Q1 2024 InspireMD Inc Earnings Call

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Operator: Greetings and welcome to the InspireMD First Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. The brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chuck Padilla. Thank you, sir. You may begin.

Speaker Change: Greetings and welcome to the inspire M D first quarter 'twenty 'twenty four earnings call.

Speaker Change: At this time all participants are in a listen only mode.

Speaker Change: A brief question and answer session will follow the formal presentation.

Operator: If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

Operator: As a reminder, this conference is being recorded.

Speaker Change: Now my pleasure to introduce your host Chuck put dollar. Thank you Sir you may begin.

Chuck Padilla: Thank you, operator, and good morning everyone. Thank you for joining us for the InspireMD first quarter financial results and corporate update conference call. Joining us today from InspireMD are CEO Marvin Schlossman and CFO Craig Shore. 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.

Operator: Thank you operator, and good morning, everyone.

Speaker Change: Thank you for joining us for the inspire M D first quarter financial results and corporate update conference call.

Chuck Padilla: 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 or any updates in our corporate reports on Form 8-K filed with the U.S. Securities and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. This call contains time-sensitive information that is accurate only as of today, Tuesday, May 14, 2024. 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 CEO Marvin Slossman. Go ahead, Marvin, please. Thank you, Chuck.

Speaker Change: Joining us today, it's been inspiring D. Our CEO, Marvin Ellison and CFO Craig shore.

Management: 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.

Management: These forward looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward looking statements.

Management: For more information about these risks please refer to the risk factors described in inspire and <unk>. Most recently filed periodically sports and Form 10-K, and Form 10-Q or any updates that are corporate reports on form 8-K filed with the U S Securities and Exchange Commission and expire in this press release that accompanies this call.

Speaker Change: Particularly the cautionary statements made in it.

Speaker Change: This call contains time sensitive information that is accurate only as of today Tuesday may 14th 2024.

inspire: Except as required by law inspire indeed disclaims any obligation to publicly update or revise any information to reflect events or circumstances that a car. After this call.

inspire: It's now my pleasure to turn the call over to CEO Marvin Swanston go ahead Martin please.

Marvin Slossman: Thank you, Chuck, and thanks to everyone for joining our call this morning. I'm pleased to report that during the first quarter of 2024, we were able to sustain the momentum with which we exited 2023 as we advanced toward our mission to be a leader in the carotid revascularization market with our best-in-class C-guard carotid stent platform. Craig will cover the financials shortly, but I wanted to touch on a few highlights from our first quarter performance.

Martin: Thank you Chuck and thanks to everyone for joining our call. This morning.

Martin: I'm pleased to report that during the first quarter of 2024, we were able to sustain momentum with which we exited in 2023 as we advance toward our mission to be a leader in the carotid Revascularization market, our best in class C Guard carotid stent platform.

Craig Shore: Craig will cover the financials, shortly but I wanted to touch on a few highlights from our first quarter performance we.

Marvin Slossman: We generated total SeaGuard revenue of $1.5 million, representing growth of nearly 22% over the $1.2 million that we reported in the first quarter of 2023. With our formal recertification under MDR now granted, we've de-risked this topic and removed uncertainty in our ability to continue to sell in EU-certified countries while also enabling our product development pipeline provided under MDR as we continue to build our OUS markets in parallel with our growing U.

Craig Shore: We generated total <unk> revenue of $1 $5 million, representing growth of nearly 22% over $1 $2 million that we reported in the first quarter of 2023.

Craig: With our formal recertification under M. D are now granted we've derisked this topic and removed uncertainty and our ability to continue to sell an EU certified countries. While also enabling our product development pipeline provided under M. D. R. As we continue to build our O U S markets in parallel with our growing U S focus.

Marvin Slossman: We sold 2,553 Seaguard stents during the first quarter of 2024, representing growth of 25.6% over the 2,033 stents sold during the first quarter of 2023. Our real-world experience with SeaGuard now exceeds 50,000 stents sold to date. Turning now to our ongoing SeaGuardians Pivotal US trial, which is evaluating the safety and efficacy of the SeaGuard carotid stent system for the treatment of carotid arterial stenosis. As a reminder, the primary endpoint of this trial is a composite of the incidence of major adverse events including death, all-cause mortality, any stroke or myocardial infarction, abbreviated as DSMI, through 30 days post-index procedure or ipsilateral stroke from day 31 to day 365 post-procedure.

Craig Shore: We sold 20 553 CCAR extends during the first quarter of 2024, representing growth of 25, 6% over the 2033 sand sold during the first quarter of 2023.

Speaker Change: Our real world experience with <unk> now exceeds 50000 extent sold to date.

Speaker Change: Turning now to our ongoing C Guardians pivotal U S trial, which is evaluating the safety and efficacy of the sea guard carotid stent system for the treatment of carotid arterial stenosis.

Speaker Change: As a reminder, the primary endpoint of this trial is a composite of the incidence of major adverse events, including death, all cause mortality and stroke or myocardial infarction, abbreviated as D. Semi through 30 days post index procedure or ipsilateral stroke from day 31 day 365 post proceed.

Craig Shore: <unk>.

Marvin Slossman: Between July 2021 and June 2023, 316 patients were prospectively enrolled in this single-arm study performed at 24 sites in the U.S. and Europe, utilizing the SeaGuard carotid stent system, including our next-generation SeaGuard Prime platform. We recently announced that an abstract of the one-year outcomes from SeaGuardians has been accepted for presentation at the Leipzig Interventional Course 2024, also known as LINC, which will be presented by Dr. Chris Metzger, System Vascular Chief at OhioHealth and Lead Investigator of the study. This presentation is scheduled for May 28th in Leipzig, Germany.

Speaker Change: Between July 2021 and June 2023, 316 patients were prospectively enrolled in the single arm study performed at 24 sites in the U S and Europe utilizing the SEDAR carotid stent system, including our next generation C Guard Prime platform.

Speaker Change: We announced recently an abstract of the one year outcomes from C. Guardians has been accepted for presentation at the Leipzig Interventional course, 2024 also known as link which will be presented by Dr. Chris Metsker system vascular cheap at Ohio Health and lead investigator of this study this.

Speaker Change: This presentation is scheduled on may 28th in Leipzig, Germany.

Marvin Slossman: Recall that the 30-day follow-up from the trial was presented in the fall of 2023 at VIVA, which demonstrated all-cause mortality, death, stroke, and myocardial infarction rates of just 0.95 percent in the intent-to-treat analysis population and 0.63 percent in the per-protocol analysis population. We believe results like these have the potential to position C-Guard with our innovative Micronet® mesh to be the gold standard Assuming the 12-month results are positive, we will be on track to submit a premarket approval application, or PMA, later this year while continuing to prepare for a U.S. commercial launch in the first half of 2025, if approved. This timeline is unchanged from our prior guidance.

Speaker Change: Recall, the 30 day follow up from the trial was presented in the fall of 2023 at Veeva, which demonstrated all cause mortality.

Speaker Change: Stroke, and myocardial infarction rate of just point, 95% in the intent to treat analysis population and 0.63% in the per protocol analysis population. We believe results like these have the potential to position see guard with our innovative microneedle mesh to be the gold standard in carotid implant.

Speaker Change: <unk>.

Speaker Change: Assuming the 12 month results are positive we would be on track to submit a pre market approval application or PMA. Later this year, while continuing to prepare for U S. Commercial launch in the first half of 2025. If approved this timeline is unchanged from our prior guidance.

Marvin Slossman: It's also worth noting that 12-month outcomes data from Sea Guardians would trigger the first tranche of the transformational financing of up to $113.6 million we announced last May. Recall that per the terms of the private placement, which was led by Marshall Wace, with participation from Orvimed, Rosalind, Nanohala, Solius, Vellon, and CERN InspireMD board members, we received $42.2 million up front, with four tranches of $17.9 million, each tied to the exercise of warrants upon achievement of pre-specified milestones, the first of which is the public release of primary and secondary endpoints related to one-year follow-up study results from the Sea Guardians Pivotal Trial.

C. Guardians: It's also worth noting that 12 month outcomes data from C. Guardians would trigger the first tranche of the transformational financing of up to $113 $6 million, we announced last may.

Speaker Change: Call that per the terms of the private placement, which was led by Marshall wace with participation from more humid roslyn nonalcoholic solely us villain in certain inspire and D. Board members, we received $42 2 million upfront with four tranches of $17 9 million each tied to the exercise of warrants upon achievement of pre specify.

Marshall Wace: <unk> milestones the first of which is the public release of primary and secondary endpoints related to a one year follow up study results from the sea Guardians pivotal trial.

Marvin Slossman: As a brief reminder, the remaining three milestones that would potentially trigger subsequent funding tranches are the announcement of receipt of premarket approval, PMA, from the FDA for the SeaGuardian's prime carotid stent system, which we've targeted for the first half of next year, receipt of FDA clearance for the SwitchGuard T-CAR kit to include our SeaGuard Prime stent, and the completion of four quarters of commercial Our plan to study and submit our SwitchGuard Neuroprotection System, Accessory Kit, and Seaguard TCAR-compatible stent platform remains on track and, if cleared, will enable our offering of a complete TCAR toolset with next-generation enhancements, including the best-performing Seaguard Prime implant.

Marshall Wace: As a brief reminder, the remaining three milestones that would potentially trigger subsequent funding tranches or the announcement of receipt of the pre market approval PMA from the FDA for the sea Guardians Prime carotid stent system, which we've targeted for the first half of next year receipt of FDA clearance for the switch Guard T car kit to <unk>.

Speaker Change: <unk>, our CCAR Prime stent and the completion of four quarters of commercial sales of C Guard in the United States, which we anticipate in the back half of 2026 or.

Speaker Change: Our plan to study and submit our switch Gardner protection system accessory kit and CCAR T car compatible stent platform remains on track and if cleared we will enable our offering a complete T car toolset with next generation enhancements, including the best performing Segar Prime implant.

Marvin Slossman: As a reminder, the SwitchGuard NPS is designed to prevent embolic debris generated during a carotid stenting procedure from traveling to the brain, passing the blood through an integrated filter and returning it to the patient in a closed circuit to minimize blood loss during the procedure. As we've said before, our ongoing investments in both CAS and TCAR methods and tools addressing the broadest patient population were done anticipating a time when technological innovation and procedural reimbursement further shifted the tides toward an endovascular first standard of care.

Speaker Change: As a reminder, the switch guard mps's designed to prevent embolic debris generated during a crowded stenting procedure from traveling to the brain passing the blood through an integrated filter and returning it to the patient in a closed circuit to minimize blood loss during the procedure.

Speaker Change: As we've said before our ongoing investments in both cash and Teacart methods and tools addressing the broadest patient population, what's done anticipating a time when technology innovation and procedural reimbursement further shifted the tides toward an endovascular first standard of care last year marked the beginning of what.

Marvin Slossman: Last year marked the beginning of what we believe is a shift away from surgery toward less invasive stenting procedures, highlighted by CMS's final national coverage decision last October, which expanded coverage of CAS and TCAR to include both asymptomatic and standard risk patients. With a best-in-class implant and C-Guard EPS, we believe we're very well positioned to be a leader in addressing this industry change. We are pleased to announce this past February that Dr. Patrick Garrity, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis, Missouri, and Dr. Pat Muck, Program Director and Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, will be serving as our lead PIs.

CMS: We believe it's a shift away from surgery toward less invasive stenting procedures highlighted by Cms's final national coverage decision last October which expanded coverage of Cas antique car to include both asymptomatic and standard risk patients with.

We: We're the best in class implant in CCAR to EPS, we believe we're very well positioned to be a leader in addressing this industry sea change.

Marvin Slossman: Together, Dr. Garrity and Dr. Muck bring a wealth of knowledge and experience to the field of TCAR carotid interventions, and we're very fortunate to be able to benefit from their extensive knowledge, insight, and direction as we build our leadership objectives and strategy. They join an established multidisciplinary group of thought leaders that are already providing guidance to us in these initiatives. We've also previously announced that we entered into a strategic agreement with the Jacobs Institute of the State University of New York in Buffalo, led by Dr. Adnan Siddiqui, Vice Chairman and Professor of Neurosurgery, to conduct an early feasibility study of C-Guard Prime for severe carotid stenosis or occlusion in conjunction with thrombectomy in patients presenting with acute ischemic stroke and tandem

Speaker Change: We are pleased to announce this past February that Dr. Patrick guarantee professor of surgery, and radiology at Washington University School of Medicine in St. Louis, Missouri, and Dr. Pat Mug program director and Chief of vascular surgery, a good Samaritan hospital in Cincinnati, Ohio will be serving as our lead pis.

Speaker Change: Together Doctor guarantee and Dr. Mark bring a wealth of knowledge and experience in the field of T car carotid intervention and we're very fortunate to be able to benefit from their extensive knowledge insight and direction as we build our leadership objectives and strategy.

Speaker Change: They join and establish a multidisciplinary group of thought leaders are already providing guidance to us and these initiatives.

Speaker Change: We've also previously announced that we entered into a strategic agreement with the Jacobs Institute of the State University of New York in Buffalo with Doctor I've, not Sneaky, Vice Chairman and professor of Neurosurgery to conduct an early feasibility study of CCAR prime for severe carotid stenosis or inclusion in conjunction with her.

Speaker Change: Back to me in patients presenting with acute ischemic stroke and tandem lesions CCAR prime but its proprietary micro mesh is designed to provide superior embolic prevention during carotid stenting procedures.

Marvin Slossman: C-Guard Prime, with its proprietary Micronet mesh, is designed to provide superior embolic prevention during carotid stenting procedures. We believe that this study will demonstrate the safety and feasibility of using our stent in these acute stroke procedures. Our investment in the study reflects our strong commitment to the neuro community and represents a critical component of our long-term growth strategy. The FDA has approved this study, and we anticipate the first patient to be enrolled this quarter. At this point, I'll turn the call over to Craig to review the financials. Craig?

Speaker Change: We believe that this study will demonstrate safety and feasibility of using our stand in these acute stroke procedures. Our investment in this study reflects our strong commitment to the neuro community and represents a critical component of our long term growth strategy.

Speaker Change: The FDA has approved this study and we anticipate the first patient to be enrolled this quarter.

Craig: At this point I will turn the call over to Craig to review the financials Craig.

Craig Shore: Thanks, Marvin. For the first quarter of 2024, total revenue increased 22% to $1,511,000 from $1,239,000 during the first quarter of 2023. This increase was predominantly driven by growth in existing markets. Gross profit for the first quarter of 2024 was $292,000, a decrease of $81,000, or 21.6%, from a gross profit of $373,000 for the first quarter of 2023. This decrease resulted primarily from higher training costs for new hires to build capacity for anticipated increased volume requirements.

Craig: Thanks, Martin for the first quarter of 2024 total revenue increased 22% to $1.511 million from 1 million to $139000. During the first quarter of 2023. This increase was predominantly driven by growth.

Speaker Change: It's an existing market.

Craig: Gross profit for the first quarter of 2024 with $292000 a decrease of $81000 or 21, 6% from a gross profit of $373000 for the first quarter of 2023.

Martin: This decrease resulted primarily from higher training class of new hires to build capacity for anticipated increase volume decline in its gross margin decreased to 19, 4%. During the three months ended March 31, 2024 from 31% during the three months ended.

Craig Shore: Gross margin decreased to 19.4% during the three months ended March 31, 2024, from 30.1% during the three months ended March 31, 2023. Total operating expenses for the first quarter of 2024 were $7.7 million, an increase of $2.9 million, or 62.1%, compared to $4.8 million for the first quarter of 2023. This increase was primarily due to higher share-based compensation resulting from the recognition of grants made during the second quarter of 2023 and the first quarter of 2024.

Martin: 31st 2023.

Speaker Change: Total operating expenses for the first quarter of 2024 for $7.7 million, an increase of $249 million or 62, 1% compared to $4 $8 million for the first quarter 2023. This increase was primarily due to higher share based.

Speaker Change: Compensation, resulting from the recognition of grants made during the second quarter of 2023 and the <unk>.

Speaker Change: First quarter of 2024.

Craig Shore: Total financial income for the first quarter was $382,000, an increase of $257,000 or 206%, compared to $125,000 for the first quarter of 2023. This increase was primarily due to a $264,000 increase in interest income from investments in marketable securities, money market funds, and short-term bank deposits. The net loss for the first quarter of 2024 totaled $7,032,000, or $0.21 per basic and diluted share, compared to a net loss of $4,256,000, or $0.53 per basic and diluted share, for the same period in 2023. As of March 31, 2024, cash, cash equivalents, and marketable securities were $34 million, compared to $39 million as of December 31, 2023. That concludes our prepared remarks. We will now open the call for questions. Operator.

Speaker Change: Total financial income for the first quarter was $382000, an increase of $257000, but 206% compared to $125000 for the first quarter of 2023. This increase was primarily due to $264000 incurred.

Speaker Change: <unk> and interest income from investments in marketable securities and money market funds.

Speaker Change: Short term bank deposits.

Speaker Change: Net loss for the first quarter of 2024 totaled $7.032 million or 21 cents per basic and diluted share compared to a net loss of $4 million $256000 53 per basic and diluted share for the same period in 2002.

Speaker Change: <unk> three <unk>.

Speaker Change: At March 31, 2020 for cash cash equivalence and marketable securities of $34 million compared to $39 million as of December 31st 2023 that concludes our prepared remarks, we will now open the call for questions operator.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. And you may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key. Our first question comes from the line of Adam Meador with Piper Sandler. Please proceed with your question.

Operator: Thank you we will now be conducting a question and answer session.

Operator: If you'd like to ask a question. Please press star one on your telephone keypad.

Operator: Formations on will indicate that your line is in the question queue.

Adam Meador: And you May press star two if you'd like to remove your question from the queue.

Speaker Change: For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.

Speaker Change: Our first question comes from the line of Adam <unk> with <unk>.

Speaker Change: Sandler. Please proceed with your question.

Adam Meador: Hi, good morning, Marvin and Craig. Thank you for taking the questions and congratulations on the progress here. Maybe to start, I wanted to ask about the SeaGuardians trial and the data set that we're going to see later this month at LingQ. I guess the question is really more around, how quickly can you package that information and submit it to FDA? You know, just trying to get a better sense for when we could see the FDA review process and their clock start. And then I had a couple follow-ups. Thanks.

Adam Meador: Hi, Good morning, Marvin and Craig. Thank you for taking the questions and congrats on the progress here.

Speaker Change: Maybe to start wanted to.

Speaker Change: Ask you about the C Guardians.

Speaker Change: Ah trial and the data set that we're going to see you later this month that link I guess the question is really more around.

Adam Meador: How quickly can you package that information and submit to FDA, just trying to get a better sense for when we could see the FDA review process and and their clock start and that had a couple of follow ups. Thanks.

Marvin Slossman: Hi Adam. Thanks. Thanks for the question. As it relates to our approach with FDA, we chose a modular submission approach, which we felt was the most efficient and expeditious that, you know, gives us the fastest pathway to approval. So, once we present this data, it will then be processed and goes into the final module, which we anticipate to be shared with FDA sometime around the August or September timeframe right now.

Adam Meador: Hi, Adam Thanks, Thanks for the question so as it relates to our approach with the FDA. We've chosen a modular submission approach, which we felt like was the most efficient and expeditious that gives us the fastest pathway to approval.

Marvin Slossman: So once we present this data it will then be processed and goes into the final module, which we anticipate to be shared with the FDA sometime around August or September timeframe right now so that that.

Marvin Slossman: So that right now seems to be the date that we've all landed on, and hopefully that submission will take place then. FDA is certainly familiar with our submission and our process, and so we hope that this is the most efficient way to get approval in the first half of next year.

Marvin Slossman: Right now seems to be the date that we've all landed on and hopefully that submission will take place then FDA has certainly familiar with our our submission in our stent and so we hope that this is the most efficient way to get to approval in the first half of next year.

Marvin Slossman: Yes, I got it thanks for the extra color there Marvin.

Marvin Slossman: I got it. Thanks for the extra color there, Marvin.

Marvin Slossman: And for the next question, I wanted to switch over to SwitchGuard or your TCAR product. I just wanted to confirm that those timelines continue to track. So are you still expecting to commence enrollment in the Sea Guardians 2 study by the end of the year? And then are you still anticipating late-calendar year 2025 approval for SwitchGuard in the U.S.? Is that correct?

Marvin Slossman: The next question I wanted to switch over to the.

Speaker Change: To switch guard or your T car product.

Marvin Slossman: I just wanted to confirm that those timelines continue to track. So are you still expecting to commence enrollment and the C. Guardians two study by the end of the year and then are you still anticipating a late calendar year 2025 approval for switch garden in the U S is that correct.

Marvin Slossman: Yeah, so let me present the landscape, I guess, for all approvals here. So our plan is to have approval for the Seaguard Prime in the first half of 2025, our cast system, followed by a TCAR indication for Seaguard Prime in the second half of twenty five. And finally, the clearance of switch guard neural protection with the full accessory kit in the first half of twenty six. So, we've gathered a lot of feedback from our vascular surgeons performing TCAR, and they've encouraged us to continue to build on the enhancements and feature set from our offering and to establish a new gold standard of what they believe they expect from their TCAR procedures.

Speaker Change: Yes, So let me let me present, the landscape I guess for for all approvals here. So our plan is to have approval for the CCAR Prime first half of 2025, our cat system, followed by a T car indication for CCAR Prime in the second half of 'twenty five and finally, the clearance of switch guard neuro protection.

Marvin Slossman: The full accessory kit in the first half of 2006.

Marvin Slossman: We've gathered a lot of feedback from our vascular surgeons performing T car and they have encouraged us to continue to build on the enhancement and feature set from our offering and to establish a new gold standard of what they believe they expect from their T car procedures. So we built a little bit of time into that effort and of course with the.

Marvin Slossman: So, we've built a little bit of time into that effort, and, of course, with the unknowns of the regulatory pathway, we feel comfortable with that approach and how we're handling the progression, both from CAST and transitioning to our C-Guard Prime with the TCAR indication, and then finally to SwitchGuard.

Unknown Speaker: Unknowns of the regulatory pathway, we feel comfortable with with that approach and how we're we're handling the progression both from cash then transitioned to.

unknown: Two our CCAR prime with the T car indication and then finally the switch guard.

Marvin Slossman: I got it. Okay. And Sea Guardians 2, is that still expected to start later this year, by year-end?

Steve: Got it Okay, and Steve Guardians too is that still expected to start later this year by year end.

Marvin Slossman: That's our yeah, that's our plan that remains consistent. Yes

Marvin Slossman: That's all that's all.

Marvin Slossman: That's our plan that remains remains consistent yes.

Marvin Slossman: Okay, thanks for the clarification there. And then moving over to the Tandem Lease-In Early Feasibility Study, I think I heard correctly that first patient enrollment is expected here in Q2. Maybe just, can you confirm that?

Marvin Slossman: Okay. Thanks for the clarification, there and then moves.

Speaker Change: Moving over to the tandem lesion early feasibility study I think I heard correctly.

Marvin Slossman: First patient enrollment.

Marvin Slossman: Expected here in Q2.

Analyst: Maybe just can you confirm that and then how quickly do you expect the trial to enroll and when should we expect to see that data and then lastly. These are are very sick patients and may be just kind of help the audience wall Street community kind of understand or level set what would a good outcomes look like for a study.

Marvin Slossman: And then, how quickly do you expect the trial to enroll and when should we expect to see that data? And then lastly, you know, these are very sick patients and maybe just kind of help the audience, the Wall Street community, kind of understand or level set, you know, what would a good outcome look like for a study like this? And then I had a couple more follow-ups. Thanks.

Speaker Change: And then I had a couple of more follow ups. Thanks.

Marvin Slossman: Yeah, thanks Adam. Great question.

Adam Meador: Yeah. Thanks, Adam Great question. So let me start with the fact that our focus through the EPS with with the tandem trial is really to refocus the attention to the neuro community as a whole so notwithstanding our objective in trying to look for a label specific to tandem our goal is to make sure. We continue to focus on.

Marvin Slossman: So let me start with the fact that our focus through the EPS with the tandem trial is really to refocus the attention on the neuro community as a whole. So, notwithstanding our objective in trying to look for a label specific to tandem, our goal is to make sure we continue to focus on the neuro community. So the EFS is scheduled around 15 patient enrollment, and we anticipate that that first patient will be enrolled, as we said in the second quarter.

FDA: Neuro community. So the first is scheduled around a 15 patient enrollment and we anticipate that that first patient will be enrolled as we said in the in the second quarter Fda's cleared that approach it is a very different.

Marvin Slossman: FDA has cleared that approach. It is a very different set of objectives, and as you mentioned, the standard by which we're measuring success is quite different because, by the nature of these patients, they are in an acute stroke scenario. So we're trying to measure that obviously against what's considered to be sort of standard carotid stenting success. And we'll have to work through that because it's a really important segment of the population.

Marvin Slossman: Set of objectives and as you've mentioned.

FDA: The standard by which we're measuring success is quite different because by by the nature of these patients are already in an acute stroke scenario. So we're we're trying to measure that obviously against what's considered to be sort of standard carotid stenting measured success and and we will have to work through that because it's a <unk>.

Speaker Change: Really important segment of the population I think it's become a.

Marvin Slossman: I think it's become a big highlight of the neuro community with all the thrombectomy that's being done. But it definitely speaks to a different outcome in terms of how we define success in the protocol and what those outcomes look like. So we're going to work hard to make sure that that's clear and that as we present the data and get feedback, especially from the EFS, we'll present that accordingly.

Etfs: A big highlight of the neuro community with all the thrombectomy, that's being done but it it definitely speaks to a different outcome in terms of how we define success in the protocol and what those outcomes look like so we're going to work hard to make sure that that's clear and then as we present, the data and get feedback, especially from the Etfs that will present that accordingly.

Marvin Slossman: Good color there, Marvin. Just a couple more, if I may, just maybe switching over to the P&L. Gross margin for Q1 was just a little bit light. Anything to call out there?

Marvin Slossman: Good color there Marvin just a couple more if I may just maybe switching over to the P&L.

Marvin Slossman: Gross margin.

Marvin Slossman: For Q1 was just a little bit light.

Marvin Slossman: Anything to call out there.

Craig Shore: Should we expect that to kind of rebound to the high 20s, near 30% level in subsequent quarters? Just trying to think through the cadence of gross margin for 24. And then for 25, any broad strokes that you want to offer up on gross margin at this juncture?

Marvin Slossman: Should we expect that to kind of rebound at the high twenty's near 30% level.

Craig Shore: In subsequent quarters, just trying to think through the cadence of gross margin for 'twenty four.

Speaker Change: And then for 'twenty five any broad strokes that you want to offer up on gross margin at this juncture.

Craig Shore: Yeah, I'll take that, Adam. We're starting to hire more people and train them for our increased forecast of growth. So that goes to the cost of goods sold, and that's the main reason for the increase in Q1. We are expecting an upturn in some of the later quarters. It'll actually get much higher in 2025 when we start launching in the United States, where prices are much higher. Don't forget, we're currently selling via distributors in Europe, and we're getting 50% of the end-user price. When we go to the United States, we'll actually be selling directly. And we also have a much higher end-user price, parenting you up.

Marvin Slossman: Yeah, I'll take that Adam.

Adam Carl Maeder: We're starting to hire more people and train them well.

Adam Carl Maeder: Increased forecast for growth.

Craig Shore: So that goes to the cost of goods sold and the main reason for the increase from Q1.

Craig Shore: We are expecting an upturn in some of the later quarters.

Craig Shore: Actually get much higher in 2025, when we start launching in the United States, where the prices are much higher.

Adam Meador: Don't forget you need we're currently selling via distributors in Europe alone as you're getting 50% of the end user price. When we go to the United States will actually be selling directly and we also have a much higher end user price.

Adam Carl Maeder: Go to Europe.

Craig Shore: Yep, yep. Good, good, good color there, Craig.

Craig Shore: Yes, yes, good color there Craig Thanks for that and then just one more for you just on the Opex.

Craig Shore: Thanks for that. And then just one more for you, just on the OpEx spend. You know, how aggressively are you going to kind of start to build up the sales force ahead of us launch, you know, in the first half of 2025? I mean, how do we think about OPEX spend going? Going forward, Craig, and I'll jump back in queue. Thanks again, guys, and congrats on the progress. Yeah, it's definitely going to go higher as we get closer and closer to the launch.

Craig Shore: How aggressively are you going to kind of start to build up the sales force ahead of the U S launch.

Craig Shore: In the first half of 2025, I mean, how do we think about opex spend going.

Greg: Going forward, Greg and I will jump back in queue. Thanks, again, guys and congrats on the progress.

Craig Shore: Yeah, it's definitely going to go higher as we get closer and closer to the launch in the United States. I mean, we're anticipating about a 60-person sales force over the next three years of operations in the States. So we'll be adding more and more people each quarter. But also, manufacturing and staff for the U.S. facility is also going to increase our OPEX costs as well.

Craig Shore: Yes, it's definitely going to go higher.

Craig Shore: Get closer and closer to the launch in the United States I mean.

Speaker Change: We're anticipating about a 60 person sales force over the next three or three years of operations in the states. So we will be adding more and more people each quarter.

Craig Shore: But also manufacturing and people for the U S facility is also going to increase our opex cost as well.

Operator: Any other questions, operator?

Craig Shore: Any other questions operator.

Marvin Slossman: At this time, we have no further questions. I would like to turn the floor back over to management for closing comments.

Operator: At this time, we have no further questions I would like to turn the floor back over to management for closing comments.

Operator: Thank you very much. I'd like to thank everyone for taking the time today to join the call and for the ongoing support. We've gone into 2024 with significant momentum and look forward to continuing to create value as we get later in the year.

Marvin Slossman: Great. Thank you very much I'd like to thank everyone for taking the time today to join the call and for the ongoing support.

Operator: <unk> got in 2024 with significant momentum and look forward to continuing to create value as we get later in the year. Thanks for participating.

Operator: Thanks for participating. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Operator: Yeah.

Operator: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Operator: Thank you. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation.

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