Leo Smit Presents Hy2Care at LSI USA '24

Leo Smit  0:04  
Hello, my name is Leo    Smit. I'm CEO of Hy2Care. And I'd like to introduce to you a new approach to cartilage repair. And that's an approach that really originated in the early years of one of our founders son about when I was 15, I started to have pain in my knee because of cartilage breaking loose. I had several cartilage repair surgeries, micro fracturing, debridement and even a mosaic plasti. Unfortunately, it did not last, and my pain returns. I know that someday I will need a joint replacements. Each here, there are millions of people like me, and many of them will ultimately get osteoarthritis suffering lots of pain. I wanted to do something about this. So I became a bio scientist specialized in regenerative medicine, I co founded high tech care to develop a better cartilage repair solution for people like me. And worldwide. Annually, there are about two and a half million people that get a cartilage repair treatment in the hospital. And too many of them after a few years have to go back to their surgeon for a second surgery. Sometimes the third surgery gradually develop osteoarthritis, suffering years of growing pain and growing disability. It's an enormous hardship for these people, but it's also a huge cost burden for our society. Now why is that? If you look at current treatments, on the right side of this graph, you see our standard of care, two techniques debridement with micro fracturing. In short, the basic issue with these treatments is that it renders regenerates fibrous tissue, you could say scar tissue that will fail in a few years time, it is possible to regenerate better hyaline cartilage tissue that lasts much much longer, notably through cell implantation. Unfortunately, that's very, very expensive method, and therefore not affordable and not reachable for many people. So what we're really looking forward we're needing is an effective way, an affordable way of creating that high quality tissue. And that is what we are aiming for. And we are proving to be possible with our country five hydrogel implant, it consists of polymers that naturally occur in your body polysaccharides. And in this animation, you see how we envision the future, you've hurt your knee, you go to your physician, and after an imaging is determined, the cartilage might be broken, and the surgeon can go through an arthroscopy inside or a mini open surgery. And after cleaning of the defect, we come in with our insertion device in which the two polymers are mixed. And in a low viscous state are inserted into effect, they nicely fill the entirety fact there are no open spaces left. And within one minute, these two polymers will start to crosslink. Very notably very uniquely, they will also crosslink with the surrounding tissue. So basically, we have an implant that glues itself to the body. The structure of the hydrogel is very open, very spongy, and Colorscience cartilage building cells will quickly move inside. And then they start to do what they do. They multiply and build native personal cartilage back. And within a few months, our gel has been resolved, is replaced by native cartilage, and the patient has his finger fully functioning joint back. Now that's an animation that's obviously easy to make, we want to see real proof we have found that proof in horses. Why horses you might ask. The horses knee has cartilage which looks a lot like that of humans, the animal is slightly heavier, so the forces on it are higher and average the conservative model. In the middle picture, you see that RDL very nicely follows all the contours of the defect with no open spaces. It is a porous structure. And on the right hand side you see that indeed within two weeks color sights already appear inside our gel. After three months, most of the gel is gone. And we have a very smooth layer of nice cartilage which contrasts rather sharply to be the rather rough mess that a micro fracturing will have given. Analyzing numerically, the cartilage after seven months, you see that we vastly outperformed the microfracture and the debridement and the scores that we have For our country, vive hydrogel implant, is equal to preclinical data from, from cell based technologies. So indeed, we have succeeded in matching that quality. So in short, we have a technology that satisfies the unmet needs of basically everyone in the value chain. It's easy to use for, for surgeons. The quality of tissue for patients is very good in a painless surgery with a lasting effect, and very affordable. That's not only my opinion, I can imagine you think I might be a little bit biased. It's also the opinion of a number of our stakeholders in the field, from science, leading clinicians, both in Europe and the US. And something we're very proud of very notably also from patients. We are strongly backed by the Dutch arthritis society, not only in their broad support, but they actually also enabled the series a investment that we had five years ago, and leave that investment. We were basically capable of building the team. And starting our true development. We're very happy that our scientific founders, Dr. Sanjay, both and professor, Masako, Perine are still within our company. And they've been complemented with a management team coming from industry. And as you see, we have a very nice, diverse team. It's diverse in nationalities, in skills, in gender, and in ages, we have Gen Z and baby boomers merrily working together on our tasks. And they've done a very good job in the past couple of years. Two years ago, we received the EIC accelerator award a two and a half million euro grant, a three and a half million euro equity for our upcoming financing round. We reached our ISO certification filed new IP, we have successfully completed our first in human study. The results are still under embargo. They will be published later this year. But I can already tell you that we have far exceeded the targets that we have stated. We're currently continuing in the pivotal part of the trial, just a few patients to go we believe we will finish treating all the patients before the summer. Last year, we also received FDA breakthrough designation, which helps us a lot with our core focus. And that is really working towards market access in the US. We are currently scoping the clinical trial, expect to have to be able to submit IDE before the end of this year. And then take roughly one and a half year to create a protocol contract all the sides. So we believe that the first US patients will be treated early 2006 2026. Sorry. Alongside that we obviously continue with our European trial, expect CE mark early 2,026th, after which we will start commercializing and we're going to try to combine the reimbursement trials with our US rail to save some of that costs to bridge the gap to the middle of 2026. And to reach those milestones. We have currently started to raise our Series V for 10 million. And obviously, two years from now I will then come back for the follow on to do the full clinical trial in the US which will probably another 30 million. For many years, people thought that cartilage could not regenerate. Cartilage could not be built back. I believe we have shown that that myth has been busted. Cartilage can regenerate your own cells can rebuild your cartilage which what you have to do, you have to provide yourself with the right scaffold the right environment, a nutritious environment for them to propagate and do what they can do best. cartilage repair is probably for orthopedics. Something like the final frontier, that whole industry is based on joint replacement. And we basically don't want that we want to preserve joints, to make sure that you can live on with your own tissues. So that's the final frontier that is what we try to reach we are on a journey to reach that. And if you like our story, if you like our approach, then I invite you to come to me and see where we can work together. Thank you