InspireMD Inc (NASDAQ: NSPR) is a medical device company that develops and commercializes stent systems with mesh-based embolic protection for carotid artery disease. Revenue comes from product sales of its CGuard carotid stent systems, supplemented by equity financing through private placements and warrant exercises. The company carries a going-concern qualification, as noted by its auditors in the 10-K filed March 18, 2026, reflecting recurring operating losses and negative cash flows from operations. Its lead product, the CGuard MicroNet mesh-covered stent system, targets carotid artery stenosis patients at high surgical risk, and was evaluated in the C-GUARDIANS trial, which enrolled 316 patients across 24 sites in the U.S. and EU between July 2021 and June 2023. The company is pursuing FDA pre-market approval through clinical trials conducted under IDE regulations. Capital needs are met through equity sales, with the May 2023 private placement generating approximately $42.2 million in gross proceeds.

Revenue model

Product sales of carotid stent systems, primarily CGuard EPS and CGuard Prime. Capital is raised through private placements and warrant exercises rather than operating cash flow, as the company has not yet reached cash-flow breakeven as of its FY2025 10-K filed March 18, 2026.

Products and services

CGuard EPS (Embolic Protection System): a MicroNet mesh-covered carotid stent with integrated embolic protection. CGuard Prime Stent System: an iteration of the CGuard platform used in the C-GUARDIANS trial from April 2023. SwitchGuard NPS: an additional stent system referenced in the pipeline, undergoing U.S. clinical development under FDA IDE regulations.

Customers and end markets

End market is interventional cardiology and vascular surgery, specifically carotid artery stenting (CAS) procedures for patients with carotid artery stenosis who are at high risk for carotid endarterectomy (CEA). Clinical sites in the U.S. and EU participated in the C-GUARDIANS trial across 24 centers. No customer concentration data disclosed in the excerpts.

Value-chain role

Medical device manufacturer and IP holder. The company manufactures carotid stent systems, holds patents covering knitted micron-level mesh sleeves over stents and related delivery mechanisms, and relies on trade secrets and confidentiality agreements to protect proprietary know-how. It sells directly into clinical settings pending and following regulatory clearance.

Geographic exposure

Commercial and clinical operations span the U.S. and the EU, as evidenced by the C-GUARDIANS trial conducted at 24 sites across both regions. No revenue breakdown by geography is disclosed in the excerpts.

Source: SEC 10-K, filed 2026-03-18

Industry: Surgical & Medical Instruments & Apparatus