GreenBone Ortho | Alastair Clemow, President

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Lorenzo Pradella  0:00  

Good morning. Delighted to be here. I'm not sure whether it's a quirk of scheduling or just fortuitous. But on St. Patrick's Day, it seems appropriate that GreenBone is presenting. So thank you. I am chairman and interim CEO. So in a sense, I'm pitch hitting today. And if anybody has any questions at the end, I'd be glad to try. But I can always fill in later. As most of you are aware, the bone replacement market is essentially that segment of the market, the orthopedic market that attempts to try and reproduce replace repair, damaged bone absent bone. The segment that we're most interested in today is the synthetic bones substitute market. And as you know, that's really characterized by a series of calcium phosphate Hydroxyapatite. products. The primary indications for our product are in the treatment of non unions and Mal unions of long bones, a significant problem where you're dealing with roughly a quarter of a million potential procedures a year. In addition, where you're dealing with instrumented spinal fusions, assistance is required in the in the form of synthetics, to assist the function to assist the fusion. And then obviously, throughout the body, there's a large number of other alternative applications. Greenbone is unique, in that what we are doing is mimicking nature. So I apologize for a little bit of a busy slide. But we start, interestingly, with wood, rattan word which is essentially a form of bamboo. And the beauty of this is that the wood comes with large longitudinal paws, throughout the structure. And we take this word, literally cut it, machine it, and then going through a fairly sophisticated and complex process, we take the word, we carbonize it, and then we take that carbon and ultimately produce hydroxyapatite answer a substitution from calcium carbonate. The advantage of this process is that you finish up with an implant that is essentially identical to your starting material, ie the wood. So the large pores and the longitudinal pores that you really want to have reproduced in the final product. The other advantage is that by so doing this process, you really don't need high temperature sintering. And as a result, the material is highly bioactive, and also much more forgiving to the surgeon, it is not a fragile ceramic. In that sense, it's a much more able to take a screw or some form of manipulation. So we look at this as the advantages over existing materials is, as they say, we do have a unique three dimensional architecture. This lack of sintering gives us a very interesting and proven bioactive surface. And then the surgeons seem to like it, because it's much easier to handle. And obviously, it is cheaper, and much less invasive than both BMPs and autographs, which are the kind of gold standard. Going back a little bit this material has been studied extensively in animals in Italy, and the first studies about rabbits. And the second study was the much more critical animal defect model was in sheep. And the results indicated very good, complete mineralization of the new bone. And over a period of approximately 12 months. Our product line is full of both cylinders, essentially, large, different length cylinders that we can provide. And then wedges and blocks that can be used in different situations as well as granules. The product is CE marked in Europe and is right now we're completing the 510 K for the US. So we're kind of doing things in a little bit different than some companies right now. We're really focused on Europe. Excuse me. And so our clinical studies to date have been focused in the first case on iliac crest reconstruction where we are going back in where an autographed has been taken from the iliac crest after reconstructive procedure, and you can see I think in the mind can't see here, but you can see in the center, picture 12 months very nice integration, essentially bone growing into the implant from the bottom and the top in a very encouraging fashion. We've extended that to doing another study on long bones. So these can be tibialis, femurs, radii, and humerus. And essentially, these become much more complex cases. In this case, you're dealing with additional adjunct fixation, be at a plate, external fixation, a rod, what have you. And again, you can see here where the implant has been used in conjunction for a non union on the left hand side, and essentially, on the radius. And you can see that very nice integration, and then on the right side, for a tibial nonunion. So these are difficult cases. And our results to date have been very encouraging. And we've been conducting these studies in the UK, Germany, Switzerland, and Italy, which has been obviously fairly challenging, given the pandemic. So, as a highlight of the company, somewhat surprisingly, we are well funded, you don't hear that too often. And our focus this year, is really on getting stale started in the UK, and Italy. The UK is becoming more challenging, for fairly obvious reasons with Brexit. But we're working through those and we expect to launch within the next couple of months, certainly a couple of weeks. Italy, obviously, it's our home base. And there we are using a distributor to provide the product next year expanding into other of the Big Five in, in Europe. Our plans in the US, obviously depend upon the 510 K, but we will be launching at some point in the US either with or without a partner. But that's really our focus right now is on Europe. And on the bottom you can see nicely our facility, which is kind of halfway between Verona and Milan. Our team is experienced. Not surprisingly, given our location, we've stolen a number of people from orthofix, Italy, which is none quite close. But we have an experienced team who are handling the key factors. In addition, our scientific adviser and a temporary was the originator of the technology and still very closely involved with the company. Our board of directors is essentially who's who of Italian funding venture capital in addition to myself as an independent originally and Diogo Molera Ratto. Some of you may know from his past time at Smith and Nephew and j&j. And then in addition, we have added to that a very strong clinical advisory board, which we'll be adding to and changing over a period obviously. So that's Greenbone Anybody has any questions? Please feel free to catch me either just after this or during the rest of the conference. Thank you