Michel Vanbrabant, iSTAR Medical - Delivering Breakthrough Eye Care Solutions | LSI Europe '24

Michel Vanbrabant 00:02
I thank the organizers for this great opportunity, and it's always great to provide a company update to the audience, including friends and close relatives. So great to be here. At iSTAR Medical, our mission is to become the leader in what we call MiGs, M, I, G, S, which stands for micro-invasive glaucoma surgery. Just a word on glaucoma. I'm sure not all of you are experts in this particular disease condition. Just a couple of things to keep in mind. First of all, it affects about 100 million people worldwide, so it's a real issue from a public health standpoint, and it costs billions to society. One number I would like you to keep in mind is that if untreated, 10% of glaucoma patients will go blind over time. That's why there is a high focus on trying to find better ways to control glaucoma. This disease is about the imbalance between the production of aqueous humor, which brings nutrients to the eye tissues, and the outflow of this aqueous humor. In glaucoma patients, the drainage pathways are blocked, and what happens over time is that there is pressure building up in the eye, which damages the optic nerve, leading to blindness.

So all therapeutic options have so far focused on trying to reduce the production of aqueous humor or enhancing its outflow. In terms of the patient journey, it always starts with eye drops. This is the least invasive modality, and those eye drops come with different active ingredients. Sometimes they are mixed together, and patients have to self-administer those eye drops every day, sometimes several classes of eye drops per day, which is relatively burdensome for patients. Not only do they not see the improvement coming from the eye drops because glaucoma is an asymptomatic disease, but they also suffer from the side effects of the eye drops. In other words, they take their eye drops, suffer from side effects, and don’t see the condition improving, which leads to something extremely important: the lack of compliance. In multiple studies, it has been shown that non-compliance is roughly about 50% when patients have to take more than one eye drop a day.

On the other side of the spectrum, traditional surgery has been around for about 50 years, but it comes with drawbacks: fibrotic reactions, complexity in following patients up, bleb management, and those sorts of things. That's why MiGs have really emerged as something extremely attractive. It is a very fast procedure. The surgeons can go into the eye through a small corneal incision, implant the MiGs, and get out within minutes. The one thing that it does, which is important, is that it shifts the control of the disease from the hands of the patient with the eye drops to the hands of the surgeon. That's why MiGs have become increasingly popular over the years.

Just quickly, financially, you may have heard about the market leader, Glaukos, an extremely successful company that introduced their initial MiG device back in 2014 in the US and has since enjoyed tremendous growth, with a market cap in the range of $7 billion today. There are also some striking examples of exits, such as Eventis, which was acquired by Alcon for about half a billion dollars back in 2016. In terms of expected growth, this segment of MiGs is still relatively small today, around half a billion, but is expected to grow at 20% CAGR over the next five years.

So where do we fit? Our technology consists of an integrated system. It has a handle connected to a sheath in which this implant is located. The sheath is made of poly(methyl methacrylate) for the current device in the market, and I'll talk about the next generation later. Our implant is made of something very special. It is not a stent or a tube like any other technology already in the market; it is a fabric. It's made of porous silicon, which consists of thousands of microscopic holes that are interconnected and together provide multiple channels for drainage. There's also a green ring that allows physicians to perfectly place the device in the right location when they are in the supraciliary space.

But I'm going to spend a minute on probably the most important slide from a technology description standpoint. This is the material that we have, which is called STAR. It's made of those microscopic holes. Why is that important? Because after being inserted in the eye, it is recognized as a friend, as opposed to a foreign body. Therefore, the surrounding tissues, like the sclera and the choroid, send some healthy cells into that implant instead of creating a fibrotic reaction, which would develop outside of the implant. Why is that important? Because a fibrotic reaction would reduce the performance of the implant over time, and that's exactly what we prevent from happening with our STAR material.

Here is an overview of our clinical trial program, with several sections in there. First of all, the STAR 1 to 4, leading to the STAR Global Program, which is almost accomplished. We are now moving to the follow-up of years four and five, depending on those studies. We also have STAR 6, which is a study in combination with cataract surgery; that's a so-called indication expansion study. The most important study currently in progress is STAR 5, our US pivotal study, which is currently enrolling. Last but not least, we also have a post-market registry running in Europe for those commercial cases.

In a nutshell, very simply, our technology enables a reduction in pressure by about 40%. That's enough to almost stop, in most cases, at least stop the progression of the disease, and at the same time, reduce medication intake by 40 to 45%. This has been presented multiple times over the last two to three years. The last one actually covered a meta-analysis of our STAR 1 to 4 trials. It was presented at the European Glaucoma Society for roughly a bit less than 100 patients. This is the first time that it gets presented. It is a meta-analysis of our four STAR trials versus four trials from the market leader. We looked at comparative trials in terms of patient indications. We looked at trials performed in standalone settings, not in combination with cataract surgery. So it is a consistent series of trials that have been compared, and what comes out of this analysis is that our mini-JEC technology enables a reduction in pressure twice as much as the market leader.

That's one important conclusion of the abstract. The second one, which is certainly as important as the first, is that there is more homogeneity. Across our STAR trials, we see the same pressure reduction. That's super important for clinicians to have predictability for their patients. That's really something key. On top of that, there was a trend towards better medication reduction; however, that was not statistically significant. So this slide is the reason why this company is still standalone. Everyone is now convinced about our efficacy. The real challenge is to demonstrate that over time, we don't have any safety problems with something called the density of cells on the inner surface of the cornea. Why? Simply because there was a technology back in 2018 called the CyPass that was recalled from the market. It was a very difficult time for us, but eventually, we went over it, found some good financing, and kept going. Today, the data is maturing, and we need to demonstrate that we are as safe as the leading technologies in the market, such as Glaukos and Eventis. Currently, the data in orange here at five years shows that we are actually comparable to the best MiGs in the market, but it's only 34 patients. So this is currently maturing, and this is the suspense for the company moving forward.

Michel Vanbrabant 08:53
So where are we today? Well, we've released our technology commercially in Europe, in Switzerland, in the UK, and in Australia. We are still very selective, only using a direct sales force. We wanted to control the baby initially, so we've treated about 4,000 eyes and have great quotes from key opinion leaders. Key directions: Number one, we are going to expand commercially in 2025, including direct and indirect channels. Number two, we have this new technology for the introducer, making it a 19 lower profile instead of the initial introducer, and we continue with our US clinical trial.

This is the team that I would like to thank for their efforts, all experts in their respective spaces, with a board that is extremely experienced, nicely balanced between US members and European members. You may recognize a few names; some of them have been in the press recently for significant exits. Last but not least, I would like to thank our investors who have supported the company all along. There are some in the room today, and I really would like to thank them: EQT, Early Bird, and Capricorn. They believed in the technology and kept supporting us, which enables us to seal an alliance with Abhi back in 2022. In total, the company has raised $115 million and is on its way to demonstrating further successes. So thank you very much for your attention. Thank you.