InspireMD (NSPR) investor relations material

Industry trends and market dynamics

• Stroke prevention is gaining focus, with a shift from surgery to endovascular stenting for carotid disease in the U.S.

• Endovascular procedures have grown from 30% to 45% in three years, projected to reach 70% in the coming years.

• Expanded insurance coverage and new clinical evidence are accelerating adoption of stenting over surgery.

• Over 1 million diagnosed patients in the U.S. remain untreated, representing significant market potential.

• Recent clinical guidelines and studies support stenting as superior to medical therapy alone for asymptomatic patients.

Product innovation and clinical evidence

• The flagship stent features a finely woven mesh, reducing the risk of embolic stroke by stabilizing plaque.

• Clinical trials (C-GUARDIANS I-III) show best-in-class safety and efficacy, with 1% 30-day and 2% one-year event rates.

• The stent was uniquely included in the CREST-2 trial, showing statistically significant stroke reduction.

• Over 70,000 patients have been treated globally, with consistent results across published literature.

• The device is designed for both CAS and TCAR procedures, addressing all major stenting approaches.

Commercial strategy and financial outlook

• Commercialization has begun in the U.S., supported by strong investor backing and recent $40 million financing.

• Two additional financing tranches are tied to commercialization milestones and TCAR system approval.

• The company is the only standalone entity focused solely on carotid disease treatment.

• Building a market-leading organization to support anticipated growth and investor engagement.

• The addressable market is expected to expand as more patients become eligible for stenting.