InspireMD Q1 Revenue Soars 122% to $3.4M, Secures FDA IDE Approval
InspireMD reported Q1 revenue of $3.4 million, up 122% year-over-year, driven by U.S. CGuard Prime demand and international CGuard sales. The company received FDA IDE approval to start its SwitchGuard neuroprotection trial, expects original CGuard delivery system approval in Q3 2026 and recalled its 135 cm delivery system for technical enhancements.
1. Q1 Revenue Growth
In the first quarter of 2026, InspireMD generated $3.4 million in revenue, a 122% increase from $1.5 million in Q1 2025. U.S. sales of CGuard Prime accounted for $1.2 million, up 36% sequentially, while international CGuard sales rose 48% to $2.2 million, supported by over 625 procedures at more than 100 hospitals.
2. FDA Approvals and Trials
The company received FDA IDE approval to initiate the CGUARDIANS III trial for its next-generation SwitchGuard neuroprotection system in TCAR procedures. It also expects FDA approval of its original CGuard delivery system in Q3 2026 and remains on track for CGuard Prime 80 cm approval in H2 2026, potentially doubling its addressable market.
3. Product Recall and Enhancements
InspireMD voluntarily recalled the CGuard Prime 135 cm delivery system to implement technical and user-experience improvements. The recall will incur reserves of approximately $700,000 for customer returns and $650,000 for inventory impairment and remediation.
4. Financial Performance and Outlook
Gross profit reached $0.7 million, or 20.2% of revenue, while non-GAAP gross margin was 34.1%. Operating expenses rose to $14.7 million, leading to a net loss of $13.7 million ($0.16 per share), with additional investments in U.S. commercial infrastructure and headcount.