NSPR News & Events

Reports Q1 revenue $3.4M, consensus $2.7M. "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," stated Marvin Slosman, Chief Executive Officer of InspireMD. "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."

InspireMD announced that, in consultation with the U.S. Food and Drug Administration, the company has initiated a voluntary recall in the U.S. for its CGuard Prime 135 cm carotid stent delivery system. "Concurrent with today's announcement, the Company is withdrawing its prior full year 2026 revenue guidance. Management believes this is the most prudent step given the impact of the temporary discontinuation of commercial activity in the U.S. pending the anticipated FDA approval of its original CGuard stent delivery system in the third quarter of 2026. Management intends to provide a full company update on this and other recent developments during its conference call for the results of the first quarter of 2026 on May 4," the company stated.