InspireMD Reports 28.1% Revenue Growth to $8.98 Million for Fiscal Year 2025

InspireMD, Inc., a medical device company focused on the treatment of carotid artery disease, reported a revenue of $8.98 million for the fiscal year ending December 31, 2025, marking a 28.1% increase from $7.01 million in 2024. This growth was primarily driven by the commercial launch of the CGuard Prime product in the U.S. following its FDA approval in June 2025, alongside continued sales growth of the CGuard EPS product in international markets. The gross profit for the year was $2.65 million, resulting in a gross margin of 29.5%, an increase from 21.5% in the previous year, attributed to a favorable revenue mix from direct U.S. sales.

Despite the revenue increase, InspireMD reported a net loss of $48.79 million for 2025, a 52.4% increase from the $32.01 million loss in 2024. This rise in net loss was largely due to a significant increase in operating expenses, which rose by $17.25 million. Research and development expenses increased by 10% to $15 million, reflecting higher staffing and clinical expenses, while selling and marketing expenses surged by 172.7% to $16.55 million, driven by the expansion of the U.S. commercial team for the CGuard Prime launch.

In terms of strategic developments, InspireMD has made significant strides in expanding its product offerings and market presence. The company received CE Mark recertification for CGuard EPS in January 2024 and CE Mark approval for CGuard Prime in June 2025. Additionally, the company is advancing its clinical trials, including the C-GUARDIANS II and III studies, which evaluate the CGuard Prime and the SwitchGuard neuroprotection system, respectively. The C-GUARDIANS II trial completed enrollment of 50 patients in early 2026, while the C-GUARDIANS III trial is expected to begin patient enrollment in the second quarter of 2026.

Operationally, InspireMD has established its global headquarters in Miami, Florida, to support the U.S. launch of CGuard Prime and has expanded its direct sales force to enhance market penetration. As of December 31, 2025, the company employed 127 full-time staff, with plans to increase this number to support its growth strategy. The company anticipates that the addressable market for its products could reach approximately $1.3 billion, with potential growth as treatment options expand and patient screening increases.

Looking ahead, InspireMD faces challenges related to its financial health, as it reported an accumulated deficit of $302.3 million and negative cash flows from operations. The company has indicated substantial doubt about its ability to continue as a going concern without raising additional capital. Future plans include continued commercialization efforts and potential capital raises through equity securities and strategic partnerships. The company remains focused on expanding its market share and product adoption while navigating the complexities of regulatory compliance and market dynamics.