Good morning, and welcome to InspireMD Third Quarter 2025 Earnings Conference Call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures. Please go ahead.

Thank you for joining us for the InspireMD Third Quarter 2025 Conference Call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; Mike Lawless, Chief Financial Officer; and Shane Gleason, Chief Commercial Officer. During this call, management will make forward-looking statements, which are based upon management's current expectations, beliefs, and projections, many of which, by their nature, are inherently uncertain. These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward-looking statements. For more information about these risks, please refer to the risk factors described in InspireMD's most recently filed periodic report on Form 10-K and Form 10-Q or any updates in its current reports on Form 8-K filed with the U.S. Securities and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. This call contains time-sensitive information that is accurate only as of today, November 4, 2025. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Thank you, and good morning, everyone. I'm pleased to welcome you to today's call. Joining me on the line is Mike Lawless, our Chief Financial Officer; and Shane Gleason, our Chief Commercial Officer. We are dialed in live from VIVA, the Vascular InterVentional Advances Conference in Las Vegas, where we're hosting many conversations on the introduction of CGuard Prime following our approval in June. I will share more on our market traction shortly, but I want to start with a detailed overview of the results of the third quarter. I'm happy to share that our business is advancing with velocity and intention. In the third quarter, we reached $2.5 million in total revenue, representing year-over-year growth of 39% and sequential growth of over 40% since the last quarter. Our growth was driven by strong early momentum in the U.S. and continued demand for our CGuard stent platform internationally. Our strong performance was a result of months of significant internal preparation, which positioned us to hit the ground running upon the FDA approval. Following approval, which we received in late June, our team immediately activated our planned commercial efforts in the United States in July. When we say commercial activation, we mean a focused and deliberate effort to make sure that our device is accessible to U.S. providers and their patients who are at risk of stroke. Our team has been engaged with many physicians and hospital systems and are working through value analysis committee approvals, contract completions, and case initiation. We are building traction methodically with the goal to drive sustainable penetration and growth in the market. Demand for CGuard Prime has been strong. As of today, we've completed more than 100 cases in the U.S., and many of these procedures were performed within some of the largest IDNs in the country. The demand and excitement for our technology reflect the foundational work we've done over the years, establishing value and awareness for our best-in-class clinical results. Globally, we are now approaching 70,000 stents sold to date as the carotid interventional market shifts to a stent-first approach. We believe the established CMS reimbursement, combined with our innovative protective mesh stent design, evidence and real-world experience provide a pathway for us to lead the carotid market. We are equipped with high-caliber sales leadership and clinical support, reflected in the remarkable progress our group has made in just a few months post-FDA approval. Their deep experience in the vascular market and established relationships with physicians and administrators combined with a best-in-class implant forms the backbone of our early and progressive success. The team is tasked with our commitment to expanding treatment to the vast patient population who could benefit from our technology. As a reminder, over 3 million people globally are diagnosed with carotid artery disease, yet only approximately 400,000 are treated annually. This massive gap in treatment leaves patients vulnerable to catastrophic stroke events. CGuard Prime aims to redefine success for these patients and their providers by lowering the risk of strokes and other major adverse events to levels never achieved with first-generation stenting or surgery, validated with rigorous evidence, proven clinical results, reimbursement, and real-world outcomes. As I mentioned earlier, we are living the excitement of our technology firsthand here at VIVA. Today, we are here in Las Vegas with many members of our team and Board of Directors, engaging with our physician partners and champions as we continue to launch CGuard Prime in the U.S. The energy of our commercial-facing teams and the unmistakable momentum around endovascular intervention gives me incredible optimism for the future of our company. Before I provide a detailed update on our clinical trial work, I wanted to take a moment to welcome our new Chief Medical Officer, Dr. Peter Soukas. Dr. Soukas will oversee clinical and medical topics, further building on our best-in-class data as well as advancing awareness of our technology stent platform to the physician community. This transformational time for carotid intervention requires continually building a world-class team and support, and Dr. Soukas will be a tremendous contributor to our work ahead. We're thrilled to have Dr. Soukas join as our CMO. Now to the clinical pipeline, a critical piece of our long-term growth strategy. We continue to advance multiple programs in clinical studies as we work to expand our reach of our technology by building clinical evidence, potentially unlocking additional market opportunities. Starting in TCAR with C-GUARDIANS II, which evaluates a short TCAR-indicated version of CGuard Prime designed to be compatible with neuroprotection systems that are already in use in the field today. I'm pleased to report that we are on track to complete enrollment by the end of the year and potential approval anticipated in mid-2026. Simultaneously, we're advancing C-GUARDIANS III, the next phase of our TCAR strategy, evaluating our fully integrated TCAR solution, combining the CGuard Prime 80 stent with our proprietary SwitchGuard neuroprotection system. This study is designed to showcase the full potential of our purpose-built solution for TCAR, offering physicians a comprehensive streamlined option that we believe can set a new standard in the field. We currently expect FDA clearance and launch in mid-2027. The impact of these two studies highlights the versatility and clinical value of our platform and is expected to give us an extremely competitive position in TCAR, a U.S. market that already exceeds 30,000 procedures annually. We also continue to make progress on our tandem lesion early feasibility study to expand the potential use of our technology in acute stroke care. The study is being conducted in partnership with Dr. Adnan Siddiqui and the Jacobs Institute in Buffalo, New York. This study evaluates the use of CGuard Prime in acute stroke patients with tandem lesions in conjunction with thrombectomy. I'm happy to share that enrollment is over 50% complete. It is inspiring to hear physicians' excitement for having an option to treat this critical need with our technology in a challenging patient population. Let me also mention our awareness of the upcoming CREST-2 data that's scheduled to be presented at the VIIF and SVIN meetings in the coming weeks. We believe the culmination and sharing of this data is another reminder of the advancement of awareness of carotid intervention and the importance of decoupling categories of therapy with specific implant-based performance to demonstrate the specificity and granularity of results. Clinical outcomes have been redefined with best-in-class evidence with CGuard implant across a large population sample of both symptomatic and asymptomatic patient cohorts measured in both short- and long-term outcomes. The baseline of nearly 70,000 implants sold and 2,000 patients studied and peer-reviewed to date speaks volumes to the validation of our exceptional results. Our strong performance in the third quarter combined with the establishment of a robust commercial foundation gives me tremendous confidence in our ability to deliver meaningful growth and value over the coming quarters and years. Now I'll turn the call over to Mike to walk us through the financials.

Thanks, Marvin. For the third quarter of 2025, total revenue increased by 39% to $2.5 million. This increase was predominantly driven by the launch of CGuard Prime in the U.S., increased penetration of international markets with CGuard and the favorable impact of foreign exchange. U.S. revenue for the third quarter was $497,000, driven by the launch of CGuard Prime. This is the first quarter we recorded U.S. commercial revenue following the FDA approval in late June. International revenue for the third quarter was $2.0 million, an increase of $223,000 or 12% compared to $1.8 million for the third quarter of 2024, driven by increased usage in over 30 markets and the favorable impact of foreign exchange. Gross profit for the third quarter of 2025 increased by $450,000 or over 100% to $864,000 compared to gross profit of $414,000 for the third quarter of 2024. This increase in gross profit resulted from higher revenue and a favorable shift in sales mix towards higher-margin revenue from our commercial launch in the U.S., partially offset by higher production variances and training costs. Gross margin increased to 34.2% of revenue during the third quarter of 2025, up from 22.9% of revenue during the third quarter of 2024, driven primarily by the previously discussed favorable revenue mix and volume leverage of fixed operating costs. We expect continued expansion of gross margins in future quarters as our commercial sales ramp in the U.S. drive continued favorable mix and volume leverage. Total operating expenses for the third quarter of 2025 were $13.9 million, an increase of $5.0 million or 57% compared to $8.9 million for the third quarter of 2024. This increase was primarily due to higher headcount-related expenses as we continue to expand our U.S. personnel, particularly our commercial team to drive the U.S. commercial launch of CGuard Prime. A second driver of the increase in operating expenses was occupancy and infrastructure expense related to the establishment of our U.S. headquarters. Financial income decreased by $229,000 to $343,000 from $572,000 in the third quarter of 2024. This decrease was primarily due to a $118,000 decrease in financial income from investments in marketable securities and money market funds and a $104,000 increase in financial expenses related to changes in exchange rates. Net loss for the third quarter of 2025 was $12.7 million or $0.17 per basic and diluted share compared to a net loss of $7.9 million or $0.16 per basic and diluted share for the same period in 2024. As of September 30, 2025, cash and cash equivalents and marketable securities were $63.4 million compared to $19.4 million as of June 30, 2025. The increase in cash resources is a result of two financing events with significant impact during Q3. First, we raised gross proceeds of $40.1 million through a PIPE offering with existing and new investors. Second, we raised gross proceeds of $17.9 million from the exercise of the second of four milestone-based financing tranches pursuant to our May 2023 equity private placement. The exercise of the warrants was triggered by the receipt of premarket approval from the FDA for our CGuard Prime carotid stent. The two remaining tranches are triggered by future milestone events, including: first, the completion of four quarters of commercial sales of CGuard Prime in the U.S., which we anticipate in the back half of 2026; and second, receipt of FDA clearance for the SwitchGuard TCAR neuroprotection system, along with TCAR indicated CGuard Prime stent, which we expect during 2027. So turning to our financial outlook. We're encouraged by the initial traction for sales of CGuard Prime in the U.S. and the continuing solid performance of CGuard internationally. For the fourth quarter, we expect sequential growth in U.S. sales and steady demand trends internationally, resulting in revenue of approximately $2.5 million to $3.0 million in the fourth quarter. When we report our fourth quarter 2025 results, we will share our 2026 growth expectations informed by insights from an additional quarter of U.S. launch progress. This concludes our prepared remarks. We will now open the call for questions.

And we'll take our first question from Adam Maeder with Piper Sandler.

Congrats on the progress. Can you hear me okay?

We can, Adam.

Okay. Perfect. I was getting a little bit of feedback there. Maybe just to start, would love to hear a little bit more about the initial physician feedback that you're getting from U.S. customers that have started to use CGuard Prime? And then the second part of that is maybe it's a little bit early, but curious how CGuard is being used in the doctor's armamentarium. Is this kind of being used as kind of the workhorse carotid stent for customers? And then I had a couple of follow-ups.

Adam, thanks for the question. We're really enthusiastic in the response from physicians. I think that there has been a buildup to anticipating CGuard Prime's launch in the U.S. because of our baseline of experience outside of the U.S. And we purposefully launched this product over the many years outside the U.S. to build a very solid foundation of best-in-class clinical data and real-world experience. As you know, this world operates globally, and it was no secret anticipating this coming launch. So we're very enthusiastic about it. Frankly, we're trying to make sure that we follow a very deliberate controlled approach to things to get on top of all the opportunity that we see in front of us, but to do it the right way and deliver deliberately. We're following our playbook that was designed for a long view and leadership in this space with durability over time. But I think the early days, even though it's one quarter of data really give us a lot of enthusiasm and encouragement. I'm going to ask Shane to kind of jump into the second part of your question in terms of where this fits in the armamentarium of our customers across a pretty broad base of carotid users.

Yes. Thanks for the question, Adam. The excitement has been really strong. And as we mentioned earlier, we're at the VIVA meeting. We're at the TCT conference last week. There are a number of other ones upcoming. And the team is in the field every day having these conversations. So the product has been very well received. And a lot of the discussion at the meeting has been exactly that. Where does this fit into people's carotid toolkit? And up until now, there tended to be trade-offs between different stent platforms, a lot of advocacy for being comfortable with both an open cell stent and a closed cell stent for various anatomies. And one of the great things about CGuard Prime is that it really meets both of those. So we envision this to be a workhorse product. That's what the folks at the podium are saying as well. So that's our expectation going forward.

Okay. Perfect. I appreciate all the color there, guys. And for the next question, I was hoping to just go a little bit deeper into U.S. launch and wanted to see if you could share some metrics, I guess, more specifically, device ASP versus volume in the quarter, number of accounts that have implanted CGuard at this point and visibility around that process for how we should think about onboarding accounts in Q4?

Thanks, Adam. I'm going to let Shane jump in on those topics. Again, early days and early data points, but I think thus far, the expectations across that spectrum that you just mentioned have been really encouraging and sort of above expectations. But Shane, do you want to add something on those?

Yes. I'll say in terms of pricing, our approach has been that we are coming in at a premium to the market, but not a prohibitive one. The conversations that we have frequently are that our major adverse event rates are half or one-third of what the first-generation stents have. So we could have taken the approach that we're two or three times as good, so we're going to charge you two or three times as much. Price it like a drug-coated balloon or drug-coated stent newly into the market. But we know that while that may eventually get us on the shelf in some places, it would likely limit adoption certainly to being a workhorse product. So our communication is that we're requesting a, I'll call it, a modest premium, something versus the CAS and TCAR stents, something in the hundreds of dollars, not thousands of dollars. and saying that we want it to be a workhorse stent. We don't want it to be priced to the point where you only use it in case of emergency, you only use it in the worst of your worst cases, but we want to be used in all of their cases. So I'd say a more modest premium to the market, which has been well received by physicians and administrators as well.

And just any color on accounts, yes, sorry, go ahead, please.

Yes, I wanted to clarify the other question. We mentioned that we've completed over 100 cases since our launch, and that number continues to increase daily. Regarding opened accounts, we recently had about a dozen sales representatives in the field. On average, each representative opened several accounts even in the first quarter, which exceeded our expectations. Typically, approvals from VACs and product committees are measured in quarters to years, not weeks or months, but we've had numerous approvals in just months instead. Additionally, we've conducted cases in many of the key integrated delivery networks across the U.S., making significant progress in opening accounts.

Yes. Adam, I would just add that this is a foundational build for us. When we talk about activation, it's all of those things. But the benefit of having a team on the field at approval, thanks to our capital strategy, was really important for us so that we could get into that activation mode quickly, and we'll obviously benefit as that continues to mature.

Sure. Totally makes sense, and I appreciate the color. And just one last one, if I may sneak one more in. Just I think you just mentioned, Shane, 12 reps in the field in the U.S. until recently. Can you just remind us kind of how we should think about the sales force expansion plan as we get into this quarter, Q4 as well as 2026? I'll leave it there, guys. congrats again.

Yes, absolutely. So what we communicated last time that we have a U.S. commercial organization that was north of 20 people with most of them in the field. I mentioned the number of reps just a minute ago, but then you add in the sales directors and clinical specialists. We were exiting this year with more than 30, again, with most of them in the field. And the additions that have all been territory manager, customer-facing sales roles. And then in terms of going forward, our plan has been to get to that point here as we exit the year, let them start to throw down some routes in their accounts and then scale accordingly as we get into and through 2026.

And we'll take our next question from Frank Takkinen with Lake Street Capital Markets.

Congrats on the solid initial launch. I was hoping to follow up on, I think there was a guide right at the end of $2.5 million to $3 million. I think I heard that was for total business. Can you maybe help us parse out OUS versus U.S. in that $2.5 million to $3 million? Apologies if I missed it.

Yes, sure. Frank, this is Mike. Yes, the breakdown of the guidance really consists of stable international sales relative to Q3 with expectations for some growth in the U.S. market in Q4.

Perfect. Okay. That's helpful. And then maybe one, I know it's probably early days here, but any comments around those who have started to use it, how they are ordering product initially? Are they starting with a few units and then reordering? Are they putting half dozen units on the shelf? How are they, generally speaking, ordering product to start?

Yes. Frank, I'll jump in there and hand it off to Shane for the back half of that question. So far, patient outcomes are great. The stent performance is great. We're thrilled by the fact that expectations are certainly being met in those two parameters, which is what's most important and consistent with how we've done this globally and how the stent has performed globally. I'll let Shane kind of answer the general theme that we're following in terms of how we're stocking shelves, doing cases, and most importantly, how the matrix of our products fits well into the size expectations that are on the shelves.

Yes, our goal is to have our team involved in the cases as we launch this product. One of the advantages of this area is that eventually, being present won't be necessary. In the short term, we want to be involved in those cases during the product launch. As we move forward, we won't need to be. This approach means we are not just leaving products on shelves and hoping for usage when we’re absent. Initially, we will manage the cases with representatives present to ensure that users and accounts are trained and familiar with the product before we leave it with customers.

Yes, Frank, I think it's all about utilization at this point. We want to make sure that this is the go-to product and it's utilized effectively as such.

Got it. That's helpful. And then maybe if I can just sneak one last one in, gross margin commentary. How should we think about where gross margins can go with scale?

Yes. Well, I think as I mentioned on the call, the clear driver of that is the increasing mix of U.S. sales as we go forward into the future. As our volumes grow, we'll get some scale leverage just from the higher revenue, but we'll also get the benefit of the much higher margin mix of sales in the U.S. market. And so I mean, I think at this point, I don't want to start giving forward guidance on margins, but suffice it to say that as the U.S. becomes a larger and larger percentage of our revenue, we would expect that our margins would approach typical medical device type margins.

At this time, we've reached our allotted time for questions. I will now turn the call back over to Marvin Slosman. Please go ahead.

I'd like to thank everyone for joining today's call and the continued support for our mission to lead and transform the carotid intervention market. We're really proud of the strong performance the team delivered globally in the third quarter and especially here in the U.S. and our first commercial quarter as we advance our activation efforts and accelerate momentum. If you happen to be here in Las Vegas at VIVA, stop by the booth, we'd be happy to see you and look forward to great progress on our business. Thank you.