Good morning, and welcome to InspireMD Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Web 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…

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. drives 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…

[Operator Instructions] 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 1 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 in to 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 1/3 of what the first-generation stents have. So we could have taken the approach that we're 2 or 3x as good, so we're going to charge you 2 or 3x 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 was just going to clarify the other question. So we mentioned that we've done over 100 cases since launch. Obviously, that number is growing every day. And in terms of accounts open, are we -- yes. We've had about a dozen reps in the field until very recently. And I'll say that we on average opened several accounts per rep even in the first quarter, which we've outpaced expectations where you kind of think VACs and product committees tend to be measured in quarters to years, not weeks or months, but we've actually had a lot of approvals in months and not quarters. And we've done cases in a lot of the key IDNs around the U.S. So we've made a lot of traction there in terms of 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.

[Operator Instructions] 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 2 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 -- we want our team in the cases as we launch this product. One of the nice things about this space is that eventually, that won't be the requirement. We know that's a question of do you build a model where you need to be present in every single one of your cases. I'd say in the short term, as we launch the product, we want to be present in those cases. And then as we open things up going forward, we won't need to be. So what that tells is that we're not stocking shelves and running away and hoping they use it when we're not there, but primarily running the cases out of reps stock with reps present in the cases as we get started and we make sure that the users and the accounts that could use it are trained and familiar with it before we leave a bunch of products on customer shelves.

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 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.