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Morning and welcome to InspireMD's first quarter 2026 earnings conference call. Currently, all participants are in listen-only mode. We will facilitate a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; Michael 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.

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 report on Form 8-K filed with the U.S. Securities and Exchange Commission and InspireMD's press release that accompanies these calls, particularly the cautionary statements made in it. During the call today, the company may discuss certain non-GAAP financial measures. For more detailed discussion of these non-GAAP financial measures and historical reconciliations to the most comparable GAAP measures, please refer to the company's earnings release. This call contains time-sensitive information that is accurate only as of today, May 4, 2026. 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, operator, and good morning, everyone. Starting with our Q1 results, our first quarter revenue of $3.4 million was a strong start to 2026, representing growth of over 120%. This performance reflects what we continue to see globally: robust and growing demand for the CGuard implant, driven by its highly differentiated clinical profile and strong physician demand. Before I go any further, I want to directly address the decision to pause commercialization for the CGuard Prime 135 delivery system, which we announced last week in coordination with the FDA. While we recognize this action represents a clear setback from our commercial momentum in the U.S., let me be very clear on three important points. First, this action is not related to the safety or performance of the CGuard stent implant, which continues to demonstrate best-in-class clinical outcomes.

Second, this was a proactive decision based on feedback from our controlled U.S. launch, where we identified opportunities to further enhance the technical performance and physician experience of the delivery system. Third, we are confident this is a temporary and correctable issue, and we have a clear path forward to restoring and expanding our U.S. commercial opportunity. Importantly, this reflects our long-standing philosophy. We prioritize clinical excellence and physician confidence over speed of commercialization. We believe taking this step now ultimately strengthens our long-term market position. In parallel, we're advancing an important and near-term solution pursuing FDA approval of our original CGuard delivery system that has already been successfully used in more than 70,000 cases globally, as well as in the majority of the cases in the successful C-GUARDIANS clinical trial.

Our ongoing discussions with FDA are positive and constructive. We anticipate FDA approval in the third quarter of 2026, which would enable us to reenter the U.S. market with a proven and highly reliable platform. Despite this temporary pause in the United States, the fundamentals of our business remain strong. Strong physician excitement and belief in CGuard, continued strong international growth. Our TCAR strategy remains fully on track and unaffected by this voluntary action. We continue to anticipate FDA approval of the CGuard Prime 80 system for TCAR procedures in the second half of this year, which we believe could potentially double our U.S. addressable market. Furthermore, we're pleased to have received FDA approval to initiate the CGUARDIANS III clinical trial, which will evaluate the company's next generation SwitchGuard neuroprotection system with the CGuard Prime 80 for use in TCAR procedures.

When approved, this will allow us to offer the full TCAR toolkit. Given the temporary pause in the U.S. commercialization, we have made the decision to withdraw our full year 2026 revenue guidance. We believe this is the most responsible approach while we complete enhancements to the CGuard Prime delivery system and gain more clarity on the specific timing of the approval for our original CGuard platform to our return to the U.S. market. That said, we remain confident in the long-term growth trajectory of the business. During this period, the entire team remains focused on approval of the original CGuard 135, which is already being reviewed by FDA. Approval of the CGuard Prime 80 with a TCAR indication for use with the only currently available neuroprotection system in the market, and completion of design changes and approval of our improved CGuard Prime 135 platform.

Enrollment of the CGUARDIANS III study for clearance of our next generation SwitchGuard neuroprotection system for TCAR procedures. Before closing, let me reiterate the following. We know there is a clear and growing global demand for our CGuard implant, as proven in over 70,000 patients to date with unmatched clinical outcomes. We have taken a proactive step to enhance our delivery system in the U.S. We have a clear path to reenter the U.S. market with a commercially proven product and line extension. We believe we have a stent that can and is redefining carotid intervention, and we remain highly confident in our long-term growth plan. Mike will now talk you through the Q1 results and financial implications of our voluntary field action. Mike?

Thanks, Marvin. For the first quarter of 2026, total revenue was $3.4 million, representing an increase of 122% compared to revenue of $1.5 million for the first quarter of 2025. This growth was driven by the launch of CGuard Prime in the U.S. and increased penetration of international markets with CGuard. U.S. revenue for the first quarter was $1.2 million, driven by the launch of CGuard Prime, representing 36% sequential growth versus the fourth quarter of 2025. Recall that we initiated the controlled commercial launch of CGuard Prime in the third quarter of 2025, we do not yet have year-over-year performance that we can report for U.S. revenue.

International revenue for the first quarter was $2.2 million, reflecting annual growth of 48% compared to $1.5 million for the first quarter of 2025. The majority of international growth was driven by higher unit sales, while changes in foreign exchange rates contributed growth of 11% to our international results. Gross profit for the first quarter of 2026 was $0.7 million or 20.2% of revenue, compared to a gross profit of $0.3 million or 19.1% of revenue for the first quarter of 2025. This increase in gross margin resulted primarily from a favorable shift in revenue mix to U.S. sales, which carry a higher margin than international sales.

Offsetting most of the improvement in the mix in revenue was a $473,000 impairment charge related to excess inventory for which we decided not to extend the useful life. On a non-GAAP basis, which excludes the impact of the impairment charge, adjusted gross profit was $1.2 million or 34.1% of revenue. This adjusted gross margin was below our expectations primarily due to additional compensation expense for the operations team in Tel Aviv, who maintained operations during very difficult conditions throughout the recent conflict. Total operating expenses for the first quarter of 2026 were $14.7 million, an increase of $2.9 million compared to $11.8 million for the first quarter of 2025. This increase was primarily due to higher staffing levels and marketing activities for the U.S. commercial launch of CGuard Prime.

Financial income was $289,000, essentially flat compared to $294,000 for the first quarter of 2025. Net loss for the first quarter of 2026 was $13.7 million or $0.16 per basic and diluted share, compared to a net loss of $11.2 million or $0.22 per basic and diluted share for the same period of 2025. As of March 31, 2026, cash and cash equivalents and marketable securities were $41.6 million compared to $54.2 million at the end of 2025. Turning to the impact of the voluntary action of CGuard Prime and the temporary discontinuation of commercial activity in the U.S.

The decision to initiate the action took place late last week in consultation with FDA after reviewing the technical performance over the duration of the controlled launch. Consequently, we will recognize the financial impact of the U.S. recall of CGuard Prime in the second quarter of 2026, with a reserve for customer returns of approximately $700,000 and a reserve for inventory impairment and remediation costs of approximately $650,000. As a result of the impact of the temporary discontinuation of commercial activity in the U.S. following the action, we withdrew our prior full year 2026 revenue guidance at least until the expected FDA approval of our original CGuard stent delivery system, which we believe will take place in the third quarter of 2026.

Until expected FDA approval of the original CGuard stent system, we expect to have no commercial activity in the U.S. market, and our source of revenue during that time will be sales of the CGuard system in international markets. Given the strong U.S. market receptivity to the CGuard stent, despite the deployment issues of the Prime delivery system, we expect the U.S. customer response to the introduction of the original CGuard system to be very positive following the anticipated FDA approval. This concludes our prepared remarks. We will now open the call for questions. For the Q&A segment, we'll be joined by Shane Gleason, InspireMD's Chief Commercial Officer. Operator?

Thank you. If you would like to ask a question, please press star one one on your telephone. You will then hear an automated message advising your hand is raised. If you would like to remove yourself from the queue, press star one one again.

We also ask that you wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster. Our first question today will be coming from the line of Frank Takkinen of Lake Street Capital Markets. Please go ahead.

Great. Thank you for taking the questions. Hi, guys. I wanted to start with just some clarification around the process to get CGuard Prime back on the market. Where do you stand in resolving the challenges internally? When can that be complete, when can that get resubmitted? Given the product's been on the market, is there any chance for some sort of expedited review with the FDA to get that on market as soon as possible to meet your first half 2027 deadline?

Frank, thanks for the question. We appreciate it. We have already begun a very extensive process in remediating some of these technical challenges for the delivery system. We've identified those early on. We understand the root cause. We've already taken action to solve those. It's now a matter of completing the V&V testing and all of the associated work to get that done and get that resubmitted to FDA. The timeline for approval of those changes remains somewhat uncertain. Whether it remains in the statutory category of a design change or expedited is still to be determined. Those two time frames are different, obviously.

In terms of our confidence in understanding the problem and having solved the issue technically, we have a very clear understanding of that and have already made all the progressive steps to be very confident that this design change will work and will work much better and give us the technical response that we're looking for. You know, at the end of the day, we want a reproducible success in the delivery system, and a delivery system candidly that's worthy of the best-in-class implant that we know that we have in the market. We're very encouraged and optimistic that we'll be able to deliver this in early 2027 or sooner.

Got it. Very helpful. With the legacy delivery system working through the approval process, how quickly can you relaunch the new delivery system in relation to maybe VAC committees, scaling up manufacturing capacity? Once you do get that approval in hand, how quickly could we start to see that revenue come back?

Yeah, Frank, our expectation is that once we have approval, we will be ready and set to launch the original CGuard. As you know, this product is the one that we sell outside the U.S., we're full steam ahead on manufacturing capacity. There's no limitations to speak of there. Shane and the team will be working over the next 90 days or so to continue to work through the accounts. We've opened all of the VAC-related topics and really put a very clear plan together as to how we can relaunch as quickly as possible. There are no constraints at this point other than getting the approval completed, which we anticipate to be in the August window.

Okay. That's helpful. Maybe just one last one, and I appreciate all the time. As you work through this transition period, how should we think about OpEx trending through this time? As it relates to OpEx, just maybe talk about retaining key talent through this transit period.

Michael, you wanna take that one?

Yeah, sure. Yeah. I think we expect to see OpEx continue to increase slightly as we move through the year. We will be making investments in R&D, you know, with the C-GUARDIANS 3 clinical trial kicking off very soon. There will be some increased expenditures in R&D as a result of that. As far as selling and marketing and G&A, I would expect those to be relatively stable. I think we're gonna probably put a pause on in terms of head count investment until we, you know, have a little more clarity about the timeline for FDA approval for CGuard. I think that's the general path you should expect to see with OpEx.

Great. Thank you.

Thank you. One moment for the next question. Our next question will be coming from the line of Adam Maeder of Piper Sandler. Please go ahead.

Hi, good afternoon. Thank you for taking the questions. I actually wanted to pick up on one of the questions that Frank just asked around VAC. I just wanted to confirm the existing customer base, the users of CGuard Prime, those centers should be grandfathered in with the CGuard original delivery system. You can hit the ground running immediately upon FDA clearance. Did I hear that correctly, Marvin?

Yeah. Why don't we have Shane maybe clarify that point? Because he's been working through that with the team.

Yeah. Happy to. I think the short answer is, this is one of those where all politics is local applies, but that's something that our team in the field is staying close to. You're exactly right. In a lot of those cases, what they really approved is the stent. You can probably imagine that the team has been out there having a lot of conversations over the last couple of working days here. What we're hearing is that many of them don't want to lose access today, and all of them are looking forward to gaining access as soon as it's available. You know, the process will look a little bit different at each and every center like it does just for the VAC process in general.

We expect receptivity to be able to plug right back in.

Okay. I appreciate the color, Shane. Thanks for all that. I guess it's a related question, but as you think about, you know, any potential impacts to prospective customers, you know, while you don't have a delivery system, while you're not selling into the U.S. market, are you able to advance those conversations with prospective accounts? Or does this also kind of put a temporary moratorium on that process?

I think there's probably the best way to put it is that there are some things that you can discuss and others you can't. Clinical data results, those are things that are fair game. Specific, you know, price lists, things like that are things that you can't do until you have that until you have CGuard, for example, or CGuard Prime and the 80 shaft approved. We can remain engaged and again, kind of follow the rules of each site that we have and, you know, continue to engage with customers that way. From talking to the physicians and centers that we have, they kind of fall into really 1 of 2 different buckets.

One is they're disappointed to be losing access to what they have today, and they'll welcome it back as soon as they can get it. The other one is those who understand, who may have had challenges and are looking forward to getting a more reliable system. In both of those cases, there's a lot of receptivity to bringing us in, whether they've started using us or not at this point, when we get those other products available.

Adam, let me just add one quick comment to your question there and Shane's answer. Although the launch of CGuard Prime was controlled to a certain extent, our marketing of that device was very broad and quite aggressive. I think that the market in general understands the value of the CGuard implant. On balance, I think over the last several months, we've created a tremendous amount of interest and demand. Although we'll be limited in our ability to sell the product, I think that awareness is clearly going to create a tailwind once we get back in the market with CGuard first and then CGuard Prime. Also remember that the CGuard device was used in the majority of the C-GUARDIANS PMA trial.

We have a lot of familiarity out there within the investigator base that participated in that.

Okay, perfect. I will leave it there, and I'll hop back in the queue. Thank you.

Thanks, Adam.

Thank you. As a reminder, if you would like to ask a question, please press star one one on your telephone. One moment for the next question. Our next question is coming from the line of Anthony Vendetti of Maxim Group. Your line is open.

Thank you. I was just wondering, Marvin, if you could talk a little bit about, you know, the decision to voluntarily do the recall here in the U.S., and then the effect, if any, on the European business. Do you expect business to slow down there, based on this voluntary recall? As you work with the FDA, do you anticipate any potential labeling changes, or you think that that's really not gonna be the issue at this point, or is it too early to tell? Thanks.

Thanks, Anthony. Let's start with the OUS market. As you can see from the results in the first quarter, the OUS market is actually standardized in using our original CGuard delivery system, that business continues to grow nicely. The demand is clear that in the OUS market, as we have continued to mature over the years, we're growing nice share there. The OUS market will continue to operate, we'll count on that to be a robust part of the overall story. The decision that we made really we felt was necessary both in the short and long term to achieving our objective. You know, you can't lead in a market of this size, scale, and transition without, you know, 100% confidence in both the implant and the delivery system.

As I said before, we absolutely are committed to having a delivery system that's worthy of these best-in-class implant results of CGuard. As much as these decisions are somewhat difficult to make, we felt that this was the right time to make it so that we can move forward in an unencumbered way of taking advantage of a market shift candidly to stenting that has been, you know, on the docket for the last 20 years, and we find ourselves in a very unique position of being able to take full advantage of that. We, we wanted the complete story to be able to do that. We feel very good about our TCAR entry with the short shaft indicated CGuard for TCAR procedures and starting our SwitchGuard neuroprotection studies shortly.

As far as changes are concerned, these are simply design and technical changes. There will be no changes to speak of in terms of the use of the product, IFU and otherwise. As I said before, we have a very clear understanding of what needs to be done. We're confident we can expedite that quickly and get that into the FDA so that we can get things back on track. In the interim, we'll utilize CGuard and then have CGuard Prime back in the market in both the 135 and the 80.

Okay, great. Maybe just lastly on the as you were doing the sort of rollout and testing, you know, I guess it was maybe too early to tell, but clearly, I guess these issues with the delivery system weren't or didn't manifest itself early on, but now, you know, it's become an issue in terms of, you know, just like you said, complaints in terms of comfort, but not in terms of your system, but the delivery system. Why do you think it wasn't picked up earlier? Maybe just a little color on that. Thanks.

Anthony, it's a good question. We had limited user experience in the PMA trial. We put CGuard Prime into that fairly late in the process. Once we began to launch this into a broader market, the combination of new user experiences, the combination of a lot of different accessory devices being used with CGuard Prime, you know, just lend itself to a learning curve that we had to appreciate once we had this product fully engaged in the market. That's why we did a controlled launch to begin with, to keep very close to those details. I think the learning curve was somewhat unfortunate, but I think we got ahead of it early. We understood the core issue and knew what to do to address it.

Unfortunately, we've had to take a pause here for a 90 or 100 day window in order to get things put together properly. We felt like under the circumstances, this was the right thing to do so that we can, we can come out of the blocks on the other side of this in a very clear way to continue to grow share.

Okay, great. Thank you very much. I appreciate it. I'll hop back in the queue.

Thank you. Thanks.

Thank you. There are no more questions in the queue. I would like to go ahead and turn the call back over to management for closing remarks. Please go ahead.

Thank you very much. I'd like to thank everyone for joining today's call and the continued support in our mission to lead and transform the carotid interventional market and stroke prevention. We look forward to a lot of success over the next couple of quarters. Thanks very much.

This does conclude today's program. Thank you for joining. You may now disconnect.

Good morning, and welcome to InspireMD's fourth quarter and full year 2025 earnings conference call. Currently, all participants on listen-only mode. We will facilitate a question and answer session towards the end of today's call. 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

Thank you for joining us for the InspireMD fourth quarter and full year 2025 conference call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer, and Michael 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 report 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, March 18, 2026. 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. As I reflect on our performance over the past several quarters, I'm extremely proud of our team here at InspireMD and enthusiastic about the impact we're having on stroke prevention and the future of an endovascular standard of care, catalyzed by our breakthrough CGuard Prime carotid stent platform. Through the C-GUARDIANS FDA clinical trial, along with our numerous multiyear studies of our CGuard implant, we have demonstrated unmatched clinical evidence reflected in the lowest adverse event rates and most durable stroke prevention, enabling our continued focus on achieving market leadership through a stent-first strategy. Becoming number one in this highly competitive market will require strong operational, commercial, and customer-focused excellence throughout our organization. To this end, we are focusing on operational expansion, establishing U.S.-based production, increasing our manufacturing capacity to keep pace with this growing U.S. demand.

On the commercial side, we're building our coverage capacity and procedural support bandwidth. Since our approval in June 2025, we have architected, implemented, and now accelerated the foundational requirements to deliver commercial sales in the U.S. market through VAC initiations and approvals, contract implementation, case completions and reorders, all building in our mission to dominate this space with our next-generation stent. Thus far, we are pleased with the physician support and pace toward these fundamental operational milestones, getting products on shelves and available to meet market demand. We met our 2025 objectives of building our U.S. commercial team to north of 30 people, with the majority in the field, as we previously shared.

We have now completed over 500 cases, gained approvals in some of the most prominent IDNs in the United States, and established ourselves as the go-to device for many physicians who now have access to CGuard Prime. We remain committed to supporting the success of every procedure with strong case support and continuous improvement with ease of use of our products. As I've stated previously, we have real-world experience with the CGuard stent in over 70,000 cases in our 30 OUS markets to date, which we are leveraging in our launch. As we have executed on our controlled rollout, we have observed opportunities to improve our delivery system's technical success and enhance ease of use. We understand what is required to exceed our customer expectations, and we plan to introduce these improvements beginning in the fourth quarter.

Now to our clinical pipeline and advanced indications for our CGuard, a critical piece of our long-term growth strategy. We continue to build on multiple programs and clinical studies as we work to expand the reach of our technology by leveraging clinical evidence, potentially unlocking additional market opportunities. Starting in TCAR with C-GUARDIANS two, evaluating CGuard Prime in a shorter delivery system, purpose-built for use in TCAR procedures and designed to be compatible with neuroprotection systems that are already in use in the market. I'm pleased to report that we have completed enrollment in this trial and submitted the request for approval to FDA, anticipating potential approval in Q3. This indication will boost our market opportunity for stent sales into the more than 35,000 current TCAR procedures annually.

Simultaneously, we are rapidly 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 plan to begin enrollment in this study in Q2, with expected FDA clearance and launch in the second half of 2027. To recap expectations for 2026, we will deliver extraordinary quality and exceed expectations for our growing range of customers. Build a sustainable foundation from which we can expand stenting market. Utilize the CGuard stent first strategy to differentiate superior outcomes. Serve the entirety of the market for all specialists treating carotid disease.

Boldly build a market-leading company worthy of lofty expectations from our customers and patients who benefit from our breakthrough technology. Finally, I would like to thank our entire team for their extraordinary commitment to our success, and I look forward to continuing to build our organizational strength with deep talent and expertise to advance our mission to prevent strokes and save lives. I am incredibly excited about our future and look forward to sharing our progress over the coming year. Now I'll turn the call over to Mike to walk us through the financials. Mike?

Thanks, Marvin. For the fourth quarter of 2025, total revenue was $3.1 million, an increase of 62% compared to revenue of $1.9 million for the fourth quarter of 2024. This growth was driven by the launch of CGuard Prime in the U.S. and increased penetration of international markets with CGuard. U.S. revenue for the fourth quarter was $866,000, driven by the launch of CGuard Prime, representing 74% sequential growth versus the results of the third quarter. We are pleased with the trajectory of U.S. launch and anticipate continued progress in 2026. International revenue for the fourth quarter was $2.3 million, reflecting growth of 17% compared to $1.9 million for the fourth quarter of 2024.

The majority of the international growth was driven by higher unit sales, while changes in foreign exchange rates contributed growth of about 7% to our international results. Gross profit for the fourth quarter of 2025 was $1.2 million, or 37.5% of revenue, compared to gross profit of $469,000 or 24.1% of revenue for the fourth quarter of 2024. This increase in gross margin resulted primarily from a favorable shift in revenue mix to U.S. sales, which carry a substantially higher margin than international sales. Our sales in the U.S. generated gross margins of about 70%, reflecting the strong pricing and value that we bring to our customers.

Total operating expenses for the fourth quarter of 2025 were $13.3 million, an increase of $3.4 million compared to $9.8 million for the fourth quarter of 2024. This increase was primarily due to higher commercial staffing levels and marketing activities for the U.S. commercial launch of CGuard Prime. Financial income was $386,000, an increase of $134,000 compared to $252,000 for the fourth quarter of 2024, resulting from the increase in financial income from investments in marketable securities and money market funds.

Net loss for the fourth quarter of 2025 was $11.8 million, or $0.14 per basic and diluted share, compared to a net loss of $9.2 million or $0.19 per basic and diluted share for the same period of 2024. As of December 31, 2025, cash and cash equivalents and marketable securities were $54.2 million compared to $34.6 million at the end of the prior year. As a reminder, we have two remaining milestone-based tranches pursuant to the private placement we closed in May 2023. Each tranche provides gross proceeds of $17.9 million if fully exercised, and the remaining tranches are triggered by future milestone events.

First, the completion of four quarters of commercial sales of CGuard Prime in the U.S., which we anticipate in the second half of 2026. Second, the completion of both the receipt of FDA approval for the TCAR-indicated CGuard Prime stent, which we expect in the third quarter of 2026, and the FDA clearance of the SwitchGuard TCAR Neuroprotection system, which we expect in the second half of 2027. Turning to our 2026 outlook. InspireMD expects revenue for the full year 2026 to be in the range of $13 million-$15 million, reflecting growth of approximately 45%-65% over full year 2025.

We expect increasing sequential revenue growth in the second half of 2026 as our business gains momentum and U.S. sales growth accelerates from the anticipated label expansion by the FDA for the use of CGuard Prime in TCAR procedures and the introduction of the enhanced delivery system for CGuard Prime for use in CAS procedures. This concludes our prepared remarks. We will now open the call for questions. For the Q&A segment, we will be joined by Shane Gleason, InspireMD's Chief Commercial Officer. Operator?

Thank you. As a reminder, to ask a question at this time, you will need to press star one one on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster.

Now first question coming from the line of Adam Maeder with Piper Sandler. You let us know, Adam.

Hi, good morning, Marvin, Mike, Shane. Thanks for taking the questions and congrats on all the progress. A couple for me today, if that's okay, and maybe we could start on the guidance front. Mike, just trying to get a better understanding of the construction of the guidance that you've put out for FY 2026. Maybe you could kind of double-click on that, help us think through U.S., the U.S. business versus OUS. Then with the CGuard Prime integration into the Boston Scientific ENROUTE system, you know, what's kind of contemplated in the guidance from that new product launch? Then I had a couple follow-ups. Thanks.

Yeah. Hi, Adam. Thanks for the question. First of all, for the OUS sales, you know, we're continuing to expect sales that are in the range of what we've been able to perform in the last several quarters, with some maybe moderate growth there. You know, continued growing penetration of OUS markets. Then on the U.S. side, we're gonna continue to sustain our controlled launch phase at this stage. That would mean somewhat moderated growth in the U.S. for the first half.

As we have those catalysts kicking in in the second half, we would see some acceleration of the growth, as a result of the anticipated TCAR indication, the anticipated enhanced clinical performance of the CGuard Prime for CAS, and then finally just the maturing of approvals and contracts, as we work through the VAC approval process.

That's helpful. Appreciate the color and maybe a good segue into the next question, which is, you know, hoping for an update on kind of exactly where you stand from an account standpoint in the, in the U.S., you know. Looking for metrics like number of accounts, number of VACs that are in process. Just trying to kind of take the temperature there, you know, even if it's not explicit, just hoping to get kind of some broad strokes color around how that's progressing.

Yeah. Good morning, Adam. It's Marvin. I might hand that one off to Shane just to provide a little bit of color on that topic. Shane, if you don't mind, grabbing that question.

Sure. Good morning, Adam. The questions around accounts and penetration. We have done cases in and these are to date not capped at Q4, but we've done cases in roughly 80 centers. As we've mentioned the VAC processes before, those are frequently not linear. In some cases there are evaluation cases before VAC approval. Sometimes the VAC approval has to happen before the first case can be performed. That's kind of a mix of those. But 80-plus centers have done cases at this point. And tracking the number that are in our pipeline, there are north of 200 centers in the pipeline of between VAC and evaluation stage. The team has been able to produce quite a lot of momentum.

We have a lot in the funnel and, you know, the job is to drive them through the funnel and make them active ongoing customers from here.

Great. Very helpful color, Shane. I appreciate all that. Sorry, I know I'm asking a bunch of questions today. Just wanted to tick through some of these. Next on the next gen delivery system and enhanced, you know, ease of use. It sounds like you're targeting that for Q4 of this year. My takeaway there is that this is kind of opportunistic. It's an opportunity to make a, you know, a great product even better versus, you know, like a pressure point or consternation from docs. But I wanted to confirm that is correct. Then what is needed from a regulatory standpoint to get the next gen delivery system across the goal line?

Yeah, Adam. Thanks for that question. You're absolutely correct in your assumption there. You know, our CGuard stent is performing extraordinarily well, as anticipated and consistent with all the work that we've done with 70,000+ implants to date. When we launched the CGuard Prime with this differentiated new delivery system, you know, we did so in a controlled manner to ensure that we're able to manage first use of this device in a market with new users unfamiliar with the delivery system and platform. We intentionally sought feedback, looking for areas to discover and improve like all good companies do, and we'll continue to iterate and improve off of that feedback to ensure we're delivering these world-class technical success results to meet the leadership goals for the company. I think you're absolutely correct about your assumptions.

These fall into that continuous improvement approach that we'll continue to take. As far as submission is concerned, these are relatively minor changes and will go to FDA in a 30-day review. I think we're always looking for those opportunities to build more confidence into the delivery side of the device itself, but the implant is performing exactly according to plan.

Okay, perfect. Thanks, Marvin. If I could just ask one last one, I promise I'll jump back into queue. Just was hoping to better understand timing for the CGUARDIANS II data specifically. You know, when will we see that, the data from that study, as well as the CGuard cohort data from the CREST-2 trial? Just when should we expect those? Thanks so much.

Yeah. Thanks, Adam. Yeah, Shane, you want to grab that one? I think you're probably latest up to date on the data.

Sure. We have a slot that's been accepted at the Charing Cross Symposium in the back half of April. That will be the first reveal of CGUARDIANS II data. That will likely be the interim cut of the data, but it will be the first time that we see any of the clinical data from that trial.

Thank you.

Thank you. Our next question coming from the line of Frank Takkinen with Lake Street Capital Markets. Your line is now open.

Great. Thank you for taking the questions. Congrats on all the progress. Was hoping to start with a question around really account adoption and productivity metrics. So maybe the first part of that, maybe any anecdotal patterns you can share when account does activate with CGuard, how are they first using the product? And have you seen any of your accounts really shift over to being an exclusive CGuard user? And then from a productivity standpoint, how should we think about how many accounts a rep can manage and maybe what peak productivity per account can look like over time?

Shane, you wanna grab that one, first part of it, and I can follow up?

Morning, Frank. We have seen adoption, and I think the one thing that's important to our strategy is we know we have a premium product. We have priced it at a premium, but not at such a premium that we want it relegated to only be used in the most challenging cases. Our goal is to be able to become the everyday stent of the people who use it. Of those docs who have made it through the evaluation stage, we do have a growing number who are using it as their everyday stent. That's the goal.

When you look at what physicians perform, the average, you know, quote, unquote, if you look at the number of procedures being performed and the number of physicians performing them, the average is somewhere in the neighborhood of 15 to maybe approaching 20 cases a year. We really look at it more as how many cases can a rep support versus how many doctors or accounts can they support. If the average physician does, you know, by those numbers, one or two a month, you know, if they're on the same day, you can cover them more efficiently than if they're spread out on separate days. You know, there's 20+ selling days most months, and our reps goals are to be in cases darn near every working day and hopefully multiple cases in the same day.

We've got a lot of room to expand, and from there it's just logistics.

Yeah. Frank, let me expand on that a little bit as well. We're taking a very deliberate approach to measuring productivity in the field as we build our commercial organization. We use a lot of claims data to measure and monitor that. I think it's safe to assume that we're going to continue to be present in these cases to make sure that the experiences are those that we expect, and we'll be prepared to expand as we get to a productivity curve that looks to be reasonable as we need to grow the organization and build it out. So far, we've been very pleased with that productivity ramp, and we'll continue to watch that closely.

Very helpful. Maybe following up on some of the points made in there. Appreciating case support is extremely important in the early days. Do you envision over a longer period of time, this is a product that can be on the shelf and just be the de facto stent that is used and not necessarily requiring rep support in every single case at a more mature state of the company?

Absolutely.

Shane, you wanna take-

Yeah, I think there are different.

Go.

Yeah. There are slightly different expectations in the market for when we get into the TCAR space. A higher percentage of those cases are supported by industry representatives than there are for the CAS cases. We have it kinda modeled by specialty of what our expectations are. Absolutely, the goal is, once someone is comfortable with the device, to be able to have them have it on their shelf and use it when we're not around. We still like to be there to provide support, but we don't need to be the rate limiting item there once physicians gain comfort with the system.

Perfect. The last one, any refresher you guys can provide on sales force hiring cadence would be great color. Thanks.

Shane, you wanna grab that?

You want me to stick with that one, guys?

You want me to take it?

I can take it. Thanks. You know, as the guys mentioned in the prepared remarks, we had last stated that our goal was to get to north of 30 people in the U.S. commercial organization by the end of the year with the majority in the field. We reached that. At this point, our goal is to continue hiring opportunistically and selectively where we need increased penetration, where we need more support. By and large, for at this point, this is the group that's going to launch our first indication. Let this group kinda set down their roots Make their ways through those, value analysis committees and processes. Then as we start to layer in additional indications, when TCAR comes along, we expect we'll probably pick that hiring back up. Our first goal was to get a somewhat uniform coverage of the major markets and, let that group throw their roots down and, you know, climb that productivity curve that we've mentioned a few times now.

Perfect. Appreciate the call. Thanks, guys.

Thanks, Frank Takkinen.

Thank you. Our next question in the queue coming from the line of Jeremy Feffer with Maxim Group. Your line is now open.

Thank you. Good morning, thank you for taking the question. First one regarding your limited or as you call it, your, the commercial rollout. Is that the 200 centers that you said are in the pipeline, is that still part of this controlled launch or does that already now bleed into a broader commercial U.S. launch? Then maybe talk about what timeline could we expect for that broader U.S. commercial launch.

Yeah, Jeremy, let me grab the first part of that and then Shane can add. I just wanna make sure we clarify the nomenclature. It's not a limited launch, it's a controlled launch. We're being very prescriptive about how we go about doing it, but growth is still the driver, and we will continue to build our pipeline and support cases with the objective of growing the business. That's a key differentiation. I just wanted to clarify there. We wanna make sure that all these experiences that these physicians have with this new device are ones that build a sustainable model for the long term. We will continue to build off of that, and we'll continue to grow the pipeline of opportunities.

With this new indication coming in the second half of the year with TCAR, we'll certainly launch that as aggressively as possible as well. Shane, I didn't know if you had any additional comments to that or not for Jeremy. Yeah, that's really well said, Marvin. I think I have just a couple additional points. One is when we look at the progress we've made, and I've mentioned the size of the sales organization, it's important to remember that roughly half of our territory managers started in Q4. We had a group that was on board when we got approval last summer. But really half of our organization has been out there for a quarter.

We always talk about how these value analysis committees tend to, and contracts tend to measure their timelines in quarters, not months. We don't work on things in serial or in series where you work on one until it's complete and then you start the next one. You get a whole lot of them moving at once in parallel, and they start to come to fruition on their own time schedules as we drive them through. To your question of where does the controlled launch end and the, you know, all systems go full bore launch pickup, many of those accounts that are in the pipeline now will be feeding into that full launch. Really well stated.

Okay. Understood. Thank you for that information. Maybe, you know, is any feedback you could share from the vascular surgeons? I know you know, we've talked about in the past, you have about, you know, shifting the whole market to a stent first approach. The physicians that have adopted the CGuard Prime platform, have they, you know, echoed that sentiment that they see this as being now the first line of care?

Yeah. Jeremy, let me grab-

Yeah.

The first part of that. Shane can jump in here as well. I think that the enthusiasm across the board, no matter what subspecialty, for a new innovative technology with these kinds of outcomes that are evidenced with the data that we have is just truly palpable. It's consistent across the board that this market has been looking for a new technology to advance an endovascular first approach to carotid stenting regardless of specialty. The feedback through the TCAR trial with the use of CGuard Prime has reiterated that to us. You know, we continue to have incredible enthusiasm on the part of all subspecialists, but in particular, the vascular surgeons are very keen on having an alternative to what up to this point has been only one device, 20-year-old device available to them.

It's really encouraging, and we're looking forward to taking advantage of the moment. Shane, anything from you there? No, nothing to add, you nailed it.

Okay. Thank you so much. That's really helpful, and thank you for taking my questions. I'll hop back in queue.

Thanks, Jeremy. I'd like to thank everyone for joining today's call and for the continued support of our mission to lead and transform the carotid intervention market. CGuard's redefining outcomes for patients and their providers by lowering risk of stroke and other major adverse events to levels never achieved with first generation stenting, surgery or medical therapy alone, validated with rigorous evidence, proven clinical results, reimbursement and real world outcomes. We're very excited for what the future has to hold for InspireMD. Thanks for joining the call today.

This concludes today's conference call. Thank you for your participation, and you may now disconnect.