Improving Vision and Quality of Life with Samsara’s Implantable Miniature Telescope

Jeff Kavanaugh: Welcome to the Knowledge Institute podcast, where we talk with experts on business trends, deconstruct main ideas, and share their insights. I'm Jeff Kavanaugh, Chief Learner and Sharer with the Infosys Knowledge Institute.

Today I'm joined by Tom Ruggia, CEO at Samsara Vision, a specialty medical device company. Their implantable devices improve vision and quality of life for people with untreatable retinal disorders. Samsara's implantable miniature telescope is the first and only FDA-approved implantable medical device demonstrated to improve vision. Tom, thank you so much for joining us.

Tom Ruggia: Jeff, thank you so much, and to the whole Infosys audience, thank you so much for listening.

Jeff Kavanaugh: It's a fascinating topic, and hopefully you'll improve our vision on this important topic. To start off with a statistic, roughly 11 million people in the US have age-related macular degeneration. Tom, can you explain what AMD is and its risks?

Tom Ruggia: Sure. Age-related macular degeneration is a condition that in the United States, 11% of elderly patients will have age-related macular degeneration, so many of them making it to the latter stages of the disease. Around the world, we see this disease in various population swaths: 8% in Asian populations, 15% in Northern European populations, but the incident is really high as a percentage of the total population.

Macular degeneration affects the tissue in the center of the back of the eye. Patients lose central vision that begins, let's say, somewhere in your 50s and can progress through your life to where you're almost centrally blind, can't see faces, can't read, can't drive, which happens rather quickly.

And there are treatments for some parts of the disease. So inside the back of the eye you may create new blood vessels, and neovascularization as common in this disease state. So when the eye creates new blood vessels in that very tight tissue plain, it's a recipe for disaster, so to speak. Generally, those patients lose vision very fast and that's referred to commonly as wet AMD or neovascular AMD, and there's treatments for wet AMD, but you're not treating the underlying condition; you're treating the neovascularization.

So there's injections like Lucentis or Eylea, which are very common today. They can rescue that fast onset of vision loss in wet-AMD patients. The patients still progress along the disease cascade. Some patients that don't experience neovascularization can be referred to as dry-AMD patients. Those patients will progress and then eventually lose that central vision, and the wet-AMD patients over time will also lose their central vision thanks to the underlying disease state. It's a very sad condition. It leads to debilitation and reliant on caregivers.

Jeff Kavanaugh: Well, you've certainly set a sobering context, because vision is so important to all of us. The good news is, I think it's why you're here, is to highlight some of the remedy solutions to this. First of all, how aware are patients and ophthalmologists that AMD can be treated with tech like this implantable miniature telescope?

Tom Ruggia: Yeah, Jeff, that's a complex question, I suppose. The doctors are very aware that wet AMD can be treated, and that's thanks to the treatment innovations, Lucentis and Eylea mostly, that have come to market over the last 15 to 20 years and have become a very common treatment for wet AMD. Those two drugs, especially Eylea today, are some of the highest-volume prescription medications in the world. They're big businesses too, but also, it's one of the more common procedures in medical technology today: an injection in the eye that reduces the blood vessel formation and the fragility of the blood vessels in the back of the eye that sometimes rupture creating lesions that can cause vision loss. So they're very aware of these injections for wet AMD.

What doctors are not as aware is the other treatments for late-stage disease, and today, really those treatments are limited to external devices that can be used to magnify light and change the central focus of the light. The retina specialists are not aware of the technology. Some are not favorable to the technology, and the patients get a bit of fatigue, because so many of them that have dry AMD are told that there's no pharmaceutical intervention, there's no surgical interventions that can help them, and they go into a reluctance to come back and see the doctor. Sometimes they see the doctor every couple of years, but definitely the patients become sedentary, stuck in their homes, reliant on family for care or possibly even sometimes in long-term care facilities because their vision can degrade over time. So yeah, I think for the most part, wet AMD, very aware; dry AMD, not as aware.

Jeff Kavanaugh: So this outside-in approach that people are aware of, maybe it's limited results and especially has this huge impact, like you said, on changing lifestyle. For this inside out approach, you're talking about, is it affordable? Is it expensive? Does insurance cover it? So what's the situation there?

Tom Ruggia: So dry AMD today, insurance definitely pays for care. There's tremendous cost associated with creating new environments for the patient to be safe in, to managing the television or giving the external devices necessary for the patient to live in their current environment. And these patients are prone to accidents, which lead to orthopedic events. So the cost of zero care is very well known, and in fact, before the wet-AMD treatments were available, there was a lot of literature around the burden of illness for wet AMD.

So that burden of illness is the same in dry AMD. It happens a little bit later for those patients, but it's quite costly. So the reimbursement for Eylea and for Lucentis on an annual basis can be north of $15,000 a year, but I think that's a trade-off that can be managed by payers, because of the reduction in risk of falls and the improvement quality of long-term life.

I think the same can be said for our technology we're bringing to market. We're currently in clinical trial with an implantable device that magnifies light for the patients and changes their focal point, and it allows them to get three and four lines' improvement on the vision chart and an improved quality of life.

Jeff Kavanaugh: Well, we're all familiar with the vision chart. What does three to four lines mean? From 20:200 to 20:50? What is that?

Tom Ruggia: Yeah, so a patient is legally blind at 20:80, and most of the patients that we see... So our device, the smaller-incision, new-generation IMT is in trial today for patients who are worse than 20:160. So imagine if you lose the ability to drive at 20:80 and lose most of your central vision, 20:160's far worse than that. Most of our patients come in, maybe they can only see the big E on the very top of the chart.

And after surgery in Europe... We're approved in Europe, we've been commercializing this device in Europe now for a year, and we're seeing an average of three to four lines improvement. What that means is the patient starts with the ability to just see the big E on the top of the chart, but then can see four lines deeper. So getting very close to that 20:80 or possibly even better than 20:80 after surgery.

Now, common question: can I drive again? The answer's no. We don't want to encourage people with very strong-

Jeff Kavanaugh: In a few years, it won't matter. Self-driving cars.

Tom Ruggia: And, Jeff, that's what we want. We want to see that. That's a better option for our patients. But yeah, three to four lines of vision improvement for these people gives them 20 years of functional life back where they thought that they would not get that.

And so our patient stories are gut-wrenching. You hear them before, and they tell their story of limited mobility and their loss of function. We had one in Italy who was a professional painter and he describes it like being in prison. He says in his video we have on our website: "Being freed from prison is not a small thing." This gentleman, he actually painted a picture, and we're fortunate to have that as a Christmas gift here at Samsara. So it's amazing to see his return to function.

Jeff Kavanaugh: The work you're doing is so critically important, and we were talking beforehand and had some work in pain management; when people had chronic pain, they'd curl up in a fetal position, literally, before their medicines or devices help them overcome it. These are life-changing solutions you provide people. And so let's go a little deeper into that because while acronyms are fun, this IMT doesn't really do justice to the words implantable miniature telescope. Are you really putting a little telescope inside someone's eye?

Tom Ruggia: Yeah, that's right. It's a fully miniaturized Galilean telescope that magnifies light 2.7 times and changes the focal point from your natural eye; points the light into tissue that is lost for the patient. This telescope will focus on tissue just around the section which has lost vision, and perifoveally is the terminology for this. So we go around the lesion with the light that we magnify, and then the brain can take that image that it gets and use it as a central image thanks to the magnified light.

Jeff Kavanaugh: The hardware itself, I'm sure, is a work of art. It's amazing. Typically today, it's that marriage of the physical and the digital, the software. What role does software play, both inside the device as well as external?

Tom Ruggia: At this point, not very much. I took over two years ago. This is an analog device. Well, at the time when I took over, we had a generation-one technology that had a wonderful optic. So the very center of the device was, like I'm saying, a Galilean telescope. It's made of glass with air in the middle. That gives a pristine refractive index, so that image quality is really good, but it is not digitally enhanced. It's simply the glass tube with air in the middle, and then the design is important. It's that telescopic design.

The issue that the original device had was the haptics were not designed for implantation. So although the center of the device, the optic was excellent, the outside or the haptic design that held it in place once it was implanted in surgery was very large and rigid, and it led to a traumatic surgery that was not surgeon-friendly or patient-friendly.

So we re-engineered the technology with human factors in mind. Surgeon factors, of course; the delivery now can be done in 28 minutes on average where it was 70 minutes prior; but also with patient-centric design in mind. Now the six and a half millimeter incision in the eye is about half the size of the previous incision, leading to faster recovery and less chance for issues with the cornea.

But these enhancements are all on the platform, so not digitally enhanced, but we look forward to the future, because these patients postoperatively will go through a series of vision-rehab sessions. So we're working with providers to look at telemedicine and home-based learning systems so we can have an occupational therapist in someone's living room versus having them come out and do in-person visits to the occupational therapist. So I think our digital transformation is a bit yet to come, but we're on our way there.

Jeff Kavanaugh: One aspect I want to bring up: you'd mentioned before the importance of partnerships. You reeled off two or three. You'd also mentioned in our earlier discussion about Kaleidoscope and your partnership with them. Can you describe how that came about, or how that evolved with this particular application?

Tom Ruggia: Sure, yeah. I like innovators, of course, but I like people who really get into the task at hand and the objective. I love to see masters at their craft, and I think we were talking about when I first met Kaleidoscope. I was working at Johnson & Johnson and we were working in a laboratory, working on a design of a drug-delivery technology that was making its way to market.

And I met Ben Coe from Kaleidoscope there when we were in this lab doing procedures on non-human subjects, and I didn't know Ben, so I saw him over the subject and working on his delivery, and I thought to myself, "Well, that's a good surgeon. That's somebody who really knows their way around an eye, really knows how to do this, and are we going to be able to do this with other surgeons? This surgeon is obviously very skilled."

And I met Ben and I asked, "Hey, where do you practice?" He's like, "No, I'm an engineer. I've been given this task to help with." I was just amazed, and you could see it in his face: he wanted to perfect this. He was given the task, and I know that's what engineers do, but you don't see everybody doing it like he was doing it. So I was intrigued and got to know Kaleidoscope well, and the output of that work together at Janssen eventually became a delivery mechanism that that's no longer at J&J, but it's been part of three different companies now and is very effective at delivering drug product to intended tissue in the back of the eye without vitrectomy. It's a amazing technology.

What they did with that, it wasn't just, "Let's create a catheter that gets there." It was, "Let's create a catheter that gets there. Let's make sure the surgeon experience is perfect." I mean, they created a magnet-based system that sat on the forehead, and then a dial that was easy for the surgeons to use and see. It was really a thing of beauty.

But what struck me is I think J&J benefited from that relationship, but how important that is for small companies. So most of the time, as small company that's owned by a founder... Maybe it was a project that was born in a small lab, or I like to say garage or something like that, and the ideas don't look final when they're presented to big companies. So let's say a small company is pitching to Johnson & Johnson; the founder has an idea in iteration and he or she thinks that J&J can see it as well, but the bottom line is they don't. So it has to look like a final product before it is final.

So that's where I think Kaleidoscope can benefit the small company. So I had given them a couple of projects that I thought would benefit the small companies that they certainly did. I did a great job for them as well, and then I used them again. After I joined Samsara, I took a look at what we were doing in surgeon training and what we were doing in some preoperative care, and I thought it looked a little garage-ish. And our product has a high sticker price, as it should. It has a big benefit and creates a very good patient benefit. So it has to look and feel premium, and that's what Kaleidoscope was able to deliver on. Our surgical videos for training are now excellent. Our collateral that we send out is now excellent, and that's thanks to the vision of the team.

Jeff Kavanaugh: Okay. So your product design, human-centric aspects are there. The next step appears to be going to scale, and that's the lesson or story that's relevant to any business. What is your roadmap to take this wonderful product that now has this good design to the masses?

Tom Ruggia: Yeah, I think we have to problem-solve for a few things. One, the masses for us... So inside the 200 million global patients with AMD, 11 million have the late-stage form of the disease, and that's growing fast. So within a few years, it'll be 15 and then more. Inside those 11 million patients, there are currently 4 million patients that are appropriate for our technology who have not had a previous cataract surgery and have concomitant late-stage AMD. So for those 4 million patients, we want to get this SING IMT out there, and we feel we can get to the masses and train the surgeons appropriately.

We've now got a procedure that's very similar to a standard cataract surgery, so training the surgeons won't be hard here. It's just I want the proper collateral. And when I talked to the Kaleidoscope team, I said surgeon training has to be quick and efficient and intuitive. So the surgeons, when they go through the training, they had to think to themselves, "I get it in a heartbeat," and we've been able to do that with Ben and the team early, and Matt and the team early, but we want to do that for the masses as we commercialize.

Now, doing that will be largely virtual, so I'd like to have the material accessible online. We'll do that with ease. And then the final frontier will be once we get faster adoption, these patients, like I was saying, they have to do six to eight visits with an occupational therapist post-operatively, like physical therapy in orthopedic surgery, and we want to do that in the patient's home, because that's where they're going to be using their vision most frequently.

So how do we encapsulate our occupational-therapy visits into a telemedicine experience that a visually impaired patient can do? So we'll be doing that while we're in trial, and we'll want to be ready for that at launch once we're approved in the United States.

Jeff Kavanaugh: This has been fascinating. For all those that are listening, you could find details on our show notes and transcripts at infosys.com/iki in our podcast section. Tom, thank you so much for your time and sharing your points of view on this very interesting and important topic and innovation medical devices. Healthcare is and will be a critical sector for us to track.

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