market. We closed an hour subscribe series A last year, and we are going to make Series B. We are going to raise Series B next year, and right now, we are raising a bridge fund to for for smooth commercialization, for early commercialization, so with just 3% of the patients in the US, we expect to have revenue around $150 million in four years and and we have a high gross margin. This is going to bring a company valuation around $2 billion in five years. We have already established our manufacturing line here in the US, and there is significant upside with out licensing to pharma and ICP monitoring and several other things. I have the privilege of working with an experienced and accomplished even ophthalmology medical devices and regulatory clearance on our advisory boards, we have world renowned ophthalmologists and industry leaders as well. So in summary, violence is addressing a significant unmet needing glaucoma with a clinically proven technology. We have a strong team secure IP and commercial launch will be in 12 months with a capital efficient business model. Thank you so much. Thank.