Please, warm welcome to you, Morten. Happy to have you here again, and so we'll start with your presentation, and then, I'll do some Q&A afterwards.
Fantastic. Thank you very much for having me. Yeah, I think it's more or less a year to the day in the same room, in the same position here. But a lot has changed in OssDsign as I'll talk to you about. As always, we have the normal disclaimer. I won't spend too much time on it, but I just want to highlight that many of you may know OssDsign as the cranial patient-specific implant company, and that is true because that's what we were for the first 10 years of our life. Now, in 2020, we acquired a company. We entered the orthobiologics space in 2021, and as you can see, it materially transformed the company. Essentially, we achieved in 18 months what took us 10 years with cranial.
So as a result of that, we announced a strategy shift in September of last year to become a pure play orthobiologics, and at least for the foreseeable future, a only US-focused company, and we've been that since the beginning of this year. Just last week, we came out with our first quarterly earnings as a pure play orthobiologics with exceptional growth, $27 million in sales, 207%, both on a reported and on a constant currency basis. And this also means that we now have, for eight consecutive quarters, reported triple-digit growth in the U.S., As you can see here on the slide, it's rolling 12-month sales, and it is a very good-looking chart. We have good underlying growth throughout the business.
We also reported 94% in gross margin, or 93.7%, to be precise. But that also means that compared to the cranial-only business that we had back in 2020 before we entered the orthobiologics space, it now means that we have more than double gross margin in just about three years. So that is, of course, something that we are very proud of. But as a pure-play biologics business, there are many applications actually for our product. I'll come back to that a little bit later. But we have a strategic focus on the spine, and I just want to spend a few minutes on that. Unfortunately, as we grow older, the majority of us will suffer from some kind of back pain.
Some of us will have what we call, spinal instability and will need a fusion surgery that you see here, on the right side. Essentially, where you use some screws and rods, and you always use some kind of bone graft to make sure that you basically fuse and stabilize one or two or more levels of the spine. And unfortunately, what we see today, is that, at least one in five patients do not get the clinical outcome that they expected and therefore have to go through revision surgery, which of course is not only extremely painful for patients, but is also, an extreme cost to the healthcare society. We have about 750,000 fusion procedures, so you can do the math. We have about 150,000 revision surgeries every year.
I think they probably start at $50,000, most of them probably above $100,000 fully loaded cost per surgery. So it's an enormous burden on society. The other reason why we're also choosing to focus on spine is, as you can see, it is by far where most bone graft is being used. With the U.S. focus we now have, it means that we are addressing a $1.8 billion market, is nicely growing around 8%. And it's also driven, or helped, I would say, by a number of macro and more industry specific dynamics. One is the underlying volume increase, which will only go up from now on. We are getting older.
We have the Second World War baby boomers now getting into an age, and of course, the life expectancy will drive a need for more surgeries. As a surgeon, you have a number of options available for how to treat patient. You can use the patient's own bone, what's called autograft. You can use a donor-based product, what's called allograft, or you can use a synthetic solution that we are offering. What we are seeing right now is, many surgeons are moving away from using autograft. It is the de facto gold standard as defined by the FDA, but it does mean a second surgery where you harvest from the iliac crest, from the hip, which means extra surgery, extra days of hospitalization, extra pain for the patient.
Similarly, when you're using a donor-based product, it always come with the risk of disease transmission. And in the U.S., there's been numerous cases, and they happen on an ongoing basis, some of them very severe, tuberculosis outbreaks, where eight patients died, 130 got infected. So you're seeing surgeons being a little bit hesitant to use that going forward. And last but not least, you're seeing synthetic solution, not just OssDsign Catalyst, also our competitors generally performing better actually, or on par, better than the gold standard from FDA. So there is a swing from surgeons moving to, towards synthetic solutions. And then the market we operate in is extremely crowded. When you look at synthetic solutions, there are a lot of products on the market.
Many are 15, 20 years old, and all evidence points to the fact that the latest generation products are just performing much, much better than the early generation, which is quite natural. So we are seeing a very significant swing. There is an expectation from the market analyst that the latest generation synthetics will grow at a ratio of four-one, compared to the early technology. So what is it we are bringing to market? Of course, things have developed. We now have some clinical data that I'll come back to, but we, we are sitting on a highly differentiated bone graft. This is our preclinical data, and the main reason we actually acquired the company called Sirakoss back in 2020, because it is the first time we see preclinical data, which is actually performing on par with a very known drug.
It's not a bone graft, it's a drug from Medtronic called BMP-2. As you can see on the right side, this is the best preclinical data we've seen. It significantly outperforms the gold standard, which is the dark gray bar here, allograft, and also a predicate device from Medtronic, significantly doing better than that. Then there is one thing which is often overlooked when you generally look at surgical or implants for surgical use, and that is, does it work in the operating theater? Does it work in the hands of a surgeon? Because you can have the best data, and if it doesn't work in the hands of the surgeon, it's not going to get used.
This is something that we have heard and seen again and again from, from the very first day. My personal belief is that actually the handling that we are offering, and handling means that, not only does it, it works well in the hands of the surgeons, but you can imagine a bone graft, which is mixed, you know, when you put it into the surgical site, it gets mixed with fluid, with blood, and other type of substances. And a lot of bone grafts starts to dissolve, what's called migration, and that means that the bone graft will spread. You don't have it where you actually want bone formation to happen, but you may actually get it where you don't want it to happen.
So this is something that significantly sets us apart from competition right now. And it's not often you get a wow effect from surgeons, but here we actually get a wow effect from surgeons. We are also very committed to making clinical investments. A week after we launched the product in the U.S., we started our TOP FUSION, which is our first in-patient study. I'll come back to that in a second. And at the same time, about six months later, we started our PROPEL, which is a prospective multicenter spinal fusion registry that we are running. We reported in September last year that we've exceeded 200 patients in that study. And we start to have publications out now.
We've done a safety study with no adverse events. We, of course, have our preclinical data, and we also have published a first case report from the TOP FUSION study. But of course, the big breakthrough for us happened in January of this year, where we published our first clinical data from the TOP FUSION study. It was 17 patients. We ended up with 14 evaluable, three were withdrawn, nothing related to OssDsign Catalyst. But as you can see, there are a number of really good data points here. One is that we achieved 93% fusion rate, and you have to compare that to the general average, which is around 75%-80%.
But I think more importantly, we know that speed of fusion is one-one with a reduction in complications such as implant loosening, infection rate, infection, and so on. And what you see on the right side, in the right bar or in the red bar, is that every single patient that we treated were either fully fused or had progression to fusion already at a three-month time point. That is exceptionally early and shows something about the potency of the product. Then, of course, we also scored well. Every single patient had improvement in their quality of life scores, and equally important, there was not a single device-related adverse event in the study.
And then I just want to draw your attention to this, because bias in clinical studies is generally an issue, many surgeons will rate their own fusion rate. What we did in this study, we actually sent it to a third-party independent company that only does this, radiologists that only do this for a living, and therefore, we took the bias completely out. So we have not even touched the assessment on whether a patient is fused or not. So of course, that gives a lot more credibility... At the end of last year, we also became the first bone graft on the entire U.S. market to get what's called an interbody clearance, which is what you see over here, to be used in a cage in the spine.
And there were two others that were cleared on clinical data, combined with their, with their spinal implants. We were the first to get cleared just on the bone graft, alone. We were also the first latest generation bone graft, to get that clearance. And I would say in the companies we typically compete with, which are the pure play orthobiologics companies, we were also the first one. So there have been more that have been given. You know, unfortunately, when you get these clearances, you also show the path for other companies of, of how to do it, but I think it is important. We were the first actually that got it, and it means you can now use OssDsign Catalyst on label for every single, spine procedure that exists.
We are exceptionally proud of the speed with which we have commercialized it. I remember when we acquired Sirakoss, we had a lot of, I would say, critical, healthy questions about whether this is something we knew. As you may know, many of us, most of the company actually have a past life before OssDsign in spine and biologics, so this is an area we knew extremely well. And within only a few years, we have really managed to build broad access in the US market. You know, in the U.S., you have to go through these value analysis committees, what's called VAC approvals. We are now approved in more than 100 hospitals and ambulatory surgery centers. We have also built full access to the military system.
We initially got on what's called a DAPA contract, which is a license to sell into certain parts of the military. That contract got expanded in 2023. We got on something called ECAT, which is an e-catalog for all active military hospitals. And just not long ago here, we reported that we've also won a contract with the Veterans Affairs, what's called VA, covering nationwide all VA hospitals. And more or less at the same time, we also managed to win our first large GPO contract in the U.S. with Premier. It's one of the absolute giants. There are probably three of them in the U.S. right now. This is one of them.
So within only a few years, we have really managed to penetrate the US market well, and having said that, there is still an enormous amount of the market that we don't even have access to, right? We're only scraping the surface as we speak, but we have very broad, profound access in the US market. And then I think it's important to note as well that this is a bone graft, and it means that we have a regulatory clearance that actually allows us to use the product also outside spine. We can be used in what's more pelvis surgeries, hip, borderline between spine and hip surgeries.
We can be used in extremities, foot, ankle, and others, and we can also be used for trauma cases as a bone void filler. Right now, we have a clear strategic focus on the spine business, but we have started, I would say, soft launching the expansion. We have done a number of sacroiliac fusion, what's called SI fusion. We have also done foot and ankle case already. So we're sitting with a product. Of course, this is a matter of priorities and investments and so on, about how broad you go in the market. We have a clear focus on spine, but this is a product that can and will be used broader over time.
So just to wrap up, OssDsign is now a pure play orthobiologics company. As I've shown you today, we are operating in a very large, very attractive market with solid underlying growth and helped by some macro tailwinds. It has incredible scalability, as you can see in our own report. Just to put into context, we are reporting significantly higher sales this year, despite the fact that we only have employees compared to only 12 months ago. As we also guided the market, we expected operating gross margin to be at above 90%, which is reported almost 94%.
And of course, over time, as that happens, as we're seeing the scalability in the business, and we're seeing more operating leverage coming through, of course, that also will translate to a reduced cash burn over time. And therefore, ultimately, we think that this strategy shift and I think actually our first Q1 report as a pure play orthobiologics very, very clearly showed that this will generate higher shareholder value going forward. So I think with that, Sten, that was everything I had to present, so I'll hand it back to you.
Excellent. Thank you very much for the presentation. So obviously, good to see the growth momentum since the launch of Catalyst. Going back to the Veterans Affairs, which was extended during Q1, can you say anything about when you expect to see sales coming from those, I think it was an additional 100 hospitals-
Yeah
—or something like that. But you know, will it be a significant boost already this year, or does it take longer?
I think what's important... So let me just ask your first question. We're already seeing sales. We did our first case-
Okay
Friday, a week ago.
Okay.
So virtually,
Great
... a week or so after we got on contract. So, compared to the GPOs, there's a much quicker translation. But I think it's important with any of these large contracts, nothing fundamentally changes in the dynamic of how you sell. You still have to find a surgeon and persuade the surgeon that we have a better offering. You still have to find someone that can help you distribute it in that given hospital. So there are still a few hoops you have to jump through to get in there, but it will be a faster translation. But of course, you know, in all fairness, if you look at the broad market as such, the VA is a smaller part.
I think what's very important with the VA and the general military access is that pricing is at the very high end.
Mm.
Which means that all sales to the military will be accretive, not just to top line, but it will also be accretive to gross margins.
That's good. In order to maintain this growth rate, or maybe not the exact numbers, but in order to maintain a momentum-
Yeah
... do you need more feet on the ground? Should we expect your sales and marketing organization to expand, or do you-
Yeah, I think in a-
I mean-
... I would say in a meaningful way, right? That's, that of course, that is a, that's a fine line you need to strike between not burning too much money, that maybe investors don't like, and at the same time, making sure that you're also doing what's right for the company. And as we said, one of the main reasons for the strategy shift was that we saw that cranial had started to drag us down. It was simply locking down funds and resources in the company that we couldn't apply to the biologics business, which was in dire need of more investment. So, what you will see from us is, yes, we do need some more. I think it's going to be moderate in 2024, more sales and marketing, in particular, horsepower in the U.S.
We also need to accelerate on our R&D and our new product development. We do need more products. We have line of sight to those projects. We need to make sure that we continue the meaningful clinical investments. I think we are starting to see now that they are paying off, and we are expecting to see the first publications coming out of PROPEL during 2024. And then of course, we have grown exceptionally fast. And as you can imagine, just keeping up with demand has been, at times, at least, fairly chaotic.
Mm.
And we have to make sure that the fundamental way we produce, we're doing fine, we have line of sight, we have safety stock, so there's no worries right now. We are in a good place. But we have to make sure that we can also cater for 10X volume going forward, and that work has to start now.
That's good. In terms of... You mentioned the PROPEL study. And you had, I think you said in September, 200 patients registered or-
Yeah
... enrolled in that study.
Yeah.
The readout will come later this year, but we don't know. Is it-
No, I think-
Second half or?
... yeah, I mean, I think it's important to remember, it's a registry.
Yeah.
It's not a clinical trial.
No.
So there is no predefined. The whole idea with having a registry is that it gives you a broad readout of how it actually works in the population, broadly speaking, across all type of procedures, right?
Yeah.
You know, as much as I like the clinical trials, they are also—they have inclusion, exclusion criteria. You can be an end stage. You don't, can't have a BMI above a certain level, and then you have an American population, which has a very high BMI in general, right?
Yeah.
So we want to have a broad readout. But it also means we are following the standard of care in the sites that we are working with. So I can't give you a definitive time, because in order to publish something, there has to be a cohort which is complete with a certain level of conformity that allows you to actually draw some general conclusions. So we are hoping, as we approach the very end of this year, that we have sufficient patients, and in that group, we have sufficient patients at one-year time point, which is the primary endpoint. And then in that group, we also have a similar cohort, so we can do a publication. But I think you will see other things coming out of PROPEL earlier than that this year.
It's primarily the fusion rate after one year, you will, you will-
It's primarily the fusion rate, but as you have seen, we appear, as we had hoped for, to have a product which is highly potent. So to the extent, of course, that we can show fast fusion, that's certainly something that we are looking into. And of course, you have to make sure that you have no adverse incidents and-
Mm
... those kind of things. But of course, in this industry, the primary endpoint tend to be fusion at 12 month.
Would it make sense to make a long-term study to see, you know, over three years or five years to see how if the fusion rate is still as high? Or has that been a problem with other products in the past?
I think, I mean, generally, and that's also why it's become the gold standard to look at a fusion at 12 months. Typically, you see most fusion taking place between six and 12 months. You actually don't normally see very much in the first six months. But with TOP FUSION, we do follow to 24 months. That's just the protocol. But of course, we are looking at what could we be doing next?
Yep.
And how would such a study look like? Of course, over time, we also want to go into markets outside the U.S., and maybe there's an opportunity if you do a study, to double dip and use that data to actually get approval in new markets. So those are discussions we're having internally.
Excellent. I think, we're actually running out of time. Thank you all for listening, especially thank you, Morten, for-
Thank you very much for having me again.
...for being loyal and coming back to us. And with that, we conclude the first presentation of today. Thank you.
Thank you very much.