Rick Wise here again with the team from LivaNova. I'm really happy and pleased and thrilled to welcome LivaNova to our Stifel Healthcare Conference this year. For the first time, I get to meet in person the still relatively new CEO, Vladimir Makatsaria, and welcome as well Matt Dodds, who now is transitioning to a strategic advisor to LivaNova. We'll ask Matt to tell us a little bit about that in just a minute. And I want to congratulate the always wonderful Brianna Gotlin, who has now been promoted to VP of Investor Relations. Congratulations. Great to work with you in that capacity. And I think in the audience we have Phil Kowalczyk, VP of Business Development and Strategy. Good to look forward to getting to know you as well. So earlier this year, in March, I think it was March of 2024, Vlad officially took the reins as CEO.
You were, I think, at J&J for 27 years. You were most recently company group chairman for Ethicon Endo-Surgery. And to my mind, in the six years I've covered LivaNova, the core business at LivaNova is actually performing really well, thanks to the team and thanks to you. And we'll talk about the drivers there and sustainability, et cetera. But to heck with all that, Matt, what the heck's going on here? It's like strategic advisor?
Yeah, so that is the title. As you know, I've been here now about seven years. You know, because you picked this up pretty much right after I joined. And if you just think about the progression, right now the businesses are doing great. DTD and OSA are moving forward. The strategic long-term work has really gone on now for a while. So it's a good time for me to look if I'm going to try to do something else in healthcare. It's a really good time. Plus, I'm staying on until May, so I'm not leaving right away. And as you mentioned earlier, Phil Kowalczyk joined us over the summer from J&J. He's taken over strategy, business development. He's got a really good long background in the area, so you're in good hands.
I never doubted that, but we'll miss you. Who will I tease with you gone?
Brianna.
Vlad's easy. Turning to the business, and of course, Matt, we wish you well and hope to stay in touch. Again, it's fine. This is the second or third CEO of this conference who's been in the job for less than a year. And I sort of feel like for the first year, every time I see a relatively new CEO, I have to say, how's it going? What are your impressions? What do you know now? So after eight months, fundamental performance continues to be solid. Cardiopulmonary, firmly double digits. Epilepsy, growing mid-single digits. Just start us off with your high-level thoughts about where you are now, what's next, and your feelings so far.
Rick, first of all, thank you for hosting us and for the opportunity to be with you today. Also, thank you to my team, and I look forward to working with Matt and with Brianna in their new capacity. And look, I've been very fortunate to join LivaNova nine months ago now. It's hard to believe. And look, the first few months are all about learning and getting to know the team, the customers, the business, a broad stakeholder group, including investors and other key stakeholders. And if I look in terms of where my energy has been over the past nine months and also the leadership of LivaNova's energy, I kind of I'll pick three areas. One is talent.
And I believe that any great organization starts with great talent and really building a strong team, continue to accelerate people from LivaNova, bringing new talent into an organization, and ultimately kind of creating this winning spirit has been really a big focus. The second one is, like you mentioned, the core business is going very strong. I think under Bill's leadership, that trend started, and kudos to him and the entire team at LivaNova for driving this, but seven quarters of double-digit growth and continue to focus on execution as the key focus area. And really within that, I would say commercial execution is one big part of it. And then being able to expand our manufacturing capacity and capability has been the second one. So talent continues to drive performance. And then the third piece is thinking about the future. What's our portfolio going to be?
What does our innovation pipeline look like? And we brought in some really good talent from the outside with Ahmet Tezel as the head of our innovation. We have a new VP of R&D for our epilepsy business, and a number of great things are happening. Phil is leading the work on the future of LivaNova portfolio, which we will make public in the first half of next year. And recently, we had a very important milestone, which was the seventh-month readout of Osprey clinical trial results, which came very positive. And that is an important element of our future strategy.
Yeah, that's great. And we'll try to touch on a lot of that. Let's kick it off with the core business and sort of stable, solid shape. Let's focus on something, a big opportunity like Osprey. As you said, the key milestone of seven months follow-up post the final patient implant, which I think was April, May, if I recall. What kind of data? When will we see data? Will we see data for the seven-month follow-up, or will the first data we see be the 13-month H1 patient follow-up in the middle of next year?
Yeah. So thank you for the question. So first of all, maybe three key takeaways, and then Brianna, maybe you can join me in this answer. But so what we saw and what we made public recently is the improvement in AHI and ODI. And I'm very, very pleased with the results. I would say they exceeded my expectations. And outside, just on behalf of LivaNova, I'm very pleased for the future patients of this technology. Given what I know and in terms of the mechanisms of kind of how this technology works, I also have high confidence that the 12-month data will continue to improve versus the six-month, and that gives us a very nice path moving forward in terms of competitiveness of clinical data.
And that, I think, for us, the key question at this point was, before we saw this data, was, can we generate value with this asset? And now the answer is there. So this is a clear path for us for value creation in OSA. And then Brianna, maybe you can unpack it a little bit.
Sure. So the 12-month efficacy data is most relevant given competitor clinical trials were single-arm studies that went out for 12 months. And then, as Vlad already touched on, but based on the assumption that neuromodulation therapy, specifically hypoglossal nerve therapy, actually improves over time, and the starting point of our six-month efficacy data, we're confident that our 12-month data will be competitive. And then based on our understanding of the six-month AHI and ODI reductions from Osprey, it demonstrates superior outcomes and more rapid onset than existing therapy within the same timeframe. And then also just a couple of factors related to Osprey itself. So first, it was a randomized controlled study, randomized two-to-one therapy versus sham, and it demonstrated superior therapy. Also, the patient population includes patients with complete concentric collapse because the trial did not require the DICE procedure.
Complete concentric collapse represents roughly 20%-25% of the overall OSA population. Then also, it's important to note that the Osprey patient cohort, the baseline starting point of these patients, they had demonstrated higher BMI, AHI, and ODI, and the reductions achieved were actually lower than what we saw from competitors.
That's great. Maybe turning to the other strategic pipeline issues, let's talk about that maybe first. Just update us on the RECOVER depression trial timelines. It's been a 20-year journey for LivaNova. Gosh. Remind us where we are in the reimbursement process. Remind us the timeline for when we see the unipolar data readout. And where are you in terms of the CMS submission now?
Yeah. Thank you, Rick, for bringing this up. Look, I want to go back and just pick on something you said. It has been a long journey, but the reason that we're so persistent on this journey is that there's a huge unmet need. There's a significant patient population that doesn't have any other treatment alternatives, and so when we look at the patients that were participating in the RECOVER study, these are the very difficult patients that on average failed 13 different treatments, and like I said, there's no other alternative for them, so just to remind you quickly that in May, we published the kind of high-level outcomes of the RECOVER study, and the disappointing piece was that we missed the primary endpoint. The treatment arm performed as expected very well, but the control arm also performed very well.
And so there was not enough differentiation to meet the primary endpoint. However, when we double-clicked on the data and engaged really top-of-the-line external advisors, what we saw in the follow-up data was very interesting from a clinical point of view. And the advice we received at that point was to pursue with CMS reimbursement. So where we are now, right after Thanksgiving, the first two manuscripts on the study will be published. And they are really the descriptions of the results of the RECOVER trial. So we will see that very shortly. And then very importantly, the results of the double-click that led us to then make a decision to pursue the reimbursement path. The manuscripts are being submitted in quarter four, and we expect the three publications on those topics early in the year.
Then those five manuscripts will be used then for the submission to CMS early in 2025. Normally, if you look at the historic kind of timeframes, it takes about a year from submission to approval or to the decision. In this case, look, I think there's motivation to do it faster because massive unmet need, and again, there's no alternative treatment. We really hope that the data will be convincing enough not only to make a positive decision, but also to make it in an expedited manner.
Talk about the bipolar patient group, and just again, is there something in the secondary endpoints that you see as encouraging?
So the bipolar arm is continuing to enroll. So that will continue on. So I would say that the market opportunity that is unlocked with CMS reimbursement decision would determine the path forward for the bipolar arm. But for now, we're continuing to enroll the bipolar arm.
Gotcha. And maybe just at a high level, just as we reflect on everything, Vlad, just as you look at your core R&D spending versus the SPI R&D spending, I think you're spending like $175 million in R&D. How are you looking at those numbers and maybe rethinking priorities or evolving priorities after your eight or nine months?
Yeah. So I think let me go back because R&D spend is really a consequence of the strategy, right, and the way kind of we frame the strategy, and please chime in, we're fortunate to have a strong foundation with the core businesses, and I think it gives us optionality moving forward, but having sustainably strong Cardiopulmonary and Epilepsy business, it really is the foundation of our strategy, then I think the second step is obviously the decision and the direction we're going to take with obstructive sleep apnea and difficult-to-treat depression, and we just talked about it, so that's the second step, and then the third kind of step in our strategy is looking longer term, what does our portfolio look like for the next decade?
And how do we get into faster growth markets, but in the areas where we have the right to win, either because of some of the R&D connectivity that we have or manufacturing or commercial? So that's kind of the approach. One of the learnings that we had is that maybe we didn't really invest enough. We over-invested in some of the SPIs in terms of R&D dollars, and we under-invested in the core business. So you've seen over the last few months that we made some decisions to reinvest in the research and development in our core businesses to make sure that we can build a sustainable product pipeline in both of those businesses. One example of that is our spend on depression. We roughly $40 million a year. And what we've announced in July is that for 2025, we will give back $20 million to the investors.
That $10 million will remain to be invested in the CMS reimbursement path, and then $10 million will go back into some of the very interesting innovation in the core.
Right. Let's turn to the core business. And cardiopulmonary has been a really extraordinary story for LivaNova. And I think that if there's one question I get most these days, it relates to the sustainability of that growth. And we had a great conversation after you reported, which I really appreciated. And you highlighted four factors that I hadn't thought through as clearly as you articulated that argue for sustained above-average growth for the business relative to the past. Take us through that. I think it's important to hear.
Yeah. Well, actually, that came from you because you challenged me to tell a better story. So we kind of said, how do we tell a better story?
We got to keep talking.
That's right. So look, when I looked at this business from outside, I mean, it's hard to believe that this business can grow sustainably at this rate. And actually, it does. And so when we dissect a little bit, where does this growth coming from? It gives us clear understanding what happened over the last several quarters, but also gives us confidence in the longer-term viability of this business. And first is the market. And normally, if you look at the procedure growth, this historically, the open heart surgery on pump surgery has been growing 1%-2%. But over the past few quarters, the growth of the procedures has accelerated. And I think there are two main drivers. One is a lot of the growth is coming from emerging markets. And the bigger emerging markets procedure pool becomes, the more growth obviously is coming out for the total pie.
And then the second one is, I believe that during COVID, when patients were not allowed into the hospitals and didn't get diagnosis, the disease progression was much more complex, right? And so post-COVID, we started to see much more complex cancer procedures, but also cardiovascular patients may potentially, instead of getting stents, they would go into the bypass procedures. And so that I think we're still living with that kind of tailwind from that. So more patients are coming in. So the market growth, what we assess rather than being low single-digit, is now at mid-single-digit. So that's number one. Number two, LivaNova has really is a benchmark with pricing. And I think it's good for me to say that coming from the outside. I have not seen another medtech company that is so disciplined about executing price.
And so this year, for example, year to date, 300 basis points of growth is coming from pricing if I exclude Essenz, Upgrade, and kind of HLM. So that's, I think, best in class. Is this sustainable at that rate? Maybe not. But kind of a 1% to 2% price increase is something that I think is sustainable in this marketplace. So that's the second growth driver. The third one is market share in disposables. So two-thirds of our business in cardiopulmonary business comes from oxygenators and other cardiopulmonary disposables. And while on the equipment side, our market share is 70%, on the disposable side, we've improved from low 30s to mid-30s, but there's still a lot of space for us to improve our market share. And so one point improvement in the disposable market share is one additional point of growth for LivaNova.
Over the last few quarters, our growth has been driven. Our market share gain has been driven by better execution and manufacturing. Moving forward, in addition to that, obviously, new product launches and launching the next oxygenator generation would be another driver of growth. Then finally, upgrading to the new generation of heart-lung machines. So Essenz, we launched last year. Last year, 20% of all of our units placed were Essenz. This year, 40%. Next year, we target 60%, the year after 80%, and then 100%. Every 20-point improvement in this penetration gives us anywhere from 200 to 400 basis points of growth for the enterprise because of the price difference. So year to date, for example, the price on Essenz is double the price of legacy machine. And that's why going from 20% penetration to 40% penetration gives us 400 basis points of growth for the enterprise.
So those four levers, price, share, upgrade, and market growth, they will remain as growth drivers moving forward. And that gives us confidence in sustainability of the business. And obviously, we need to feed it with the innovation and good execution.
No, for sure.
Anything that I missed?
No, that was very clear. Turning to epilepsy, Vlad, both you and your immediate predecessor, Bill Kozy, have been incredibly positive about Stephanie Bolton, the leader of the epilepsy division, and the work she's doing and the changes she's making. We have seen new patient implants drive growth to the 7%-8% range, which is great to see. Help us understand how sustainable, what do we do, where do we go from here. Particularly, I'm a tad more anxious about the replacement headwinds because of declining implants back in the early days of COVID. Now we're at the point where you'd normally get those replacement volumes happening. How do we put all that in context and think about epilepsy?
Yeah. No, great question. I'll start, and then I'll turn it to Brianna and Matt to build on this. Look, I think where you started is, and thank you for bringing up Steph's name. So Steph Bolton is our president for epilepsy business. And that's why I started. Great people make great things happen. And Steph and her leadership team really focused on bringing best talent to the team, creating winning spirit in the organization, and ultimately, real focus, laser focus on commercial execution. And so through maybe tactical improvements, better targeting of accounts, better incentive system for the organization, clear accountability, that just kept improving the commercial execution machine. And that has been one of the biggest drivers of that success. Moving forward, what makes me optimistic about this space and this business is the penetration rate of the procedure is very low still.
There are over a million patients that are untreated that suffer from drug-resistant epilepsy. And it's about 1% procedure penetration at this point on neuromodulation, whether it's VNS or other ways to neuromodulate. So there's still huge space to grow the patient by. And then maybe you can make some comments on.
Sure. So Rick, you're right. We are anticipating a slowdown in the fourth quarter in U.S. replacement volumes, and that trend is expected to continue into 2025. Our model output is projecting anywhere from flat to low single digits at the unit level. On the new patient implant side, we've commented that we believe procedures are going in the mid-single digit range, while we won't give 2025 guidance at this point, but we are focused on disciplined commercial execution and, again, driving growth into this significantly under-penetrated market, and then on top of that, we do intend to take our inflationary price increase, which should add another 2% on top of the units.
Manageable is the takeaway. Is there anything in the pipeline there that maybe we haven't heard about, or is there the possibility of hearing about more innovation or commercial initiatives?
Yeah. So from the commercial point of view, I think the initiatives are very much focused on expanding the market, driving the penetration of the procedure up. So a lot of education, partnership with key opinion leaders to drive the procedure penetration moving forward. And of course, the oxygen of the business is in innovation. So we are working on the next innovation that is going to come is really digitalization and connectivity. So making the device connected to the digital ecosystem, making sure that the physicians can read and monitor and control data distantly. So that is really the next wave of innovation. And then we constantly are looking at this space to see other and have some external investments in the areas of innovation in the broader space of epilepsy.
This next generation, it sounds like intriguing technology to incorporate. Is that a '25 event, or is that a possibility, or?
So we don't disclose timing for competitive reasons, but these are projects in kind of mid-development. They are not early-stage projects.
Gotcha. That's great. Talk about also operating margin expansion potential from here. I think that, I mean, that's clearly been a priority. Is it a priority for you, and maybe talk about some of the high-level drivers there.
Yeah. So first of all, absolutely, it's a priority. And I started with this kind of strong foundation in the core business. And beside growing top line above market, expanding on the margins and building the cash for the organization are obviously clear priorities in order to give us optionality moving forward. So when I think about, obviously, what drives I talked about price and continue to drive price and expanding the margins is going to be a big driver in expanding the margins. That's number one. Number two, the mix of the business is really helping the margin expansion. So for example, in the cardiopulmonary business, heart-lung machine margin is close to 70%, while disposable is at close to 50%. And obviously, because the heart-lung machine business is growing significantly faster, that helps us in terms of margin expansion.
And then finally, we're looking at efficiencies within our businesses, both on the manufacturing side, but also broader in the business. And I think the combination of those three are helping us to continuously improve our margins.
I want to make sure to ask you for an update on the SNIA Italian litigation. Obviously, not a lot. I know there's not a lot of time to say, but any incremental color there? And Vlad, does just that overhang restrict your ability to think strategically and creatively and innovatively in some way that you feel like you're wrestling against an invisible wall or something?
Yeah. So maybe I'll ask Matt to start and kind of give an update where we are. And then I'm going to come back and
Ask you the strategic part. So no, nothing's changed, Rick. We still believe 2025. That's not locked in, but we do think 2025 is likely. It's at the Supreme Court. There should be the final decision. And what we've laid out is that the appellate court's damage number was EUR 454 million. If that happens to be the final ruling, we've estimated around $0.50. So we've given the color on sort of what the impact could be. A lot of different outcomes, though. I mean, they could kick back the damage decision to a lower court. They could come up with a slightly different decision. We think that's the cap at the higher end. But there's still a lot of moving parts left in terms of how this could play out.
But so we can't even say to ourselves yet that 2025, one way or the other, it's out of the picture.
Correct.
Yeah, and then from a strategic point of view, look, like I said, where I started, we're working on long-term strategy, how to get in the faster growth markets and how to make sure that our portfolio is sustainably winning over the last decade. This is one of the important milestones into that decision. It's not an existential milestone, but it is a milestone that will help us to make some will give us more freedom to make some of the future choices on the portfolio.
That makes sense. We'll stop there. Thank you all for being here. Again, congratulations, Brianna. Congratulations to you, Matt. You don't have to put up with people like me anymore. But thank you so much, Vlad. Appreciate it.