Executive Summary / Key Takeaways

• InspireMD is a medical device company focused on carotid artery disease, leveraging its proprietary MicroNet mesh technology for enhanced embolic protection during stenting procedures.
• The company's CGuard Prime stent system demonstrated best-in-class clinical outcomes in the pivotal C-GUARDIANS trial (1.95% MACE at 1 year), forming the basis for its U.S. FDA Premarket Approval (PMA) submission, now anticipated in Q3 2025.
• A successful U.S. launch of CGuard Prime, supported by a growing U.S. commercial and operational infrastructure, represents the primary near-term catalyst for significant revenue growth, given the large U.S. market size and higher ASPs compared to existing international sales.
• InspireMD is actively expanding its pipeline with TCAR-specific solutions (C-GUARDIANS II/III studies, SwitchGuard NPS) and exploring new indications like acute stroke, aiming to address the broader carotid revascularization market.
• Despite strong clinical data and market opportunity, the company faces significant liquidity challenges, with a history of losses and negative cash flow leading to substantial doubt about its going concern ability, necessitating successful capital raising through milestone-based financings and ATM program.

The MicroNet Difference: Setting a New Standard in Embolic Protection

InspireMD is a medical device company dedicated to improving outcomes for patients with carotid artery disease and other vascular conditions. At the heart of its strategy is the proprietary MicroNet technology, a unique micron mesh sleeve wrapped over a stent. This innovative design is engineered to provide superior embolic protection during stenting procedures, aiming to prevent potentially devastating strokes caused by debris dislodged during the intervention.

The company's flagship product, the CGuard Embolic Prevention System (EPS), combines this MicroNet mesh with a self-expandable nitinol stent. Initially launched in Europe in 2015 after receiving CE Mark approval, CGuard EPS has built a solid foundation in international markets, now sold through distributors in over 30 countries. This international presence, while operating in a smaller market with lower average selling prices compared to the U.S., has allowed InspireMD to accumulate significant real-world experience, with over 64,000 implants sold to date. This operational history and market penetration, achieving double-digit share in served markets, demonstrate the company's ability to generate demand and manage a commercial supply chain, albeit on a smaller scale than the anticipated U.S. opportunity.

The strategic focus has now squarely shifted to the lucrative U.S. market. The pivotal C-GUARDIANS trial, a prospective, multicenter, single-arm study evaluating the safety and efficacy of the CGuard Carotid Stent System (including the next-generation CGuard Prime) in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS), serves as the cornerstone of this U.S. entry strategy. The results from C-GUARDIANS were compelling, demonstrating a major adverse event rate of just 0.95% through 30 days and an unprecedented 1.95% composite rate (30-day DSMI and 31-365 day ipsilateral stroke) through 12 months post-procedure. Management highlights this as the lowest event rate ever reported in a pivotal study for a carotid stent or embolic protection device, providing a strong clinical foundation for the CGuard platform.

This robust clinical data underpins InspireMD's competitive positioning. While larger, more diversified medical device companies like Abbott Laboratories (ABT), Medtronic plc (MDT), and Boston Scientific Corporation (BSX) possess significant scale, broader product portfolios, and extensive distribution networks, InspireMD's MicroNet technology offers a distinct, quantifiable performance advantage in embolic protection. This technological edge, validated by the C-GUARDIANS data, is the company's primary moat against rivals who may offer comparable or superior durability or lower manufacturing costs due to scale. The "so what" for investors is the potential for CGuard Prime to command premium pricing and capture market share, particularly in high-risk patient populations where minimizing stroke risk is paramount, differentiating itself from competitors' more commoditized stent offerings.

Building the U.S. Launch Engine

The path to the U.S. market hinges on securing FDA Premarket Approval (PMA) for the CGuard Prime carotid stent system. The company submitted its PMA application in September 2024, utilizing a modular approach to facilitate the review process. While initially anticipating approval in the first half of 2025, the timeline has been adjusted, with management now optimistic for approval in the third quarter of 2025. This revised timeline is attributed to the scheduling and follow-up required from the facility site audit, which is handled by a different group within the FDA, impacting the overall review window. Despite this slight delay, management expresses confidence in addressing the feedback and achieving approval, noting ongoing interactive engagement with the agency.

In parallel with the regulatory process, InspireMD has been diligently building the necessary infrastructure for a successful U.S. commercial launch. This includes establishing a new global headquarters in Miami, Florida, which will serve as the base for U.S. operations, including potential domestic production capacity to diversify the supply chain and meet anticipated demand. The company is actively recruiting and onboarding a U.S. commercial team, having trained approximately 20 sales and marketing professionals by Q1 2025 and planning to continue adding talent. This team is being equipped with tools like claims data to inform strategic targeting and optimize market penetration. Management emphasizes that they are "not just prepared for launch," but "ready to aggressively execute a comprehensive commercial launch," believing CGuard Prime is "positioned to redefine the treatment of carotid disease and stroke prevention."

The U.S. market opportunity is substantial, significantly larger than the international markets where InspireMD currently operates. The recent CMS National Coverage Determination (NCD) in October 2023, expanding coverage for both CAS and TCAR to include asymptomatic and standard risk patients, has further expanded the addressable market. Management illustrates the potential by benchmarking their international unit sales against estimated U.S. average selling prices (ASPs). For instance, the 2,611 CGuard stents sold internationally in Q1 2025, if sold in the U.S. at current market ASPs (assuming a balanced CAS/TCAR mix), would have generated approximately $12 million in revenue. This compares to the company's actual reported revenue of $1.53 million for the quarter, highlighting the potential revenue uplift upon U.S. market entry. Similarly, Q4 2024 international sales of 3,512 units were benchmarked to over $16 million in potential U.S. revenue, noted as being close to 50% of the U.S.-only TCAR market procedure volume in that quarter, even before NSPR's entry.

Expanding the Endovascular Footprint: TCAR and Beyond

InspireMD's strategic vision extends beyond the initial transfemoral CAS indication for CGuard Prime. The company is actively developing solutions for the growing Transcarotid Artery Revascularization (TCAR) market, which represents a significant opportunity with over 30,000 procedures performed annually in the U.S. This involves a two-pronged clinical strategy:

• C-GUARDIANS II: A pivotal study evaluating the CGuard Prime 80cm carotid stent system for use during TCAR procedures when compatible with commercially available neuroprotection systems. The IDE for this study was approved in October 2024, and enrollment is reported as strong and growing, with anticipated FDA approval in the first half of 2026.
• C-GUARDIANS III: An IDE submission for the investigation of InspireMD's fully integrated TCAR solution, combining the CGuard Prime 80 stent with its proprietary SwitchGuard Neuroprotection System (NPS). Management anticipates FDA approval and initiation of this study in Q3 2025, with possible FDA clearance for the SwitchGuard system in late 2026.

The development of the SwitchGuard NPS reflects a "second mover advantage" strategy, incorporating feedback from over 100,000 TCAR procedures performed with existing systems to design next-generation features aimed at improving usability, access, and deliverability. This comprehensive approach to carotid revascularization, addressing both CAS and TCAR, is intended to serve the broadest base of physicians and position InspireMD to lead as procedural trends continue to shift towards endovascular-first approaches, further catalyzed by the CMS NCD.

Beyond carotid revascularization, InspireMD is also exploring new indications for its MicroNet technology. An early feasibility study is underway in partnership with the Jacobs Institute to evaluate the CGuard Prime stent in acute stroke patients presenting with tandem lesions in conjunction with thrombectomy. The first patients were enrolled in this study by Q1 2025, reflecting the company's commitment to the neurovascular community and a critical component of its long-term growth strategy.

Financial Performance and the Liquidity Imperative

InspireMD's financial performance reflects its stage as a growth-focused medical device company heavily investing in future market opportunities, particularly the U.S. launch and pipeline development. For the first quarter of 2025, the company reported total revenue of $1.53 million, a modest 1.2% increase compared to $1.51 million in Q1 2024. This growth was primarily driven by continued adoption in international markets, although partially offset by foreign exchange impacts and distributors managing inventory levels ahead of potential CGuard Prime approval in Europe. Gross profit remained flat year-over-year at $292,000, resulting in a slight decrease in gross margin to 19.1% from 19.3%. The most significant financial trend is the substantial increase in operating expenses. Total operating expenses rose by 52.5% to $11.75 million in Q1 2025, up from $7.71 million in the prior year period. This surge was primarily driven by increased research and development expenses (up $1.43M or 54.6%, due to SwitchGuard development, CGUARDIANS II IDE expenses, CGuard Prime U.S. launch preparation, and compensation), selling and marketing expenses (up $1.51M or 122.3%, mainly compensation and travel for building the U.S. commercial infrastructure, plus promotional activities), and general and administrative expenses (up $1.10M or 28.6%, due to compensation for new hires at the Miami HQ, salary increases, and recruitment fees). The increased operating expenses resulted in a significant widening of the net loss, which grew by 58.8% to $11.17 million in Q1 2025, compared to $7.03 million in Q1 2024. This trend of increasing losses is consistent with the full year 2024 results, where total operating expenses increased by 52.5% year-over-year, leading to a net loss of $32 million.

This financial profile, characterized by recurring losses and negative operating cash flows, presents a significant liquidity challenge. As of March 31, 2025, cash and cash equivalents and marketable securities totaled $26.09 million, down from $34.64 million at December 31, 2024. Net cash used in operating activities increased substantially to $8.79 million in Q1 2025, up 73.6% from $5.06 million in Q1 2024, reflecting higher operational spending and decreased cash receipts from customers.

The company explicitly states that it expects to continue incurring losses and negative cash flows until CGuard EPS reaches commercial profitability, and based on its current cash position and expected burn rate, it does not believe it has sufficient resources to fund operations for at least the next 12 months. This leads to substantial doubt about the company's ability to continue as a going concern.

To address this, management's plans are centered on continued commercialization and, critically, raising additional capital. The company has a significant potential funding source through a transformational private placement offering closed in May 2023, which could provide up to $113.6 million in gross proceeds across four milestone-based tranches. The first tranche ($17.9 million gross) was triggered in July 2024 by the positive one-year C-GUARDIANS data. The second tranche ($17.9 million gross) is triggered by the FDA PMA approval for CGuard Prime. The remaining two tranches are tied to FDA clearance of the SwitchGuard TCAR kit and the completion of four full fiscal quarters of U.S. commercial sales of CGuard Prime. The company also has an active ATM program, through which it has raised approximately $2.4 million gross proceeds as of May 8, 2025. The success of these capital-raising efforts is paramount, as there are no assurances that the company will be able to obtain the necessary financing, which could necessitate reducing activities, curtailing, or ceasing operations.

Competitive Dynamics and Strategic Positioning

InspireMD operates within the highly competitive interventional cardiology and vascular device market, dominated by large, well-established players like Abbott Laboratories, Medtronic plc, and Boston Scientific Corporation. These competitors possess significant financial resources, extensive R&D capabilities, broad product portfolios, and entrenched global sales and distribution networks.

InspireMD's strategy to compete is centered on technological differentiation and targeting specific, high-growth segments within the market. The MicroNet technology, with its demonstrated superior embolic protection, provides a key competitive advantage, particularly in the carotid space where stroke prevention is the primary concern. While larger competitors offer a wide range of stents and vascular devices, NSPR aims to position CGuard Prime as the "best-in-class" carotid implant based on its clinical outcomes. This technological edge is crucial for gaining traction against rivals who benefit from economies of scale, potentially lower manufacturing costs, and existing relationships with physicians and hospitals.

The U.S. market entry is a direct challenge to the status quo. The expansion of CMS coverage for CAS and TCAR creates a larger addressable market ripe for disruption. InspireMD's dual focus on both transfemoral CAS (with CGuard Prime) and TCAR (with C-GUARDIANS II/III and SwitchGuard) is designed to address the broadest physician base – interventional cardiologists, neurointerventionalists, and vascular surgeons – positioning the company to capitalize on the ongoing shift towards endovascular procedures. The "second mover advantage" in TCAR allows InspireMD to potentially introduce a more refined system with SwitchGuard, incorporating feedback from the extensive real-world use of existing TCAR devices by competitors like Silk Road Medical (SILK).

However, competing with industry giants comes with significant challenges. These companies can leverage their scale for more efficient manufacturing, broader marketing reach, and stronger negotiating power with hospitals and payers. NSPR's reliance on international distributors and the ongoing transition to U.S. manufacturing (with Aptyx) introduce operational complexities and potential vulnerabilities compared to the more vertically integrated supply chains of larger competitors. Geopolitical risks associated with manufacturing in Israel also add a layer of uncertainty not faced by competitors with more diversified production footprints. Changes in trade policy, such as tariffs, could disproportionately impact NSPR's cost of goods sold for the U.S. market while it remains dependent on Israeli manufacturing.

Despite these challenges, InspireMD's strategy is to leverage its differentiated technology and strong clinical data to carve out a significant position in the carotid market. The success of this strategy hinges on the timely execution of its U.S. launch plan, the successful adoption of CGuard Prime by U.S. physicians, and the ability to effectively compete against established players with a focused, high-performance product offering.

Risks and Outlook

The outlook for InspireMD is heavily weighted towards the successful execution of its U.S. market entry strategy and its ability to secure necessary funding. The anticipated FDA PMA approval for CGuard Prime in Q3 2025 is the most critical near-term catalyst, not only enabling commercial launch in the world's largest market but also triggering a significant financing tranche. Subsequent catalysts include the anticipated FDA clearances for its TCAR-related programs (C-GUARDIANS II in H1 2026, SwitchGuard in late 2026) and the associated financing milestones.

However, significant risks temper this outlook. The most pressing is the company's liquidity position and dependence on external financing. The substantial doubt about its ability to continue as a going concern underscores the critical nature of successfully triggering and closing the remaining private placement tranches and potentially utilizing the ATM program. Any delays in FDA approvals directly impact the timing of these financings, exacerbating liquidity risk.

Regulatory risk remains, despite positive clinical data. While the C-GUARDIANS results are strong, the FDA review process is rigorous, and unforeseen issues could arise. The revised timeline for CGuard Prime approval highlights the potential for regulatory processes to impact commercialization schedules.

Operational risks include successfully scaling up manufacturing capacity, particularly the transition to the U.S. facility with Aptyx, and managing potential disruptions from geopolitical instability in Israel. The ability to build and effectively deploy a U.S. commercial team capable of competing against established players is also crucial.

Competitive intensity is a persistent challenge. Larger competitors may respond to NSPR's market entry with aggressive pricing, marketing, or product enhancements. The outcome of the CREST-2 trial, while not expected to drastically alter practice based on initial commentary, could still influence the treatment landscape for asymptomatic patients.

Despite these risks, management remains optimistic, citing the strength of the C-GUARDIANS data, the significant U.S. market opportunity, and the enthusiasm from physicians for next-generation technology. Operating expenses are expected to increase significantly in 2025 (estimated 30-40% increase over 2024) as the company continues to invest in U.S. launch preparation and pipeline development. While revenue guidance is withheld pending PMA approval, the company's focus is on building the foundation for robust growth driven by the U.S. market and expanded indications.

Conclusion

InspireMD stands at a pivotal juncture, poised to potentially enter the large and dynamic U.S. carotid revascularization market with a differentiated technology platform backed by compelling clinical data. The MicroNet mesh technology represents a genuine competitive advantage, offering superior embolic protection that could set a new standard in stroke prevention during stenting procedures. The strategic focus on the U.S. launch of CGuard Prime, coupled with the development of TCAR-specific solutions and exploration of new indications, positions the company to capitalize on the ongoing shift towards endovascular therapies.

However, the path forward is not without significant hurdles. The company's current financial state, marked by losses and negative cash flow, creates a critical dependence on successful capital raising tied to regulatory and commercial milestones. Investors must carefully weigh the substantial market opportunity and the potential of the MicroNet technology against the significant liquidity risks, execution challenges of a U.S. launch against entrenched competitors, and potential impacts of geopolitical and regulatory factors. The anticipated FDA approval in Q3 2025 serves as the immediate key catalyst, potentially unlocking both market access and crucial funding, and will be a critical event to monitor for those assessing InspireMD's investment narrative.