Video Transcription
Leo Smit 00:00
Leo, hello. My name is Leo Smit. I'm CEO of Hy2Care, and I'd like to introduce to you the next breakthrough in cartilage repair, a story that started with one of our founder's sons. About before she was in her early 20s, she had already received three separate cartilage repair surgeries, but ultimately they all failed. She's currently in pain again and knows that sometime in the future she will need a joint replacement. As such, she is an illustration of millions of people that get cartilage repair surgery that fails, and ultimately they develop osteoarthritis, suffering years of pain and disabilities. The reason for that is shown in this graph. On the right-hand side, you see that 70% of the people get a standard of care treatment, which is either a debridement or a microfracturing. The issue with that treatment is that it creates fibrous tissue, scar tissue with suboptimal properties, and ultimately that will fail. We can do better, much better with cell technologies that have very long-lasting survival data. Unfortunately, that technique is extremely expensive, poorly reimbursed, and therefore only applicable to a few people. So what we need is the best of both worlds: the quality of cell technology, but at a much more affordable price, and that is where the Cart Revive hydrogel implant comes into play. Our implant consists of natural polymers, polysaccharides, or sugars that already occur inside your body. In this little animation, you see how we intend to revolutionize cartilage repair. You've hurt your knee, and the image shows that there is a defect, a damage. So the surgeon can go in with his scope, he can inspect the defect, prepare it, and then we come in with a very simple-to-use insertion device. In that device, the two polymers are being mixed, and in a low-viscous, free-flowing state, the gel mixture is inserted into the defect which perfectly follows the contour of any shape defect. Then in the next minute, magic happens. The two polymers start to cross-link. They shape up into a solid implant with exactly the shape of the defect, and moreover, they also cross-link with the surrounding tissue. So the plug is actually gluing itself to your body. It's an open structure, so chondrocytes, the cartilage building cells, can populate the gel very easily, and once they are inside the gel, they start rebuilding cartilage at the same rate that our gel is resorbing itself, turning into a nutrient for the cells, and within a few months, you have a fully operating joint again. Now that's an animation. Disney and Pixar have taught us that in an animation, everything works. But let's look at real life. Here you see our preclinical equine studies. You see that the gel is perfectly following the contours of the defect, it has an open structure, and indeed, the chondrocytes are already present in the gel. Within two weeks after implantation, three months after implantation, our gel is gone, and a smooth, perfect layer of cartilage tissue has been formed, and that contrasts sharply with the chaotic structure of microfracture. Then when we analyze those tissues after seven months, while they're still developing, we see that we already have beaten the standard of care significantly, and indeed, we're making a tissue that is similar to what cell technology provides. Then, from horses, let's go to humans. Here you see one of our patients from our first in-human study. On the left side, the left MRI, you see the open defect, the white spot, and 12 months later, it's completely filled with a very smooth layer of cartilage. That's the picture. What do the patients say themselves? We measure the outcomes from the patients, their performance through the KOOS score, which is an aggregate score of less pain, better mobility. You see that we raise from baseline 24 points after 12 months, which is two and a half times the level of minimum clinical relevance. If we then compare that to standards of care and cell technology, we get a similar picture as in the horses; we beat the standard of care by 50 to 60%, and we are on par with cell technology. So summing up, we have a new technology that satisfies the unmet need of all the actors in the value chain. It is a very easy-to-use, error-free method for surgeons. It creates beautiful cartilage which promises long-lasting performance and is very affordable in its cost. With our team, we've been able to reach a lot of milestones in the past two years. You see them here: the clinical trial that we just showed you the results from; we have finished treating all the patients, so we are now preparing the dossier for CE submission. Also, last year, we got FDA breakthrough device designation from the FDA, which is very helpful in our core project, getting market access in the US. Here you see the timeline. We're currently scoping out the trial. We're preparing the IDE, and we will be submitting that any day now. That will take another year for preparation, contracting the sites, optimizing the protocol, and we expect the US patient number one in the clinical stage to be treated in early 2026, and that's about the same timeline that we will also start treating the first commercial patient in Europe. We are finishing that trial right now, submitting the duo. We expect to have CE marking also early 2026. In order to get to those two major milestones, we are currently, as so many of us, fundraising. We are looking for 9 million euros or 10 million. We have a syndicate that can cover most of this. We would like to extend it with one more private healthcare party fund to join us. If this amount is too little for your appetite, I'd like to remind you that you don't have to worry about that. There is another round coming up as well, of 30 million to complete the US trial, and we're also happy to discuss joining together those two rounds. So summing up, for many, many years, people have thoroughly believed that cartilage cannot rebuild, it cannot regrow. That's a myth, and that myth has been busted. Your body is very well capable of regrowing your own cartilage if you give it the right protection at the site, if you give it the right scaffold to the cells, if you give some local nutrients. That is exactly what the Cart Revive hydrogel implant does. With that new therapy, we at Hy2Care are moving on a journey, a journey to what you could say is the final frontier in orthopedics, to go to a state where we can prevent the need for the heavy and invasive metal and plastic implants, but go to true, effective joint preservation. We are very enthusiastic about that journey, and if I have given you some enthusiasm as well, then I invite you to come over, talk to us, and let's make that journey together. Thank you.
