InspireMD Announces Completion of Enrollment in C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial

Trial designed to support potential U.S. marketing approval of the CGuard Prime EPS stent system

Study also included first-in-human cases treated with CGuard Prime CAS stent delivery platform

Company anticipates study results and Premarket Approval (PMA) submission in H2 2024, potential U.S. approval in H1 2025

TEL AVIV, Israel, June 26, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it completed enrollment of its ongoing C-Guardians U.S. Investigational Device Exemption (IDE) clinical trial, designed to support potential U.S. marketing approval of the CGuard Prime EPS stent system.

Marvin Slosman, chief executive officer of InspireMD, stated, “The completion of enrollment in our IDE trial is a significant milestone and brings us one step closer to potential U.S. approval of the CGuard Prime EPS stent system. Notably, the trial was fully enrolled in less than two years, including first-in-human cases treated with our next generation CGuard Prime CAS delivery platform. We believe the rapid enrollment reflects the comfort and support of the CGuard stent system by our investigators as we work to be the only company developing comprehensive next generation delivery and neuro protection platforms that achieve best implant performance and patient outcomes though both transfemoral (CAS) and trans carotid (TCAR) solutions. Completing enrollment of the C-Guardians trial, advancing our PMA submission and obtaining FDA approval would allow us to launch CGuard Prime EPS commercially in the U.S. and catalyze market adoption. We look forward to building on our global expansion and fulfilling our mission to deliver best patient therapy for carotid disease and stroke prevention.”

The C-Guardians clinical trial is evaluating the safety and efficacy of the CGuard Carotid Stent System for the treatment of carotid artery stenosis. The study, which commenced enrollment in July 2021, enrolled 315 patients across 25 trial sites in the U.S. and Europe.

The trial includes both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, and myocardial infarction (DSMI) through 30‐days post‐index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke from 31‐365-day follow‐up, based on CEC adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.