Quarterly ResultMay 4, 2026, 04:13 PM
InspireMD Q1 2026 Revenue Jumps 122% to $3.4M; IDE for CGUARDIANS III
AI Summary
InspireMD reported Q1 2026 revenue of $3.4 million, a 122% year-over-year increase, driven by strong demand for CGuard Prime in the U.S. and original CGuard internationally. The company received FDA IDE approval for the CGUARDIANS III clinical trial of its SwitchGuard neuro protection system and anticipates FDA approval for the original CGuard delivery system in Q3 2026. However, InspireMD initiated a voluntary recall of its CGuard Prime 135 cm carotid stent delivery system to implement technical enhancements, expecting a financial impact of $700,000 for customer returns and $650,000 for inventory impairment and remediation costs.
Key Highlights
- Q1 2026 total revenue was $3.4 million, a 122% increase year-over-year from $1.5 million in Q1 2025.
- U.S. revenue for Q1 2026 was $1.2 million, representing a 36% quarter-over-quarter increase.
- International revenue for Q1 2026 was $2.2 million, up 48% year-over-year.
- Gross profit for Q1 2026 was $0.7 million (20.2% of revenue), compared to $0.3 million (19.1%) in Q1 2025.
- Adjusted gross profit (non-GAAP) was $1.2 million (34.1% of revenue), excluding a $0.5 million inventory impairment.
- Net loss for Q1 2026 was $13.7 million, or $0.16 per basic and diluted share.
- Received FDA IDE approval to initiate the CGUARDIANS III clinical trial for SwitchGuard neuro protection system.
- Initiated a voluntary recall of CGuard Prime 135 cm delivery system, with expected costs of $700,000 for returns and $650,000 for impairment.
Price Impact
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