Q4 2023 InspireMD Inc Earnings Call & Business Update Call

Operator: Welcome to InspireMD's fourth quarter and full year 2023 earnings call. At this time, all participants are in a listen-only mode.

Greetings welcome to inspire M D fourth quarter and full year 2023 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.

Operator: A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please call 1-866-333-4255 and press star zero on your telephone. Please note this conference is being recorded. I will now turn the conference over to Chuck Padala with LightSight Advisor. Thank you, operator. And good morning, everyone.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded.

Now I'll turn the conference over to check the dollar with outside advisors. Please proceed.

Thank you operator, and good morning, everyone. Thank you for joining us for the inspire in the fourth quarter and full year 2023 financial results and corporate update conference call.

Chuck Padala: Thank you for joining us for the InspireMD fourth quarter and full year 2023 financial results and corporate update conference call. Joining us today from InspireMD are CEO Marvin Slosman 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.

Joining us today for inspire and D are CEO, Mark with Boston 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.

Lease 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.

Chuck Padala: 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 to our current 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, March 6, 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 this call over to Marvin Slosman, Chief Executive Officer. Marvin, please go ahead.

For more information about these risks please refer to the risk factors described in inspire <unk>. Most recently filed periodic reports on Form 10-K, and Form 10-Q or any updates at our current reports on form 8-K filed with the U S Securities and Exchange Commission and its iron <unk> press release by the company.

He's just call, particularly the cautionary statements made in it.

This call contains time sensitive information that is accurate only as of today March six 2024.

Except as required by law inspire indeed 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 this call over to Barbara Boston, Chief Executive Officer Robin. Please go ahead.

Marvin L. Slosman: Thank you, Chuck, and thanks to everyone for joining the call this morning. I'm pleased to share a tremendously productive fourth quarter, completing a remarkable end to 2023 for our company. We have carried this energy and enthusiasm into the new year as we continue our mission to lead the carotid revascularization market with our best-in-class C-guard carotid stent platform. We look forward to reporting one-year primary endpoint results from the C-guardians trial in the first half of this year with a view to potential approval and commercialization in the United States in the first half of 2025, as well as our continued Our investment in both CAS and TCAR methods and tools addressing the broadest market potential was purposeful and done anticipating a time when technology, innovation, and procedural reimbursement moved the tides toward an endovascular standard of care.

Thank you Chuck and thanks to everyone for joining the call. This morning.

I'm pleased to share a tremendously productive fourth quarter, completing a remarkable end to 2023 for our company.

We have carried this energy and enthusiasm into the new year as we continue our mission to lead the carotid revascularization market with our best in Class T Guard carotid stent platform looking forward to reporting one year primary endpoint results from the sea Guardians trial in the first half of this year with.

With a view to potential approval and commercialization in the United States in the first half of 2025.

Well as our continued focus on growth in our 30 plus served O U S markets.

Our investment in both cash and T car methods and tools addressing the broadest market potential was purposeful and done anticipating a time when technology innovation and procedural reimbursement.

The tides toward an endovascular standard of care.

Marvin L. Slosman: 2023 marked the beginning of what we believe to be a sea change toward this shift away from surgery with best-in-class outcomes, with SeaGuard catalyzing our leadership potential. We plan to continue to build our growing body of data and real-world evidence from our OUS markets as we create inertia to lead the U.S. market post-approval. Craig will cover the financials shortly, but I wanted to share a brief review of our fourth quarter performance. We generated record total SeaGuard revenue of $1.76 million, representing growth of 71.6% as compared to the fourth quarter of 2022.

2023 marked the beginning of what we believe to be a sea change toward this shift away from surgery with best in class outcomes with C Guard Catalyzing our leadership potential.

We plan to continue to build our growing body of data and real world evidence from our O U S markets as we create a nurse to lead the U S market post approval.

Craig will cover the financials shortly but I wanted to share a brief review of our fourth quarter performance we.

We generated record total she garden revenue of $1 $76 million, representing growth of 71, 6% as compared to the fourth quarter of 2022.

Marvin L. Slosman: Recall that our fourth quarter 2022 sales were negatively impacted by the temporary expiration of our CE mark in November of last year, as European regulators transitioned from the Medical Device Directive, or MDD, to the new Medical Device Regulation, or MDR. We indicated at that time that the temporary suspension of our CE mark impacted our fourth quarter 2022 sales by approximately $250,000. Even considering these circumstances on an adjusted basis, we generated year-over-year sales growth of 38 percent, reflecting our commercial focus on building a growing awareness of C. guard's superior patient outcomes as we work to make it the gold standard of carotid implants globally. We sold 3,107 stents, up more than 74% year-over-year, advancing our global sales to date to more than 48,000 stents, building on our real-world market penetration and experience.

Recall that our fourth quarter 2022 sales were negatively impacted by the temporary exploration of our CE Mark in November of last year and European regulators transitioned from the medical device directive or M. D D to the new medical device regulation or MTR framework.

We indicated at that time that the temporary suspension of our CE Mark impacted our fourth quarter 2022 sales by approximately $250000. Even considering these circumstances on an adjusted basis, we generated year over year sales growth of 38%.

Selecting our commercial focus on building a growing awareness of <unk> superior patient outcomes as we work to make it the gold standard of carotid implants globally.

We sold 3107 cents up more than 74% year over year.

Our global sales to date to more than 48000 stents building on a real world market penetration and experience.

Marvin L. Slosman: Another significant highlight was the notification from the European regulators of our CE mark recertification under MBR. The transition from MDV to MDR was challenging and required us, like the rest of the medical device industry broadly, to be patient, persistent, and comprehensive in our approach to addressing these changes in requirements, timelines, and priorities during this lengthy process. 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 enabling our product development pipeline provided under MDR as we continue to invest in our OUS markets in parallel with our increased US focus. Turning to C-Guardians, our U.S. pivotal IDE trial, which is designed to support approval of C-Guard Prime in the U.S. Dr. Chris Metzger, System Vascular Chief at Ohio Health in Columbus, Ohio, and principal investigator of the C-Guardians trial, presented 30-day follow-up data from the trial at VIVA-23 and then at V-Composium, both of which took place in November of last year.

Another significant highlight was the notification from the European regulators have our CE Mark recertification under M. D R.

Transition from MDI to MTR was challenging and required us like the rest of the medical device industry broadly can be patient persistence and comprehensive in our approach to addressing these changes and requirements timelines and priorities. During this lengthy process.

With our formal recertification under MTR now granted we've derisked this topic and remove the uncertainty and our ability to continue to sell an EU certified countries, while enabling our product development pipeline provided under M. D. R. As we continued to invest in our O U S markets in parallel with our increased U S focus.

Turning to see Guardians, our U S pivotal <unk> trial, which is designed to support approval of CCAR Prime in the U S. Dr. Christopher Metzger system, vascular cheap and Ohio Health in Columbus, Ohio, and principal investigator of the Sea Guardians trial presented 30 day follow up data from the trial at Veeva 'twenty three and then at least.

Symposium, both of which took place in November of last year.

Marvin L. Slosman: As an important reminder of the results, the primary endpoint of the trial is a composite of incidents of major adverse events including death, all-cause mortality, any stroke or myocardial infarction, DSMI, through 30 days post-index procedure or ipsilateral stroke from day 31 to day 365 post-procedure. Between July 2021 and June 2023, 316 patients were prospectively enrolled in a single-arm study performed at 24 sites in the U.S. and Europe, including the Seaguard Carotid Stent System, which also included our next generation Seaguard Prime. With the acknowledgment of FDA, 30-day results were presented, reporting best-in-class data with the lowest 30-day MACE rate of any carotid pivotal trial to date. Patients with carotid artery stenosis at high risk for carotid endarterectomy treated with C-Guard had a DSMI rate of 0.95% from procedure through 30-day follow-up.

As an important reminder of the resolve the primary endpoint of the trial is a composite of incidence of major adverse events, including death, all cause mortality and stroke or myocardial infarction DSM I drew 30 days post index procedure are ipsilateral stroke from day 31 to date $3 65 post procedure.

Sure.

Between July 2021, and June 2023, 316 patients well prospectively enrolled in a single arm study performed 24 sites in the U S and Europe, including.

Let's see guard carotid stent system.

Which also included our next generation <unk> Prime.

With the acknowledgment of F. D. A 30 day results were presented reporting best in class data with the lowest 30 day mace rate of any carotid pivotal trial to date page.

Patients with carotid artery stenosis at high risk for carotid endarterectomy triggered the C Guard had a D. S M I rate of 95% from procedure 330 day follow up.

Marvin L. Slosman: This data continues to validate the unique neuroprotective qualities of C-Guard utilizing our innovative Micronet mesh, and it's consistent with our real-world experience. We remain on track to report 12-month primary endpoint results anticipated in mid-year, followed by the submission of our pre-market approval application, or PMA, in the third quarter of this year. Based on these timelines, we anticipate possible FDA approval of C-Guard in the United States in the first half of 2025. These timelines remain consistent with our prior guidance. Turning now to our major product development and clinical programs. SeaGuardians 2, the clinical study of our SwitchGuard neuroprotection system, along with our short shaft SeaGuard and accessory devices for TCAR procedures, continues with intention as we look to advance our TCAR tool set with next generation enhancements. As a reminder, the SwitchGuard NPS is designed to prevent embolic debris generated during the 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.

This data continues to validate the unique neuroprotective qualities of C guard utilizing our innovative micro mesh and it's consistent yeah.

Our real world experience.

We remain on track to report 12 month primary endpoint results anticipated in mid year, followed by the submission of our pre market approval application or PMA in the third quarter of this year.

Based on these timelines, we anticipate possible FDA approval of <unk> in the United States in the first half of 2025.

These timelines remain consistent with our prior guidance.

Turning now to our major product development and clinical programs.

Guardians two the clinical study of our switch garden Neuro protection system, along with our short shaft C Guard and accessory devices for T car procedures continues with intention as we look to advance our T car toolset with next generation enhancements.

As a reminder, the switch guard NPS is designed to prevent embolic debris generated during the carotid stenting procedure from traveling to the brain.

The blood through an integrated filter and returning it to the patient in a closed circuit to minimize blood loss during the procedure.

Marvin L. Slosman: We were pleased to announce just a few weeks ago that Dr. Patrick Garrity, Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis, Missouri, and Dr. Pat Muck, Director and Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, have enthusiastically agreed to act as our lead PIs for Sea Guardians 2, and that Dr. William Gray, System Chief of Cardiovascular Division at Mainline Health in Ly Together, Drs. Geraghty, Muck, and Gray bring a wealth of knowledge and experience in the field of carotid interventions in both TCAR and CAS, 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 multi-specialty group of thought leaders that are already providing guidance to us in these initiatives. Turning now to reimbursement. In October, the Centers for Medicare and Medicaid Services, or CMS, expanded coverage for CAFs and TCAR to include both asymptomatic patients at either high or standard risk for carotid endarterectomy.

We were pleased to announce just a few weeks ago, the Doctor Patrick guarantee professor of surgery, and radiology at Washington University School of Medicine in St. Louis, Missouri, and Dr. Pat and Mark Director and Chief of vascular surgery at good Samaritan Hospital in Cincinnati, Ohio have enthusiastically agreed to act as our lead Pis foresee Guardians too.

And then Dr. William Great system, Chief of cardiovascular division that mainline helping wynwood.

And professor of Medicine at Thomas Jefferson University in Philadelphia will act as an adviser to the company.

Together doctors guarantee mark and great bring a wealth of knowledge and experience in the field of crowded interventions in both T car and cash 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 and establish multi specialty group of thought leaders that are already providing guidance to us and these initiatives.

Turning now to reimbursement in October the centers for Medicare and Medicaid services or CMS expanded coverage for cast and T. Car to include both asymptomatic patients at either high or standard risk for carotid endarterectomy.

The broader availability of these less invasive options will enable physicians to tailor treatment plans to meet the needs of their individual patients.

This expansion of coverage by CMS validates our strategy, which is to be agnostic to whether the stent is implanted via cast or T car as we are unique in offering comprehensive solutions. The timing of these changes in reimbursement and a potential approval of <unk> in the U S provides us a tremendous opportunity to lead the.

Marvin L. Slosman: The broader availability of these less invasive options will enable physicians to tailor treatment plans to meet the needs of their individual patients. This expansion of coverage by CMS validates our strategy, which is to be agnostic to whether the stent is implanted via CAS or TCAR, as we are unique in offering comprehensive solutions. The timing of these changes and reimbursements and our potential approval of C-Guard in the U.S. provides us with a tremendous opportunity to lead the market with the stent-first approach. Also, during the fourth quarter, we announced a strategic agreement with the Jacobs Institute at the State University of New York in Buffalo and Dr. Adnan Siddiqui, Vice Chair and Professor of Neurosurgery, to conduct an early feasibility study of C CIGAR-PRIME, with its proprietary Micronet mesh, is designed to provide superior embolic prevention during carotid artery stenting.

A market with the stent first approach.

Also during the fourth quarter, we announced a strategic agreement with the Jacobs Institute at the State University of New York in Buffalo and Dr. <unk>, Vice chair and professor of Neurosurgery to conduct an early feasibility study of CCAR crime person for your carotid stenosis or inclusion in conjunction with thrombectomy and pay.

<unk>, presenting with acute ischemic stroke and tandem lesions.

<unk> prime with its proprietary micro mesh is designed to provide superior embolic prevention during carotid artery stenting.

We believe that this study will demonstrate safety and feasibility of using our stance in these acute stroke procedures are.

Our investment in this study reflects our unwavering commitment to the neuro community and represents a critical component in our long term growth strategy.

We are pleased to share that FDA has approved our study and we anticipate first patient enrollment in Q2 of this year.

Marvin L. Slosman: We believe that this study will demonstrate the safety and feasibility of using our stent in these acute stroke procedures. Our investment in this study reflects our unwavering commitment to the neuro community and represents a critical component in our long-term growth strategy. We are pleased to share that FDA has approved our study, and we anticipate first patient enrollment in Q2 of this year. Before turning the call over to Craig to review the financials, I'd like to welcome Pete Ligotti, who joined in January as Executive Vice President and General Manager of North America. Pete brings more than 30 years of general management and commercial leadership experience to InspireMD and is the latest addition to what I believe is a truly world-class team capable of achieving our goals and growth objectives. At this point, I'd like to turn the call over to Craig for the financials. Craig?

Before turning the call over to Craig to review the financials I'd like to welcome Pete <unk>, who joined in January as Executive Vice President and General manager of North America <unk>.

He brings more than 30 years of general management and commercial leadership experience to inspire M. D. And is the latest addition to what I believe is a truly world class team capable of achieving our goals and growth objectives.

At this point I'd like to turn the call over to Craig for the financials Greg.

Thanks, Martin for the fourth quarter of 2023 total revenue increased 71, 6%.

$1 million $761000 from $1 million and $26000 during the fourth quarter of 2022.

Greece was predominantly driven by the CE, Mark Recertification, which occurred subsequent to the end of the fourth quarter 2022, and overall growth in existing and new markets.

Gross profit for the fourth quarter of 2023 increased by $307000 or 155, 1%.

Craig Shore: Thanks, Marvin. For the fourth quarter of 2023, total revenue increased 71.6% to $1,761,000 from $1,026,000 during the fourth quarter of 2022. This increase was predominantly driven by the CE Mark recertification, which occurred subsequent to the end of the fourth quarter of 2022, and overall growth in existing and new markets. Gross profit for the fourth quarter of 2023 increased by $307,000, or 155.1%, to $505,000, compared to a gross profit of $198,000 for the fourth quarter of 2022. This increase resulted from higher revenue offset by a decrease in miscellaneous expenses.

$505000 compared to a gross profit of $198000 for the fourth quarter of 2022.

These resulted from higher revenue offset by a decrease in miscellaneous expenses gross margin increased to 28, 7%. During the three months ended December 31, 2023 from 19, 3% during the three months ended December 31 2022.

Total operating expenses for the fourth quarter of 2023, or $6 $3 million, an increase of $1 $2 million or 23% compared to $5 $1 million for the fourth quarter of 2022.

This was primarily due to increases in expenses related to the salaries and share based compensation.

Have they ever adoption in clinical expenses.

Craig Shore: Gross margin increased to 28.7% during the three months ended December 31st, 2023, from 19.3% during the three months ended December 31st, 2022. Total operating expenses for the fourth quarter of 2023 were $6.3 million, an increase of $1.2 million, or 23%, compared to $5.1 million for the fourth quarter of 2022. This increase is primarily due to increases in expenses related to salaries and share-based compensation, offset by a reduction in clinical expenses as we near completion of the Sea Guardians trial. Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000, or 293%, compared to $119,000 for the fourth quarter of 2022. This increase was primarily due to a $349,000 increase in interest income from investment in marketable securities, money market funds, and short-term bank deposits.

Near completion of the <unk> trial.

Total financial income for the fourth quarter of 2023 with $468000, an increase of $349000 or 293% compared to $119000 for the fourth quarter of 2022.

This increase was primarily due to 349000 increase in interest income from investment in marketable securities money market funds and short term bank deposits.

Net loss for the fourth quarter 2023 totaled $5 $4 million for 16 cents per basic and diluted share compared to a net loss of $4 $8 million or 60 cents per basic and diluted share for the same period in 2022 as of December 31 2000.

<unk> 'twenty free cash cash equivalents short term bank deposits and marketable securities.

$39 million compared to $17 $8 million over December 31, 2022 that concludes our prepared remarks, we will now open the call for questions.

Peter.

If he would like to ask a question. Please press star one on your telephone keypad.

Information tone will indicate your line is in the question queue. You May Press Star two if you would 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 star he is.

Operator: The net loss for the fourth quarter of 2023 totaled $5.4 million, or $0.16 per basic and diluted share, compared to a net loss of $4.8 million, or $0.60 per basic and diluted share for the same period in 2022. As of December 31, 2023, cash, cash equivalents, short-term bank deposits, and marketable securities were $39 million, compared to $17.8 million as of December 31, 2022. That concludes our pre-prepared remarks, as we will now open the call for questions. Operator. Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.

Our first question is from Adam Maeder with Piper Sandler. Please proceed.

Hi, good morning, Marvin and Greg.

Thank you for taking the questions here and congrats on the nice finish to the year.

Maybe just to start as we think about the international business for 2024, I know you don't have guidance out there.

But was hoping you could just kind of walk us through some.

Puts and takes as we think about the business.

This year from a top line standpoint.

Specifically wondering.

About some of the potential new products that may be coming down the pipe with <unk>.

In regard prime and switched <unk> in in Europe, and then I had a couple of follow ups. Thanks.

Okay, Hey, Adam Thanks, Thanks for the question so as it relates to our European business, we are continuing to invest heavily in our commercial effort. We will continue to do so as you know this M D. Our overhang from a pipeline perspective has been a bit of a challenge and now that we have the M. D. R.

Adam Carl Maeder: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question is from Adam Maeder with Piper Sandler. Hi, good morning, Marvin and Craig. Thank you for taking the questions here and congratulations on the nice finish to the year.

Vacation it allows us to open up some of those channels of product development and look to you know advancing new products, which are which was a bit of a challenge before under the M. D. D. So I would say on balance we continue to invest heavily in the markets. We're looking to try to integrate our new product pipeline.

Marvin L. Slosman: Maybe just to start, as we think about the international business for 2024, I know you don't have guidance out there, but I was hoping you could just kind of walk us through some put-and-takes as we think about the business this year from a top-line standpoint and specifically, you know, wondering about some of the potential new products that may be coming down the pike with DGuard Prime and SwitchGuard in Europe, and then I had Hey Adam, thanks for the question. So as it relates to our European business, we're continuing to invest heavily in our commercial efforts, and we'll continue to do so. As you know, this MDR over...

Into the markets that are that are open to that and we'll continue to hopefully grow it at a double digit pace, but.

No plans to to limit our access to that market. It continues to grow aggressively and it's given us a great foundation to build our business.

That's helpful color I appreciate that.

Sorry.

Here, a little bit, but just on CCAR prime and switch guard for.

CE Mark approval do you expect that to come in 'twenty. Four is that 25 of that just any any finer point you can put on it.

Marvin L. Slosman: Pipeline perspective has been a bit of a challenge, and now that we have the MDR, certification, it allows us to open up some of those channels of product development, you know, advancing new products, which was a bit of a challenge before under the... So I would say, on balance, we continue to invest heavily in the market to try to integrate our new product pipeline into the markets that are open to that, and we'll continue to hopefully grow it at double the rate. No plan, you know, will limit our access.

Yeah. Our hope is to is to have CCAR prime in 'twenty four.

We have been as I said somewhat restricted by our ability to get our files reviewed which have been delivered to our notified body for some time and so now that that's opened up that process. We hope that that review will go quickly and we'll be able to integrate C guard prime and into the market in 2004 as it relates to switch guard, we're still assessing.

The market potential of T car in Europe, and trying to figure out.

How we advance that through our channels and what the return on that investment looks like so that will likely shift outside of 24, Budd for CCAR Prime purposes. Our plan is to get it into the market as quickly as we can.

Marvin L. Slosman: Progress. Thank you for giving us a great foundation. That's helpful, Culler. I appreciate that. And sorry to push you a little bit, but just on Seaguard Prime and Switchguard.

Got it okay. That's helpful. Thank you.

And then I guess pivoting over to the U S. Good here timelines there.

Marvin L. Slosman: DMARC approval, do you expect that to come in 24? Is that a 25 event? Just any finer point you can put on it?

For potential commercialization or are still tracking consistent with.

Marvin L. Slosman: Yeah, our hope is to have Seaguard Prime in 24. You know, we have www.inspiremedia.com As it relates to SwitchGuard, we're still assessing the market potential of TCAR in Europe and trying to figure out how we can, you know, advance that through our channel, and what the return on that investment is for that will be outside of 24, but for Seaguard Prime. Our plan is to get it into the market. I've got it. Okay, that's helpful.

Past timelines.

I wanted to ask you about the.

Uh huh.

The data disclosure strategy for the company.

I guess, what I'm trying to ask is will you topline the full results from seed Guardians you know in the form of a press release or investor call or should we you know the investment community expect to wait for a presentation at a medical meeting <unk> Journal publication and.

In the back half of the year, just any more kind of.

Adam Carl Maeder: And then, I guess, pivoting over to the US, good to hear timelines there for potential commercialization are still consistent with past timelines. You know, I wanted to ask about the data disclosure strategy for the company. You know, I guess what I'm trying to ask is, will you top line the full results from SeaGuardian? You know, in the form of a press release or investor call? Or should we, the investment community, expect to wait for a presentation at a medical meeting and or, you know, a journal publication in the back half of the year? Just any more kind of color on the disclosure strategy would be helpful.

Color on disclosure strategy would be helpful. Thank you.

Yeah, Adam I think our intention there is to obviously disclose this data as quickly as possible.

A lot of reasons, why we want to do that and we're trying to pick the appropriate format. We certainly would prefer to do it in a conference setting as we did with the 30 day data, we're trying to time that out to see how that looks but our intention is to do more than just a just press released that and and do it in a.

In a much more robust setting as we've done done previously that the challenge is being able to time their disclosure with what conferences are happening at what period of time as you know the summer the summer gets a little quiet, so where we're trying to match our intention to get it out as quickly as possible, but in a format that gives us the.

Marvin L. Slosman: Thank you. Yeah, Adam, I think our intention there is to obviously disclose this data as quickly as possible. There are a lot of reasons why we want to do that, and we're trying to pick the appropriate format.

The greatest response.

I got it that's helpful.

And if I was to ask about the.

Marvin L. Slosman: We certainly would prefer to do it in a conference setting, as we did with the 30-day data. We're trying to time that out, see how that looks. Our intention is to do more than just... Please see the complete disclaimer at https://sites.americano.com; the challenge is being able to time that disclosure with what conferences are happening at what periods of time.

The commercial sales force and plans for hiring.

I was hoping you could kind of illuminate that for us.

Where are you today when would you look to onboard folks I presume that's more of a.

You know our back half of the year exercise, but maybe.

Maybe just talk about kind of the the plans there.

Marvin L. Slosman: The summer gets a little quiet, so we're trying to match our intention to get it out as quickly as possible, for I've got it. That's helpful. And if I were to ask about the commercial sales force and plans for hiring, you know, I'm hoping you could kind of illuminate that for us. Where are you today? When we look to onboard folks, I presume that's more of a back half of the year exercise, but maybe just talk about kind of the plans there. And for Craig, you know, just any color around OPEX spend in 2014. So our intention is to begin to build commercial infrastructure in the back half of the year, as you mentioned. We spent a tremendous amount of time with, Thank you, heaviest as far as higher.

Craig you know just any color around opex spend in 'twenty four.

So our intention is to is to begin to build commercial infrastructure on the back half of the year. As you mentioned, we've spent a tremendous amount of time with with Shane figuring out how to build and architect the the optimal approach to territory size coverage and so forth. So on approval we get.

Most out of our our launch and go to market strategy. So back half of the year would be would be the heaviest as far as hiring is concerned but theres a lot of work to be done between now and then in terms of you know developing tools training infrastructure all of those things that we're investing in we've got people on board as our general manager now that Youre working on.

U S infrastructure as well so we want to be able to support the commercial effort. In addition to having a full team of high powered sales reps are ready to go.

That's helpful and just a couple more for me if that's okay. So.

Marvin L. Slosman: But there's a lot of work to be done between Now and Then, developing the tools. Infrastructure, all those things that we're investing in. Pete Ligotti on board as our general manager now that's working on U.S. infrastructure. So we want to be able to support the commercial effort in addition to having a full team of, you know, high-powered sales reps. Thank you, that's helpful. And just a couple more for me if that's okay.

Wanted to ask about the U S. T car study, so you've announced the.

The Pea is.

Marvin when should we expect that study to.

Commence and what can you share on.

The study design in terms of number of patients and patient follow ups.

Even endpoints.

And then as we think about <unk>.

Commercial timing for switch guard.

Is that a back half 'twenty five, but then I just want to make sure that.

Marvin L. Slosman: So I wanted to ask about the US T-CAR study. You've announced the PIs. You know, Marvin, when should we expect that study to commence, and what can you share about the study design in terms of the number of patients and patient follow-ups and even endpoints?

Those timelines are still are still good thanks.

Yes. It was as we mentioned in our previous call. Adam We had a very productive pre sub meeting with the FDA to map out our strategy for switch guard in our T car.

Marvin L. Slosman: And then, you know, as we would think about commercial timing for SwitchGuard. Is that a back half 25 event? I just want to make sure that those timelines are still good.

Entry into the U S and so we're following their lead.

We also gathered a tremendous amount of feedback from our strategic advisory board and the vascular surgery community to make sure that the tool set that we're developing addresses some of the open topics that they felt were important we want to make sure that this is world class next generation technology, we like the position of a second mover advantage.

Marvin L. Slosman: Yeah, so as we mentioned in our previous call, Adam, we had a very productive pre-sub meeting with FDA to map out our strategy for SwitchGuard and our TCAR. We also gathered a tremendous amount of feedback. Advisory Board, and the vascular surgery community to make sure that the tool set that we're developing is world-class, next-generation technology. www.inspiremedia.com Craig Shore, Scott Gordon, Amir Kohen, InspireMD, have a structure in place; we have to validate that with the FDA, but we hope to get started on study. Expeditor. Subs by www.zeoranger.co.uk, hand on it, and FDA finalizing our approach there. But I think the timelines that we've previously seen, www. InspireMD.com is very good.

As long as we can take advantage of addressing some of those things. So we've integrated that feedback into our design and device approach and that you know adds the next layer of V. N V. And then we get into the regulatory pathway. So the simple and short answer is we've we've identified RP is we've got a structure in place.

We have to validate that with FDA, but we hope to get started in that study late late this year and our direction in terms of availability will depend on enrollment and FDA finalizing our approach there, but I think the the timelines that we've previously discussed remained consistent likely late.

25 or.

For them for approval.

Very good I will hop back in queue. Thanks Marvin.

Our next question is from Ben Hayner with Alliance Global Partners. Please proceed.

Benjamin Charles Haynor: I will hop back in queue. Thanks, Marvin. Our next question is from Ben Haynor with Alliance Global Partners. Good afternoon, gentlemen, or good day, gentlemen, I guess I should say. Thanks for taking the questions.

Hey, good afternoon, gentlemen, good good day, gentlemen, I should say.

For taking the questions.

First off on me.

Benjamin Charles Haynor: First off for me, just on the study design, the tandem lesion 15-patient study, you know, how quickly do you expect that to enroll? It sounds like that will kick off next quarter. Any other color you can provide there?

The design.

The tandem lesion 15 patient study.

How quickly do you expect that to enroll.

It sounds like that will kick off next quarter any other color you can provide there.

Marvin L. Slosman: Hey, Ben, good to hear from you. You know, I think the EFS, as we've structured it with Dr. Siddiqui and the group at Jacob, is really intended to test drive the setting behind how SeaGuard performs. Thank you, that allows us to continue to provide information as we go as we go along. This is not going to be a fast march to an event; the whole theory behind the EFS is to... do things in a very deliberate manner, carefully, to make sure that what we believe to be the case. Profile Perspective is true, and so I wouldn't put any timelines on enrollment.

Hey, Dan good to hear from you you know I think the Etfs as we've structured it with a doctor Siddiqi and the group at and Jacobs Institute is really intended to test drive.

The thesis behind how CCAR performs in this acute setting.

One back to me and other things are being applied.

We're going to we're going to go at a pace that that allows us to continue to provide.

Data to F D. A as we go as we go along this is not going to be a fast March to the finished of event the whole theory behind the U S is to is to do things in a very deliberate manner carefully to make sure that what we believe to be the case from a safety profile perspective is true and so I wouldn't put any time.

Marvin L. Slosman: I think what's most important is our commitment to the neuro... in making sure that we're acting on the feedback. We know that there's a lot of competition. There's not a dedicated label for that in some of these settings, guard, back from the physician.

<unk> two enrollment I think what's most important is our commitment to the neuro community and making sure that we're acting on the feedback we know that Theres a lot of carotid stenting. That's taking place there is not a dedicated label for that in some of these settings and we think that C guard based on the feedback from the physicians is optimally suited for that so we're going to take it a step at a time and use it.

Marvin L. Slosman: So we're going to take it a step at a time and use EFS, the big first step to make sure that. Okay, got it. So, a methodical approach there.

First is a a big first step to make sure that that thesis is validated and then we'll go from there.

Okay got it so methodical approach there I guess.

Benjamin Charles Haynor: I guess not a big surprise for you guys. That's good. And then, you know, just any more reactions that you can share from the 30-day data for Sea Guardians. I know we talked about VEVA on the last call, but, you know, VEAF and anything that's kind of flowed in since then. You know, Ben, overall, I think it was a remarkable presentation that I won't say caught a lot of people by surprise but was very favorably received. From our perspective, it was consistent with our real-world experience, which was also great to have. Obviously, we have to take next steps here to follow up on the one-year data so that we've got a comprehensive package to www.InspireMD.com, FDA, but you know so far on the foundation of our 30-day data, there's been a tremendous amount of confidence in our movement forward and the ability to get FDA approval.

Not a big surprise with you guys.

Good and then just any more reactions that you can share to the from the 30 day data or see Guardians.

Talk about Veeva on the last call but.

These on anything that has kind of flowed in Samsung.

Yeah.

You know been overall I think it was a it was a remarkable presentation that Ah I won't say caught a lot of people by surprise, but it was very favorably received.

From our perspective, it was consistent with our real World experience, which was which was also great to have obviously, we have to take next steps here to follow up on the one year the one year data.

So that we've got a comprehensive package to to prepare and present to FDA, but you know so far on the foundation of our 30 day data theres been a tremendous amount of confidence in and our our movement forward and the ability to get and secure FDA approval. So we'll look to this next readout as the next step in that process, but.

Benjamin Charles Haynor: So, we'll look to this next readout as the next step in that, http://www.inspiremedia.com. Okay, makes sense. And then, more for Craig, on the CRDs too and the expenses they have running through R&D. How should we model that as the year goes on this year?

Excitement up to this point.

Okay that makes sense and then more for Craig.

Uh huh.

CRT is too and I'm, just kind of the expenses.

We have running through R&D, how should we model that.

It goes on this year.

Craig Shore: Is there a step up in any particular quarter as you kick that thing off later this year? Or anything in particular that we should be thinking about? Yeah, I think for R&D, you should think that there's going to be step-ups for the ESS as well as the trial for SwitchCard for Guardians 2. So, yeah, I would just, you know, within the first couple quarters already start to include a step up. OK. Step up and then step up for a couple quarters and then kind of level off, is that the thinking, or does that continue to step up throughout the year? No, no, no, no, no, no. In the first couple quarters, step off and then just level it off.

Step up in any particular quarter as you kicked that thing off later this year or.

Anything that anything in particular that we should be thinking about.

Yeah, I think for R&D, you should you should think that theres going to be step up.

For the Etfs as well as the trial for switch hard.

Sure Guardians too.

So yeah I would just you know within the first couple of quarters already start to include a step up.

Okay.

Step up and then step up for a couple of quarters, and then kind of level off thinking or does that continue to step out.

No no no no.

Last couple of quarters, the step off and then just level it off.

Benjamin Charles Haynor: Okay, that's helpful. And then I guess, maybe a little bit for both of you. Marvin, you mentioned a full team of high-powered sales reps. How big is that team? You know, how quickly do you bring them on board? Anything else that you can help us out with there? Yeah, I think we've Shane has spent a considerable amount of time modeling this, and we're working through some different scenarios. We've both done this before. I think for the U.S. market, you know, the optimal number is somewhere in the ballpark of...?

Okay. That's helpful and then I guess, maybe a little bit for both.

Marvin you mentioned a whole team of high powered sales reps.

That team how quickly do you bring them on.

Any anything else you can help about what there.

Yes, I think we've seen has spent a considerable amount of time modeling this and we're working through some different scenarios. We've both done this before I think for the U S market you know the optimal number is somewhere in the ballpark of 60 dedicated full time direct sales reps with obviously support structure.

Marvin L. Slosman: ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?

Marvin L. Slosman: dedicated, you know, full-time direct sales reps with, obviously, a support structure clinically and other things. And so we're building our models around that. In terms of absorption in the market, our goal is to make sure that we're addressing each of the markets appropriately, and we're not getting ahead of our speed. But at the same time, we're anticipating a very robust response to that approval. So, you know, we're working hard to kind of figure out how we take these people on at what period of time. It's probably about a two-year runway, I would anticipate, Ben, to sort of get fully locked and loaded on our commercial go-to-market strategy. But we're obviously going to address those markets that are most robust, and we're going to go as fast as the market sends us signals that they're ready to buy and use SeaGuard.

Clinically and other things and so we're building our models around that in terms of absorption in the market. Our goal is to make sure that we're addressing each of the markets appropriately and we're not getting ahead of rfps, but at the same time, we're anticipating a very robust response to that approval. So.

We're working hard to kind of can can figure out to figure out how we how we take these people on at what period of time, it's probably about a two year runway I would anticipate then to sort of get fully locked and loaded on you know on our commercial go to market strategy, but we're obviously going to address those markets that are most.

Robust and we're going to go as fast as the market sends us big knows that there, they're ready to buy and use C guard. So architect the plans first step as you can imagine we've had a lot of inbound inquiries from a lot of really talented reps in this market that see us as being sort of this next next step in carotid.

Marvin L. Slosman: So, architecting the plan's first step, and as you can imagine, we've had a lot of inbound inquiries from a lot of really talented reps in this market that see us as being the next step in carotid revascularization, and they love the direction we're headed. So inbound inquiries are always a good indicator of, you know, how we can, where we can land. It's good to hear the excitement from the inbound end. I think that's all I have, gentlemen.

Revascularization and they loved the direction, we're headed so inbound inquiries are always a good indicator of our of how.

How we can how we can land in a good and a good place.

Good to hear excitement from the inbound.

I think that's all I had gentlemen, congrats on the progress and thanks for taking my questions.

Benjamin Charles Haynor: Congratulations on the progress and thanks for taking the question. Thanks, Ben. Thanks for staying in touch. This concludes our question and answer session. I would like to hand the conference back over to Marvin for closing.

Thanks, Ben Thanks for thank you much.

This concludes our question and answer session I would like to hand, the conference back over to Marvin for closing comments.

Great. Thank you operator, we appreciate everybody calling in today and we're really looking forward to a very robust 2024, and thank you for calling in.

Marvin L. Slosman: Thank you, operator. We appreciate everybody calling in today, and we're really looking forward to a very robust 2024. Thank you for calling. Thank you, this will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.

Thank you. This will conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.

Thank you.

Hmm.

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Uh huh.

Yeah.

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Okay.

Operator: Thanks for watching! InspireMD.com, Thanks for watching! InspireMD.com, Thanks for watching! InspireMD.com, ?? ?? ??

Okay.

Okay.

Uh huh.

[music].