Max Ostermeier Presents Implandata Ophthalmic Products at LSI Europe '23

Transcription

Max Ostermeier  0:04  
Hi everyone, my name is Max Ostermeier. I'm the CEO and founder of Implandata and we are going to transform some management of glaucoma patients. So as you may know, blood coma is a chronic IDCs. As most of the ITC is age related and several will see a strong increase in the number of patients in coming years. The bad thing about glaucoma is that it's causing permanent loss of eyesight. And you can see the different disease stages early stage mid stage late stage. Unfortunately glaucoma is very often detected a rather advanced stage because the brain is able to compensate for loss of eyesight. Eventually it can lead to blindness of patients. And it's important to understand it's a pressure related disease means that increased pressure inside the eye is causing damages to the optic nerve, which over time leads to loss of eyesight. So the best you can do with a diagnose glaucoma patients is really to preserve their current status. Because unit you cannot regain vision back to the patient. So there's different options to lowers patients and control a patient's eye pressure. first line treatment is by medication patients have to apply eyedrops to their eyes to lower the eye pressure. So there's more and more non invasive procedures laser procedures there's also now cube Shan mix devices whatsoever. So says a wealth of treatment options to really control a patient's eye pressure, but mostly depends on the patient's adherence. And it also all these therapeutic options have limited effectiveness patients responses changing over time, if you create an artificial outflow by a cube shunt over times that will be obstructed again because of tissue grows. So big problem in managing glaucoma patients is not set there is not sufficient turbulator options. A big problem is that right now, monitoring is only office based. Typically a glaucoma patient is only seen a few times a year by the eye doctor, whereas we always take a measurement of the eye for sure. But in between office visits, there is no understanding at all what a patient's approach really is, and how effective therapies to the patient. And as pointed out, therapy, adherence of patient is really bad because there is no way of self monitoring. It's as symptomatic so patients really don't feel you sir, I press it too high, or if it's controlled. And these are all reasons why still so many patients are losing eyesight because of glaucoma. In order to change this, we have developed. Moving we have developed the Iman system, which consists which consists of a tiny implantable micro sensor, which is placed permanent in a patient's eye. So patients really don't feel it, they don't sense it. And that sensor is able to continue to measure and monitor a patient's eye pressure under normal life conditions. So data sent sent sent via an RFID device into the reference database. We're also patient is collected. So the doctor would be able to early on understand, okay, if there's a problem, I have to do something I have to change therapy, I have to further escalate therapy, we can also introduce and empower patients by self monitoring, which is improving therapy adherence. Let me show you a brief video which are housing systems going to work. So some sound Please can you

Video playing  3:39  
eye surgeries, such as cataracts, or glaucoma surgery, the harmless micro sensor is placed to permanently inside the eye, but the patient can't feel it. And it doesn't affect the vision measurement is initiated by the patient and tele metrically read out with a handheld device after measurement. The data is sent and recorded to an app on a device of your choice. It allows AI specialists to pinpoint that therapy works best for you to reduce and control eye pressure.

Unknown Speaker  4:15  
So it really add something to the current glaucoma care ecosystem. As at right now it's office based so we are not replacing in office diagnostic. We are complementing it by providing home monitoring. And it's also complimentary to any therapeutic or any therapy which is applied right now because we've our system, patients therapy can be really personalized. Right now it's trial and error. But with our solution, we provide real life data, enabling Iraq just to really tailor therapy to the individual needs of a patient. So the product has been extensively tested including the studies I said it's an implant a long term implant. So safety and performance has been key in our clinical studies, we have now up to 10 year data in patients. It's even marked as MBR. We also have obtained FDA breakthrough device designation. It was only one of sofar eight authentic devices which have obtained breakthrough device designation and is aminos that has the advantage of an expedited approval but also reimbursement has a new CMS program for brief breaks for devices, which ensures that you have from first day on reimbursement in the US. See, business model is quite attractive, not only for the company, but especially for the eye doctor. So the adopters have an high incentive to use our system. It has two components on the one hand to devices and to placement such placement of the devices. But more importantly, it also produces general recurring revenues for the data provision. So existing CPT codes for remote patient monitoring are applicable for our system means an eye doctor can bill up to 200 US dollars a month per patient for providing this remote patient monitoring service. So there is a huge incentive for doctors kind of using our system and also to more efficiently manage patients and keep patients out of the office and only get them in when it's really necessary. Sigmar submarket potentially is quite significant and further growing, we are addressing a global disease in certain countries, countries of the world like in Asia incidences even higher so and we will do first revenues significant revenue next year. With a CE marking we are starting to launch with early adopting AI centers. Across Europe, you're already in discussions with potential distribution partners, Middle East and Asia. And we will see certainly a champion our revenues once you have FDA approval in 2027. The team is quite seasoned and experienced definitely myself or two founders, we have already done two startups before which we successfully exited. We have people from the industry from like from Alcon and we have also a very seasoned board of directors with people from Tai Chi Alcon so I think that has been a strong asset of ours in the past to have such a strong team here. We accomplished so far, very important milestones, we have so far raised 20 million little bit more than 20 million, and have accomplished the FDA breakthrough device designation CE marking long term studies to really demonstrate the value of our technology have established strong IP with 16 patents, and a lot of publications kind of really presenting our progress. So we are right now out to raise another 10 million in order to fund the commercial launch with our CE mark product to move ahead with our FDA studies. And also to advance our pipeline. We are already now working on next generation products militarizing of the centers making them even smaller and we are also working on a closed loop therapeutic device so vs sensor is actuating. The therapeutic action means releasing the drugs if the patient's pressure is out of control. So that would really eliminate any therapy adherence problems or issues with patients. We are clearly positioning for a trade sale in three years in the optical industry trade sale is the preferred exit companies like Alcon like Bhushan plump, like j&j tend to acquire companies and technologies in raw early stage very aggressively in especially in the glaucoma space. There have been several deals in the glaucoma space. In the last five years in Oberg companies have been acquired for half a billion up to 1 billion. And we are already on the radar screen of all these potential buyers. And maybe one of them will also come in standing around with no strings attached. So in summary, we are addressing a huge unmet need and the number of patients growing significantly we have accomplished important milestone as the CE marking a strong team also has the business model is very compelling not only to us, but also to us as our product and said we are offering also a extensive product pipeline of next generation products. Thank you very much