Ladies and gentlemen, welcome to the BONESUPPORT press conference. Throughout this call, all participants will be on listen-only mode. Afterwards, there will be a question and answer session. If you have a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. I'm pleased to present CEO Emil Billbäck and CFO Håkan Johansson. Please begin.
Thank you so much, operator, and welcome everyone to this beautiful day where Håkan and I are sitting here with a big smile on our face. What we want to do is to take you through a brief presentation on the news that we have released early this morning and then open up the line for questions and answers. We have a presentation that the operator will manage. If we go to slide two. As usual, there are some disclaimers regarding what we will share with you today, and let's immediately jump to slide number three, please. What we released this morning is that CERAMENT G has received market authorization. We received the email notification from FDA sometime after midnight early this morning, and we woke up to these very good news.
It is the first ever antibiotic eluting bone graft that has been authorized for the U.S. market. As a matter of fact, it is the first ever combination product, combination of device and drug that has ever been approved through the De Novo process. We have understood from the documentation sent to us on the approval notice why potentially the final notification was somewhat delayed. It very much relates to the fact that this is the first ever of its kind, so a new category has been set up and developed specifically for this product. Needless to say, CERAMENT G is now the only product in that category. The product CERAMENT G has received market authorization grant order for bone infections, and it's a broad and wide covering approval.
The bone infection does not take into account different etiologies. It means that CERAMENT G is approved for bone infection regardless of how that bone infection has started. When I say regardless, I mean the indication, and not the term of pathology related to different bacteria, because of course there are certain bacteria that are resistant to gentamicin and here, other treatment modalities would have to be taken into consideration. The product is also specifically to be used in extremities by adult patients, so it doesn't have the pediatric indication. As I mentioned before, there are no real relevant clinical restrictions. The material that has been sent in to FDA to receive the market authorization is extensive, and we will look at some of the details later on in the presentation. We go to slide four, please.
When we have spoken about the U.S. bone graft market, before, and what is also available in public reports is that the market is about 360,000 surgical procedures per year. This represents a market value of $360 million, and this consists of all the different treatment options that currently are available. As you know, autografts, meaning when own bone tissue is taken from the patient and transplanted into the injury, is part of the procedures but is not part of the value because there is no way to put a price tag on autograft. The value today is made up of all the commercially available products while the procedures are all the procedures. That means that about 70,000 procedures doesn't have a value.
We see a clear tendency that the market is moving away from autograft and more into synthetic products, and this is also why there's exceptionally strong value growth in this market segment. In terms of procedures, it's 50,000 procedures a year where bone grafting is done and the patient present themselves at the clinic with a bone infection. We've also added in this slide, you can see 90,000 procedures where the patient does not have a bone infection, but the surgeon is suspecting that an infection could develop over the next couple of days, or this is maybe a high-risk patient. Many of them, as we know, come from open fractures and trauma. If we look then to the right side of the values, CERAMENT G has now a granted order, and it's a full, widespread granted order for bone infection.
It is applicable to all of the $98 million or almost $100 million of market value. The market value for preventing infections with local antibiotics is $112 million, and the rest of the market is about $150 million. One could react and say that there is a big discrepancy between procedure and value for the non-infected, while no local antibiotic is used. That is correct. The biggest discrepancy here is on the autografts which doesn't have a value. If there's an infection, it's very unlikely to use an autograft. If you're preventing an infection, autograft is also much less used. Autograft has a big presence in the blue part of this pie chart. Let's move on to slide five, please.
If we look at the total market, let's say, for local antibiotic treatment, it is about SEK 200 million. The 100 million, 98 million that CERAMENT G has received market authorization for, and then there's the $112 million, where we are considering to pursue also in the future to extend the label also into preventative care and treatment. If you look at slide five, you can see what different treatment modalities are used today, both when a surgeon is addressing an existing infection and when a surgeon is trying to prevent and use local antibiotics to avoid that an infection might occur. Sorry for the gory picture there to the left, where you see a picture actually from a surgery where PMMA beads are removed from a wound.
PMMA beads represents close to 40% of the treatment choices or the situations where infections are either managed, treated, or prevented. As you know, with PMMA beads, it's something that is implanted and later on has to be removed. This procedure is repeated a couple of times until the infection is completely eradicated, and then focus is on healing the actual bone injury. Operator, if you please could take me to slide eight. We jump three slides forward. If we look at the material, this is a busy slide, so I will just highlight and also give even further insight to why it took quite a while to get the De Novo approval. We have submitted extensive data both on the treatment group as well as the control group, the comparison.
Slightly above 400 patients in total. BONESUPPORT have, together with our advisors and together with our partners, collected, processed, concluded, and submitted more than close to 17,000 data points. In a way, you can say that what we have submitted is actually as extensive as if we would have done a PMA application. We have supplemented both the treatment group and the control group with extensive amount of X-rays that have been interpreted by experts. This has been part of supplementary packages that we sent in September of last year. Some of you might remember that we were asked by FDA in February, end of February 2021, to bring additional patients in the control group.
This was quite extensive work, which was submitted by my great team in end of September. With this data, FDA could proceed to what we have today, which is a market approval. Also would like you to look at the graph on slide eight at the top right corner. What we had to do, because this is the first ever combination product of device and drug in De Novo, we had to submit extensive documentation, preclinical and clinical data regarding the elution profile of CERAMENT G. This relates to the pharmacokinetics and the pharmacology of gentamicin and distribution volumes.
As you know, the very strong results of CERAMENT G comes from the fact that it's a one-stage procedure where you treat and address the bone and skeleton injury, and you have a very high dose of gentamicin, in this case, eluted over more than 30 days. The scale on this graph is logarithmic, so you can see that in the very first days, the concentration that you have locally is more than thousandfold of the minimum inhibitory concentration. This now without any systemic side effects, which we also had a demand from FDA to show extensively with clinical data. If we go to slide nine and actually share with you for the first time ever, what is the outcome of and what is the result of the data that we have submitted.
The treatment group had eventually 163 patients, and the control group eventually landed at 270 patients. The control group consists of patients that have been treated with the most common treatment modality in the U.S. today, which is PMMA beads. The data for the PMMA beads comes from publicized clinical study and also from a meta-analysis of some seven different published clinical data. That's how we could eventually build our control group significantly above what we had in the first application submission. The treatment results is based on the Oxford data, which is one of the bone infection centers in the world that has the most extensive clinical documentation, not only on CERAMENT but in total, we would say.
Here we can see the results that the patients treated with CERAMENT G had a recurrence rate of infection of 4.3% after two years. At a mean of four years, this number was 5.5. When it says mean four years, that means that some patients were followed up significantly longer, up to six, seven years. The average of those follow-up patients was four years. The PMMA control group had infection rates between 13.2% and 13.3%. CERAMENT G shows clearly superior clinical outcome versus PMMA. This is strong in the clinical setting and has led to strong statistical significance.
What I would like to show you now is also the clinical data result we have submitted. I also would like to take you through some of the marketing intelligence that we have, because we have conducted a quite extensive market research. I'd like to share some of those details with you to back up some of the statements that we have made this morning that we believe that this product is very much longed for in the US market. If you go to slide 10, please. We conducted this market research in 2020 at almost 180 interviews with decision-makers, either physicians or value analysis managers, in the purchasing departments of the hospitals.
The questions that were asked is how is bone infections treated today and how satisfied are the surgeons and the administrators with the current treatment options that are available. If you go to slide 11, please. The question I received a couple of times this morning is this product really new? Does it bring something of value? And is it really something that the surgeons are looking for? We found out from this research that 94% of the surgeons dealing with bone infections believe that there have to be improvements made. That means basically in short that 94% are dissatisfied with the treatment options that are available today.
It was also concluded, as you see on the bottom right, that both the surgeons and the healthcare system believe that bone infection is a difficult and challenging condition, and that it has a high rate of recurrence. When the surgeons were asked how their patient perceive having a bone infection, of course, 62% responded that it was a challenging indication for their patients. If we go to the next slide, twelve, please. We saw the reinfection rates with CERAMENT G. They were 4.3%-5.5%. We saw that with PMMA beads from these extensive clinical studies, many of them done at some of the best infection centers in the world, was 13.2% and 13.3%. The surgeons that we asked in the market research claimed that they had reinfection rate of 24%.
Maybe that is even a better reflection of the reality. We know that when we start a clinical study and we follow a strict protocol, sometimes the results are improved just by the fact that you're doing a clinical study. The surgeons in the U.S. said that about 24% of the cases have reinfection. When we look at meta-analysis from Europe, that number is rather between 10%-16%. I think again, this shows the market potential in the U.S. When the surgeons were asked how they feel about multi-stage procedure, 92% expressed dissatisfaction with a multi-stage procedure and a clear preference for a single-stage procedure, which CERAMENT G is the only one that can offer. Go to slide 13, please. This is the final slide based on the market research.
Again, it gives a bit of flavor to what is it that the US orthopedic surgeons are looking for. 88% said that it's most important is to have sustained local antibiotic over a period of time, that the drug elution is consistent, which, of course, none of the off-label current treatments with local antibiotics have proven a predictable drug elution. Also high scoring for bone remodeling capabilities. Of course, when we finished this market research in 2020 and saw the results in the very end of 2020, it was a strong encouragement for us at BONESUPPORT and our teams to continue to work on these projects despite the setbacks and sometimes challenges that we had with FDA in the beginning of the progress.
If you go to slide 14, now we're coming more down to the tactical part. What's gonna happen? Well, we have communicated to the market this morning that we are aiming to launch somewhere between September and October. We keep it a bit open because we now have to go through the entire granted order and see what modifications we might have to do to labels or our claims in the promotional material. We start producing labels, material for the salespeople, do final training. We have to produce product and ship it over to the U.S., and then we will start shipping to customers. The selling will though start a bit earlier. That will start to inform the most prominent surgeons in this field.
As you know, we have received a very generous, I would say, NTAP for the product. It's not only covered by the DRG. For all the CMS patients, there will also be an extra payment of $4,920. We also know that many of the private insurance companies use the CMS guidelines as guiding principles that they later also adopt. If we go to slide 15, please. Here we see some further details on the reimbursement. I think we have covered that.
What I also would like to add is, as we expected, and we had discussions also early on with FDA, this is the first ever combination of device and drug, and that's why FDA is very keen on those who are doing a post-market surveillance study. This was clearly expected from our side. We know that it takes place for all the PMA applications, for example. Given how few De Novo approvals there has been, we were anticipating that this demand will come. We are looking at collecting real-world patient data to include about 160 patients. This will be done over the next 4-5 years. Patients with bone infections in the U.S. Sorry, not in the U.S. We will actually later on determine where the center will be.
That will be done in the dialogue with FDA. There will be 160 patients included over 4-5 years, and the cost of this will be about SEK 25 million, plus minus SEK 5 million. That will be spread over the period of 4-5 years. Slide 16, please. Well, coming to the end of this presentation, the only thing actually to add here is that the launch, as I mentioned, will take place at the very end of quarter three, beginning of quarter four. Once my very hardworking team have had a bit of a break, we're gonna start now also to analyze the available data in terms of label broadening, where we anticipate to be able to submit something to FDA between quarter two and quarter three next year.
We had a slightly earlier timing in previous presentations, but since we are now three months delayed from the original date, I think it's fair to say that between quarter three and quarter two and quarter three next year is when this will be submitted. We will look at different indications, but highest priority, of course, is trauma, as you know. If you go to the final slide 17. To just conclude what we have said today, CERAMENT G, last night or early this morning, has received market authorization. This is clearly a milestone for us as a company, but I would say even more so, it's the milestone for the patients in the U.S. We know that there is about 150,000 amputations per year in the U.S. on lower extremities, legs.
The second most common reason for going into an amputation is trauma. Trauma, open fractures, bone infections. Hopefully, by bringing CERAMENT G to the market, that will make a big difference. We have seen the clinical studies. We have seen the market research implying that there is indeed a large unmet clinical need in the market. Very happy to announce that CERAMENT G has indeed shown clear superiority to what is currently the US market standard. We will be launching hopefully somewhere early October or late September, and we're aiming at a list price somewhere between $5,200-$5,800. This is not yet fully determined, but it will be in that range.
I'm happy also to say that we have already the 375 salespeople that today are selling CERAMENT BVF, very eager and hungry to get CERAMENT G into their portfolio and start the next chapter for BONESUPPORT in the US. That concludes my presentation, and let's now open up for questions.
Thank you. If you wish to ask a question, please press zero one on your telephone keypad. Our first question comes from the line of Kristofer Liljeberg. Please go ahead. Your line is open.
Thank you, and congratulations, of course, big day for you. Three questions. The clinical benefit you show there in percent, is that something that you would be able to include in the label? Also, I didn't fully understand what you mean with your planning here to broaden the label, if you could explain that a bit more. When it comes to access to U.S. clinics, with the setup you have today, is it possible to say how large proportion of U.S. clinics that you currently do business with, or at least have access to?
Would you say that there's a need here to add more resources when it comes to sales capability, both with external partners and internally, to really being able to catch this great opportunity in the US? Thank you.
Yeah. Thank you, Kristofer. Look, we're super happy to have received this approval. Now let me try to answer your question. First of all, on the label, FDA does not allow that we put any numbers in terms of how superior the product has come out in the, say, the clinical study. The label is quite neutral and quite clinical, just stating what the product should be used for and how it should be used and what warning signs there could be for patient safety. When we speak about a broadened label, today, the purpose of the product is to supplement the surgical treatment of a bone infection. Bone infection is our indication.
As you saw on the pie chart, we also would like to use CERAMENT G to prevent infection in, for example, trauma. Now that FDA has granted approval, they have gone through a massive amount of documentation showing the work mechanism and how gentamicin is absorbed and spread, let's say, locally and how it eliminates the bacteria. All that data will be the same, but we will have to find additional data on the indication trauma. Here, I think we will be very much helped by the Aljawadi and Jahangir papers that are specifically on trauma. The work mechanism and the product as such has now gone through the scrutiny of FDA with a positive verdict.
We believe that extending the label into other indications such as trauma, maybe ortho-oncology and so on is probably more like a 510(k) process rather than a new De Novo, but that has to be investigated. It, it's a potential positive in terms of the timing and complexity. Finally-
On trauma, you see, you know, an easier path to getting US approval there following the failure of the large phase 3 trial, the sort, the last one.
Yes. Well, easy. I've learned the hard way that nothing with FDA is easy. Now that we have the approvals, there is the chance possibility of a 510(k) application rather than a full new De Novo. That takes off a lot of burden, of course.
Yeah. In Europe, do you have an approximate figure how much of CERAMENT G and B usage or sales that goes to prevention versus treating existing bone infection?
A majority of the sales we have in Europe, I would say close to 60% of the sales we have in Europe for these products is for treating, and then the remaining part is for prevention.
Great. Thanks.
The big part is bone infections in Europe and then, but we do believe in the longer term that prevention is gonna grow faster.
Okay.
Your final question was on market access. Well, the beauty with the setup we have in the US is that it's highly scalable. I actually have great distributors that we have qualified over the last three years. I said it's about 370 salespeople that are selling CERAMENT today. We think that can increase to 500 salespeople because CERAMENT G is such a unique and special and expensive product. Since they're paid on commission, I think it would be a lucrative way to get all hands on deck.
The payment you will do, is that the same percentage for terms as for the standard version in the U.S.?
Yes, it will be. Yeah. They are paid 30% on the standard.
Yeah.
CERAMENT, and they will be paid 30% on the much more expensive CERAMENT G. Correct.
Great. Thank you.
Thank you, Kristofer.
Our next question comes from the line of Hans Boström, Trinity Delta. Please go ahead.
Hey, good morning. I'd like to extend my congratulations as well. I like to understand of the 360,000 procedures you mentioned, how large share of those would be immediately addressable relating to the treatment indication of infection. Secondly, also just like to tally the $360 million that you mentioned, which would suggest $100 or $1,000 per procedure. Is this I mean will you be charging a premium to the average price at the moment, or how should we view that? Will this market then therefore expand considerably in size?
Yep. Yeah. Thank you. Thank you also for your question, of course. The 360,000 procedures that are being done annually, 50,000 of those are on patients that have an existing infection, and that's where the approval has been given. These 50,000 procedures represents $100 million today. The current treatment options that are being used average just south of $2,000. If you would take these 50,000 procedures and say all of it would be CERAMENT, well, the market opportunity is a bit north of $200 million.
The answer is yes, we do believe that the market value is gonna significantly grow now that the first product that is approved on the US market has a substantially higher price than the previous versions, but also a significantly higher payment through the NTAP system.
Great. I just would be curious, would you expect any competitive response to this? I mean, there's obviously a very large competitor in the trauma market in the U.S., which presumably is also active in this market. I mean, do you see any interaction with existing incumbent providers and that they would be responding relating to your entry in the market in any way?
I'm sure there will be something. I don't know. I have to somehow emphasize that the bone graft market in the U.S. is underdeveloped and a bit tired. The regular Cerament has come as a fresh innovation and quickly gained very strong market share in a short period of time. The big competitors have tried to innovate in this space, but I would say there's nothing material that have come to the market other than Cerament. When we now come in additional with Cerament containing local antibiotics, I think we're already a few miles ahead of competitors.
For sure, I mean, we live in a competitive world, but for someone to take a product to the market, similar product, they will have to go through the same pathway that we have done, and it will take a lot of years, a lot of clinical implementation. I think even the big companies will think twice before they try to challenge us in our turf and then o f course, we have the patents that are protecting us. I think this is our space to rule now for a while forward.
Oh, great. Thank you very much, and best of luck.
Thank you so much.
As a reminder, please press zero-one on your telephone keypad to ask a question. Our next question comes from the line of Sten Westerberg from Analysguiden. Please go ahead. Sten, your line is open. I think you're on mute, Sten.
Can you hear me?
Yes.
Yes, we can hear you.
Thank you so much, and let me join the choir of congratulations to this event. Now, could you explain a little bit more about this preventive market in the United States, which you have not received approval for, but I guess there is an extensive use of off-label products in this market area. For example, have you included the coatings or fixations and that kind of product in this 90,000 procedures?
Yeah. Thank you, Sten, for your question. Maybe operator, you could help me. Let's go back to slide four so that the participants can see that slide while we're talking. Slide four, please. This is only on bone grafts. If we look at the European market, we know that sometimes the surgeon will use plates or screws and nails that they will also coat with Cerament. There's some early sign, uh anecdotal stories, but also case studies showing that this could be very effective to creating osseointegration, meaning having the bone grow close, let's say, to the plates, sometimes grow into the plates, and also to prevent infection. That is not at all calculated in the data you see here.
We're talking only about bone graft when CERAMENT is used to fill the void between two ends of a bone that the doctor would like to grow together. What you talked about is an additional market which we're looking at for the future. The first step there is to provide clinical evidence and then also broaden the label to include coating of metal hardware. We're not there yet. That's a project in our pipeline.
Thank you. One additional question. I do see some reports asking for single-step procedures for PMA-PMMAs as well. Could you comment this practice? Is it at all in use in the U.S.?
Yeah, I know that there are discussions on PMMA, which is bone cement, as a one-stage procedure. None of the big centers are recommending this. I would say even opposite, if we look at the French CRIOAc centers, they clearly state that when PMMA is used, it needs to be removed afterwards. I think the only possible application area where it could potentially be tolerated if the right clinical studies are made and the right regulatory hurdles are passed, is in joint replacement, potentially, which is one of our smallest area. Otherwise, I don't see any merit for it actually.
If you want to have a one-stage procedure, and you want to build bone, and you want to prevent or treat an infection, then CERAMENT G or CERAMENT B are the options you have.
Okay, thank you. That concludes my questions.
Our next question comes from the line of Erik Cassel from ABG. Go ahead, your line is open.
Hi. Congratulations, Emil Billbäck and Håkan Johansson. Very impressive feat you managed. My first question, the 50,000 cases that are addressable with this approval. But how many additional cases would be reasonable to assume through sort of off-label use?
I don't dare to speculate in that. I think, you know, within a year we will know what the doctor decide to do. We will only promote CERAMENT for what it is approved for, meaning bone infection. What I think we should bear in mind, we should look at reality. Reality is such that an orthopedic surgeon comes to the office, to the clinic, and let's say in the morning, they have two patients with bone infection. Now that CERAMENT G is approved and it's very convenient to use, I think there's a high likelihood that that surgeon will prefer to use an approved FDA product rather than do off-label mixing. I think the advantages are more than obvious.
In the afternoon, if the same doctor has a trauma patient with a high risk of infection, well, I think we can ask ourselves, what is that physician gonna do? Are they gonna then go back to use off-label, or are they gonna use the same product that they successfully used that morning for bone infections? I think that's the consideration that many doctors will have. To what degree that will take place over the next year or so, I think we will have to find out. I don't dare to speculate in it. What we can see in Europe where there are more local antibiotics approved and where CERAMENT G and B have been on the market longer, the preventative market is growing very fast.
If you look at the U.S. proportions, it's actually slightly underdeveloped. Of course, if you don't have the product and it's not approved, I guess that it doesn't reach its full potential. A regulatory approval, of course, is one of the keys to get there, and that's the next of our priorities now to work on, also to get, for example, trauma as an extended label.
Okay. Thank you. I assume you can be a bit more aggressive on pricing given that you have the fairly strong NTAP. Considering that the sort of off-label use won't be covered by the NTAP, and you most likely will be quite aggressive with pricing, do you think that will hold back off-label use to some extent?
If we look at the market research, cost and price was not the major concerns of the orthopedic surgeons. They had many other vectors and parameters that were much higher in their priority order. We don't have any such indications. I think the price has been well chosen. The final price is, as I said, not set yet. That's why we gave a range. We should remember also that CERAMENT G has gone through tremendous clinical documentation, which we will use in our promotion to the physicians. When an orthopedic surgeon has a procedure and the patient comes back after a few days with a bone infection, the reimbursement for that clinic, the reimbursement for that doctor drops dramatically.
It's almost to the extent that a failure by an orthopedic surgeon, a failure which presents itself that the patient has developed an infection, will lead to a loss-making on the patient when they come back because they get a minuscule DRG for the follow-up visits, and they have to treat that bone infection. I think the doctor will have quite a high acceptance for choosing a slightly premium product if it gives enough security to avoid that the patient comes back. By that, I say, of course, the well-being of the patient goes first. Once that is covered, I think there's also a strong financial aspiration by the doctor in which product they use.
Okay. Thank you, Emil. Good, good answer. Can you just remind us, is the standard DRG for this somewhere in the range between $20,000-$25,000?
Yeah. I think applicable now with bone infection, it's some 50-60 different DRGs. As we got a broad label, there could be infection in the bones in the hand. It could be infection in the collarbone or in the leg or in the arm. If you take the most common indication like a tibia, an open tibia fracture that has led to an infection, then the DRG is around that level that you mentioned. Of course, the more difficult it is, the higher the DRG moves up.
What you could say now is if you have even a rather small procedure, let's say there's an infection in the bone in the hand, which would have a very low DRG normally, the doctor can now choose to use Cerament G because they get an NTAP also on these indication codes. If you say that Cerament G would potentially be cost-prohibitive to fix a finger, but if there's an infection in the bone in the finger and the NTAP kicks in, all of a sudden it's all of a sudden a good cost reimbursement benefit again for the doctor.
Okay. Yeah, that makes sense. Just on the list price, I know you won't get into the specifics, but could you tell us which part of the range you're sort of leaning towards? Because this is a fairly wide range at the moment.
The upper part of the range.
Good to hear. Just the last question before I jump back in the queue. I mean, considering the data used in the submission for bone infection and that it led to an approval, I know trauma is a bit more challenging of an indication, but do you feel that the data you have on hand for trauma is sort of sufficient to meet this bar that FDA has set, or are you a bit less certain about trauma?
Well, let me start with what I have at hand. I actually believe that over the last 3-4 years, and also before that, we have built one of the strongest regulatory teams in the industry. If anyone can do it's these guys here. They deserve a break. It has been intensive with FDA all the way to the end. After that, we will start looking into some of those studies I mentioned before. We don't know. I cannot really say until we have seen the patient granular details behind those studies. I promise we will come back once we've made that determination and give a clear outlook both on timing and success rate.
Okay. Thank you very much, Emil. Congratulations. Well done.
Thank you so much, Erik. Appreciate it.
We have a follow-up from Kristofer Liljeberg from Carnegie. Please go ahead.
Yes, very quick. When it comes to manufacturing of CERAMENT G, do you have any sort of limitation and how easy is it for you to scale up?
We don't have any limitations at hand. We don't see that. To produce the products takes about three months to go through the different sterilizations and receive all the different parts from different manufacturers. There's a complexity with it, of course, and the quality controls are meticulous. This is. We couldn't start producing, actually. We didn't want to do that before we got the approval. We know and we've heard from some of our suppliers that, yeah, it's a tougher environment, shipping costs going up, components, there is lack of supply. We haven't seen anything so far, which it doesn't mean that we couldn't have disruption, but I cannot foresee that.
In three months from now, if we get started next week, we should have the first U.S. designated products, and then we have the chance to ship them over to the U.S.
Okay. Thank you.
We have no more questions at this time, so I hand the word back to the speakers for concluding remarks.
I would like to say it has been a long journey. It was very intense from time to time. This autumn, we had several discussions with FDA when we submitted our supplementary information. We waited for almost four months, and we thought we were gonna get a final approval. The last 10 days, the dialogue again intensified, focused on more practical questions regarding the product and label and the details. We are now extremely happy, of course, after this long journey, to finally be able to deliver also and offer our breakthrough technology and our blockbuster product from Europe into the U.S. market as the first ever approved device drug combination and as the first ever approved synthetic bone graft with antibiotics. A new chapter has started for BONESUPPORT, and we're of course, very happy.
Thank you everyone for making the time today. Look forward to speak to you all soon. Thank you.