การแถลงผลประกอบการไตรมาส 2 ปี 2026 ของ InspireMD (NSPR): ผลกระทบจากการเรียกคืนสินค้าและปัจจัยเร่งจาก FDA

ประเด็นสำคัญ

• InspireMD รายงานรายได้ไตรมาส 2/2026 ที่ระดับ 1.8 ล้านดอลลาร์ ซึ่งเกือบจะไม่เปลี่ยนแปลงเมื่อเทียบรายปี แม้จะมีการเรียกคืนระบบขยายหลอดเลือดคอ CGuard Prime 135 โดยสมัครใจก็ตาม
• รายได้จากต่างประเทศเพิ่มขึ้น 21% สู่ระดับ 2.1 ล้านดอลลาร์ โดยได้รับปัจจัยหนุนจากอุปสงค์ที่ต่อเนื่อง มากกว่าความเคลื่อนไหวของอัตราแลกเปลี่ยน
• การคืนเงินให้แก่ลูกค้าเกี่ยวกับการเรียกคืนสินค้าจำนวน 734,000 ดอลลาร์ และการด้อยค่าสินค้าคงเหลือจำนวน 612,000 ดอลลาร์ ฉุดให้กำไรขั้นต้นพลิกเป็นขาดทุน 0.8 ล้านดอลลาร์ คิดเป็นอัตรากำไรขั้นต้นติดลบ 43.7%
• ขาดทุนสุทธิขยายตัวเป็น 14.3 ล้านดอลลาร์ จาก 13.2 ล้านดอลลาร์ ขณะที่ผลขาดทุนต่อหุ้นลดลงเหลือ 0.17 ดอลลาร์ จาก 0.26 ดอลลาร์ ทั้งนี้ เงินสด รายการเทียบเท่าเงินสด และหลักทรัพย์ในความต้องการของตลาดมีจำนวนรวม 30.4 ล้านดอลลาร์ ณ สิ้นไตรมาส
• ผู้บริหารระบุว่า การตัดสินใจของ FDA ที่คาดไว้สำหรับ CGuard Prime 80 สำหรับ TCAR และแพลตฟอร์ม CGuard ดั้งเดิมสำหรับ CAS ยังคงตั้งเป้าไว้ในไตรมาส 4/2026
• การลดพนักงานเกือบ 20% คาดว่าจะช่วยประหยัดค่าใช้จ่ายได้ประมาณ 9 ล้านดอลลาร์ต่อปี โดยคาดว่าจะเห็นผลกระทบด้านต้นทุนอย่างเต็มที่ในไตรมาส 4/2026

ผลประกอบการทางการเงินหลัก

ค่าใช้จ่ายในการดำเนินงานเพิ่มขึ้นสาเหตุหลักมาจากต้นทุนพนักงานฝ่ายพาณิชย์ในสหรัฐฯ ที่สูงขึ้น รวมถึงการใช้จ่ายด้านการพัฒนา คลินิก และกฎระเบียบที่เพิ่มขึ้นสำหรับ SwitchGuard NPS และ CGuard Prime 80 สำหรับ TCAR โดยได้รับการชดเชยบางส่วนจากค่าใช้จ่ายตอบแทนการบริหารทั่วไปที่ลดลง

ผลการดำเนินงานทางธุรกิจและการปฏิบัติการ

การเรียกคืนสินค้าโดยสมัครใจซึ่งประกาศในต้นเดือนพฤษภาคมส่งผลกระทบต่อรายได้ในสหรัฐฯ ผ่านการระงับการขาย CGuard Prime และการคืนเงินสำหรับผลิตภัณฑ์ CGuard Prime 135 ที่ยังไม่ได้ใช้ ทั้งนี้ บริษัทสร้างยอดขายในสหรัฐฯ ได้น้อยกว่าหนึ่งเดือนก่อนที่การเรียกคืนจะมีผลบังคับใช้

การดำเนินงานในต่างประเทศยังคงเป็นปัจจัยขับเคลื่อนรายได้หลัก โดย InspireMD ได้จำหน่ายอุปกรณ์ฝัง CGuard ไปแล้วมากกว่า 75,000 ชิ้นนอกสหรัฐฯ ทั้งนี้ ผู้บริหารระบุว่ากำลังทบทวนสมมติฐานด้านราคาและอัตรากำไร เพื่อปรับปรุงการมีส่วนร่วมของธุรกิจในต่างประเทศให้ดียิ่งขึ้นนอกเหนือจากการเติบโตของรายได้ระดับบน

สำหรับระบบนำส่ง CGuard Prime 135 ที่ได้รับการออกแบบใหม่ บริษัทได้ระบุการปรับเปลี่ยนที่จำเป็นแล้ว และกำลังอยู่ระหว่างการตรวจสอบความถูกต้องของการออกแบบและการทดสอบประสิทธิภาพ โดยผู้บริหารกล่าวว่ากลไกการนำส่งที่ออกแบบใหม่ทำงานได้ตามที่คาดไว้ รวมถึงในสภาวะกายวิภาคที่มีความท้าทาย

นอกจากนี้ บริษัทได้ลงทะเบียนผู้ป่วยรายแรกในการศึกษาสำคัญ CGUARDIANS III ของระบบป้องกันระบบประสาท SwitchGuard โดยผู้บริหารกล่าวว่าการลงทะเบียนในระยะแรกและข้อคิดเห็นจากผู้วิจัยเป็นไปในเชิงบวก พร้อมระบุว่าการขยายการทดลองจะขึ้นอยู่กับทรัพยากรที่มีอยู่ส่วนหนึ่ง

แนวทางของฝ่ายบริหาร

• CGuard Prime 80 สำหรับ TCAR: ผู้บริหารยังคงมองเห็นโอกาสที่จะได้รับการอนุมัติจาก FDA ในไตรมาส 4/2026 ขึ้นอยู่กับการพิจารณาของหน่วยงานกำกับดูแล
• แพลตฟอร์ม CGuard ดั้งเดิมสำหรับ CAS: ขณะนี้บริษัทคาดว่าจะมีคำตัดสินจาก FDA ในไตรมาส 4/2026 โดยผู้บริหารกล่าวว่ากรอบเวลาดังกล่าวสะท้อนถึงข้อกำหนดในการทดสอบและความจำเป็นในการเผื่อเวลาสำหรับรอบการตอบกลับของบริษัทและ FDA
• CGuard Prime 135 ที่ออกแบบใหม่สำหรับ CAS: ผู้บริหารยังคงตั้งเป้ากลับเข้าสู่ตลาดสหรัฐฯ ในช่วงครึ่งแรกของปี 2027 โดยมีโอกาสได้รับการตัดสินใจเร็วกว่านั้น หากข้อกำหนดการทดสอบและแนวทางการพิจารณาของ FDA เป็นไปอย่างราบรื่น
• SwitchGuard: บริษัทคงกรอบเวลาการอนุมัติและการเปิดตัวในช่วงครึ่งหลังของปี 2027 ตามที่เคยหารือไว้ก่อนหน้านี้ พร้อมเน้นย้ำว่าความคืบหน้าในการลงทะเบียนจะส่งผลต่อกรอบเวลา
• การลดต้นทุน: มาตรการปรับโครงสร้างส่วนใหญ่อยู่ระหว่างการดำเนินการแล้ว ผู้บริหารคาดว่าจะเริ่มประหยัดได้บางส่วนในไตรมาส 3/2026 และจะเห็นผลกระทบเต็มที่จากโครงสร้างต้นทุนที่ปรับปรุงใหม่ในไตรมาส 4/2026
• ค่าใช้จ่ายในการปรับโครงสร้าง: InspireMD คาดว่าจะมีค่าใช้จ่ายในไตรมาส 3/2026 จำนวน 900,000 ดอลลาร์ ถึง 1.2 ล้านดอลลาร์ ซึ่งเกี่ยวข้องกับค่าชดเชยการเลิกจ้างและค่าใช้จ่ายที่เกี่ยวข้อง

ความเสี่ยงและประเด็นที่ต้องติดตาม

กรอบเวลาในการกลับเข้าสู่ตลาดสหรัฐฯ ยังคงขึ้นอยู่กับการพิจารณาของ FDA สำหรับ CGuard Prime 135 ความไม่แน่นอนสำคัญ ได้แก่ ความจำเป็นที่จะต้องทำการทดสอบความเป็นพิษต่อเซลล์และเนื้อเยื่อเพิ่มเติมหรือไม่ และ FDA จะตกลงให้ใช้การพิจารณาแบบเร่งด่วนสำหรับการเปลี่ยนแปลงการออกแบบหรือไม่

การเรียกคืนสินค้ายังคงส่งผลกระทบต่อรายได้ อัตรากำไรขั้นต้น และมูลค่าสินค้าคงเหลือ แม้ว่าผู้บริหารจะมองว่าปัญหานี้ได้รับการแก้ไขในเชิงเทคนิคและสามารถจัดการได้แล้ว แต่กำหนดเวลาการเปิดตัวเชิงพาณิชย์อีกครั้งยังคงขึ้นอยู่กับการอนุมัติจากหน่วยงานกำกับดูแล

กำหนดการพัฒนา SwitchGuard ขึ้นอยู่กับการลงทะเบียนทางคลินิกและทรัพยากรที่มีอยู่ ทั้งนี้ บริษัทกำลังรักษาสมดุลระหว่างการสงวนเงินสดกับความจำเป็นในการรักษาศักยภาพเชิงพาณิชย์ที่เพียงพอสำหรับการเปิดตัวอีกครั้งในสหรัฐฯ

ประเด็นสำคัญจากการถาม-ตอบกับนักวิเคราะห์

นักวิเคราะห์เน้นน้ำหนักไปที่กรอบเวลาการกำกับดูแล โดยผู้บริหารระบุว่าการเปลี่ยนคาดการณ์การอนุมัติสำหรับระบบ CGuard ดั้งเดิมจากไตรมาส 3 เป็นไตรมาส 4/2026 เป็นผลมาจากการเผื่อเวลาที่เป็นจริงสำหรับการทดสอบ การตอบกลับของบริษัท และรอบการพิจารณาของ FDA ไม่ใช่ปัญหาผลิตภัณฑ์ใหม่ที่เพิ่งพบ

เกี่ยวกับการ CGuard Prime 135 ผู้บริหารกล่าวว่าการทดสอบยืนยันความถูกต้องของการออกแบบกำลังดำเนินอยู่ และได้ยื่นคำขอการยื่นเรื่องล่วงหน้าต่อ FDA แล้ว การหลีกเลี่ยงการทดสอบความเป็นพิษต่อเซลล์และเนื้อเยื่อเพิ่มเติมและการได้รับการพิจารณาที่เร็วขึ้นอาจช่วยย่นกรอบเวลาในช่วงครึ่งแรกของปี 2027 ในปัจจุบันให้สั้นลง แต่บริษัทไม่ได้ให้ข้อผูกมัดว่าจะเร่งกระบวนการ

ในด้านความพร้อมเชิงพาณิชย์ InspireMD กล่าวว่าได้รักษาบุคลากรภาคสนามสำคัญไว้และปรับปรุงกลยุทธ์การเปิดตัวโดยใช้ข้อมูลการเรียกร้องค่าสินไหม การวางแผนพื้นที่ และกระบวนการอนุมัติของลูกค้า ทั้งนี้ ผู้บริหารกล่าวว่าแพทย์ยังคงให้ความสนใจอย่างมาก แต่คำแถลงเหล่านี้สะท้อนถึงการประเมินของบริษัทก่อนได้รับการอนุมัติจากหน่วยงานกำกับดูแล

ผู้บริหารอธิบายว่า SwitchGuard มีความสำคัญอย่างยิ่งต่อกลยุทธ์ TCAR ในระยะยาว เนื่องจากหัตถการ TCAR แต่ละครั้งต้องใช้ทั้งโครงค้ำยันหลอดเลือดและอุปกรณ์ป้องกันระบบประสาท โดยบริษัทเชื่อว่าการนำเสนอผลิตภัณฑ์ทั้งสองอย่างอาจเพิ่มโอกาสสร้างรายได้และอัตรากำไรหากได้รับการอนุมัติ

บันทึกการประชุมแถลงผลประกอบการฉบับเต็ม

บทถอดเสียงฉบับเต็มของการประชุมทางโทรศัพท์ผลประกอบการ

คำชี้แจงจากฝ่ายบริหาร

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.

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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.