InspireMD’s New Study on Neuroprotection System: A Potential Game-Changer?

InspireMD Inc (NSPR) announced an update on their ongoing clinical study.

InspireMD Inc. has announced a pivotal clinical study titled ‘CGUARDIANS III IDE Pivotal Trial.’ This study aims to evaluate the safety and efficacy of the SwitchGuard™ Neuroprotection System (NPS) when used alongside the CGuard™ Prime 80 Carotid Stent System. The primary goal is to provide cerebral embolic protection during Transcarotid Artery Revascularization (TCAR) procedures for patients with carotid artery stenosis who are at high risk for complications from Carotid Endarterectomy (CEA).

The intervention being tested is the SwitchGuard™ NPS, a device designed to enhance cerebral protection during carotid artery stenting procedures. It works in conjunction with the CGuard™ Prime 80 Carotid Stent System to minimize the risk of embolic events during TCAR.

This is a prospective, multi-center, single-arm study with a focus on treatment. The study design involves a single group of participants receiving the experimental intervention without any masking, ensuring transparent results on the intervention’s effectiveness.

The study is set to begin recruitment on December 2, 2025, with the most recent update submitted on December 10, 2025. These dates are crucial as they mark the initiation of participant involvement and the latest information available regarding the study’s progress.

The announcement of this study could influence InspireMD’s stock performance positively, as successful outcomes may enhance the company’s market position in the medical device industry. Investors will be keenly observing the study’s progress, especially in comparison to competitors in the neuroprotection and stenting market.

The CGUARDIANS III IDE Pivotal Trial is ongoing, with further details accessible on the ClinicalTrials portal.