InspireMD (NSPR) investor relations material

Market opportunity and technology differentiation

• Developed a self-expanding carotid stent with a 20-micron mesh outer layer, significantly reducing post-procedural strokes by preventing plaque prolapse.

• Over 75,000 stents sold globally, with CE mark for 10 years and presence in 35 markets.

• U.S. market opportunity is estimated at $1 billion, with 80,000 procedures annually and rapid adoption following CMS reimbursement approval in October 2023.

• Technology is protected by detailed patents and is currently the only asset of its kind in the market, attracting strategic interest.

• Significant funding secured, including $113 million in May 2023 and an additional $40 million PIPE, with a clear path to cash flow break even.

Clinical outcomes and regulatory progress

• Clinical trials, including a 50-patient TCAR trial, demonstrated sub-1% complication rates and zero adverse events, outperforming competitors.

• FDA approval for the CAS device was obtained in June 2025, with TCAR indication approval expected by early November.

• Real-world and physician-initiated studies confirm consistent, superior outcomes compared to other stents.

• CREST-2 NIH study showed stenting is superior to medical management alone, supporting a stent-first approach.

• Voluntary recall of the CAS delivery system was initiated to address catheter friction, with plans to relaunch after improvements.

Commercial strategy and growth plans

• Focused on both TCAR and CAS markets, leveraging a second-mover advantage after Silk Road Medical's acquisition by Boston Scientific.

• 12 experienced field representatives target high-procedure locations using Acuity claims data to drive sales productivity.

• U.S. market offers higher margins compared to international markets, where distribution is through partners.

• Plans to scale the sales organization based on productivity and market absorption, with significant growth expected post-relaunch.

• Strong support from major investors and a strategy to raise additional capital to support expansion.