Stefano Di Lullo Presents GreenBone Ortho at LSI Europe '23

Transcription

Stefano Di Lullo  0:05  
Good afternoon, everyone. And it's my pleasure to be able to present GreenBone Ortho to you. So GreenBone operates in the 2.8 billion bone replacement market. And so, you know, you might be asking yourself, there's a significant number of competitors that exist today in synthetic bone materials. Why do we need another synthetic bone graft today. And what I hope to show you is that green bone by having looked to nature for inspiration brings a truly innovative solution which addresses some of the significant pain points and unmet clinical needs that still exist today in the marketplace. So what do we mean by being inspired from nature. So, a number of researchers from the Italian National Research Institute kind of went through a discovery process through nature to see if they could find a better solution for bone substitutes, and they came across for rattan wood and found and you can see, if you look at the magnified photo on your left, that rattan wood has an internal architecture of pores longitudinal pores, which almost perfectly mimic what exists in human bone, which is on the middle of magnify magnify structure. So on the basis of that, start, let's say and on the basis of that source material, they then developed a multi step process to convert the wood into a biocompatible ceramic. There is no sintering required in the process, which allows us to maintain the internal structure of the source material. And so, at the end of the day, what you see on the magnified photo on the right, you have a bio ceramic, which is completely mimics the structure of human bone. So, what are the competitive advantages that we bring to the market versus what exists today? Well, first, as I indicated, we have a perfectly biomimetic structure that replaces bone. The hierarchical structure and the architecture of our product really promotes bone healing, by supporting and actually encouraging cell homing, and differentiation because the pores are the same size as human bone pores, it makes it very easy for the cells to repopulate the scaffold. The second piece is that the non sintering process allows us to create a nano crystalline structure. And the addition of magnesium ions and strontium ions which exist in human bone allows us to further accelerate the repopulation of the scaffold, which in turns results in an acceleration of the bone healing process. The third advantage that we bring versus what exists today is we have a truly surgeon Flint friendly implant, the product can be shaped, it can be cut, it can be nailed, it can be screwed, essentially, the surgeon during the procedure can customize the product to the specific patient need. We have a number of different shapes and sizes we have wedges, granules, blocks and cylinders. Today we have MDD CE Mark and we are launched in Italy. And and and in the UK. We will get MDR in the first part of next year. And we will enter by the end of this year, the pre sub phase with the FDA. We do have clinical evidence today there are about 100 patients that have been implanted with our product. And what we've demonstrated is that we effectively treat surgical bone defects. The bone healing is in fact accelerated. The platform and the scaffold supports well organized and well remodeled bone. We avoid donor site complications because you avoid the need to extract the autologous bone from the patient. And the product is obviously totally safe and biocompatible. We want to continue to develop and build more robust clinical evidence. So we are in the process of launching a multi site. prospective clinical study. Sorry. So we're looking to enroll 200 patients in 50 sites in Europe and in the UK. Our principal investigators are Professor Peter Janudas from Leeds and Volkeralt from Germany. And will we be looking at all comers and looking at clinical outcomes one year in terms of bone healing. We have a couple of papers that have come out this year, which support our claims. And we are expecting another two or three papers to come out before the end of the year. So where are we today? Today, we've raised a total to date of 22 million euros. Our priorities over the next couple of years are to continue to build out our clinical evidence and ensure that we have the most robust clinical evidence possible to obtain MDR and FDA approval. We need to continue to grow our and expand geographically beyond Italy in the UK. And we are also looking to expand our indication into spinal fusion. We have an experienced international team that has a significant experience in medical devices and in orthopedics. And we're also supported by a world class clinical advisory board with key opinion leaders from all around Europe, the UK, Germany, Zurich, Paris, etc. So in summary, what I'd like to tell you is GreenBone is providing to the market today, a truly innovative solution for bone healing, based on the fact that we are delivering a perfectly biomimetic bioactive and patient specific solution to bone healing. Thanks for your attention.