Good afternoon, everyone, and welcome to this presentation with OssDsign AB. Very pleased to have the CEO, Morten Henneveld, with us today, to present the company. I'll let you take the floor right away, Morten, and follow up with a short Q&A afterwards.
Thank you very much, and thank you a lot for having us again this year. If we can move to the next slide, please. As always, when we have these presentation, we have the normal disclaimers. Just if there are any new to OssDsign, then we are a Swedish company. We're headquartered in Uppsala. We're about 50, a little more than 50 employees, and we operate in 10 markets globally. I'll come a little bit back to the result that we just posted, which was quite extraordinary after Q2. Everywhere we operate, we operate with full patents, full clearances, and we're fully reimbursed. Next slide, please. Before we really get into the company, I wanna talk about the clinical challenges that we are solving.
Next slide, please. Because the big problem, as you see, unfortunately, a lot of people have traumatic brain injuries if we start with our cranial business. You know, more than 1 million have some kind of head injury per year. Some will need to be hospitalized, and ultimately, some will need to have an implant. Now, the big issue we see there is that 10%, or we hear about even above that, implants get infected, and many of which will need a removal of the implant, so what we call an explantation. A little bit similar if we take the example from our spine business. Unfortunately, as we grow older, many of us will suffer from some kind of lower back pain or spinal instability, will need a procedure.
Ultimately, if we get to that point, what we want to have is something called a fusion. Where the spine is stabilized using some kind of metalware, but also using bone graft as we are offering right now. Today, more than 20%, about 20% actually don't get the clinical outcome, which is called a fusion. Now, when you add up what we see in our cranial business and what we see in our biologics business, then this amounts to hundreds of thousands of patients that every year do not get the clinical outcome that they need, therefore have to undergo a revision, maybe multiple revision, which is extremely painful for the patients, but also hugely costly to the society. We're dealing with some very real unmet clinical needs right now. Next slide, please.
What is our response really to that? Well, we have decided to focus on really bringing the next generation bone replacement to market. What sets them apart probably is a better description, is really that they are designed by the very nature of the products that we're taking to market to really work with the body's own healing capabilities. We're trying to stimulate what the body is naturally trying to do, and we largely believe that's why we have so good results so far on our products. Next slide, please. If we start with our Cranial business, then consistently all the way from the very first start in 2018, we have shown very low removal rate because of infection in the implants.
Recently, we came out with almost 1,500 implants in our post-market surveillance studies, more than 200 hospitals worldwide, and actually with some improved implant removal rate of 1.6%. We've now consistently throughout many, many years shown a much better clinical outcome than what you typically see in the marketplace today. This product is cleared in EU, US, and now also in Japan. Last year, we're also the only one who has what we call an osseoconductive market clearance, which essentially means that the FDA acknowledges that the implant resorbs and turns into bone during the healing process. Next slide, please. After the acquisition in 2020 of Sirakoss, we now also have a bone graft that we are applying in the spine segment.
We'll come back to that in a second. What this product has shown is essentially a performance in the preclinical models, which is a very discriminatory model which outperforms other synthetics that were tested in the same model, but actually had a performance which was equal to the best performing solution right now because it's not a bone graft product, but the solution called BMP-2 or Medtronic's Infuse product. We saw a fusion rate close to 90% after 12 weeks and 100% after 26 weeks. Again, this is a preclinical model. It's not clinical. We are in process of doing that right now.
It's a very substantial, very significant, outcome we're seeing in that data set and something we're certainly is resonating well with surgeons who we speak to right now. Next slide, please. Where is OssDsign right now? If you go to the next slide. We are becoming a broader company with more potential. For the first 10 years in the company's lifetime, we really worked on with a strict focus on cranial implants, and what we have established ourselves as is really the innovative leader in that field. Now, last year in August, we launched our new bone graft called OssDsign Catalyst, which is a very different market, but with a lot of synergies. What characterize that market is that it's highly scalable, and it's very high margin, gross profit market.
By playing in that field now, we actually have expanded our market potential 5x , which means that today we're operating in a total market in excess of $3 billion potential. Next slide, please. I just wanna zoom in a little bit on the bone graft business that we're now bringing to market because bone graft is essentially used to stimulate surgical outcomes throughout the body, so in many different types of procedures. We have decided very consciously to focus on the spine segment. As you see, it is by far the biggest part of the bone graft, but it is also an area where it may be new to OssDsign, but it's not new to many of us. We have been in this business before. We have existing surgeon relationships.
It was a very natural move for us to really focus on what is also the largest part of the market. Next slide, please. How are we gonna do this, and how are we gonna generate growth in the future? It is quite unique actually, a company of OssDsign's size. We already have a global footprint. Now, we're headquartered in Uppsala. We have direct sales forces in mid and Northern Europe. Southern Europe is covered with agents. We have distributors in Singapore and Japan. In the U.S., we have our subsidiary with a direct sales force working together with a broad net of sales agents over there. We already have the infrastructure.
We will keep building of course, but what it has allowed us to do is really to accelerate, in particular with our recently launched bone graft called OssDsign Catalyst. Next slide, please. I also wanted to take the opportunity by not just talking about the long-term story of OssDsign, but really also give you an insight into how things are going right now. We recently just reported our second quarter results of 2022, and what we see is a heavy accelerating trajectory of the company now. We recorded a record sales quarter in every sense of the word. We had highest sales ever. First time double-digit quarterly sales. Highest cranial PSI sales. Highest U.S. sales. And we also treated twice as many customers as we've done in any other quarter.
A total of 63% growth overall for the group in the quarter. The highlight of the quarter was really the US, where we recorded an exponential growth of 155%. We're really starting to see the US taking off, which is completely in line with the strategy we communicated in the early part of 2021. During the quarter, we also finally managed to launch in Japan. That has been a little bit delayed because of the pandemic, and we also recorded our first sale. Now we are also present in the second-largest med tech market in the world.
Another highlight was also that the OssDsign Catalyst, the bone graft which we launched in U.S., in August of last year, during the quarter, we could already announce that we've now treated the first 100 patients, in the U.S. Then last but not least, we have two very important clinical programs running, for OssDsign Catalyst. TOP FUSION, our first-in-patient study, completed all patient enrollment. PROPEL, which is our prospective spinal fusion registry, has now launched and is actively enrolling patients. We are now in a position where we see much stronger momentum in the company right now than we've ever seen. If you go to the next slide, please. Now, what you see here, because I wanted to zoom in a little bit on the U.S., which was really the highlight.
What you see here is what we call rolling 12-month sales, quarterly sales, in the US. As you can see, from the early part of 2019 into here the second quarter of 2021, we're seeing a steady growth, essentially US growing in line with the business overall. Then something extraordinary has happened here in the last 12 months, where we are now seeing that growth trajectory being a lot more exponential. I think it's also worth here looking at the absolute numbers. We launched in the US in 2017. It took us about, give or take, four years to get to a point of rolling SEK 10 million in sales.
During the last year alone, we have more or less doubled that again, essentially, showing the very significant momentum we're seeing right now in the US, which we are, of course, extremely happy with. It seems to be robust. It seems to be sustainable. Therefore, our clear expectation is that we will continue to see that acceleration also, in the coming quarters, going forward. Next slide, please. I also wanted to zoom in a little bit on our clinical programs. For those of you who know OssDsign and the strategy called Ascend'25, we'll get back to it in a second. Really, one of our big priorities going forward in the company is really acceleration on our clinical programs.
If we start with our Cranial franchise, then there are really two important things here in that franchise. One is the post-market surveillance that we're publishing every year, and we will see that updated publication coming out towards the end of 2022. We are also working very actively on setting up a prospective registry in the U.S. on our Cranial PSI product. The reason for that is we just know that when publications are coming out, we tend to outperform the market that's out there. If there are any comparative studies, we also tend to do better. One of the challenges is that there is just not enough publications in this franchise.
We want to set up a registry to really try to start collect more data and also ultimately, of course, have more publications. For OssDsign Catalyst, I mentioned our TOP FUSION first-in-patient and our PROPEL registry. TOP FUSION is now completed. We have patients back for six-month follow-up right now. For PROPEL, it's really about expanding the number of sites. We took in some first sites. You have to get them up and running. They're now enrolling patients on a weekly basis, so we felt that it was time to raise the ambition level a little bit by expanding the number of sites, and we've now set ourselves a target of having 100 patients in that registry by year-end. Next slide, please.
Other than that, we have a strong momentum in the company right now that you can see and certainly a lot better than we've ever had with several quarterly records being set at the moment. Therefore, we will just continue executing on our strategy Ascend'25, which is really keeping a very, very high focus on the U.S., keep building our global bone graft business, a high focus on innovation, expansion of the portfolio. As I said, accelerate clinical programs and registries, and of course also keep working on operational efficiencies, specifically for us, reducing our lead time on our Cranial PSI product and of course, being very mindful on relative to COGS reduction. No change to strategy.
We are turning a corner in the company right now and with a momentum. We certainly don't want to change anything. We're very happy with what we see, so we will keep executing to the plan that we already announced last year. Next slide, please. Just as a summary, I think OssDsign is uniquely positioned for growth. We are seeing very significant growth now, right now, but we also expect significant growth as we look into the future. Why is that? One, as you saw from today's presentation, there is a very clear high unmet clinical need. We are bringing the latest and greatest in terms of next generation bone replacement products to the market.
We have a very big and a much better growth potential than we've ever had, and also, as I said, we have a strong momentum going on right now. Our Cranial PSI and our OssDsign Catalyst both have exceptional clinical performance, one in a clinical setting and the other one in a preclinical setting. We already have the strong commercial presence in place, the teams in place that we of course will keep building. It does mean that we are using that very actively right now to accelerate the company. Thank you very much for listening. I hope the story intrigues you. I hope the trajectory the company is on is intriguing. I think with that, I'll hand over for Q&A.
Thank you very much, Morten, for a very interesting presentation, as usual. I'm gonna have a couple of questions, and I thought that first we should touch upon the macro situation. I mean, you've been quite severely affected by the, let's call it hospital volatility in procedures, over the past year, maybe a bit more even. That has sort of lingered on. Just yesterday, I heard some very positive comments coming out of Stryker and NuVasive. Maybe if you can just touch upon how you're seeing the sort of macro environment within orthopedics right now. Is it sort of reaching the end of the tunnel?
Yeah. I think you have to be careful what you're saying these days. Listen, we've definitely seen an improvement from the early part of the year into the second quarter. We have seen more procedures taking place again. As you also know, I think we're still looking at an elective index around the 70 mark, at least when we exited the second quarter. I think we have to expect that the impact of the staff shortages, which are very significant, that they are more systemic in nature. Unfortunately, that means that they don't fundamentally improve things overnight. Are things getting better? Yes. Are we back to normal? Nowhere near, I would say right now.
You know, but of course, with the performance we have right now, we're seeing that as a big opportunity once we start to get back to more normal levels again, but we're certainly not there quite yet.
Okay. Thank you. You know, as lead time has been somewhat of an issue, I mean, you worked a lot to improve this, and you touched upon it briefly in your presentation. Could you maybe, you know, go into a bit more detail on, so what you're doing to shorten lead times and what that means for, you know, scalability of Cranial PSI?
Yeah. No, I mean, we launched a program towards the end of last year internally known as Project Bold. That has one aim, which is reduce the lead time. Unfortunately, there is no silver lining here or magic bullet that you can use. It's really working through all the processes all the way from the very early part of how we get design approval from surgeons to how we order the titanium meshes to how we produce to how we actually ship it. That program is looking all roll on that. We already have seen the first improvements, but clearly we want to be able to deliver even faster than we are doing today. It is a very high focus internally in the company.
Catalyst, your bone graft that you, as you said, had meaningful sales now in Q2, I mean, that's the first time you said that it has meaningful sales.
Yeah.
You know, generally the sales trajectory of this type of products tends to be sort of S-shaped.
Mm.
What I'm wondering now is if the meaningful sales is coming from, you know, that there's a lot of evaluation going on that's initial sales for, you know, surgeons, or if it's more like a few surgeons that has adopted this product and has started to use it quite a bit more than normal?
Yeah. No, I mean, you know, we don't want to get too close. It's still sort of early days into the operational aspect of that commercialization. But I can say we're extremely happy with what we're seeing. I think we do start to see the benefit of having a team that fundamentally know the side of the spine business where we are applying it. We've seen a very accelerating growth. We set some fairly high ambitions internally relative to the trajectory. We are on that trajectory right now, so we're delivering to plan. That goes actually for both sales, but also on the underlying metrics in terms of, you know, number of users, the number of, you know, VAC approvals, known as VAC approvals or the hospital's approvals that is a prerequisite for selling.
On actually all of those parameters, we are on plan right now. We are extremely happy with how things are going in the U.S. and of course have, you know, high expectations for also for the rest of the year for that product line.
That's good to hear. I just want to ask my last question, sort of go back to the clinical data aspect of it all. I mean, the preclinical data is very impressive, compared to, you know, the product that's out there right now. Say that you could provide similar data in terms of fusion rates, etc , for, you know, in-human trials as well. I mean, what could that mean for adoption rates of Catalyst in the, you know, medium to long term?
Yeah. Well, I think, you know, I remember when we launched our OssDsign Catalyst, like I received a lot of questions, or maybe more skeptical questions, whether we're able to sell on preclinical data. The clear answer, as I said back then, is yes, and I think we are showing that right now, that is happening. Of course, right now, first and foremost, what we need to is generate clinical data, which is essentially around two things. You have a safety profile on the product and you have an efficacy. If I start with the safety profile, which ultimately is the most important aspect when you're launching a new med tech product. You know, we have our first-in-man trial in Hungary, and now we've treated more than 100 patients.
I think we feel very comfortable around the safety profile on the product. Of course, you know, we want to see the efficacy as well. We will go as high as we can. I don't think necessarily that the fusion rate at one year, which is the kind of gold standard to measure on, is necessarily the only thing. You also have speed of fusion, which is particularly important. You have how the product is fusing in the body, in the procedures and so on.
There are many things that actually you can come out and make claims around once you have the data, and that's where PROPEL is crucially important because that allows us to get to a very broad data set with a lot of patients in a much faster manner than a larger clinical trial. We expect a lot from that. Of course, you know, it takes time to collect the data, get people in for checkups, publish the data. But until then, I think we are proving that we certainly can commercialize and succeed on preclinical data. And then as we generate more and more clinical data, of course, we'll start to use that actively to accelerate and go to more surgeons.
Okay. Thank you very much, Morten. This was very interesting.
No, thank you very much, Paul.
Thanks for doing it with us.
Yeah. Thank you very much for having me again this year. Pleasure.