Ladies and gentlemen, welcome to the Fresenius Medical Care HDF Expert Call. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for question at any time by pressing star one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Dominic Heger, Head of Investor Relations. Please go ahead.
Thank you, Sasha. We would like to welcome all of you to our HDF expert call. We appreciate your interest. As always, I'm happy to begin the call by mentioning our cautionary language that is in our safe harbor statement on slide two of the presentation. For further details concerning risks and uncertainties, please refer to this document as well as to our SEC filings. Our expert call series is designed to provide a deeper dive into key topics for Fresenius Medical Care, and to give investors and analysts the opportunity to hear directly from the leading experts. As I'm sure you will have noticed from our recent presentations at capital market conferences, we are very excited about high-volume hemodiafiltration, or HDF, and the opportunity to bring a new standard of care to the U.S.
We wanted to spend some time explaining what is HDF, how it differs from traditional hemodialysis, what it means for patients, as well as our experience with this therapy in international markets. I'm very pleased to have Frank Maddux, our Global Chief Medical Officer and member of the management board, here today to share his experience from a medical perspective. Today's call is not meant to cover rollout plans for the U.S., nor pricing strategies or any other financials. We will share more on our strategy at our Capital Markets Day in June next year. At the end of Dr. Maddux's presentation, we will open up the line for questions. If you would prefer to submit a question via email, you can send your questions to ir@FreseniusMedicalCare.com. I will now hand over to Frank to begin the presentation. Frank, the floor is yours.
Great. Thank you very much, Dominic, and I appreciate the chance to speak to everybody a little bit about, hemodiafiltration and some of the medical and scientific information that we have that leads us to believe that this is a preferred therapy for patients that we treat with end-stage kidney disease. Let's start on slide four with the, basic schematic of hemodialysis, and just thinking through the physical principles of how we modify human blood, recognizing that the primary, mechanism that we've used for years in treating people with end-stage kidney disease is the principle of diffusion. It is where high concentration of substances on one side of a, compartment divided by a semipermeable membrane, flow down through that membrane, into a compartment of lower concentration.
And that is the basic principle of hemodialysis, where in the circuit, we have blood flowing inside a series of hollow fibers. These fibers are the semipermeable membrane made out of a substance called polysulfone. And these hollow fibers allow the blood to travel through, with dialysate traveling in the opposite direction on the outside of the fibers. Diffusion allows for the ability of substances, small substances predominantly, to flow through the semipermeable membrane, and that flow through actually gives us the opportunity to extract some of these toxins that build up in patients over time, through the hemodialysis procedure. If we move to the next slide. Within hemodialysis, there are a couple of things that have occurred over the years, in innovation.
There is a change in the membrane structure, in which the membrane porosity increased from low flux, where the pores are very small and there's low water permeability, to areas of high flux, where the pores are slightly larger and have increased water permeability, which allows us to move slightly larger molecules. There are also on the market very high porosity membranes, but the risk with those is the risk that you remove molecules of a certain size that you might not actually want to remove, albumin being one of the core molecules for that. So this concept of current hemodialysis is really around high flux. Hemodialysis is probably today's general standard, with the concept of a new modality that's innovative, called hemodiafiltration, including not only the physics principle of diffusion, but also that of convection.
Convection is where you take high hydraulic forces on the blood side, and you create a large pressure gradient across the semi-permeable membrane that removes a significant portion of plasma water and some larger molecules with it across these specialized membranes that can tolerate those pressures. That convective volume becomes a second mechanism for modifying blood, so you're using diffusion and convection within those particular treatment, and the clearances become significant, while the need to replace that plasma water that is lost is part of the differentiation of this form of therapy called HDF. If we move on to the next slide, this will be slide six, we're now looking essentially in these three compartments down the end of the barrel of an individual hollow fiber.
And you can see in the leftmost panel, the hollow fiber isn't permeable at all, so nothing is getting out. You're getting neither diffusion nor convection moving any molecules out. When the semipermeable membrane is such that certain molecules can go through, you can see that you're moving molecules somewhat of different sizes, but to a greater extent, the smaller sizes are preferentially moved into the dialysate or the blue compartment here. With the combination of diffusion and convection, the rightmost panel will show you what HDF does. It has the opportunity to remove some of the larger molecules, and one of the markers that we look at is called beta-2 microglobulin.
These are larger molecules that we would choose to remove, but we would choose to try to retain albumin within the blood space, 'cause albumin is one of the key components and markers of nutritional status for our patients, and the competence of the ability to use albumin in the blood to bind up other substances that need to be carried through the blood, and we would prefer not to lose albumin during these treatments. So with this additional cleansing effect, you get a fundamentally different treatment that's this combination of diffusion and convection. We'll talk about high-volume convection in a moment. In the next slide, you'll actually see HDF in a little closer schematic that shows some of the variations that can occur.
Over the years, there have been different forms of replacing the plasma water that is taken out with HDF and has to be replaced in the patient. We prefer the post-dilution method, but in various parts of the world, some people actually reinfuse that in the middle of the dialyzer, some do it before the dialyzer part of the circuit. But our feeling is that for our ability to use some of our tools to manage volume management in the patient and to look at how we optimize this treatment, we think post-dilution HDF is the ideal reinfusion place.
The second piece that's really important is that we've had to be able to develop the opportunity to create replacement fluids, and these replacement fluids replace the plasma water, and it's one of the core elements that allowed us to look at when we removed high convection volumes in the patient, and we removed a lot of plasma water. You can see in the clinical trials that I'll talk about in a minute, there were opportunities to have better outcomes for patients.
So with the newly created machines, dialyzers that can withstand the hydraulic pressure and have the appropriate size porosity, software that enabled the ability to control the hydraulic pressure that's in there dynamically within the machine, through a feature called the AutoSub Plus feature, it allowed us to create practical, safe, efficient, and reliable high-volume post-dilution HDF. Next slide, Dominic. So when we look at how we built our platform for being able to deliver HDF, it required a number of things. We need to make sure we had a machine that was designed for high-volume HDF that could both achieve the desired physical components of creating transmembrane pressure across that semipermeable membrane that allowed us to remove high convection volumes.
We had to have dialyzers that could withstand these pressures and reliably deliver the ability to remove the molecules that were desired, but at the same time, withstand some of this hydraulic pressure. The 5008 , 6008 series machines can provide the software and the basics and the mechanics for doing this. The Coral dialyzer and the dialyzer that we have been using most recently is highly designed for this therapy to be able to achieve the most biocompatibility that we can for patients, at the same time, being able to deliver this high volume and high convective volume therapy.
We require water that meets certain standards, and most of the water in the markets where we operate around the world can now deliver clean enough water that is acceptable for HDF therapy and the production of replacement fluid. And you've got to have a vascular access that can deliver blood flow at a reasonable rate to allow the patient to have enough of blood processed during this treatment to generate the convective volumes that we have. And you'll see that with some of the features on the new machinery, we've actually been able to deliver, even with central venous catheters, high convection volumes in many of the patients that are treated there.
So the substitution fluid pumps, the ultrafiltration that is occurring, the ability to create online fluids that generate replacement fluid that can be given back to the patient... and the ability for dialyzers with adequate surface area, that will both provide the removal of small and middle molecules while avoiding larger molecules like albumin loss, is quite important. If we move to the next slide, this will be slide eight. When we see the aggregate of clinical benefits and our take-home message here is that we believe that the clinical benefits of high-volume HDF should make this ultimately a standard of care, that not only improves survival, but improves many of the clinical conditions that we would be looking to try to either avoid or to mitigate from the kidney replacement therapy.
And that includes, dealing with hypotension during the treatment and the inter-treatment reports, increasing nutritional status, and improving that through both nutritional status in patients feeling better and therefore eating better, but also reducing inflammation. Better anemia control and our ability to optimize the use of erythropoietin-stimulating agents through their supplementation in patients. Recognizing again that toxin removal is improved, inflammatory states are reduced, and most recently, with the CONVINCE trial, we have been able to show that there is an improvement in patient-reported outcomes, and this is one of the key differentiators I believe that's occurred. Our belief is that high-volume HDF presents this optimal therapy, but as you will see on the next slide, there have probably been five randomized controlled trials around HDF over the years.
The CONVINCE trial was certainly not the first of these trial, but is probably one of the most important trials, because it in fact used high volume. It was a diverse patient population, had multiple providers and multiple countries involved, a long follow-up time, and it measured patient-reported outcome measures and health-related quality of life measures. So of these, five major RCTs that we're looking at it, where we saw high-volume HDF and where we saw post dilution, we saw consistent results in these, and not all of the studies utilized the exact same technique. And so the CONVINCE study was really a very important study. It was designed to test a high-volume HDF hypothesis against high-flux hemodialysis. Next slide.
So the CONVINCE trial, which was supported by the European Union's Horizon 2020 Research Fund, and a grant under this was a large multinational study of 1,360 patients randomly assigned to either HDF or high-flux hemodialysis. Long follow-up, the average follow-up time was 30 months, and in 61 dialysis centers, eight different European countries, including both Eastern, Northern, and Southern Europe, and this recognition that the primary outcome was all-cause mortality. And in this study, the mortality rate reduction was 23%, and this particularly pragmatic trial was delivered in a way that was very consistent and showed that, number one, you could achieve high convection volumes.
Number two, we saw a consistent reduction in mortality, even though it was in the middle of this pandemic time that we saw when the study was performed, and recognized a significant advantage for HDF over high-flux HD. If you go to the next slide, I want to point out just a couple of things that were recently published this summer, and that was the patient-reported outcome measures. These measures were studied intensively and allowed for the the CONVINCE consortium team to look at over 10,000 surveys of patients during their time on therapy with both HDF and high-flux HD. Looking at a variety of markers, cognitive function, physical function, fatigue, sleep disturbance, anxiety, depression, pain, and social participation were the core elements. And the health-related quality of life measures showed that HDF positively affected these.
It was also shown that there was a mitigation of the decline in cognitive function that we know can occur in patients with long-term dialysis, and there was an opportunity to combine this with better survival. That really leads us to believe that optimal care today would look like high-volume HDF with a significant convective volume and the opportunity to treat patients with this therapy over a long period of time to get both the quality of life measure benefits, but also the hard benefits that were included with that. So if we go to the next slide, this would be slide 13.
We've looked at our real-world evidence to pair with the CONVINCE trial to see if even in a broader population, less selected than any randomized controlled trial study population would look like, do we get results that look similar when we analyze these? So we understand CONVINCE and these randomized controlled trials are essentially the gold standard in medicine. We think the trial being done in multiple settings, multiple countries, and multiple providers was one of its greatest strengths. But we also said, what does our own data look like in our own clinics? Because we've had extensive experience outside the US with this therapy for some number of years.
We looked at our own data in over 660 facilities based in 23 countries, totaling about 25.5 million treatments over four years and about 85,000 patients, to recognize that we got a very similar all-cause mortality reduction, and we also saw a reduction in cardiovascular mortality coded through this period. You'll see those results on the right here. In addition to that, we were able to show that we saw a significantly higher level of our adequacy measures on our clinical operational data. We showed lower evidence of inflammation and for the C-reactive protein, which is a biomarker of inflammation in patients, it was almost a 20% reduction.
Likewise, we've shown that patients with mineral and bone disease that's related to advanced kidney failure showed that their need for phosphorus binders and other mechanisms to try to mitigate mineral and bone disorders was significantly less as well in the HDF population. And then finally, we showed a significant reduction in the utilization of ESA needed to maintain anemia in patients. And this is also probably related to resistive indices that are part of the inflammatory process. By controlling inflammation, we probably had some advantage in anemia management.
These studies were done in our EMEA clinics, and it is part of our real-world evidence that we have presented at a variety of medical meetings and is in line with the CONVINCE study, and I think has informed us that not only in a very population of patients that are willing to go through the disciplines of a clinical trial, but also general patients that are being treated by practicing nephrologists in the field also were significantly showed these significant improvements. If we move on to slide 14. When we look at HDF, it's grown substantially over the last 10 years. It's had about a 13% annual growth rate, and right now there are over 500,000 people being treated by HDF. We think that this is, and that's all outside the US.
There are no patients chronically being treated by high-volume HDF within the United States. And our feeling is that it's now time to recognize this as a preferred therapy, with the goal being that this becomes a standard of care in the future, as we believe that this modality, which is fundamentally different than standard high-flux hemodialysis, is an opportunity to take a leap forward in providing this more innovative therapy. So if we go to what I think is my last slide here, we want to talk a little bit about how we are looking to bring HDF as a standard of care into the United States. That will include recognizing that we've had our Coral dialyzer approved in 2023, which is an HDF-capable dialyzer in the U.S.
We have a machine system called the 5008 X machine that has been approved and is in its early stages of bringing it into experience within the United States, and that we anticipate that we will have a significant launch in 2025 with the for HDF and making sure that we have options available to physicians with machines that are capable and dialyzers that are capable to deliver this particular therapy. So I think with that, Dominic, I'll stop my formal comments and be open to any questions that you or the audience might have.
Thank you for the presentation, Frank, and the remarks, which I think were quite insightful. Before we open the lines for questions, kindly be reminded that we are focused on HDF from a medical perspective and our experience internationally. I know that the investment community is clearly eager to hear more details about the US launch and specific financial information. Again, that will come with our CMD next year to the extent we are able to share for competitive reasons, and with that, I will ask Sasha to open the lines, please.
We now begin the question and answer session. Anyone wish to ask a question may press star one on the telephone. If you wish to remove yourself from the question queue, you may press star and two. Anyone with a question may press star one at this time.
Thank you. So the first caller is Oliver Metzger from Oddo BHF. Oliver, your questions, please.
Yes, good afternoon, and Frank, thanks for your presentation. The first one is about your go-to-market strategy in the US, so there are obviously a lot of clinical benefits, so if I'm just thinking out loud, so it provides basically, if you do it in your own centers, you have basically an opportunity to distinguish between competition, in particular in some urban areas as-
... eventually, the better clinical outcome should attract more referrers from doctors. So, so can you just share with us your idea how to think between the expected external versus internal sales in the US at one point of time? And the second question is, if you look deeper into the 22% reduction in all-cause mortality from real world data, how does this distribute between the period the patient is just starting in dialysis, or in most cases, crashing into dialysis? And how is the difference after the first three or six months? Thank you.
Yeah. Thanks, Oliver. There was a little breakup there, but I think I got the gist of your question. First thing I would say is we've got to make sure that within the U.S., there are opportunities for physicians to prescribe this therapy. So there will need to be the adequate machinery in place that is brought into place, and our business teams are working steadily on trying to make that available, and recognize that over the years, we have had such a reliable base of both machines and dialyzers. We want to make sure that that reliability is maintained.
With regard to bringing into the United States, we've got to make sure that we work with physicians directly and help them recognize that they can, in fact, understand and prescribe under these conditions of both using diffusion and convection. There's some educational efforts that will be needed and necessary to make sure that they're ready to do this and manage that, and we've begun quite an extensive process of socializing this amongst the physicians and the nephrologists in the United States.
Secondly, I think when you begin to look at the patient populations that are going to benefit from this, we think that with the combination of both the hard outcomes, the real-world evidence, and the outcomes that we see in patients that are incident to dialysis, we believe that both incident patients and prevalent patients will benefit from this particular therapy, and there are protocols that we have developed that are significant for both of those as a patient is getting settled into dialytic therapy, and for patients that are transitioning from high flux hemodialysis to HDF, and that's part of the experience that we've had with so many, you know, tens of millions of treatments with HDF and the experience that we've learned outside of the United States.
So the patient population, we think should be offered, at the very least, a trial of HDF in the sense that, given the patient-reported outcomes, that are seen in combination with the hard outcomes, it's our view that there are very few patients that would not be reasonable candidates for at least an HDF trial, once all of the parts are put in place for the system to be able to do that. That being the case, it will be a significant effort to make sure that, our US physicians and nephrologists and nurses understand well this particular therapy, and that they have access to people that have had significant experience with this over time.
That will help socialize the therapy and make them feel more comfortable prescribing the therapy as they begin to get their own patients on it. So I hope that helps a little bit.
Yes, it does. Thank you. And about the reduction in the all-cause mortality?
Yes. Our view is that both all-cause mortality, and we actually think there's also a cardiovascular cause mortality benefit that's improved. There is a study that's been done of looking at all five of these RCTs that I believe will be published quite soon, and in the next month or two. And that study, I think, will look at some further detail on how important this is to cardiovascular health as well.
Okay. Thank you.
Thank you. The next question comes from Hugo, from BNP Paribas Exane.
Hey. Hi, guys. Thanks for taking my questions and sorry for the line. So just, Frank, thank you for the presentation. On the countries that it seems to be very European and Asia Pac patients, to what extent do you think you will be able to leverage these results when launching in the US or any additional US patient countries where you are ongoing? And second, on the cost of treatments, do you see benefits in terms of, I don't know, maybe time for treatment, and which you can deliver the treatment that would enable you probably to have a higher number of patients for that? Thank you.
Hugo, could you repeat the second question, maybe?
I'm sorry, I missed that. I couldn't hear that question completely.
... Yeah, so the other second question, in terms of cost, of treatment, do you see benefit in terms of the time it's necessary for one patient to do one day session with HDF? Thank you.
Yeah. So the cost of therapy, the way that we have seen this, is certainly in those places where they were using very low dialysate flow volumes, we saw an increased use of water. And, but in the United States, where we have very high dialysate flows, we've done a variety of analyses on how we look at the costs, and we think the costs will be significantly controlled to where we can, in fact, deliver this therapy in a reasonable way. In various countries, there have been tenders where the cost is slightly higher because of various treatments, but our hope is that we will be able to both report, and the CONVINCE trial will also recognize that the health economic benefit of this is substantially positive.
The last feature on the 5008X machine that is really quite a differentiator that will help reduce labor cost is we have developed this version of the 5008X machine so that it does not require disinfection between treatments. That's a critical feature in trying to make sure that patients can get their therapy and that the labor costs related to this treatment are kept as low as possible.
Okay, thank you. And on your ability to leverage the results from the CONVINCE trial in the U.S., even if only or seems to be only European and Asian patients? Thank you.
Yeah. So our general feeling about the patient population is that there was a significant diversity of the population in the European population. But given the trial parameters around the patient-reported outcomes, when you begin to look at the features and the translatable degree of those features, even though we have patients with some different ethnicities that might be more predominant in the United States, and we've got patients with slightly higher body mass index, we think there will be a significant translation of these results. And certainly an opportunity to recognize that the qualitative results that came from the patient-reported outcomes in both the delayed cognitive decline and the hard outcomes of mortality are likely also to be seen in this group of patients.
It was good that the CONVINCE trial had a population of patients that were outside of a single center, and so this ability to take patients from both Eastern, Southern and Northern Europe, I think was a very strong component of that trial.
Thank you very much.
Thank you. And the next question comes from Victoria from Berenberg.
Great, thanks for taking my questions. I have two. So the first one is just, I understand that the HDF penetration rate is still quite low in Europe. I think it's around 20%. How is this expected to change in the medium term now that the CONVINCE study is published and shows these clinical benefits? And then the second question is just, I understand your HDF product is the only one with FDA approval in the US. Are there other competitive products that we should be watching that could be approved in the next few months? Yeah, that would be helpful. Thank you.
Yeah. So, I think for the first part of your question, let me actually answer the second part first. I think our machines are currently approved and the only approved ones. We do see other machines around the world that can utilize HDF, so we continue to believe that there will be competition out there. We think we've got some advantages over those competition with a variety of features on the machines that we have, a very sophisticated substitution fluid software, as well as this no disinfection. Today, there are no other FDA-approved machines on the market for this particular therapy.
We think that, given the reliability and the stability and experience with machines that we have that perform this therapy, it will be one of the stronger components. Today, our in-center market share is over 90%, and we would hope to keep it that way. Can you, Victoria, can you just give me the first question again real quick?
Sure, so it was just, I understand that the HDF penetration rate is still low. It's around 20% in Europe, and I just wanted to get your thoughts on how this could change. Maybe uptake will improve now that the CONVINCE study is out.
... thank you, so the rates in Europe are really quite interesting. In Europe, the 20% rates in aggregate, you have some countries that are close to 100%. You have some countries that are down in the 5% range. In many cases, this is related to payment policy. This may be related to other access to care policies in that regard. Our feeling is the CONVINCE trial is, in fact, quite convincing, and that it should be an opportunity for governments to recognize that this particular therapy that does better for patients is one that should be superior and should have an advantage.
In many countries, there is a higher reimbursement for HDF, and so there are some limits that the various payment systems have put on the use of HDF. We don't anticipate those kind of limits in the United States. We think the market will drive for the betterment of patients, which of these treatments is preferred, and our clinical opinion is that HDF is clearly the preferred treatment. When this meta-analysis is likewise presented, it will show these five European trials that have an opportunity to really show where the benefits are, and I think that will begin to tip the balance in Europe quite a bit.
Thank you. Just on the CONVINCE trial, is that the one studying the cardiovascular benefits, and when is that supposed to be published?
This is a trial that a group of academic physicians have put together in doing a meta-analysis on the five clinical trials that were on one of my previous slides. And this is a trial I've been aware of, a study that I've been aware of, that I believe is either just been accepted for publication or is about to be accepted for publication. And I'm hoping it will come out sometime between now and the middle of the fall. And it will give a fair amount of greater detail on what's been learned by these five larger studies.
Great. Thank you.
Thank you. The next question comes from Seferina from HSBC.
Hi. Thanks for taking my questions. I hope you can hear me all right. One thing I want-
Yes, we can.
Can you hear me?
Yes, we can hear you.
Yes, I can.
Go ahead.
One thing I was wondering about is the impact on home treatment, because as far as we understand, five hundred and eight is just being approved for in-center therapies. How will fast ramp up of HDF affect your home dialysis ratios? And how are payers looking towards that in terms of differentiating reimbursement? And you've also mentioned that there are some different reimbursement policies throughout Europe and other countries. Can you give some color as to how systems are approaching this, and what kind of differentiations are there in terms of reimbursement?
Sure. So, on the home therapies front, I think, again, what we're trying to do is make sure that physicians and their patients have sort of a full set of options to look at where they would, what modality a patient would use. We don't expect that all patients will want to either go home or want to be in-center on HDF. I do think over time, one of the questions that will be raised is whether or not we could provide HDF in a home setting as a part of a future innovation pathway. But at the same time, recognizing that patients and their physicians need to have this full set of options that would allow them what they need to do at any given time in their life.
Because across the course of an individual patient's life, they may spend time at home, they may spend time on peritoneal dialysis, they may spend time in-center, and they may spend time with a transplant. And so we want to make sure that there is that broad accessibility. With regard to the payer systems, I think differentiated pay for HDF is fundamentally been driven by various ministries of health and healthcare payment systems, in which they have elected to create either some caps or limits on the number of patients, and we think that the body of data is beginning to overwhelm this. Our business case in the US does not assume either higher reimbursement right now, nor that we get some sort of add-on payment specifically for this therapy.
I think that the case that we'll be moving forward in the U.S. will be one to recognize that the clinical benefits are significant, the optionality for providers in the kind of modality that a patient would want to try, and the body of evidence should support that, again, this is a clinical standard of care that looks like what we believe optimal care in 2020, you know, the mid-2020s would look like.
... Thanks so much. Just as a follow-up, are there any patients for which HDF is not indicated?
I think that there will be patients that, there's probably no distinct contraindication, but the patient has to have the ability to work through their treatment and have a vascular access, whether it's a catheter access or a traditional vascular access, AV fistula or graft, that's capable of delivering the volume of blood that's needed for the high convective volumes. I think we will find over time that there will be benefits even at different convective volumes, but that's to be seen in some of these future studies.
But it is remarkable that if, in fact, the patient-reported outcomes are significantly better in health-related quality of life features, as well as mitigating some of the cognitive decline over time that patients have. It's very hard to say it isn't worthwhile to at least offer a trial or a consideration of this. And at the end of the day, this becomes a patient and physician decision that they need to make.
Thanks very much.
We are almost out of time, but we'll take the last caller for this round, and James from Jefferies.
Hi, thanks for taking my questions. Two, if I can, please. Firstly, sorry if you covered this at the start of the call, but perhaps you can give some historical context why we've only got to this point now to launch HDF in the US, but it's available in ninety other countries. So what caused the delay and the catalyst to get to this point? And second question is, you mentioned in June this year, the first US patient to be treated with the 5008X system. From memory, a lot in the US are on the 3008 . So given the clinical data, what are the motivating factors to drive a potential upgrade of existing machines, and how should we think about the 6008 in the US in this setting down the line?
Thank you.
Great, thanks. So I think I'll answer the second question first. The first patients were treated in June, and the 5008X machine looks like the machine that was configured most directly towards the workflow that's needed in the clinics and the way they operate within the US. The current machine, the 2008 machine, was a 1980s version of a hemodialysis machine, and it really is nearing end of life in the sense of its ability to be upgraded. It can't deliver these particular types of therapies. And so the 5008 machine was the machine that gave us the newest machine and the machine with the broadest experience in HDF to bring into a country that hadn't had any exposure to it at all.
So the question of why it's taken so long, the machinery and the approvals in the United States is one that has taken a long time, and the two thousand eight machine has been sort of the reliable workhorse of the dialysis floor for many, many years. I think until CONVINCE came out, there was question about whether this was truly a level of additional therapy that would become a standard of care. The CONVINCE trial was, in fact, really a very seminal point in time that said, "Look, this is clearly a type of therapy that has broad application. It has values that go beyond simply the dialysis treatment and the removal of certain molecules, because it has an impact on mortality.
It has impact on these patient-reported outcomes that we've seen." It's a fundamental game changer, and for that reason, it- and the fact that the 2008 machine is nearing its end of development life, having been in the marketplace for so long, having been a super reliable machine for a long, long period of time, we felt the 5008 machine was the best machine to bring into the United States. We do not have current plans to bring the six thousand eight into the United States.
That's great. Thank you.
Thank you, Dr. Maddux, for taking the time to speak to us and to the capital market today. We really appreciate that, and we are excited about the 5008X going to the US. Thank you all for your really great and insightful questions. We look forward to speak about that topic a lot more in the future, and then maybe with some other details around it, too. Thank you very much.
Ladies and gentlemen, the conference is now over. Thank you for your participation. You may now disconnect your lines. Goodbye.