I'm told to hold this in English, so I will.
If you want.
Yeah, yeah. Easier. Okay, Anders Svensson, OssDsign CFO. I'll try to tell you a little bit about OssDsign as a pure-play orthobiologics company. The usual disclaimer and OssDsign's presentations. Last year we actually started as a pure-play orthobiologics company. This quarter, Q1, Q2025, is the first time we've been able to compare like for like with the previous year. I just want to show you how that comparison pans out. We reported 65% sales growth, 60% in constant currency terms. We managed to grow the gross margin from an already high level last year to 96.4%, almost 300 basis points up. This combines into us reporting the best-ever operating result for OssDsign, minus $5.6 million is the adjusted EBIT.
On top of these financial performance indicators, we've managed to release a couple of studies or publications in the quarter, which I will come back to later on. As good as those quarterly figures are, we still believe that the best way of looking at this and getting a feel for the momentum in the company is to look at the last 12 months' sales, which is what you see in each bar in this chart. As you can see, it's quite a nice trajectory over a long period of time. It continues in Q1, and we've now reached $151 million in Q1, last 12 months, and it's 83% up from last year. A pretty good development. Yesterday afternoon, I had news from the US, so I had to throw in a new slide in the presentation.
We found out that we've now passed or met our milestone of 10,000 patients being treated in the U.S. with OssDsign Catalyst. Twenty times what we started reporting only two years ago, so it's happening pretty fast. It is a testament to the successful market adoption of OssDsign Catalyst in the U.S. market. The market I'm talking about is the spinal orthobiologics market. It's a huge market globally, but 70% of it is in the U.S. , so that's sufficient for a company like OssDsign for sure. $1.8 billion with a very healthy underlying growth rate. In this market, there's an unmet need, which is good for us, not for the patients, but it's good that OssDsign is on board. Because nearly 80% of all Americans will experience back pain at some point in their lives, usually later.
This translates into about 1.5 million spinal procedures being performed each year. About half of those are so-called fusion procedures where you try to make two or more vertebrae fuse and stabilize. Interestingly, about 20% of these fusion procedures do not have a successful outcome, so they do not fuse, which means revision surgery for about 150,000 patients every year. The clinical goal of a fusion surgery is quite simple: to stabilize the spine and relieve the pain. It is not always that simple because the fundamental human biology does not support this procedure in some instances. I will tell you more about that. What you really do is you remove the degenerated disc, replace it, and you stabilize with screws and rods, one, two, or three levels, how many constructs you now have.
You start growing bone around the vertebrae where there are blood cells that stimulate bone growth. That's not the real challenge. The real challenge is, as you see in the schematic picture on the right, in the middle, in the center of this construct, it's a very avascular environment, so not much blood flow, not many blood cells, hard to grow bone. Looking at how a traditional bone graft then would grow bone, it starts, like I said, out here where it's easier to grow bone, and then it's a creeping bone formation in towards the center, which sometimes succeeds, quite often succeeds, 80% of the time, but sometimes it doesn't. The reason being two. First of all, it doesn't reach the middle. You don't get the bridging bone, and therefore the vertebrae will not be stabilized. It's a failed procedure and revision.
The second instance is that maybe it will reach the middle eventually, but it takes too long. In the meantime, you will get infections, you will get implant loosening, and then you have to go in for revision surgery anyway. Another failed surgery. What we see in OssDsign is a different way of growing bone. Yes, it does start at the ends as well, because that's the easy part. At the same time, it also starts with the same speed in the center, where it gets no help from the body. We could see this, so it's a dual pathway, you could say, of bone growth. We could see this already in the early stage, the Boden model that we used, preclinical data, that it was about four times as efficient to grow bone in the center of the mass as the comparable synthetic product.
Why is this? We believe it's because, A, it's a very, very nano structure, so very small, very similar to native human bone, and also because we have a silicate substitute in the product, and these two together result in a very highly potent product, which triggers this dual bone formation pathway. It has always been the target and the holy grail in synthetic bone grafts to mimic human bone. I think with this fourth generation, of which OssDsign is a part, we can see that we're on the level now that we don't actually just mimic the human bone on a macro level. We managed to mimic the mineral crystals inside the bone. This has been our proposition all along. We've said it, but we really commercialized up until last year only on the original preclinical data. We haven't had anything else.
That's the Boden model. This is what was used to get our clinical clearance, sorry, the clearance, the market clearance in the U.S. We followed that up a week after we launched the product with the Top fusion, the first in-patient study, small one, but necessary. We only got results from that last year, and they seemed to confirm what we saw in the preclinical. Propel, which is not a study as such, it's a prospective multi-center registry. We take in everyday patients, and we just build a database in this registry. Enrollment's still ongoing, but we're now past 300 patients in this registry. Lastly, we did something called the ovine model. We wanted to try and test OssDsign Catalyst in this most challenging environment, where there is no blood flow and no assistance from the body.
We used that in a sheep model. I'll come back to that. How much evidence do you need? I'll just take you through, I think it can be debated, but I think I'll take you through what we've seen in our data, which has been confirmed over and over again, starting with the preclinical. We had a 100% fusion rate. We were on par with rhBMP-2, which is a drug and which is known for being the leader in the market, and much better than comparable synthetics. That wasn't a really interesting thing, the high fusion rate. It's good, it's nice, it's excellent. Even more important is the fast fusion. We could see really rapid fusion, already at six weeks, and even more so at 12.
We did the top fusion, and we got, like I said, the results from the 12-month time point last year. Only a few weeks ago, we got the 24-month long-term results. We can now see high fusion rates, so it confirms what we saw in the preclinical, 100% fusion. To us, the more important part is what I've highlighted in red, the early bone formation. If you can get early bone formation, you avoid the risk of implant loosening and infections, you have a much better chance of a successful outcome. What we could see was that all our patients in this study were either partially or fully fused already after three months. Very fast progression to fusion. Propel then.
We've been getting questions about this, and we promise we will soon publish the results from the first 100 patient cohort in that registry. We're just not quite there, but almost. In the meantime, what we've done is we've done some case studies that we've published. They, again, seem to confirm what we've seen before, but now it's not a study with a perfect study sample. Now it's everyday patients that come in needing help, patients with comorbidities, patients that are obese, smokers, diabetics, patients who in some cases have had three previous attempts at fusion and failed with other products. What we see is in a very large construct, the patient was fully fused at six months despite three previous failed attempts. In a two-level construct, the patient was fully fused at three months. This is something that resonates with the surgeons.
Like I said, I hope to be able to publish the first 100 patients soon. The last study was last year, the ovine study. What we did was we took to sort of do something that's similar to the center of the fusion mass where there's no blood flow. We put OssDsign Catalyst and two other products, synthetics with silicate, in a muscle pouch of a sheep. There is absolutely no blood flow, no blood cells, no assistance. You have to do it on your own as a bone graft. What we could see was very fast progression, again, even in this environment. After 12 weeks, we're about twice as far gone on the bone formation as the nearest competitor.
One of the researchers who led this study, it's quite a well-known guy who's been doing a lot of reviews for most of the synthetic bone grafts on the U.S. market today. He has now concluded that OssDsign Catalyst is the first clinically available synthetic bone graft, which can actually generate functional bone in this challenging avascular environment at such an early time point. I think we've come a long way. I think we've come a long way also on publications. We're building the clinical repository. It's preclinical and clinical. It's partly peer-reviewed publications, and it's also internal white papers. Interesting as well, we did a strategy shift just about a year ago, and we now have 16 publications. Ten of those have come since we did the strategy shift. We've now freed up resources to focus also on clinical.
Looking forward then to the future, what do we see and why do we think OssDsign Catalyst is so perfectly positioned for the future? We see three very strong underlying trends in the market. The first one is the population. We treat all sorts of people of all ages, but the majority is clearly 60+ . This part of the population is expected to double in the next many years, but grow very fast. That increases the market for us. What we also see as a second trend is that autograft, which used to be the gold standard and preferred option, a lot of surgeons are now moving from both autograft and allograft towards synthetics. I guess mainly because of the efficacy of synthetics having increased so much.
It wasn't so impressive to start with 25 years ago, but now it's on par with autograft or even better. The third trend that we see is within the synthetics community. The surgeons who already operate with synthetics, some of the stuff, some of the product that came out 25 years ago are still in the market. You can imagine that the new ones, the latest generation, are so much more efficient. We see a big move from the old products towards the new. What have we achieved in terms of market access? We've achieved a lot, we think. We've come a long, long way. We're really proud of having reached almost 10% of the market in terms of access, not market share by any means, but access.
Of course, as proud as we are, the converse of this is there's 90% that we haven't even touched yet. There's a huge growth opportunity for us if we continue down this path. Another growth opportunity is that we have a clearance that's actually more than just spine. We are cleared for pelvis surgery, we're cleared for extremities, we're even cleared for trauma if we were that way inclined, which we're not really at this point in time. We've done some sacroiliac fusions that's performed by the same surgeons who perform the spine surgery, so it's quite a natural development. We've also done a lot of foot and ankle. Ever since the start, actually, the second case we ever had was a foot and ankle case. We've continued doing them, but we haven't talked a lot about it.
It's a smaller market, it's not a focus market for us. The spine market is so huge and we're a small organization, so we need to stay focused and not spread ourselves too thin. Clearly, there's room for expansion here. Just tying it all together with the strategic priorities then. We've seen the access that we've built in the U.S. market. This, I believe, is extremely important for the growth going forward. We need to continue building that access and taking more of that remaining 90%. We have such a fantastic product, which all the results show. It's a shame and it's silly to stay with only one product. We want to use this base and leverage it and capitalize on what we have and expand the product portfolio. Also something we're working on.
Yes, we've come a long way on the real-world clinical evidence, but we want to go further there. This resonates extremely well with surgeons, with hospitals, and I think this is the way of the future, so we'll continue that. With time, not tomorrow, you will see us focus more on adjacent orthopedic segments like the ones I showed before. I think all these four together will contribute immensely to shareholder value, as it actually already has in the last four years. Let's not forget about that. I have no idea how I am on time, but I'm actually done.
Excellent. Thank you very much, Anders. It leaves us roughly nine minutes for Q&A, so that's perfect. My first question, you talked about the old legacy products, the golden standard, the autografts and allografts.
Do you have any idea what the split today is between the old autograft products and the new synthetic products in spine?
The data is not really fantastic in this field, but what we have seen is about a third. You can say that a third is the old autograft, a third is, or a third is allograft at least, you can say pretty clearly. A third is synthetics, and then a third is autograft and some other things mixed in.
Roughly one third is synthetic. Do you have any sense of the growth you have today? Where is it coming from? Is it from older synthetic products, or is it sort of more driven by doctors giving up on that old standard?
I think what we see is the main part of the growth is actually within the synthetics community.
It's much easier for a surgeon or to approach a surgeon who's already a convinced synthetics user to swap to a better product than it is for someone who grew up learning about the procedure using autograft and convincing them to move to synthetics. There's part of that as well.
Yeah, I mean, I'm sure it's going to take quite a long time to get some of the old surgeons.
Exactly. You see the young surgeons much more willing to adapt to the new technologies, for sure.
Yeah. You showed us a picture of the, you have 10% access today. Do you have any sense of how many surgeons you have trained out of the U.S. population of orthopedic or, well, spine surgeons?
I don't actually think we've trained anyone because our procedure.
What has received training from your ideas, maybe I should say.
The surgeons, if you use a different product today, a synthetic, and you start using OssDsign Catalyst, it's exactly the same procedure. There's no difference. It's just a different colored box. Really, really pretty much the same as if you're using autograft, but there might be some. The standard of care is the same, so there's no education needed.
All right. I'll rephrase the question. How many of the spine surgeons have you met today?
Oh, we don't normally give out numbers on that, but
is it close to the 10% of the access you have, or is it, I suppose, it's a smaller number than even, so you have a long runway of growth ahead of you.
We have a good growth potential just within those 10% because that's the access we had.
It's not all those users are not using at the speed we'd like to. Yes, we can grow within that segment, but then we have the 90% as well.
The access is related to number of hospital systems or something like that. Also, within each hospital, there are a number of surgeons.
That's right. There might be five surgeons and we've convinced one.
Yeah, exactly. How do you balance growth and profitability today? You have enormous growth potential, but enormous funds available. I mean, how do you work on that?
If you look at our U.S. team, you can see that it's not much bigger now than it was two years ago. It's pretty much the same. Maybe in the last month or so, we've added one or two net. Otherwise, we've just replaced non-performing sales guys.
We're still about 12 people in the sales organization. I'd say we're growing the sales force slowly and cheaply. We've had to balance it because we haven't had the resources. I think the difference we see now is that we have a choice. We have optionality. We can either continue like this with $5 million negative, we're sort of approaching break even, or we can decide to go for more growth. That's really a board decision. I'm not going to second guess them. I'll wait for them to tell me.
Sounds good. Could you elaborate a little bit more on that second part here, expand product portfolio? What exactly are you thinking about here? I mean, is that in licensing new products or?
No, we actually have started developing two new products.
It's a product that you would see as sort of hygiene products that you need to have if you want to compete seriously in this market. The whole market is going towards minimally invasive surgery, MIS. We need something for that. You can also see that when I spoke about these three or four-level constructs that we have done successfully, a lot of surgeons will not use a bone graft in this format for the larger constructs. They will use it for one level between two vertebrae. As soon as the construct gets bigger, I mean, it can be seven levels, so it can be huge. They will use a strip, a hydrophilic strip, which is basically bone graft encapsulated in other material. It's all ready-made just to fold out and put there. You don't have to do anything to pretreat it.
That's something we're also working on.
Okay. Given the growth you have delivered, I assume more and more companies in this field are becoming aware of you. It would be perhaps a natural evolution to team up with anyone in this field. I'm thinking about the metal suppliers in this industry, dominated by a few relatively large giants. What's the sort of sentiment here? Are they approaching you and they want to sort of team up with you and co-promotion or?
Yeah. I mean, a lot of those guys don't have much in terms of bone graft. They have very old bone grafts. They are living on their metal. It also means that the bone graft is less important to them. It's such a small source of revenue. We've had propositions, but nothing has been good enough.
But I also think that if you team up with someone like that, then you're gone.
Okay.
They're so big that they will swallow you whole. We will wait for the right moment in that case.
All right. My final question is on the upcoming publication of the first 100 patients from Propel. What kind of, I mean, it's real-world data. It's not so controlled. What kind of expectation can we have on that? What will you actually read out? Is it the fusion rate we're looking at, or what else can we expect?
Yeah, certainly the fusion rate. As much of the data as we can get, we shouldn't expect 100% fusion because this is real-world data. We should hope for as high a percentage as possible. I can't say how high because the data isn't done yet.
I think it's going to be a huge breakthrough for OssDsign that we can show this in a real-world setting. Because normally when you do a study, which we've also done, you choose the perfect patient with no comorbidities. It's almost a certainty that it's going to work with bone graft or, sorry, bone growth in them. This is real-world data. These are the patients that quite often shouldn't fuse. Then again, those are the patients that are going to need to be treated tomorrow.
Have you looked at other registry protocols? What kind of, I mean, the clinical data would be 80% in a controlled clinical trial, I guess. Here, I suppose it's going to be a lower number.
I would think so, but I can't say until it's done.
I would get my expectations down a little bit. Yeah, let's see what we achieve. I think you can be proud of a much lower number in this real-world data.
Absolutely. Excellent. Thank you very much, Anders. Best of luck in the future with the growth you have going for you.
Thank you.
We're actually going to stop here and there's going to be a coffee break. I'm not sure if the next presentation starts at 9:45 A.M., but I'm sure there's a schedule outside. Thank you very much.
Thanks very much, Sam.
Thank you.