Anita Brinks, ATRO Medical - The Artimis® Meniscus Prosthesis | LSI Europe '24

Anita Brinks 00:02
Imagine having knee pain every day, a pain that even makes simple movements difficult. And now imagine having this pain for decades, for millions. It's a reality, but I'm here today to present a solution to take away that pain. I want you to meet Marc. He's a former pro soccer player who had to end his career early because of a meniscus injury. He had surgery, but despite the surgery, the pain persisted. And Lisa, who is a 35-year-old school teacher, shares a similar story. She had meniscus surgery, but her pain never went away. And Marc and Lisa are not alone. 18% of people continue to suffer from knee pain after meniscus surgery, and without any better solutions, Lisa has to endure another 30 years of living in this pain until she's 65 years old and eligible for knee replacement surgery.

So my name is Anita Brinks, and I'm here to introduce a solution that can change the lives of Marc, Lisa, and countless others. 1.2 million people get meniscus surgery every year across Europe and America, hoping to be free from knee pain. But for over 200,000 of these patients, the reality is far different, and they often have no choice but to change their careers and quit the sports they love. There are treatments like pain medication and physical therapy, but those offer only short-term relief. As for surgical options, there is transplant surgery; however, that's only available for less than 5% of people affected and also has a high risk for additional surgery.

So let me introduce you to Artemis. This is the implant, and what makes Artemis so remarkable? Well, first, it's available just off the shelf, so no more waiting for the right donor. But that's not all. Artemis reduces surgery time by an impressive 50% compared to transplant surgery. So it's not just another treatment option, but a revolutionary solution that makes surgery more efficient, more affordable, and more accessible. Artemis nearly cuts recovery time in half compared to current surgical options. And perhaps even more impressive, pain is greatly reduced after just six weeks. So that's a transformation for patients like Lisa, who can go back to work much sooner than with any other option.

Artemis is protected with six patents, and we have FDA breakthrough device designation. The procedure is straightforward for surgeons to adapt, with a clear and recognizable indication for use. At ATRO Medical, we are pioneering a range of innovative meniscus solutions, and our priority project is the medial meniscus, which is the inner side of the knee, but we're also working on the lateral side, the outer side of the knee, allowing us to treat a wider range of patients. And because every patient is unique, we're also developing a personalized meniscus solution.

So we are now in our second clinical trial. We have 14 patients implanted with our meniscus, and five of them have reached two-year follow-up. We are measuring success in the COS pain score, which assesses pain and knee function, and what we see in our results is that we have significant improvement in pain scores, and patients reach levels similar to those of healthy, pain-free individuals. So that is the 85 points that you see over there. That's similar to what normal, healthy people have, and that's what we score after two years. In knee surgery, even a 10-point improvement is considered a meaningful difference to patients. And we don't just achieve that; we achieve a 34-point improvement. So it's really a huge impact on patients.

So our meniscus not only alleviates pain and restores mobility, but it really has superior outcomes compared to other surgical options. But how interesting is this market? Well, we are entering a blue ocean market, completely untapped. We are the first to come up with a solution by initially focusing on the existing transplant patients. We anticipate a five-fold expansion of the market, and in the longer term, with market expansion and additional indications, we can reach projected turnover to exceed $900 million annually.

So where are we in entering the market? Well, we want to be the first on the market with an artificial meniscus. Our strategy is to go to the US first, as there is a huge opportunity, and we already have a strong network in place over there. Our FDA approval process is on track, and we will initially target the private market, with other markets soon to follow.

So here's our study roadmap, highlighting key value inflection points. We are currently performing our AIR 2 study and preparing for the AIR 2.1 confirmatory study to start later this year. In the meantime, we are also working on our IDE approval and preparing for the pivotal study for the required regulatory approval. As we get our data and secure IDE approval, we will reach several important value inflection points along the way.

So we are actively seeking an investor to join us on this journey. We are now extending our Series A and are preparing for a larger Series B investment. But who are we? We are a dedicated team of nine, all with extensive experience in med tech. Our team consists of Martin von, our Chief Implementation Officer, Tony van Tienen, who is our founder and orthopedic surgeon who founded the company in 2016, and me, Anita Brinks. I am the CEO, ensuring that our vision becomes reality.

We are backed by an international scientific advisory board composed of leaders in meniscus research and surgery. Scott Rodeo, recognized as NFL Doctor of the Year, is one of the key advisors, and he makes sure that no athlete has to endure the challenges that Marc faced. We are also happy to have Andy Wayman, who is also present here today, as one of our advisors. He is the former CMO of Smith and Nephew and brings extensive experience to our company. We collaborate with numerous national and international organizations to bring solutions to the market for patients like Marc and Lisa.

So to summarize, we offer a unique de-risk product that stands apart in the market. There's a proven market need addressing significant unmet demand. Our regulatory pathway is clear, and FDA approval is anticipated within five years. We are a highly experienced team with a strong network of partners ensuring success at all the steps along the way.

So thank you for your time. Today, I would like to invite you to connect and see how we can work together to bring Artemis to patients in need. So my name is Anita Brinks. Here are my contact details. Feel free to grab me during lunch or dinner, and I look forward to talking to you.