| Metric | Value ($ M) | Q1 FY25 |
|---|---|---|
| Revenue | 3.40 | 122.2% |
| Total Income | 3.40 | 122.2% |
| Expenditure | 17.38 | 33.8% |
| PBT | — | |
| Net Profit | -13.69 | 22.6% |
| OPM | — | |
| NPM | — | |
| EPS | -0.16 | 27.3% |
InspireMD Reports Q1 2026 Revenue of $3.4 Million, Up 122% Y-o-Y
05 May 2026 · 5 May, 1:43 am
Summary
InspireMD, Inc. announced its financial and operating results for the first quarter ended March 31, 2026. Total revenue for Q1 2026 was $3.4 million, representing a 122% increase compared to the same period in 2025. The company's U.S. revenue increased by 36% quarter-over-quarter, while international revenue increased by 48% year-over-year. The company anticipates FDA approval of the original CGuard delivery system in Q3 2026 and is on track for expected FDA approval of the CGuard Prime 80 cm for TCAR procedures in H2 2026.
Key Highlights
- 1
InspireMD reported total revenue of $3.4 million for Q1 2026, representing a 122% year-over-year increase.
- 2
U.S. revenue for Q1 2026 was $1.2 million, a 36% increase compared to Q4 2025.
- 3
International revenue reached $2.2 million in Q1 2026, reflecting a 48% year-over-year increase.
- 4
The company's gross profit for Q1 2026 was $0.7 million, or 20.2% of revenue.
- 5
InspireMD received IDE approval from the FDA to initiate the CGUARDIANS III clinical trial of its SwitchGuard neuro protection system for use in TCAR procedures.
- 6
FDA approval of the original CGuard delivery system is anticipated in Q3 2026.
- 7
The company is on track for expected FDA approval of the CGuard Prime 80 cm for TCAR procedures in H2 2026.
Management Comments
Marvin Slosman
Our first quarter results reflect strong underlying demand and consistent clinical outcomes for our CGuard carotid stent implant both in the U.S. and internationally. While our decision to voluntarily pause commercialization of CGuard Prime 135 cm in the U.S. will impact its availability in the short term, we are in the process of implementing several enhancements to the delivery system that we are confident will elevate technical performance and accelerate rapid adoption. Importantly, our TCAR program is unaffected by this voluntary action, and we were also pleased to have recently received FDA approval to initiate the CGUARDIANS III clinical trial with our SwitchGuard NPS, which, if successful, would enable us to offer a full TCAR tool kit leveraging our best-in-class implant. In parallel, we are pursuing FDA approval of our commercially-proven CGuard stent delivery system which we anticipate in the third quarter of 2026. This delivery system was successfully used in over 70,000 implants globally. Having this additional delivery system available in the U.S. will enable us to offer physicians multiple options to deliver the best implant to their patients.
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