Nova Eye Medical Limited (EYE.AX) Earnings Call Transcript & Summary

Good morning, everyone, and thank you for joining us at Nova Eye. We're here to walk you through the clinical use of the iTrack Advance and share some direct insights from the field. With us today is, as always, Nova Eye's Medical CEO and MD, Thomas Spurling, and also joined by Dr. Khaimi, leading glaucoma surgeon and one of the key voices in canal-based surgery in the U.S.A. and globally. I'll now hand over to Tom to introduce our guest and set the tone for today's session.

Thanks, Mark. Look, good morning, everyone. Thanks for coming on board. We really appreciate the interest everyone shows. I'm really excited to have Dr. Mahmoud Khaimi with us today. Dr. Khaimi is one of the most experienced canal-based surgeons -- that's Schlemm's canal-based surgeons in the world, not just the U.S., and he performed the first ab-interno canaloplasty, that's canaloplasty from inside the front of the eye, and has helped shape how surgeons -- that technique has been rolled out by our company over the years. In addition, that work has helped us develop the iTrack Advance, which is the product you see on the screen, which that slider and the ergonomics was all work done with Dr. Khaimi back in 2022 and earlier. Dr. Khaimi spent more than 15 years at Dean McGee Eye Institute in Oklahoma as a clinical professor. He held the James P. Luton Endowed Chair, led glaucoma services in that institution and trained the next generation of glaucoma specialists through the fellowship program there. He moved to private practice last year and founded Glaucoma Surgeons of Oklahoma, which I visited Dr. Khaimi in October to check out his great facility there. He's got lots of beds and lots of room and lots of ambition to treat people, which is great. Dr. Khaimi can give us clinical insights on our stent-free tissue-preserving repeatable glaucoma surgery, and we're excited to have him today. So over to you, Dr. Khaimi.

Thank you, Tom. Thank you, Mark. It's a real pleasure to be able to share some of my experience with iTrack Canaloplasty. As Tom has mentioned, I've done this for essentially my whole career, which started off in 2006 in the world of ophthalmology. So I've been swimming in canal for almost 2 decades now. And it's amazing to see that the whole glaucoma community now and really the whole world of ophthalmology has really jumped on board with our procedure as well as using this as a first-line treatment for glaucoma patients. So let's talk a little bit about the iTrack Advance and where iTrack is nowadays. The iTrack Advance was cleared by the FDA in 2023. The beauty about this device is that it is implant free. And so there's no foreign materials left in the eye. It goes along beautifully with cataract surgery, the most widely performed surgery in the world. And so it's a great adjunct to those who have both cataracts and glaucoma. We have pretty good reimbursement for physicians in the United States. I'll speak to -- I'll just keep it to the United States from right now. And there's quite a few procedures -- thousand procedures done per year. Why -- let's talk a little bit about why surgeons choose iTrack Advance. The beauty about canaloplasty and really all along with iTrack is really to restore the natural outflow system of the eye. So I'll just set some foundation down so that you guys can understand why it is that we do this. Just think of the eye as having internal to the eye, just think of a faucet that's always on that produces fluid within the eye. And there has to be a drain that drains that fluid. When that drain doesn't work well for, say, the drain has either collapsed or clogged up with debris or what have you, the faucet is always on, so fluid is always produced and you can't get that fluid out. That fluid then backs up in the eye creates pressure in the eye and damages the optic nerve. The optic nerve is the structure in the back of the eye that really is like the motor that allows you to see. So the more damage to the optic nerve, the less you see and eventually you can go completely blind. So the beauty of this procedure is that it restores the natural outflow system of the eye. And not only is it an elegant procedure, but it's so easy to describe to our patients. I basically tell them that I'm going to restore your natural outflow system. So we're not removing the outflow system. We're not putting a brand-new drain device in the eye. And so it's widely accepted by all patients. It's FDA approved to treat glaucoma. And the beautiful thing about it is that it treats the whole outflow system starting from trabecular meshwork which is the screen or the mesh right in front of Schlemm's Canal, the main drain system of the eye and off to the collector channels. So this is the only device out there right now that does this so well. As I mentioned before, it's implant-free and we don't destruct any tissue. And the tissue preservation -- I'll get to that in a little bit as to why that is so important. We're allowed to treat with this device the whole outflow system. So we're not guessing at where the obstruction is. Our diagnostics are lagging in that we don't know where the outflow obstruction is. And so the beautiful thing about this procedure is that it's comprehensive, and it treats the whole outflow system. So I really don't know where the outflow is clogged up, so why not treat all of it. And we're allowed -- we're able to express or viscodilate the whole outflow system starting at canal anteriorly to trabecular meshwork and distally to the collector channels. Compared to MIGS devices out there, we're not destructing any tissue, and we're not putting any implants behind. So we'll skip this slide for right now, and we might come back to it where I might have Tom just present that. As Tom mentioned, I'm the leading surgeon at Glaucoma Surgeons of Oklahoma. And I've had a long academic career and now I'm currently in my own center of excellence. We can go forward, please, to the next slide. So everybody -- so having a device and saying that it treats glaucoma is one thing, but let's look at some data to make sure that we've got not only a beautiful device, an eloquent device, but one that actually works. I'm in the business of lowering intraocular pressure in treating glaucoma. That's the only way we can treat glaucoma currently. And here are several studies that show preoperative intraocular pressure. And then after iTrack canaloplasty, how much lower the pressure is decreased to in various studies that were not only done in the United States, but internationally also. So there's a plethora of data that shows very good IOP reduction with a procedure that is minimally invasive and comprehensive to the outflow system. We can go to the next slide, please. A big thing in the glaucoma treatment world is eye drops. And so you guys are perhaps familiar with glaucoma drops. And so years ago, this was the mainstay of treatment. And now because therapy is so minimally invasive, we jump to it much earlier in the treatment paradigm. But I imagine folks taking 2 or 3 drops and which can be quite irritating to the eye, toxic sometimes to the eye, a definite cost burden on the patients. And to be very frank, patients are just horribly noncompliant with taking drops. Imagine having to take anywhere from 2 to 3 different types of medications and 3 to 4, 5, 6 drops a day in someone's busy lifestyle. So drop therapy is very difficult for a lot of folks. And so you can see here with all these studies, how we're able to drop the medication burden for patients afterwards after this procedure. So they're not on as many drops. So not only were we able to lower the intraocular pressure, but we got them to use less drops afterwards. We can go to the next slide, please. Here's a study that I actually did. And one thing that we showed here in this study is really the study is termed long-term medication reduction in control glaucoma. So these are patients that have control glaucoma that were trucking along just fine on multiple drops. And as a stand-alone procedure, so where we didn't combine it with anything else or combined with cataract surgery. And we looked at these patients basically to see how we can decrease their medication burden because that's such a big deal in the world of glaucoma. And we have an 89% reduction in mean number of medications at 12 months. So they started off preoperatively with 1.83 drops and down to 0.16 drops at 1 year. And we're able to maintain that almost 70% reduction out to 36 months with 0.48 drops, all while we were able to keep intraocular pressure stable. So these were patients that didn't have an intraocular pressure issue. They were just on a lot of drops and I was able to tell -- it's a great thing to be able to tell my patients, "Well, listen, I know you're suffering from taking these drops and your eyes are beat red. Why don't I do this procedure, which is minimally invasive with very minimal risk, and we can maintain your eye pressure and not have to use many drops." So you can imagine that patients -- it's an easy sell and quite effective. Next slide, please. The iTrack -- looking at global data by looking at the iTrack Registry, where we've had physicians from throughout the whole world, give us their data, we can see that with regards to intraoperative complications, they are -- I mean, they're extremely rare. It's a very, very safe procedure. And whenever you think about adaptability, and being able to successfully do a procedure and actually maintain good relations with your patient, you want to make sure that they have an effective procedure, but one that keeps their eyes safe. And so you can look at the numbers there with regards to intraoperative complications just nominal. Postoperative complications are also very rare. And I would argue that these are complications that one would even see with just regular cataract surgery for that matter. So not exclusive to iTrack canaloplasty. So we've got a great postoperative complication profile also. And rarely did we ever have to -- if there was a complication after surgery rarely from the global iTrack Registry, rarely did we ever have to intervene postoperatively to fix a complication. And that's what that third column shows there. We can go to the next slide. So why do -- I mean, in the world of glaucoma, you have to be very comfortable with minimally invasive glaucoma surgery. That's just -- the trend is going that way, and it just makes absolute sense. And I think this is here to stay for decades on end. And so why do I choose iTrack Advance and why is that my primary minimally invasive glaucoma surgery? Well, for one, I do a lot of cataract surgery. And like I mentioned earlier, cataracts is a disease of the elderly. And along with that is glaucoma. So those comorbidities go hand-in-hand sometimes with in patients. And so I'm able to complement cataract surgery with this procedure. It barely adds any time to the procedure itself, and I'm able to take care of two things at one time. So that's all -- that's pretty -- that's a no-brainer. It is a very efficient procedure. It's pretty streamlined. And now that the catheter is on a hand piece, it's that much more efficient and that much more intuitive. The fact that it's so minimally invasive really adds no post-op chair time -- additional chair time. So let's say, I'm seeing a cataract patient that was combined with iTrack canaloplasty, I'm not going to have to follow that patient any closer. And that's valuable to physicians because chair time equals quite a bit of economics when you think about it. I've just started my whole practice and the more efficient I can be and take care of patients in the right way, I'm definitely going to look for that. It's extremely versatile in that I mentioned that we can combine it with cataract surgery. But for some folks, we can also do a GATT treatment with it also. So not only just viscodilate, but we can also take away some disease tissue. And one thing that I've been doing for the past year now which has really caught my attention because it's so tissue sparing and there's no stents placed in the eye, I've combined iTrack canaloplasty with iDose, which is a medical insert, which releases a medication for several years afterwards. And so I've done about 60-plus cases of this. And it's -- it's in line with regulations and what CMS wants the physicians in the United States not to do, and that is combine multiple MIGS all at once because iTrack is a MIGS procedure and the iDose is a medical insert, they are 2 separate things, so I can do that. And hopefully, I'll be able to present that data in the near future. So it's exciting that I can combine it with drug delivery, which is going to play a major role in the future, would not be able to do that if we destructed the whole outflow system. So a lot of the medical inserts now or drug delivery is targeted at the outflow, an intact outflow system. So that's why this procedure, I think, is here to stay. In fact, I know it's here to stay. Safety profile, it's excellent. I actually conducted a study that showed 3,000 patients that we've done had a lower rate of bad eye infection or what we call endophthalmitis than cataract surgery. So imagine how often cataract surgery is done. This procedure actually had a lower rate of infection than cataract surgery, which allows me to speak extremely confidently to patients and then get them in the OR sooner. There's a plethora of data out there that shows that it is very effective in IOP reduction and medication reduction. I love the fact that now everybody is catching on to canaloplasty and realizing that it is really a procedure that is very effective, minimally invasive and nondestructive and it treats the whole outflow system. So we're not just targeting one part of the outflow system. And the fact that we're not putting any hardware in the eye, that is also a very big thing when I see patients and explain the procedure to them. Why don't we -- we've talked a lot about the procedure. Let me show you a video on the procedure. So here, you'll see the iTrack Advance in the eye. And the beautiful thing about this procedure is that you can see the green light here. And this is the only device that shows the physician exactly where they are in the outflow system. And so you can -- it's not only is a massive wow factor in the OR but it's pertinent for the physician to be able to see where they're at all times. And so here, I've gotten around 360 degrees. And as I'm coming out, I'm ballooning open or viscodilating the whole outflow system and reconstituting the natural outflow system in the eye. And all in a 360-degree procedure where here you see me advancing -- and I'm in -- I take my gonioprism away so I can make sure I know where I'm at. So I'm, in fact, in the outflow system. And I can't stress enough on how important this is to a surgeon to know exactly where they're at. I think this is what keeps us -- I mean, this is truly an amazing device. And here, I am coming back out of the outflow system essentially rejuvenating it and getting the outflow system to function properly. Thanks, Mark. I think that's it. I think that comes to the end of my slides, if I'm not mistaken. Yes. So I'll give it back to Mark and Tom.

Thank you. Tom, can you come off mute there? Yes.

Yes. So thanks so much, Dr. Khaimi for that talk and Mahmoud talked to this slide. This is a slide that I wanted to show how Dr. Khaimi work fits with our total business. So I've got here down the bottom, strong foundation clinical data and regulatory clearances. It's the clinical data. It's the safe and effectiveness that Dr. Khaimi has helped us in determine. And also as we execute a consistent surgical technique, clinical trainers that have been trained by Dr. Khaimi by -- so that we make the outreach to other surgeons. And also the idea that Dr. Khaimi as well as some other KOLs really -- he's our leading cheerleader, if you like, the key opinion leader that really makes our story resonate with the market. If we just go back to the headline, there's a few things before we close that I wanted to highlight from Dr. Khaimi's talk, which I think are really interesting. First of all, he was saying what I often say that cataract is the most common procedure in the world, the most and the comorbidity of glaucoma provides an opportunity to treat, and I really like and want everyone to remember, it's easy to describe to patients and patients are relaxed about natural rejuvenation of their outflow. They don't like the irritants associated with putting drops in their eyes as well as inconvenience. And I wanted to highlight that iTrack Registry. It is a major investment. It's a major asset of the company, that iTrack Registry. We'll be providing more updates about that. That's just -- that's a compilation of data global physicians putting into that registry. The combination with iDose is something that the doctors are getting onto. And Dr. Khaimi has pointed out that he will be one of the first people in the world to have a nice data set associated with the combination of Glaukos iDose with canaloplasty. And last of all, as Dr. Khaimi said, it's here to stay for decades. We have a wonderful product. Dr. Khaimi has helped us get it there, and we've still got a lot of runway to get this message out to more surgeons. So thanks very much for attending today and listening to our story. Mark?

Thank you, everyone. Thank you, Tom, and thank you, Dr. Khaimi. That concludes today's webinar. If you'd like to receive a copy of this, please email me and we'll hopefully talk to you all very soon. Thank you very much.