Good day, ladies and gentlemen, and thank you for standing by. Welcome to the InspiredMD third quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question at that time, you will need to press star 1-1 on your telephone keypad. As a reminder, this conference call is being recorded. At this time, I would like to turn the conference over to Ms. and Alexandra Grossman with LifeSci Advisors. Ma'am, please begin.

Thank you. 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 in 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, November 12, 2026. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

Thank you and good afternoon, everyone. The third quarter marked a turning point for InspireMD, and today I'm pleased to discuss what we believe is one of the most significant milestones in the company's history. I first want to briefly address the financing announcement we issued today. As you saw in a separate press release issued this afternoon, we have announced a proposed underwritten equity public offering. This financing is intended to support the next phase of our growth, including the full commercialization of Seagard Prime in the US and the broader execution of our strategic priorities. Given that the offering process is ongoing, there are SEC imposed limitations on what can be discussed beyond the information including in today's announcement. Thus, we are not commenting on the potential size, pricing, timing, and other terms of the transaction during this call. We appreciate your understanding and look forward to providing additional information through the appropriate public disclosures as it becomes available. As I just mentioned, today I'm pleased to discuss what we believe is one of the most significant milestones in our company's history. With FDA approval of our Seaguard Prime trans carotid stent system for TCAR procedures, we are returning to the U.S. market with our next generation carotid implant, supported by a strong body of clinical evidence, which we believe positions us to significantly expand our market penetration and pursue our mission to lead the carotid revascularization field. Let me take a moment to thank the entire team at InspireMD, as well as the physician partners who have been instrumental in this approval. This return to the U.S. market represents more than a regulatory achievement. We believe it reinforces the clinical value of our Seaguard Prime carotid stent as the best-in-class device for treating patients and helping prevent stroke. And it marks the beginning of the next phase of InspireMD's evolution, shifting our focus back to growing our commercial presence in the U.S. market. As a reminder, our next generation C-Guard implant has demonstrated unmatched clinical evidence and results in over 75,000 procedures globally, and we believe these clinical results establish a new standard of care and stroke prevention. When we spoke to you last quarter, we outlined a clear set of priorities centered on advancing our regulatory programs to approvals in the U.S., strengthening our international business, enhancing our cash delivery system, and aligning our organization and cost structure. We've made meaningful progress against each of these objectives. The approval of the C-Guard Prime trans carotid stent system was supported by the C-Guardians II pivotal trial, which demonstrated 100% acute device success among 50 patients with no deaths, strokes, or myocardial infarctions through 30 days and complete stent patency at 30 days amongst evaluated patients. We believe these results reinforce the clinical value of our C-Guard implant in its proprietary Micronet mesh technology. Our value proposition has always been centered on treating the lesion and providing durable protection against stroke. This TCAR indication expands our US addressable market by approximately 40,000 annual procedures, effectively doubling our opportunity, which we plan to immediately pursue with a world-class commercial team on the field ready to execute. It also enables an indication for use of our implant in TCAR, a major carotid revascularization approach. Our strategy is to make C-Guard available across both TCAR as well as transfemoral cast procedures to address the broad range of patients and physician needs. We believe we were the first company to focus on the entirety of the carotid field with an implant-first approach, building on the clinical evidence derived from our mesh-protected platform. With this approval, our focus now shifts to commercial execution. As we commence U.S. sales, we intend to build on the base and momentum of our account approvals, physician awareness, and enthusiasm we've developed for this technology. We will continue to follow our commercial playbook with a disciplined and direct approach to sales growth. Over the past few months, we prepared for this return with an emphasis on commercial readiness, physician engagement, training, and clinical support. We strengthened our leadership at the appointment of Kathy Kennedy as Senior Vice President of Global Sales and Marketing along with the promotion and addition of several key leaders on our engineering, clinical, regulatory, and operations functions to support this launch and prepare for future approvals and platform enhancements. We see this approval as only the beginning in the pursuit of our mission to lead this important and growing segment of vascular medicine with a comprehensive set of devices supported by clinical evidence. Sustained success will depend on consistent execution, physician confidence, and our ability to translate clinical differentiation into routine use, which we believe is achievable. Our international business continued to grow with third quarter revenues increasing approximately 9% year over year to $2.2 million. Through the first nine months of 2026, international revenue increased approximately 24% to $6.6 million, reflected continued adoption of our Seaguard platform across our markets. While reported U.S. revenue remained affected by our absence from the market following the May voluntary recall of Seaguard Prime 135 delivery system, international demand continues to demonstrate the underlying appeal of our implant technology. Beyond TCAR, we continue to advance programs designed to broaden our carotid intervention portfolio. Our original C-Guard carotid stent system for Cas remains under FDA review. We believe this platform, with its extensive history of international clinical sales and over 75,000 patients, could complement our offering and further expand access to our technology subject to FDA approval. For the C-Guard Prime 135 Cas delivery system, We have implemented design enhancements following the voluntary recall. Validation and performance testing are underway, and we currently anticipate an FDA submission before year's end. We continue to work toward reentry of this platform in the first half of 2027, subject to regulatory review and approval. Enrollment is progressing in our Sea Guardians III pivotal trial, evaluating our proprietary switchguard neuroprotection system for TCAR procedures. We believe SwitchGuard represents an opportunity to complement our implant with a comprehensive set of proprietary tools and technology to expand our procedural reach. As a next step in expanding our capabilities into TCAR, we plan to introduce a proprietary micropuncture kit designed to support vascular access, which we currently expect in a planned release early Q1 2027. Together, these initiatives reflect our goal of building a more comprehensive carotid intervention platform, offering physicians a broad set of solutions across both TCAR and CAS. We remain focused on aligning our resources around the highest priority of regulatory and commercial opportunities During the third quarter, we implemented a workforce reduction of approximately 20%, which we expect will better align our resources with key product development, regulatory, and clinical commercialization priorities while reducing our overall operating expense base. We will remain financially disciplined as we fund our commercial reentry and advance our pipeline. Mike will provide additional details on the financial performance, liquidity, cost structure, and so forth in a few moments. Before turning the call over to Mike, I want to reinforce four key messages. First, FDA approval for TCAR represents a major milestone. We're turning Seaguard Prime to the US market with the next generation implant and significantly expanding our addressable opportunity. Second, we believe we are positioned to execute on our growth strategy and continue building toward profitability. Third, we are moving into a growth phase focused on commercial execution with an experienced team and a disciplined approach to driving physician adoption. Fourth, we continue to advance a differentiated portfolio across TCard and CAST, including the original C-Guard system, the enhanced Prime 135 delivery platform, SwitchGuard, and complementary procedural technologies. and finally, we have taken meaningful steps to streamline our global operations and align our cost structure with these priorities. We recognize that important work remains ahead of us, but with a differentiated implant, a compelling clinical evidence base and expanding product portfolio in a more focused organization, we believe InspireMD is well positioned for its next phase. With that, I'll turn the call over to Mike to review third quarter financials. Mike, go ahead.

Thank you, Marvin. For the third quarter of 2026, total revenue was $2.2 million, down $0.3 million, or 11% from revenue in the third quarter of 2025. This decline was a result of the voluntary action that we took back in May to temporarily withdraw from the U.S. market until we could implement enhancements to the delivery system of Seaguard Prime for CAS. International revenue was $2.2 million, representing growth of $0.2 million, or 9%, Thank you for joining us. resulting primarily from sales recorded as part of the C-Guardians III pivotal trial for the SwitchGuard neuroprotection system. Gross profit for the third quarter of 2026 was $0.2 million or 10.7% of revenue compared to a gross profit of $0.9 million or 34.2% of revenue for the third quarter of 2025. This variance resulted primarily from the absence of revenue from the US resulting from the voluntary action we took in the second quarter. We also experienced lower than expected margins in international sales, primarily as a result of a higher mix of sales to countries with lower ASPs. Total operating expenses for the third quarter of 2026 were $10.2 million, a decrease of $3.7 million, or 27%, compared to $13.9 million for the third quarter of 2025. This decrease was primarily due to the impact of the workforce reduction action that we took during the past quarter. About $1.8 million of this decrease is due to a one-time reversal of previously recognized stock compensation expense for share grants that were forfeited as part of the headcount reductions. The savings from the workforce reduction were partially upset by higher spending on the Sea Guardians III clinical trial. Financial income was $191,000 as compared to the income of $343,000 for the third quarter of 2025. Net loss for the third quarter of 2026 totaled $9.8 million or 12 cents per basic and diluted share compared to a net loss of $12.7 million or 17 cents per basic and diluted share for the same period in 2025. As of September 30, 2026, cash equivalents and marketable securities were $19.2 million compared to $54.2 million at the end of 2025. With our announcement today of the FDA approval of C-Guard Prime for TCAR, we have triggered the 20-day expiration period for the amended Series J and K warrants, during which the holders can exercise their warrants. If exercised in full, these warrants could result in up to $10 million of net proceeds. Following this 20-day period, the only remaining milestone-based warrants left in our cap table will be the original Series J warrants, which have an expiration period that is triggered by FDA approval of SwitchGuard, our neuroprotection system currently in Phase III clinical trials. As Mark discussed earlier, we also announced today that we have launched a potential financing transaction If completed, we expect to use the proceeds to support, among other things, our commercial launch activities in the U.S. and our CDR NH3 pivotal trial for our SwitchGuard neuroprotection system. The terms of the potential transaction, including the amounts of proceeds, have not yet been determined. This concludes our prepared remarks. We will now open the call for questions. Operator?

Yes, sir. Ladies and gentlemen, if you have a question or comment at this time, please press star 11 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press star 11 again. Again, if you have a question or comment at this time, please press star 11 on your telephone keypad. Please stand by while we compile the Q&A roster. Our first question or comment comes from the line of Adam Mader from Piper Sandler. Mr. Mader, your line is now open.

Good afternoon. Thank you for taking the questions and congrats on the short shaft C-Guard approval. Maybe we could start there. Marvin, we just love a little bit more color in terms of how you're thinking about potential uptake of that product. You know, what does it look like in terms of that committee process? and is there an attach rate that you're targeting for those TCAR procedures? And then I have to follow up. Thanks.

Thanks for the question, Adam. Yeah, I think the overall feeling here is that we want to pick up where we left off relative to our VAC approvals and traction in the marketplace. The sales organization has been continuing to work behind the scenes to make sure that we've got very well laid account plans and targeting. and our previous recall of the 135 system, it remained approved and so we are able to take advantage of the previous momentum in terms of approvals and we will continue to launch the short shaft system in the TCAR environment as such. So we feel like that we will be able to build off of a warm start.

Okay, that's, that's helpful, Marvin. Thank you for that. And then maybe just two more for me, if that's okay. I'll ask them both up front. Was wondering if there was an update on timelines for the original C-Guard delivery system. You know, when do you expect that product to be available in the market? And then I heard you touch on the C-Guardian III clinical trial. in a prepared remarks. I just wanted to confirm that that's still targeting a back half 2027 approval. Thank you.

Yeah, thanks. Thanks again, Adam. So in terms of the legacy system, we still anticipate feedback from FDA by the end of the year, which was our original intention. And so all of the information that's been provided to FDA and they continue to evaluate the legacy system for approval, which we continue to anticipate according to those timelines. As far as Sea Guardians 3 is concerned, we're actively enrolling in that trial and continue to build off of that momentum in terms of activating more sites. There's continued enthusiasm on the part of the vascular surgery community, especially those that have used our stent device in previous trials. And so we're looking forward to continuing to accelerate those enrollments and those timelines that we discussed end of 2027. continue to hold there.

Great to hear. Thank you.

Thank you. Our next question or comment comes from the line of Frank Takkanen from Lake Street Capital Markets. Mr. Takkanen, your line is now open.

Great. Thanks for taking the questions. I was hoping to start with one on Seagarden TCAR. as well. Can you maybe just talk through what is left that needs to be complete before you can actually start shipping product? Maybe talk through inventory. Have you built up some inventory? How meaningful of an inflection do you think we can see here at the end of the year, or is it really just getting the VACs back up and running and laying the foundation for next year? Any additional could be great. Thanks.

Yeah, thanks for the question, Frank. We are ready, and product is being shipped as we speak. We prepared that well in advance of disapproval. Now that we have the Miami facility in place, we're operationally set there. And so we expect that cases will begin immediately. We think that there is a lot of pent up demand for this implant, a lot of enthusiasm within the vascular surgery community to have a differentiated product after being limited for a number of years on their opportunities to use other devices. and so I would expect, as I discussed with Adam's question, we have approvals in place, we have a team in place, we've done a lot of account planning and operational readiness and so we are not only ready to go but past ready to go and products are moving today.

Okay, very helpful. And then just for my second one, maybe for Mike, can you just refresh us how we should be thinking about The go-forward OPEX profile now that the cost cuts have come out of the model. And I think I heard, and maybe it wouldn't hurt to clarify, that you said there was a $1.8 million item that made OPEX look a little bit lower than it actually was. Can you maybe clarify on that a little bit and then just how we should think about OPEX going forward? Thanks.

Yeah, sure. Good talking with you, Frank. So, yeah, in Q4, we, as part of the restructuring that we took, we had to, from an accounting standpoint, reverse some previously expensed stock comp expense. So, that amounted to $1.8 million in the quarters. That was a one-time item that will not repeat itself going forward, which served to reduce the overall level of OpEx that we reported. and then on a going forward basis, I'd say that, you know, we've clearly reduced our cost structure as we described when we announced the restructuring. I think that, I mean, at this time we're not providing a lot of guidance, but I'd say that, you know, you should look to see incremental savings, you know, starting in Q4 and that would carry over into the first several quarters of next year as well. And then depending on the sales ramp and the progress we make in launching Seaguard Prime 80, we'll start to make some incremental investments again in sales and marketing in the back half of the year. But I think you'll see that there's a lower cost structure going forward starting in Q4. Perfect.

Thanks, David. Questions?

Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star 11 on your telephone keypad. I'm sure no additional questions in the queue at this time. I'd like to turn the conference back over to management for any closing remarks.

Thank you again for joining us today in the continued interest in InspireMD. While we still have important work ahead of us, we believe we've made meaningful progress over the last several months. We have a clear path forward, multiple important regulatory milestones ahead, and a team that remains fully focused on execution. We appreciate the continued support and look forward to updating the progress next quarter.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.