Video Transcription
Karianne Lindenhovius 00:03
I'm going to tell you more about ArthroSave and about our proven breakthrough approach in joint preservation. I think that I know I don't need to tell you that we have a huge challenge in the treatment of osteoarthritis. This is a large group of patients that is growing every year, and it will be the number one chronic disease in 2040 and on. Osteoarthritis, the most common type, is knee osteoarthritis. These patients have a damaged, very painful knee joint due to the fact that there is a loss of cartilage. What we see is that the most effective treatment today is knee replacement with an artificial knee joint, but osteoarthritis with this type of treatment is causing a major socio-economic health issue. It costs us as a society a lot of money, and when we look at the figures, we see that yearly in the seven major markets, 1.7 million patients are undergoing a knee replacement. That's the thing, because a knee replacement, an artificial joint, has a limited lifespan, and that results in failure. In the end, the knee joint needs to be replaced by revision surgery, which is expensive and often invalidating. So we need to postpone this knee replacement for years, especially because what we see in research published in The Lancet is that for patients who are relatively young, for example, under the age of 60 years, the time to survival to a revision replacement after a knee replacement is only five years. It's actually less than five years. So we have a serious treatment gap, and the gap is for 900,000 patients a year because these patients are too young for the first knee replacement. We really need to postpone that first knee replacement. What we see is that there is real fast potential for regenerative techniques and devices in this surgical area, and looking at the ArthroSave solution, this reflects a 2 billion market opportunity as an annual serviceable market. And why? Why is ArthroSave the team that can try to solve this problem? Why are we the ones that can make a success out of it? My name is Karianne Lindenhovius. I'm the CEO and co-founder of ArthroSave, and I have a background in medical technology. I stand by the Medical Technology Innovation Center in an academic hospital in the Netherlands, and that was meant to bring academic knowledge into tangible commercial products for patients and for healthcare. And guess what? My favorite innovation I was working on was in joint preservation. That was about cartilage repair, and that was an invention by Dr. Peter von Rummens. He is my CMO and co-founder of the company. He is the one who has the medical surgical experience, and very important to my company is Tim Ovan Din. He's my commercial officer, and he has over 25 years of experience in the commercialization of medical devices in the big orthopedic companies. So we are the ones that can change this world in joint preservation. This is Carlo. Carlo is an active patient suffering from knee osteoarthritis, so he has daily pain, and he is limited in what he can do while he's quite active. He wants to have a solution for that. But you see his age; he is way too young for a knee replacement, so ArthroSave has a solution for that. We have developed a Knee Reviver enabling knee joint distraction. We put the Knee Reviver on the outside of the knee joint and distract the knee joint for a few millimeters. We unload it, and by unloading, we initiate cartilage repair and joint tissue repair. It's a temporary treatment of only six weeks, and during the six weeks, research shows us that we stimulate an intermittent fluid pressure change, which actually takes care of the nutrition of the cartilage. We have gained quite a bit of clinical evidence. It's a proven treatment. We have done 250 patients over the years in seven clinical trials. What we see is, maybe the most important, is the clinical benefit. We see significant reduction of pain and significant improvement of function. What you can see in the images is from the top to the bottom, the change before knee joint distraction with the Knee Reviver and years afterward. We create a joint space that was not there anymore, but it is there again. That means that there is something in between, and that's what you can see on the MRI; that is cartilage. But the most important is the effect of all of this, and that is that we have a survival of 81% after five years, which means that five years after our treatment, 81% of the patients still have their own natural knee, and after nine years, it is still 48%. So we have long-term clinical follow-up data, and it's proven to be a cost-effective solution. I'm not a scientist, so I always avoid showing too many details, graphs, and figures. But this is something that I would like to show you because this is what everyone says is not possible, and we show it is possible. What we see here is the growth in cartilage thickness. So at point zero is the moment before the treatment. You have small cartilage thickness. Within one year, it increases and stays quite stable over the years. It decreases over time, but still, after 10 years, you have more cartilage thickness than you had before the treatment. So where we are today, we have a validated design, clinically validated, and we have organized our supply chain. The product is CE certified. We have owned different patents, three patent families, and we are preparing for the NoVo pathway in the US. We are having market access. We have pre-sales of 250 Knee Revivers in Europe. We started a pilot program in Germany, and this year we started the first reimbursement trial. It's in the Netherlands. It's an RCT with 1,200 patients. Looking at our funding pathway, we are originally a spin-off company from the University Medical Center in Utrecht, and we have gained funding for different phases, from technical development to clinical validation, and now we are currently working on our market access by getting access to different European countries for our next funding round. We are focusing on getting the treatment reimbursed to really fulfill our market access strategy and to create stable EU market presence. In parallel, we prepare ourselves for the FDA in the US for market entrance over there. So we invite investors to invest with us in the future of joint preservation. Looking in more detail, we are looking for an investment round of 5 million euros to further commercialize our strategy in Europe for market presence and an additional 8.5 million euros for our activities to create the entrance into the US market. And this is very old. We are doing it for the patients, the happy patients. We have a sustainable solution for many patients. It is unique as it is temporary, it is regenerative, and it is cost-effective. There are many alternative developments on the way, but they are all focusing on early-stage osteoarthritis. Our solution is for the severe, the last stage of osteoarthritis, when the patient is actually ready to get a knee replacement. However, there are many alternative developments going on; there is not enough clinical data yet, and there is no long-term clinical follow-up data. So I invite you to join us. Get involved, contact me, and we will make a success out of it. Thank you.
