InspireMD reports Q1 2026 revenue up 122%, FDA approves clinical trial for new neuro protection system.

InspireMD announced a 122% year-over-year revenue increase to $3.4 million in Q1 2026, driven by strong demand for its CGuard Prime carotid stent system. The company received FDA approval to start the CGUARDIANS III clinical trial for its next-gen SwitchGuard neuro protection system in TCAR procedures and expects FDA approval for its original CGuard delivery system by Q3 2026. Despite a voluntary recall of the CGuard Prime 135 cm delivery system for technical improvements, InspireMD remains confident in its product enhancements and market growth potential, aiming to expand its addressable market with the upcoming CGuard Prime 80 cm approval in H2 2026.