InspireMD (NSPR) investor relations material

Key clinical data and market trends

• CREST-2 trial showed statistically significant benefit for stenting over medical management, accelerating the shift from open surgery to endovascular approaches for carotid disease.

• CMS approval of the NCD in October 2023 expanded the market for stenting, supporting a stenting-first approach.

• Feedback from both interventionalists and vascular surgeons is highly favorable, with expectations for more patients to be treated earlier in their disease.

• Closed-cell and second-generation stents, such as CGuard, demonstrated superior outcomes in meta-analyses and contributed positively to CREST-2 results.

• The shift is expected to increase the number of patients treated and the proportion receiving stents, not just the number of operators.

Commercial launch and financial outlook

• U.S. commercial launch began in Q3 2024 with a trained sales force, doubling to about 30 reps, and over 100 patients treated early in the launch.

• The company is focused on a controlled rollout, prioritizing quality of experience and physician adoption.

• Q3 2024 revenue was $2.5 million ($2M international, $0.5M U.S.), with Q4 guidance of $2.5–3M and expectations to reach the higher end.

• Growth is driven by increased U.S. adoption and continued international performance.

• No specific number of accounts disclosed, but commercial trends remain positive.

Pipeline and clinical development

• C-GUARDIANS II trial (CGuard with EnRoute neuroprotection) is progressing well, targeting FDA submission in H1 2026.

• C-GUARDIANS III (SwitchGuard neuroprotection system) to start after Q1 2026, with FDA clearance targeted for H1 2027; trial will enroll ~105 patients at 25 sites.

• SwitchGuard system aims to maintain familiar functionality for vascular surgeons, with added features for safety and ease of use; pricing strategy aims for a premium but within market norms.

• Early feasibility study for tandem lesions is over 50% enrolled, targeting neurointerventionalists and acute stroke settings.

• Success in acute stroke settings is measured differently, and future direction will depend on clinical outcomes and neuro community adoption.