InspireMD (NSPR) Investor presentation summary

Market opportunity and growth drivers

• U.S. carotid intervention market projected to reach nearly $1B by 2030, with stenting procedures growing at a 12–13% CAGR post-2024, driven by coverage expansions and clinical validation.

• Only 10–15% of diagnosed patients are treated annually, indicating significant underpenetration and room for growth.

• CMS expanded coverage in 2023 to include standard surgical risk and asymptomatic patients, broadening the eligible population.

• CREST-2 trial results reinforce the benefits of carotid artery stenting over medical therapy, supporting a shift to a stent-first approach.

• CGuard® Prime platform aims to double the addressable U.S. market by enabling both CAS and TCAR procedures.

Product innovation and clinical evidence

• CGuard® Prime features MicroNet™ mesh and SmartFit™ technology, designed to prevent embolization and improve long-term outcomes.

• Demonstrates the lowest 30-day and 1-year death/stroke/MI rates among FDA approval trials for carotid intervention, with 0.95% and 1.93% event rates, respectively.

• Supported by over 2,000 patients in ten clinical trials, including pivotal CGUARDIANS studies and strong real-world data.

• Meta-analysis shows CGuard® outperforms both first- and other second-generation stents in reducing stroke and restenosis rates.

• OUS data from over 1,300 patients in Europe confirm periprocedural safety and low adverse event rates.

Commercialization and financial position

• Active commercial presence in over 30 countries, with more than 70,000 systems sold and a 25% market share outside the U.S.

• U.S. launch milestones include PMA approval in 2025, TCAR indication, and SwitchGuard NPS launch in 2027.

• Recent financings in 2023 and 2025 raised up to $153.7 million to support U.S. commercialization and growth.

• Robust intellectual property portfolio with 20 issued U.S. patents and 54 issued globally, plus numerous pending applications.