InspireMD reported flat second-quarter revenue due to the voluntary recall of its CGuard Prime 135 system, which required $734,000 in customer credits that offset underlying U.S. sales growth. International business grew 21% year-over-year, and the company implemented a 20% workforce reduction to align costs with near-term regulatory priorities. Management anticipates potential FDA approval for both the CGuard Prime 80 and the original CGuard CAS platform in the fourth quarter of 2026, with the redesigned CGuard Prime 135 delivery system targeted for a first-half 2027 market reentry. The recall resulted in a $612,000 impairment charge and a restructuring charge between $900,000 and $1.2 million is expected in the third quarter of 2026. Cash and equivalents decreased to $30.4 million as of June 30, 2026, down from $54.2 million at year-end 2025.
InspireMD IncVoluntary recall of CGuard Prime 135 and regulatory delays impact revenue and costs.
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