Cuộc họp công bố kết quả kinh doanh Q2 2026 của InspireMD (NSPR): Tác động từ việc thu hồi và các yếu tố thúc đẩy từ FDA

Thông tin chính

• InspireMD đã báo cáo doanh thu quý 2/2026 đạt 1,8 triệu USD, về cơ bản không đổi so với cùng kỳ năm ngoái, bất chấp việc tự nguyện thu hồi hệ thống stent động mạch cảnh CGuard Prime 135.
• Doanh thu quốc tế tăng 21% lên 2,1 triệu USD, được thúc đẩy bởi nhu cầu tiếp tục duy trì thay vì biến động tỷ giá hối đoái.
• Các khoản bồi hoàn cho khách hàng liên quan đến đợt thu hồi trị giá 734.000 USD và khoản trích lập giảm giá hàng tồn kho 612.000 USD đã đẩy lợi nhuận gộp xuống mức lỗ 0,8 triệu USD, tương ứng với biên lợi nhuận gộp âm 43,7%.
• Lỗ ròng tăng từ 13,2 triệu USD lên 14,3 triệu USD, trong khi lỗ trên mỗi cổ phiếu giảm từ 0,26 USD xuống 0,17 USD. Tiền, các khoản tương đương tiền và chứng khoán có giá khả nhượng đạt tổng cộng 30,4 triệu USD vào cuối quý.
• Ban lãnh đạo cho biết các quyết định tiềm năng của FDA đối với CGuard Prime 80 cho TCAR và nền tảng CGuard nguyên bản cho CAS vẫn được đặt mục tiêu vào quý 4/2026.
• Việc cắt giảm gần 20% lực lượng lao động dự kiến sẽ giúp tiết kiệm khoảng 9 triệu USD mỗi năm, với tác động đầy đủ đến chi phí dự kiến sẽ thể hiện rõ vào quý 4/2026.

Kết quả tài chính cốt lõi

Chi phí hoạt động tăng chủ yếu do chi phí nhân sự thương mại tại Mỹ cao hơn và chi phí phát triển, lâm sàng cũng như pháp lý lớn hơn cho SwitchGuard NPS và CGuard Prime 80 cho TCAR. Chi phí thù lao quản lý và chung thấp hơn đã bù đắp một phần.

Kết quả hoạt động và kinh doanh

Đợt tự nguyện thu hồi được thông báo vào đầu tháng 5 đã ảnh hưởng đến doanh thu tại Mỹ do việc tạm dừng bán CGuard Prime và các khoản bồi hoàn cho sản phẩm CGuard Prime 135 chưa sử dụng. Công ty chỉ ghi nhận chưa đầy một tháng doanh số tại Mỹ trước khi đợt thu hồi có hiệu lực.

Hoạt động kinh doanh quốc tế vẫn là động lực doanh thu chính. InspireMD đã bán được hơn 75.000 thiết bị cấy ghép CGuard ngoài lãnh thổ Mỹ. Ban lãnh đạo cho biết hiện đang xem xét lại các giả định về định giá và biên lợi nhuận để cải thiện đóng góp của mảng kinh doanh quốc tế ngoài việc tăng trưởng doanh thu.

Đối với hệ thống phân phối CGuard Prime 135 được thiết kế lại, công ty đã xác định được các sửa đổi cần thiết và đang tiến hành kiểm tra xác nhận thiết kế cũng như thử nghiệm hiệu suất. Ban lãnh đạo cho biết cơ chế phân phối được thiết kế lại đã hoạt động đúng như kỳ vọng, kể cả trong các cấu trúc giải phẫu phức tạp.

Công ty cũng đã tuyển bệnh nhân đầu tiên vào nghiên cứu trọng yếu CGUARDIANS III cho hệ thống bảo vệ thần kinh SwitchGuard. Ban lãnh đạo đánh giá việc tuyển bệnh nhân giai đoạn đầu và phản hồi từ các nghiên cứu viên là tích cực, đồng thời lưu ý rằng việc mở rộng thử nghiệm sẽ phụ thuộc một phần vào các nguồn lực hiện có.

Dự báo của ban lãnh đạo

• CGuard Prime 80 cho TCAR: Ban lãnh đạo tiếp tục thấy khả năng được FDA phê duyệt vào quý 4/2026, tùy thuộc vào quá trình xem xét của cơ quan quản lý.
• Nền tảng CGuard nguyên bản cho CAS: Công ty hiện kỳ vọng quyết định từ FDA vào quý 4/2026. Ban lãnh đạo cho biết mốc thời gian này phản ánh các yêu cầu thử nghiệm và nhu cầu dành thời gian cho các chu kỳ phản hồi của công ty và FDA.
• CGuard Prime 135 được thiết kế lại cho CAS: Ban lãnh đạo tiếp tục đặt mục tiêu gia nhập lại thị trường Mỹ vào nửa đầu năm 2027, với khả năng có quyết định sớm hơn nếu các yêu cầu thử nghiệm và lộ trình xem xét của FDA thuận lợi.
• SwitchGuard: Công ty duy trì mốc thời gian phê duyệt và ra mắt vào nửa cuối năm 2027 đã thảo luận trước đó, đồng thời nhấn mạnh rằng tiến độ tuyển bệnh nhân sẽ ảnh hưởng đến tiến trình này.
• Cắt giảm chi phí: Hầu hết các hoạt động tái cấu trúc đang được triển khai. Ban lãnh đạo kỳ vọng sẽ tiết kiệm được một phần chi phí trong quý 3/2026 và đạt tác động đầy đủ của cơ cấu chi phí sửa đổi vào quý 4/2026.
• Chi phí tái cấu trúc: InspireMD kỳ vọng chi phí trong quý 3/2026 sẽ từ 900.000 USD đến 1,2 triệu USD liên quan đến trợ cấp thôi việc và các chi phí liên quan.

Rủi ro và các điểm cần theo dõi

Thời điểm gia nhập lại thị trường Mỹ vẫn phụ thuộc vào quá trình xem xét của FDA. Đối với CGuard Prime 135, các yếu tố không chắc chắn chính bao gồm liệu có cần thử nghiệm độ tương thích sinh học bổ sung hay không và liệu FDA có đồng ý xem xét rút ngắn thời gian đối với các thay đổi thiết kế hay không.

Đợt thu hồi tiếp tục ảnh hưởng đến doanh thu, biên lợi nhuận gộp và giá trị hàng tồn kho. Mặc dù ban lãnh đạo coi vấn đề này đã được giải quyết về mặt kỹ thuật và trong tầm kiểm soát, thời điểm tái ra mắt thương mại vẫn phải chờ phê duyệt từ cơ quan quản lý.

Tiến độ phát triển của SwitchGuard phụ thuộc vào việc tuyển bệnh nhân lâm sàng và các nguồn lực hiện có. Công ty cũng đang cân bằng giữa việc bảo toàn tiền mặt và nhu cầu duy trì đủ năng lực thương mại cho việc tái ra mắt tại Mỹ.

Các điểm chính trong phiên Q&A với chuyên gia phân tích

Các chuyên gia phân tích tập trung nhiều vào mốc thời gian phê duyệt của cơ quan quản lý. Ban lãnh đạo giải thích việc chuyển thời điểm dự kiến phê duyệt hệ thống CGuard nguyên bản từ quý 3 sang quý 4/2026 là do tính toán thực tế cho thời gian thử nghiệm, thời gian phản hồi của công ty và các chu kỳ xem xét của FDA, chứ không phải do vấn đề mới phát sinh ở sản phẩm.

Liên quan đến CGuard Prime 135, ban lãnh đạo cho biết việc thử nghiệm xác nhận thiết kế đang được tiến hành. Yêu cầu nộp sơ bộ ban đầu đã được gửi lên FDA. Việc tránh thử nghiệm độ tương thích sinh học bổ sung và đảm bảo quy trình xem xét nhanh hơn có thể rút ngắn mốc thời gian nửa đầu năm 2027 hiện tại, nhưng công ty không đưa ra cam kết nào về việc đẩy nhanh tiến độ.

Về sự chuẩn bị cho thương mại hóa, InspireMD cho biết họ đã giữ chân lực lượng nhân sự chủ chốt tại địa bàn và hoàn thiện chiến lược ra mắt bằng cách sử dụng dữ liệu bồi thường, quy hoạch địa bàn và quy trình phê duyệt của khách hàng. Ban lãnh đạo cho biết sự quan tâm của các bác sĩ vẫn rất lớn, nhưng những tuyên bố này phản ánh đánh giá của công ty trước khi nhận được sự phê duyệt của cơ quan quản lý.

Ban lãnh đạo mô tả SwitchGuard là yếu tố nền tảng cho chiến lược TCAR dài hạn vì mỗi thủ thuật TCAR đều sử dụng cả stent và thiết bị bảo vệ thần kinh. Công ty tin rằng việc cung cấp cả hai sản phẩm có thể gia tăng cơ hội tăng doanh thu và biên lợi nhuận nếu được phê duyệt.

Toàn văn Biên bản Cuộc họp Báo cáo Kết quả Kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Good morning, and welcome to InspireMD Second Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes.

Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; and Mike 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. 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. 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, 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.

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

Marvin Slosman

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. market. Over the last several months, we've remained focused on 4 priorities: optimizing our international business, advancing our key regulatory programs and milestones to U.S. market reentry, 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 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 CGuard across our international markets. 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. 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 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. relaunch. We continue to believe CGuard is the most differentiated technology available for carotid revascularization and stroke prevention.

Turning now to our CGUARDIANS 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 the fourth quarter, 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.

Also, as previously noted, our submission of the original CGuard platform for CAS, clinically proven in over 75,000 global OUS cases continues, and based on the progress to date, we currently expect a decision from 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.

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-sub dossier. These modifications and testing have gone exceedingly well, and we are optimistic that the associated time lines of first half of 2027 for market reentry 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. We also believe we've 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'd like to leave you with 4 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've identified the solution, and we are executing against a clear regulatory pathway to reestablish traction and growth.

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.

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 are a more focused and disciplined company and ultimately have better positioned ourselves for success.

With that, I'll turn the call over to Mike to review the financials. Mike?

Michael Lawless

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. For the second quarter of 2026, total revenue was $1.8 million, which was essentially flat with the revenue for the second quarter of 2025.

The recall action affected our reported revenue in 2 ways. First, we ceased commercial sales of CGuard Prime late in April, so we generated less than 1 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. The entirety of international growth was driven by continued demand, while changes in foreign exchange rates were immaterial.

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. 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.

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 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. 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.

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

Operator

[Operator Instructions] Our first question comes from Adam Maeder with Piper Sandler.

Phần hỏi đáp

Adam Maeder

A couple for me, and maybe we can just start on the CAS side of the business. So first, original CGuard delivery system approval timing for U.S., 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. And I don't mean to nitpick over a couple of months, but can you just talk about kind of what's driving the shift there? Any color you can give us on your recent interactions with FDA? That's question one. And then I have another 1 or 2 for you guys.

Marvin Slosman

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 time frames as always, request from FDA and just general time frames. We have testing that has been required and is completed, and we're just trying to make sure that we're understanding a realistic approval time line here relative to the workload, our responses to FDA and so forth. 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, specific to the legacy system.

Adam Maeder

Yes. Perfect. Okay. And then if we switch over to CGuard Prime, the delivery system there. Good to hear you're still tracking towards first half 2027 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 as folks just try and understand how derisked the first half '27 approval it truly is. And then I had one more for you guys.

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've 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. And so the delivery mechanism performs well. We are 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 measured approach.

So we're confident in the system. We're confident that we've solved it, and this is our platform for the future. So we originally guided around a first half 2027 approval. We think that, that remains realistic. There's a couple of long poles in the tent that we're still sorting out related to biocomp testing, the statutory review process that FDA puts on these things. We have submitted early our pre-sub 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're calling the first half of '27 as being realistic, and we're optimistic that we can make those improvements.

Adam Maeder

Okay. 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. 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 is advancing? And just from a time line standpoint, I just want to confirm that you're still tracking to back half 2027 for U.S. approval and launch.

Marvin Slosman

Yes. The enrollments thus far have 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. 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 time line that you had previously mentioned as being what we're calling at this point. Obviously, the enrollment process will determine time lines. But so far, we're really pleased about the responses and the performance of the device itself.

Operator

Comes from Frank Takkinen with Lake Street Capital Markets.

Frank Takkinen

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 kind of the first quarter of the refreshed operating expense run rate? And then you made a comment related to a 20% reduction in headcount. Can you maybe talk to the distribution of where those 20% came from inside the organization?

Michael Lawless

Frank, good questions. So in terms of the timing for when we'll realize those cost savings, those -- 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 that -- 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. So from a clean standpoint, I would say Q4 should be a good view of what the new cost structure looks like.

Marvin Slosman

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. So even though we're conserving our financial resources to extend the cash runway, we're trying to strike a balance in maintaining the commercial readiness to do so. 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 a great team on the field. So we're -- we feel good about the ability to do that.

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 kind of key variable to sliding that time line is. I know you've mentioned kind of maybe earlier part of first half '27, if you're able to accelerate that process a little bit, but you're remaining conservative and to keep the first half '27 guidance. But what is the key variable that kind of changes that time line? And is that something that's more in your control? Or is that related to maybe how quickly the FDA can process?

Marvin Slosman

Yes, it's a great question, Frank. So as I mentioned, there's 2 testing scenarios that we're looking at here. Biocomp testing, it takes a bit of time. We don't believe that is necessary, but we need to validate that with -- obviously, with FDA and their review of this under the pre-sub scenario that we have set up. 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. And if FDA agrees with that, those could pull those time lines in significantly.

But again, no commitments at this point. We're still guiding around all of those factors being as they are. So 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 FDA agrees with that assessment and that we can pull that in.

Operator

Our next question comes from Marie Thibault with BTIG.

Marie Thibault

I wanted to ask a question here on sort of the updated commercial strategy. If all goes well, you'll have the relaunch and then other launches to follow pretty quick succession here. 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 commercially? Any changes to the strategy? Any thoughts on VAC 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. So 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. So 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. 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. And so obviously, that playbook will be executed, and we feel like that 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 time lines and our process here. So that part of the work, we spent a lot of time looking at to make sure we get the full benefit of the value of our relaunch. 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. So that feels very good.

Marie Thibault

Okay. That's wonderful to hear. 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.

Marvin Slosman

Yes, 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, 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 U.S. market as well.

We've 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. It's obviously not as a robust 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. So we're thrilled to have the results that we do in our OUS market.

Operator

Our next question comes from Jeremy Pearlman with Maxim Group.

Jeremy Pearlman

First, I guess, are you in touch with the physicians who are using the recalled 135-centimeter delivery system? And what's their take on the time line? And are they going to be happy to reengage with the company and the CGuard Prime once it's hopefully recleared?

Marvin Slosman

Yes, 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're, of course, in touch with all of those customers. I think they're excited and anticipating having this product back in their hands is unanimous. It's consistent, it's unanimous. That's why our sales team, we've 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. So that's 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.

Jeremy Pearlman

Okay. That's great to hear. And then just last question for me. Regarding how important is the SwitchGuard to the long-term TCAR strategy, let's say, versus just the CGuard 80? I mean, how much does that -- obviously pending FDA approval, how much does that materially expand your addressable TCAR market? Like -- and what would -- why would a physician, let's say, use the entire SwitchGuard system versus a prior system with just the CGuard 80-centimeter?

Marvin Slosman

Yes. It's very fundamental to our overall TCAR strategy. The fact is that for every TCAR procedure, there's an implant use, there's a stent use and then a neuroprotection device that's also used in the procedure, 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. 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. So it remains a fundamental part of our overall plan.

Operator

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

Marvin Slosman

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

Operator

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