Video Transcription
Virpi Muhonen 00:02
So hi. Great to see you all here. So I'm Virpi Muhonen. I'm the CEO and founder of Askel Healthcare. So who we are? We are a clinical phase medical device startup from Helsinki, Finland. We have 10 full-time employees, and we have raised 10 million so far: 6 million in seed funding and 4 million in non-dilutive funding. Of course, we have patented technology, but we also produce our product in-house, so we have a lot of trade secrets covering it. Well, I will talk about the market later, but everybody here who knows anything about osteoarthritis and cartilage repair knows that it is a huge problem globally, and we are now raising 20 million in Series A. But first, I want to introduce you to one of our patients, Tina. Tina is a 42-year-old woman with an active lifestyle. She loves skiing, playing tennis, you name it. She isn't a professional athlete, but she could be described more or less as an active adult. Unfortunately, she had a knee injury while playing tennis, and she was forced to give up all her hobbies because the pain and functional limitations were overwhelming. Of course, she went to see a doctor, and an MRI was taken, and the images revealed a 1.7 square centimeter lesion and a loose piece of cartilage in her joint cavity. So the reason for her pain and discomfort was found. So how is Tina's future actually looking like? Her problem is kind of too vast for these initial pain medications and physiotherapy, these palliative treatments. She is also too advanced for injection therapies like hyaluronic acid injections. So Tina needs a surgical intervention for her knee; she has a few options. There could be a debridement operation, which is basically cleaning all that damaged tissue out of her knee, or going through microfracturing, which is actually the most used treatment. So it's basically the cleaning, but the surgeon makes small holes in the bone underneath the cartilage to release blood and bone marrow elements that can create scar tissue—not the right type of tissue, but at least some tissue—or small pieces of healthy bone and cartilage could be removed and the lesion filled with those. That's the old procedures. So those are her options. But unfortunately, whatever the surgeon chooses to do, it's not really an optimal solution because these first-line surgical treatments have really poor long-term outcomes, so she will be facing, most likely, another surgical treatment later, and she also would have few options, but these are either extremely expensive and require two operations, like the MACI operations, or rely on organ donor materials, which are not really accessible all the time. And then later on, when these fail, she would be facing a total knee replacement at quite an early age. So how can we help her and everybody else suffering from this problem? We have developed a cartilage implant called CopLA. It is, of course, simple to use off the shelf; these are kind of like basic parameters you need to have if you want to treat the vast amount of patients who are suffering from this problem as early as possible in that first-line treatment category. But CopLA has been designed to actually allow immediate full weight-bearing for the patient. So this is really different because that allows the patients to actually start utilizing the leg, so the patients don't need to go weeks and weeks and weeks with partial weight-bearing. The patients love it; all our patients have loved it. But actually, in addition to kind of enabling this quick rehabilitation, because it can be more aggressive, because they can actually use the leg immediately, the immediate full weight-bearing, the mechanical loading, together with our implant, creates an environment that the cartilage can actually repair and regenerate, so we can create better quality cartilage. And that is actually the only way we can have long-term outcomes because if you have the wrong type of tissue, it will deteriorate over time because it is in quite a harsh environment. So talking a little bit about the competition, or how does the landscape look like? This is one way of putting it. This is based on the care guidelines in the US. So these first-line surgical treatments, these easy and early, quick and dirty treatments, are for active adults with no OA or osteoarthritis stereotypes. They are for small to medium-sized lesions below three square centimeters. They are affordable, they are accessible, they are the first surgery, they are easy surgery, and they have a short recovery time. And those procedures that are available are debridement and microfracture, which I already explained. Then these more complex and late surgeries, the second-line treatments, are more like revision surgeries. They are for older patients who can already have OA, more large, more complex defects, and they are typically the secondary procedure after the first one has failed. They are high in cost, they are complex, and they have very long recovery times. And those are like the MACI, the cell therapy products, and then the Agile C, and then different allografts. At the moment, the first-line surgical treatments have problems also, so the patients don't actually return to the activity levels that they were having before whatever caused their trouble. So they don't reach the pre-injury level. And also, the results are short-term. So this is where we step in. So CopLA is used as an add-on to microfracturing or debridement, and it kind of solves the problems while keeping all those benefits and being able to treat a massive patient group. And how massive, actually? So there are 750,000 knee cartilage repair surgeries done each year in the US. 600,000 of those are for small and medium-sized defects. This is actually the market we are aiming for. Let's go a little bit back to the tissue we are actually trying to regenerate and heal. So cartilage is a difficult tissue. It doesn't have blood vessels, it doesn't have a lymphatic system, it doesn't repair itself, but you can help that. But one of the key elements of how you can actually do this, and this is from the cell biological perspective, and I'm a cell biologist myself, so this is what I love. So cartilage cannot regenerate without loading. If you unload healthy cartilage, within weeks it starts to degenerate. So the loading is kind of the number one mechanical stimulus for guiding the tissue to cartilage, not scar tissue, and our implant is the only one that can allow that mechanical signal at the right time. That has, of course, a lot of benefits. As I said, fast pain relief, this kind of quick return to activity, quick return to play. Long-term benefits are creating better quality tissue, you have that long-term durability. It's off the shelf, affordable, easy to use, arthroscopic delivery, and from the payer perspective, it is affordable, accessible, and we aim to lower the reoperation rates, the 30% reoperation rate that is seen in the microfracture category at the moment. So we are in the clinical phase. We are running our first in-human trial. We have recruited all 20 patients and are getting really exciting data. We have been able to prove that, well, CopLA is safe to use in humans, and we see already at three months statistically and clinically significant changes. Here, I want to highlight just a kind of sneak peek on the results: the pain and function, the KOOS, which is the standardized patient-reported outcome for cartilage repair. At 12 months, we are hitting almost 100 points, which is the healthy cartilage. And of course, because we are allowing the patients to move, we wanted to measure how they are moving, how much they are moving. And at six weeks, when normally they are basically still with crutches, our patients are actually taking almost 9,000 steps. And what is amazing, why CopLA kind of creates that capability of starting to move is that it takes the pain away. None of the patients used any pain medication at any time. So ever since my co-founder, Anna Maria, and I started the company, we have really focused on building a team that knows those things that we don't know and is capable of executing the milestones as efficiently as possible. And of course, we work with great partners. So what exactly lies ahead? We started the first in-human trial last year; we will start next year with the pivotal trial. We aim for getting market authorization in 2024. A little bit back to Tina, so she was treated with microfracture. She used crutches for four days for balance, and the surgeon gave her permission to run on her six-week follow-up visit, and her MRI supported the good feeling that she is recovering well. So of course, our mission is to help Tina and everybody else suffering from painful cartilage lesions, and that's why we are raising the 20 million to carry out our pivotal trial for market authorizations, both in the US and in Europe. Thank you.
