Florian Coppers Presents Medical Magnesium at LSI USA ‘23

Transcription

Florian Coppers  0:05  

Hello, my name is Florian, co founder and CEO of Medical Magnesium. It's a pleasure to be here today. Imagine you have a knee injury in which you have a joint your fracture. And chances are very high that after first painful surgery and an implantation of a permanent metal implant, you will most likely go undergo a second major surgery like this one. It will take you several months to get back on your feet and additionally, it's a very expensive burden to every healthcare system around the globe. More than 4 million similar surgeries are performed per year to remove permanent implant material in the US and Europe alone. So the question is, why isn't there any implant material around that disappears after the bones here without any such removal surgery, titanium or steel are not bio absorbable and existing polymer solutions lack the mechanical strength for most of the applications. Medical Magnesium overcame this technology get by combining a medical grade magnesium alloy together with a patented surface conversion to create an implant platform that we call MMX. And therefore, our implants combined the best of both worlds stability of a metal and bio absorption in a controlled manner. We are already commercial in Europe. So far we have performed over 400 cases. We are implanting about five implants a day and we are on track to double this figure in the next three months. Innovation in the orthopedic fixation market over the past 20 years has been rather incremental and introducing another class of implants into this market requires a lot of solid clinical evidence. At the moment we are enrolling over 180 patients in three different multicenter clinical studies with good preliminary results backed by solid real world evidence and this led to over 30 Paying hospitals so far that all use our implants on a regular basis mostly for elective forefoot surgeries but also for joining of fractures. Here for example, you can see a joint your fracture treated with our compression screws, which is a focus device. With this implant, we could avoid a second intervention of a 14 year old femer patients because surgeons still rely on removing titanium implants as part of the standard of care. Because of the elimination of the removal surgery and the formation of new bone tissue, medical magnesium addresses a clear clinical need a single surgery therapy using our implants offers a unique value proposition to every healthcare stakeholder. We're enabling surgeons to provide superior and value based outcomes because our implants either reduce the healing phase behalf when in any case, they restore the natural state of the bone come on, no one and I really mean this. No one wants to go under the knife a second time. And of course we significantly improved in the total cost of care. The cost saving potential for a joint fractures is staggering 44%. Or to put it in the words without assertions, these very compelling arguments were supported by leading European surgeons. Daniel Gunther, for example is among the top three surgeons in Germany to perform joint fractures, he converted to using our implants and as part of our Clinical Advisory Board, the clinical performance of this product is good and thus we are very confident to become market leader for joint new fractures in our home market in 2025. When we look at the addressable market, we always concentrate on indications in which our products are solving the biggest unmet clinical need. We found product market fit in our beachhead market joint fractures. And the next market where we solve an unmet clinical need is pediatric surgery, a market in which almost every permanent implant material needs to be removed any second intervention. Using our implants means eliminating the unnecessary risk of infection risk of anesthesia since avoiding the mental trauma your child would have to go through in a second time. And adding up to a market size of 7.4 billion USD we're already got products approved and available to tackle unmet clinical needs in the market for Foot and Ankle trauma and Sports Med. Our portfolio serves multiple clinical needs all over the body. Our compression screw is for soft tissue as is for cartilage fixation and for bone fixation, and is a FDA breakthrough device. The MNPRP for hematol correction in the MMRF for ACL reconstructions are both high volume products they already approved and commercialized in Europe. still in development or mn Fix n mn plate, a medical magnesium suture anchor and a fracture plate system that already showed good preclinical results and also is the first and only of its kind in breakthrough device. This year we will sell about 2000 units of our focused product decompression screw NMCs. This quarter alone, we are at 37% above or OPlan. We are growing 30% on a monthly basis through our direct sales force, and we are on track to deliver on a revenue goal of over half a million. Additionally, we signed two major agreements with the orthopedic industry one to commercialize in the foot and ankle market and another one to develop a product in sports medicine. The clinical demand for a stronger bioabsorbable solution in the orthopedic fixation market is evident when you look at the competitive landscape. OSU has managed to raise over 70 million in a very attractive market and to get on to 10 million in sales in the last year, they are tackling the same indications as Medical Magnesium. And well, when you look at the material, we were twice as strong, and since the material has some favorable features such as good X ray visibility, we are very keen to grab a good piece of the market once we receive FDA approval. We are team of 20 that is eagerly working towards a vision to significantly improve surgical cell therapy. We got all what it takes to bring class three medical devices onto the market. We've already approved three class III medical devices and ran three clinical trials. Medical magnesium is set up to expand to the starting with the MMCs. This product is a FDA breakthrough device and the clinical strategy will be aligned with the FDA in the next six months. In order to get to US market will focus on two very important things running a clinical trial. We already have a clinical protocol validated by US and American surgeons, we got to budget a timeline to enroll the first patient in early 2024. And second, to me that is most importantly, engaging with us key opinion leader early on. There's nothing more important than a surgeon telling another surgeon This is solving an actual problem that I'm having. And for this we will leverage our European key opinion reader to act as ambassadors combined with the high number of already performed cases to win surgeons in before we obtain approval. From a financial perspective, the US expansion room materialized and 2026. At this time, the one time investment for clinical approval and about also for the ongoing PMCF studies in Europe will pay off to M for breakeven in the same year. We're looking for funding of 7 million to get to years approval with the first product in 2026. And to further scale the business in Europe. We're looking out for investors who love this as much as we do and who want to join our mission to support surgeons on a global scale. By the way, 2 million are already committed by existing investors. Thank you very much and join us so that no one must unnecessarily go under the knife a second time