InspireMD, Inc.

We are a medical device company specializing in the development and commercialization of products for the treatment of carotid artery disease and other vascular conditions. Our portfolio includes two commercial products based on our proprietary CGuard carotid stent technology, designed to provide market-leading embolic protection during and after stenting procedures. A stent is an expandable scaffold-like metallic device placed in an artery to widen the lumen and restore blood flow. Our first product, the CGuard Carotid Embolic Prevention System ( CGuard EPS ), integrates a self-expanding nitinol stent with a MicroNet mesh sleeve as a single device for carotid artery revascularization. In January 2024, we received CE Mark recertification for CGuard EPS under the EU Medical Device Regulation ( MDR ). Our CGuard EPS previously held CE Mark approval under the former Medical Device Directive ( MDD ). CGuard EPS is marketed in over 30 countries outside the United States through a network of distributors. Our second product, the CGuard Prime Carotid Stent System ( CGuard Prime ), uses the same stent and MicroNet mesh as the CGuard EPS with a differentiated deployment mechanism. CGuard Prime received premarket approval ( PMA ) by the U.S. Food and Drug Administration ( FDA ) on June 23, 2025, and is marketed exclusively in the United States through our direct salesforce. It also received MDR CE Mark approval on June 12, 2025.