Virpi Muhonen presented Askel Healthcare at LSI USA ‘24

Virpi Muhonen  0:04  
Hi. Good morning. It's absolutely great to be here. I'm Virpi Muhonen. I'm the CEO and co founder of Askel healthcare. So we are a clinical stage orthopedic or sports medicine company from Helsinki Finland. We are addressing the unmet clinical and market need of treating these severe and poor healing cartilage lesions, and we are in the clinical phase collecting evidence for our lead product, Gopal cartilage implant. And of course, we target do a great exit when the time is right. But first, I want to introduce you to Tina with two eyes, because she's a fin. Tina is an active person. She's a 42 years old. She loves skiing, riding, horses, running, etc. Unfortunately, she suffered a trauma technique injury when she was playing tennis, and all this pain caused her to not being able to continuing to doing the sport she loves. She went to see a doctor, and an MRI was taken, and that MRI revealed that there was 1.7 centimeter lesion in her knee joint and also a loose body in her joint cavity. So what's going to happen to Tina? So we know that these cartilage lesions, if they are not treated, they get traversed, and they basically the patients end up of having osteoarthritis, so this degenerative joint disease, and we don't want that to happen to Tina, of course, but it's too late for these pain medications, injections and so forth. So Tina will need a surgery. She will have few options, so the surgeon can choose to have this kind of a cleaning procedure, so just taking off this kind of impacted cartilage, or she can have her under the subcontract, bone perforated, and that will release this kind of bone marrow elements that will be capable of producing scar tissue, and that's called micro fracturing, or she can have these healthy cortiles blocks removed from her other part of her joint and filled the lesion. And that's called the oats procedure. Unfortunately, all these first line surgical treatments have poor long term outcomes. So Nina will Tina will need to go through another operation later, most likely this second line operation, she will have few options, also having these cell therapies that take two operations and are quite expensive, or she will have an allocraft operation, which is limited to the organ donor materials. This is the most crowded place in the market. There's a few companies and products as an example. And then these products also have their problems, and they tend to have very, very long rehabilitation periods. And when time goes by, they also fail at some point. And in that point, Dina would be eligible for total knee but we need to remember that at the time of the accident, she was only 42 years old, so even though it would take 10 years from the first surgery the total joint replacement, she would only be 52 and that's still Too Young from a total arthroplasty. But Tina isn't alone with this problem. If all of us would went through a knee atroscopy, 1/3 of us would be diagnosed with a cartolysis lesion in here, in the US, there are 750,000 cortilous repair operations, knee cortisol repair operations, done every year, and 600 of 1000 of these are these first line treatments, these cleaning procedures and the micro drilling procedures. And we focus on that patient population. We focus on making that whole category of surgery better. How do we do that? So our product is called cop lacartes implant. It's made of biodegradable polymers, and it creates this three dimensional environment that allows cortals tissue to heal. It allows the patients to immediately bear weight. And by that, I mean there's no weight bearing restrictions. After the operation, the patient is ready and free to move the leg immediately, as much as she or he wants to. Of course, this is super convenient for the patient. It leads the rehabilitation, It fastens the pain reduction. But what is even more important is that it actually creates this kind of environment for cortex tissue to heal, because the mechanical loading is the key signal for cartilage to regenerate, and without that, we will end up having scar tissue. So it's really key for the long term results. If we don't get good quality tissue, we will not get good long term results. In addition to these copies, it's crazily easy to use. It can be test. Stacked. It can be just cut with sutures. It can be delivered atroscopically in open surgery. It's just simple. We produce it in house with a really nice cross marching already. It's protected by patents and trade secrets. It has the breakthrough device designation by the FDA and what is kind of the best part is that we have clinical evidence to support what I just said. So we have brought copla from Academic Innovation to patients. So we have done a lot of in vivo studies, both experimental and also clinical. We have done all those biocompatibility testings and bench testing and you name it, built the in house manufacturing to prove that GOP is safe to use in humans. So we have a clinical trial ongoing at the moment, and it's going on really well. So 15 patients have been operated. We target to have 20 patients. We will follow them for two years, but the safety will be proven from the first 10 patients six months results, and that we will have in June. And I chose to have this quite exciting data point here. This is the average steps taken by the patients. And what is really amazing is that on six week six, the patients are already taking almost 9000 steps. So in the other methods, they would be allowed to have basically their first scratch free steps. So this is something that we are really, really interested about. And also, when we look at the most used patient reported outcome measure, a coups, we can also see that the patients are doing super well, and as Professor Matt spritter says, he's expecting to have good long term results. And those of you who don't know him, he's the father of cell therapies for cardist repair, and we are, of course, super proud to have him in our advisory board ever since Anne Marie and I started a company seven years ago, we have been focusing on building a team that knows what lies ahead and is really capable of effectively doing every milestone that lies ahead but what actually lies ahead. So we started the first in human pilot last year, and we will start the pivotal trial for market authorization next year. We will still do one animal study to get the IDE and we will enroll first the patients for the pivotal in Europe, and they will and then follow with the US patients doing the same trial, and we expect to have the FDA clearance by 2013 so what happened to Tina? So she participated in the copla trial. So she was treated with micro fracturing and copla she used scratches only for four days for balance, and on the six week follow up visit, the surgeon gave her the freedom to start running again, and these MRI images really support her good feeling and the fact that she's capable of continuing with all the sports that she loves. So our mission is to keep Tina and of course, everybody else suffering from painful cartilage lesions in motion. So we are raising a 10 million series A we have this EIC accelerator blended finance. So we have been granted two and a half million grand and a 5 million equity option to support this a round. So we are now looking for one or two lead investors to join this round. And before I go, of course, I want to thank you. But also I want to teach you one word in Finnish so askel It means a step. So let's take a step together to help all these millions of patients who are suffering from painful cartilage lesions. Thank you and enjoy your day. Thank.