Q2 2026 InspireMD Inc Earnings Call

August 17, 2026

Operator: Good morning, and welcome to InspireMD's Q2 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, and Michael Lawless, Chief Financial 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.

Speaker #2: Good morning, and welcome to InspireMD's second quarter 2026 earnings conference call. Currently, all participants are in listen-only mode. We will facilitate a question-and-answer session toward the end of today's call.

Speaker #2: As a reminder, this call is being recorded for replay purposes. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer, and Michael Lawless, Chief Financial Officer.

Speaker #2: 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.

Speaker #2: 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 detailed information about the company, and the risk factors that may affect the realization of forward-looking statements, is set forth in the company's filings with the U.S.

Operator: More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in the company's filing with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K, quarterly report on Form 10-Q, any updates in its current reports on Form 8-K, as well as InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. During the call today, the company may also discuss certain non-GAAP financial measures. For a more detailed discussion of these non-GAAP financial measures and historical reconciliation to the most closely comparable GAAP measures, please refer to the company's earnings release. This call contains time-sensitive information that is accurate only as of today, 17 August 2026.

Operator: More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in the company's filing with the US Securities and Exchange Commission, including its annual report on Form 10-K, quarterly report on Form 10-Q, any updates in its current reports on Form 8-K, as well as InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. During the call today, the company may also discuss certain non-GAAP financial measures. For a more detailed discussion of these non-GAAP financial measures and historical reconciliation to the most closely comparable GAAP measures, please refer to the company's earnings release. This call contains time-sensitive information that is accurate only as of today, 17 August 2026.

Speaker #2: Securities and Exchange Commission, including its annual report on Form 10-K, quarterly report on Form 10-Q, any updates in its current reports on Form 8-K, as well as InspireMD's press release that accompanies this call, particularly the cautionary statements made in it.

Speaker #2: During the call today, the company may also discuss certain non-GAAP financial measures. For a more detailed discussion of these non-GAAP financial measures and historical reconciliation to the most closely comparable GAAP measures, please refer to the company's earnings release.

Speaker #2: This call contains time-sensitive information that is accurate only as of today, August 17, 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.

Operator: 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.

Speaker #2: It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Speaker #3: Thank you, operator, and good morning, everyone. The second quarter was an important period for InspireMD. While our reported financial results reflect the accounting impact of the voluntary recall of our approved CGuard Prime 135 carotid stent system, the quarter was defined by the actions we took to strengthen the business, sharpen our execution, and position our company for a successful return to the U.S.

Marvin Slosman: Thank you, operator, and good morning, everyone. The Q2 was an important period for InspireMD. While our reported financial results reflect the accounting impact of the voluntary recall of our approved CGuard Prime 135 cm carotid stent system, the quarter was defined by the actions we took to strengthen the business, sharpen our execution, and position our company for a successful return to the U.S. market. Over the last several months, we have remained focused on four priorities: optimizing our international business, advancing our key regulatory programs and milestones to U.S. market re-entry, implementing design enhancements to the CGuard Prime delivery system, and aligning our organization and cost structure around these priorities. I believe we are making meaningful progress on each of these objectives. Notwithstanding our temporary absence from the U.S. market, our total revenue was essentially unchanged from the Q2 of last year.

Marvin Slosman: Thank you, operator, and good morning, everyone. The Q2 was an important period for InspireMD. While our reported financial results reflect the accounting impact of the voluntary recall of our approved CGuard Prime 135cm carotid stent system, the quarter was defined by the actions we took to strengthen the business, sharpen our execution, and position our company for a successful return to the US market. Over the last several months, we have remained focused on four priorities. Optimizing our international business, advancing our key regulatory programs and milestones to U.S. market re-entry, implementing design enhancements to the CGuard Prime delivery system, and aligning our organization and cost structure around these priorities. I believe we are making meaningful progress on each of these objectives. Notwithstanding our temporary absence from the U.S. market, our total revenue was essentially unchanged from the Q2 of last year.

Speaker #3: Over the last several months, we've remained focused on four priorities: optimizing our international business, advancing our key regulatory programs and milestones to U.S.

Speaker #3: market re-entry, implementing design enhancements to the Seagard Prime delivery system, and aligning our organization and cost priorities. I believe we are making meaningful progress on each of these objectives.

Speaker #3: Notwithstanding our temporary absence from the U.S. market, our total revenue was essentially unchanged from the second quarter of last year. It's important to note our international business continued to perform very well, growing approximately 21% year over year, reflecting continued physician adoption and strong demand for Seagard across our international markets.

Marvin Slosman: It's important to note our international business continued to perform very well, growing approximately 21% year-over-year, reflecting continued physician adoption and strong demand for CGuard across our international markets. At the same time, our reported US revenue reflects customer credits associated with the voluntary recall announced at the beginning of May. Those credits more than offset gross US product sales during the quarter and therefore obscure the underlying performance of the business. Importantly, our confidence in the CGuard implant remains the foundation value driver of our business and will continue to be the asset that builds our market leadership regardless of which delivery method is chosen for each patient's need. The clinical outcomes and evidence we've developed over many years has set a new standard of care, translating to physician enthusiasm and utilization, which remains strong, giving us confidence as we anticipate our US relaunch.

Speaker #3: At the same time, our reported U.S. revenue reflects customer credits associated with the voluntary recall announced at the beginning of May. Those credits more than offset gross U.S. revenue.

Speaker #3: Product sales during the quarter may therefore obscure the underlying performance of the business. Importantly, our confidence in the Seagard implant remains the fundamental value driver of our business and will continue to be the asset that builds our market leadership, regardless of which delivery method is chosen for each patient's needs.

Speaker #3: The clinical outcomes and evidence we've developed over many years have set a new standard of care, translating to physician enthusiasm and utilization, which remains strong, giving us confidence as we anticipate our U.S.

Speaker #3: Relaunch. We continue to believe Seagard is the most differentiated technology available for carotid revascularization and stroke prevention. Turning now to our Seaguardians II submission for approval of our Seagard Prime 80 platform for TCAR.

Marvin Slosman: We continue to believe CGuard is the most differentiated technology available for carotid revascularization and stroke prevention. Turning now to our C-GUARDIANS II submission of approval of our CGuard Prime 80 platform for TCAR. We recently announced an outstanding 30-day results from the trial, which we believe strengthen our pending submission. In fact, our latest discussions and feedback from FDA remain constructive and interactive, and all signals point to potential approval in Q4 as we previously indicated. Once approved, the CGuard Prime 80 platform would essentially double our addressable market by offering our implant for TCAR in addition to CAS procedures. We also enrolled the first patient in CGUARDIANS III, our pivotal study evaluating next generation SwitchGuard Neuroprotection System. Taken together, we're encouraged by the progress across our comprehensive TCAR programs.

Speaker #3: We've recently announced outstanding 30-day results from the trial, which we believe strengthen our pending submission. In fact, our latest discussions and feedback from the FDA remain constructive and interactive, and all signals point to potential approval in the fourth quarter, as we previously indicated.

Speaker #3: Once approved, the Seagard Prime 80 platform would essentially double our addressable market by offering our implant for TCAR in addition to CAAF procedures. We also enrolled the first patient in SEAGUARDIANS III, our pivotal study evaluating the next-generation SwitchGuard neuroprotection system.

Speaker #3: Taken together, we're encouraged by the progress across our comprehensive TCAR programs. Also, as previously noted, our submission of the original Seagard platform for CAS has been clinically proven in over 75,000 global U.S. cases.

Marvin Slosman: Also, as previously noted, our submission of the original CGuard platform for CAS, clinically proven in over 75,000 global US cases, continues, and based on the progress to date, we currently expect a decision from FDA in Q4 of this year. Should these anticipated approvals be realized, we would have both TCAR and CAS platforms commercially available before the end of the year, giving us the opportunity to address the entirety of the approximately 75,000 annual stenting procedures in the US. When we spoke to you last quarter, we outlined a clear plan to address the improvements for the CGuard Prime 135 CAS delivery system. Since then, we've identified the required design modifications, initiated validation and performance testing, and continue to work closely with the FDA as we advance these improvements with a completed early submission of our Pre-Submission dossier.

Speaker #3: Cases continue and, based on the progress to date, we currently expect a decision from the FDA in the fourth quarter of this year. Should these anticipated approvals be realized, we would have both TCAR and CAS platforms commercially available before the end of the year, giving us the opportunity to address the entirety of the approximately 75,000 annual stenting procedures in the U.S.

Speaker #3: When we spoke to you last quarter, we outlined a clear plan to address the improvements for the Seagard Prime 135 CAS delivery system. Since then, we have identified the required design modifications, initiated validation and performance testing, and continued to work closely with the FDA as we advance these improvements, with a completed early submission of our pre-sub dossier.

Speaker #3: These modifications and testing have gone exceedingly well, and we're optimistic that the associated timelines of the first half of 2027 for market re-entry of this platform have the potential for an earlier approval.

Marvin Slosman: These modifications and testing have gone exceedingly well, and we're optimistic that the associated timelines of H1 2027 for market re-entry of this platform has the potential for an earlier approval. While this has clearly been a challenging time for the company, I believe our ability to weather these setbacks has made us a stronger and more focused organization. The CGuard 135 delivery system modifications and remediation is well understood. The path forward is clearly defined, and our team remains fully focused on implementation. During the quarter, we also took decisive actions to better align our organization and cost structure with our near-term priorities. These decisions allow us to focus our resources on the regulatory and commercial milestones that we believe will have the ability to create the greatest long-term value for our shareholders.

Speaker #3: While this has clearly been a challenging time for the company, I believe our ability to weather these setbacks has made us a stronger and more focused organization.

Speaker #3: The Seagard 135 delivery system modifications and remediation are well understood. The path forward is clearly defined, and our team remains fully focused on implementation.

Speaker #3: During the quarter, we also took decisive actions to better align our organization and cost structure with our near-term priorities. These decisions allow us to focus our resources on the regulatory and commercial milestones that we believe will have the ability to create the greatest long-term value for our shareholders.

Speaker #3: We also believe we've created a leaner, more efficient, and focused organization that is better positioned to execute—not only to return Seagard to the U.S.

Marvin Slosman: We also believe we have created a leaner, more efficient, and focused organization that is better positioned to execute, not only to return CGuard to the U.S. market, but to expand access for our physicians and patients they treat. Before turning the call over to Mike, I would like to leave you with four key messages. First, the underlying fundamentals of our business remain strong, as demonstrated by continued international growth, physician anticipation for our CGuard implant as what we believe is the best treatment for carotid disease, with clear line of sight for our U.S. market relaunch. Second, we believe the voluntary recall is proving to be a well-defined and manageable event. We understand the issue, we have identified the solution, and we are executing against a clear regulatory pathway to reestablish traction and growth.

Speaker #3: ...market, but to expand access for our physicians and the patients they treat. Before turning the call over to Mike, I'd like to leave you with four key messages.

Speaker #3: First, the underlying fundamentals of our business remain strong, as demonstrated by continued international growth and physician anticipation for our Seaguard implant, which we believe is the best treatment for carotid disease, with a clear line of sight for our U.S. launch.

Speaker #3: Market relaunch. Second, we believe the voluntary recall is proving to be a well-defined and manageable event. We understand the issue, we've identified the solution, and we're executing against a clear regulatory pathway to reestablish traction and growth.

Marvin Slosman: Third, we continue to advance multiple regulatory catalysts, including CGuard Prime 80 for TCAR, the redesigned CGuard Prime 135 platform for CAS, the original CGuard delivery system, as well as our next-generation SwitchGuard Neuroprotection System. Finally, we have aligned our organization and cost structure to support these priorities while positioning InspireMD for long-term sustainable growth. While we still have important work ahead of us, I believe today we are a more focused and disciplined company, and ultimately have better positioned ourselves for success. With that, I will turn the call over to Mike to review the financials. Mike?

Speaker #3: Third, we continue to advance multiple regulatory catalysts, including CGuard Prime 80 for TCAR, the redesigned pre-CGuard Prime 135 platform for CAS, the original CGuard delivery system, as well as our next-generation SwitchGuard neuroprotection system.

Speaker #3: And finally, we've aligned our organization and cost structure to support these priorities while positioning InspireMD for long-term, sustainable growth. While we still have important work ahead of us, I believe today we're a more focused and disciplined company and ultimately have better positioned ourselves for success.

Speaker #3: With that, I'll turn the call over to Mike to review the financials. Mike.

Speaker #1: Thank you. As Marvin described, the second quarter financial results need to be interpreted in the context of the voluntary recall that we announced at the beginning of May.

Michael Lawless: Thank you. As Marvin described, the Q2 financial results need to be interpreted in the context of the voluntary recall that we announced at the beginning of May. For Q2 2026, total revenue was $1.8 million, which was essentially flat with the revenue for Q2 2025. The recall action affected our reported revenue in two ways. First, we ceased commercial sales of CGuard Prime late in April, so we generated less than one month of sales in the U.S. before the recall took effect. Second, we booked a $734,000 credit for the return of the CGuard Prime 135 product that had not yet been consumed by our customers. International revenue was $2.1 million, representing growth of 21% versus the same quarter a year ago. This performance continues to reflect the growing global demand for our CGuard stent platform.

Speaker #1: For the second quarter of 2026, total revenue was $1.8 million, which was essentially flat compared to revenue for the second quarter of 2025. The recall action affected our reported revenue in two ways.

Speaker #1: First, we ceased commercial sales of Seagard Prime late in April, so we generated less than one month of sales in the U.S. before the recall took effect.

Speaker #1: Second, we booked a $734,000 credit, with a return of the SeGuard Prime 135 product that had not yet been consumed by our customers. International revenue was $2.1 million, representing growth of 21 percent versus the same quarter a year ago.

Speaker #1: This performance continues to reflect the growing global demand for our Seagard stent platform. The entirety of international growth was driven by continued demand, while changes in foreign exchange rates were immaterial.

Michael Lawless: The entirety of international growth was driven by continued demand, while changes in foreign exchange rates were immaterial. Gross profit for Q2 2026 was a loss of $0.8 million, or -43.7% of revenue, compared to a gross profit of $0.3 million, or 17.6% of revenue for Q2 2025. This decline in gross margin resulted primarily from the $734,000 credit to revenue that I described previously and a $612,000 impairment charge for CGuard Prime 135 inventory on our books that was no longer commercially viable as a result of the recall. On a non-GAAP basis, which excludes the impact of the recall-related customer credits and impairment charge, adjusted gross profit was $0.6 million. A reconciliation of adjusted gross profit to gross profit, the most directly comparable GAAP measure, is included in today's earnings release and posted in the investor relations section of our website.

Speaker #1: Gross profit for the second quarter of 2026 was a loss of $0.8 million, or negative 43.7% of revenue, compared to a gross profit of $0.3 million, or 17.6% of revenue, for the second quarter of 2025.

Speaker #1: This decline in gross margin resulted primarily from the $734,000 credit to revenue that I described previously, and a $612,000 impairment charge for Seagard Prime 135 inventory on our books that was no longer commercially viable as a result of the recall.

Speaker #1: On a non-GAAP basis, which excludes the impact of the recall-related customer credits and impairment charge, adjusted gross profit was $0.6 million. A reconciliation of adjusted gross profit to gross profit, the most directly comparable GAAP measure, is included in today's earnings release and posted in the Investor Relations section of our website.

Speaker #1: Total operating expenses for the second quarter of 2026 were $13.7 million, an increase of $0.4 million compared to $13.3 million for the second quarter of 2025.

Michael Lawless: Total operating expenses for the second quarter of 2026 were $13.7 million, an increase of $0.4 million compared to $13.3 million for the second quarter of 2025. The increase was primarily due to greater headcount-related expenses for the U.S. commercial team and higher development, clinical, and regulatory expenses related to SwitchGuard NPS and CGuard Prime 80 for TCAR, partially offset by lower general and administrative compensation expenses. Financial income was $121,000 as compared to a loss of $132,000 for the second quarter of 2025. Net loss for the second quarter of 2026 totaled $14.3 million, or $0.17 per basic and diluted share, compared to a net loss of $13.2 million, or $0.26 per basic and diluted share for the same period in 2025. As of 30 June 2026, cash and cash equivalents and marketable securities were $30.4 million, compared to $54.2 million at the end of 2025.

Speaker #1: The increase was primarily due to greater headcount-related expenses for the U.S. commercial team, and higher development, clinical, and regulatory expenses related to SwitchGuard, NPS, and Seagard Prime 80 for TCAR.

Speaker #1: Partially offset by lower general and administrative compensation expenses. Financial income was $121,000, as compared to a loss of $132,000 for the second quarter of 2025.

Speaker #1: Net loss for the second quarter of 2026 totaled $14.3 million, or $0.17 per basic and diluted share, compared to a net loss of $13.2 million, or $0.26 per basic and diluted share, for the same period in 2025.

Speaker #1: As of June 30, 2026, cash and cash equivalents and marketable securities were $30.4 million, compared to $54.2 million at the end of 2025. As Marvin discussed, we have proactively taken actions to reduce our cost structure and improve our financial flexibility and operational efficiency.

Michael Lawless: As Marvin discussed, we have proactively taken actions to reduce our cost structure and improve our financial flexibility and operational efficiency. Included in these efforts was a workforce reduction action initiated in the third quarter that reduces the number of positions in our organization by almost 20% and saves the company approximately $9 million on an annual basis. We expect to incur a restructuring charge of between $900,000 and $1.2 million in the third quarter to account for the severance and related costs associated with this workforce reduction event.

Speaker #1: Included in these efforts was a workforce reduction action initiated in the third quarter that reduces the number of positions in our organization by almost 20 percent and saves the company approximately $9 million on an annual basis.

Speaker #1: We expect to incur a restructuring charge of between $900,000 and $1.2 million in the third quarter to account for the severance and related costs associated with this workforce reduction event.

Speaker #1: This concludes our prepared remarks. We will now open the call for questions. Operator?

Marvin Slosman: This concludes our prepared remarks. We will now open the call for questions. Operator?

Speaker #2: If you'd like to ask a question at this time, please press star 1 1 on your touch-tone phone and wait for your name to be announced.

Operator: If you'd like to ask a question at this time, please press star one one on your touch-tone phone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from Adam Maeder with Piper Sandler.

Speaker #2: To withdraw your question, please press star 1, 1 again. Our first question comes from Adam Mater with Piper Sandler.

Adam Maeder: Hi. Good morning, Marvin, Mike. Thank you for taking the questions. A couple from me, and maybe we can just start on the CAS side of the business. First original CGuard delivery system approval timing for US, if I heard correctly, was Q4. I think in the last earnings call, you mentioned Q3, so a little bit of a wiggle there versus prior expectations. I do not mean to nitpick over a couple of months, but can you just talk about what is driving the shift there? Any color you can give us into recent interactions with FDA? That is question one, and then I have another one or two for you guys. Thanks.

Speaker #3: Hi, good morning Marvin, Mike. Thank you for taking the questions. A couple from me, and maybe we can just start on the CAS side of the business.

Speaker #3: So first, the original Seagard delivery system approval timing for the U.S., if I heard correctly, was Q4. I think in the last earnings call, you mentioned Q3.

Speaker #3: So, a little bit of a wiggle there versus prior expectations. And I don't mean to nitpick over a couple of months, but can you just talk about what's driving the shift there?

Speaker #3: Any color you can give us on your recent interactions with the FDA? That's question one, and then I have another one or two for you guys.

Speaker #3: Thanks.

Speaker #4: Thanks, Adam. Thanks for the question. I think the "wiggle," as you mentioned it, is we're just trying to be realistic about the regulatory timeframes, as always.

Marvin Slosman: Thanks, Adam. Thanks for the question. I think the wiggle, as you mentioned it, is we are just trying to be realistic about the regulatory timeframes as always, requests from FDA and just general timeframes. We have testing that has been required and is completed, and we are just trying to make sure that we are understanding a realistic approval timeline here relative to the workload, our responses to FDA and so forth. I think we are on top of the details and what is necessary and required. It is really nothing more than that. We just want to be realistic about giving ourselves some room here on these responses and FDA’s response back.

Speaker #4: Requests from the FDA and general timeframes—we have testing that has been required and is completed. We're just trying to make sure we're understanding a realistic approval timeline here, relative to the workload, responses to the FDA, and so forth.

Speaker #4: So, I think we're on top of the details and what's necessary and required. So, it's really nothing more than that. We just want to be realistic about giving ourselves some room here on these responses and FDA's response back.

Adam Maeder: Okay, perfect.

Speaker #4: That's specific to the legacy system.

Marvin Slosman: Specific to the legacy system.

Speaker #3: Yeah, yeah, perfect. Okay, thanks, Marvin. And then, if we switch over to Seagard Prime, the delivery system there—good to hear you're still tracking towards the first half of 2027.

Adam Maeder: Yep. Perfect. Okay, thanks, Marvin. If we switch over to CGuard Prime, the delivery system there, good to hear you are still tracking towards H1 2027 approval for that technology. I guess my question is what is left to do before submission? It would be really helpful if you could put a finer point on FDA submission timing, as folks just try and understand how de-risked the H1 2027 approval truly is. I had one more for you guys. Thanks.

Speaker #3: Approval for that technology. I guess my question is: what's left to do before submission? And it would be really helpful if you could put a finer point on FDA submission timing.

Speaker #3: As folks just try to understand how de-risked the first half 2027 approval truly is. And then I'd want more from you guys. Thanks.

Speaker #4: Sure. The progress on the CGuard Prime and the Prime system, on the Prime technical improvements, is really solid, Adam. In fact, we feel confident that we've not only solved the delivery challenges but also produced a solution that performs exactly as we anticipated—with the trackability, even in challenging anatomy, and so forth.

Marvin Slosman: Sure. The progress on the 135 technical and the Prime system on the 135 Prime technical improvements is really solid, Adam. In fact, we feel confident that we have not only solved the delivery challenges, but produced a solution that performs exactly as we anticipated with the trackability and even in challenging anatomy and so forth. The delivery mechanism performs well. We are in the process right now of doing V&V testing and making sure that all of the technical work that we have done from the engineering group is now stacking up in terms of measured approach. So we are confident in the system. We are confident that we have solved it, and this is our platform for the future. We originally guided around a H1 2027 approval. We think that that remains realistic.

Speaker #4: And so the delivery mechanism performs well. We're in the process right now of doing DV testing and making sure that all of the technical work that we've done from the engineering group is now stacking up in terms of a measured approach.

Speaker #4: So we're confident in this system. We were confident that we've solved it, and this is our platform for the future. So we originally guided around a first half 2027 approval.

Speaker #4: We think that that remains realistic. There are a couple of long poles in the tent that we're still sorting out related to biocomp testing and the statutory review process that the FDA puts on these things.

Marvin Slosman: There is a couple of long poles in the tent that we are still sorting out related to biocompatibility testing, the statutory review process that FDA puts on these things. We have submitted early our Pre-Submission request to FDA to review all of the results to date and our anticipated response. We hope that that gives us a little more clarity and is more favorable. But if we can eliminate some of these long pole items, we believe that there is a possibility that we could pull that approval process in. But right now, we are calling the H1 of 2027 as being realistic, and we are optimistic that we can make those improvements.

Speaker #4: We have submitted early our pre-sub request to the FDA to review all of the results to date. And our anticipated response—we hope that gives us a little more clarity and is more favorable.

Speaker #4: But if we can eliminate some of these long-pole items, we believe that there is a possibility we could pull that approval process in.

Speaker #4: But right now, we're calling the first half of '27 as being realistic, and we're optimistic that we can make those approved improvements.

Speaker #3: Okay, thanks for the color there. And maybe just one last one—sorry, it's another kind of regulatory question. But just flipping over to SwitchGuard, which I think is important—your proprietary TCAR system.

Adam Maeder: Okay. Thanks for the color there. Maybe just one last one. Sorry, it is another kind of regulatory question, but just flipping over to SwitchGuard, which I think is important, your proprietary TCAR system. I think in June you enrolled the first patients in that study. Any comments you can give us, color you can give us, Marvin, on the enrollment progress there and how that trial is advancing. Just from a timeline standpoint, I just want to confirm that you are still tracking to H2 2027 for US approval and launch. Thank you.

Speaker #3: So, I think in June, you enrolled the first patients in that study. Just any comments you can give us—color you can give us, Marvin—on the enrollment progress there and kind of how that trial's advancing?

Speaker #3: And just from a timeline standpoint, I just want to confirm that you're still tracking to the back half of 2027 for U.S. approval and launch. Thank you.

Speaker #4: Yeah, the enrollment thus far has gone very well. We don't take any of that for granted. Obviously, this is the first time SwitchGuard has been used in human applications.

Marvin Slosman: Yeah, the enrollments thus far have gone very well. We don't take any of that for granted. This is the first time SwitchGuard has been used in human applications, so I think the investigators are very pleased with the performance, and we continue to enroll in the trial. Our expansion of that trial will, to a certain extent, depend on the resources that are available to us. But so far, we have initiated sites that we believe are high volume and enthusiastic about SwitchGuard and continue to progress in those enrollments with the timeline that you had previously mentioned as being what we're calling at this point. The enrollment process will determine timelines, but so far, we're really pleased about the responses and the performance of the device itself.

Speaker #4: So I think the investigators are very pleased with the performance, and we continue to enroll in the trial. Our expansion of that trial will, to a certain extent, depend on the resources that are available to us.

Speaker #4: So far, we have initiated sites that we believe are high-volume and enthusiastic about SwitchGuard, and we continue to progress those enrollments according to the timeline that you had previously mentioned, which is what we're calling at this point.

Speaker #4: Obviously, the enrollment process will determine timelines, but so far we're really pleased with the responses and the performance of the device itself.

Speaker #3: That's great to hear. I'll jump back in the queue. Thank you.

Adam Maeder: That's great to hear. I'll jump back in queue. Thank you.

Speaker #4: Thanks.

Marvin Slosman: Thanks.

Operator: Next comes from Frank Takkinen with Lake Street Capital Markets.

Speaker #2: This is Frank Takinen with Lake Street Capital Markets.

Speaker #3: Great, thank you for taking the questions. I wanted to follow up on the comments around some of the cost-saving initiatives. First, when should we expect those to be fully realized?

Frank Takkinen: Great. Thank you for taking the questions. I wanted to follow up on the comments around some of the cost-saving initiatives. First, when should we expect those to be fully realized? Understanding there's going to be some restructuring expense that occurs in Q3, when should we see the first quarter of the refreshed operating expense run rate? You made a comment related to 20% reduction in headcount. Can you maybe talk to the distribution of where those 20% came from inside the organization?

Speaker #3: Understanding there's going to be some restructuring expense that occurs in Q3, when should we see the first quarter of the refreshed operating expense run rate?

Speaker #3: And then you made a comment related to a 20% reduction in headcount. Can you maybe talk about the distribution of where those 20% came from inside the organization?

Speaker #5: Yeah. Hi, Frank. Good questions. So, in terms of the timing for when we'll realize those cost savings—the vast majority of those actions that we described have already been set in motion. I would expect that we should see the full impact of those cost savings in Q4 of this year.

Michael Lawless: Yeah. Hi, Frank. Good questions. In terms of the timing for when we will realize those cost savings, the vast majority of those actions that we described have already been set in motion. I would expect that we should see the full impact of those cost savings in Q4 of this year. There will be some partial savings in Q3, but there will be also some offsetting costs associated with restructuring. From a clean standpoint, I would say Q4 should be a good view of what the new cost structure looks like.

Speaker #5: There'll be some partial savings in Q3, but there will also be some offsetting costs associated with the restructuring. So, from a clean standpoint, I would say Q4 should be a good view of what the new cost structure looks like.

Speaker #4: Frank, let me jump in on the second part of your question there. Obviously, we want to make sure that we're anticipating a very aggressive relaunch, and we've built a plan to enable that commercial readiness, built for that momentum.

Marvin Slosman: Frank, let me jump in on the second part of your question there. Obviously, we want to make sure that we are anticipating a very aggressive relaunch, and we have built a plan to enable that commercial readiness, built for that momentum. Even though we are conserving our financial resources to extend the cash runway, we are trying to strike a balance in maintaining the commercial readiness to do so. Reducing these layers makes a lot of sense to us, but at the same time, I think we are continuing to maintain the strength of our commercial organization to make sure that we are ready in a fairly tight window here, that we are out of the gate relaunching and doing so properly with a great team on the field. We feel good about the ability to do that.

Speaker #4: So, even though we're conserving our financial resources to extend the cash runway, we're trying to strike a balance by maintaining the commercial readiness to do so.

Speaker #4: So, reducing these layers makes a lot of sense to us. But at the same time, I think we're continuing to maintain the strength of our commercial organization to make sure that we're ready in a fairly tight window here—that we're out of the gate relaunching and doing so properly with the great team on the field.

Speaker #4: So, we feel good about the ability to do that.

Speaker #3: Okay, very helpful. Very helpful. I just wanted to follow up on one of Adam's questions on the PRIME system. Just hoping you can put a little bit of a finer point on what the key variable to sliding that timeline is.

Frank Takkinen: Okay. Very helpful. I just wanted to follow up on one of Adam's questions on the Prime system. Just hoping you can put a little bit of a finer point on what the key variable to sliding that timeline is. I know you have mentioned maybe earlier part of H1 2027, if you are able to accelerate that process a little bit, but you are remaining conservative and to keep the H1 2027 guidance. What is the key variable that changes that timeline, and is that something that is more in your control, or is that related to maybe how quickly the FDA can process?

Speaker #3: I know you've mentioned possibly the earlier part of the first half of '27 if you're able to accelerate that process a little bit, but you're remaining conservative and keeping the first half '27 guidance.

Speaker #3: But what is the key variable that kind of changes that timeline, and is that something that's more in your control, or is that related to maybe how quickly the FDA can process?

Speaker #4: Yeah, it's a great question, Frank. So as I mentioned, there are two testing scenarios that we're looking at here. Biocomp testing takes a bit of time.

Marvin Slosman: Yes, it is a great question, Frank. As I mentioned, there is two testing scenarios that we are looking at here. Biocompatibility testing takes a bit of time. We do not believe that is necessary, but we need to validate that, obviously, with FDA and their review of this under the Pre-Submission scenario that we have set up. Then the statutory review process, we would be looking for more of an accelerated review of those changes that we have made to the Prime. If FDA agrees with that, those could pull those timelines in significantly. But again, no commitments at this point. We are still guiding around all of those factors being as they are.

Speaker #4: We don't believe that is necessary, but we need to validate that, obviously, with the FDA and their review of this under the pre-sub scenario that we have set up.

Speaker #4: And then the statutory review process—we would be looking for more of an accelerated review of those changes that we've made to the Prime.

Speaker #4: And if FDA agrees with that, those could pull those timelines in significantly. But again, no commitments at this point. We're still guiding around all of those factors being as they are.

Marvin Slosman: H1 2027 is what we are calling at the moment, but given the fact that we believe we have solved this problem technically, with minimal implications from a technical point of view, we are hopeful that FDA agrees with that assessment and that we can pull that in.

Speaker #4: So, the first half of '27 is what we're calling at the moment. But given the fact that we believe we've solved this problem technically, with minimal implications from a technical point of view, we're hopeful that the FDA agrees with that assessment and that we can pull that in.

Frank Takkinen: Okay. Very helpful. Thank you.

Speaker #3: Okay. Very helpful. Thank you.

Operator: Our next question comes from Marie Thibault with BTIG.

Speaker #2: Our next question comes from Marie Tibold with BTIG.

Marie Thibault: Morning. Thanks for taking the questions. I wanted to ask a question here on sort of the updated commercial strategy. If all goes well, you will have the relaunch and then other launches to follow in pretty quick succession here. I know you have a new head of sales and marketing, maybe a smaller, tighter team on the commercial side. Just any updates on how you are thinking about the launches, commercially, any changes to the strategy, any thoughts on VAC committee processes, all of those sorts of details would be helpful.

Speaker #6: Good morning, thanks for taking the questions. I wanted to ask a question here on the updated commercial strategy. If all goes well, you'll have the relaunch, and then other launches to follow in pretty quick succession here.

Speaker #6: So, I know you have a new Head of Sales and Marketing—maybe a smaller, tighter team on the commercial side. So, just any updates on how you're thinking about the launches?

Speaker #6: Commercially, any changes to the strategy? Any thoughts on the committee processes? All of those sorts of details would be helpful.

Marvin Slosman: Sure. Thanks, Marie. Glad to have you on the call, by the way. I think what we've spent a lot of time doing over the last month or so is making sure that we are optimizing the structure of our field organization for the folks that performed really well on our initial launch. As you know, we take a very deliberate approach to where carotid procedures are through claims data and territory management. We're looking very closely at time to productivity of our team. This is a very deliberate and structured approach. The playbook for our commercial launch and relaunch has been looked at very closely. We have a new head of sales and marketing who has real clarity on how we go about doing that.

Speaker #4: Sure. Thanks, Marie. Glad to have you on the call. By the way, I think what we've spent a lot of time doing over the last month or so is making sure that we are optimizing the structure of our field organization for the folks that performed really well on our initial launch.

Speaker #4: As you know, we take a very deliberate approach to where carotid procedures are, through claims data and territory management. We're looking very closely at the time to productivity for our team.

Speaker #4: So, this is a very deliberate and structured approach to the playbook for our commercial launch and relaunches. It's been looked at very closely. We have a new Head of Sales and Marketing who has real clarity on how we go about doing that.

Marvin Slosman: We're thrilled with the group that we have on the field, their ability to understand where their customers are and what the anticipated and pent-up demand is going to be. Obviously, that playbook will be executed, and we feel like the group that's with us now will be able to reestablish our commercial presence quickly. VAC committees and otherwise, we continue to look closely at where we have those approvals and making sure that customers understand timelines and our process here. That part of the work we've spent a lot of time looking at to make sure we get the full benefit of the value of our relaunch.

Speaker #4: And so we're thrilled with the group that we have on the field—their ability to understand where their customers are and what the anticipated and pent-up demand is going to be.

Speaker #4: And so, obviously, that playbook will be executed, and we feel that the group that's with us now will be able to reestablish our commercial presence quickly.

Speaker #4: That, through committees and otherwise, we continue to look closely at where we have those approvals, making sure that customers understand timelines and our process here.

Speaker #4: So that part of the work, we've spent a lot of time looking at, to make sure we get the full benefit of the value of our relaunch.

Marvin Slosman: We know that there is pent-up and anticipated demand for this product, and this voluntary recall gave us the opportunity to take a quick pause and make sure that we're being very efficient and realistic and aggressive about our relaunch plans. That feels very good.

Speaker #4: We know that there is pent-up and anticipated demand for this product, and this voluntary recall gave us the opportunity to take a quick pause and make sure that we're being very efficient, realistic, and aggressive about our relaunch plans.

Speaker #4: So that feels very good.

Marie Thibault: Okay. That's wonderful to hear. Thank you. A quick follow-up here. You mentioned, I think, international grew over 20% this quarter. What's been driving that? That's a really nice bright spot. I'm curious if that's a sustainable growth there. Thanks for taking the questions.

Speaker #6: Okay, that's wonderful to hear. Thank you. A quick follow-up here—you mentioned, I think, international grew over 20% this quarter. What's been driving that?

Speaker #6: That's a really nice bright spot. I'm curious if that's a sustainable growth there. Thanks for taking the questions.

Marvin Slosman: Yeah. Marie, I think it is a great question. Our OUS business has matured very well over the last several years. Remember, we have been in the OUS markets now for years, sold over 75,000 implants. We think, first of all, the performance of this device drives world-class outcomes and that the physicians in our OUS markets are very accustomed to that being the new standard of care, which we hope to translate into the US market as well. We have grown that OUS business significantly and nicely over time, but we also recognize the need to pivot a bit and look for higher margins and margin expansion in those markets.

Speaker #4: Yeah, Marie, I think it's a great question. Our OUS business has matured very well over the last several years. Remember, we've been in the OUS markets now for years and have sold over 75,000 implants.

Speaker #4: We think, first of all, the performance of this device drives world-class outcomes, and that the physicians in our OUS markets are very accustomed to that being the new standard of care, which we hope to translate into the US market as well.

Speaker #4: We've grown that U.S. and O.U.S. business significantly and nicely over time, but we also recognize the need to pivot a bit and look for higher margins and margin expansion.

Marvin Slosman: It is obviously not as robust economic market as the US and so we are beginning to look closely at fine-tuning those pricing and margin assumptions so that we can count on that business not only being a great top-line business, but being able to contribute at least partially on the bottom line. So we are thrilled to have the results that we do in our OUS market.

Speaker #4: And those markets, it's obviously not as robust an economic market as the U.S. And so we're beginning to look closely at fine-tuning those pricing and margin assumptions so that we can count on that business not only being a great top-line business, but being able to contribute at least partially on the bottom line.

Speaker #4: So, we're thrilled to have the results that we do in our OUS market.

Marie Thibault: Great. Thank you.

Speaker #6: All right. Thank you.

Operator: Our next question comes from Jeremy Pearlman with Maxim Group.

Speaker #2: Our next question comes from Jeremy Perlman with Maxim Group.

Jeremy Pearlman: Good morning. Thank you for taking my questions. First, are you in touch with the physicians who are using the recalled 135 cm delivery system, and what is their take on the timeline and are they going to be happy to reengage with the company and the CGuard Prime once it is hopefully re-cleared?

Speaker #3: Good morning. Thank you for taking my questions. First, are you in touch with the physicians who are using the recalled 135-centimeter delivery system, and what's their take on the timeline? And are they going to be happy to re-engage with the company and the C-Guard Prime once it's hopefully re-cleared?

Marvin Slosman: Yeah, Jeremy, great question. We are absolutely in touch with all of our customers, including the current users and new users. The anticipation in this marketplace is palpable. When we launched this product, we saw a terrific reaction to a new technology that came to market after 20 years of older technology, and we are of course, in touch with all of those customers. I think they are excited and anticipating having this product back in their hands is unanimous. It is consistent. It is unanimous. That is why our sales team, we have kept them together and allowed them to continue to cultivate those relationships and the expectation is as soon as we have approval of the 135 as well as the approval on the 80 for TCAR, we will be able to transfer that interest and enthusiasm into revenue in a quick fashion.

Speaker #4: Yeah, Jeremy, great question. We are absolutely in touch with all of our customers, including current users and new users. The anticipation in this marketplace is palpable.

Speaker #4: When we launched this product, we saw a terrific reaction to a new technology that came to market after 20 years of older technology. And we're, of course, in touch with all of those customers.

Speaker #4: I think their excitement and anticipation about having this product back in their hands is unanimous. It's consistent, it's unanimous. That's why we've kept our sales team together and allowed them to continue to cultivate those relationships. The expectation is, as soon as we have approval of the 135 as well as the approval on the 80 for TCAR, we will be able to transfer that interest and enthusiasm into revenue in a quick fashion.

Marvin Slosman: That is the work of the sales organization right now is to prepare for that relaunch, and the feedback from customers is excitement and enthusiasm for having it back in their hands.

Speaker #4: So that's the work of the sales organization right now: to prepare for that relaunch, and the feedback from customers is excitement and enthusiasm for having it back in their hands.

Jeremy Pearlman: Okay. That is great to hear. And then just last question from me. Regarding how important is the SwitchGuard to the long-term TCAR strategy, let us say, versus just the CGuard 80? Obviously pending FDA approval, how much does that materially expand your addressable TCAR market? Why would a physician, let us say, use the entire SwitchGuard system versus a prior system with just the CGuard 80 centimeter? Thanks.

Speaker #3: Okay, that's great to hear. And then just a last question from me. Regarding how important is the SwitchGuard to the long-term TCAR strategy? Let's say versus just the C-Guard 80.

Speaker #3: I mean, how much does that—obviously pending FDA approval—how much does that materially expand your addressable TCAR market? And why would a physician, let's say, use the entire SwitchGuard system versus a prior system with just the CGuard 80-centimeter?

Speaker #3: Thanks.

Marvin Slosman: Yeah, it is very fundamental to our overall TCAR strategy. The fact is that for every TCAR procedure, there is an implant used, there is a stent used, and then a neuroprotection device that is also used in the procedure, and we felt it was important to have both. We have made some improvements on the current predicate in the market that is approved with our SwitchGuard. So we think we will have a device that has some features and functions that the customers have been looking for that are otherwise unavailable. Obviously, the sales dollars and margin associated with that product are significant, and so the ability to address the entirety of the TCAR market with both the implant and the neuroprotection system here are really fundamental to our TCAR strategy overall. So we think we benefit by better technology and obviously internally with higher revenue and margin opportunities.

Speaker #4: Yeah, it's very fundamental to our overall TCAR strategy. The fact is that for every TCAR procedure, there's an implant used, there's a stent used, and then a neuroprotection device that's also used in the procedure.

Speaker #4: And we felt it was important to have both. We've made some improvements on the current predicate in the market that's approved, with our SwitchGuard.

Speaker #4: So, we think we will have a device that has some features and functions that the customers have been looking for, that are otherwise unavailable.

Speaker #4: Obviously, the sales dollars and margin associated with that product are significant. And so, the ability to address the entirety of the TCAR market with both the implant and the neuroprotection system here is really fundamental to our TCAR strategy overall.

Speaker #4: So we think we benefit from better technology and, obviously, internally with higher revenue and margin opportunities. So it remains a fundamental part of our overall plan.

Marvin Slosman: It remains a fundamental part of our overall plan.

Jeremy Pearlman: Okay, great. Thanks for all the information. I will have back in the queue.

Speaker #3: Okay, great. Thanks for all that information. I'll have that on the queue.

Marvin Slosman: Thank you, Jeremy.

Speaker #4: Thank you, Jeremy.

Operator: That concludes today's question and answer session. I would like to turn the call back to Marvin Slosman for closing remarks.

Speaker #2: That concludes today's question-and-answer session. I'd like to turn the call back to Marvin Slosman for closing remarks.

Marvin Slosman: I would like to thank everyone again for joining the call today and the continued interest in InspireMD, Inc.. We certainly recognize we have important work ahead of us, but we believe that we have made meaningful progress over the past several months. We have got a clear path forward, multiple important regulatory catalysts ahead, and a team that remains fully focused on execution. We appreciate the continued support and look forward to updating on our progress next quarter.

Speaker #4: So I'd like to thank everyone again for joining the call today and for your continued interest in InspireMD. We certainly recognize that we have important work ahead of us, but we believe that we've made meaningful progress over the past several months.

Speaker #4: We've got a clear path forward, multiple important regulatory catalysts ahead, and a team that remains fully focused on execution. We appreciate the continued support and look forward to updating you on our progress next quarter.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.