Q1 2025 InspireMD Inc Earnings Call
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Operator: Good morning and welcome to InspireMD's first quarter 2025 earnings conference. Currently, all participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.
Speaker Change: Good morning, and welcome to inspire MTS first quarter 2025 earnings conference call.
Currently all participants are in a listen only mode.
Speaker Change: We will be facilitating a question answer session towards the end of today's call.
Speaker Change: As a reminder, this call is being recorded for replay purposes, I would now like to turn the call over to web Campbell from Gilmartin group for introductory disclosures.
Webb Campbell: I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory discussion. Thank you for joining us for the InspireMD first quarter 2025 conference call.
Marvin: Thank you for joining us for the inspire and the first quarter of 2025 conference call joining us today from inspire and D are Marvin <unk>, Chief Executive Officer, and Craig Shore, Chief Financial Officer.
Unknown Executive: Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer, and Craig Shore, Chief Financial Officer. During this call, management will be making forward-looking statements, not historical facts, which are based upon management's current expectations, beliefs, and projections, many of which, by their nature, are inherently uncertain. These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward-looking statements. For more information about these risks, please refer to the risk factors. described in InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q and any updates in our current reports on Form 8-K filed with the U.S.
Speaker Change: During this call management will be making forward looking statements not historical facts, 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.
Speaker Change: Expressed in such forward looking statements for more information about these risks please refer to the risk factors.
Speaker Change: Described in inspire and <unk>. Most recently filed periodic reports on Form 10-K, and Form 10-Q, and any updates and our current reports on form 8-K.
Speaker Change: With the U S Securities and Exchange Commission and inspire in these press release that accompanies this call.
Unknown Executive: Security and Exchange Commission and InspireMD's press release that accompanies this call. particularly the cautionary statements made in it.
Speaker Change: Particularly with the cautionary statements made in it.
Unknown Executive: This call contains time sensitive information that is accurate only as of today, May 9th, 2020. accept as required by law, InspireMD disclaims any intention or obligation to publicly update or revise any information to reflect events or circumstances that occur after this.
Speaker Change: This call contains time sensitive information that is accurate only as of today may 19 2025.
Speaker Change: Except as required by law inspire and <unk> disclaims any intention or obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call.
Marvin Slosman: It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead. Thank you and good morning. We're pleased to welcome everyone to the call today.
Marvin: It is now my pleasure to turn the call over to Marvin solving Chief Executive Officer Marvin. Please go ahead.
Marvin: Thank you and good morning, we're pleased to welcome everyone to the call today I'd like to start by highlighting our first quarter performance.
Marvin Slosman: I'd like to start by highlighting our first quarter performance. Seaguard revenue reached $1.53 million, reflecting a 1.2% growth year over year. This revenue translates to unit sales of 2,611 Seaguard stents sold, providing world-class treatment to thousands of patients suffering from carotid artery disease. These results contribute to our growing body of real world experience with roughly 64,000 implants sold to date, underscoring our expertise in the space. and Global Commercial Foundation as we prepare for the anticipated U.S.
Marvin: <unk> revenue reached $153 million, reflecting a 1.2% growth year over year. This revenue translates to unit sales of 2600, 11, <unk> stent sold providing world class treatment, the thousands of patients suffering from carotid artery disease.
Marvin: These results contribute to our growing body of real world experience with roughly 64000 implants sold to date underscoring our expertise in this space.
Marvin: Global commercial foundation as we prepare for the anticipated U S approval and launch of <unk> Prime.
Marvin Slosman: approval and launch of Seaguard Prime. Turning to our SeaGuard Prime approval status, based on our latest communication with FDA, we are optimistic for approval in the third quarter of 2025. We are actively addressing feedback and remain confident in achieving this approval. Anticipating a positive outcome, we're preparing for commercial launch with a growing world-class team, expecting significant demand for Seaguard Prime as the only next-generation proven carotid stent platform, demonstrating best-in-class results and superior patient outcomes. To better illustrate the opportunity ahead in the U.S., using our current sales as a benchmark, during the first quarter we sold $0.2611 internationally.
Marvin: Turning to our CCAR time approval status based on our latest communication with the FDA. We are optimistic for approval in the third quarter of 2025.
Marvin: We are actively addressing feedback and remain confident in achieving disapproval.
Marvin: Anticipating a positive outcome, we're preparing for commercial launch with a growing world class team expecting significant demand for CCAR crime as the only next generation proven carotid stent platform demonstrating best in class results and superior patient outcomes.
Marvin: To better illustrate the opportunity ahead in the U S. Using our current sales as a benchmark during the first quarter. We sold 2600 11 states internationally.
Marvin Slosman: Had this volume been realized in the U.S. at current market ASPs, it would have generated approximately $12 million in revenue, assuming a balanced mix of CAS and TCAR procedures. The market growth of both CAS and TCAR remains significant with data suggesting the conversion of majority of the procedures from surgery to stenting is underway with endovascular procedures potentially representing the majority sometime next year. We believe the introduction of Seaguard Prime will further catalyze this shift as it introduces true next generation performance and results. Given this strong starting point, we are highly confident that the U.S. launch of Seaguard Prime combined with the potential introduction of our SwitchGuard Neuroprotection System for TCAR will serve as a powerful catalyst for significant revenue expansion following regulatory approval.
Marvin: This volume being realized in the U S. At current market Asp's it would've generated approximately $12 million in revenue, assuming a balanced mix of cash and T car procedures.
Marvin: The market growth at both casting T car remains significant with data, suggesting the conversion of the majority of the procedures from surgery to stenting, it's underway with endovascular procedures potentially representing the majority sometime next year.
Marvin: We believe the introduction of CCAR Prime will further catalyze this shift.
Marvin: It introduces true next generation performance and results.
Marvin: Combined with the potential introduction of our switch gardener or protection system for T-car will serve as a powerful catalyst for significant revenue expansion following regulatory approval.
Marvin Slosman: We remain committed to strategically expanding our commercial and clinical foundation throughout 2025, and we believe these investments will drive robust growth over the coming years. As we continue to engage with the FDA, we've been diligently building a world-class commercial and operational engine to support our highly anticipated U.S. launch. We've onboarded and trained roughly 20 high powered sales and marketing professionals. Our cadence will continue adding talent to the team to address what we believe to be tremendous demand from our Karate technology. Thus far, we're thrilled by the caliber of individuals who bring extensive experience, deep relationships, and proven track records of launching new products in the vascular space.
Marvin: We remain committed to strategically expanding our commercial and clinical foundation throughout 2025 and we believe these investments will drive robust growth over the coming years.
Marvin: As we continue to engage with the FDA, we've been diligently building a world class commercial and operational engine to support our highly anticipated U.S. launch.
Marvin: We've onboarded and trained for roughly 20 high-powered sales and marketing professionals. Our cadence will continue adding talent to the team to address what we believe to be tremendous demand from our carotid technologies.
Marvin: Thus far we're thrilled by the caliber of individuals who bring extensive experience, deep relationships, and proven track records of launching new products in the vascular space.
Marvin Slosman: Their expertise in this field, along with their trusted connections to our customers, builds a foundation of field presence across the United States, ready to deliver results. The overwhelming interest from highly talented seasoned professionals who are eager to join our organization at this pivotal time is a clear reflection of the excitement surrounding Sea Guard Prime and the broader shift taking place in carotid revascularization toward endovascular first solution. Our sales organization will also leverage robust claims data, along with their knowledge of market dynamics and relationships to inform strategic targeting and optimize opportunity capture. Our evolving data ecosystem is laying the groundwork for precision and execution.
Marvin: Their expertise in this field along with their trusted connections to our customers builds a foundation of field presence across the United States ready to deliver results.
Marvin: The overwhelming interest from highly talented seasoned professionals who are eager to join our organization at this pivotal time is a clear reflection of the excitement surrounding Seagard Prime and the broader shift taking place in Crawford Revascularization toward end of Ascular for Solutions.
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Marvin: Our sales organization will also leverage robust claims data along with their knowledge of market dynamics and relationships to inform strategic targeting and optimize opportunity capture.
Marvin: Our evolving data ecosystem is laying the groundwork for precision and execution. We are not just prepared for launch, we are ready to aggressively execute a comprehensive commercial launch.
Marvin Slosman: We are not just prepared for launch, we're ready to aggressively execute a comprehensive commercial launch. We firmly believe Seaguard Prime is positioned to redefine the treatment of carotid disease and stroke prevention, and we intend to fully capitalize on the market's momentum toward less invasive solutions. We expect our state-of-the-art facility in Miami, Florida, to complement our commercial buildout, illustrating our commitment to scaling U.S. operations. Domestic production will enable us to meet market demand efficiently, while also providing a diversified supply chain in the face of macroeconomic uncertainty.
Marvin: We firmly believe C. Gard prime is positioned to redefine the treatment of crowded disease and stroke prevention, and we intend to fully capitalize on the market's momentum toward less invasive solutions.
Marvin: We expect our state-of-the-art facility in Miami, Florida to complement our commercial build-out illustrating our commitment to scaling U.S. operations. Thank you very much.
Marvin: Domestic production will enable us to meet market demand efficiently, while also providing a diversified supply chain in the face of macroeconomic uncertainty.
Marvin Slosman: I was able to witness the excitement of our technology firsthand a few weeks ago at the Charing Cross International Symposium in London. The focus on the carotid intervention and groundswell around our technology was palpable, with great interest in our booth, both from physicians already using C-Guard and from those who are just learning of our story and want to be involved, including prominent U.S. doctors. Additionally, there were about five hours of carotid programming, plus two fully subscribed CAST hands-on workshops, and a tremendous shift in focus from prior years. Contingent upon U.S. approval, we believe we are exceptionally well positioned to meet robust demand for Seaguard Prime.
Marvin: I was able to witness the excitement of our technology first hand a few weeks ago at the Charing Cross International Supposium in London. The focus on the crotted intervention and ground swell around our technology was palpable.
Marvin: With great interest at our booth, both from physicians already using C guard and from those who are just learning of our story and want to be involved, including prominent US doctors.
Marvin: Additionally, there were about five hours of carotid programming plus two fully-subscribed cast hands-on workshops and a tremendous shift in focus from prior years.
Marvin: Contingent upon U.S. approval, we believe we are exceptionally well positioned to meet robust demand for Seagard Prime. With the infrastructure, expertise, operational readiness we've built, we're confident in our ability to drive significant and sustained success in the U.S. market.
Marvin Slosman: With the infrastructure, expertise, operational readiness we've built, we are confident in our ability to drive significant and sustained success in the U.S.
Marvin Slosman: market.
Marvin Slosman: Shifting to our clinical pipeline, where we continue to make strong progress. As a reminder, in October 2024, we received FDA approval for our Investigational Device Exemption, or IDE, application to begin the C-Guardians II Pivotal Study of our C-Guard Prime Carotid Stent System and TCAR procedures. This important study is designed to evaluate the safety and effectiveness of our novel Cigar Prime Stent platform in a short TCAR-indicated version compatible with existing commercially available neuroprotection systems. I'm pleased to share our enrollment remains strong and growing, with new sites participating and contributing, and we remain on track to achieve our clinical milestones with an anticipated first half of 2026 approval.
Marvin: Shifting to our clinical pipeline where we continue to make strong progress. As a reminder, in October 2024 received FDA approval for our Investigational Device Exemption or IDE application to begin the Sea Guardian's two pivotal study of our Sea Guard of the Prime Crotted Stent System in T-Carp Procedures.
Marvin: This important study is designed to evaluate the safety and effectiveness of our novel Seagard Prime Stand platform in a short T-car-indicated version compatible with existing commercially available neuroprotection systems.
Marvin: I'm pleased to share our enrollment remain strong and growing with new sites participating and contributing and we remain on track to achieve our clinical milestones with an anticipated first half of 2026 approval.
Marvin Slosman: At the same time, we're advancing our broader TCAR strategy, we're engaged with FDA and our C-Guardian III IDE submission, which will study our fully integrated TCAR solution, pairing the C-Guard Prime 80 stent with our proprietary SwitchGuard neuroprotection system. We anticipate approval and initiation of our study in Q3, with possible FDA clearance in late 2026. as we advance our TCAR focus with next generation switchguard kit design. TCAR represents a significant and growing opportunity with more than 30,000 procedures performed annually in the U.S. As we expand our clinical footprint, we're building a differentiated, comprehensive solution for carotid revascularization, one we believe can meaningfully reshape the market and drive long-term growth.
Marvin: At the same time, we're advancing our broader T-car strategy, we're engaged with FDA and our C-Guardians 3 IDE submission, which will study our fully integrated T-car solution, pairing the C-Guard Prime AD Stint with our proprietary switch gardener protection system.
Marvin: We anticipate approval and initiation of our study in Q3 with possible FDA clearance in late 2026 as we advance our T-car focus with next generation switch guard kit designs. Thank you very much.
Marvin: Tico represents a significant and growing opportunity with more than 30,000 procedures performed annually in the US.
Marvin: As we expand our clinical footprint, we're building a differentiated, comprehensive solution for carotid revascularization. One we believe can meaningfully reshape the market and drive long-term growth.
Marvin Slosman: Turning now to our other clinical initiatives, we're excited to announce that we have successfully enrolled the first four patients in our tandem lesion early feasibility study. This study, conducted in partnership with Dr. Adnan Siddiqui and the Jacobs Institute in Buffalo, New York, focuses on evaluating C-guard prime stent in acute stroke patients with tandem lesions in conjunction with thrombectomy. As a reminder, the Seaguard's prime stent features a proprietary Micronet mesh, which is designed to provide superior embolic protection during carotid artery stenting. We believe this study will demonstrate the safety and feasibility of using our stent in these acute stroke procedures.
Marvin: Turning now to our other clinical initiatives, we are excited to announce that we have successfully enrolled the first four patients in our tandem lesion early feasibility study.
Marvin: This study conducted in partnership with Dr. Adnan Sidiqi and the Jacobs Institute in Buffalo, New York focuses on evaluating C-Guard Prime of Stent and acute stroke patients with tandem lesions in conjunction with from back to me.
Marvin: As a reminder, the C-Gards Prime Stent features a proprietary micronet mesh, which is designed to provide superior and ball of protection during corroded artery stenting. We believe the study will demonstrate the safety and feasibility of using our stent and basic huge stroke procedures.
Marvin Slosman: This investment reflects our deep commitment to the neurovascular community and underscores a critical component of our long-term growth strategy. Our ongoing focus of both CAS and TCAR technology positions us to serve the broadest physician base. while also preparing us to lead as procedural reimbursement and clinical practice increasingly shift toward an endovascular first standard of care.
Marvin: This investment reflects our deep commitment to the neurovascular community and underscores the critical component of our long-term growth strategy. Our ongoing focus of both CAS and T-CAR technology positions us to serve the broadest position in base.
Marvin: while also preparing us to lead as procedural reimbursement in clinical practice increasingly shift toward an endovascular first standard of care.
Marvin Slosman: As a reminder, receipt of premarket approval from the FDA would trigger the second of four milestone-based financing tranches, pursuant to the transformational private placement of up to $113.6 million that we originally announced in May of 2023. If fully exercised, the second tranche would raise an additional $17.9 million in gross proceeds. After premarket approval, the remaining two milestones would each trigger additional tranche financings, including the receipt of FDA clearance of SwitchGuard TCAR Neuroprotection System, along with the TCAR indication for the C-Guard Prime stent, and the completion of four full fiscal quarters of commercial sales of C-Guard Prime in the United States, which we anticipate in the back half of 2026, pending the approvals I mentioned earlier and based on our current plan.
Marvin: As a reminder, receipt of pre-market approval from the FDA would trigger the second of four milestone based financing tranches pursuant to the transformational private placement of up to $113.6 million that we originally announced in May of 2023.
After pre-market approval, the remaining two milestones.
Marvin: with each trigger additional trance and assings including the receipt of FDA clearance of switch guard T-carpet neuroprotection system.
Marvin: along with the T-Car indication for the C-Guard Prime Stent in the completion of four full fiscal quarters of commercial sales of C-Guard Prime of the United States, which we anticipate in the back half of 2026 pending the approvals I mentioned earlier and based on our current plans.
Marvin Slosman: For more information visit www.fda.gov This quarter has positioned us to hit the ground running as we move toward these transformational miles.
Craig Shore: Now, I'll turn the call over to Craig to walk through the financials. Craig. Thank you, Marvin. For the first quarter of 2025, total revenue increased 1.2% to $1,529,000. This increase was driven by growth in existing markets, offset by the impact of foreign exchange and distributors managing Seaguard inventory levels in anticipation of Seaguard Prime approval in Europe. Gross profit for the first quarter of 2025 of $292,000 was flat compared to the first quarter of 2024. Gross margin during the three months ended March 31st, 2025 was 19.1%.
Marvin: Thank you Marvin for the first quarter of 2025 total revenue increased 1.2% two $1.529 million. This increase was driven by growth in existing markets offset by the impact of foreign exchange and distributors managing.
Marvin: <unk> inventory levels in anticipation of CCAR prime approval in Europe.
Marvin: <unk> profit for the first quarter of 2025 of $292000 was flat compared to the first quarter of 2024.
Marvin: <unk> margin during the three months ended March 31, 2025 was 19, 1%.
Marvin: Total operating expenses for the first quarter of 2025 were $11 million $752000, an increase of $4 million or 52, 5% compared to $7.706 million for the first quarter of 2024. This increase was.
Craig Shore: Total operating expenses for the first quarter of 2025 were $11,752,000, an increase of $4,000,000 or 52.5% compared to $7,706,000 for the first quarter of 2024. This increase was primarily due to higher salaries and share-based compensation tied to U.S. sales force expansion ahead of FDA approval. Additional increases stemmed from Seegar Prime launch preparation, U.S. facility rent, and CFL recruitment fees.
Marvin: Primarily due to higher salaries and share based compensation tied to U S. Sales force expansion ahead of FDA approval additional increases stemmed from CCAR Prime launch preparation U S facility rent and CFO recruitment fees.
Craig Shore: Total financial income for the first quarter of 2025 was $294,000, a decrease of $88,000 or 23% compared to $382,000 for the first quarter of 2024. This decrease was primarily due to less interest income from investments in marketable securities and money market funds.
Marvin: Total financial income for the first quarter of 2025 was $294000, a decrease of $88000 or 23% compared to $382000 for the first quarter of 2024. This decrease was primarily due to less interest income.
Marvin: From investments in marketable securities and money market funds.
Craig Shore: Net loss for the first quarter of 2025 totaled $11,166,000 or $0.22 per basic and diluted share compared to a net loss of $7,032,000 or $0.21 per basic and diluted share for the same period in 2024.
Marvin: Net loss for the first quarter of 2025 totaled $11.166 million or 22 cents per basic and diluted share compared to a net loss of $7 million $32000 or 21 cents per basic and diluted share for the same period in two.
Marvin: And in 'twenty four.
Craig Shore: As of March 31st, 2025, cash and crash equivalents and marketable securities were $26,086,000 compared to $34,637,000 as of December 31st, 2024.
Marvin: As of March 31, 2025, cash and cash equivalents in marketable securities were $26.086 million compared to $34 million $637000 as of December 31, 2024.
Unknown Executive: This concludes our pre-prepared remarks.
Marvin: This concludes our prepared remarks, we will now open the call for questions for the Q&A segment, we will be joined by Shang Gleason inspire Mb's Chief commercial officer operator.
Unknown Executive: We will now open the call for questions for the Q&A segment.
Operator: We will be joined by Shane Gleason, InspireMD's Chief Commercial Officer Operator. Thank you. At this time, if you'd like to ask a question, please press the star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. And once again, that is star 1 to take a question.
Speaker Change: Thank you at this time, if you'd like to ask a question. Please press star one on your telephone keypad, you may remove yourself from the queue at any time by pressing star two and one.
Speaker Change: Once again that is star one to take a question we will take our first question from Adam <unk> with Piper Sandler. Please go ahead.
Adam Maeder: We'll take our first question from Adam Maeder with Piper Sandler. Please go ahead. Hi, good morning, Marvin, Shane, Craig, thank you for taking the questions.
Adam: Hi, Good morning, Marvin Shannon Craig. Thank you for taking the questions. Just a couple from me and really kind of wanted just.
Marvin Slosman: Just a couple for me and really kind of wanted just to level set on timelines for the different products and, you know, maybe just starting with C-Guard Prime, your transformal stents, and just FDA approval. It looks like maybe a little bit of a pushout on anticipated FDA approval now to Q3. So, you know, what's the primary reason for this slight change in timing? You know, certainly realize it's unique times at the agency, but wanted to get some more color there. Just level of confidence that you'll get across the regulatory goal line in Q3 and maybe just flesh out the, you know, the latest dialogue with FDA and kind of what's left to do from your side, if anything.
Speaker Change: Level set on timelines for the different products and maybe just starting with CCAR Brian.
Speaker Change: Youre transdermal stance and just FDA approval, it looks like maybe a little bit of a pushout anti.
Speaker Change: The anticipated FDA approval now to Q3.
Speaker Change: So whats the primary reason for the slight change in timing certainly realize its unique times at the agency but.
Speaker Change: Wanted to get some more color there.
Speaker Change: This level of confidence that youll get across the regulatory goal line in Q3, and maybe just flesh out.
Speaker Change: The latest dialogue with FDA and kind of what's left to do from your side, if anything and then I had a follow up or two thanks.
Adam Maeder: And then I had a follow-up or two. Thanks.
Marvin Slosman: Great, thanks, Adam, and good morning. I think it's important to level set the context that in June of 2024, we submitted Module 3 of our PMA, which is the site inspection component, and subsequently, we filed the final PMA dossier on September the 16th. So, following the submission, we maintained active engagement with the FDA, including a successfully completed 100-day meeting. That key milestone obviously underscores the strength of our submission, and we've remained very interactive with the agency since that time. The facility site audit, unfortunately, could not be scheduled until February of 2025 and was only complete on February 18th, so less than a month before this 180-day statutory review deadline.
Speaker Change: Great. Thanks, Adam and good morning, I think it's important to level set the context that in June of 2024, we submitted module three of our PMA, which is the site inspection component and subsequently we filed the final PMA dossier on September the 16th.
Speaker Change: So following the submission we maintained active engagement with the FDA, including successfully completed 100 day meeting.
Speaker Change: The key that key milestone, obviously underscores the strength of our submission and we remain very interactive with the agency since that time.
Speaker Change: The facility site audits, Unfortunately could not be scheduled until February of 'twenty, five and was only complete on February 18th so less than a month before this 180 day statutory review deadline.
Marvin Slosman: And so, the subsequent time required for FDA's feedback on responses and the necessary follow-up has just compressed that window for final approval. We continue to engage interactively with FDA on the feedback and responses to the observations from the audit and continue to be very confident in the approval. We're simply building some room into the approval timeline to accommodate these final steps, which, given the current situation, as you noted, we believe is a prudent step to take. So, I think on balance, the simple answer is that we're very engaged with FDA and we feel that we're on top of all the remaining details and topics, but we believe, given the current circumstances, Statutory response times and otherwise we wanted to build in some some additional room That's a really helpful color.
Speaker Change: And so the subsequent time required for FDA feedback our responses and the necessary follow up is just compressed that window for final approval.
Speaker Change: We continue to engage interactively with FDA on the feedback and responses to the observations from the audit and continue to be very confident in the approval. We're simply building some room into the approval timeline to accommodate these final steps, which given the current situation as you. As you noted we believe is a prudent step to take.
Speaker Change: So I think on balance the simple answer is is that we're very engaged with the FDA and we feel that we're on top of all the remaining details and topics, but we believe given the current circumstances.
Speaker Change: Statutory response times and otherwise we wanted to build in some some additional room.
unknown: That's really helpful color I appreciate all that Marvin.
Adam Maeder: Appreciate all that, Marvin. Thank you.
Speaker Change: Thank you and.
Adam Maeder: And, you know, I guess for the follow ups, just You know, wanted to see if we could get some more color on enrollment progress in Sea Guardians 2. It sounds like that's still tracking to first half 26. FD approval. I think I heard that in the prepared remarks. But yeah, just maybe many, just any more color you can provide in terms of, you know, enrollment and at trial and kind of how things are going. And then I had one more follow up. Sure. Thanks, Adam. Enrollment is going remarkably well. Most importantly, there's tremendous enthusiasm for the users of C-Guard Prime, in this particular case, vascular surgeons who are using the product for the first time.
Speaker Change: I guess for the follow ups just.
Speaker Change: Wanted to see if we could get some more color on enrollment progress and see guardians too it sounds like that's still tracking first half 'twenty six.
Speaker Change: FDA approval I think I heard that in the prepared remarks, but.
Speaker Change: Just maybe just any more color you can provide in terms of.
Speaker Change: Enrollment in that trial and kind of how things are going and then I had one more follow up thanks.
Adam: Sure. Thanks, Adam enrolment is going remarkably well. Most importantly, there is tremendous enthusiasm for the users of Hep C Guard Prime in this particular case vascular surgeons, who are using the product for the first time the long pole in the <unk> was obviously a lot of administrative work building the number of sites and getting them.
Marvin Slosman: Yeah, the long pole in the tent was obviously a lot of administrative work, building the number of sites and getting them online and active. We have 8 active sites currently. And so the cadence of enrollment continues to progress really nicely, and we believe will remain consistent with all those approvals that we've previously discussed. But, as is always the case, 1 aspect is to perform a well executed trial. Most importantly, the feedback from the doctors has been resoundingly positive and enthusiastic about ultimately being able to use this device in TCAR procedures, which has been long overdue in many of their minds.
Adam: Online and active we have eight eight active sites currently.
Adam: And so the cadence of enrollment continues to progress really nicely and we believe will remain consistent.
Adam: With all those approvals that we've previously discussed but as is always the case one aspect is to perform a well a well executed trial. Most importantly, the feedback from the doctors it's Ben.
Adam: <unk> positive and enthusiastic about ultimately being able to use this device in CCAR procedures, which has been long overdue and many of their minds. So we're we're very enthusiastic on every level and continue to maintain our pace there.
Adam Maeder: So we're very enthusiastic on every level and continue to maintain our pace there. Okay, perfect. Good color there.
Speaker Change: Okay perfect. Good color there and just one last one from me and then I'll jump back in queue.
Adam Maeder: And just one last one for me and then I'll jump back in queue. Just wanted to discuss switch guard and you know, the update there. So, it sounds like you're engaged with FDA regarding Sea Guardians 3 submission. Hopefully, I heard that right. I did hear possible clearance in late 2026 for U.S. Is that a little bit of a wiggle, Marvin? Because in my notes, I had mid-26 approval for SwitchGuard. So, did we have a little bit of a slide to timelines? And if so, what's driving the revised timeline there? Thank you.
Speaker Change: Just wanted to discuss switched garden.
Speaker Change: The update there.
Speaker Change: So it sounds like you're engaged with FDA regarding C. Guardians resubmission hopefully heard that right.
Speaker Change: I did hear possible clearance in late 2026 for U S.
Speaker Change: Is that a little bit of a wiggle Marvin in my notes I had mid 26 approval for switch guard.
Speaker Change: So did we have a little bit of a slide to timelines.
Speaker Change: If so what's driving the revised timeline there. Thank you.
Marvin Slosman: Yeah, thanks, Adam. To answer that question specifically, we have resubmitted our IDE to FDA and expect approval on that in the next month or so, so that we can begin enrollment. At this point, we're calling late 26 clearance for the device, and some of that is just driven by the enrollment process, obviously, which is still somewhat undetermined. Until we get formal feedback from FDA, so I think that that window remains the right one to take, which is late 26 clearance for the device there. Thank you.
Speaker Change: Yeah. Thanks, Adam to answer that question, specifically, we have resubmitted, our IV the FDA and expect approval on that job in the next month or so so that we can begin enrollment.
Speaker Change: At this point, we're calling.
Speaker Change: Late 'twenty six clearance for the device and some of that is just driven by the enrollment process, obviously, which is still somewhat undetermined.
Speaker Change: Until we get formal feedback from FDA. So I think that window remains the right one to take which is late 'twenty six clearance for the device there.
Speaker Change: Thank you.
Speaker Change: Thank you.
Frank Takkinen: We'll take our next question from Frank Takkinen with Lake Street Capital, please go ahead. Great. Thanks for taking the questions. And maybe I'll kind of follow up on Adam's first question related to CERs and growth time in Q3. It sounds like it's really just related to a matter of timing, but just given some of the cost cuts in the FDA and some of the layoffs there, I just wanted to check one more time on, have you had any change to your review team? Has there been any feedback that's been coming slower, or is this really just things are just taking a little bit anticipated, but the team still remains intact and we're still in good shape from an interaction perspective with the FDA?
Speaker Change: We will take our next question from Frank <unk> with Lake Street Capital. Please go ahead.
Frank: Great. Thanks for taking the questions and maybe I'll follow up on Adam's.
Speaker Change: Adam first question related to <unk> in Q3, it sounds like it's really just related to a matter of timing, but just given some of the key.
Speaker Change: Cost cuts and the FDA and some of the layoffs. There just wanted to check one more time on have you had any change to your view team has there been any.
Speaker Change: Feedback that's been coming slower or is this really just things are just taking a little bit longer than anticipated, but the team still remains intact and we're still in good shape from a interaction perspective with the FDA.
Marvin Slosman: Frank, good morning. Thanks for the question. So I would characterize it this way. Everything that we have been progressing on related to FDA, including the lead enroller, or I'm sorry, the lead administrative contacted FDA remains consistent. And in fact, we're very positive and continually interactive with that group. The follow up that that's required is from the audit, which is a different group within FDA. And so just the combination of being able to communicate these this information back and forth and provide all the evidence from the results of that audit, you know, continue to create time.
Speaker Change: Frank Good morning, Thanks for the question. So I would characterize it this way everything that we have been progressing on related to FDA, including the lead and roller or I'm sorry, the lead administrative contacted FDA remains consistent and in fact were very positive and continually interactive what that grew.
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Speaker Change: The follow up that Thats required as from the audit, which is a different group within FDA.
Speaker Change: So.
Speaker Change: Just the combination of being able to communicate these.
Speaker Change: This information back and forth and provide all the evidence from.
Speaker Change: The results of that audit.
Speaker Change: <unk> to create time.
Marvin Slosman: And so the disruptions in the FDA have clearly, you know, impacted to a certain extent the overall program. But I would say within the context of our submission, we remain confident that everything is on track. However, as you know, there's statutory requirements for certain timelines of responsiveness and otherwise. We've completed all of our evidence and responses, and we're just trying to build in a reasonable bandwidth there in order to get that feedback processed and assimilated, given, you know, circumstances and resources and just being prudent about the timeline.
Speaker Change: And so the disruptions of the FDA have clearly impacted to a certain extent the overall program, but I would say within the context of of our submission. We remain confident that everything is on track. However, as you know there are statutory requirements for certain timelines of responsiveness and otherwise we've completed all of our evidence.
Speaker Change: Where sponsors and we're just trying to build in a reasonable.
Speaker Change: Bandwidth there in order to get that feedback processed and assimilated given circumstances in resources and just being prudent about the timeline.
Speaker Change: Okay.
Frank Takkinen: Okay, that's helpful.
Speaker Change: Okay. That's helpful. And then I wanted to ask one commercial organization related obviously, you guys have been ramping up.
Marvin Slosman: And then I wanted to ask one commercial organization related. Obviously, you guys have been ramping up a really high quality team in the in the last couple quarters in advance of the trial. How should we kind of think about your cadence of hiring with in light of some of the FDA commentary? Should we expect you to maybe moderate that a little bit until you get the approval? And how does that kind of maybe impact models as we're thinking about operating expense throughout the year?
Speaker Change: A really high quality team.
Speaker Change: And the last couple of quarters in advance of the trial, how should we kind of think about your cadence of hiring with in light of some of the the FDA commentary should we expect you to maybe moderate that a little bit until you get the approval and how does that maybe impact our models as we're thinking about operating expense throughout the year.
Speaker Change: I'll take the first pass on that and we've got Shane on the line and I'm sure. He can add some additional color I think we've established a tremendous foundation within the commercial organization, thus far and are building a team of professionals that we think can launch the product very effectively we always architected. This plan around that.
Marvin Slosman: I'll take the first pass on that we've got Shane on the line and I'm sure he can add some additional color. I think we've established a tremendous foundation within the commercial organization thus far, and are building a team of professionals that we think can launch the product very effectively. We always architected this plan around the consistency of the timelines that we just noted. I mean, clearly, we want to be very prudent about how fast we add additional resources. But I think in terms of our establishment of architecting the right people in the right places, given the timeline and the launch sequence and our intention to aggressively launch the product into the market, we feel very comfortable that we've, we've got the right start and the right foundation and certainly we'll keep a close eye on next classes that are added to our training program.
Speaker Change: Consistency of the timelines that we just noted I mean clearly.
Speaker Change: We want to be very prudent about how fast we add additional resources.
Speaker Change: But I think in terms of our establishment of architects the right people in the right places given the timeline and the launch sequence and our intention to aggressively launch the product into the market. We feel very comfortable that we've got the right start and the right Foundation and certainly we will keep a close eye on next classes that are.
Speaker Change: <unk> added to our training program, maybe Shane can add additional to that.
Shane Gleason: Maybe Shane can add additional to that. Yeah, I think that's exactly right.
Shane: Yes, I think thats exactly right and good morning, Frank.
Shane Gleason: And good morning, Frank. The plan has been to get the the foundation built, training, marketing, sales operations, and the foundational members of the of the field team, and then to be able to scale in earnest upon approval. So that all remains unchanged. Perfect. That's helpful.
Shane: The plan has been to get the the foundation built training marketing sales operations and the foundational members of the of the field team and then to be able to scale in earnest upon approval. So that all remains unchanged.
Shane: Perfect.
Frank Takkinen: And then maybe one related to Crest 2. I know it's come up on conference calls in the past, but I think we're looking for a read out of that trial in the second half of 2025. So maybe kind of help us or maybe reiterate how you think that that could go and different market impacts we could see from that.
Shane: That's helpful. And then maybe one related to cross two I know it's come up on conference calls in the past, but I think we're.
Shane: Looking for a readout of that trial in the second half of 2025.
Shane: You kind of help us or maybe reiterate how you think that could go in different market impacts we could see from that.
Shane: So things that come our crest to expert in the organization not to put him on the spot, but maybe I'll, let let Jim take that one if you don't mind.
Shane Gleason: So Shane's become our Crest 2 expert in the organization, not to put him on the spot, but maybe I'll let Shane take that one, if you don't mind. I'd be happy to. So the enrollment's been completed. Just as a reminder, CREST-2 is really two separate trials. One was randomizing optimized medical therapy against carotid endarterectomy. And then a separate enrolling trial was randomizing optimized medical therapy to carotid stenting. And in both of those intervention parts, surgery and stenting, the patients also received optimal medical therapy. And as I'm starting to hear this quite a bit from the podium at the conferences, the tone seems to be that it all depends, what the results look like all depends on the types of patients that are enrolled.
Jim: Yes, I'd be happy too. So the enrollment has been completed just as reminder, crest. Two is really two separate two separate trials one was randomized <unk> optimized medical therapy against carotid endarterectomy.
And then a separate separate enrolling trial was randomized <unk> optimized medical therapy to carotid stenting and in both of those intervention surgery and stenting. The patients also received optimal medical therapy.
Jim: So I'm starting to hear this discussed quite a bit from.
Jim: From the podium at the conferences the of the tone seems to be that.
Jim: It all depends what the results look like all depends on the types of patients that are enrolled.
Shane Gleason: If a lot of patients who are unlikely to have strokes are enrolled, patients with less severe disease, then there won't be many strokes to prevent, and the intervention won't likely be overwhelmingly positive or superior there. Again, if you're treating patients who are unlikely to have strokes within the follow-up window, there won't be as many strokes to prevent, so the curves won't be able to diverge. However, if patients that have more severe disease are enrolled time and time again in the studies, those patients are shown to have events if they're not intervened upon. And if the patients who were enrolled had more severe disease, then that's going to look more and more positive for the intervention arms. So I think we're all kind of waiting to see what the results are.
Jim: A lot of patients who are unlikely to have strokes are enrolled patients with less severe disease.
Jim: Ed.
Jim: There won't be many strokes to prevent and the intervention.
Jim: Likely be overwhelmingly positive or superior there again, if youre treating patients who are unlikely to have strokes within the within the follow up window.
Jim: There wont be as many strokes to prevent said the curves won't be able to diverge. However, if patients that have more severe disease are enrolled time and time again to this study as those patients are shown to have events, if theyre not intervened upon.
Jim: And.
Jim: If the patients who were enrolled had more severe disease, that's going to look more and more positive for the interventional arms.
Jim: So I think we're all kind of waiting to see what the what the results are there will be subset analysis and I think the expectations are that it won't change practice much because.
Frank Takkinen: There will be subset analysis, and I think the expectations are that it won't change practice much because The less severe patients are the ones in practice, although the guidelines may allow treatment in practice, they typically are not treated until the disease gets more severe. So I think the tone that I hear from the meetings is a lot of people kind of expect it to tell us exactly what we already know and not change practice in any meaningful way. Got it. That's helpful. Thank you. I'll stop there.
Jim: The less severe patients are the ones in practice, although the guidelines may allow treatment in practice. They typically are not treated until the disease gets more severe.
Jim: So I think the.
Jim: The tone that I hear from the meetings, there's a lot of people kind of expect it to tell us exactly what we already know and not change practice in any meaningful way.
Jim: Got it that's helpful. Thank you I'll stop there.
Speaker Change: Thank you and that does conclude our question and answer session I would now like to turn the call back to Marvin's Hoffman for closing remarks. Please go ahead.
Unknown Executive: Thank you and that does conclude our question and answer session.
Marvin Slosman: I'd now like to turn the call back to Marvin Slosman for closing remarks. Yeah, thank you very much. I'd like to thank everyone for joining the call and for the ongoing support of our mission to lead the carotid revascularization market at InspireMD. We're very pleased with our execution in Q1 of 2025 and look forward to the many milestones ahead, including potential M&A US approval and launch of C-Guard Prime. Thanks very much.
Speaker Change: Yes. Thank you very much I'd like to thank everyone for joining the call and for the ongoing support of our mission to lead the carotid revascularization marketed inspire empty. We're very pleased with our execution in Q1 of 2025 and look forward to the many milestones ahead, including potential emanate U S approval and launch of <unk> Prime Thanks very much.
Operator: Thank you and this concludes today's program. Thank you for your participation. You may disconnect at any time.
Speaker Change: Thank you and this concludes today's program. Thank you for your participation you may disconnect at any time.
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Unknown Executive: Sean Hill goes to prison just because Claire Loulin got on to him with a thunder worm gate.
Speaker Change: Okay.