NSPR · InspireMD, Inc.

InspireMD's Q1 2026 results demonstrated robust revenue growth to $3.4 million, a 122% increase year-over-year, driven by strong demand for CGuard Prime in the U.S. and original CGuard internationally. U.S. revenue rose 36% quarter-over-quarter to $1.2 million, reflecting expanding adoption across over 100 hospitals and 625 cumulative procedures since launch. International revenue grew 48% to $2.2 million. GAAP gross profit improved to $0.7 million or 20.2% of revenue from 19.1% YoY, aided by a higher-margin U.S. sales mix, though offset by a $0.5 million inventory impairment; non-GAAP adjusted gross margin reached 34.1%. Operating expenses increased 25% to $14.7 million due to U.S. commercial team expansion and infrastructure investments, contributing to a net loss of $13.7 million or $0.16 per share, narrower than the prior year's $0.22 per share. CEO Marvin Slosman highlighted consistent clinical outcomes and confidence in delivery system enhancements post-recall. The voluntary U.S. recall of CGuard Prime 135 cm, aimed at technical improvements, includes $700,000 reserve for returns and $650,000 for inventory/remediation, temporarily pausing commercialization but not affecting TCAR. Key catalysts include FDA IDE approval for the CGUARDIANS III trial evaluating SwitchGuard NPS with CGuard Prime 80 cm for TCAR, anticipated original CGuard approval in Q3 2026 after 70,000 global implants, and CGuard Prime 80 cm approval in H2 2026 to expand the addressable market.