InspireMD-NSPR Stock May Gain as First Patient Enrolls in CGUARDIANS II Study

Company Overview - InspireMD Inc. (NSPR) has announced the first patient enrollment in the CGUARDIANS II clinical trial, which evaluates the CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach [1][2] - The CGuard Prime Carotid Stent is designed to prevent strokes in patients with carotid artery disease, utilizing proprietary MicroNet technology for embolic protection [5][8] - The company currently has a market capitalization of $81.64 million [4] Clinical Trial Details - CGUARDIANS II is a prospective, multi-center, single-arm pivotal study aiming to enroll at least 50 evaluable patients to assess the acute device success and technical success of the CGuard Prime in conjunction with an FDA-cleared TCAR neuro-protection system [2] - The trial has shown positive clinical outcomes, with a major adverse event rate of 1.95% over a one-year follow-up, the lowest reported for any carotid stent or embolic protection device in a pivotal trial [7] Regulatory Approval and Market Potential - In October, the company received FDA premarket approval for the CGuard Prime Carotid Stent System, allowing it to market the device in the U.S. for treating carotid artery stenosis [6][9] - The global carotid artery stents market was valued at$ 559.7 million in 2021 and is expected to grow at a CAGR of 3.0% from 2022 to 2030, driven by the rising prevalence of cardiovascular diseases [10] Stock Performance - Following the announcement of the clinical trial, NSPR shares closed flat at $3.14, with an 11.7% gain year-to-date compared to the industry’s 6.4% growth [3]