Maarten van der Zanden, ATRO Medical - Flexible Artificial Meniscus | LSI USA '24

Maarten van der Zanden  0:03  
The question I get most these days is sort of first meniscus replacement. How on earth is it possible that it's not out there yet everyone knows people with meniscus issues. But if you put something in the knee joints, it grinds it and spits it out if it's not meant to be there. So you need to be anatomical which our device is and needs to be material which is slippery, and strong, and flexible and combination that we have in our product. I need to iterate, iterate, and iterate. So we started in 2006. I was there in the first brainstorming session about our device to 10 years in academia before starting the company by Dr. Tony van tienen and 2018. We were able to put it in human for the first time. And we had a study which we stopped our five patients because the implant failed in four out of five. So we had not a successful first inhuman, or we had lots of learnings. So we iterated we changed the design, we changed the fixation, we changed the surgical procedure, got FDA breakthrough designation and went back in. So second clinical study is now underway. We're getting the first two year data points. And it looks really good to patient I'm doing well. We've learned learn a lot to market size. Everyone agrees with fu j&j our track. So this is a market that is available that is out there. And it's it's not being harvested yet because there's no solution. So automatic team, myself, I've done multiple successful launches in radiotherapy in IPD. And in orthopedics, design, hip implants, knee instrumentation, etc. It's only continuing, he's our orthopedic surgeon, the founder, the inventor of the implant. He is a an opinion leader in Europe, presenting us as well as meniscus expert. And Anita, our CEO, she's really took a lot of experience from Medtronic to our company and operations and commercialization. And together with the other six ft in our team and engineering and clinical finance, we're able to get this to market. So what do we work on, we work on the post mastectomy pain syndrome is a debilitating disease. So if you have your pristine meniscus, it's a great shock absorber in your knee. If you tear it, you may need to repair it repair fails and it's painful. You will get a mastectomy over 1 million meniscectomy is being performed in US and Europe each year. So you take part of the meniscus away or the entire meniscus. And if it doesn't work, you have chronic pain. And at severe pain, it's great three or four out of four. So it's really debilitating. You can't do your job anymore to groceries in normal way. And then to fix it, you will think there would be a surgical solution but there's not there's a huge treatment gap. Just 5% of the eligible patients have a surgical solution to nine five do not. So that's the tremendous surgical treatment gap that we see for meniscus. And you can do injections you can do temporary relief by bracing physical therapy, but it's ineffective in the long term. Then we have solutions which are surgical, but you're impractical. Like the ministry aircraft and sanitation is beautiful biological solution but it has matching issues logistics and long war time. Rehabilitation is typically very long and you have a high reputation risk. Same goes for reparation risk of the competitive device that was out there because it got an FDA denial, and I believe it filed for bankruptcy very recently. So what do we do we are presenting the Artemis Mrs. prosthesis, a flexible implant nature inspired geometry, nature inspired fixation and a very flexible implant from a DSM material bio Nate, it expands if the forces get too high, it gets out of the way so it doesn't get destroyed but it's still absorbs the shock that's given this is a 5 million cycle. You've heard it before in this talk. This is a gait analysis that we do based on ISO standard. This is really worst case for a meniscus implant and it survives. We've also demonstrated pain relief. So you see the graph going up means pain is going down. There's pain relief. The dashed line is the minimal clinically important difference. So we're way above that. This is 12 month data. Last week, the first 24 months came in draw this is our best patient so he's over over 90 points. So that's tremendous pain relief. And this is the video the clinicians like most Is it six weeks only after surgery, the nice stable, it's calm, there's no fusion, this patient is doing great at six weeks already. So to Blue Ocean market, there's no solution yet out there, the market is large. And if you start with the telegraph market, you can expand that we have FDA NC E is a market of for hundreds million dollars per year. And on the long term if you add Brazil, Japan Korea, you'll outperform the 600 million. So development stage where are we We're at design freeze so the design is clinically validated. We have full design controls for all the material going into the body and the surgical tools are ours. And all IP is ours as well. We have three patent granted we have three, which are on the way, regulatory we have FDA breakthrough designation, we have the pathway clear to five think a de novo, a study design, which has been agreed upon by the FDA and a great us regulatory adviser, Max's medical. We've also been working on the market access because we realize that there's no reimbursement out there yet for this device. But we had roundtable discussions with CMS with Cigna, Aetna blue blueclaws, Cross Blue Shield, we've evolved us key opinion leaders. So Hospital for Special Surgery, Mayo Clinic, Brigham Women's UPMC, they're all involved. And we're aligning our pivotal study to meet the clinical needs, the reimbursement needs and the FDA needs. We have a great help. In the former CMO of Smith Nephew, he's really helping us out as an advisor, and me personally as well. So we are underway for our starting up the air three study. So the next clinical study, we start out in the Netherlands and rest of Europe and add us to it to reach FDA approval and an exit. So this is what are we building with JIRA scared because we have trained physicians in the Netherlands that can train Europeans and Europeans can train us guys. So we're decreasing the learning curve and trying to get as smoothly as possible to the end result. current funding we've raised 14 million in total in Grants Loans equity, we have still about 4 billion to spend. Because it's it's milestone based grants, for example, use proceeds look look like you would expect probably so r&d, the team and clinical is largest chunk of it. We have a burn rate of 300k per month, we have runway and so next year, we're looking to raise $25 million towards that exit. So the exit strategy is be the number one like we duchies know, if you're leading the race, how not to overtake, someone will let you have take you. So we're engaged in key opinion leaders in Europe and US. We are involving the users so patient organizations, physical therapists, and the strategic obviously so all strategics they are aware of what we're doing. We met them last month in at a WS meeting to Altra exchange J Smith Nephew. And I agree that probably we will be sold upon FDA approval. We've seen it before for example a car dealers great example recently that was sold upon FDA approval, so no commercialization yet, but still an asset so we target 2028 as our exit and it's almost five years from now. If we look now five years back, that's why the mattress happened hats our implant for the first time he likes it, and he's aware of what we're doing as well. We really invite you and allowed us to get involved. To get in touch with me. I'm Martin from the zone are companies at dramatical and we will change meniscus replacement. Thank you