InspireMD, Inc.

We are a medical device company focused on developing and selling products for carotid artery disease and other vascular conditions. Our product line includes two commercial products based on our CGuard carotid stent technology, which aims to protect against embolisms during and after stenting procedures. A stent is an expandable metallic device placed in an artery to widen it and restore blood flow. Our first product, the CGuard Carotid Embolic Prevention System ("CGuard EPS"), combines a self-expanding nitinol stent with a MicroNet mesh sleeve into a single device for carotid artery revascularization. CGuard EPS received CE Mark recertification under the EU Medical Device Regulation ("MDR") in January 2024, having previously held CE Mark approval under the former Medical Device Directive ("MDD"). CGuard EPS is sold in over 30 countries outside the United States via distributors. Our second product, the CGuard Prime Carotid Stent System ("CGuard Prime"), uses the same stent and MicroNet mesh as CGuard EPS but with a different deployment mechanism. CGuard Prime received premarket approval ("PMA") from the U.S. Food and Drug Administration ("FDA") on June 23, 2025, and is sold exclusively in the United States by our direct salesforce. It also received MDR CE Mark approval on June 12, 2025. In October 2024, the FDA approved our Investigational Device Exemption (IDE) to begin the CGUARDIANS II pivotal study for the CGuard Prime 80 cm carotid stent system during transcarotid revascularization ("TCAR") procedures. We completed enrollment in the CGUARDIANS II pivotal study in the first quarter of 2026. In October 2023, the Centers for Medicare & Medicaid Services ("CMS") issued a final National Coverage Determination ("NCD"), which expanded coverage for both carotid artery stenting ("CAS") and TCAR procedures to include asymptomatic and standard risk patients.