Hello, and welcome to today's webcast with Integrum, where CEO Rickard Brånemark, CFO Jörgen Svanström, and U.S. President Jeff Zanni will present the report. After the presentation, there will be a Q&A. So if you have any questions to the company, you can send them in via the form to the right. And with that said, I hand over the word to you guys.
Thank you very much, and welcome everyone to Integrum's company presentation, the first quarter this fiscal year. Next slide, please. So we go directly to the introduction, and so it's, I'm Rickard Brånemark. I'm its founder and CEO, and to my left here I have-
Jörgen Svanström, CFO.
And on the other side of the pond, we have-
Good afternoon. Jeff Zanni, U.S. President.
We start with a quick recapitulation of the company. You know, we have been the real pioneer in bone anchored prosthetics and also into the neuromuscular integrated prosthetics. Our core product, that's the OPRA Implant System, and it is still the only FDA-approved osseointegrated prosthesis for amputees, and currently the approved indication is for above-knee amputees. We have since 2020 had an annual revenue growth of about +30%. We have had increasing profitability, and we have been trying to scale up the company. We also have a growing pipeline of new products and new indications, such as not only above-knee, also above-elbow amputations with prosthesis, and we are also working on what we call e-OPRA. That is a brain-controlled smart prosthesis.
We think that we now are well-positioned to capitalize on the large and growing global market for advanced prosthetics, and it's estimated that the market size currently is about $8 billion. I think we have a proven track record of clinical excellence, scientific innovations, and commercial success. We've been in this field for more than 20 years, and there are now more than 700 treated patients worldwide. Next slide, please. Here are some of the milestones. We started in nineteen ninety-eight. We went to the U.S. first in 2015 , where we had a limited FDA approval called Humanitarian Device Exemption. And then end of 2020 , we got the full market approval. That's called Premarket Approval, or PMA, so we can really start to scale up the business in the U.S.
And last fiscal year, our annual revenue surpassed 100 million SEK. Next slide, please. So our key market, that is the U.S. You know, that's the most important med tech market in the world. We got the PMA in 2020. We have our subsidiary that is run by Jeff. We have our internal sales force that is now strengthened. We work with different distribution partners that Jeff will also talk about. There is a substantial market size. In Europe, we have had less focus, but we're starting to work. We call that actually not Europe, we call it the rest of the world. We also there have a similar structure with an internal sales force, distribution partners, and it is a smaller market, but still a substantial market, about $2 billion.
We have some of the, you know, most prestigious institutions in the world that we collaborate with. On the experimental side, primarily, MIT, Massachusetts Institute of Technology, and on the clinical side, for instance, Johns Hopkins and the Mayo Clinic. Next slide, please. So what is the core product, OPRA? Next. So this is in the field of amputations, but not all amputations. This is towards the subpopulation of persons living with amputation due to trauma, accident, war, related injuries, or cancer-associated amputations. So that is what we are targeting today with the indication. And only with that limited subpopulation, we have this substantial total addressable market. So in the U.S. right now, we are only approved for above-knee amputations, but there is a very, very significant additional market if we can move into below-knee amputations.
We have publicly stated that we are initiating clinical studies funded by, actually the partner of ours, but through the Walter Reed National Military Medical Center, that is the major military hospital in the U.S. That means that over time, we will be able to expand the total addressable market substantially. Next slide. OPRA, what is it really? What is the difference compared to standard prosthesis? The standard prosthesis is a socket-based prosthesis, and the socket sits on the outside of the amputated stump. There are certain mechanical constraints to that solution because it's not really anchored to the skeleton, so you get mobility problems.
You get infections or pressure wounds because the socket is rubbing towards the skin, and you need to change the sockets frequently due to these problems, and also because the body is all the time changing in shape. If you add weight or you lose weight, et cetera, over time you lose some of the muscle mass, and then you lose volume. The OPRA implant, on the other hand, is directly connected to the skeleton, then bypassing all other problems related to the impaired mechanical solution with the socket. So that means we eliminate all our socket-related problems, and we can increase range of motion, that's how much you can move the joint, and limb strength.
It's also so that with a direct connection to the skeleton, you get a feeling for your prosthesis, and it's a combination of proprioception, that is a joint position feeling, and what we call osteoception, that you can actually feel with the implant, and it's very easy to put on the prosthesis, so what is really the difference here? If you have a socket, and you've been taking a shower, and you want to put on the socket, it could be very difficult because it needs to dry out. With an implant that is connected to the bone and there's a mechanical connection to the prosthesis, you can just snap it on in a matter of seconds. Next slide, please.
So the way we do it, we have a surgical two-step procedure, and that's been shown to be an efficient and now a standardized treatment. We have also added additional features. So the Axor II release system, that is like a ski binding. So if you get an overload, that will reduce the risk for fractures to the implant system, and also for fractures to the skeleton. We have also, since the introduction, actually in the early nineties, added what we call the BioHelix surface. That is a novel surface that increases the success rate of the implant and the integration to bone tissue through mechanisms that is making the healing more rapid and the connection between bone tissue and implant stronger. And we have now more than 700 users globally. Next slide, please. We have worked extensively with scientific evaluations.
So we're-- I think we're still the only ones that have published prospective studies, and we can show that we have a 92% clinical success rate with five years follow-up. And this is actually the data that paved the way for the PMA in the U.S. We can show that we have an increased mechanical function and the sense of self or osteoception. You take more step counts per day with a prosthesis like that, and in overall, you also increase your mental wellness and quality of life. Next slide. So even though in the U.S., or we're today only with the above-knee amputation indication approved, we have, outside of the U.S., been working with upper arm, lower arm, thumb, index fingers, and below-knee.
What is currently CE marked under MDR, that is the new regulation in Europe. It's the upper arm, it's the above knee, and it's the thumb and index fingers. Next slide, please. So let me very briefly talk about e-OPRA. That is still experimental. Go to the next slide. But it's the most advanced control system that is in the scientific evaluation phase. And it. So it is a way to create direct brain control to external prosthesis, but we don't do it directly in the brain. We use a neuromuscular integration. We use pattern recognition algorithms, that is the state-of-the-art artificial intelligence, and we're also adding tactile sensory feedback. And why is that important?
Well, you know, an extremity without sensory feedback is not really a real extremity, and we would like to try to make an artificial limb become a true part of your body. Next slide, please. So this is what we call, you know, signal from the brain to move the prosthesis. Sensory signal to the brain from the prosthesis, and this is what we call the closed loop. This is how an intact limb is working. That's what we're trying to recreate. But this is challenging, and it's not something that we can fully develop by ourselves. So for instance, we work with leading institutions, and the recent years, we've been working a lot with Massachusetts Institute of Technology. Next slide, please. So I'll leave the word to you, Jörgen.
Thank you. And as you've seen in the report, we have net sales of SEK 18.5 million Swedish krona for the quarter, in comparison to SEK 20.4 million in the corresponding quarter last year. And this leaves a year-on-year growth of -9.5%. The operating profit for the quarter was -SEK 12 million, in comparison to -SEK 2.9 million in the corresponding quarter previous year. And of course, both of these operating profits lead to negative EBIT margins. But I also want to note that we are still at above SEK 100 million for the last 12 months in net sales, and our annual growth rate is 33.4%.
If you look at the quarterly revenue, you can see historically it's been a bumpy ride, so it's not exactly a linear curve pointing just one way. I guess you can say that it's the same thing for the operating profits. If we compare the currency effect on the revenue, we had minus 9.6. The currency effect is not that big for this quarter in comparison to the last corresponding quarter. Of course, if you exclude the currency effects, they were negative. The direct currency effect, you have an EBITDA of minus 10.6. More or less minus 1.4 in currency effect for the quarter.
Looking at the operating costs, they are, as you can see, higher than last year. I want to point out that there are one-off effects of SEK 1.2 million, and also that we are more active, which leads to more professional services and also that we use more consultancy services. If we look at it regionally, United States had net sales or revenue of SEK 13.7 million, in comparison to corresponding quarter last year of SEK 15.2 million, and this leads to minus 9.8% growth. I guess a highlight is the Hanger agreement, which we signed in the quarter, and Jeff will talk more about that later on in the presentation.
And from my point of view, I want to point out that we secured a trade term loan agreement, and I suppose that you can say that it's almost like a factoring deal. But it means that we can actually finance on our purchase order instead of selling the invoices, which is much, much better for us because it means that we can finance at an earlier stage. The agreement is specifically made for the U.S., but we are currently negotiating to include the rest of the world as well. So that will come in quarter two. Looking at the rest of the world, the revenue was SEK 4.8 million in comparison to SEK 5.2 million, which meant minus 8.5% in year-on-year growth.
I think it's worth pointing out that we, in the quarter, we got the market approval in Israel, which means that the certification is out of the way. I also want to highlight or emphasize that we talk about the inventory build-up, and it's quite an effect, actually, when starting out in a new market, so I think this is something important to understand. The U.K. adopted the MDR regulations, so they use the same regulations, which means that we actually fulfill the demands, but they still need to go through the administrative process of approving it and this is what we are waiting for in the U.K. before, or at least we did in the quarter, before we can start operating.
Yeah, and also a comment on e-OPRA. We are also in a memorandum of understanding with Coapt to further develop e-OPRA. I now hand over to Jeff for the U.S. market update.
Great. Thank you, Jörgen. Next slide. I'd like to share with you some focus points. First is ecosystem and how we're executing. The second is, I'll give you a highlight, as Jörgen and Rickard have said, on our strategic partnerships, and an opportunity that we found that will help us speed. Some of the partnerships with key facilities and how we're working with hospitals, as well as prosthetists and clinics. A plan of building out the U.S. commercial team, and then one of the most important pieces, the voice of the customer. Next slide. In January of 2024, we launched the ecosystem approach, really learning how to properly put together a plan to execute against our budget. We currently have three reps covering the United States. We call them regional business development reps in the market....
We're really establishing what works well, how do we come up with a proper plan, and how do we expand that when we find exactly what works, so that we can build growth and replicate it across the country? The ecosystem model is working. What we've realized is that we need additional resources, and I'm gonna get into that on the next few slides. Next slide, please. So I've shared with you the ecosystem model before, and what it takes to generate patient production in the periphery of this ecosystem to send those patients to the center of the nucleus, which we see as hospitals and the surgeon. The key is the prosthetist. The key is the prosthetist, because they're the ones that have the relationship with our targeted customer.
They are the ones that will drive the patients to the facilities, and what we needed to find is a way to get to more prosthetists faster, versus having three regional business development managers moving around the country, along with a smaller organization, executive organization with three additional people in a support system. Next slide. So on June 10th, we entered into a strategic partnership with Hanger. Hanger has 925, and growing, clinics across the U.S., with employed prosthetists. This gives us an opportunity to partner with Hanger, to train their trainers, to train their regional business vice presidents of business development across the country, in an effort to stand up patients and identify patients that are OI candidates.
Additionally, Hanger has a distribution channel that will help distribute the Axor II to the market, and create a channel for awareness to the prosthetists and our technology. Next slide, please. By having this strategic partnership with Hanger, as well as SPS, it enables us to focus in on what you're seeing here referenced, the step one, which is connect and qualify. We now have not only our direct sales force, but we now have, and are building to, Hanger and SPS's sales force, helping us identify candidates for osseointegration, and utilizing our technology as a differentiated platform for their channel. What that'll help us do is move through the steps much faster than we have before, and generate more patients in step one, in getting them to the surgery center for S1 production. Next slide.
So, as I said, we only have three regional business managers working in the United States right now. With our capital injection, it's gonna allow us to take what we've learned, the model that has been proven, and expand our team and expand our footprint. We're also developing an onboarding and training program, so that we can pick up new hires and get them up to speed quickly. With this increased focus, we're going to hire a sales team that's strictly calling on prosthetists, and helping with our strategic partners in generating new patient production. We also, in June, launched this collaborative agreement with this additional partner called SPS. SPS is an independent distribution channel that will also operate very similar to Hanger, in the sense that they have regional business managers that we're also partnering with.
So we can leverage our current ecosystems that we've had partnerships with, and establish better harmonization between Hanger, SPS, other strategic partners, and the contacts that we've had. And lastly, really qualifying and driving patient referrals. Design a capture process for these newly identified patients to the current ecosystems we work with, so that there's a good inbound program, and then create a concierge service between the CPO and Integrum to walk this patient through the journey. So as we develop this and we fine-tune it, we'll expand our market, and I'm gonna share with you in the next slide, Jörgen, if you could advance to the next slide, our initial phasing here of the strategic partnership. We decided that we wanted to stay laser-focused with this partnership that we just executed.
We've established relationships with four centers for excellence or ecosystems across the U.S., and this is our primary focus in creating good collaboration and execution with the partnership. Next slide. Lastly, this deeper focus will create stronger relationships. It creates stronger relationships with the surgeons, our strategic partners, as well as Integrum-referenced individuals, RBDs, and resources. We're able to conduct faster penetration with field-based cadaver trainings, bringing surgeons to get the best clinical training with our technology. And lastly, which we're really happy about and excited to share, is that we were able, in June, to bring together the top 16 osseointegration surgeons in the U.S. to what we refer to as a master's course.
These surgeons came on their own time and spent time with each other, sharing best practices for osseointegration, true testimony to the support that we have from our surgical side of the business, with Integrum. And lastly, this new strategic partnership has created focus. This focus will create an opportunity to call on prosthetic centers across the U.S. and build out a sales team to support the efforts of capturing more patients. Next slide. I'll go back to Rickard.
Thank you, Jeff. Thanks for the update. Next slide, please. In principle, rest of the world is following a lot of what Jeff already described. We're focusing on the CPOs, that is certified prosthetist and orthotist, that's a orthopedic prosthetist. To help them and also combine that with what in rest of the world called excellence centers, that is very similar to the ecosystem. How can we execute that in the rest of the world? Compared to Jeff's present organization, the organization in Europe has been very small. In principle, we have a sales and marketing manager, and a training and education, and a key account manager or clinical coordinator, and then a marketing and events coordinator. Now you can see here we're expanding with clinical support experts, upper extremities.
Why upper extremities? Because that's a clear indication when you see market the rest of the world. Business development coordinator to follow up the KPIs, a sales support assistant to support the sales and marketing manager. A clinical sales rep towards the prosthetist, which is similar to what Jeff is doing, and he will start in Germany. And another clinical support expert, a prosthetist, to work with the lower extremity, and that will be primarily initially on the U.K. market. Next slide, please. So if we have a brief snapshot here, U.K., a distributor, and we just started in Germany and associated countries. We go direct, and we focus on three excellent centers. In Italy, we're gonna go direct, and then we're targeting with Rizzoli Institute, that is one of the top five orthopedic hospitals in the world.
In Ukraine, you can say we have more of a hybrid model. So right now it's direct to some extent, but you also know from our press releases that we have been able to sell an inventory. Over time, we see that this will change more to a distributed solution. In Turkey, we work with distributor, and Israel, we're also starting out with distributor. And you see all the distributors is starting, you know, right now, and that's also reflecting on what Jörgen said about inventory and stuff, and if needed, we can come back to that. Next slide, please. So what is the way forward? Next slide, please. Focused growth, and how we'll be able to execute that? We continue to work with the ecosystem strategy in the U.S.
Hanger is a very, very important part to be able to scale this rapidly over time, not this quarter. We will use a specialized sales force within the ecosystem, targeting on prosthetics. In Europe, we will penetrate key markets with a direct sales model and via distributors. Next slide, please. So we have been growing, you know, from just a few employees to now, I think we have about 35 globally. And everything is happening, and we need to make sure that we can continue to grow. So we're working to align the organization to this continued growth. We're going from a small company now passing SEK 100 million in revenue. We feel we need to upgrade certain key roles, and we also need to improve the efficiency by adding key systems to our headquarters and U.S. office.
And what do we mean by that? You know, we cannot trust that I would check every X-ray. So we're setting up system to be able to execute that. That is one thing. And you say, "Oh, is that important?" Well, you know, at this point, we are evaluating every single patient manually, because we need to have a very high quality and get great success rates. But this is something that we are now moving on to a more streamlined system. And if you're interested, I'm sure that Jeff can fill you in on that later. Next slide. So how can we get to operational excellence? Well, we need to drive economic value to the key customer, our core constituents. We need to establish the right sales force productivity. We continue to develop new products and launch new products to the market.
And we need to work efficiently with our money. And as Jörgen pointed out, I think what I call a factoring solution in the U.S., is something that will help our working capital challenges when we continue to grow. So let me stop there and go to the next slide. So, you know, this is what we do. We are changing people's lives forever. ... Yeah! Just as I do. Thank you very much for your attention, and let us now turn over to any questions you might have.
Thank you so much for the presentation here, and we received a large number of questions. I think we'll go straight ahead here. Can you tell us more about the status of the study on below the knee? Is it one or two operations per patient, or... And have you started receiving income linked to the study?
So the study protocol is approved by FDA, and FDA requires it to be a two-stage procedure, so that's what the protocol says. The protocol has received clearance from FDA, which is called an IDE, Investigational Device Exemption. But the study has not started to include any patients yet, and so there is still no revenue.
Thank you. Why is Europe so weak versus Q4?
Yes, so to some extent, I think we've tried to explain that when we do an inventory build up, we get the revenue when we do the inventory build up and I think that the most typical example here would be Ukraine, so end of Q2, we reported that they bought inventory for 3.5 million SEK and of course, that will be affecting revenue because they used an inventory that we already sold, so that is, I think, a key mechanism, but it's also so that if you go check, you know, the quarters, we have a volatility quarter from quarter, so that can also affect and that's because we have fairly low volumes there.
Thank you. What are you doing differently now compared to twelve months ago?
I think that the big difference is not really what we do now. I think it's more related to what we're going to execute forward. And I don't know if you want to add something yet, but you know, the Hanger deal will change a lot what you will be doing and how you will focus your team going forward. And this is not, you know, just for this quarter or next quarter. This is a plan for long-term growth. Jeff, do you have anything to add?
I do. We have a fantastic surgeon-based foundation. We have clinicians and surgeons that are eager to use our technology, want to use our technology, stand with us on our technology. What we need now, and this is why the focus has shifted, to not just securing more surgeons, it's not what we need. What we need is patients for the surgeons, and the way we get those patients is hyper-focused in on the prosthetist, 'cause they're the ones that hold the relationship with the current amputees, so as we move forward, our target now is not just on the ecosystem, it is at the top tier of the ecosystem, and calling on prosthetists and expanding our sales force to prosthetists to generate more patient production.
Thank you. Is the financial performance in Q1 an outlier compared to the last couple of quarterly reports?
Yeah. So yeah, to some extent, you can say that, but it's also so that these have been, you know, our best quarters ever. So whether what is an outlier, that can maybe be discussed. And as I was trying to explain, with a couple of new distributors coming on board during those quarters, as compared to no new distributor coming on board this quarter, that will, of course, also affect. But, you know, we, we're not going to sit here and have no growth for this company. So that's not the plan. So of course, we feel that the figures that we did last year and when we reached SEK 100 million, that's still just a part of our journey.
I think also relating to the last – the previous question of what we're doing differently, I mean, twelve months ago, we didn't have any distributors like we have now. So of course, in the short perspective, the inventory buildup will lead to an immediate revenue stream. But I mean, the major revenue streams from the distributor partnerships will come in the future and not from selling the first inventory.
Thank you. Does Integrum have to actively participate in selling its products in the promoted medical centers?
I'm not sure I really understand the question, but you know, we sell in the U.S., and you can fill in also, Jeff, you know, we sell our implant system directly to the hospitals. But the Axor, and additional prosthetic components, that's sold to the prosthetist.
Thank you.
Mark, could you just repeat that question, please?
Yeah, of course. Also, does Integrum have to actively participating in selling its product in the promoted medical centers? Or to add some more color, does the centers not promote the product as a part of its, their service on ongoing basis?
Let me try to answer that question. So, on the surgical side, to Rickard's point, here in the United States, we go through the standard orthopedic implant process, which is called VAC approval. So the product gets submitted to the hospital, it goes through approval committee, and then gets access to the surgeon at that facility or ecosystem. From a promotional standpoint, what's been really interesting to watch here in the U.S. is that as we've gotten deeper relationships through the ecosystem approach and started working and collaborating with the institutions, we're finding these institutions utilizing their own resources to market and share that they are now an osseointegration site. So they're using it as a differentiator for competitor hospitals.
Thank you. What are the remaining steps to complete the Hanger agreement, and what is the expected timeframe?
You know, Hanger is a big entity, and we have a good rapport, good relationship. There's two pieces to that, that agreement. One is the Hanger side, which owns prosthetists as well as clinic, clinics. And then there's the SPS side, which is more of the distribution side, but they both fall under the Hanger umbrella. It's a big organization, and, you know, they're excited to be working with us as a differentiated technology. We've already done some collaboration out in the field with these co-branded opportunities of bringing patients together and collaborating, and identifying new opportunities for OI. I think it's a slow-moving ship. I think it's going certainly in the right direction. The relationship is extremely strong and is starting to roll out.
You know, again, reflecting on one of my slides, we have essentially three business development managers here that are running the United States in all of our centers. So as we start to expand our sales staff and our resources, I think we'll be able to speed opportunity. But right now, it's going at a very good pace where we're identifying and harmonizing and teaching their teachers, so train-the-trainer mentality on our technology. So we'll have more sellers out there now in this collaboration.
Thank you. Can the lower U.S. sales be explained by any surgeons moving hospitals during the quarter, resulting in a stop of surgeries that would otherwise have been carried out?
As Rickard had said, you know, we're not a highly utilized product. We have a potential, but we're not a high volume product just yet. When you have a surgeon that shifts or moves facilities, it does hurt you, right? It does make impact. You know, the good thing is that we have had a couple surgeons relocate to new facilities, and the surgeons that have moved is generally a surgeon that will pick up that facility from the departure and become the new leader of osseointegration for that facility. But then, when that surgeon lands at their his new opportunity or their new opportunity, it does take time to stand up a new program, and that can make some impact.
Thank you. Is there a continuous work with Hanger or any other products that will take focus away from increasing sales in the shorter term, meaning the next quarter and forward? Or should we expect a continuous depressed sales development into Q2 and Q3 as well?
I remain very, very confident in, in our ability to grow this organization, and I think with this new strategic partnership, it's gonna allow us to generate more patients. Again, we need to, we need to ramp up our team and increase our sales team. We have eight people here in the U.S. covering the United States, three regional field people. My expectation is certainly positive for the future, and I think this is gonna help us in the long term.
Thank you. You previously announced a reversed profit warning when your sales were higher than market expectations. Why did you not announce a profit warning for the low Q1 sales?
We have checked this with our legal advisors and certified advisors how we should handle this, and we have followed their advice.
Thank you. Considering the low Q1 sales, is there a particularly high demand for your surgeries in Q2 that could propel sales back to the anticipated higher levels?
Could you repeat that question?
Yeah, of course. Considering the low Q1 sales, is there a particularly high demand for your surgeries in Q2 that could propel sales back to the anticipated higher levels?
Rickard, I don't know how you want... how you'd like me to answer that.
No, I can start maybe with, you know, rest of the world. So there we had a lower revenue than expected, but we don't share any further details. So that can, and I'm now trying to indicate, and we still have surgeries going on that we don't get any revenue from because they've already been sold to that inventory. So that can be one mechanism in rest of the world, but I think you're primarily talking about the US, and you know, what we are trying to do now is a fairly big shift to make sure that the Hanger collaboration is working, but it's also. So and we haven't really talked about that. You know, we did a capital injection, and that would give Jeff also additional resources to be able to expand-...
the work outside Hanger, because I think that's where we had a, maybe a primary weakness. So, maybe you can expand around that, Jeff?
Yeah, you know, we originally had stayed focused in on these ecosystems, which again, were the periphery of diagram that you saw. So we had a small organization calling on PM&R, surgeons, distributors, prosthetists, all the above. And now with this focused mechanism, calling on prosthetists to generate patients, we feel as though it's gonna be much more impactful. And now that we have this collaboration with strategic partners, we will have many others that are indirect sales, essentially calling on prosthetists to generate opportunity for us.
Thank you so much. Can you tell us about your expectations on the Hanger agreement in more concrete terms for the fiscal year? What will be good sales contribution, and what will be below your expectations?
Let me first say, you know, we don't give any prognosis, so we cannot say anything about the figures. We stated in the report that we expect that the Hanger collaboration will have effect this fiscal year, so I think, unfortunately, we have to leave it with that. Yeah, let me just give you an example to get a feeling for the magnitude of the opportunity, so it's up to you, Jeff, to fix it. You know, Hanger is sitting on about a third of the amputee population in the U.S., and our targeted indication is about, say, 180, to make it easy, 150,000 patients, so that means that if they have a third, they have about 100,000...
They have about 50,000 transfemoral amputees that could maybe fit our treatment. So even if, Jeff, short term can only get a small fraction of that, it's a very, very important opportunity. And if, over time, that can be a good part of that, that's why we feel that this Hanger setup is a very, very important way for us to rapidly meet a big part of our potential patient population. Jeff, do you want to expand on that?
No, I actually think you covered it, you covered it perfectly. It's an opportunity for us to get to the market much faster, and quite frankly, with a partner that's interested and excited about this technology. They won't represent any technology that's not approved. We are certainly FDA approved here in the United States, and they are excited to have us as part of their portfolio.
Thank you so much. Have Hanger started building its Axor II inventory yet?
So Hanger is a distributor, and yes, they have acquired and continue to acquire stock of Axor inventory for distribution.
Thank you. A question to you, Rickard. In Kyiv, what is the maximum number of operations that can be conducted per week in the current setup?
It's not a normal setup. They are at war, and they work a lot. And this hospital is not just focused on our implant system. But if we can switch more, so say that they, at maximum, do one or two surgeries, which is maybe a half day or a day's work with our technology. So you see there is still an enormous upside if we can do more, but I think that's not the plan. We have created one center of excellence, and that's the way how you, I think, in the best way you enter a market, and this is not our model. This is actually, if you go back to dental implants, that's how you enter the global market, and then how you place million of implants.
You create a center of excellence, and you use that as a training vehicle for other centers, and then they will be centers of excellence in their regions, and then they train others. This is a cascade effect that been used effectively, I think, not only for dental implant, but for many other implant systems also. So that's why we feel that it's this is not the limitation what they can do in Ukraine, and hopefully it is not, because the volume of amputees is predicted to, at the end of this year, bypass a hundred thousand.
Thank you. Could you provide more detail on distribution of sales during the quarter? Did you face issues in the first half or the second half of Q1? Secondly, how far off were these Q1 results from your own expectations?
Okay. Do we know if this is toward the U.S. or rest of the world?
It says it doesn't mention in the question.
Primarily, our distribution from a European perspective is what we have in the rest of the world. I think we said here that, you know, we have signed up distribution agreements, but in principle, it's only the hybrid thing in Ukraine that's already up and running, where the U.K. is not approved. We have approval in Israel, but we haven't started surgeries there yet. That's still in the works, but we have inventory in place.
Thank you. How many new surgeons has gone through education in the quarter and are now ready to do surgery by themselves?
... Yeah, Jeff, maybe you and I can talk about that because, you know, we discussed that previously. That's not a limiting factor. I don't know how many surgeons you have that would like to start in their hospital. So you're really cherry-picking, and we're more focusing on, you know, this ecosystem more than and gonna work with that together with Hanger to have, you know, where do we have the right density of Hanger clinics around it, et cetera. And in the rest of the world, we also have trained enough surgeons, so that's not the limiting factor. Frankly, I think that is a key message here, and that was Jeff trying to say, the surgeon is not the limiting factor right now.
It's to make sure that we have patient awareness and that we have the right value proposition to the prosthetist. So Jeff, do you want to add?
Yeah, 100%. So, the surgeons are, again, extremely supportive of our technology, and they want to do more cases. What is the challenge now is to get the patient to the surgeon. What's really interesting is we reflect upon the master's program, where we brought those top-tier surgeons together. We think about some of the centers that we work with, and I can tell you that all the big academic centers, the Mayos of the world, the Hopkins of the worlds, were in attendance at that master's meeting. So it's not the surgeon standpoint, the hospital standpoint that is a factor. It is now going after the prosthetist, creating a value message to the prosthetist to generate that patient production.
Thank you so much. Moving on to the last question here. Could you please describe the situation in Ukraine? Do they have the financing in place to continue to buy your products? Do you see Ukraine growing from here?
Yeah, I think that's a very good question, and it's also a bit challenging to answer it. They are at war. The center has been moving forward with negotiations with the government to get this treatment in the sort of the curriculum to be a standard of care for the niche patient population we are targeting in the Ukraine, which is still a very big patient with what we call the short stumps from the tourniquet syndrome. You know, you're a soldier, you have your harness. You go in, you get hurt, you have bleeding from your arm, you activate the tourniquet.
A medic will see you and say, "Okay, you need to be sent back to the lines." It takes many, many hours, and when you have someone that can really take care of the trauma, you know, a surgeon and so on, you have had this tourniquet on for so long, so the arm is dead, and you have to do a short stump amputation. So that is what we are focusing on right now in Ukraine to get into the government. But it's also so that there is a lot of international money floating into Ukraine and support the current business we have. So short term, without being, you know, we cannot say anything what's happening with the war, but there seems to be enough money floating in to support our growth.
Longer term, and I don't really know what that is, because, you know, negotiations with governments might take time, but the, we feel that this will be a standard of care for the very selected patients at least, and they are still enough to support a long-term business opportunity in Ukraine.
Thank you so much for presenting here today and answering our questions, and thank you all for tuning in. I wish you a pleasant weekend.
Thank you very much.
Thank you.
Thank you.