Teleflex Incorporated (TFX) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and welcome to the Teleflex Vascular Intervention Investor Meeting. [Operator Instructions] Please note that this conference call is being recorded and will be available on the company's website for replay shortly. And now I will turn the call over to Mr. Lawrence Keusch, Vice President of Investor Relations and Strategy Development.

Good morning. Thank you for joining us. On today's call, we will discuss the Vascular Intervention business, which we acquired from BIOTRONIK on June 30 of this year. Slides to accompany this call are available on our website at teleflex.com. In addition, a replay of today's event will be available on our website shortly after the meeting concludes. We are excited about the opportunity to grow the Teleflex Interventional business and wanted to take a deeper dive on the acquired Vascular Intervention business to help investors gain an appreciation for the portfolio and the opportunities for the future. Participating on today's call from Teleflex are Liam Kelly, Chairman, President and Chief Executive Officer; Matt James, President of Teleflex Global Interventional Access; Thierry Glauser, Vice President of R&D for EMEA, Vascular and Interventional; and Chris Buller, MD, Dr. Buller is Medical Director, Clinical and Medical Affairs at Teleflex and a practicing interventional cardiologist. In addition, we will have remarks from two prominent interventional cardiologists on the call. Dr. Kevin Croce, Interventional Cardiologist at Brigham and Women's Hospital and Assistant Professor of Medicine at Harvard Medical School; and Dr. Elliot Smith, Interventional Cardiologist at Barts Health NHS Trust and Royal Free London NHS Trust. After the prepared remarks, we will open the call to Q&A. Please limit your questions to the Vascular Intervention business as we will not be discussing other Teleflex business units or updating financial guidance. Before we begin, I'd like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in the slides posted to the Investor Relations section of the Teleflex website. We wish to caution you that such statements are in fact forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include, but are not limited to, factors referenced in our filings with the SEC, including our Form 10-K, which can be accessed on our website. Moving to today's agenda. We will begin with the drivers of growth in the interventional markets and an overview of the current Vascular Intervention product portfolio. We will then move to a discussion on the strategic direction for new product innovation to drive growth. Following the overview of the Vascular Intervention business, Dr. Buller will lead a discussion with Dr. Croce and Dr. Smith. We will end the prepared portion of the call with closing remarks from Liam. Following the prepared comments, Liam and the Teleflex team will take your questions. Of note, Dr. Buller is joining us from the hospital today prior to performing a number of interventional cases. Now I'd like to turn the call over to Matt James to discuss the Vascular Intervention portfolio.

Thanks, Larry. As separate entities, Teleflex Interventional and the acquired Vascular Intervention business have been admired by interventionalists for their technology, device quality and innovative pipelines. With the acquisition of the Vascular Intervention business, we've created something that is greater than the sum of its parts, the merging of two complementary portfolios into one, underpinned by synergies in engineering, manufacturing, clinical expertise and commercial execution. Teleflex now has the means to support our customers in both coronary and peripheral vascular domains with the devices that span access, procedural enablement and state-of-the-art therapeutics. By being able to offer a best-in-class sirolimus-eluting stent and in many geographies, a paclitaxel-based drug-coated balloon, we have a portfolio that is immediately relevant to all coronary and peripheral intervention list. Simultaneously, we're pointing the way to the future through a robust clinical development program for the sirolimus-eluting metal scaffold freesolve resorbable metallic scaffold. The attempt is not to be just competitive is to be transformative. Over the past several years, there have been observations of falling age-adjusted mortality from ischemic heart disease, suggesting that heart disease could potentially be going away. Far from it, falling age-adjusted mortality substantially reflects the widespread application of better treatments leading to better outcomes, not a decline in disease prevalence. Indeed, the ready availability of emergency coronary revascularization for acute heart attack in Western medical systems has been an important part of this story. Patients undergoing primary percutaneous coronary intervention, or PCI, now overwhelmingly survive heart attack to enter a chronic disease phase. Yet that chronic condition often requires episodic revascularization for disease progression. As minimally invasive technology and techniques have improved, episodic revascularization is most often delivered by PCI, not bypass surgery. The facts are that by 2050, global coronary heart disease incidence is projected to reach 67.3 million people an increase of 116%. Prevalence is estimated to reach 510 million people, a rise at 80%. A non-age adjusted mortality rates are projected to reach 60 million people up 62% from 2022. And for peripheral vascular disease, the worldwide incidence is projected to increase by 220% by 2050, reaching 360 million and prevalence is projected to surge to 21.7% in women and 14.8% in men. Metabolic diseases are anticipated to be the primary drivers of the rising Peripheral Artery Disease, or PAD, burden. With diabetes playing a key role in an increasing peripheral vascular disease prevalence in severity. So for both coronary and peripheral vascular disease, we see a number of long-term trends that will continue to expand the amount of people impacted on a global basis. Importantly, these underlying trends are expected to influence coronary heart disease and peripheral vascular disease by becoming more severe and complex, shaping and driving demand for advanced durable treatment options. With the combination of the legacy Teleflex Interventional platform and the acquisition of the Vascular Intervention business. Teleflex is now well positioned to compete effectively with an expanded portfolio to address complex disease, regulatory access, strong channel and commercial capacity to grow our market share globally. Beyond today, we have a full pipeline of active product development projects to further drive our competitive position in the coronary and peripheral vascular markets. And we'll hear more about that in today's presentation later. Historically, the focus in interventional cardiology has been on treating the disease vessel, solving the immediate clinical challenge. But that mindset is shifting. Today, clinicians are thinking more holistically. How do I treat this patient effectively now whilst preserving future options for interventions. This shift towards lifetime disease management is emerging from the podium as a critical driver of innovation and clinical value in this space. Over the past 2 decades, the coronary interventions market has undergone tremendous transformation, particularly since the introduction of drug-eluting stents. Many of the technical barriers that once cause procedural failure such as lesion restenosis, crossing CTOs or Chronic Total Occlusions and managing heavy vascular calcification have largely been addressed individually. The focus now is on optimizing procedures with a toolkit to improve outcomes, not just completing the case. While some may view the market as mature and undifferentiated, we see something different. We see a community of interventionalists who remain deeply committed to incremental improvements in long-term outcomes, and who are eager for partners that bring meaningful innovation to the table. In uniting Teleflex Interventional and the acquired Vascular Intervention business, we are demonstrating our commitment, investment and focus on the coronary and peripheral Vascular markets, committed to delivering interventionalists more technologies that support both their everyday patients and their complex patients, invested in shaping the future of intervention going forward, new technology, evidence and training, and we're focused on co-creating with physicians to empower choice for the interventional community the right therapy for every patient today and beyond. This is the market where Teleflex now operates, and we are uniquely positioned to compete effectively. Teleflex has built a reputation for solving procedural complexity with category-defining tools like the GuideLiner and TrapLiner guide extension catheters, Turnpike and SuperCross microcatheters, these are products that change how complex procedures are performed. The acquired Vascular Intervention business, on the other hand, has focused on durable treatment, offering a comprehensive portfolio that positions the company to compete effectively, including drug-eluting stents, drug-coated balloons and Resorbable Magnesium Scaffold or RMS. This is a comprehensive suite that addresses the full spectrum of anatomical and individual patient needs. As discussed, the interventional markets are large and growing. For Teleflex, the focus will be on geographical expansion and increased presence within our markets, strong execution and new product innovation. Given our current market share, we see opportunities to enhance our global position. Drug-eluting stent or DES are expected to remain a workhorse therapy for the next 10 years due to treatment guidelines that are supported by a wealth of excellent data. Our company's Orsiro Mission drug-eluting stent is a differentiated and well-positioned DES on the market. with recognized technical performance. Teleflex has room to grow DES in several geographies with a larger commercial footprint over an expanded size matrix coming to market to cover larger vessel diameters and eventually longer lesions. However, there is a recognized shift in coronary artery therapy towards the leave less or leave nothing behind philosophy. Today, around 25% of patients visiting cath labs have had previous coronary interventions. Physicians are increasingly thinking about lifetime management of disease as people live longer, meaning a higher likelihood of multiple interventions and are therefore less keen to leave a metallic stent in an artery, which may limit options for future interventions. This has resulted in increased usage of drug-coated balloons in the last 5 years, which is set to continue with positive clinical evidence as we've seen this past October at the TCT '25 medical meeting. The Vascular Intervention portfolio includes the Pantera Lux DCB, which has a leading position in markets where it's available. It's our intention to invest in both coronary and peripheral, leave nothing or leave less behind devices to secure a leadership position in the emerging lifetime management segment. Resorbable Magnesium Scaffold or RMS technology Vascular Intervention is leading the market with Freesolve RMS. Freesolve RMS provides the acute benefits of a drug-eluting stent by providing a metallic scaffold to prop the artery open through the restenosis cascade which then uniformly is absorbed by the vessel within 12 months, resulting in an artery without a permanent implant. As fruit of RMS evolves and lays the foundation of clinical research with partnering investigators, who will further explore treatment algorithms like a hybrid approach, where a lesion could benefit from a proximal scaffold with the distal vessel treated with DCB. It's truly an exciting time to lead the way for a lifetime management with a leave nothing or leave less behind product portfolio. Furthermore, physicians are taking a more planned approach to durable definitive therapy. As new imaging techniques reveal more about specific lesion characteristics such as calcified, lipid-rich and/or fibrotic lesions. This is driving selective use and a combination of technologies. Finally, Freesolve RMS overcomes limitations in shortcomings of polymer-based PLLA resorbable scaffold. We have rigorous and extensive clinical programs ongoing to build an evidence base and pursue regulatory approvals. But we're not just bringing products to market. We're building a high-value engagement program that elevates the conversation from devices to durable treatment strategies. Our expanded commercial teams are trained to add value, not just sell, and that is resonating with customers. For example, the current acquired Vascular Intervention business has relatively limited market share in the United States. We see an opportunity to increase access to the cath lab in the U.S. through leverage from the legacy Teleflex Interventional business and strong sales force execution. The U.S. is a large market and methodical gains for Teleflex can be meaningful. This combination of market-leading tools for complexity, a complete therapeutic portfolio and a customer-first commercial model gives us the confidence that we can compete effectively in this large market. Both Teleflex and Vascular Intervention have a shared history of providing excellent medical education programs, investing in customer education and benefiting from a strategic defocus of major competitors in the cath lab. Generating and sharing evidence to build trust and deepen collaboration as well as profiling breakthrough technologies in the scientific community to drive penetration. The combined sales force significantly widens territory coverage in key markets. and opens new untapped markets in growing geographies. For example, in the large and important North American market, the sales team is expected to expand by approximately 50% under the combined business. This means we can serve more hospitals, more frequently. We have more relevance in GPO contract negotiations, and we can cross-sell the full interventional portfolio leveraging our market-leading position in complex PCI with an expanded share of each case, addressing more of the procedural journey. Together, we now offer a complete portfolio for drug-eluting platforms, DES, RMS and DCB in Interventional Cardiology. This positions us to engage more deeply with clinicians, not just as suppliers with our strategic partners in patient care. I'll now turn the presentation over to Thierry Glauser for a discussion of our new product strategy. Thierry?

Thank you, Matt. I'm pleased to share the exciting progress and strategic direction of our Vascular Intervention pipeline, which will continue to demonstrate strength across both coronary Vascular Intervention and peripheral vascular Intervention. We remain committed to maintaining our commercially successful products while expanding our market share through more attractive and differentiated offerings. In coronary Vascular Intervention, our flagship drug-eluting stent or remission is setting the benchmark for performance. We are working to expand its offering to larger diameters and initiating a clinical study focused on long length applications. addressing a critical unmet need in complex coronary cases. Building on the long-term success of our Pantera Lux Paclitaxel DCB, we're enhancing the deliverability of its catheter platform while simultaneously advancing our DCB clinical program with [ dusted ] diabetes and Biohybrid, further reinforcing our innovation leadership. These two investigator-initiated randomized clinical trials are designed to demonstrate the performance of a leave nothing behind strategy for the DCB plus RMS bailout strategy compared to a DS only treatment for diabetic patients and long diffuse lesions, respectively. Both trials have been initiated with [ dusted ] diabetes enrolling patients and biohybrid expecting the first patient to be enrolled soon. We are also actively working to transition our PK Papyrus Covered Coronary Stent from its current humanitarian device exemption status to a full premarket approval to help unlock broader commercial potential in the U.S. market. In peripheral Vascular Intervention, we have successfully launched the Passeo-18 Lux Paclitaxel DCB now available with balloon length up to 200 millimeters, offering physicians greater flexibility in treating longer lesions. We anticipate entering new addressable markets with breakthrough technologies, such as the Akoya ultra high-pressure balloon designed for calcified or fibrous lesions and the [ explore crossing balloon ] intended to facilitate access through tight calcified anatomy and enable definitive treatment. Looking ahead, our pipeline includes what we believe will be a best-in-class covered stent for the iliac artery, leveraging VI's hallmark deliverability and low profile. We're also investing in digital health solutions to support chronic limb-threatening ischemia patients, improving follow-up and ensuring the right patients receive the right care. A pillar of our long-term strategy is the development of Freesolve RMS which we believe can be a competitive resorbable metallic capital technology and play into the emerging theme of leave nothing or leave less behind. Our BIOMAG platform is progressing rapidly. The data from BIOMAG-I with 3-year follow-up shows compelling evidence with a target lesion failure rate remaining at 3.5% and no new major events between 18 and 36 months. The BIOMAG-II seek clinical trial is ahead of schedule with more than 50% of patients enrolled and will deliver 1 year results by the end of 2027. The BIOMAG LL, long-length, seek clinical trial is on track in Europe and Asia with patients currently enrolling and the BIOMAG-III U.S. trial is in the finalization stage. We have further intention to maximize the indication potential of core competencies, such as Freesolve below the knee, which already has FDA breakthrough device designation. Finally, we're accelerating our geographical expansion and are prioritizing Asian markets such as Japan. By uniting Teleflex Interventional and Vascular Intervention, we're demonstrating our commitment investment and focus on the coronary and peripheral vascular markets by creating a position in the market as a meaningful contender. I will now turn it over to Dr. Chris Buller to lead a panel discussion with our esteemed physician guests. Dr. Buller.

Thanks, Thierry. My name is Chris Buller. I'm the Global Medical Director for Interventional here at Teleflex, and I'm delighted to have with me Dr. Kevin Croce and Dr. Elliot Smith, who have joined for a panel discussion today. Kevin Croce is the Director of complex coronary intervention at Brigham and Women's Hospital in Boston. He's the Director of their translational discovery lab as well and, of course, a faculty member of the Harvard Medical School. Also with us is Elliot Smith Dr. Smith is an interventional cardiologist at London's St. Barts and Royal Free Hospitals, where he's really become the national and international face of what is one of the largest PCI programs anywhere and certainly in the United Kingdom. Welcome to both of you. Kevin, why don't you just take a moment to describe your current practice or what does a day or a week look like for you?

Thanks, Chris. I am faculty at the Brigham and Women's Hospital, which is a large teaching hospital affiliated with Harvard Medical School in Boston. I run our complex PCI program. My practice is focused on procedural medicine. I spent about 3 days in the cath lab, treating complex PCI and CTO patients. And then the rest of my time is involved in research and education. I run an entity called the Translational Discovery Lab, which is a large animal and cadaver lab where we partner with lots of companies like Teleflex to develop new technologies in the interventional space and new therapies for coronary artery disease.

Elliot, I thought we'd give the audience just a moment to understand what your practice looks like at Barts and Royal Free.

I am based in London at Bart Heart Center, which is one of the largest U.K. centers for interventional cardiology and for cardiac surgery as well. where we do around 3,500 PCIs a year and where about 70% of that work is Acute Corning syndrome work, 30% would be Elective. My practice is predominantly in the higher risk and complex category performing coronary interventions and also specifically for Chronic Total Occlusions.

I wondered if you could give me some general impressions of the products that you're aware of from BIOTRONIK that you've seen both in your own lab and, of course, in use during your travels as a teacher.

So I think we'd start with BIOTRONIK being a well-known, well-respected, reliable source of coronary stent technologies in the first instance. And the key offering is the Orsiro stent, which we know is an ultra-thin platform with a fully biodegradable polymer, which can be used and has been extensively studied in huge populations over a number of trials and over a number of years. In addition, I'm familiar with the Freesolve technology, the bioresorbable magnesium scaffold that we are currently seeing emerging currently in the clinical trial setting and we're a center for one of those trials at a heart center. And then the drug-coated balloon technology, the Pantera Lux is the other therapy. So these are all destination therapies, if you like. But in addition to that, more recently, since the interaction with Teleflex. Then there's also the range of technologies that are there to help you deliver and facilitate your procedure. So microcatheters some wires and, in particular, guide extensions and specialist guide extensions. So I suppose that would really be the offering from BIOTRONIK that I would be familiar with.

Thanks Elliot. Kevin, I wonder if we could talk a little more specifically about BIOTRONIKs drug-eluting stent, the Orsiro Mission platform that is now the commercial device. Maybe start with the design of that and its mechanical characteristics, what you know about them, how it performs intraprocedurally?

Happy to, Chris. It's a very good stent in terms of its deliverability and the value proposition of its designed with thin struts, going back to my experience as a vascular biologist in both my PhD training and in several postoperal fellowships. A large part of what I spent my time training on was how arteries become inflamed and how they heal and inherently a thinner strut stent like the BIOTRONIK stent has positive effects with regard to patients getting a stent result that tends to heal better and induces less flow perturbation as blood flows through the stent while it is healing and certainly is associated with better properties with regard to healing, less restenosis and patency at least from a mechanistic standpoint. So when we think about the design of the stent, it was designed in a rational manner to hopefully perform better. And outside of that, what interventions look at outside as you know, the form each function designed in a way where it potentially delivers better outcomes, how usable is it really what interventions, let's think a lot about is deliverability. And if stents are becoming longer for more complex disease. And we try to do our cases through the radial artery and the wrist, where there's potentially a limitation in terms of the size of catheters that physicians are willing to put in, which gives you a little less pushability, a stent which has a favorable design from a strut thickness that delivers easily is something which is certainly a positive as we think about where this has a place in treating the patients that we see every day in the cath lab.

Kevin, what's your view of the evidence basis for Orsiro, the scale of the evidence, if you will, and the performance of Orsiro in long-term studies?

I alluded to this earlier, rational design to hopefully a better outcome, thinking about the stent, the strut thickness and the drug, with thinner stents, you're hopefully going to have a favorable response to arterial healing. And what I mean by that is it heals well, there's less turbulence and you get less restenosis, which is borne out in an endpoint often called Target Lesion Revascularization, TLR, or Target Vessel Failure TVF, which I think from the standpoint that if you've got a senti delivers well, it is easy to use and has a favorable metric of not failing as much, that's certainly an advantage. And then I think that there's an opportunity to revisit that because if you think about the fact that somewhere between 1 and 5 to 1 and 7 stents that we place are going to fail between 5 and 10 years out that's an advantage both to the poor patient who has to come back for another procedure or potentially has some terrible event for it, but also to our health care system and those of us who put these in patients where we want to be able to keep them from having to come back many years later.

Dr. Smith, I wonder if you could share your perspective on this topic.

So I suppose the real question is what is it that we want out of the coronary stent platform. And what we want is durability and reliability of the device itself once it's in we want to have deliverability. We want to be able to get it over into the vessel, into the target lesion. And we want retention. We don't want the thing to come off or come away. So those are some key aspects that we're looking for. And there are specific design characteristics. And I suppose the one that jumps out is the Ultra thin strut technology. The fact that it has a slightly thinner strut, particularly in the smaller devices than any of the other competitors is potentially desirable, particularly in terms of theoretically for deliverability and also particularly in those smaller vessels that you're leaving less metallic footprint. Then there is the polymer, whether it's desirable for the polymer to completely disappear or whether some polymer can remain and be inert as an area for discussion. So that's something that we could come back to. So I suppose the third thing really that I would talk about from my own personal perspective, that tends to get overlooked a little bit is the expansion characteristics of a particular platform. We know that coronary arteries taper and if you're covering long lesions, you may want a much smaller diameter distally and a much bigger diameter proximally. And sometimes the only way to do that is to do it with overlapping stents. So one of the desirable characteristics, certainly for me for the BIOTRONIK device is the fact that you can take the 2.5 platform up to larger diameters and therefore, hopefully, maintain its radial strength and its integrity. I think that's actually very important and potentially overlooked.

You'd talked about the importance of avoiding stent overlap, there are under development new, very long lengths and very large diameter Orsiro Mission devices on the way in terms of length, we're going to see devices up to 48 millimeters, and we're going to have devices that are capable of expanding beyond 6 millimeters diameter, are those going to be useful additions to the range of sizes of Orsiro in your practice?

Yes, I think they actually are. And it's interesting because we'll speak to a little prejudice now if you see what I mean. That in a world where we're moving towards leaving less metal work behind why an Earth would we want much longer platforms with much bigger diameters. But we're dealing particularly at the complex end of the spectrum. With some areas of disease that simply do need to be covered by stent strut. And they are long, they're complex, they may be tortuous. And they taper. And we're dealing with left main stems where they are not dedicated technologies available that readily will expand up to 6 millimeters and even beyond where we know that there are vessels that require exactly those characteristics. We've even seen and you may remember this from some years ago, we were having to put biliary stents, into some arteries because they weren't appropriately sized. So I think there will definitely be a market for longer stents. There's no doubt about that. And I think they are going up to 50 millimeters or 48 millimeters is a sensible move and also speaks to competition within the marketplace. But I think that safely having good expansion characteristics with good radio radial integrity up to 6 millimeters or even beyond, is going to be very important.

Kevin, you've established a rather unique program for patients with stent failure, often repetitive stent failure, you're one of just a very few hospitals that have intracoronary brachytherapy still available. So you very much see the worst consequences of stent failure in your practice at the Brigham. I wonder what that means for you as you consider the concept of leaving less behind during PCI and whether you feel that, that is a direction that we are wise to pursue as a community or whether it's a false alley?

We treat somewhere between 120 and 180 patients every year. that are referred into us for advanced stent failure treatment. And the typical cadence of these cases is if you have a young patient who 8 years earlier had a stent in an artery that stent failed and a second stent went into it, and you've got these multiple cages of metal that start to crowd the lumen or the blood carrying capacity. They are when it comes time to treat the intent -- it's really, really tough to get the metal stent to expand. That's the worst-case scenario, multilayer, sent with instant incident restenosis, which not having drug-coated balloons in the United States, there's a lot of patients who suffer from that, and it's made us very, very busy with remediating stents that our multilayer are often under expanded, and we have to work really, really hard to try to make the lumen big again to then be able to apply some antiproliferative therapy to deliver a result which is hopefully going to be durable. And despite best efforts, a lot of these patients still come back. So if you step back to the beginning, even in the first layer of stent, if it tends to reach those, because of aggressive coronary disease. It's much, much easier to retreat that patient if the artery is not constrained by a durable metal scaffold, which remains behind after the drug is diluted. If you think about the fact that set things, they prevent recoil, they deliver drug to reduce restenosis, and they pack up dissections when you have them, once the recoil has been prevented acutely, the artery often will remodel to stay big and open. The drug goes away and the dissection will heal. So the idea that in patients that suffer from restenosis, which there's going to be some effective rate no matter what we do because of the advanced disease that patients have. If you have a scenario where there's renarrowing but you're not fighting with a metal cage, to try to reestablish the size of the looming. It's going to be super advantageous, and we are earning desperately for technologies to do this. Especially in young patients that come in with heart attacks. I mean if a 45-year-old patient comes into the cath lab you place a stent, they're going to have to live with that spend for the next 50 years or longer potentially. And so that stent when it renarrows is really a bar, it's super tough to treat because the metal that was left behind makes it difficult to establish a large lumen size and establishing a large lumen size when treating in stent restenosis, we know is the most important thing in helping that are stay open again. And so if we're able to do that with the page, it prevents us from expanding the artery, expanding the tissue I believe strongly, it's really helped, and we're super excited about resorbable technologies in the coronary space.

Elliot, let's chat for a few minutes about pipeline. And I do want to emphasize here that we're talking about products that are not yet approved or fully approved for some of the indications that we will be discussing. But one that is perhaps receiving the most attention from the interventional community is the bioresorbable magnesium scaffold the Freesolve device, which is the third generation mechanically of the BIOTRONIK resorbable technology. What are you hearing about? What do you know about it? And how does it fit in to a concept of leaving less permanent appliance behind in the coronary arteries of patients who have been treated with PCI?

I think is hugely significant. I think it's very exciting, and I think it's hugely important. We have seen a global move towards trying to leave less metal work behind for very good reason to avoid causing problems with future interventions to avoid jailing side branches to avoid treating longer and diffuse lesions distally, particularly where someone might later be able to have a bypass operation which would not be able to take place when we leave metal work behind. So there has long been a desire to be able to leave very little behind. And so much so that now in the era of drug-coated balloons, there has become a narrative that when you do put a stent in, you're caging the vessel and you may even be harming the vessel, whereas previously you were taming it. And so there's been a sort of huge move, particularly with the latest devices towards using drug-coated balloons only. But drug-coated balloons only leave a problem. And that is that vessels can abruptly close and they can dissect and it can be unpredictable. And so you can't always use drug-coated billions in those settings. I think the bioresorbable story is extremely important for that reason because I think that there will always be a need for stent and that to be able to have a stent that offers the promise of dealing with the immediate radial strength problem and preventing restenosis early, but then disappearing and leaving an intact improved blood vessel behind is going to be important. And I think that it was particularly important that BIOTRONIK continued on that journey when the first iterations from -- in the bioresorbable space, which were with polymeric stents, didn't work. There was a move away completely from dealing with that concept. The concept was brilliant. The first iteration wasn't, but the concept was still important. And the fact that you've continued with that concept and are now bringing a new offering with the magnesium scaffold market is going to be hugely important.

Kevin tell us what you know about Freesolve and perhaps contrast it with prior buyer experience with absorbable scaffolds in humans.

Yes, the absorbable scaffolds, which were approved in use, particularly the Abbott product was a good device, but it was first generation. And it's very different than the magnesium Scot fold, which BIOTRONIK has been developing. But the first thing you can look at is strut thickness. One of the negatives about the older generation bioresorbable scaffold is that it was pretty thick, and it was difficult to deliver. It was difficult to see. If you expanded it over its expansion range, you tended to fracture. And so just we talked a little bit earlier about thin strut stents potentially having an advantage thinner strut devices are going to be better. And my understanding for the Freesolve magnesium resorbables, the structure are much thinner than prior versions of bioresorbable scaffolds, which has been brought to market. And so inherently, that had some advantage. And I think the fact that metal potentially has a better scaffolding capacity for some of the polymer BRS platform is going to be helpful. And then the fact that it takes about a year or so, I've been told for the scaffold to resorb is great because going back to the fact that the three things stents do, they prevent recoil, they pack up dissections and they deliver drug. In my mind, the fact that it stays around for an optimal period of time to allow all that remodeling and healing to establish and buttress a large lumen. But as the device goes away, the hope and the early data looks good, that the area is going to stay open and you're not going to leave a cage behind, which it is going to make it super, super difficult if the patient does happen to suffer from a restenosis event in that area. Your options are completely open in terms of what you can do. And additionally, we have so many -- it's sad, patients that have full metal jackets of stent and arteries, which prevents them from having bypass surgery and all sorts of stuff might try to do after they've had recurrent stent failure multiple times. And so we love the concept of a leave nothing behind technology, especially one that is gone in a relatively fast period of time, that has thin strut and is able to buttress the artery to keep it open and then go away.

Let's change gears or a second and talk about PK Papyrus. You mentioned that earlier on, Kevin, I'd like to hear how PK Papyrus fits into your current algorithm for managing coronary dissections and perhaps just share with us coronary perforations as a problem for interventional cardiologists and more importantly, for patients.

Yes. So probably in some part why I have gray hair is that Complex PCI patients are more difficult procedures. And chronic occlusion patients, which are another focus of our practice are more difficult procedures. They're more difficult because they take longer getting your wires into the downstream artery to be able to balloon and stent for a chronic to occlusion of 100% blockage, which is long-standing takes longer, it's harder to do. But the other thing we know from robust data sets is that for complex PCI and for CTOs, there is a higher rate of perforations. And so as a complex PCI TT operator, unfortunately, and it's a little stressful for what we do, a higher rate of perforation is part and parcel with what we do. It's an invariably difficult part of our job that comes from tackling the hardest cases. So because of what I do, despite being careful, there's no getting around the fact that there's about a 4% perforation rate. And we do several hundred these cases a year, so I'm somewhere between 8 to 20 of these year, depending on how busy we are. And so we get pretty practiced at dealing with them. And it's terrifying, right? There's probably nothing else in what we do in interventional cardiology that's as time-sensitive as getting a perforation seal. Because you have a coronary perforation, you get a pocket of blood around the heart, it compresses a chamber. And if you don't get rid of that blood, the patient will not do well, and they can often pass. Perforations had the highest mortality in cath lab for anything we do. And so avoiding them. But when you have them, which in complex PCI or even in regular PCI cases, there's a set number that is published somewhere between 0.4% for simple cases to upwards the 4% to 5% for complicated cases where these things are going to happen. Unfortunately, it's a cost of new business. It's lethal for patients if we don't address it quickly. There's a lot going on. You're trying to stabilize the patient, stop the bleeding, support their blood pressure. Sometimes, we have to put in mechanical circuitory support. And so you're really going through in these cases that an amazingly quick need to task prioritize to deal with one problem than another. And anything we can do to speed the capacity of covering the hole in the coronary artery really is transformative from a destressing from an expediency of care and from a saving a patient's life. And so the older technology we had was much, much more difficult to deal with. It was incredibly stiff. The majority of intervention is done in the United States to use something called a Six French guiding catheter. It's a relatively small tube through which we place our balloons and stents. The larger sizes of the [ geometric ] stent wouldn't fit in the equipment that we had in the coronary artery. So you imagine that you get a hole in an artery, you put a balloon up to stop the bleeding. The patient's artery is blocked, having chest pains because they have no flow. And you have to put a second guide catheter in. You have to get another hole and another artery bring another tube up to the heart only because the coverage stent you need to put in, won't fit in the equipment you already have in the artery. That's really, really difficult. And so as soon as Papyrus came out, one of the nice things about it is many of the size and the majority are actually Five French compatible. That goes through relatively small catheters which allows you to do all sorts of cool stuff. If you've got a Six French guide catheter, the one standard we used, and you want to be able to kind of get the Papyrus down, it will actually go through these great little guide extenders, which we have to help deliver these tools. And so being, unfortunately, because of what I view an expert in treating perforations we are so excited that we've done a better tool that we used to have. And the minute Papyrus was U.S. commercially available, I was calling to be able to get it ourselves because it's transformative. And I believe this technology saves patients' lives because the time needed to place a Papyrus is so much less than the prior technologies. And I mean a credit to BIOTRONIK were going through all the difficulty to get this to the United States. But physicians and more importantly, patients are way better off because of it.

It's a tool I presume that you think has to be in every lab. Is that a fair statement?

Without question. And if I was going to a hospital tomorrow leave my current practice, the administration, I would have built them mercilessly until they got it on the shelf compared to the older technologies. And so for us, it was a conversation of how many do we buy, what are we okay in terms of stocking. And we made darn sure if we use a couple of them. We've got them replaced by the next morning, especially because of what we do. And so it is a life-saving thing every lab should have.

I want to thank you both, Elliot and Kevin, for your time today. It's been a very helpful conversation. Your insights are remarkable. I know that we'll have questions that arise, and I look forward to hearing and addressing those. So thanks so much. We'll let you get back to your busy days in the cath lab in Boston and in London. Over to you now, Liam.

Thank you, Dr. Buller. We are very excited about the recent Vascular Intervention acquisition. We believe it's a strong strategic fit for Teleflex and a major step forward for our interventional business. . This acquisition brings a highly complementary product portfolio that strengthens our offering in the coronary intervention space, which is seeing mid-single-digit growth. While giving us new access to the fast-growing high single-digit growth Peripheral Intervention segment. It enables us to deliver more complete differentiated solutions for cath lab procedures that helps us better serve both existing customers and new markets. We will have a unique combination of three technologies with drug-eluting stents drug-coated balloons and resorbable magnesium scaffolds, which allows us to be truly objective when it comes to promotion of device selection for the best patient outcome for any given procedure. The Vascular Intervention business, which generates approximately half of its revenues in EMEA balances our geographic revenue mix with more than half of our legacy Teleflex Interventional revenues being sourced in North America. The combination of the two businesses creates a clear opportunity to leverage our commercial infrastructure to accelerate growth through enhanced access to cath labs on a global basis. The combination of our two companies will allow us to expand our customer engagement and clinical education program. We are confident in the revenue synergies this acquisition will bring over time. The combined Teleflex Interventional and Vascular Intervention sales force will have increased global presence. We are also positioned to convert select existing Vascular Intervention distributors to direct sales, leveraging the Teleflex global footprint. By expanding our sales force and offering a more comprehensive suite of coronary and peripheral cath lab products, we will be better positioned to gain market share. This includes the potential for expanding registrations to new geographies, unique product opportunities such as FDA-cleared solutions for coronary perforations and even longer-term upside optionality potential through innovations like Freesolve. As discussed by the clinicians on this call, Freesolve is a promising technology that provides a resorbable scaffold option for interventional procedures. We look forward to the data readout from BIOMAG-II in late 2027. From a financial perspective, the Vascular Intervention business has a strong gross margin, which is comparable to the Teleflex corporate average. And as revenues expand, and we drive efficiencies in the business, we see opportunities to expand operating margins over the next several years. Moving on to integration of the Vascular Intervention business. We have owned the acquired business for 4.5 months and are meeting the milestones laid out in our deal model. We will continue to focus on integration activities over the next 12 to 18 months to position us for strong growth. In summary, the Vascular Intervention acquisition strengthens our portfolio, expands our commercial reach and reinforces our commitment to innovation and growth. and we couldn't be more excited about what it means for the future of Teleflex. That concludes my prepared remarks. Now I'd like to turn the call back to the operator for Q&A.

[Operator Instructions] Your first question comes from the line of Patrick Wood with Morgan Stanley.

Beautiful. I'll keep it to just the one. Obviously, you've had this for 4.5 months, but we saw the growth last quarter, I think it was 7% or so. So running ahead of the underlying markets already, but yet quite EMEA exposed today, which is obviously a slightly slower volume growth area. So like in the existing , we can see the opportunity on resorbable scaffolding. But in the existing assets and DCBs that you're running today in the business, what's driving that growth that's above the market already today? Is that you're starting to put out to new accounts? Or help us understand how you guys are doing that already.

Patrick, thanks for the question. Yes, you're absolutely correct. We grew 7% approximately in the quarter. Geographically, we had strong performances in all the geographies. Everything came in pretty much in line that we were expecting. From a product perspective, where the growth came from the drug-eluting stents were pretty much flat. So that wasn't a big driver. But the big driver was coming from the covered stents and the drug-coated balloons in both the coronary and the peripheral, we saw really solid growth in those areas. And obviously, peripheral markets are growing in the upper single digits. And we have -- we've obviously grown above that market rate as well. So we grew above the key market rates. And with regard to the other part of your question, Patrick, is a combination. It's a little bit too early to get the benefit from that yet, Patrick. We would anticipate as we bring these sales forces more and more together, training is going on right now as I speak with the organizations, and we would expect to see that impact begin in 2026 and beyond.

Your next question comes from the line of Ravi Misra with Truist Securities.

Thanks, Liam, and thanks, everyone, for joining us. Just kind of on the kind of growth profile of VSI. Can you maybe help us understand that 6% growth rate, how does that kind of fit in with where the portfolio is today? And kind of where could that go, do you think, in 3 years? It sounds like kind of with BIOMAG-II readout end of 2027. A that's maybe a 2028 kind of approval type product. I mean how much acceleration do you guys kind of contemplate if the study details are positive?

So I think -- Ravi, thanks for the question, first of all, and thanks for joining the call. I think that as we look at this, a good start as my mother used to say, is half the battle. And right out of the gate in our first quarter of ownership, we were pleased with the growth rate. Regarding your question on the BIOMAG-II, you're accurate. That study should be published in 2027, and we should have an impact as we go through to 2028. I would remind you, Ravi, it is already CE marked from the previous study, but we do need the BIOMAG-II to in order to be able to make claims out there in the marketplace and to accelerate the growth. The longer term, our view on this asset has not changed. We always said it would grow 6% plus. Nothing has changed in my outlook for 6% plus growth from the VI business. And I like the optionality of Freesolve into the future. As you heard from our two clinicians, Dr. Smith and Dr. Croce. Dr. Smith has actually placed Freesolve as part of the clinical trial. And this concept are focusing on complex PCI and this concept of leave nothing behind we are front and center in that with this type of a technology and looking forward to bringing it to the market, looking forward to kicking off the BIOMAG-III study. So thanks for the question, Ravi.

I think you set it up and right into my follow-up. I guess maybe for the clinicians, but I was trying to understand how meaningful could the study be in terms of this philosophy and perhaps creating a definitive outcome to the debate, I believe, nothing behind? Or is there an additional clinical work across industry that would need to be done on that front?

Yes. There's Ravi. Our two doctors had to go and save patients live, so we didn't want to hold them from that. But Dr. Buller is still with it. So Chris, if you don't mind, I might ask you to answer that question.

Sure thing. And it's not a simple answer. I think it's important to understand that the readout at 12 months of BIOMAG-II in 2027 is not the final answer on the performance of this device by any means. We'll be accruing data through 5 years. And it's really between year 1 and year 5 when we expect a fully resorbable technology to show its best performance when it's gone away and when the downside of having ongoing metallic stents in the artery has disappeared. So '27 will be the beginning of the story. And the story will continue to be told over the following 5 years for BIOMAG-II and another -- roughly a 2-year lag behind that for the full 5-year results from BIOMAG-III, the North American pivotal. So it's going to be an evolving story. And with noninferiority, we suspect shown at 2027 and then superiority will be what we're looking for going forward. If we achieve superiority, of course, then all that are off on what this would look like in the marketplace.

Your next question comes from the line of Larry Biegelsen with Wells Fargo.

Liam and Larry, just a couple of near-term ones. So the drug-eluting stent portfolio, Liam, Orsiro has terrific data from BIOFLOW V, et cetera. You said it was flat. Liam, in your hands under Teleflex, can you grow that franchise? And just remind us of the BIOTRONIK sales that you acquired, how much -- what percent is Orsiro?

Yes, Larry, thank you very much for the question, and thanks for joining us. As we -- as is normal, we don't break out individual components. It's a chunk of the revenue, Larry, but there's a lot more to the vascular interventions business than drug-eluting stents. And that's what we were trying to convey today. You've got covered stents. You got coronary balloon, which is Pantera, the docs spoke about. You've got drug-coated balloons, the Passeo that the docs spoke about. And we also have, like I said earlier, the optionality coming with the -- following the leave nothing behind as we continue to focus and niche out the complex PCI market where we already have a beachhead with many of our complex catheters. Regarding the growth profile of our serial, the drug-eluting stent, I'm actually going to ask Matt James with us here to cover some of that for me, Matt.

Yes. Thanks, Liam. Larry, thanks for the question. So as you say, we probably arguably have the best for eluting stent on the market in Orsiro mission. It's probably the most studied stent in the market and has some strong clinical data behind it. So Vascular Intervention is technically and engineering-wise, a fantastic company, developing great products. I think they had some issues penetrating the U.S. market due to scale. Only 25% of their revenue is in the U.S. So they struggle to gain access to the cath lab, and that's where the synergy benefit really that Teleflex can bring is a benefit. We have great access to the cath lab with our tools with complex PCI and CTO and great relationships. So that looking forward, I think that's what's really going to make the difference.

Okay. That's helpful. Just for my follow-up, Liam, on Pantera and Passeo, the DCBs. Those are available outside the U.S., I believe. It sounds like there's no plan to bring those to the U.S. Is that correct? And just maybe if you could tell us why that is?

Yes. In the immediate term, Larry, I would agree with you. We don't have plans to launch them immediately. There are some IP considerations with the coating technologies that are on those products. In the longer term, I think that barrier lessens and it's ultimately removed in the future, and we would envision an opportunity to bring them to the market in the U.S. in the longer term. And we're working through that right now with the team. And I think that you will ultimately see those products for sale and available in the U.S. market in the coming years, Larry. And as always, good insight by you into this market.

Your next question comes from the line of Matthew O'Brien with Piper Sandler.

I'll ask them both upfront here. Liam, historically, you guys have done a really nice job of taking assets, integrating them and then getting a halo effect out of it. So can you just talk about some of the opportunities you're seeing owning the BIOTRONIK assets now in terms of new accounts and halo benefits? And then the second question -- and you know I'm a simpleton here, but we've seen these bioresorbable stents historically, trying to enter the market and unsuccessfully uniformity of how they're absorbing has been an issue, what is it that's unique now with Freesolve that you've solved for where this can be a successful product eventually versus some of the historical challenges that we've seen with other companies trying to bring this type of technology to the market?

Yes. I'll ask Dr. Buller to answer the Freesolve question in a moment. But I will say there's a massive difference, Matt, between the predecessors, which were based polymer-based and had some issues versus a magnesium absorbable stent, scaffold. Regarding the halo effect, Matt, I think that I'll just cover it for a second with the area of focus, and I'll ask Matt James, who's with me here to cover as well. So if you got me, Matt and then to Dr. Buller. So from the halo effect, one area, I think, that's really important for the investment community to understand is our acute focus on complex PCI. We already have a strong presence in complex PCI with our complex catheters at the likes of the GuideLiner, TrapLiner, Turnpike. And I'll ask Matt now to elaborate on the halo effect from putting these two businesses together.

Yes. Thanks, Matt. Yes, the Teleflex and the VI portfolios fit together really well. We've got now market-leading tools across most steps of the complex PCI procedure from access with our GuideLiner and TrapLiner devices, to lesion crossing with Turnpike and SuperCross to therapy with the Orsiro Mission and Pantera Lux and also complication management with PK for iris. So in terms of fitting together in halo effect, we cover the whole kind of range of steps of the procedure. So it's a very synergistic acquisition from a portfolio fit perspective, I would say.

And Chris, do you want to cover the difference between the Freesolve and the predecessors, please?

Sure. And I think Thierry is on the call as well. But essentially, without getting into the metallurgy of it, because that's outside my area of expertise. The alloy itself as well as the stent geometric design has evolved twice through what the internal project names were dreams, the DREAMS 1, DREAMS 2 and now DREAMS 3, which is the platform for Freesolve, a prior brand name being Magmaris. And with the change in alloy and change in stent geometry, the mechanical performance of the stent as a scaffold itself on initial deployment has improved considerably. The effectiveness at reducing light loss has improved and, most importantly, perhaps, the evenness with which the device absorption is occurring is substantially improved so that you don't get as was the case with Absorb and was the case certainly with DREAMS 1, some uneven absorption that leaves pieces behind, so to speak, in the wall of the artery that are detatch from one another. It's interesting, actually, you may be aware of technologies that are unhinging conventional metallic stents over the first months and years of their deployment. The concern there that I have is that you are by intent leaving fractions of a stent in the wall of the artery and no one has to date thought that, that was a good thing to do. whereas with the current magnesium alloy in Freesolve, we see a very, very even and very predictable 12-month complete resolution of the metal.

And Thierry, would you like to comment on magnesium versus polymer from a technical aspect?

No. Absolutely. The big advantage of the metal is it will not bounce back. So if I deploy it, it will stay where it is, and that's very important for acute results. And really, the other big advantage of metals over polymers. Polymers really in the degradation or the overexpansion will have fractures. And that a very irregular process, as a lot of discontinuities the support really changes dramatically quickly. In this case, we get resorption through an erosion of the surface of the scaffold. So we really just gradually decrease that radial strength until really it's not needed. So we don't have these step changes and allows for a much more uniform healing of the vessel. I think another thing that I just want to highlight maybe from my engineering background is we really used the Orsiro as our benchmark in designing the Freesolve. We didn't want to have the physicians to have any compromises in their acute performance, deliverability, how does this feel? How do I need to think about treating the lesion to really simplify the work of the physicians. On the opposite, the polymer scaffold, require more care, more attention, more lesion preparation. So I think we have some very strong advantages there with the magnesium technology.

Your next question comes from the line of Shagun Singh with RBC.

Just two quick ones for me. Could you talk about the competitive landscape a little bit and how you think the portfolio changes the current treatment paradigm? Where are you most excited? And then, Liam, I know you've previously indicated that this acquisition really positions you differently and allow -- would allow you to do differentiated M&A going forward. So just curious to get your early thoughts on where you could further boost this portfolio? I know there's a lot in the pipeline already and how you think about adjacencies that you could look into?

Thank you very much, Shagun, I'll ask Matt to comment on the competitive landscape. I think Shagun for the next 12 months, we're going to focus on the integration of BIOTRONIK and taking it into Teleflex. And then we'll make a decision as to where tuck-in adjacencies would be a possibility for us. With regard to the competitive landscape, I think that when we bought brought Vascular Solutions into Teleflex, I think we demonstrated our ability to expand and to focus in certain areas. And our focus has definitely been and I think the biggest competitive advantage we have to get math started is a focus on complex PCI. That is where we are incredibly strong. That is where we can bring these products together. And Matt can expand on that if I ask you to, Matt, please.

Yes. Thanks, Yes. So to expand on that, we're really focused on that complex PCI and CTO space. So that's really the sweet spot for our portfolio rather than the whole of the PCI market, and it's a faster growing subsegment of that bigger PCI market with vascular interventions, we've added those market-leading therapeutic devices to a comprehensive range of complex PCI and CTO tools. So the complex PCI market is really where we're playing and where we're really well known. As I said before, we cover a large portion of the procedure now. We have really, really good strong access to cath labs for both sides of the business. With the acquisition, we have an expanded sales footprint, allowing it to service more customers more often push into new geographies. Alongside that, the new product pipeline, as we've heard from Thierry is set to deliver a strong cadence of short-term incremental products as well as more strategic long-term transformational products. And at the end of the day, it's really all about adding value in the cath lab and helping customers to achieve better patient outcomes with products, people, support, innovation, education and that's where those high-value engagement programs that I mentioned in the prepared remarks really are going to make an impact.

Your next question comes from the line of Travis Steed with Bank of America Securities.

This is a [indiscernible] on for Travis. Quick one for me. Can you remind us what percentage of the acquired products are currently available in the United States. And obviously, it sounds like you're doing a number of things to generate the data to bring certain products into the market. But is the target to eventually get 100% coverage of the acquired products in the United States?

Yes. Thanks for the question. As you know, 50% of the revenues in EMEA, about 1/4 in the United States and 1/4 in Asia Pacific. So I think there's obviously opportunity wins within the United States. The bulk of the portfolio is available within the United States with the exception both the coronary and peripheral drug-coated balloons that we discussed a little bit earlier with Larry. And it is our intention to bring those products into the marketplace. New product launches will be on a global basis, and as Thierry outlined, we have a robust pipeline of new products coming to the market. They will be launched globally simultaneously in Europe and in the United States and just from registrations a little bit delayed is the normal cadence in Asia Pacific and in Latin America just because of registrations. But yes, in the future, you will see all products, new products brought to the global market. And we will also have programs to bring some of these other technologies to the United States.

There are no further questions at this time. I would now like to turn the call back over to Laurence Keusch for closing remarks. Please go ahead.

Thank you, Eric, and thank you to those that joined us on the call this morning. I hope that it provides some increased insights into the Vascular Intervention business that we recently acquired. And at this point, this will conclude our event.

You may now disconnect your lines.