those points with this innovation, which we'll talk, we'll call it bio-integrative rebar for subchondral reinforcement of the knee. And my disclosures are here, and this is patent pending for this innovative device, and the indication itself. And you know that we spent a lot of time and energy dealing with replacing cartilage, but one of the things that we've come to know is that the bone, as per our last speaker, may be actually more important in the cartilage as load-related symptoms are probably the most important in terms of why these patients come to our office. And what we've learned is that when patients have joint surface failure, there's this element of subchondral insufficiency, and the level of insufficiency, for example, the amount of edema, is proportional to pain and more closely correlated with symptoms than is X-ray joint space narrowing. So the concept here is a rafter screw, or a rebar, for subchondral support and repair. This is a well-known method when it comes to treating intra-articular involvement for tibial plateau fractures to prevent depression, but typically uses hardware that's painful often and has to be removed. So this innovation is a biointegrative cannulated trimmable nail that's four millimeters in diameter that provides regional stability and promotes a biologic healing response. In an effort to investigate this, we performed a sheep study last year that looked at integration of this material with the absence of a phagocytic response that you see with typical resorbable materials, full replacement by bone, and in the setting of apposition to a ligament, promoted cellularization. So the device is basically a continuous reinforced fiber, osteoconductive materials, which is basically silica, magnesium, and minerals, that's held together by PLDLA, and has a balanced pH, and with interconnected pores, gets completely replaced by bone based upon our animal and histology work. So the surgical procedure is actually quite straightforward. So the objective here is to support the subcondal bone where load is being transmitted, where many of our patients who would otherwise, for example, fail arthroscopy, may benefit from this additional rebar support. So a 1.4 millimeter K wire is sent across the joint line to go cortex to cortex to help share the load, and then a indirect ruler is used to measure this distance, and then a four millimeter drill bit is used, which is a line-to-line drilling, but the device itself is cannulated and hexagonal with ribs that holds it into position. It's basically a nail or a fixation nail that has indications for fracture fixation. And the objective is basically to place rebar below the surface to help support the load transfer that will presumably lead to reductions in pain, and then hope that it will go away over time. So it's a very straightforward procedure, does not add much in terms of time, at the time of arthroscopy, for a patient who's probably indicated for arthroscopy and debridement. So that's pretty much the procedure in a nutshell. So as this is an innovative procedure, which is very new, we only have implanted 15 patients to date. We have our first 10 at six months. Eight of 10 had substantial clinical improvements in pain and function, and this graph basically shows the delta in these outcome scores. In addition, we're using MRI evaluating edema change, and four of the six had a substantial reduction in volume in their bone marrow edema from pre-op to post-op, as you see in these four patients here. So the data is very early, but it appears very promising. So to Matt's point, these are the four points that the judges are considering. Innovation, novel implant with load-shearing biointegrated fixation. The impact on surgeons is such that this is a novel technique for very common pathology that I think we would agree has an unmet need in patients with osteoarthritis that traditionally respond very poorly to arthroscopy alone. In terms of its impact on patients, it seems to be promising with our early results, and we're seeing a reduction in bone marrow edema at six-month MRI. And then finally, as far as enthusiasm, we are about to launch a multi-center trial to now refine some of the indications and get a better look at the outcomes over a six and 12-month timeframe. Thank you very much. Brian, perfect. We got questions from the judges. Yes. Yeah. The question is concurrent procedures. Yeah, so these patients are being indicated because they have pain, typically load pain. The inclusive criteria would be that they have to have some subchondal edema in that region, but they are getting concomitant procedures in terms of debridement and meniscectomy. So obviously, it's going to require a control group. As far, you know, MRI is not the only outcome variable. We're gonna have to understand the differences because of the heterogeneity of this group. So that's gonna be a very important part as far as the clinical trial goes. Mark. So the nails are very strong. Like you can take one of them and you will not, even you, Mark, will not be able to break it, okay? It's as strong at time zero as cortical bone and or the equivalent is like resorbable metal, if you will. And it's only four millimeters in diameter and we have not seen a phagocytic response in our histology. And insertion is based upon sort of inferential fit. You're drilling a circular hole, but it's hexagonal and it has ribs on it. It's basically a nail that goes line-to-line, cortex-to-cortex, like a rebar type screw or a rafter screw. Last question. Leah. So in terms of bipolar, we did sort of address some of that. The question is femur versus tibia, bipolar one side or the other. So we gotta figure that out. In terms of evaluating it, we're trying to get a relatively pure group with unipolar edema, but truth be told, some of these patients present with bipolar disease. So a lot of work has to be done to refine the indications, but it's a much different approach than say subchondroplasty, if you will. It's designed really for load sharing because we believe there at least is enough support that there's evidence that load is transferred with a joint that's failing. And the reason we may not do well in load-related pain is because we do nothing to the surface below the bone. Cole got 15 extra seconds just because I did my fellowship at Rush, no bias. Aaron Critch.

bio-integrative rebar

subchondral reinforcement

knee

cartilage replacement

bone