InspireMD's U.S. revenue for the fourth quarter was $0.9 million, reflecting a sequential growth of 74% during the second quarter of the product's launch. International revenue also saw a 17% increase, totaling $2.3 million, driven by expanding market penetration. The company has supported over 500 carotid procedures utilizing CGuard Prime across leading hospitals since its launch.
The company completed enrollment in the pivotal CGUARDIANS II trial, which evaluates the safety and performance of CGuard Prime for use in transcarotid artery revascularization (TCAR) procedures. InspireMD has submitted a Premarket Approval Supplement (PMA-S) to the U.S. Food and Drug Administration (FDA) for indications of use of CGuard Prime in TCAR procedures, which could potentially double its addressable U.S. market opportunity.
Despite the positive revenue growth, InspireMD reported a net loss of $11.8 million for Q4 2025, compared to a net loss of $9.2 million in Q4 2024. The increase in losses was primarily due to higher operating expenses, which totaled $13.3 million for the quarter, up from $9.8 million in the previous year. The company attributed this rise to increased headcount-related expenses for its U.S. commercial team and additional investments in resources to support the product launch.
Looking ahead, InspireMD anticipates revenue for the full year 2026 to be in the range of $13 million to $15 million, reflecting expected growth of approximately 45% to 65% over 2025. The company remains optimistic about its growth trajectory and the potential for further catalysts in 2026 that may accelerate the adoption of its next-generation stent platform.
