Good morning, and welcome to InspireMD's Second Quarter 2025 Earnings Conference Call. [Operator Instructions] We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Marissa Bych with -- from Gilmartin Group for introductory disclosures.

Thank you for joining us for the InspireMD Second Quarter 2025 Conference Call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; and Mike Lawless, Chief Financial Officer. During this call, management will be making forward- looking statements, not historical facts, 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 reports on Form 10-K and Form 10-Q or any other updates in our 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, August 5, 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. We're happy to welcome you to today's call at this exciting and transformative moment for our company. Before we review our recent progress and second quarter results, I'd like to take a moment to formally welcome Mike Lawless, our new Chief Financial Officer. Mike brings decades of financial leadership and deep expertise to InspireMD as well as a clear commitment to our mission and to the patients we serve. I'd also like to thank Craig Shore for his contribution and dedication over the past 15 years. His impact on the company's foundation and trajectory has been invaluable and is a big part of why we are here today. Turning to our recent progress as a business. Today's call comes just about a month after we received FDA premarket approval for our CGuard Prime Carotid Stent System, the most significant milestone in our company's history to date. We are now commencing on our U.S. commercial launch, leveraging our wealth of experience from over 30 OUS markets with over 60,000 patients treated to date to take the first step toward our mission of leading the U.S. carotid interventional market. I want to take a moment to reiterate what sets us apart as we step into this immense opportunity. Our mission is clear: to transform the carotid intervention market and deliver best-in-class patient outcomes through a stent-first approach. Over 3 million people globally have been diagnosed with carotid artery disease with countless others remaining undiagnosed, while only 155,000 are treated annually in the United States. These patients are at risk of stroke with deadly and profound debilitating outcomes. We've invested years of effort and expertise to build an innovative stent platform, CGuard Prime, that redefines success for these patients and their providers by lowering the risk of…

Thanks, Marvin. Before I begin, I'd like to briefly say how excited I am to join InspireMD at such a pivotal moment in the company's trajectory. It's a tremendous opportunity to contribute to a team that's driving meaningful progress, and I look forward to supporting our continued growth and success. With that, let's turn to the second quarter results. For the second quarter of 2025, total revenue increased by 2% to $1.8 million. This increase was predominantly driven by increased usage in our international markets from the continued adoption of CGuard technology and the positive impact of foreign exchange, partially offset by decreased revenue from Russia and European distributors managing CGuard inventory levels in anticipation of the CGuard Prime launch in Europe. As expected, we did not recognize commercial revenue in the U.S. in Q2 as our FDA approval came in the last week of the quarter. However, we have begun to recognize U.S. commercial sales this quarter, positioning us for sequential revenue growth in Q3 and beyond. Our Q2 volumes add to the growing body of real-world experience. Globally, we have sold more than 60,000 implants to date. This track record reinforces our expertise, validates our innovative platform and highlights the strength of our global commercial infrastructure, all of which position us well as we shift our focus to the significant U.S. opportunity. Gross profit for the second quarter of 2025 decreased by $18,000 or 5.7% to $313,000 compared to a gross profit of $331,000 for the second quarter of 2024. This decrease in gross profit resulted from an increase in some production variances, partially offset by lower material and labor costs. Gross margin decreased to 17.6% during the 3 months ended June 30 from 19.0% during the 3 months ending June 30, 2024, driven by the above factors.…

[Operator Instructions] We'll take our first question from Adam Maeder with Piper Sandler.

Congrats on the progress. And to you, Mike, welcome and Craig, wishing you the best in the future. Two for me, and I guess I'll start with the first one, which is a little bit of a myopic question, but I just wanted to see if there's any more detail that you can share regarding your progress with U.S. account openings since FDA approval for CGuard Prime in late June? And as we think about subsequent quarters and even 2026 for that matter, are there any targets or framework that you want to provide for The Street as we think about kind of initial launch, whether that's revenue, market share, number of accounts, et cetera? And then I did have one follow-up.

Adam, this is Shane. I'll go ahead and start that one off and then maybe hand it off to Marvin for the second part of that. So we got approval about 6 weeks ago this week, and we're really excited about the progress that we've made. As we've noted previously, we have a commercial organization in the U.S. of around 20 people with a great majority of them in the field. We plan to continue scaling that and we're planning on adding roughly 10 people to that number by the end of the year. Having that group onboard at the time of approval, let us hit the ground running, I think it's common to see 6 weeks into an approval that very little, if anything, has occurred in the way of cases. We've actually done procedures with double-digit physicians, and we've even reached the point of beginning to secure shelf space with stocking orders in a number of those accounts. So I'd say the early reception has been exactly what we'd expected and hoped it to be, and we're off to a healthy start.

Adam, yes, this is Marvin. I think Shane framed it perfectly. I think that the opportunity for us was in our May 2023 financing. We were able to fuel a commercial team, a game plan and a playbook that allowed us to hit the road when we had approval, and we will continue to build off that momentum. We certainly understand that there's headwinds involved with building administrative approvals and all the things associated with readiness, and we have to have some patience in that regard. But I think overall, we've hired to the standard of being able to build access to these facilities and physicians. And so far, as Shane said, the reception has been overwhelming, and we really appreciate the fact that the market is receiving CGuard Prime as well as they have.

Okay. Perfect. That's great color there. And for the follow-up, I did want to ask about C-GUARDIANS III and SwitchGuard, your proprietary TCAR device, if I heard correctly in the prepared remarks, now expect clearance and launch in '27, a little bit of a wiggle from late '26, which I think was the prior expectation. Just wanted to, I guess, kind of better understand kind of what's driving the change in expected time lines? Is it related to device design? Is it pinning down clinical strategy and trial construction? Is it something else? And yes, just trying to kind of better understand the change in timing there and the confidence in getting clearance in '27.

Sure, Adam. Thanks. So just let's go back as a reminder of our overall TCAR strategy. It was built around the entry into the market with a TCAR indicated catheter first to unlock the potential of the implant first, which is most sought after by the physicians and remains Phase I, which is in line with our prior time lines. SwitchGuard was designed as a next-generation platform for neuroprotection and as such, requires the entirety of the development process from design through production build. And in parallel, we've also considered the clinical enrollment aspect, FDA regulatory requirements, statutory time lines, all those kinds of things. So we're progressing exceptionally well in all of these areas, but just believe that the time line should reflect a broader window to clearance. There's variability in all of these aspects of bringing new products to market, and we're just trying to expand the window to give us room to deal with the uncertainties of those aspects of all of these launch parameters, but nothing other than that trying to be realistic and compensate for that. As you've seen in the past, we've previously demonstrated that we'll continue to find passive lease resistance and deliver accordingly and time lines in our world remain as aggressive as we can in hopes that we can beat expectations.

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

Congrats on all the progress. I was hoping you could refresh us on some account metrics. I know we've talked about it in the past, how many high potential accounts do you see out there? How many do you intend to target with the initial sales footprint? And then how does that kind of roll out progress as you bring on more reps?

Yes. Thanks, Frank. This is Shane again. So one of the nice things here is that carotid stenting is an established market. We have claims data that shows we know that there are roughly 60,000 annualized procedures and growing. They're performed by 4,000 physicians in the U.S. We have claims data showing who they are, where they are, where they practice and what their volumes are. So in terms of the old fish where the fish are, we're putting -- we're hiring our team selectively in locations that have the highest density of procedures. We're targeting the physicians that do above average number of procedures, obviously, in the busier accounts. So what we're tracking early on, the obvious one is revenue. The other ones are just physicians in every stage of our sales funnel who's expressed interest, who's in their value analysis committee who is evaluating the product and where have we secured business. So we're tracking all of those metrics in the early stages, and they're tracking in the direction that we expected them to do.

Got it. That's helpful. And then maybe also partially a refresher and just a kind of update on the broader market. The 60,000 procedures you talked about, my understanding is that's transfemoral as well as TCAR in that number. And then there's approximately another 100,000 or so that are still being completed open. What are kind of the latest trends in that mix? And then how do you think about that trend towards an endovascular first mindset progresses over the next few years?

Yes, that's exactly right. We see the trend where it used to be 70% plus surgery, that gap is closed to where it's now less than 60% surgery. And with the 40% plus being stent-based, which, to your point, could be transfemoral, could be transradial, could be TCAR. And we see those lines continuing to converge. So we expect within the next year or so that we'll likely reach a 50-50 point for the first time. And then in the coming years for carotid intervention to look just like every other vascular intervention in the U.S. where there are products, there's reimbursement and an endo first standard of care. So between CAS and TCAR, we -- that is -- there is a mix there. It's about 50-50. And really, what we do with the claims is we can tell who's doing cases. We choose not to assume which approach they're going to take. Not all surgeons prefer TCAR, not all interventionalists prefer CAS. So we don't assume what they're doing, but then with our long-term strategy, we'll be able to serve all approaches. But in the short term, the goal is to find those that have a use for our CAS indicated stents and target those in the early stages here.

We have reached the end of our question-and-answer session. I will turn the program back over to Marvin Slosman for any additional or closing remarks.

Great. I'd like to thank everyone for joining the call today and your continued support of our mission to lead and transform the carotid intervention market. We're proud of the strong execution we delivered in the second quarter of '25 and even more excited about the milestones ahead as we enter the critical first quarters of our U.S. commercial launch of CGuard Prime. With a differentiated technology, strong clinical foundation and a clear strategy to expand the market and improve outcomes, we believe InspireMD is uniquely positioned to reshape stroke prevention in the United States. As we execute on this launch and build momentum, our focus remains on driving meaningful impact for patients, physicians and shareholders alike. We're confident in our path forward and energized about the opportunity ahead to expand provider treatment options, advance patient care and establish CGuard Prime as the standard of carotid intervention. Thanks for joining today.

Thank you. This does conclude today's program. Thank you for your participation. You may disconnect at any time, and have a wonderful day.