OcuSciences Hopes To Give Early Warning On Ocular Disease

Episode 057

Kurt Riegger, President and COO of OcuSciences, tells a start-up’s tale. OcuSciences’ OcuMet Beacon is being developed to give optometrists and ophthalmologies the ability to see the onset of disease earlier than ever.

Transcript:

Tom Salemi: Hi, everyone. This is Tom Salemi, content director of Healthegy and your host of the OIS Podcast. Thank you for joining us today. Today we’re going to take a little bit of a diversion. We’re going to move away from the therapeutic side of the ophthalmology spectrum and we’re going to go way over onto the diagnostic side. We’re talking with a company called OcuSciences. It’s a medical diagnostic company that’s developed this system called the OcuMet Beacon that the company says measures retinal metabolic analysis, or analyzes the retina for the presence of mitochondrial dysfunction. By doing this, the company, it says, OcuSciences, is able to determine how far along diseases of the eye are progressing. Glaucoma of course would be one. Diabetic retinopathy, macular degeneration. It’s able to get a measure of the progression of these diseases before it’s really becoming visible to either the patient or to ophthalmologists using existing methods. Now the hope is that they would develop a new vital sign that would give a red flag early enough in the progression of, say, diabetic retinopathy to have that patient really change their behavior, perhaps really maintain their treatments and really manage their disease so they’re less inclined to go down that terrible route of losing their vision. So our guest today is Kurt Riegger, the President and COO of OcuSciences. Again, it’s a very early stage company, so we’ll talk a bit about the technology, but also how a company in its earliest stages tries to create a new market for a device or a test that really doesn’t currently exist. Thanks for joining us. Have a listen.

TS: Kurt, welcome to the Podcast.

Kurt Riegger: Thank you, Tom, it’s good to be here.

TS: It’s nice to finally actually talk to you. I know we’ve been sort of circling each other on Twitter back and forth. I’ve been tracking your company and you’ve been pinging me back and giving me updates. And it seemed like a nice opportunity to sit down and finally learn a little bit more about OcuSciences and about your product, the OcuMet Beacon. Now this is your system you’re developing, a platform you’re developing is retinal metabolic analysis. It’s an interesting concept. It’s sort of a we’ve been focusing so much on therapeutics, both drugs and devices, I haven’t really given much attention to the diagnostic side of ophthalmology. But it really, it could be, it should and it is a vital part of the treatment spectrum and could guide treatment even further along, especially when you get a system like this in place. Tell us a bit about OcuSciences and the OcuMet Beacon.

KR: Thanks, Tom. OcuSciences was formed to develop a functional metabolic imager. The technology was developed at the University of Michigan in Kellogg Eye Center to help clinicians there really understand the earliest stages of retinal diseases. And some of the researchers working in AMD as well as glaucoma wanted a more sensitive, faster, more quantitative measure for those diseases so that they could help guide the therapies that they might offer to their patients, as well as to assess more specifically the stage of the disease for those patients.

TS: And how is this done? The description of it, this sounds like something that we would want to have in the healthcare system, an ability to measure progress and to really help guide the treatment pattern so you’re not steering the patient inadvertently in a wrong direction. Tell us a little bit about how OcuMet Beacon works, what exactly you’re measuring, and what you’re able to determine.

KR: Sure. So OcuMet Beacon looks at a signal from the retinal tissue, the most metabolically active tissue in the body, looking at the mitochondria, the power plant in cells. And it specifically looks at the flavoproteins, which have a natural fluorescence that can be excited when the flavoproteins are not actively working to produce power. So when the mitochondria are damaged and you can’t produce power, then the cells will give off a natural fluorphor. And that’s the signal that we’re measuring. So we’re stimulating to see how much of that signal we’re getting. In a young, normal, healthy patient, there’s very little signal. In an elderly, diseased patient, there’s a lot of signal. And so by mapping that signal as well as measuring it carefully, we can help tell the clinician the state of the disease for the patient as well as if there’s any change from the last visit or perhaps a change with therapy or treatments.

TS: So are you essentially – it sounds like you’re almost looking at a battery range in a cell phone or something, when something is turning red and you can see that there’s some trouble coming.

KR: Yes, right. And again, the studies that we’ve done show that at the very earliest onsets of disease, the mitochondria begin to get this damage. In some cases it’s a sub-threshold damage that can be reversed, and that’s where we hope that our pharma partners will develop therapies that will go in and help the patient when there’s a significant population of retinal cells still left, versus many times when the disease is first detected, when visual acuity begins to deteriorate, disease has been in play for a long enough period of time that there’s significant cell damage and cell loss, which are never recoverable, and hence the patient’s vision or situation cannot be well addressed.

TS: And how precise is this system in determining what type of disease is progressing and what sort of treatment is necessary? You’re able to tell the difference between the different diseases within the eye?

KR: So we’re not specific for a particular disease. So if you have a systemic source of damage or if you have a particular kind of disease, we can’t tell you that you have that disease type. That’s coming in a next generation of our device where we can actually resolve in 3 dimensions which cell layers, which areas are being damaged. What we can tell you today, though, is the level of damage, and so if the patient is, say, a glaucoma suspect or if the patient’s already been diagnose with diabetes, has glucose tolerance tests showing that they’re diabetic and they’re becoming a diabetic retinopathy patient, we can assess how much progress that disease has made, and hence how much damage is occurring in the tissue. So it’s a very sensitive but not disease specific marker for the change in the patient.

TS: And I know you point this out in your literature and in your discussions of the company, but to be able to tell someone who has been diagnosed with diabetes that look, you’re going in a path where you’re damaging your eye. That’s really the kind of red flag that I think people pay attention to.

KR: Yeah, they do. And in fact, there’s about 8% of the population that are called latent diabetics, people that have the disease but don’t know it yet. And again, significant damage can be occurring while that’s happening. Many people, when you tell them that the eye is involved with diabetes, as opposed to, for instance, just kidney damage or amputation of an extremity, their interest in doing the treatment or staying on the regimen that the physicians recommend is much higher. And so getting them both aware that the level of damage is proportional to how much they take care of their body, do exercise, diet changes, and our measure can then tell the physician and the patient that this has been effective versus needing to then add Metformin or some other drug, and then eventually, as the disease progresses into retinopathy and proliferative diabetic retinopathy, how aggressive to treat that disease to stave off some of the damage that might occur.

TS: So like a cholesterol test that might be high during one exam, if you go the next time and it’s back down to where it needs to be, you can get an Atta boy and walk away?

KR: Exactly.

TS: Let’s talk a bit about the origins of the company and the technology. Where was the technology developed and how did the whole concept for OcuSciences come about?

KR: So the technology was developed by two researchers at the University of Michigan Kellogg Eye Center, Dr. Victor Elner and Dr. Howard Petty. And Dr. Elner is a long-standing researcher in retinal diseases as a pathologist and an ophthalmologist. He studied the early markers, molecular markers for things like AMD, has a research lab developing new targeted therapeutic areas. The other development partner, Dr. Howard Petty, is a biophysicist immunologist and runs a primary research lab looking at in cellular markers of disease, in particular inter-cellular signaling. So what’s happening between cells. And together they brainstormed a way to have a noninvasive, rapid, quantitative measure that would be useful for looking at new therapies that they might produce in their labs, or that pharmaceutical companies might produce for the treatment of these diseases. They wanted a method that you could use regularly as opposed to some of the methods that they were able to use as a standard of care at Kellogg Eye Center have a very long study time. So not very often patients were getting measured, and they were looking for something that could give a readout in 6 months rather than a 3-year trial. And so again, developing a native fluor biomarker that could be measured with a very quick, you know, less that 5-minute timeframe, was something that they felt would make a big difference at their research center, the University of Michigan Kellogg Eye Center, but one that we found at many other centers as well that needed a nat for them to assess patient.

TS: I’d like to take a moment away from this conversation just to remind you all that your tales of innovation are important to us. We want you to appear at your upcoming OIS conferences. So go to ois.net, fill out a presenting form, presenting company application form, rather, and tell us your story. And we’ll hopefully have you on the floor at a future OIS or on this podcast. Love to get more stories, different stories like OcuSciences’ tale, and get them out to the masses in ophthalmology. Now let’s get back to our conversation with Kurt Riegger.

TS: And how did this technology become a company? It’s a difficult time to raise capital, especially in medtech and in diagnostics has this problem. What – give a bit of the history of the origins of OcuSciences.

KR: Sure. Well, again, the technology was licensed from the University of Michigan into OcuSciences. The company then raised a round of capital from people in industry, ophthalmologists, optometrists, people that are industry veterans of medical diagnostics equipment. And got started in a bit of a time where people expected a lot to happen with the Affordable Care Act, but the secondary challenge was that we entered into sort of the great recession, and that definitely stalled venture capital raises, but actually forced us to do something that’s probably been positive for the company, which is to reach out to strategic partners and to pharmaceutical partners and to help develop something for them that they can use as part of the clinical trials or as part of their new product development areas.

TS: And so the ophthalmologists and optometrists were among the angel investors. What sort of feedback did you get from them when they heard this idea? Obviously if they’re putting their money toward it, it’s a positive feedback. But what kind of stories or what kind of testimony were you hearing from those folks?

KR: Well, all of them felt that again, as they treat their patients, they were looking for this sort of thing. We actually did also interviews, customer discovery interviews with probably 50 other optometrists, ophthalmologists out in the marketplace, just to make sure that what we were hearing was true. And almost everybody said that a more quantitative, more precise, metabolically focused diagnostic is something that they would be very interested in. And again, we were looking at a time when Optos had brought their Widefield out, and was really making a lot of progress in optometry. And again, we thought that that kind of model, where patient comes in, maybe gets a baseline assessment at no cost, but then becomes a regular patient of optometry, one of the things that they were signaling was that this could be an enhancer to their practice, both giving better care to their patients as well as being perceived as offering a more sophisticated assessment of their patients’ eye care.

TS: And how do you move from where you are to fulfilling their desires, getting the test into their offices, and building this whole new line of diagnostics for ophthalmology and optometry? What are the barriers in front of you, and how do you see yourself positioning this company so you can hit the ground running once you are fully commercialized in this space?

KR: Well, our commercialization path is to do a couple of different levels. One, what we’re doing today is providing instruments out into large research centers where they’re doing clinical trials, studies, as well as conducting trials with pharmaceutical partners. So we have a research grade instrument that we’re currently commercializing, a lower cost instrument for optometry/ophthalmology is something that we have in development, and will have out shortly. That’s going to be a smaller footprint device with a lower price point that should be readily obtainable for most optometry practices and certainly all ophthalmology practices. We’ve modeled it out such that the business case for it would be that you could purchase the capital equipment and then, with the CPT code reimbursement, have less than a one-year payback. So again, our commercialization path is to then start selling that instrument to particularly targeted markets, metropolitan markets where there’s a large population of folks that optometry/ophthalmology sees on a regular basis, where they may be grading their diabetic retinopathy or AMD and could use our instrument to give a more precise assessment as to how much progress or how much change they’ve seen in disease since their last visit.

TS: And did you say this test would be applicable in other diseases as well? And is that something you’ve explored?

KR: Yeah. We think in diabetic retinopathy, early dry AMD, as well as glaucoma it has – we’ve studied all those diseases and have some publications in each. And again, we think that all those are unmet needs. One of our clinical centers for glaucoma said that again, they see this as part of getting almost all of their patients screened with the device. So again, the opportunity is, we think, to have as you walk in to any ophthalmology/optometry visit is to have this as one of their standard assessments that they would provide patients. And our report would then help guide the clinician as to whether everything is normal or whether there’s some follow up or further investigation that’s required.

TS: And how about outside of ophthalmology?

KR: Well, again, one of our partners has suggested this could be a new vital sign. So again, because the retina is your most metabolically active tissue, it’s also connected to the central nervous system, and it’s a good marker for how the health of your most important, most conserved and most protected tissue in the body is. So if there’s a systemic damage process occurring, that would also be a very important area to take a look at. And so again, we think general practitioners and maybe just general screening for the health of patients that you’d look at the back of their eye, the retina as a good marker for how their overall body health is. There is some thought that that would be, again, a general diabetes screening. But metabolic syndrome and some of the other damage processes that happen with high blood pressure would also be potentially caught with that.

TS: And last question: what do you see the outcome being for this company in 4 or 5 years? Is this something you can build out into a full commercial operation? Or do you see yourself becoming part of a larger entity?

KR: Well, we have designs to be a full commercial entity, but we would definitely partner with device makers to help get our method onto their instruments. We think that that’s a great opportunity. Eventually, beta analytics and image analysis is where the company is going to be focused on. We have our own software algorithms today, but we’ll be getting improved sensitivity and specificity of those algorithms with larger and larger data sets. And eventually, that’s probably the focal area for the company is to develop more advanced algorithms, more advanced software that can ride on our own instrument or on any modality of someone else’s more complete instrument, for instance, an OCT maker that might want to bundle this modality with their OCT.

TS: Terrific. Well, it’s an interesting story. I’m glad that we had the chance to finally talk and not just tweet.

KR: Thank you very much, Tom. I appreciate the opportunity as well.

TS: Thanks for joining us.

KR: OK, thank you.

TS: Kurt Riegger, thank you for joining us today on the OIS Podcast. Again, it’s nice that we finally spoke, as opposed to tweeted. And I invite you folks to follow my Twitter feed @medtechtom.com, or go to @oistweets. And either of those accounts can get you in touch with me if you want to share your stories, your tales of innovation. Of course, once again, I’ll remind you to go to ois.net if you’d like to present at our upcoming OIS@AAO conference, or a future conference. Go to ois.net if you want to register to attend the upcoming OIS conference on November 12 in Las Vegas. So think you again for listening. Go to ois.net, register to attend our upcoming conference, and I’ll see you in Las Vegas.

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TOM SALEMI

Tom-Salemi

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

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