Quarterly ResultMay 4, 2026, 04:08 PM
InspireMD Q1 Revenue $3.4M, +122%; FDA IDE for SwitchGuard NPS
AI Summary
InspireMD, Inc. reported Q1 2026 total revenue of $3.4 million, marking 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 to initiate the CGUARDIANS III clinical trial for its SwitchGuard neuro protection system and anticipates FDA approval for the original CGuard delivery system in Q3 2026 and CGuard Prime 80 cm in H2 2026. However, InspireMD also initiated a voluntary recall of its CGuard Prime 135 cm delivery system for technical enhancements, which is expected to impact short-term availability and incur approximately $1.35 million in related costs. The net loss for Q1 2026 was $13.7 million.
Key Highlights
- Q1 2026 total revenue was $3.4 million, a 122% increase year-over-year.
- Received FDA IDE approval to initiate CGUARDIANS III clinical trial for SwitchGuard neuro protection system.
- Anticipates FDA approval of the original CGuard delivery system in Q3 2026.
- Anticipates FDA approval of CGuard Prime 80 cm for TCAR procedures in H2 2026.
- Initiated a voluntary recall of CGuard Prime 135 cm carotid stent delivery system.
- Q1 2026 net loss was $13.7 million, or $0.16 per basic and diluted share.
- Gross profit for Q1 2026 was $0.7 million, or 20.2% of revenue.
- Recall expected to incur approximately $700,000 for customer returns and $650,000 for inventory/remediation costs.