Monica Wellejus, Ossiform - 3D Printed Resorbable Bone Implants | LSI USA '24

Monica Wellejus  0:03  
Hi everyone. I'm very excited to be here today to present Ossiform, a pioneering bone printing company. And as you form we have a proven technology and value proposition. And we're already supplying research products to laboratories worldwide. Currently, we are anticipating FDA clearance of our first bone implant for orthopedic extremity surgery this spring. And meanwhile, we are developing the next generation of resolvable spinal fusion devices, as well as bone printing point of care setups. And so we are here to meet with investors and strategics, who want to be part of this exciting venture as we're about to enter the US market this year, with the aim of investment enhancing bone healing outcomes within ortho and spine. Today, more than 4 million bone implants are inserted globally each year and an additional 1.3 million procedures utilize autographs where bone is harvested from the patient. Auto grafting is still the gold standard because surgeons need the biology to heal bone. But it comes with several drawbacks including limited supply and prolonged recovery. And this leads to a high demand for better bone graft substitutes. Now when surgeons want something that naturally integrates with the patient's bone, they can use donor bone or ceramic grafts. However, these tend to collapse, fracture and degrade too quickly making them highly unreliable. And therefore surgeons are highly reliant on metal because they need the structure. And while a lot of progress has happened to achieve better bone in growth into porous metal, it still comes with high risk of infections, re surgeries and tissue damage because metal is not natural. And because metal is much harder than bone. For example, if you're upgrading a child whose bones are still growing, or any patient where risk needing to take out the metal, again, metal is not optimal. Another challenge today is that medicine or implants are generally delivered in a few standard sizes. And I'm sure many of you have experienced this before. Depending on the shoe brand, you may not exactly be a size seven or a size eight, a seven and a half would be perfect. But that's not a standard offering. So like with shoes, many patients are between sizes when it comes to implants. And therefore the surgeon may need to modify your bone to fit the metal. And that just sounds wrong right? Or if the implant is modifiable like a ceramic block, the surgeon must spend precious time doing that in the O R. And again, the issue with these current ceramic solutions is that they lack structural support. So what do you do? What we've done at assay form is we've taken the widely recognized ceramic material beta tricalcium phosphate, and we developed a 3d printing technique to give it shape and structure. The material has been used clinically for the past 40 years primarily in non structural forms like paste but also molded blocks. Our bodies recognize the material as bone, so it carries minimal risk of complications and it remodels into natural bone over time. So we take this remmick powder and mix it with fatty acid which makes it printable. And once an implant is printed, we burn off the fatty acid through sintering and the entire production takes one day. Now we can precisely control the structure and resorption rates of our implants to match the specific demands of diversified applications. For every indication there is an ideal trade off a sweet spot between the porosity that enables good bone and growth and controls how fast the implant resolves and the biomechanical factors that ensure structural stability throughout the healing process. This is what we specialize in adults form hitting that sweet spot. And furthermore, what we want to do is to provide more size flexibility will provide surgeons with more size options to fit more patients both small and large, and will provide them with a metal free solution that they have confidence in both in the short and long term. So how do we know that it works? We've done extensive preclinical testing, all with very positive results. And very recently, we submitted our first application to the FDA. And anticipating approval this spring, we are poised to commence our first clinical study later this year, a post market study in extremity surgery. Our total addressable market is estimated at $11.9 billion and consists of the global bone grafts and substitutes market and the global spinal fusion devices market. And we're targeting the US extremity market first because it offers high demand for novel structural solutions like ours, and it also provides us with a stepping stone to launch the next generation of resolvable spinal fusion devices. The potential of our technology extends beyond pure implant provision, we are actually working to democratize bone printing by making our solution solution available and scalable for hospitals worldwide. Our patented material enables reconstruction of bone in virtually all areas of the human body and we are collaborating with, with printing companies to establish this book bone printing solution at the point of care, which has already been validated on several printer setups. Today, we are in the fortunate situation that we have cleanroom production and quality management system established. We have a worldwide IP portfolio, a highly experienced team that I'll present in a minute collaborations with key opinion leaders from esteemed clinical institutions. And we have raised $10.77 million so far through seed and a round. So looking ahead, as I mentioned later this year, we expect to initiate our first clinical study a post market study which is part of the market adoption activities for our first orthopedic extremities implants. Then in 25, we expect to launch our first bone printing hub at the point of care, first in Asia. And this business area will allow us to expand our technology in the APEC region fairly quickly. And further out in the future also in in in the US and Europe. And meanwhile, we are expecting to launch our first spine product in the US as the first market in 26. With subsequent expansion into more regions. To get there, we are now seeking $22 million. And this funding round will help us drive the commercialization of our first medical device in the US. It will help us establish as you form on us grounds including with the state of the art production, grow the organization obtain further IP protection and partnerships and not least get to market with our first spine product. Our team I have the pleasure of being here at LSI together with our talented CEO Tia will woloson former CEO of BioPortal. On the team we also have minimally Hallel as our chairman, former VP at Medtronic and among our primary clinical advisors, we have Jose Canseco spine surgeon from the Rothman Institute. So Medtronic a key opinion leader in the shoulder and elbow space based in Australia and our infant cradle to trauma surgeon that works at Brigham and Women's Hospital in Boston. This was all from me and as for thank you so much for your attention and please feel free to grab me and tear if you want to. If you want to connect