Thanks, operator. Good afternoon, and thank you for joining the call today. Joining me today from Artivion's management team are Pat Mackin, CEO; and Lance Berry, CFO. Before we begin, I'd like to make the following statements to comply with the safe harbor requirements of the Private Securities Litigation Reform Act of 1995. Comments made on this call that look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements made as to the company's or management's intentions, hopes, beliefs, expectations or predictions of the future. These forward-looking statements are subject to a number of risks, uncertainties, estimates and assumptions that may cause actual results to differ materially from those forward-looking statements. Additional information concerning certain risks and uncertainties that may impact these forward-looking statements is contained from time to time in the company's SEC filings and in the press release that was issued earlier today. You can also find a brief presentation with details highlighted on today's call on the Investor Relations section of the Artivion website. Now I'll turn it over to Artivion's CEO, Pat Mackin.

Thanks, Laine, and good afternoon, everybody. I'm pleased to report that our strong business momentum continued through the second quarter as we delivered total constant currency revenue growth of over 14% and adjusted EBITDA growth of 33% year-over-year. Further, we made continued early progress with our ongoing AMDS launch following FDA Humanitarian Device Exemption approval or HDE approval, and we remain on track with each of our key clinical and pipeline initiatives aimed at expanding our addressable market. During the quarter, we also took steps to strengthen our balance sheet and meaningfully reduced our net leverage by retiring our convertible note due in 2025, which Lance will detail further. Our Q2 performance was enabled by continued growth across our product portfolio with exceptional strength in U.S. On-X sales. From a product category standpoint, On-X revenue increased 24% year-over-year on a constant currency basis as we continue to take market share globally with the only mechanical aortic heart valve that can be maintained at a low INR of 1.5 to 2.0. Based on the proven clinical results of the On-X aortic valve and the growing body of evidence supporting the use of mechanical valves in younger patients, we maintain our strong conviction that the On-X is the best aortic valve in the market for patients under the age of 65, and we'll continue to take market share worldwide. Our U.S. On-X performance was particularly strong as we benefited from our continued growth in awareness and adoption of our On-X valves, driven by positive new data and cross-selling opportunities from our initial AMDS launch. This cross-selling dynamic, in particular, has reinforced our conviction in our innovation-driven multipronged growth strategy and further strengthen our confidence in both our near- and long-term outlooks for growth and profitability. To that end, stent graft revenues grew 22% on a constant currency basis in the second quarter compared to the same period last year as the U.S. AMDS launch accelerated our growth rate. Our stent graft portfolio remains a key component of our growth strategy, and we are encouraged by our strong results, which are driven by our differentiated portfolio of products focused on the more complex segments of the stent graft market. Today, the products in our stent graft portfolio are sold primarily in Europe, where we leverage our existing direct sales infrastructure to create significant cross-selling opportunities across our unique aortic product offerings. Our pipeline consists largely of bringing some of these proven products to the U.S. and Japan, representing a significant growth opportunity. The first of these products is AMDS. As mentioned, we're pleased with the ongoing U.S. launch of AMDS following our recent HDE approval in late '24. As a reminder, there are three steps that each center must complete before implanting an AMDS as part of the AMDS launch process. First, each hospital needs to receive a site-wide IRB approval, except in the case of an emergency use. Second, we need to have AMDS approved by the hospital Value Analysis Committee, or the VAC. And third, surgeons must be trained on this device. Reception to the launch has remained extremely encouraging with more hospitals progressing through the IRB and VAC approval process. As expected, AMDS revenue grew meaningfully on a sequential basis in Q2, reflecting strong early demand and revenue from initial stocking orders. Meanwhile, feedback from physicians already using the device has been overwhelmingly positive. Overall, we're encouraged by the early commercial traction of AMDS as we begin to tap into what we estimate to be a $150 million annual market opportunity with limited competitive alternatives. In addition, BioGlue grew 4% on a constant currency basis compared to the same period last year, and we continue to see growth with the product in all of our major markets. Lastly, tissue processing, which has been the category most heavily impacted by last year's cyber event, increased 3% year-over-year on a constant currency basis in Q2. As a reminder, a significant portion of our tissue revenues come from our Sygraft pulmonary valve for which demand outstrips supply every quarter, and therefore, we hold no inventory. Due to extended lead times for tissues that were in process or received during the period impacted by the cybersecurity event, there is a backlog of product that has not yet been released. Since last quarter, we've continued to make progress in reducing the backlog and remain on track to clear it by the end of the third quarter. Looking ahead, we are confident that our tissue business can be a mid-single-digit grower for the full year of 2025 and over the long term. I'll now turn to the pipeline. In July, we received investigational device exemption approval or IDE approval from the FDA to begin our U.S. pivotal trial for Arcevo LSA. This is our third-generation frozen elephant trunk used to replace the entire aortic arch. The trial will evaluate the safety and effectiveness of Arcevo in the treatment of acute and chronic Arch pathologies and will enroll 132 patients in up to 30 sites. We are optimistic that the trial would be successful, which is supported by the positive clinical results from our current generation frozen elephant trunk called the VITAOPANEO. We look forward to providing additional updates on future calls as we prepare to launch the trial by year-end. While the HDE enables us to commercially distribute AMDS in the U.S. prior to receipt of the PMA, we continue to focus on securing the PMA for AMDS. Last quarter, we were pleased to have been informed by the FDA that it completed its review of our manufacturing and quality management system modules. To date, we've already filed three of the four modules, and this keeps us on track for an FDA approval in mid-2026. Lastly, on our pipeline, assuming we acquire Endospan, NEXUS remains on track for approval in the second half of 2026. As I spoke about during the Q1 call, Endospan presented its late-breaking 30-day data from the NEXUS U.S. IDE trial at AATS in early May. This is the first FDA trial for an endovascular treatment of chronic dissections in the aortic arch, focused on patients at high risk for open surgery. The data indicated the trial would meet its protocol-defined primary endpoints of a 63% reduction in major adverse events relative to the comparators. In our conversations with physicians at AATS, surgeons were generally impressed with the 30-day results and were extremely positive. Overall, it was a great quarter. We accelerated our top-line growth rate for both On-X and stents to over 20%. We hit another significant milestone in our pipeline execution with our CVA IDE approval, and we significantly improved our capital structure by eliminating approximately $100 million of convertible debt. We're excited about our progress to date in 2025 and are confident in our ability to deliver sustainable double-digit revenue growth, drive EBITDA margin expansion and grow adjusted EBITDA at twice the rate of constant currency revenue growth.

Thanks, Pat, and good afternoon, everyone. Before I begin, I'd like to remind you to please refer to our press release published earlier today for information regarding our non-GAAP results, including a reconciliation of these results to our GAAP results. Additionally, all percentage changes discussed will be on a year-over-year basis, and revenue growth rates will be in constant currency unless otherwise noted. Total revenues were $113 million for the second quarter of 2025, up over 14% compared to Q2 of 2024. Meanwhile, adjusted EBITDA increased approximately 33% from $18.6 million to $24.8 million in the second quarter of 2025. Adjusted EBITDA margin was 21.9% in the second quarter of 2025, an approximately 300 basis point improvement over the prior year, driven by improvements in gross margin, leverage in SG&A and timing of R&D spend. From a product line perspective, On-X revenues increased 24%, stent graft grew 22%, BioGlue grew 4% and tissue processing revenues grew 3% in the second quarter of 2025. On a regional basis, revenues in North America increased 18%, Asia Pacific increased 15%, EMEA increased 10% and Latin America increased 7%, all compared to the second quarter of 2024. Our as-reported expenses included approximately $1.7 million in Q2 associated with the 2024 cybersecurity incident, which are excluded from adjusted EBITDA. While we have sought insurance reimbursement for some of these costs, the process will take some time. We will exclude any insurance proceeds we receive from adjusted EBITDA as well. Gross margins were 64.7% in Q2 compared to 64.6% in the second quarter of 2024. Non-GAAP gross margins were 65.1% in Q2 2025, reflecting a 50 basis point increase from 2024 due primarily to favorable mix from AMDS HDE revenues in the U.S. and exceptional On-X growth, particularly in the U.S. General and administrative and marketing expenses in the second quarter were $57.7 million compared to $49.3 million in the second quarter of 2024. Non-GAAP general and administrative and marketing expenses were $53.4 million or 47.2% of sales in the second quarter compared to $47.3 million or 48.2% of sales in the second quarter of 2024, reflecting a 100 basis point improvement while funding our AMDS HDE launch costs. R&D expenses for the second quarter were $7.1 million compared to $7.5 million in the second quarter of 2024, reflecting timing of clinical expenses. Interest expense net of interest income was $7.2 million as compared to $8 million in the prior year. Other income and expense this quarter included foreign currency translation gains of approximately $4.5 million. Free cash flow was $11.7 million in the second quarter of 2025. As Pat mentioned, during the quarter, we took action to significantly deleverage our balance sheet by retiring our convertible senior notes due 2025. As we announced in May, we successfully completed exchange agreements to convert approximately $99.54 million principal amount for an aggregate of 4.3 million shares of common stock. Approximately $460,000 in aggregate principal amount remained outstanding as of June 30 and was settled with approximately 20,000 shares of common stock at maturity on July 1. Turning to cash and liquidity. We ended the quarter with approximately $53.5 million in cash and $215.6 million in debt, net of $4.9 million of unamortized loan origination costs. We do not anticipate the need to raise additional capital to fund our debt obligations, our investments in our channels or our pipeline in the foreseeable future. At the end of the second quarter, our net leverage ratio was 2.2, down from 4.1 in the prior year. And now for our outlook for the remainder of 2025. Given our momentum in the first half of the year, we are raising the midpoint of our full year 2025 revenue guidance and now expect constant currency growth between 12% and 14% compared to the previous range of 11% to 14%. We expect reported revenues to be in the range of $435 million to $443 million compared to our previous range of $423 million to $435 million, reflecting greater confidence in our overall growth outlook and an adjustment to our foreign currency assumptions for the second half of the year. This guidance range reflects our current estimate of the full year 2025 currency impact will be approximately flat to 2024. Given our strong top-line revenue growth and success with general expense management through the first half of the year, we are also raising the midpoint of our full year adjusted EBITDA guidance. We now expect adjusted EBITDA to be in the range of $86 million to $91 million compared to $84 million to $91 million for the full year 2025, representing a 21% to 28% growth over 2024 and approximately 200 basis points of adjusted EBITDA margin expansion at the midpoint of our ranges. This guidance reflects a second half revenue growth rate of 17% at the midpoint, 2.5 percentage points higher than Q2, driven primarily by the expected normalization of our remaining preservation services backlog in Q3 and the continued sequential growth of AMDS HDE revenues in the U.S.

Thanks, Lance. So to conclude, we're very pleased with our second quarter performance, which we believe reflects the strength of our highly differentiated and highly defendable product portfolio. We continue to deliver meaningful top and bottom line growth, advance our robust pipeline and enhance our balance sheet. We remain confident in our ability to deliver double-digit revenue growth at double the growth of EBITDA as we expand our presence across markets with limited competition and leverage our existing global infrastructure and cross-selling capabilities. More specifically, we expect future growth to be driven by the following key initiatives: First, the AMDS HDE launch. We're in the middle of commercializing AMDS in the U.S. and starting to penetrate the $150 million annual market opportunity. Second, On-X heart valve data. We are marketing the JAK, which is the Journal of American College of Cardiology clinical data, showing a mortality benefit in patients under 60 years of age compared to bioprosthetic or tissue valves. This is a new $100 million annual market opportunity that we will be pursuing with the only mechanical aortic heart valve that can be maintained at an INR of 1.5 to 2.0. Third, the NEXUS PMA positive 30-day data from Endospan's TRIUMPH trial. Endospan remains on track for PMA approval in the second half of 2026. This data presented in May would, assuming if we exercise our option to acquire Endospan, bring us one step closer to being able to access the annual market opportunity of $150 million. And fourth, the Arcevo LSA IDE approval. We're preparing to launch the U.S. IDE trial for our third-generation frozen elephant trunk for the treatment of acute and chronic dissections in the aorta. Finally, I want to thank all of our employees around the globe for their continued dedication to our mission of being a leading partner to surgeons focused on aortic disease. With that, operator, please open the line for questions.

Your first question comes from Bill Plovanic with Canaccord Genuity.

Great. Thanks for taking my question. Just really want to just focus in on the AMDS. I think last quarter, you had made the comment regarding 150 hospitals actively seeking IRB and back. Kind of where are you in that process? Have you added more accounts because I think there's 600 total? And are there other KPIs that you're looking at? And then just secondly, I think really interestingly, you talked about the cross-selling. I wonder if you could expand on that. What products are they picking up? What type of penetration rates are you seeing on those training sessions? Anything to help us kind of give us some color on how that may impact the rest of the business?

Bill, this is Lance. Maybe I'll address the metrics question and let Pat talk about how things are going. So last quarter, we did give some nonfinancial metrics to try and give everyone some feel for how the launch is going early on, particularly given that revenue was pretty minimal. I think we try to be clear with people to not necessarily expect us to continue to give that every quarter, and we didn't give it this quarter. I will say that our pipeline is continuing to build, and those metrics had I given them would be larger this quarter than they were last quarter, but probably leave it at that. And then I'll let Pat talk about how the launch is going.

Yes, there are about 1,000 accounts that handle acute Type A in the U.S., not just the 600 mentioned. We previously noted that around 75% of the volume comes from the top 600 centers. In terms of cross-selling, we conduct monthly training sessions where up to 20 surgeons come to learn about implanting the AMDS. This is a one-day program designed to build relationships with these customers. Some of them are already customers, while others have only purchased BioGlue and may not yet buy our On-X valve. As they become familiar with the AMDS technology and the On-X technology, along with the new data, we have observed that some customers leave the AMDS training and begin using On-X immediately upon returning to their hospitals. We anticipated some benefit from cross-selling, but the impact has been more significant and rapid than we expected.

Great. And then if I can ask one more, I will. It's just BioGlue in China. There wasn't really any commentary on that. Just wondering if you could give us an update there.

Yes. So when we talked about the launch of BioGlue, we said it was really a second half 2025, given all the kind of hoops you have to jump through with the provinces and the hospital contracts, et cetera. So we should start seeing BioGlue in the second half of this year. So we really haven't talked more about it than what we've previously put out.

Your next question comes from John McAuley with Stifel.

Congrats on the strong 2Q performance. Just wanted to start off on guidance. There's a few moving pieces. I just want to make sure I have this right. There's currencies moving towards flat impact for the year. There was 2Q outperformance, but you're also feeling pretty strongly about 2Q '25. Could you just talk through how all those dynamics are impacting the updated guidance?

In the second quarter, we had provided a midpoint expectation of 13% constant currency growth, and we exceeded that with a result of 14.5%. This indicates strong underlying performance. Additionally, our currency assumption turned out to be conservative, especially regarding the euro and dollar movements, which contributed to the revenue outperformance in Q2. We should acknowledge these positive currency movements and incorporate some of that into our guidance for the second half of the year. Overall, we have raised our full-year expectation for constant currency revenue to a range of 12% to 14%.

Got it. That's helpful. And I wanted to follow up on AMDS. I know Bill just asked about it, but we've recently done some checks in that space. And just wanted to get your sense on physician adoption and utilization. What we've heard is that once doctors get this in their hands, they're not really feeling a sense of caution that it's a new device. They're excited about it and they're sort of immediately integrating it into their practices. Can you just talk about what you're seeing from that dynamic? Are physicians steadily ramping? Are they adopting immediately? Any thoughts there would be helpful.

Yes, I believe one of the key advantages of AMDS is that it provides a straightforward and effective solution to a significant clinical issue, which is malperfusion. We have consistently received reports of patients suffering from malperfusion, where blood isn't circulating properly, leading to legs not appearing on MRIs or CT scans. After the AMDS is implemented, these patients regain blood flow to their legs. The device is remarkable in its simplicity. We conduct a one-day training to ensure that users understand how to size and implant it properly. Beyond that, it's quite straightforward and user-friendly. This is a significant benefit because virtually every aortic surgeon in the U.S., or any surgeon who performs aortic valve procedures, can utilize this device effectively. Unlike some complex technologies, this one is not difficult to use, which I believe will greatly enhance its appeal in the future.

Your next question comes from Frank Takkinen with Lake Street Capital. This is Nelson on for Frank.

Congrats on all the progress here. Obviously, we've talked in the past about AMDS and future launches kind of layering on to the existing sales force. Maybe just talk a bit more about that. I think the last I saw was the 55-person commercial team handling the ramp. Correct me if I'm wrong there, but I understand it's still early innings, but any incremental targeted expansion that you're looking at kind of now? Or is that something you'd maybe take on with PMA approval?

Yes, we've discussed this before. We don't really see a significant change with the PMA approval, aside from not having to obtain an IRB. The point you raise is valid. Earlier, I mentioned that there are about 1,000 centers that conduct AMDS implants and perform acute Type A dissection surgeries. Our team of over 50 representatives is quite effective in the top 600 centers. While we engage with all 1,000 centers, the last 400 aren't a primary focus for us. We are assessing this for the second phase of the launch, but we won’t provide specifics on this call. We will discuss it further when the time is right.

Makes sense. And then on Arcevo, maybe just walk us through kind of the next steps there with IDE approval in hand. And I heard you say you expect to start that trial kind of by year-end, but maybe just any additional color you can provide there on timelines or anything.

Yes. So we were super excited to get the approval. So we got FDA approval. Now it's just like any clinical trial in the medical device space. We've got to get contracts with the hospital. We have to get an IRB with the hospital for the trial. We've already got devices, sterile devices coming in. So it's really just how long it takes us to get through the contracting and the IRBs at the hospitals, and we expect to enroll our first patient before the end of the year.

Your next question comes from Suraj Kalia with Oppenheimer.

This is Jacob on for Suraj. Congrats on the quarter. So I just wanted to start off with your guide to adjusted EBITDA growing about twice as fast as the top line, which suggests a shift in mix. Could you help break down what's driving that leverage? And I guess, more specifically, what's the expected contribution from the AMDS launch on gross margin expansion? And how accretive do you see that being over time?

Yes. I think things are unfolding as we anticipated at the start of the year. We mentioned that the EBITDA margin would benefit from both SG&A leverage and an expected one-point gross margin expansion this year, primarily due to product mix. We're beginning to see that trend, with approximately 50 basis points of gross margin expansion this quarter, and we're still in the early stages of the launch. We believe this will continue to drive gross margin expansion in the future, which should help improve the EBITDA margin as well. This year, we are committed to investing all necessary resources into this launch to ensure it starts off successfully. While the drop-through may not be as substantial right now, looking ahead, this high gross margin product will be sold by the same sales team, and we expect it to significantly enhance EBITDA over time.

Yes. No, that's very helpful. And then just on On-X. So it's been a consistent growth driver for you in the past few years. How stable is that business looking ahead? And really, on that note, can you provide any directional color on what's embedded in the guide for On-X and the stent graft portfolio?

Yes, I'll take the first part. Ever since we launched low INR for the On-X valve, which coincided with our acquisition of the company in 2016, we have consistently experienced double-digit growth in that business. The compound annual growth rate over the last 7 or 8 years has been around 12% or 13%. I mentioned in the last call that several factors are working in our favor. We hold the exclusive indication for low INR, we have the AMDS launch creating cross-selling opportunities, and we have five years of post-approval data indicating an 87% reduction in major bleeding. Additionally, a paper presented at STS in January highlighted that if you receive a mechanical valve before age 60, you have a mortality advantage compared to a tissue valve. We haven't fully started marketing this to cardiologists, yet the business is growing over 20%. Therefore, we are seeing an acceleration of On-X driven by these factors. We will not disclose our projections for the latter half of the year, although we do have the segments we report against, and the performance has been very strong.

Yes. And I think on the guidance thing, we're not going to get into the nitty-gritty on what's the change. But at the beginning of the year, we laid out kind of our standard set of parameters of how we think about the different product lines, growing longer term with kind of BioGlue and tissue as a mid-single-digit growth rate businesses and On-X is a low double-digit and stent grafts before taking into account AMDS in the U.S. is kind of a mid-teens business and then U.S. AMDS adding incremental growth over that. And then since then, we've moved our midpoint up twice in both of the first and second quarter call. And I think I would just say, definitely, the On-X performance in the U.S. and the strength we're seeing in that business is definitely a big contributing factor to our ability to raise the midpoint.

Your next question comes from Mike Matson with Needham.

This is Joseph filling in for Mike. To start off with On-X, you mentioned stocking orders for AMDS. I'm curious if there were any one-time factors that impacted On-X this quarter. As you indicated, there are cross-selling opportunities between AMDS and On-X, so I'm wondering if there are any one-time effects with On-X or if everything is driven by data and awareness.

Yes. The largest and fastest-growing market is in the U.S. We do not engage in bulk deals or individual sales; everything operates on consignment. Therefore, a significant portion of that growth rate is attributed to implants.

Okay. Okay. Perfect. And then maybe just a quick one on the ARTIZEN trial. I appreciate the color you guys have given so far. I'm just curious maybe a little bit more on the trial. What does follow-up time look like? Is there any idea on when data readouts could be? And I guess, just given the complexity of the procedure, does it take a while to train surgeons who opt into this trial? Has training like that already happened with you with Artivion?

Yes, this situation is somewhat similar to my previous comments on AMDS. One of our company's key principles is to develop simple and elegant solutions that enhance outcomes, and ADS exemplifies that. The Arcevo device, part of the ARTIZEN trial, is the first frozen elephant trunk device with a branch subclavian feature, which will facilitate the procedure. It's important to mention that all the surgeons involved in this trial are already experienced with frozen elephant trunk operations using a competing device. We believe our device will be easier to operate, quicker to use, and will yield better outcomes. While some hands-on training will be necessary for the surgeons to familiarize themselves with our delivery system and the new device, it won’t require extensive training. Therefore, we anticipate this trial to progress rapidly.

Your next question comes from Destiny Hance with Ladenburg Thalmann.

Just one for us. I'm sorry if I missed it, but curious if you could talk about some pricing trends and if you're seeing any changes in pricing and power there.

Yes. So Destiny, your question was just an overall question about pricing environment and what we're seeing. Is that correct?

Yes, please.

Yes. I mean we talked about this before. I mean the nature of our devices is they're generally life-saving and not super high volume from an individual line item in the hospital. And because of that, we typically have not seen price pressure and have really had an ability to drive modest inflationary type price increases consistently over time, and that continues to be the case. Now I know in previous years, we've had some kind of exceptionally large price increases in individual products. We don't really have any of that going on at the moment. This is really more volume-driven with just kind of normal inflationary price benefit.

Your next question comes from Dan Stouter with Citizens JMP.

I just had a few quickly. So following up on the On-X growth. It's been talked a lot about, but I just wanted to try to get a sense of how much of it was due to those cross-selling benefits. It seems like the business is still really strong beyond that. But could you give us any color on how much of the quarter's contribution was from new accounts and that halo effect with AMDS? And maybe if you have any metrics on higher utilization for On-X, that would be really helpful.

Yes. So we're not going to get into the nitty-gritty on utilization, but I will say definitely, there was a meaningful uptick from new accounts. Now is that due to cross-selling or due to the new data or a combination of both, that's really hard to tease out. But it's not just increased utilization in our existing customer base. It is definitely also driven by new customers.

Okay. That's great. And then just one follow-up on free cash flow, great improvement during the quarter. I just wanted to get a sense of how we should be thinking about it for the back half of '25. Any cadence we should keep in mind? And any more notable cash items that we should be thinking about for the rest of the year?

Yes. I want to emphasize that cash timing can lead to fluctuations from one quarter to another. However, we have consistently said, and we continue to say, that we expect to be positive for the full year. We had a very strong quarter this year, which was necessary because some of that was a recovery from the first quarter. Overall, we feel optimistic about meeting our goal of being free cash flow positive for the entire year.

Mr. Mackin, there are no further questions at this time. I would like to turn the floor back over to management for closing remarks.

Well, thanks for attending. Again, we're super excited about the quarter. We appreciate you all joining. We've got a lot of momentum. We're growing double digits. We're growing twice as fast on the bottom line. We're generating cash. We've deleveraged, and we've got a lot of growth drivers we talked about in new clinical trials starting. So we're super excited and look forward to reporting that again next quarter.

This concludes today's call. Thank you for attending and have a wonderful rest of your day.