Q2 2024 InspireMD Inc Earnings Call
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Operator: Good morning and welcome to the Inspire MD second quarter 2024 earnings call. Currently, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star and one on your telephone keypad. You may withdraw yourself from the queue by pressing star and two.
Operator: Please stand by. Your program is about to begin. If you should require assistance during your conference today, please press star zero. Good morning, and welcome to the InspireMD second quarter 2024 earnings call.
Speaker Change: Good morning and welcome to the InspireMD second quarter 2024 earnings call.
Operator: Currently, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and one on your telephone keypad. You may withdraw yourself from the queue by pressing star and two. Please note this conference is being recorded. I will now turn the conference over to Chuck Padala, with live advisors. Thank you, and you may begin.
Speaker Change: Currently, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star and 1 on your telephone keypad.
Operator: Please note, this conference is being recorded.
Speaker Change: You may withdraw yourself from the queue by pressing star and two. Please note, this conference is being recorded. I will now turn the conference over to Chuck Padala with Life Advisors. Thank you, and you may begin.
Chuck Padala: I will now turn the conference over to Chuck Padalala with Live Advisors. Thank you, and you may begin.
Chuck Padala: Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD second quarter financial results and corporate update conference call. 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.
Chuck Padala: Thank you, operator, and good morning, everyone. Thank you for joining us to the Inspire MD second quarter financial results in corporate update conference call. Joining us today from Inspire MD are Marvin Slossman, Chief Executive Officer, and Craig Shore, Chief Financial Officer.
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 10-Q, or any updates in our current reports on Form 8-K filed with the U.S. Security 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, August 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 the call over to Marvin Slosman, Chief Executive Officer of InspireMD. Please go ahead, Marvin.
Chuck Padala: Thank you, Operator, and good morning, everyone. Thank you for joining us for the InspireMD second quarter financial results and corporate update conference call.
Chuck Padala: 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 factor described in InspireMD's most recently filed periodic reports on Form 10-K and 10-Q, or any updates in our current reports on Form 8-K, filed with the U.S. Security and State Commission, and Inspire MD's press release that accompanies this call.
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.
Speaker Change: These forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those expressed in such forward-looking statements.
Unknown Executive: Particularly, the Cross Area statements made in it.
Unknown Executive: This call contains time-sensing information that is accurate only as of today, August 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.
Marvin Slosman: It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer of InspireMD. Please go ahead, Marvin.
Speaker Change: It is now my pleasure to turn the call over to Marvin Slosman, Chief Executive Officer of InspireMD. Please go ahead, Marvin.
Marvin Slosman: Thank you, Chuck, and thanks to everyone for joining our call this morning. I'd like to begin with a recap of perhaps the most significant milestone in the company's history, the presentation of one-year outcomes data for our pivotal C-Guardians clinical trial of the C-Guard carotid stent system presented at the Leipzig interventional course on May 28th. The data presented by our lead principal investigator, Dr. Chris Metzger, System Vascular Chief at OhioHealth, demonstrated an independently adjudicated major events rate of just 1.95% through 12-month post-procedure, which is the lowest such event rate of any carotid pivotal trial to date.
Marvin Slosman: Thank you, Chuck, and thanks to everyone for joining our call this morning.
Marvin Slosman: I'd like to begin with a recap of perhaps the most significant milestone in the company's history. The presentation of one-year outcomes data for our Pivotal Seaguardians clinical trial of the Seaguard Caraudet Stent System was presented at the Leipzig Interventional Course on May the 28th. The data presented by our lead principal investigator, Dr. Chris Messer, System Vascular Chief at Ohio Health, demonstrated an independently adjudicated major events rate of just 1.95 percent through 12-month post-procedure, which is the lowest such event rate of any Caraudet pivotal trial to date. These results build on the 30-day DSMI results of 0.95 percent first presented in October of last year and establish a new high bar for clinical outcomes, which remains the focus of our patient-first implant-driven strategy as we work toward an anticipated US approval in the first half of 2025.
Marvin Slosman: These results build on the 30-day DSMI results of 0.95%, first presented in October of last year, and establish a new high bar for clinical outcomes, which remains the focus of our patient-first, implant-driven strategy as we work toward an anticipated U.S. approval in the first half of 2025. As remarkable as these results are, it is important to note that they also closely mirror the results we've seen across multiple studies involving over 1,100 patients in the published peer-reviewed literature showing that similarity of excellent patient outcomes can be achieved with C-Guard in real-world treatment, as we have seen in this FDA IDE trial.
Marvin Slosman: which is the lowest such event rate of any carotid pivotal trial to date.
Speaker Change: These results build on the 30-day DFMI results.
Speaker Change: of 0.95% first presented in October of last year and established a new high bar for clinical outcomes, which remains the focus of our patient-first, implant-driven strategy as we work toward an anticipated U.S. approval in the first half of 2025.
Marvin Slosman: As remarkable as these results are, it is important to note that they also closely mirror the results we've seen across multiple studies involving over 1,100 patients in the published peer-reviewed literature, showing that similarity of excellent patient outcomes can be achieved with Seaguard in real-world treatment, as we've seen in this FDA IDE trial. With the state-end hand, we are on track to submit a pre-market approval application, or PMA, to the FDA this quarter, which have approved what allows us to execute on a robust commercial launch of Seaguard Prime in the US beginning in the first half of 2025.
Speaker Change: As remarkable as these results are, it is important to note that they also closely mirror the results we've seen across multiple studies.
Speaker Change: involving over 1,100 patients in the published peer-reviewed literature showing that similarity of excellent patient outcomes can be achieved with C-Guard in real-world treatment as we've seen in this FDA IDE trial.
Marvin Slosman: With this data in hand, we're on track to submit a premarket approval application, or PMA, to the FDA this quarter, which, if approved, would allow us to execute on a robust commercial launch of Cigar Prime in the U.S. beginning in the first half of 2025. C-Guard's foundation of more than 55,000 devices sold to date has consistently demonstrated superior short and long-term patient outcomes, which we believe has the potential to catalyze C-Guard as the gold standard carotid implant.
Marvin Slosman: Seaguard demonstrated superior short and long-term patient outcomes, which we believe has the potential to catalyze Seaguard as the gold standard crotted implant. The presentation of these one-year results also triggered the first of four milestone-based financings pursuant to the transformational private placement of up to $113.6 million we announced in May of 2023. We were pleased to announce just a few weeks ago the full exercise of Series H warrants, which were a 17.9 million dollars in gross proceeds for the company. We are very grateful to the highly regarded institutional investors who continue to show their support for our company and our vision, including Marshall Waste, Orby Med, Rosalyn, Nanahala, Solius, Valin, as well as members of our Board of Directors.
Marvin Slosman: The presentation of these one-year results also triggered the first of four milestone-based financings pursuant to the transformational private placement of up to $113.6 million we announced in May of 2023. We were pleased to announce just a few weeks ago the full exercise of Series H warrants, which raised $17.9 million in gross proceeds for the company.
Marvin Slosman: We're very grateful to the highly regarded institutional investors who continue to show their support for our company and our vision, including Marshall Weiss, Orvi Med, Rosalyn Nanihala, Solius Vellon, as well as members of our board of directors. We continue to work tirelessly to achieve additional significant milestones, which would trigger the three remaining tranches and bring in an additional gross proceeds of $53.7 million. These milestones include, number one, an announcement of receipt of pre-market approval, PMA, from the FDA for the Seaguard Prime carotid system, which we are targeting for the first half of next year.
Speaker Change: We are very grateful to the highly regarded institutional investors who continue to show their support for our company and our vision, including Marshall Weiss, Orvi Med, Rosalyn Nanahala, Solius, Vellon, as well as members of our board of directors.
Marvin Slosman: We continue to work tirelessly to achieve additional significant milestones, which would trigger the three remaining tranches and bring in an additional gross proceeds of $53.7 million.
Speaker Change: We continue to work tirelessly to achieve additional significant milestones, which would trigger the three remaining tranches and bring in an additional gross proceeds of $53.7 million.
Marvin Slosman: Number two, receipt of FDA clearance for SwitchGuard TCAR kit to include our Seaguard Prime stent. And number three, the completion of four quarters of commercial sales of Seaguard in the United States, which we anticipate in the back half of 2026. Turning now to an update on our U.S. commercial preparedness activity. We are working with one of the leading medtech search firms, the Mullings Group, to accelerate the build-out of our world-class operations and commercial teams.
Marvin Slosman: These milestones include, number one, an announcement of receipt of pre-market approval (PMA) from the FDA for the Seaguard Prime Crotted System, which we are targeting for the first half of next year. Number two, receipt of FDA clearance for Switch Guard T-CAR kit to include our Seaguard Prime Stand. And number three, the completion of four quarters of commercial sales of Seaguard in the United States, which we anticipate in the back half of 2026.
Speaker Change: Number two, receipt of FDA clearance for SwitchGuard TCAR kit to include our Seaguard Prime stent. And number three, the completion of four quarters of commercial sales of Seaguard in the United States, which we anticipate in the back half of 2026.
Marvin Slosman: Turning now to an update on our U.S. commercial preparedness activities. We engage with one of the leading MedTech search firms, the Mullings Group, to accelerate the build-out of our world-class operations and commercial teams. This process is ongoing, and we are very pleased to be onboarding several high-caliber candidates for critical roles to prepare the business for a robust market launch. We have also previously announced we will be establishing the U.S. headquarters in Southeast Florida, including production capacity and customer training and support. Our growing leadership team will drive execution and launching our C-Guard Prime in the U.S.
Marvin Slosman: This process is ongoing, and we are very pleased to be onboarding several high-caliber candidates for critical roles to prepare the business for a robust market launch. We have also previously announced we will be establishing a U.S. headquarters in Southeast Florida, including production capacity and customer training and support.
Speaker Change: This process is ongoing, and we are very pleased to be onboarding several high-caliber candidates for critical roles to prepare the business for a robust market launch.
Speaker Change: We have also previously announced we will be establishing a U.S. headquarters in southeast Florida, including production capacity and customer training and support.
Marvin Slosman: Our growing leadership team will drive execution and launch our Seaguard Prime in the U.S. market with world-class operations, sales, and sales support for both our CAS and TCAR programs. 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 allow us to offer a complete TCAR toolset with As a reminder, the SwitchGuard NPST card platform 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.
Speaker Change: Our growing leadership team will drive execution and launching our Seaguard Prime in the U.S. market with world-class operations, sales, and sales support for both our CAS and TCAR programs.
Marvin Slosman: market with world-class operations, sales and sales support for both our CAS and T-Car programs. Our plan to study and submit our C-Guard neuroprotection system, accessory kit and C-Guard T-Car compatible stent platform remains on track and is cleared will allow us to offer a complete T-Car tool set with next-generation enhancements, including the best-performing implant and C-Guard Prime. As a reminder, the C-Guard NPST-Card platform is designed to prevent symbolic debris generated during a crowded stenting procedure from traveling to the brain, passing the blood during integrated filter and returning it to the patient in a closed circuit to minimize blood loss during the procedure.
Speaker Change: 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 allow us to offer a complete TCAR toolset with next-generation enhancements, including the best-performing implant and Seaguard Prime.
Speaker Change: As a reminder, the SwitchGuard NPST card platform 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.
Marvin Slosman: Both SeaGuardians2 and SeaGuardians3 remain on track for submission and clinical enrollment from previous guidance. As we've said before, our ongoing investment in both CAS and TCAR products and programs was intended to address the broadest physician base performing carotid revascularization and was done anticipating a time when product innovation and procedural reimbursement further shifted the tides toward an endovascular first standard of care. Last year marked the beginning of what we believe is a shift toward a stent-first approach, ignited by CMS's Final National Coverage Determination in October, which expanded coverage of CAS and TCAR to include both asymptomatic and standard risk patients.
Marvin Slosman: Both C-Guardians 2 and C-Guardians 3 remain on track for submission and clinical enrollment from previous guidance. As we said before, our ongoing investment in both CAS and T-Car products and programs was intended to address the broadest physician base performing carotid revascularization and was done anticipating a time when product innovation and procedural reimbursement further shifted the tides toward an endovascular-first standard of care. Last year marked the beginning of what we believe is a shift toward a Stent First approach ignited by CMS's final national coverage determination in October, which expanded coverage of CAS and T-Car to include both asymptomatic and standard risk patients.
Speaker Change: Both SeaGuardians2 and SeaGuardians3 remain on track for submission and clinical enrollment from previous guidance.
Speaker Change: As we've said before, our ongoing investment in both CAAS and TCAR products and programs
Speaker Change: was intended to address the broadest physician base performing carotid revascularization and was done anticipating a time when product innovation and procedural reimbursement further shifted the tides toward an endovascular-first standard of care.
Speaker Change: Last year marked the beginning of what we believe is a shift toward a stent-first approach, ignited by CMS's final national coverage determination in October , which expanded coverage of CAS and TCAR to include both asymptomatic and standard risk patients.
Marvin Slosman: With a best-in-class implant and C-Guard, we believe we're very well positioned to be the leader in this C-Change.
Marvin Slosman: With a best-in-class implant and C-guard, we believe we're very well positioned to be the leader in this sea change. I would now like to provide a brief update on the ongoing CREST-2 clinical trial. CREST-2 enrollment and randomization of 1,240 subjects across 142 trial sites in the United States, Canada, Spain, and Israel evaluating transfemoral stenting, or CAST, plus intensive medical management, IMM, versus IMM alone, while also evaluating carotid endarterectomy plus IMM versus IMM alone. The primary endpoint is the composite of any stroke and death within 44 days following randomization, and stroke it's a lateral, to the target vessel thereafter, up to four years.
Speaker Change: With a best-in-class implant and C-guard, we believe we're very well positioned to be the leader in this sea change.
Marvin Slosman: I would now like to provide a brief update on the ongoing Crest2 clinical trial. Crest2 enrollment and randomization of 1240 subjects across 142 trial sites in the United States, Canada, Spain, and Israel, evaluating transdemoral stenting or CAS, plus intensive medical management (IMM), versus IMM alone, while also evaluating carotid endorectomy, plus IMM, versus IMM alone. The primary endpoint is the composite of any stroke and death within 44 days following randomization, and stroke its collateral to the target vessel thereafter up to four years. This week we announced that enrollment in these trials was now complete, a tremendous milestone for Crest2, and we're very pleased to have had C-Guard included as the only investigational device approved by the FDA and used in 23 cases, despite being introduced late into the enrollment process with 82 percent complete at the time.
Marvin Slosman: This week we announced that enrollment in these trials has now completed, a tremendous milestone for CREST-2. And we are very pleased to have had C-Guard included as the only investigational device approved by FDA and used in 23 cases, despite being introduced late into the enrollment process with 82% complete at the time. We extend our congratulations to Drs. Brott, Messiah, and Lahl, along with the entire CREST-2 Executive Committee, investigators, and sites in completing this tremendous study and appreciate the opportunity to have contributed with our next-generation C-Guard carotid stent platform.
Speaker Change: I would now like to provide a brief update on the ongoing CREST-2 clinical trial.
Speaker Change: CREST-2 enrollment and randomization of 1,240 subjects across 142 trial sites in the United States, Canada, Spain, and Israel evaluating transfemoral stenting or CAF
Speaker Change: plus intensive medical management, IMM, versus IMM alone.
Speaker Change: while also evaluating carotid endarterectomy plus IMM versus IMM alone. The primary endpoint is the composite of any stroke and death within 44 days following randomization and stroke it's a lateral.
Speaker Change: to the target vessel thereafter up to four years. This week we announced that enrollment in these trials was now complete, a tremendous milestone for CREST-2.
Speaker Change: And we are very pleased to have had C-Guard included as the only investigational device approved by FDA and used in 23 cases, despite being introduced late into the enrollment process with 82% complete at the time.
Marvin Slosman: We extend our congratulations to Dr. Brott, Dr. Masea, and Dr. Law, along with the entire Crest II Executive Committee, investigators, and sites in completing this tremendous study, and appreciate the opportunity to have contributed with our next-generation C-Guard carotid stand platform.
Marvin Slosman: Turning now to our pipeline of expansion initiatives, we previously announced that we entered into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo and Dr. Adnan Sidiqi, Vice Chairman and Professor of Neurosurgery, to conduct an early feasibility study of C-Guard Prime for severe carotid stenosis and occlusion in conjunction with thrombectomy and patients presenting with acute ischemic stroke and tandem lesions. As a reminder, C-Guard Prime, with its proprietary micronet mesh, is designed to provide superior and ball of prevention during the carotid artery stenting, and we believe that this study will demonstrate safety and feasibility of using our stand in these acute stroke procedures.
Marvin Slosman: Turning now to our pipeline of expansion initiatives, we previously announced that we entered into a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo and Dr. Adnan Siddiqui, Vice Chairman and Professor of Neurosurgery, to conduct an early feasibility study of C-Guard Prime for severe carotid stenosis and occlusion in conjunction with thrombectomy in patients presenting with acute As a reminder, Seaguard Prime, with its proprietary Micronet mesh, is designed to provide superior embolic prevention during carotid artery stenting, and 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 strong commitment to the neuroscience community and represents a critical component of our long-term growth strategy. We anticipate that the first patient will be enrolled this quarter.
Speaker Change: Turning now to our Pipeline of Expansion Initiatives.
Marvin Slosman: Our investment in this study reflects our strong commitment to the neurocommunity and represents a critical component of our long-term growth strategy. We anticipated the first patient will be enrolled this quarter.
Speaker Change: Our investment in this study reflects our strong commitment to the neuro community and represents a critical component of our long-term growth strategy. We anticipate that the first patient will be enrolled this quarter.
Marvin Slosman: Finally, we're pleased to announce total C-Guard revenue for the quarter was $1.74 million, representing a growth of 5.4% over the second quarter of last year, including a significant growth quarter in production of devices to meet anticipated market demand. We sold 2,969 C-Guard implants during the quarter, representing growth of nearly 6% over the same period last year. As we approach our potential approval for C-Guard in the U.S., it is worth noting for context the difference in top line revenue of our current served markets outside the U.S. and the potential of how these quarterly results would have translated in U.S.
Marvin Slosman: Finally, we're pleased to announce total Seaguard revenue for the quarter was $1.74 million, representing a growth of 5.4% over the second quarter of last year, including a significant growth quarter in production of devices to meet anticipated market demand. We sold 2,969 C-guard implants during the quarter, representing growth of nearly 6% over the same period last year. As we approach our potential approval for SeaGuard in the U.S., it is worth noting for context the difference in top-line revenue of our current served markets outside the U.S. and the potential of how these quarterly results would have translated into U.S. revenue.
Speaker Change: We sold 2,969 C-guard implants during the quarter, representing growth of nearly 6% over the same period last year.
Marvin Slosman: revenue. Outside the U.S., we compete in a much smaller cast market of approximately 40,000 total procedures versus 155,000 in the U.S. Without reimbursement for T-CAR, pricing pressure through low reimbursement of an average sales price of $1,100 and distribution through channel partners resulting in a $600 transfer price per system. Despite these limitations, our investment in these 30 markets has enabled us to build an incredible foundation of best-in-class results, establishing a new standard of care for crowded intervention with double-digit chair in all markets served, along with the most robust clinical evidence in studies of over 1,100 patients, having sold over 55,000 devices to date.
Marvin Slosman: Outside the U.S., we compete in a much smaller CAS market of approximately 40,000 total procedures versus 155,000 in the U.S. Without reimbursement for TCAR, pricing pressure through low reimbursement of an average sales price of $1,100, and distribution through channel partners resulting in a $600 transfer price per system.
Speaker Change: Outside the U.S. we compete in a much smaller CAS market of approximately 40,000 total procedures versus 155,000 in the U.S.
Marvin Slosman: Despite these limitations, our investment in these 30 markets has enabled us to build an incredible foundation of best-in-class results, establishing a new standard of care for carotid intervention with double-digit share in all markets served, along with the most robust clinical evidence and studies of over 1,100 patients, having sold over 55,000 devices to date. As we approach possible FDA approval in the first half of 2025, it's worth a comparison of how our current unit volume would translate to top-line revenue.
Speaker Change: along with the most robust clinical evidence in studies of over 1,100 patients having sold over 55,000 devices to date.
Marvin Slosman: As we approach the possible FDA approval in the first half of 2025, it is worth a comparison of how our current unit volume would translate to top line revenue. On $2,969 sold in the U.S., revenues would have been approximately $13.6 million for the quarter, assuming an equal mix of cast and T-CAR sales at current ASPs. Further, to put these nearly 3,000 quarterly stents in perspective, we have a competitor with a T-CAR-only business that reported $48.5 million in revenue on 6,700 procedures last quarter. So, in terms of patients treated, our device would have treated nearly half the number of patients that they did without our device having even entered the U.S.
Marvin Slosman: On $2,969.00 sold in the US, revenues would have been approximately $13.6 million for the quarter, assuming an equal mix of CAF and TCAR sales at current ASPs. Further, to put these nearly 3,000 quarterly stents in perspective, we have a competitor with a key car only business that reported $48.5 million in revenue on 6,700 procedures last quarter. So in terms of patients treated, our device would have treated nearly half the number of patients that they did without our device having even entered the U.S. market.
Speaker Change: On $2,969 sold in the U.S., revenues would have been approximately $13.6 million for the quarter, assuming an equal mix of CAF and TCAR sales at current ASPs.
Speaker Change: Further, to put these nearly 3,000 quarterly stents in perspective, we have a competitor with a key car only business that reported $48.5 million in revenue on 6,700 procedures last quarter.
Speaker Change: So in terms of patients treated, our device would have treated nearly half the number of patients that they did without our device having even entered the U.S. market.
Marvin Slosman: market. So we believe that our entry into the US market, along with the future introduction of our switch guard NPS, sets us up very favorably for significant revenue growth beginning next year.
Marvin Slosman: So we believe that our entry into the U.S. market, along with the future introduction of our SwitchGuard NPS, sets us up very favorably for significant revenue growth beginning next year. We know how to create and service demand, are building a world-class commercial team, and are thrilled about the opportunity to enter the biggest carotid market in the world. At this point, I'll turn the call over to Craig to review the financials. Craig? Thanks.
Speaker Change: So we believe that our entry into the U.S. market, along with the future introduction of our SwitchGuard NPS, sets us up very favorably for significant revenue growth beginning next year.
Marvin Slosman: We know how to create and serve a demand, are building a world-class commercial team, and are thrilled about the opportunity to enter the biggest carotid market in the world.
Speaker Change: We know how to create and service demand, are building a world-class commercial team, and are thrilled about the opportunity to enter the biggest carotid market in the world. At this point, I'll turn the call over to Craig to review the financials. Craig?
Craig Shore: At this point, I'll turn the call over to Craig to review the financials. Craig. Thanks, Marvin. For the second quarter ended June 30th, 2024, revenue increased by $90,000 or 5.4%. To $1,739,000 from $1,649,000 during the second quarter ended June 30th, 2023. This increase was driven by growth in existing and new markets, offsetting a decrease in clinical trial revenue, driven by the completion of the Seaguardians enrollment in June of last year.
Craig Shore: Thanks, Marvin. For the second quarter ended June 30th, 2024, revenue increased by $90,000, or 5.4%, to $1,739,000 from $1,649,000 during the second quarter ended June 30th, 2023. This increase was driven by growth in existing and new markets, offsetting a decrease in clinical trial revenue driven by the completion of Sea Guardian's enrollment in June of last year. However, with a few months into June 30, 2024, gross profit decreased by $160,000 or 32.6% to $331,000 from $491,000 during the equivalent period last year.
Craig: Thanks, Marvin. For the second quarter ended June 30th, 2024, revenue increased by $90,000 or 5.4%.
Craig: to $1,739,000 from $1,649,000 during the second quarter ended June 30, 2023.
Craig: This increase was driven by growth in existing and new markets, offsetting a decrease in clinical trial revenue driven by the completion of Sea Guardian's enrollment in June of last year.
Craig Shore: For the two-on-cented June 30th, 2024, growth profit decreased by $160,000 or 32.6% to $331,000 from $491,000 during the equivalent period last year. This decrease in growth profit resulted from an increase in material labor costs, mainly due to compensation expense for new and current employees. By-ersale volume, additional space to build capacity for anticipated increased volume requirements, and additional training expenses as we begin the scale or capacity to accommodate the planned U.S. launch beginning next year, offset by an increase in revenue.
Speaker Change: For the three months ended June 30th, 2024, gross profit decreased by $160,000 or 32.6% to $331,000 from $491,000 during the equivalent period last year.
Craig Shore: This decrease in gross profit resulted from an increase in material labor costs, mainly due to compensation expense for new and current employees. Higher sales volume, additional space to build capacity for anticipated increased volume requirements, and additional training expenses as we begin to scale our capacity to accommodate the planned U.S. launch beginning next year, were offset by an increase in revenue. Gross margin decreased to 19% during the three months ended June 30, 2024, and 29.8% during the three months ended June 30, 2023, driven by the factors just mentioned.
Speaker Change: This decrease in gross profit resulted from an increase in material labor costs mainly due to compensation expense.
Speaker Change: for new and current employees.
Speaker Change: higher sales volume, additional space to build capacity for anticipated increased volume requirements, and additional training expenses as we begin to scale our capacity.
Speaker Change: to accommodate the planned U.S. launch beginning next year, offset by an increase in revenue. Gross margin decreased to 19% during the three months ended June 30, 2024, from 29.8% during the three months ended June 30,
Craig Shore: Growth margin decreased to 19% during the three-month end of June 30th, 2024, from 29.8% during the three-month end of June 30th, 2023, driven by the factors just mentioned.
Speaker Change: 2023, driven by the factors just mentioned.
Craig Shore: Total operating expenses for the second quarter of 2024 were $8,591,000 and increased to $2,785,000, or 48%, compared to the $5,806,000 for the second quarter of 2023. This increase was primarily due to an increase in compensation and development expenses, with the vast majority being non-cash-share-based compensation-related expenses.
Craig Shore: Total operating expenses for the second quarter of 2024 were $8,591,000, an increase of $2,785,000, or 48%, compared to $5,806,000 for the second quarter of 2023. This increase was primarily due to an increase in compensation and development expenses, with the vast majority being non-cash share-based compensation related expenses. The net loss for the second quarter of 2024 totaled $7,909,000 or $0.22 per basic and diluted share compared to a net loss of $5,077,000 or $0.24 per basic and diluted share for the same period in 2023.
Speaker Change: Total operating expenses for the second quarter of 2024 were $8,591,000, an increase of $2,785,000.
Speaker Change: or 48% compared to the $5,806,000 for the second quarter of 2023. This increase was primarily due to an increase in compensation and development expenses, with the vast majority being non-cash, share-based compensation-related expenses.
Craig Shore: Net loss for the second quarter of 2024 totaled $7,909,000, or 22 cents for basic and diluted share, compared to a net loss of $5,777,000, or 24 cents for basic and diluted share for the same period in 2023.
Speaker Change: Net loss for the second quarter of 2024 totaled $7,909,000 or $0.22
Speaker Change: for basic and diluted share compared to a net loss of $5,077,000 or 24 cents per basic and diluted share for the same period in 2023.
Craig Shore: As of June 30th, 2024, cash equivalents and marketable securities were $47.2 million compared to $39,000,000 as of December 31st, 2023. This includes gross proceeds of $17.9 million from the exercise of the Series H warrants related to the announcement of the one-year follow-up from the Cigarians' pivotal trial.
Craig Shore: As of June 30, 2024, cash, cash equivalents, and marketable securities were $47.2 million compared to $39 million as of December 31, 2023. This includes gross proceeds of $17.9 million from the exercise of the Series H warrants related to the announcement of the one-year follow-up from the Sea Guardians Pivotal Trial. This concludes our prepared remarks. We will now open up the call to questions, Operator.
Speaker Change: As of June 30, 2024, cash, cash equivalents, and marketable securities were $47.2 million compared to $39 million as of December 31, 2023.
Speaker Change: This includes gross proceeds of $17.9 million from the exercise of the Series H warrants related to the announcement of the one-year follow-up from the Sea Guardians Pivotal Trial.
Unknown Executive: This concludes our prepared remarks.
Operator: We will now open up the call for questions. Thank you. And at this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may remove yourself from the queue at any time by pressing star and two. And we will pause for a moment to allow questions to queue.
Speaker Change: This concludes our prepared remarks. We will now open up the call for questions. Operator.
Operator: And at this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may remove yourself from the queue at any time by pressing star and two. We will pause for a moment to allow questions to queue. And we will take our first question from Adam Maeder with Piper Sandler.
Speaker Change: Thank you. And at this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may remove yourself from the queue at any time by pressing star and two. And we will pause for a moment to allow questions to queue.
Adam Maeder: And we will take our first question from Adam Maeder with Piper Sandler. Hi, good morning, guys. Thanks for taking the questions here. Congrats on the progress. Apologies. I always have been some technical issues. So you may have covered some of this in the previous remarks, Marvin. But you know, I guess the first question I wanted to ask was just around the full data from Steve Guardians that was presented at Link. I'm curious; you know, what type of feedback you've gotten thus far. You know, obviously very low adverse event rates on the composite primary endpoint, you know, both at 30 days and one year.
Speaker Change: And we will take our first question from Adam Maeder with Piper Sandler.
Adam Maeder: Hi, good morning guys. Thanks for taking the questions here. Congratulations on the progress. Apologies, I was having some technical issues.
Adam Mader: Hi, good morning guys. Thanks for taking the questions here.
Adam Mader: Congrats on the progress. Apologies. I was having some technical issues. So you may have covered some of this in the previous remarks, Marvin, but you know, I guess the first question I wanted to ask was
Speaker Change: Just around the the full data from Sea Guardians that was presented at length. I'm curious
Adam Maeder: So you may have covered some of this in your prepared remarks, Marvin, but, you know, the first question I wanted to ask was just around the full data from SeaGuardians that was presented at LINC. I'm curious, you know, what type of feedback you've gotten thus far, obviously very low adverse event rates on the composite primary endpoint, you know, both at 30 days and one year. I think that's straightforward. But, you know, I'm curious if there are other subtleties in the data that you think are worth kind of mentioning or calling out for investors. And then I had a handful of follow-up questions.
Speaker Change: You know, what type of feedback you've gotten thus far, you know, obviously very low adverse event rates on the composite primary endpoint, you know, both at 30 days and 1 year. I think that's straightforward, but.
Marvin Slosman: I think that's straightforward. But you know, I'm curious if there are other subtleties in the data that you think are worth kind of mentioning or calling out for investors. And then I had a handful of follow-ups. Thanks. Yeah, thanks for the question, Adam. Obviously, we're pleased with the data as best in class and really first-time results. I think the thing that was remarkable to us as well was just the consistency of that data as compared to our ongoing trials outside the US and our real-world experience. You know, so in addition to being able to, I think continue to bolster our confidence that we'll be able to get approval with these kinds of results and focused on the FDA effort.
Speaker Change: I'm curious if there's other subtleties in the data that you think are worth kind of mentioning or calling out for investors, and I had a handful of follow-ups. Thanks.
Marvin Slosman: Yeah, thanks for the question, Adam. Obviously, we're pleased with the data as best-in-class and really first-time results. I think the thing that was remarkable to us as well was just the consistency of that data as it compared to our ongoing trials outside the U.S. and our real-world experience. You know, so in addition to being able to, I think, continue to bolster our confidence that we'll be able to get approval with these kinds of results and focused on the FDA effort, we're also pleased with just the overall consistency, having sold a lot of So, I think, on balance, we were pleased on all those levels.
Speaker Change: Yeah, thanks for the question, Adam. Obviously, we're pleased with the data as best-in-class and really first-time results.
Speaker Change: I think the thing that was remarkable to us as well was just the consistency of that data as it compared to our ongoing trials outside the U.S. and our real-world experience.
Speaker Change: You know, so in addition to being able to, I think, continue to bolster our confidence that we'll be able to get approval with these kinds of results and focused on the FDA effort.
Marvin Slosman: We're also pleased with just the overall consistency, having sold a lot of stents and study them in markets outside of the US work. So I think, on balance, we were pleased on all those levels.
Speaker Change: We're also pleased with just the overall consistency, having sold a lot of stents and studied them in markets outside of the U.S. work. So, I think on balance, we were pleased on all those levels.
Unknown Executive: Yeah, that's good color. Appreciate that.
Marvin Slosman: That's a good color. I appreciate that.
Marvin Slosman: And then I wanted to pivot over to the US launch. And you know, specifically, you know, ask about kind of the US Salesforce hiring process. And, you know, I'm going to lump this in for Craig to just kind of op-ex spend going forward. So, you know, just remind us how you're thinking about US commercialization and head count, proceed our launch in the first half of 25. And how do we think about kind of the op-ex spend as we, you know, go forward in subsequent quarters? Well, I think it is the question, the right question that we've all been asking and working on hard within the company.
Speaker Change: That's good color. Appreciate that. And then I wanted to pivot over to the
Adam Maeder: And then I wanted to pivot over to the US launch and, you know, specifically ask about kind of the U.S. Salesforce hiring process and, you know, I'm going to lump this in for Craig to just kind of op-ex spend going forward. So, you know, just remind us how you're thinking about US commercialization and headcount for SeaGuard launch in the first half of 25. And how do we think about the kind of the op-ex spend as we, you know, go forward in subsequent quarters?
Speaker Change: to US launch and, you know, specifically.
Speaker Change: you know, ask about kind of the the US salesforce hiring process. And, you know, I'm going to lump this in for
Speaker Change: For Craig too, just kind of OPEX spend going forward. So, you know, just remind us how you're thinking about U.S. commercialization and headcount for Sea Guard launch in the first half of 2025.
Speaker Change: And how do we think about kind of the OPEX spend as we, you know, go forward in subsequent quarters?
Marvin Slosman: Well, I think it is the question, the right question that we've all been asking and working on hard within the company. All of our focus right now is on US readiness, not just commercially but operationally as well. We have established a great relationship with a couple of recruiting firms. I think the inbound interest in joining our company has also been overwhelming, which has been great. So I think we've got a great talent pool set up to both produce, support, and launch the product in the US.
Speaker Change: Well, I think it is the question, the right question that we've all been asking and working on hard within the company. All of our focus right now is on U.S. readiness, not just commercially, but operationally as well. We established a great relationship with a couple of recruiting firms.
Marvin Slosman: All of our focus right now is on US readiness, not just commercially, but operationally as well. We established a great relationship with a couple of recruiting firms. I think the inbound interest in joining our company has also been overwhelming, which has been great. So I think we've got a great talent pool set up to both produce support and launch the product in the US. And over the next several months, we'll be building that and adding that. Obviously, the timing of this is important, especially on an op-ex basis. We want to time our hires appropriately and get the right infrastructure in place as well.
Speaker Change: I think the inbound interest in joining our company has also been overwhelming, which has been great.
Speaker Change: So I think we've got a great talent pool set up to both produce, support, and launch the product in the US. And over the next several months, we'll be building that and adding that. Obviously, the timing of this is important, especially on an OpEx basis.
Marvin Slosman: And over the next several months, we'll be building on that and adding to it. Obviously, the timing of this is important, especially on an OpEx basis. We want to time our hires appropriately and get the right infrastructure in place as well. We announced a US-based headquarters in Southeast Florida. We're beginning to build that process out. So I think, on balance, we're trying to be ready for an appropriate, aggressive launch of the product when we get approval without overspending in the process. But I would say that in terms of talent, access, and availability, we've been really overwhelmed by the levels of interest and quality of talent. So we're pleased by that and looking forward to adding more.
Speaker Change: We want to time our hires appropriately and get the right infrastructure in place as well. We announced a U.S.-based headquarters in southeast Florida. We're beginning to build that process out. So I think on balance, we're trying to...
Marvin Slosman: We announced a US-based headquarters in Southeast Florida. We're beginning to build that process out. So I think, on balance, we're trying to be ready for an appropriate aggressive launch of the product when we get approval, without overspending in the process. But I would say that in terms of talent and access and availability, we've been really overwhelmed by the levels of interest and quality of talent. So we're pleased by that and looking forward to adding those people to the team.
Speaker Change: Be ready for an appropriate aggressive launch of the product when we get approval without overspending in the process But I would say that
Speaker Change: In terms of talent and access and availability, we've been really overwhelmed by the levels of interest and quality of talent, so we're pleased by that and looking forward to adding those people to the team.
Craig Shore: Yeah, I am. Hi Adam, it's Craig.
Craig Shore: Yeah, I am. Yeah, good. Hi, Adam. It's Craig. So, in regards to your question about operating expenses, there's two things going on right now. One is our C guardians; two and C guardians; three trial that will be starting shortly. And that's also going to add to our operating expenses in addition to the US readiness. Shane, for example, we'll be adding sales people, but we also have to be ready to start being able to produce in the United States as long as we just signed a lease for our US operations. So we should be saying, you know, an increase, maybe 30 to 40% on average next year over this year, which takes into account all those pieces that I guess mentioned.
Marvin Slosman: That's helpful, Marvin. Yeah, I am.
Craig: Hi Adam, it's Craig.
Craig Shore: So in regards to your question about operating expenses, there are two things going on right now. One is our Sea Guardians II and Sea Guardians III trials that we'll be starting shortly. And that's also gonna add to our operating expenses in addition to U.S. readiness. Shane, for example, will be adding salespeople, but we also have to be ready to start being able to produce in the United States as well. And also, we just signed a lease for our U.S. operations.
Speaker Change: So in regards to your question about operating expenses, there's two things going on right now. One is our Sea Guardians 2 and Sea Guardians 3 trial that will be starting shortly.
Speaker Change: And that's also going to add to our operating expenses in addition to the U.S. readiness.
Speaker Change: Shane, for example, will be adding salespeople, but we also have to be ready to start being able to produce in the United States as well, and also we just signed a lease for our U.S. operations.
Craig Shore: So we should be seeing, you know, an increase of maybe 30 to 40% on average next year over this year, which takes into account all those pieces that I just mentioned. It's helpful, Craig. Thanks for the incremental color there and quantifying it.
Speaker Change: So we should be seeing, you know, an increase, maybe 30 to 40 percent on average next year over this year, which takes into account all those pieces that I just mentioned.
Unknown Executive: It's helpful, Craig; thanks for the incremental color there and quantifying it. Okay, great.
Speaker Change: It's helpful, Craig. Thanks for the incremental color there and quantifying it.
Adam Maeder: Okay, great. And, I guess just wanted to now ask about the Guardians for the TCAR study, you know, I think I saw or heard you in the prepared remarks, that's expected to commence and enrollment in the back half of this year. Just curious if you can kind of give any more. Craig Shore, Unknown Executive, Craig Shore, Unknown Executive, Craig Shore, Unknown Executive. That's out there, but just wondering kind of what the receptivity has been to a potential second key card, player, I guess I should say. Yeah. Thanks.
Adam Maeder: And I guess just wanted to now ask about C guardians, two, the T Carr study. You know, I think I saw or heard you in the preferred remarks, you know, that's expected to commence enrollment in the back half of this year. You know, just curious if you can kind of give any more color around the trial design, number of patients, like the follow up. And then I would also just love to hear some thoughts about the interest in working with Inspire MD to the extent that you can share. You know, obviously there's a size of a T Carr player in the market today.
Speaker Change: Okay, great. And I guess just wanted to now ask about
Speaker Change: Sea Guardians 2, the TCAR study.
Speaker Change: You know, I think I saw or heard you in the prepared remarks, you know, that's expected to to commence and enrollment in the back half of this year, you know, just curious if you can kind of give any more.
Speaker Change: You know color around the trial design number of patients like the follow-up
Speaker Change: And then I would also just love to hear some thoughts, you know, about the interest in working with InspireMD to the extent that you can share. You know, obviously, there's a sizable key car player in the market today. You know, that's.
Marvin Slosman: You know, that's out there, but just wondering kind of what the receptivity is bound to a potential second T Carr competitor player, I guess I should say. Yeah, thanks. Thanks, Adam. Great, great question. Let's start with the end question there. I think we've been overwhelmed at the amount of enthusiasm and interest by the vascular surgery community, in particular. We had a great SPS meeting, and we're just again overwhelmed by the number of vascular surgeons that are interested in not only participating in the study effort, but looking forward to the next generation, best in class stand platform, as well as an NPS system and switch guard, which also brings next generation technology to them.
Speaker Change: That's out there, but just wondering kind of what the receptivity has been to a potential second TCAR competitor, player, I guess I should say. Yeah. Thanks.
Adam Maeder: Thanks, Adam. Great, great question. Let's start with the end question there.
Speaker Change: Thanks, Adam. Great, great question. Let's start with the the the end question there I think we've been overwhelmed at the amount of enthusiasm and interest by the vascular surgery community in particular we had a great SBS meeting and we're just again overwhelmed by the number of Vascular surgeons that are interested in not only participating in the study effort But looking forward to the next generation best-in-class stent platform as well as an NPS system and switch guard Which also brings next-generation technology to them
Marvin Slosman: I think we've been overwhelmed by the amount of enthusiasm and interest by the vascular surgery community, in particular. We had a great SVS meeting, and we're just, again, overwhelmed by the number of vascular surgeons that are interested in not only participating in the study effort but looking forward to the next generation best-in-class stent platform as well as an NPS system and switch guard, which also brings next-generation technology to them. So I think on balance that TCAR, you know, continues to be a priority for us as it has been for a long time.
Marvin Slosman: So I think, on balance, T. Carr, you know, continues to be a priority for us, as it has been for a long time. And for both our CAST program and T Carr program, the goal has been to build feature sets and next generation thought and technology into that in order to enable as many C Guardian plants as possible. That’s really been the goal for some time in terms of timing of trial enrollment. And otherwise, we've been in touch with the FDA. We've submitted both of these programs to the FDA and are just waiting for their final approval so that we can get started.
Marvin Slosman: And for both our CAST program and TCAR program, the goal has been to build feature sets and next-generation thought and technology into that in order to enable as many C-guard implants as possible. That's really been the goal for quite some time. In terms of timing of trial enrollment and otherwise, we've been in touch with the FDA. We've submitted both of these programs to the FDA and are just waiting for their final approval so that we can get started, but we've already aligned ourselves with a CRO, and are beginning the process of how we enroll both of these efforts for both the stint with a TCAR indication as well as the broader SwitchGuard NPS kit and do that So all those timelines remain consistent with what we've said before, with no change.
Speaker Change: So I think on balance TCAR, you know, continues to be a priority for us as it has been for a long time. And for both our CAST program and TCAR program, the goal has been to build feature sets and next generation thought and technology into that in order to enable as many C-guard implants as possible. That's really been the goal for quite some time.
Speaker Change: In terms of timing of trial enrollment and otherwise, we've been in touch with the FDA, we've submitted both of these programs to the FDA and are just waiting for their...
Marvin Slosman: Well, we've already aligned ourselves with the CRO and are beginning the process of how we enroll both of these efforts for both the stent with a T Carr indication as well as the broader Switch Guard NPS kit and do that as expeditiously as we can. But also keeping in mind that we want to run a very favorable trial. So all those timelines remain consistent with what we've said before with no change.
Speaker Change: final approval so that we can get started but we've already aligned ourselves with a CRO are beginning the process of how we enroll both of these efforts for both the stint with a TCAR indication as well as the the broader
Speaker Change: SwitchGuard NPS kit and do that as expeditiously as we can, but also keeping in mind that we want to run a very favorable trial. So all those timelines remain consistent with what we've said before with no change.
Unknown Executive: Very helpful, Marvin.
Adam Maeder: Very helpful, Marvin. And if I could squeeze in just one last question, you know, I would be curious to hear a little bit more about Crest for You. And, you know, I saw. The press release from you guys, I think that was earlier this week. The first question is, do you know how the data is going to be presented in the release? Will the data set be bifurcated by stent technology? I guess that is really the question or, or, you know, device manufacturer.
Adam Maeder: And if I could squeeze in just one last question, you know what would be curious to hear a little bit more about Crest2, and you know, I saw the press release for you guys, I think that was earlier this week. You know, I, the first question is do you know, kind of how the data is going to be, you know, presented in, in release. Will the, will the data set be bifurcated by stent technology, I guess, is really the question or for, you know, device manufacturer? So, in other words, will you be able to compare C guard patients and how well they did versus, you know, the other patients in the study?
Speaker Change: Very helpful, Marvin. And if I could squeeze in just one last question, you know, what would be curious to hear a little bit more about crest to and, you know, I saw.
Speaker Change: The press release from you guys, I think that was earlier this week.
Speaker Change: The first question is, do you know how the data is going to be presented and released?
Adam Maeder: So, in other words, will you be able to compare C guard patients and how well they did versus the other patients in the study? I guess, that's the question I'm trying to ask. And then, probably not a fair question, but I'll ask it anyways, do you have a sense for when we could actually see the CREST-2 data presented or released publicly? Thanks so much for taking the time to answer my question.
Speaker Change: Will the dataset be bifurcated by stent technology, I guess, is really the question, or, you know, device manufacturer. So, in other words, will you be able to compare C-Guard patients?
Shane Gleason: I guess is the question I'm trying to ask. And then probably not a fair question, but I'll ask it anyways: do you have a sense for when we could actually see the Crest2 data presented or released publicly? Thanks so much for taking the question, guys. Yeah, thanks, Adam. I'm actually going to hand that off to Shane Gleason, who's here in the room. He's been closest to the, the Crest2 effort to give you the, the answer there. Thanks, Marvin. Good morning, Adam. So, the first analysis we expect to see will not include being split out by stent type.
Speaker Change: and how well they did versus, you know, the other patients in the study, I guess, is the question I'm trying to ask. And then probably not a fair question, but I'll ask it anyways. Do you have a sense for when we could actually see the CREST-2 data presented or released publicly? Thanks so much for taking the question, guys.
Marvin Slosman: Yeah, thanks, Adam. I'm actually going to hand that off to Shane Gleason, who's here in the room. He's been closest to the CREST-2 effort to give you the answer there.
Shane Gleason: Yeah, thanks, Adam. I'm actually going to hand that off to Shane Gleason, who's here in the room. He's been closest to the CREST-2 effort to give you the answer there.
Shane Gleason: Thanks, Marvin. Good morning, Adam.
Shane Gleason: So the first analysis we expect to see will not include being split out by stent type, although we know that they do plan to do that at some point.
Shane Gleason: Thanks, Marvin. Good morning, Adam.
Shane Gleason: So, the first analysis we expect to see will not include being split out by stent type.
Shane Gleason: We know that they do plan to do that at some point. You know, our 23 stents represent one way to look at it. Is that it's only about 4% of overall stent enrollment. So, not enough to really move the needle in terms of overall results. But Marvin also mentioned that we are introduced when 82% of the trial had already been enrolled. So that's over 20% of the stents that were enrolled since then. And I know 13 of those were done in the last five months. So, in terms of the pace of enrollment, we really like how quickly it was adopted by the investigators.
Shane Gleason: One way to look at it is that it's only about 4% of overall stent enrollment, so not enough to really move the needle in terms of overall results. But Marvin also mentioned that we were introduced when 82 percent of the trial had already been enrolled, so that's over 20 percent of the stents that have been enrolled since then. And I know 13 of those were done in the last five months.
Speaker Change: We know that they do plan to do that at some point. You know, our 23 stents represent, one way to look at it is that it's only about 4% of overall stent enrollment. So, not enough to really move the needle in terms of overall results.
Marvin Slosman: But Marvin also mentioned that we were introduced when 82% of the trial had already been enrolled. So that's over 20% of the stents.
Shane Gleason: So in terms of the pace of enrollment, we really like how quickly it was adopted by the investigators. We think that shows really favorably for our entry into the U.S. market since the investigators are among the top CAS sites in the U.S. But back to your original question, our four percent of the overall stents, we expect the overall rates to be low. So we don't anticipate being able to see anything measurably different in the trial results. Certainly nothing that would approach statistical significance.
Speaker Change: that were enrolled since then. And I know 13 of those were done in the last five months. So in terms of the pace of enrollment, we really like how quickly it was adopted by the investigators. We think that shows really favorably for our entry into the U.S. market since
Shane Gleason: We think that shows really favorably for our entry into the US market since the investigators are among the top cast sites in the US. But back to your original question, are 4% of the overall stents. We expect the overall rates to be low. So we don't anticipate being able to see anything measurably different in the trial result. Certainly, nothing that would approach statistical significance. Thanks for the color, Shane.
Shane Gleason: The investigators are among the top CAS sites in the U.S.
Speaker Change: But back to your original question, our 4% of the overall stents, we expect the overall rates to be low, so we don't anticipate being able to see anything measurably different in the trial results, certainly nothing that would approach statistical significance.
Speaker Change: Thanks for the color, Shane.
Frank Toccanon: Thank you. And our next question comes from Frank Toccanon with Lake Street Capital Markets. Great. Thanks for taking the questions.
Operator: Thank you. And our next question comes from Frank Takinen with Lake Street Capital Markets.
Speaker Change: Thank you. And our next question comes from Frank Takinen with Lake Street Capital Markets.
Frank Takinen: Great, thanks for taking the questions. Maybe I'll just piggyback off Adam's questions at the end there on CREST. I was hoping you could kind of give us a broad strokes theory of what the outcomes could look like from that and how that could impact the market. I know there's a theory out there that there's the potential for less treatment of asymptomatic patients. What could something like this do?
Shane Gleason: Maybe I'll just piggyback off Adam's question at the end there on crust. I was hoping you could kind of give us a broad strokes theorization of what the outcomes could look like from that and how that could impact the market. I know there's a theory out there that there's a potential for a less treatment of asymptomatic patients. What could something like this cause to the mix of procedures out there and how you think your physician if this does come to fruition?
Frank Takinen: Great, thanks for taking the questions. Maybe I'll just piggyback off Adam's questions at the end there on CRUST.
Frank Takinen: was hoping you could kind of give us a broad strokes theorization of what the outcomes could look like from that and how that could impact the market. I know there's a theory out there that there's the potential for less treatment of asymptomatic patients. What could something like this
Frank Takinen: cause due to the mix of procedures out there and how you think your position if this does come to fruition.
Speaker Change: cause to the mix of procedures out there and how you think your position if this does come to fruition.
Shane Gleason: Yeah, Frank, this is Shane. I'll go ahead and keep going with the crust here. Thanks for the question. So one thing that we recognize is that there are a very high percentage of patients diagnosed with asymptomatic carotid disease who are not treated today. So the premise of the Crestiast study was that intensive medical management has improved from the early days of cryotid trials, but so is intervention. So what they're really looking at and why they're looking through four years as a primary endpoint is to see if the treatment affect enough to merit doing the procedure upfront, and the better your initial outcomes are, the more likely that is to happen.
Shane Gleason: Frank, this is Shane. I'll go ahead and keep going with Crest here. Thanks for the question. So one thing that we should recognize is that They a very high percentage of patients diagnosed with asymptomatic carotid disease are not treated today. So the premise of the CREST-2 study was that intensive medical management has improved from the early days of carotid trials, but so has intervention. So, what they're really looking at and why they're looking through four years as the primary endpoint is to see if the treatment effect is strong enough to merit doing the procedure up front. And the better your initial outcomes are, the more likely that is to happen.
Shane Gleason: Yeah, Frank, this is Shane. I'll go ahead and keep going with the crests here. Thanks for the question. So, one thing that we recognize is that.
Speaker Change: There are a very high percentage of patients diagnosed with asymptomatic carotid disease are not treated today.
Shane Gleason: So the premise of the CREST-2 study was that
Speaker Change: Intensive medical management has improved from the early days of carotid trials, but so is intervention.
Speaker Change: So what they're really looking at and why they're looking through four years as the primary endpoint is to see is the treatment
Shane Gleason: affect enough to merit doing the procedure up front, and the better your initial outcomes are, the more likely that is to happen.
Shane Gleason: So we know in the Crestiast registry, the event rates were below 3%, and that included symptomatic patients. So we're anticipating that the overall event rates will be low, and therefore intensive medical management won't have a big head start in terms of the initial outcomes. And then through four years, especially with the inclusion of, you know, a step like ours, we know that will do nothing but benefit the results. So if you look at the overall, the possible outcomes, one is that stance don't show an improvement over intensive medical management. And there we think that the market looks like it does today.
Shane Gleason: So we know that in the CREST-2 registry, the event rates were below 3%, and that included symptomatic patients. So we're anticipating that the overall event rates will be low, and therefore, intensive medical management won't have a big head start in terms of initial outcomes. And then through four years, especially with the inclusion of, you know, a stent like ours, we know that will do nothing but benefit the results. So if you look at the overall possible outcomes, one is that stents don't show an improvement over intensive medical management, and there, we think that the market looks like it does today.
Speaker Change: So, we know in the CREST-2 registry, the event rates were below 3%.
Speaker Change: and that included symptomatic patients.
Speaker Change: So, we're anticipating that the overall event rates will be low, and therefore...
Speaker Change: Intensive medical management won't have a big head start in terms of the initial outcomes, and then through four years, especially with the inclusion of, you know, a stent like ours, we know that will do nothing but benefit the results.
Speaker Change: So, if you look at the overall...
Speaker Change: the possible outcomes. One is that stents don't show an improvement over intensive medical management. And there we think that the market looks like it does today. Remember that to be enrolled in the study.
Shane Gleason: Remember that to be enrolled in the study, the investigator has to think that there's clinical acroploias for that patient. In other words, they need to think that that patient may be just as well off with drugs versus an intervention. If it's a patient that the investigator, you know, quote unquote, knows, knows that they need an intervention, that patient is randomized. So I think the majority of the patients that are really being treated in clinical practice today are not the ones being enrolled in Crest 2. So for those that are kind of a jump ball, we don't know if an intervention will benefit them.
Shane Gleason: Remember that to be enrolled in the study, the investigator has to think that there is clinical equipoise for that patient. In other words, they need to think that that patient may be just as well off with drugs versus an intervention. If it's a patient that the investigator, quote-unquote, knows that they need an intervention, that patient isn't randomized. So I think the majority of the patients that are really being treated in clinical practice today are not the ones being enrolled in CREST-2.
Speaker Change: The investigator has to think that there's clinical equipoise for that patient. In other words, they need to think that.
Speaker Change: that patient may be just as well off with drugs versus an intervention. If it's a patient that the investigator, quote-unquote, knows that they need an intervention, that patient isn't randomized.
Speaker Change: So I think the majority of the patients that are really being treated in clinical practice today are not the ones being enrolled in CREST-2.
Shane Gleason: So for those that are kind of a jump ball, we don't know if an intervention will benefit them, those are patients that probably aren't getting interventions today, and that's going to make up the majority of the patients who are enrolled. So really, the net outcome could be very favorable for stenting and for surgery, where more of those patients who are diagnosed but not treated today may be treated in the future. If this comes out looking like where there's not a difference or even where drugs show better, it probably doesn't move the market because it ends up looking a lot like it does already today.
Frank Takinen: Got it. That's a helpful color.
Frank Toccanon: Those are patients that probably aren't getting interventions today. And that's going to make up the majority of the patients who are enrolled. So really, the net outcome could be very favorable for stenting and for surgery, where more of those patients who are diagnosed, but not treated today, may be treated in the future. If this comes out looking like where there's not a difference or even where a drug shows better, it probably doesn't move the market because it ends up looking a lot like it does already today. Yeah, that's a helpful color.
Speaker Change: So for those that are kind of a jump ball, we don't know if an intervention will benefit them.
Speaker Change: Those are patients that probably aren't getting interventions today and that's going to make up the majority of the patients who are enrolled. So really the net outcome could be very favorable for stenting and for surgery where more of those patients who are diagnosed but not treated today may be treated in the future.
Speaker Change: If this comes out looking like where there's not a difference or even where drugs show better, it probably doesn't move the market because it ends up looking a lot like it does already today.
Frank Takinen: And then maybe just one last one on the commercial strategy. I know there's been a fair amount of commentary on it, but I wanted to maybe follow up on one question related to back-to-back conversations. When can you start to have those conversations? And how do you think about getting through the different value analysis committees and after approval during approval or whatever that looks like in 2025?
Marvin Slosman: And then maybe just one last one on the commercial strategy. I know there's been a fair amount of commentary on it, but wanted to maybe follow up on one question related to back conversations. When can you start to have those conversations and how do you think about getting through the different value analysis committees and after approval, during approval, or however that looks in 2025? Great question. We know that entering the U.S. market, but that is the longfall of the 10 frequently. One thing I know is that creating demand with physicians will not be the hardest part of my team's job.
Speaker Change: And then maybe just one last one on the commercial strategy. I know there's been a fair amount of commentary on it, but I wanted to maybe follow up on.
Speaker Change: One question related to VAC conversations. When can you start to have those conversations and how do you think about getting through the different value analysis committees and after approval, during approval, or however that looks in 2025?
Shane Gleason: Great question. We know that entering the U.S. market is the long pole in the tent frequently. You know, one thing I know is that creating demand with physicians will not be the hardest part of my team's job. It will be doing exactly what you just described.
Speaker Change: Great question. We know that entering the U.S. market, but that is the long pole in the tent frequently. You know, one thing I know is that creating demand with physicians will not be the hardest part of my team's job. It will be doing exactly what you just described.
Shane Gleason: But we've had a lot of, I'd say, physicians volunteering to help with the process already due to their enthusiasm for getting the new technology. We are ramping up our IDN outreach efforts now and checking with them to see what we can do and when. Obviously, you can't pre-promote, but in terms of when a new technology is available, how do we get ourselves quickly into the queue and with built-in physician demand where, you know, they won't go to bat for every new device, but the ones they really care about, they will.
Marvin Slosman: It will be doing exactly what you just described, but we've had a lot of, I'd say, physicians volunteering to help with the process already due to their enthusiasm to get the new technology. We are ramping up our IDN outreach efforts presently and checking with them to see what we can do and when. Obviously, you can't pre-promote, but in terms of when a new technology is available, how do we get ourselves quickly into the queue and with built-in physician demand where they won't go to bat for every new device, but the ones they really care about, they will. We're already getting that outreach from physicians who are excited to bring C-Gard crime into their hospitals just from what they're hearing from the podium.
Speaker Change: But we've had a lot of, I'd say, physicians volunteering to help with the process already due to their enthusiasm to get the new technology.
Speaker Change: We are ramping up our IDN outreach efforts presently.
Speaker Change: and checking with them to see what we can do and when. Obviously, you can't pre-promote, but in terms of when a new technology is available, how do we get ourselves quickly into the queue and with built-in physician demand where
Shane Gleason: We're already getting that outreach from physicians who are excited to bring C-guard and C-guard Prime into their hospitals just from what they're hearing from the podium. So, we're doing everything we can to be at the front of the line for those reviews when we get approval. And we plan to have a small team already hired and onboarded at the time of approval out in the field that can move those conversations through quickly.
Speaker Change: You know, they won't go to bat for every new device, but the ones they really care about, they will.
Frank Takinen: Got it. That's helpful. Thanks for taking the questions.
Speaker Change: We're already getting that outreach from physicians who are excited to bring C-Guard, C-Guard Prime.
Marvin Slosman: So, we're doing everything we can to be at the front line for those reviews when we get approval, and we plan to have a small team already hired and onboarded at the time of approval out in the field that can move those conversations very quickly.
Speaker Change: into their hospitals just from what they're hearing from the podium. So
Speaker Change: We're doing everything we can to be at the front of the line for those reviews when we get approval and we plan to have a small team already hired and onboarded at the time of approval out in the field that can move those conversations through quickly.
Marvin Slosman: Thank you for being on the call.
Craig Shore: Thanks, Craig. Thanks for being on the call. I'd like to thank everyone for taking the time to join the call today and for the ongoing support. We're obviously very pleased with our progress through the first half of the year and, with our SeaGuardians data now in hand, believe that we've got line of sight for approval for SeaGuard in the U.S. next year. Thanks for joining us. Thank you. This does conclude today's
Speaker Change: Got it. That's helpful. Thanks for taking the questions.
Speaker Change: Thanks. Thanks, Craig. Thanks for being on the call.
Marvin Slosman: I'd like to thank everyone for taking the time to join the call today and for the ongoing support. We're obviously very pleased with our progress through the first half of the year, and with our C-Guardians data now in hand, believe that we've got line of sight for the approval for C-Guard in the US next year.
Operator: Thank you. This does conclude today's InspireMD second quarter 2024 earnings call. Thank you for your participation. You may disconnect at any time.
Speaker Change: I'd like to thank everyone for taking the time to join the call today and for the ongoing support. We're obviously very pleased with our progress through the first half of the year.
Operator: Thanks for joining. Thank you.
Operator: This does conclude today's Inspire MD 2nd quarter 2024 earnings call. Thank you for your participation. You may disconnect at any time. ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶ ¶
Speaker Change: Thank you. This does conclude today's InspireMD second quarter 2024 earnings call. Thank you for your participation. You may disconnect at any time.
Speaker Change: [inaudible]
Speaker Change: [inaudible]
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