Hello and welcome to today's webcast with OssDsign. Our CEO Morten Henneveld and CFO Anders Svensson will give a clinical study update. After the presentation, there will be a Q&A. With that said, I hand over the word to you guys. Thank you very much. Good morning and welcome, everyone. My name is Morten Henneveld. I'm the CEO of OssDsign. As always, I have our CFO, Anders Svensson, with me. Thursday last week was one of the best days in the history of OssDsign as we published absolutely phenomenal one-year data on the first 108 patients in our PROPEL spine registry. We will elaborate on this today. We will also have time for some few questions at the end. Given the timing of this call, we will only address the PROPEL clinical study today and not address or answer questions on the board of business or any forward-looking questions. As always, when we do these things, the normal disclaimer. To start off, I just want to remind everyone what PROPEL is. PROPEL is a prospective multi-center spinal fusion registry that aims to bridge the gap between the device performance in a controlled clinical trial and its use in everyday clinical practice over time through the collection of real-world data. There are recent trends in published literature that show that the use of real-world data is gaining acceptance, as evidenced by a marked increase of its use in orthopedic and surgical journals. Regulatory authorities like the FDA have launched initiatives to highlight the use of registries to serve as a way to generate a real-world view of clinical practice, patient outcomes, and safety. To this date, we have enrolled more than 300 patients in the registry. As you may also recall, the primary endpoint is the fusion rate, which is defined as bridging bone after 12 months. We also have secondary endpoints with clinical outcomes assessed, including quality of life questionnaires. That's the VASCO, ODI, NDI, but also the SF-36 and the maintenance or improvement of neurological function. Of course, we also do a safety review for all adverse events. Now, before we go into the details, we just want to make sure everyone understands the context for the results, as this is crucial to understand the magnitude of the success that we reported. There is an enormous difference in the complexity of patient profiles in a real-world setting compared to randomized controlled trial cohorts. Why is that? It all comes down to the exclusion criteria that are applied when selecting patients to be included in a study. The more exclusion criteria you apply, the more "perfect" patients you will include. Now, if we look at the Propel registry, then there are no such exclusion criteria. The only thing is an inclusion criterion for the patient to be, and I quote, "any patient age 21 years or older requiring spinal fusion surgery for which OsDsign Catalyst was being used" was considered appropriate for inclusion if, in the investigator's opinion, the patient could comply with the registry protocol requirements. This means that virtually every spinal fusion patient can be included and therefore represent patients with all the known risk factors. For example, comorbidities, previous spine surgery failures, diabetes, osteoporosis, et cetera, all of which inevitably translates into a more complex and therefore significantly harder-to-fuse patient population. Consequently, lower fusion rates are expected in real-world data. Randomized controlled trial cohorts, on the other hand, apply a wide range of exclusion criteria to reduce variables and find the "perfect" patient. This means that a range of criteria are used to exclude patients, which typically leads to exclusion of patients with prior spine surgery, high BMI, comorbidities, smokers, diabetes, osteoporosis, if the patient is on NSAIDs or similar medication, and a lot more. Trauma cases are often also excluded, and any complex multilevel procedure is also excluded. This means that randomized controlled trial patients generally are in much better health compared to the real-world average patient and therefore simply more prone to fuse, resulting in higher expected fusion rates. It is absolutely vital to understand this difference in the patient populations between these two types of studies, as it means you can't, as such, draw direct comparisons between registry outcomes and outcomes in randomized controlled trials. When you look at the cohort profile of the first 108 patients, you will see exactly what we just described. This is a highly, highly complex cohort. Let me walk you through why. We had an average BMI of 31.9, meaning that the average patient is highly obese. 93.6% of patients had at least one comorbidity, with 48% having three or more comorbidities. We had 50% that had previous spinal fusion surgery performed and another 15.7% having decompression, which is a non-spinal fusion surgery performed. In total, this means that we have about 2/3 of the entire cohort that had previous spine surgery. 48% were active or previous smokers. We had just over 20% of all procedures that involved three or more levels of the spine. We had 12% that suffered from either Type 1 or Type 2 diabetes, and we had just over 6% that had osteoporosis. The result that we reported has to be viewed through these lenses. These are very complex and very difficult-to-fuse patients who suffer from so many other things and where so complex procedures had to be performed that really you should not be expecting a high fusion rate on this group of patients. How do we do? Despite the complexity of the cohort, we managed to achieve a fusion rate at 12 months of 88.4%, which is absolutely phenomenal. The fact that we can achieve fusion rates in such a difficult real-world population, and then even beating most of the randomized controlled studies, is no other than remarkable and well beyond what you generally see in the market. What's even more remarkable is that we achieved high fusion rate throughout patients with all the known risk factors. As you can see in the bar chart on the right side, it doesn't really matter if the patient was old, obese, smoking, diabetic, osteoporotic, had previous spine surgery, or had large multilevel constructs performed on them. Throughout all of these groups of known hard-to-fuse patients, we achieved very high fusion rates. I can tell you, even the authors, as well as our surgical advisory board, were blown away by the result. Dr. Strenge, who's one of the investigators and also the lead author on the paper, actually says it very clearly, and I quote, "Typically, I would expect to see dramatically lower fusion rates for such a complex real-world patient population, with 48% of the patients in the study having three or more comorbidities, increasing their risk for potential nonunion." Most clinical studies exclude these difficult patients, which unfortunately represent the majority of patients in need of spinal fusion. The OsDsign Catalyst fusion rate of 88.4% achieved in the Propel study significantly exceeded my expectations." I think this statement says it all about how doctors themselves actually view this magnificent result. To summarize the paper and what we've been talking about today, and also what it means to OsDsign, what we saw in the study is the following. We used real-world data from 108 patients. We achieved 88.4% fusion success in a highly complex cohort at 12 months. Even across the high-risk groups, we showed fusion rates between 84.7% and 93.4%. All patients also saw significant clinical improvements in pain, function, and quality of life. We can also conclude that the presence of multiple comorbidities did not reduce fusion success. We can also conclude that known risk factors for non-fusion did not negatively impact fusion rate outcomes. Importantly also, we had no unexpected device-related adverse events. These results are therefore a crucial building block in OssDsign's clinical strategy, showing OssDsign Catalyst to be a robust, differentiated nanosynthetic bone graft that performs as intended regardless of patient profile. Although strong real-world performance was expected, the remarkable consistency with the earlier clinical trial results exceeds our own expectations. These results completely transform expectations for fusion surgery outcomes using OssDsign Catalyst, offering comfort and confidence that all patients, whether they are complex or simple, can return to an active life. With those final words, I want to thank you for listening to the presentation and hand back to the operator for any questions. Thank you so much for the presentation. Thank you so much for the presentation here. As you mentioned, I will now carry on with the Q&A. If you have any questions for OssDsign here, you can send them in via the form to the right. Let's see here. Now we have received a question here. How come we do not see data on more than 108 patients in PROPEL, given that OssDsign Catalyst has been used in over 10,000 patients in the U.S.? I think it's important that the total number of patients treated are not the same as patients that are enrolled. The Propel registry covers approximately 10 sites, a little more than 10 sites so far. It's only patients from those specific sites that are enrolled to the extent that the investigator believes that the patient can follow up with the protocol requirements. That's very naturally the difference. As we also reported, we have more than 300 patients in PROPEL in total. Thank you. How should we read into the upside on sale prospects from Catalyst in light of the data out? I think as we said in the beginning, this is about the clinical prospects. And given the timing, we'll refrain from giving any forward-looking statement at this point in time. Of course, as a general comment, the more clinical data, as I've said before, and the better clinical data you have, of course, that positions the company much, much stronger for the future. Thank you. What do you perceive as the next big readout in terms of clinical data for OssDsign going forward? I think there are a number of things. As the registry grows, which means that we have more and more patients that mature in terms of one or two-year data, then of course, we'll be able to publish bigger cohort studies, more cohort studies as we look into the future. Equally important, as the size of the registry grows, it also means that we can start to do cohort studies specifically, for instance, on some of these sub-risk groups as smokers or diabetics, osteoporotic patients, surgical procedures, and so on. The amount and the robustness of publications we can do will be one-to-one correlated with the tenure or the aging of the patients in the registry and the size of the registry. As we also said when we announced the strategy, we have now embarked upon starting a large level one clinical study. Thank you. Given the strong data in combination with very few patients getting Catalyst in combination with autograft and allograft, is there a priority now to get standalone use on label? I think, you know, as we've said before, we know that it's not uncommon that there is off-label usage on these types of products. And of course, as you can see in this specific paper, there is quite a lot of standalone usage in that. So of course, that is a potential for the future. Thank you so much. I think we'll give it a couple of seconds here if anyone else wants to send in some questions here. I think that was all the questions we received here today. Thank you so much, Morten and Anders, for presenting here today. Let's see here. Sorry, we received a couple more questions here. The first question here is, you mentioned you exceeded your own expectations. Can you share what they were? Yeah, I think we are prepared to do that now. We've obviously known about the cohort profile for a while. I can tell you, when we saw that and discussed that internally and with some of the surgeons, what we said at the time was, if we can get a fusion rate in the 60s, then that is something that we would deem as a good result. Of course, the fact that we end up with 88% or over 88% fusion rate is extraordinary. Thank you. Why is it that the real-world data is becoming more relevant or accepted? I think we all of us who work in this industry and as doctors, we appreciate randomized controlled trials because they isolate the number of variables to look at certain things specifically, which gives them a high scientific or academic value. At the same time, everyone also knows that the patients that you're treating in a randomized controlled trial is not the same as the everyday patients that surgeons meet in their practices throughout the states. That, of course, also means that surgeons cannot replicate whatever fusion rates are reported in most of the randomized controlled trials in their clinical practice. They just see a very different picture. That is why both surgeons, journals, but also FDA actually are showing an increasing level of interest in real-world data because it is a much better proxy or more representative, at least, of what you can expect once the product is being used in the market as opposed to a very "perfect" patient group. Thank you. If I understand correct, there are not really any exclusion criteria in PROPEL. Isn't this going to make life harder for you? It seems like you almost have reverse bias. It's an interesting question, but yes, you're absolutely right. I mean, once you have a registry that is based on real-world data, then of course, you open up for all the complex cases, as you have seen in exactly our paper here today with 108 patients. So yeah, if anyone thinks that there is a bias in the selection, I think the registry is actually quite the opposite. I think you are absolutely spot on. There is a reverse bias. As you can see, I think the one we are doing extremely well in this patient group, and that, of course, makes the data even stronger, and surgeons will also see it as even stronger. I think it's also important to show the real efficacy of the product in a real population and not just in a purely randomized controlled trial. Thank you. How will surgeons interpret the data? Is your argument that if you can fuse the complex patients, then the simple patients will be easy? Yeah, I think that's a fairly common logic, of course, that there are known groups of patients that everyone knows are the hardest to fuse. That's typically where the patients or the surgeons would use multiple products, sometimes even drugs and other things like the BMP-2. Of course, all things equal, if you can fuse the complex patients, then you should be expecting an even higher fusion rate on the patients that are more prone to fusing, so simpler patients. Yes, that would certainly be the logic. Thank you so much. That was all the questions we had. Sorry for a little bit of delay there in the Q&A earlier. Thank you so much, Morten and Anders, for presenting it today and answering all the questions. I wish you all a pleasant summer. Thank you very much.