Video Transcription
Carl Vause 00:00
Good afternoon, everyone. My name is Carl Vause. I'm the CEO of Hyalex Orthopaedics. And what is Hyalex Orthopaedics?
Carl Vause 00:07
Hyalex Orthopaedics is based on a transformative material innovation that we call Hyalex cartilage, which is an off-the-shelf, paradigm-shifting polymer that allows surgeons to resurface damaged joint surfaces at time zero, with a polymer that works like, feels like, and is a direct synthetic analog of healthy hyaline cartilage. Where we are today is we're avoiding the cost, the uncertainties, and the availabilities of these expensive biologic therapies, and we're ready to address multiple joint spaces with scalable manufacturing that can go across the body. So let's take a quick look at the coming today. We have two products in the pipeline. Our first product is a 510(k) into the high-growth Foot and Ankle space, which is the first MTP. And we currently have a knee resurfacing product that is in full IDE approval trials in the US, as well as trials in the EU. I'll show you some data in a minute. All of this is protected by 17 issued patents that cover everything from our material, our chemical process, and our full construct. We have an amazing team of folks leading this company who have decades of experience in medical devices and orthopaedics, and our most recent hire was Dr. Mira Sahney. She retired recently as the head of orthopedic surgery at the University of California, San Francisco, and joined us as our CMO. So what is so amazing about this material? So let's talk about healthy hyaline cartilage. It's composed of two components: a structural component, which is type two collagen, and locked into that matrix is a hydrophilic tissue called proteoglycans. So at rest, healthy hyaline cartilage is actively hydrating through synovial fluid. The mechanism of action is when you load hydrous fluid, that creates a fluid bearing, and you get a very lubricious articular surface. When cartilage is damaged or it scars, you lose that interstitial water content. You lose that ability to self-lubricate. What our inventors at Stanford University did is they took two well-understood polymers, one that had very similar material properties to the type two collagen, they expanded that matrix through our proprietary chemistry, locked in a second hydrophilic polymer, and have put a negative charge on that. So it truly does function exactly like healthy hyaline cartilage. It pulls water into the matrix. When you compress the material, it exudes that interstitial water and lubricates just as healthy cartilage does. And you can see this video here of our scientists bending and manipulating the material. And it does exactly do that: exude and reabsorb water into the matrix. We have both the material properties of healthy cartilage from an impedance, stiffness, and the coefficient of friction of our material on cartilage as that of healthy cartilage on cartilage. We make it in sheets, so we can make this in significant amounts, and then we can cut, shape, and build a number of implants. You see three of our knee SKUs here, as well as our MTP device, and then we can take this across the full body in a number of articular joints. So let's talk about the first indication, which is the first metatarsal. So today, the standard of care for the first metatarsal arthritis is to fuse the joint. While this alleviates the pain, the patients are very dissatisfied with this surgery in that they lose the range of motion. They're unable to do the things they used to do. And surgeons, I was at the American Orthopaedic Foot and Ankle meeting last week, the number one unmet need is: how do you treat this and maintain range of motion using the Hyalex material? Once again, we can resurface the damaged joint surface. We can maintain the natural anatomy in a straightforward four-step procedure. If you look at what we're doing, we're taking a polymer designed to both take a press, designed to be fitted to porous titanium for both a press fit and an osteointegrated approach to fix into the toe. Once again, a four-step procedure. We resurface it. This is a 510(k) approach into a $700 million US market. We will follow that 510(k) before the end of this year. And you can see here what a metatarsal looks like when it's resurfaced with Hyalex. We preserve the anatomy, we resurface the joint, and maintain the biomechanics of the joint. Our second indication is looking at the multi-billion dollar knee market. And once again, this is data that's publicly available from the US, where we talk about 1.2 million arthroscopic procedures. There are about 6 million globally annually, and there are about 750,000 cartilage lesions that are diagnosed in the operating room. About 585,000 of those are grade two to grade four, which surgeons believe they would treat. Here is a straightforward off-the-shelf, guaranteed resurfacing that restores the natural anatomy, restores the biomechanics of the joint, and lets these patients get back. But if you take a further cut at the market, it becomes more interesting. So there are biologic approaches. They're expensive, they're difficult to get to, but really, when you look at patient biology, the literature will tell you, once a patient is over 35 years old, they really start to lose the ability to regenerate. So if you look at the gold standard, which is MACI by Vericel, their market is limited by their ability to get reimbursed by patient age and patient biology. If you look at once you're over 65, you've got end-stage osteoarthritis. It's time to do a total joint replacement. Those patients do very well. Patients 67 and older have complete satisfaction. So what do you do with someone 35 to 65 years old who has an acute cartilage injury right now? What the surgeons tell them is: deal with the pain, modify their activity, and wait until they're ready for a total joint replacement. It's not what we want. And what these patients want is they want immediate reduction of pain and a return to activity, a return to life, if you will. And so that's what we can do with our material. And so you see here today, we've got 13 patients in, we're treating the widest range, and I'll talk through two cases real quick. This is a 49-year-old skier. She was skiing with a lateral meniscus tear. There was a cartilage signal on MRI during the scope. You see the second panel. This is an 18-millimeter full-thickness lesion in a 49-year-old woman. This lesion probably would have been debrided, and she probably would have been indicated for a unicompartment knee replacement or total knee replacement when she was ready to give up. Instead, in a 15-minute procedure, we resurfaced the joint. You can see the implant there. She's doing extremely well a number of months out. The second is, this is a failed microfracture with an adjunct where they microfractured, they put in a scaffold, and you see here that you have this three-dimensional scar tissue that has formed in the joint, very painful, limited range of motion. The surgeon was able to open this joint to debride that scar, remove the damaged bone, because microfracture does create a sclerotic bone layer, and they used one of our deep 12-millimeter implants. So at the same time, they treated the surface lesion of the joint and the bony lesion that was about eight millimeters deep in this patient. So what are we doing today? In our trial, we're treating those cartilage gaps in weekend warriors. We're treating both surface and bony lesions, bony edemas. We're treating semi-unique compartment arthritis. It's early stage. The rest of these good why would you do a total knee replacement when you can just replace that one compartment? And we're actually seeing revisions of failed treatments. The patients are doing exceptionally well. KOOS score. Mean KOOS is what the FDA really likes to see. Our patients at six months are seeing a 30-point average. If you look at the standard of care, microfracture debridement, they're looking at a 20-point improvement over two years, 30 points at six months. It's very compelling. And then our subscales that we track of pain, activities of daily living, and quality of life all far exceed the clinically important difference at six months. So if you look at the technology that's available today, really when you have to treat the widest range of lesions, the depths of lesions, both surface and bone involvement, down to 12 millimeters, restore the biomechanics of the joint, restore the articular surface at time zero in a straightforward 15-minute procedure, and something that's off the shelf. It's a four-step procedure. We built the manufacturing process to scale. Once again, we produce the cartilage sheets in mass, we cut, we shape. We have fixed porous titanium or other substrates to address joint pathologies, and we're able to take this technology across the full body. So today, first indications, MTP, 510(k) will be filed here in a few weeks, it will be on the market. In 2025, we have the full IDE study running in the US, with the EU study running in the knee, with very compelling early data, and we're already thinking about where that next joint space is. Once we get the MTP done, it will be on to the next indication, near-term activities, obviously, at 510(k) clearance, commercialization of the MTP. We do have a US safety review that will be completed in October and submitted to the FDA, and then we'll roll up early next year, one-year data on our IDE study. The IDE study does have a one-year endpoint, and we'll continue to enroll that. So today, Hyalex, we have a transformative material that is a direct synthetic analog of healthy hyaline cartilage, the same mechanism of action through interstitial water, and allows us to resurface these damaged joint surfaces and get these patients recovering back to activity quickly, without the uncertainty of biological or other treatments. Thank you. Applause.
