Implandata’s Hands-On Approach To Tracking IOP

Episode 059


Implandata Ophthalmic Products GmbH is putting the task of tracking intraocular pressure into the hands of patients. Company Co-Founder and General Manager Max G. Ostermeier shares the story of EyeMate, an implantable micro sensor capable of measuring absolute intraocular pressure continuously or on demand.

Podcast Guest

Max G. Ostermeier

Max G. Ostermeier, MBA

Max has extensive experience in the commercial development of technologically advanced products and in building operational capabilities for aggressively growing companies.

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Transcript

Tom Salemi: Hi, everyone. This is Tom Salemi from the OIS Podcast. Thank you for clicking on our Podcast today and for joining us for another great conversation, another tale of innovation in ophthalmology. We’re going to be talking about glaucoma today. Specifically, though, we’re going to look at intraocular pressure or the monitoring of IOP. Our guest today is Max Ostermeier of Implandata. Max has presented at OIS’s in the past. And Implandata has a really novel sensing approach to monitoring IOP. It involves an implant in the eye and a hand tool outside that the patient can hold up to their eye and get regular monitorings of IOP. It’s actually a technology that has a very unique origin, and it’s something that could really, as sensors become more integral parts of ophthalmic treatment, could really become a big part of treating glaucoma. So we hope you enjoy this conversation with Max Ostermeier from Implandata.

TS: Max Ostermeier, welcome to the Podcast.

Max Ostermeier: Thank you, Tom. My pleasure.

TS: Let’s start at the beginning. Your company, Implandata, was founded in 2010. What was the origin of the technology and what problem did you identify that you felt needed a solution?

MO: So actually, if you look into the past there is literature back in the 60s talking about telemetric measurement of intraocular pressure by permanent implantable sensors. And also we started later in 2010, actually I’m involved in that project now for more than 15 years. And we have been encouraged by thought leaders like Rob Weinreb from San Diego or George Spaeth from Wills Eye Institute that a better monitoring of IOP is really crucial for better care of glaucoma patients. And knowing that, you know, we have been in touch with some engineers in the automotive industry, and they work on tire pressure sensors. And for us it made a lot of sense, you know, because also tire pressure sensors, you work with telemetric systems. But the challenge was really to make the sensors so small that they also can be placed in a human eye. So I said we have been encouraged by ophthalmologists to work on that. We have been encouraged by engineers in the automotive industry from a technology point of view that that is something which is doable. And then we started in 2008 or 2009 working with from the National Eye Institute and doing the first patients. And that went quite successful. Of course, we did also some animal studies before that. But that was really successful, so that in 2010 we said, OK, now we’ve got a technology which works, which was proven in clinical studies or in preclinical studies. And that was then starting point to form the company and say, OK, now let’s get serious. We’ve got the technology, there is a need, and so we started in 2010 the fundraising. And that’s what kind of the beginning of Implandata. But the story is longer; we started way earlier.

TS: Oh, interesting. You started before 2010?

MO: Absolutely. I started – I’m involved in that project since 2001, actually. I came back from the US. I worked in the US for a while for a biotech company. And then I got back and became attention of that project. And then I said, Wow, that’s an amazing project. There’s a need. I talked to many ophthalmologists and they all stressed there is a need for better monitoring, and on the other hand that from an engineering point of view it’s possible to realize such a solution. So that was really how it started.

TS: How much in common does your sensor have in common with sensors used in the automotive industry? Is it really just a modification of what people would have in their tires? Or did you basically take the concept and then find a new way of delivering the same function?

MO: Basically, it’s the same approach. You know, basically we are using the similar technology. So it’s not so much different. The challenge was really, you know, if you place a sensor in a tire, you got a lot of space. You don’t have that in the human eye. So the challenge was really to make it so tiny and to make it so sensible that you measure also very accurately very small pressures, which we see in the intraocular pressure. So that was really the challenge. And initially it was underestimated what that means. At the same time, it needs to be a long term, robust system. Also true for automotive. You know, if you have a tire pressure sensor, you want to be sure that it works for 10, 15, 20 years. Same with glaucoma patients. You want to be sure that an eye sensor measures the pressure with high precision and accuracy also after ten years, if not longer. But there is a lot of similarities there in all the technology is not so much different.

TS: And how long do you feel that these sensors will be able to monitor the pressure? Obviously, you’ve been at it for a time. I don’t know if you need to get long-term data to really come out with a declarative statement.

MO: Yes.

TS: Or do you have a sense of what –

MO: Actually, we have done accelerated testing which shows us that the sensors work for 30 years and longer. The longest implant in a human is now for 6 years. And the sensor is working quite well. There is no reason why it shouldn’t work for years and years and years.

TS: And how exactly is it measuring the pressure and sending the data to the device that’s capturing the data and then sending it to the physician? What sort of technologies are we talking about?

MO: So actually we are using RFID technology, meaning it’s a series of tiny micro sensor implanted inside the eye, which has capacitive pressure membranes. It’s powered from the outside by induction. So basically you have two induction coils. The central one is for harvesting energy sent from the outside by RFID. The sensor chip is activated, takes pressure readings through the capacitive pressure membranes, and at the same time the metadata is sent to the external device and by that, once the sensor sits inside the eye, you can take pressure readings at any chosen [site?] and you can do on demand measurements, you can do on line measurements. So the hurdle is to get the sensor inside the eye. But once it’s sitting there, you can take pressure readings at any chosen frequency.

TS: We’ve certainly spent a lot of time talking about glaucoma with MIGS and other treatments. Where does the accurate and continued monitoring of IOP really fit into the treatment of glaucoma? Why is such precision necessary? What are the benefits?

MO: So you know in glaucoma treatment, the overall goal is always to control IOP to reduce IOP. That’s true for any therapy, either medication or by surgery or also by the MIGS. You know, the goal is always to reduce intraocular pressure. But the problem right now is there is only very limited means to really measure intraocular pressure. Right now you do that at the doctor’s office. And usually it’s done every couple of months. But right now, nobody really understands what’s going on in between office visits. So imagine you got a high blood pressure patient, and you take blood pressure readings just every couple of months. In between, all sort of things can happen. And that’s true also of glaucoma patients. We see out of the studies we are conducting right now, we see there is a lot of fluctuation in certain patients. Patients react differently on medications. It’s not that all patients react the same way on one sort of medication. So there’s a lot of fluctuations going on in between office visits. And it’s also completely unknown what’s going on over the course of a day. You take a pressure reading at the doctor’s office at 9 in the morning, but the pressure is way different, or can be way different at 9 in the evening. So you really don’t understand what’s going over the course of the day. And by having a sensor which tells you, OK, pressure is OK, is under control, or it’s too high, that would really would allow to titrate therapy. You know, most of the glaucoma patients, they are on the medication for the rest of their life. And I think MIGS and surgery procedures kind of help, but still, most of them are on the medication. Means the patients have to be monitored. And also, surgery procedures have only a certain lifetime, you know. After a while, sooner or later, they stop to work, and then you have to a revision of the surgery. So also these patients need to be closely monitored so that you find out early on that there is something wrong, or they are doing fine.

TS: We’re going to take a quick break from this conversation to highlight a new feature of OIS. If you’ve been reading your Eye on Innovation newsletters, and why wouldn’t you be reading them, you will know that we have a breakfast breakout session, several of them, in fact, scheduled for the morning at OIS starting at 7:30. They will be very intimate and interactive settings for conversations around presbyopia, glaucoma, combination therapies for wet AMD and DME, retinal prostheses, drug and devices for dry eye, gene therapy. Obviously, these are huge areas of interest to anyone who is looking to innovate in ophthalmology. So if you want to get in the session that is most appealing to you, you should go to ois.net right now to register for the conference. Now back to this conversation with Implandata.

TS: So in the video that you put together showing the device, you had a measurement – the subject in the video I think measured at 12 and then 25, and then 12 and 12 and 12 for the rest of the day. So that high reading, that single high reading of the day, that could be because of what? They didn’t take their medication? Or some other reason? It gives the doctor meaningful data for them to give the patients perhaps better instructions or restate some instructions?

MO: Absolutely. You know, for example, if you know you’ve got a patient, and typically the pressure is pretty high, let’s say, by noon, and you can adjust medication in ways that you say – you can tell the patient, OK, dear patient, typically you got pretty high pressure at noon. Take your medication maybe at 10 a.m. so that the pressure is kind of under control at noon. And then we know that prostaglandins work different than beta blockers, and patients respond differently. Some patients have pretty high – we see that in the studies. We see the data that some patients have pretty high pressures in the morning, others don’t. We see that patients sometimes have a lot of fluctuation in the first weeks, and by change of medication, this fluctuation can be reduced. And also pressures can be reduced. So it’s really eye opening to the eye doctor because for the first time they see how a patient reacts to the therapy. And if there is pressure too high, they can do something up front instead of waiting until further visual field loss has happened to the patient.

TS: So you’ve got the physicians. They see a need for this, so there’s a demand. You’ve got the technology. You’re developing a product. What were the challenges in creating a company around this? Is this kind of product something which can build a company around? Or were there concerns that perhaps it was more of an add-on to existing products, and maybe wasn’t a standalone company on its own?

MO: So you know, if you look at, at first glance, you would see, OK, this is a sensor company. This is doing sensor, implantable sensors for diagnostic purposes or for monitoring. But at the end, you know, we offer much more. Actually, by – actually, you know, I would see us as a company which is combining medical technology with information technology. You know, digital health is a big topic. So with our sensor, you are – the patient is able to take pressure readings by himself at home. Patient’s data is sent to the doctor’s office. So he would have immediate access to his patient’s data, and of course you wouldn’t look at thousands of data points; he wants to be alerted if there is something wrong with the patient. If the patient is doing good, fine, no need to look at the data. But if there is something wrong means there is very high pressure for a couple of days, you really want to pay attention to that patient. But at the end, you know, we are delivering data. We deliver actionable data. And that data is used for therapeutic purposes. So we are not just offering micro implants for measuring intraocular pressure. We are offering a whole solution for also for home care. We are empowering patients by enabling patients to take pressure readings by themselves. That’s really empowering patients. Glaucoma is a very emotional disease. The threat to get blind or lose vision is very, very concerning to patients. You know, that means loss of quality of life and that means being dependent on somebody else. So most of the patients are very, very concerned about that disease. And by being able to take pressure readings at home by yourself, and we also have seen the studies patients are – relieving patients’ peace of mind, so to relieve patients to understand OK, everything is good with me, and if pressure is too high, I can do something; i.e., take medication as directed by the eye doctor, or if medication is taken, I give the eye doctor a call and tell him OK, my pressure is too high. Is it OK or is something to be done? I think that’s also for patients very important. But coming back to your question, I think I said we are offering more. And we are already thinking about integrating further monitoring, too, for glaucoma patients, not just pressure. There is other parameters which are of importance. So we want to really present a whole solution to the glaucoma patients.

TS: No, you’re right. I mean if you’ve got cholesterol problems and you get tested every year or so, you obviously don’t know what those tests are, those outcomes are. But if you’re eating well and you’re exercising, you’re kind of hopeful – you hope you’re trending in the right direction unless there are some other medical concerns there. With this, there’s really nothing you can do. You can’t have a salad or something to help alleviate your glaucoma. So the uncertainty of always living with that notion that your vision is deteriorating must be very stressful.

MO: Absolutely. And you know, we have already realized – that’s still in pilot, you know, but we have realized that the patient app by which he can see on his smart phone how is my pressure doing, how was it yesterday, how was it the week before, and we use that app also as a communication interface between the eye doctor and the patient. So for example, if the eye doctor wants to see the patient, he shoots him a message to that app. Or he can also place a medication reminder so if there would be an alert, an alarm to the patient when it’s time to take his medication. So that’s, I think, that’s really additional things which are very helpful to the patients to [improve?] adherence of the patient.

TS: So instead of checking their Facebook update, they can check their IOP.

MO: Absolutely.

TS: That’s a great notion. And you’re right. You came along 6 years ago, but now we’re seeing obviously the digital health movement is gone strong. It’s something that we’ve all talked about, empowering the patients, giving them the information. And on top of that, we’re seeing Google and Alcon come up with their plans for contact lenses of their own to do this or that.

MO: Right.

TS: There seems to be a real convergence of the eye and digital health technology that you guys –

MO: And I said, you know, you would see right away how patients – and that’s a big data component here. You know, you would see right away how certain medication works for certain patients. You know, if you collect all the data, I think we will bring a lot of light into the still very unknown areas. There’s still a lot of estimations and guesses what is really responsible for progression, and why are certain medications working differently. I think by having better ways to really measure intraocular pressure, I think there will be a lot of expertise and experience gained how it’s really working.

TS: So what are your next steps? What do you need to do to get these sensors in the hands or the eyes of patients?

MO: So actually we are right now conducting clinical studies in Germany for getting CE Marking. So we expect CE Marking next year. And then we will do a first market launch in Europe. Of course there will be further post market studies. At the same time, we are preparing an IDE to start a first pilot study in the US. That’s on its way. So we hope that that study can be started also sometime early next year. But we are a small startup company, so right now we are really focused to establish first centers in Europe, to do some further post market studies. And still, you know, it’s an invasive product. There’s always something which can happen, so we want to be careful in introducing that product to the market. So far, you know, the data we got of safety is really excellent. We haven’t seen any device malfunction; we haven’t seen any serious adverse device-related events. So overall, the data really is good, looks good, you know. But once you spread out, you know, there’s always chances that something goes wrong.

TS: And you’ve raised just over €6 million in the past five years. How are you keeping your burn rate so low?

MO: I think we are pretty efficient in what we are doing. You know, we are – also production everything is happening outside. So that allows us to stay lean as a company. And on the other hand, you know, when you start you don’t have any clinical data yet. You know, investors are very reserved to put – because there’s still a lot of risk involved into that, to put a lot of money into the company. So for us it was kind of OK, let’s look what we can raise and if that makes sense to us, and if it makes sense, we raise it. So but I think with that that 6 million we came pretty far. But we are right now working on the next funding round, and I can promise you that this next funding round will be, since we have reached now a stage and a lot of risks have been eliminated, that this next funding round will be more aggressive than what we raised in the past.

TS: So what is the long-term vision of this company? I’m not sure if you can build a large company around sensor technology. Perhaps you can in this day or age. Or do you see yourself moving more into a therapeutic area, including some therapeutics with your devices?

MO: You know, of course it is the holy grail would be sometime in future kind of combining sensor technology with therapeutic devices in the form of a closed loop system. So any time the pressure is beyond a certain threshold, there would be a device or a drug kind of taken care of automatically, taking care of reduction of intraocular pressure. That would be the holy grail because that would eliminate any patient’s compliance issues. But I think that’s still a long way to go. But I think we see it on the horizon. That will be something sometime in future. So for us as a company now of course intraocular pressure is really important and good application, but there might be other applications where pressure inside the body is of relevance. So for example, in the cardiovascular area. If you do that with an Implandata, future will tell us, but I think the most realistic scenario or the long-term vision for us is to get the company, the product to a certain stage, and then to partner with a strategic in regard to commercialization. And we see a lot of fit, you know, we see a lot of fit to ophthalmic surgery companies, but also to pharmaceutical, ophthalmic pharmaceutical companies. So I think in my point of view, that’s the most realistic scenario for the ophthalmic application.

TS: That certainly would sound like a great outcome for everyone. And hopefully I know you’ve attended OIS, so maybe the next time you’re there you’ll make the connection that creates an opening for that partnership someday.

MO: Happy to do that.

TS: All right, Max. Thanks for joining us today.

MO: Thanks a lot, Tom. Take care.

TS: Max Ostermeier, thank you for joining us on the OIS Podcast. The advancing of sensors and implants and such for ophthalmology is really exciting, and it’s great to see a company like Implandata sort of go get in early on the whole digital health monitoring movement. So great story to tell here, happy to share that tale of innovation, and want to remind you one more time: go to ois.net to register for the conference and to sign up for your breakfast breakout session. OIS will be on November 12 at the Planet Hollywood Hotel in Las Vegas. And we hope to see you there.

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Joining the company in 2014, to create and manage a new line of podcasts, publications and other editorial products.

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