Hi everyone, hope you've been enjoying day three of the J.P. Morgan Healthcare Conference. My name is Vidhushi Taduri, and I'm an associate in the healthcare team here at JPM. It's my pleasure to introduce XVIVO's CEO, Christoffer Rosenblad, who will be presenting to you today. Over to you.
Thank you so much, and welcome to XVIVO's presentation. XVIVO is a company that scientifically pushed the boundaries of organ care prior to transplantation. And since you so amicably introduced me, I would jump to the XVIVO's vision. Today, organ failure is the most common cause of mortality. XVIVO is determined to change this, and one day make sure that our vision comes true, which is that nobody should die waiting for an organ. Alex, on this picture, used to live in Perth, Australia, which is a very remote town in Australia. Before XVIVO, Alex would have died due to organ shortages or too far distances to recover a new heart. Now, she got enrolled in the XVIVO Australian study for the Heart Assist Transport device, and she did receive a heart from across the country. And this would have been impossible without XVIVO's technology.
I actually met her in Europe. Today, she's living her fullest life. She's taking her PhD in Amsterdam, in the Netherlands, and living a normal life like the rest of us, going to the gym every day. What do we do in XVIVO? This is an overview. If we start with the company's name, XVIVO, it actually means outside the body. And that is exactly where we operate in the transplant process. We are between the organ donation and the transplantation. And our job is to optimize organ care and evaluation of organs to enable more organs and better organs to be transplanted. This is the snapshot of XVIVO. Basically, XVIVO's products are based on over 30 years of intensive research. It's hundreds of thousands of man-hours that got into basic research to come to where we are today.
We started in thoracic, the thoracic region, hearts and lungs. We started with lungs, and later actually intensified our research into heart technology. Now, we'll come back to this technology later in the presentation. In 2020, we acquired the abdominal portfolio, so that's liver and kidney, and became the first global all-organ company within transplantation. In the following years after 2020, we acquired service modules so we can enhance our go-to-market strategy and be a true partner to our customers. In terms of financials, we always had very healthy financials, and in the past years, healthy growth rates as well, especially in the years when we started to commercialize our paradigm-shifting technology. We look pretty much in terms of market. We look like a lot of medtech companies, with 60% in the Americas, 35% in EMEA, and 5% in APAC.
Then we can jump into the transplant market and the problem we are facing today, for later on in the presentation, to explain how we want to solve this problem. Today, we know that approximately two million people are in need of a transplant every year. However, in the year of 2024, only 170,000 transplants were performed. Hence, we are now meeting 10% of the global need for transplantation, and to explain a little bit more, for sure, to fill that gap of one to 10, we need to have more donors, but to be very clear, the key problem is that we're using too few of the actually donated organs, as you see in this picture. To increase the use rate of the donated organs we have today, we need machine perfusion.
The other challenges we are facing is a changing dynamic of the donor population. There are two types of donation. It's either DBD, donation after brain death, and the other one is DCD, which is donation after circulatory death. During the past 10 years, we've seen a shift of a typical donor. From 10 years ago, it was typically a young DBD donor, and now it's typically an older DCD donor. Both DCD and donor age introduce uncertainty into the organ quality. And this is where machine perfusion comes in, both in terms of keeping the organ in good condition and evaluation tools to determine what is a good or a bad organ. And the best impact, or the impact that is best shown, is the introduction of our lung technology.
Even though we have seen overall a fairly low number in growth of donors with lungs indicated in the last five years, the number of lung transplants where we have commercialized our portfolio has grown 11% in the same period. So this is where we see that technology can shift how many organs we can use. So coming back more into how do we actually solve the problem. For decades, XVIVO has been in the forefront of saving lives. Today, we have the best innovation in the market. This is great, but not enough. We also need to provide the best-in-class services to help OPOs and transplant programs to grow. And our goal is to become the preferred partner in the transplant process in the next couple of years. And this is the offering of the best-in-class products we are providing to the market.
XVIVO. A few things to point out. XVIVO is the only company that develops perfusates that are the bags and the bottles you see in the picture. XVIVO is also the global leader in both lung preservation, transportation preservation, and in lung evaluation today. We are the European number one in livers, but the most interesting technology is the XVIVO heart technology. It's really the crown jewel of the product portfolio. Today, it's not commercialized yet. It's awaiting approval in Europe, but it has the potential to change transplantation forever, and we'll come into that a little bit later. On the right-hand side of the slide, you can also see the service offering. This is under build-up to be fully built up during late 2027. If we look at slide 14, the regulatory approval stage is in the core market. A few things are clear.
And one thing that strikes me is that we see that we have the majority of our growth in front of us. Today, the main share of revenue comes from our lung products. And we see that we have global approval on kidneys, as well as European and Australian approval of liver. And the most innovative product, the heart, is not even approved yet. But all regulatory trials are completed, and we are on the brink now to launch those products and change the paradigm for heart in the world. And if we look at the liver, we are investigating our regulatory pathway for the U.S. market for liver as well. The impact XVIVO will have to the transplant industry is mainly four, and this is how we want to reshape transplantation. The first two points are patient-centric, and the last two points are more transplant and society-centric.
But the first and more important, which is completely linked to our vision, is that we need to make more organs available for transplants. And with our technology, we can do that. The other thing we see in all clinical trials is that by using XVIVO, we can improve the patient's life by better outcome and longer survival. But this is not enough. We also need to support our partners, the transplant clinic and the OPOs. And we're going to do that by reducing costs and increasing efficiency in the transplant system so we can enable more transplants for the same US dollar amount. But what we also want to do is to reshape how transplants are performed and make it a plannable procedure. And we can see that already on liver in Europe, for example.
It's now a plannable procedure versus before it was something you did in the middle of the night, so we are in the process to do that already. I started to say that we spent three decades on research, and this is something that makes us completely unique in the field we are. We have really tried to optimize organ care with best-in-class perfusion solutions, and as I said, we are the only company who actually brought those solutions to market. The third point which makes us unique is that we have spearheaded and have a large body of evidence for HOPE, which stands for Hypothermic Oxygenated Perfusion, and that has proven to be the best way of transporting an organ between the donor site and the transplant hospital. You keep them in the best condition possible with the lowest risk and with the best patient outcome.
It has also been proven that with HOPE, you can increase the out-of-body time more than you could before. The last part of the presentation will go more into the future and the outlook. We start with the little bit shorter-term outlook, and since the U.S. is our largest market and also has the greatest growth potential, both short and long term, the catalyst for next year is to drive lung evaluation adoption, where we are already leaders today, and we're going to grow that market. We also will implement NRP into our service offering on customer request. The most important milestone next year will be to file the heart file to the FDA, and we will invest heavily into our commercial organization, both to drive growth from existing products we have today, but also to prepare for the heart launch that will come in 2027.
In Europe, we have a very strong position, and we are looking forward to the CE mark also for heart in Europe that will drive growth for the next decade in Europe as well. And we will enable customers to use the best-in-class products. And it's a question I get every day from European clinics: when can I buy your heart product so I can start recovering more hearts and get better patient outcome? And I can also make heart a plannable procedure versus today, an extremely stressed procedure where you have approximately four hours out-of-body time. If we look a little bit further into the future and how we want to change the paradigm of especially heart, I promise to come back to heart. And if I want to highlight one thing, it's the transatlantic flight that was performed.
It's the first time ever a heart flew across the Atlantic Ocean. And not only was it unprecedented due to distance, it was also the longest out-of-body time ever recorded with more than 12 hours. And it's amazing. But typically today, even for short distances, you use private airplanes. This was done on a commercial airline, an Air France in commercial. And as you see on the picture here, this is an actual picture from that recovery. It's an economy seat, which is unprecedented for three things. What is even more striking with this case, there have been many more after this, but what is striking with this case is that Professor Lebreton, he really pushed the boundary because the donor was very old. And more so, the patient was an older patient and too sick to transplant. So he was delisted from the transplant list.
But thanks to Professor Lebreton's hard work and XVIVO's Heart Box, the patient got a second chance to live and actually had a very good recovery after transplantation. And to sum up why you should invest into XVIVO, as I started, the market potential is huge. In terms of number of transplants, it is 10 times larger than what standard of care can accomplish today. XVIVO is the only global company that can offer a portfolio for all organs that increases availability and improves patient outcome. We have, similar to the previous presenter here, we have a history of continuous profitable growth. And last point I want to point out that spending those three decades of heavy research has paid off, that the portfolio we have now is truly innovative.
And when we go into the next generation of organs, such as xeno organs or printable organs, that's when XVIVO products really need to be used. So for example, there have been two xeno hearts made here in the U.S. Both were made possible with XVIVO technology. Without it, those would have not been possible to have been done at all. And with that, I want to end the presentation with a little bit longer look into the future. When you fly, you might be seated next to one of those heart boxes. That is a heart donated that is transported to a patient. This patient has likely been on the waiting list for a long time, hoping for a donated heart. At the same time, there is a donor family. And in the darkest of moments, choose to give the gift of life to someone else they don't know.
I invite you today to be part of this journey and share this vision that one day, nobody should die waiting for a new organ. Thank you for listening.
I think we can move on to Q&A if there's any questions from the floor and any that are coming through online.
To kick things off, it'll be really interesting to hear what makes XVIVO really unique to your competitors versus your peers in the market.
Yeah, thank you for that question. I think the three decades of ground research into how do you actually keep cells alive, how do you optimize organ preservation, how do you optimize organ evaluation, what type of perfusion liquids do you actually need to accomplish this, makes us truly unique in a couple of ways. But the most striking way is that we're the only company who brings perfusates to market in the transplant industry today. And the perfusate is the blood substitute, and that is so important to keep cells alive. And that's why we see in clinical trial superior outcome over and over again when we run clinical trial. So that makes us truly unique. We're the only one in the world doing this today.
Secondly, I would say we have spearheaded the HOPE way of transporting organ, and that is by finding the right temperature, which is hypothermic, but not ice, and oxygenate it and perfuse it both during transport, but also for making plannable surgery in a safe way, and HOPE offers a lot of benefits. It will prolong the out-of-body time, but it will also be the safest way of actually transporting an organ. For example, if something goes wrong with the device or if anything happens during flight, the organ will be in good shape no matter what because it will be kept at optimal temperature. It will be far better than ice, which is the standard of care today, so even in the worst-case scenario, it's still better than what we actually do today.
Thank you. In your presentation, you often refer to the paradigm shift when describing your heart technology. What do you mean by that? Would you mind expanding a little bit further?
Yeah, absolutely. Thank you for the question. We believe the heart has the potential to become the gold standard in heart transplantation and heart preservation transplantation. The reasons are manifold, but one patient outcome is better. If we compare normal hearts that we did in Europe, we saw that we got an improved patient outcome using this. And this is normal hearts below four hours, DBDs, that they are improved. We can also see that not only can we improve patient life, we can also make more organs available because of matching. Today, matching is limited, or opportunity of matching is limited due to the short out-of-body time, which is approximately four hours, which doesn't allow for optimal matching. But with the heart box in the market, you could go for national allocation in Europe, in the United States, in large areas.
We can already see one example of this is Australia, which is prior to approval. So we can't market the product. We can't sell the product. But in DBD hearts, we have a 40% market penetration already without actually selling the product or promoting it. So I think that's a hint to why I think it will change the paradigm. Lastly, the heart product and the heart box you see in the picture here, it allows for reducing huge amounts of cost into the transplant system. Where you before had to pay hundreds of thousands of USD in transportation costs, you can today go on a commercial airliner or for shorter distances, opt for car instead of private airplanes, which is what we use today. So with driving down costs, we will enable more transplants to be made and hence more patient lives to be saved.
So this is why we believe this should be the gold standard going forward and once approved.
Yeah, that's great. Any questions from the audience? Okay, I think a final question from my side. I think when we look forward into 2026 and the years forward, what should investors keep an eye on, and what should we be excited about?
I hope the same things as I am looking forward to, and I'm excited. Number one, we are looking forward to the biggest heart and lung transplant congress. It will be held in April. We will have hopefully some great presentations there. We hope for U.S. data to be presented, or U.S. data will be presented during the conference. We also run a direct procurement DCD trial in Europe that we hope to be presented, which is fantastic on 40 patients, which will make the DCD recovery process so much easier than we do today, and we will drive again, drive down costs by using this simple device. Besides that, we are obviously looking forward to handing in our application to the FDA for the heart box and the CE mark hopefully this year in Europe so we can start selling it and start marketing in Europe.
Besides that, I will keep an eye on what we have seen in the last couple of years, the increasing penetration of existing technologies we have on the market. That's, of course, something to keep an eye on. We have a great lung product approved everywhere in the world and liver technology in Europe to see that continue its market penetration.
That's great. Thanks for nodding yet. I think we've got one question in the audience.
I don't necessarily need a microphone. I was just going to ask, do you have any updates on the liver regulatory process in the U.S.? I know you maybe commented that you'll be approaching a different option. I don't know if you're able to say if there's any updates there on that.
We are still investigating, and there is no update today on the regulatory process for the United States. That was the question, but as soon as we have an update, we will come back in a quarterly investor call.
Thank you. One question. Once your cardiac device is approved and it seems to be a lot simpler to use and more easy to transport, how does XVIVO plan to really expand that and potentially compete with the NMP system from one of your biggest competitors?
I mean, I think in Europe, there is fairly limited competition from NMP today. In the United States, there will be a need for a service component for some clinics. So the feedback I get today is that this is so easy to use, so we don't need any service. We can do this ourselves, a lot of clinics. But there will be some clinics due to size or lack of recovery surgeons that want to have an additional service component to enable the use of the XVIVO Heart Box.
Okay. Thank you very much. Thank you.
Thank you.