Leo Smit Presents Hy2Care at LSI Europe '23

Transcription

Leo Smit  0:05  
Hello, my name is Leo Smit, I'm CEO of Hy2Care, I'd like to tell you about a new avenue for cartilage repair. And the journey of our company started with one of our founders and I'd like to briefly let her explain what motivates our team

Video playing  0:27  
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 emotionally Ploesti. Unfortunately, it did not last, and my pain returned. I know that someday I will need a joint replacements. Each year, 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 Hy2Care to develop a better cartilage repair solution for people like me.

Leo Smit  1:09  
So two and a half million people every year are treated with a cartilage repair surgery. And within one, three, sometimes five years, a lot of them have to go back to the surgeon for a secondary operation and sometimes a third operation and gradually they develop osteoarthritis, a joint degenerative disease, which gives them years of pain, disability and cost society an awful lot of money. Now, why is that shall we think if you look at current treatments than the standard of care methods, debridement micro fracturing, they don't really create cartilage tissue. What happens in fact is that after the surgery, fibrous tissue is being created scar tissue that over time will fall out again and give problems. Now, there are methods that are much better, which you see on the left side, for instance, cell implantation technologies. But these are very, very expensive technologies and therefore cost prohibitive, often not reimbursed in several countries. So we were looking for solving this this problem of creating optimal cartilage tissue, but at an affordable cost. And that is where cart revive or hydrogel implant comes into play. It is an implant that consists of materials that natively are occurring already in the joints, so they form a perfect surrounding to create new cartilage. And in this video, you see in this animation, you see a glimpse of how we see the future. You're in the weekend, you've hurt your knee, and over time you come to your surgeon who will then do an arthroscopy to get a better view of what a defect looks like. And if it is applicable, then the surgeon can basically solve this immediately by bringing in the implant, basically the precursor of the implants to polymers, that will be brought in and nicely filled the entire defect in all its corners. And directly during the surgery within a minute, the polymers in this implant will start to crosslink and form a solidification of solidified implants. And more importantly, this crosslinking also takes place with the surrounding tissue. So here we have an implant that basically fixates glues itself to the body. It's a very open structure, and the cartilage building cells, the Congress sides from the environment can quickly move in. And once they are populating the gel, then they do what they do, they multiply and start building new personal tissue for the patients within a few months. Basically, the joint is fully functioning again. Now, a video animation is easy. You of course have to get get proof and then we come to horses, why horses or horses have similar cartilage yet, you and I. But obviously, the animals are a little bit heavier, so the loads are much higher. So it's a conservative model for cartilage repair surgeries. And here you see the effect of the filling of our hydrogel, in the defect of the horse and the open structure that is created within a minute. You'll also see our statement that within two weeks already Condor sites are available in the hydrogel. And after three months, you see a beautiful tissue being created here very smooth cartilage and contrasting sharply with the standard of care. The fibrous tissue that microfracture fracture creates after several months, numerical scores show that the car to revive hydrogel beats standard of care with great strides and actually the numbers that we We've obtained are at par with the best in class cell based technologies, yet for a very affordable price. So basically what we have is a new implant to repair cartilage, which is easy to use for pay for surgeons gives good tooth tissue and long lasting effects for patients and still very affordable. I'm not biased I work for the company. But we've also gotten a lot of kudos from the experts in the field. And people from science, leading clinicians support us, but very, very prominently also patients with Bucha try the society is strong and standing strongly behind us and they actually are a partner in high tech care. We're lucky that the original inventors and founders Professor Masaka Perine, doctors on the bottom are still with us. They continue to share with us their insights into science and their fast network. They've been complimented with a strategic management team that's really complimentary because they have a fully industrial background. And we all have a track record in orthopedics and joint preservation technologies. Now with our team, we've been able to reach some very nice milestones in the past 15 months. Last year, we received the EIC accelerator Award, which gives us a grant, but also part of the upcoming equity that we need. We have finalized the first steps of our quality system and approved, we filed a new pattern. But most importantly of all, we started our clinical trial have finished the first cohort of safety patients in a successful way. And we're currently treating the patients for our pivotal part. So that brings us to the plans for the future. The clinical trial that we're currently executing in Europe, we intend to finish by 2025. Aim for CE marking 2026 And then we will launch the products commercially in selected countries. In parallel, we have started the discussions with the FDA we've had our pre first pre submission discussion already held, we intend to get IDE by the end of next year, and then further prepare, also to start first US patients in 2026. And for that, we basically are now raising a new Series B 9 million euros for which we want to start us clinical and finish European clinical and start commercialization. For many, many years people have thought that cartilage cannot regenerate it cannot heal. And that in the past decades has been proven wrong. Cartilage can actually revive itself, but you have to give it the right environment, the right conditions to do so. And that is the basic phenomenon of Cartery Five. It is a surgeon friendly, easy to use implants. It's effective for patients long term effect and very affordable. So if you like this journey that we are on, then we would be happy to talk to you and see where we can collaborate. Thank you