InspireMD C-GUARDIANS Trial Results Published, 30-Day DSMI Rate at 0.95%
InspireMD announced that results from the Company's C-GUARDIANS trial have now been published in the Journal of the American College of Cardiology. The data demonstrate the safety and efficacy of carotid artery stenting, CAS, with the Company's MicroNet covered stent in patients with asymptomatic carotid stenosis. "The C-GUARDIANS results are exceptional, with a 30-day DSMI rate of just 0.95% and a one-year ipsilateral stroke rate of 1.93%, which are the lowest reported in high-risk patients," said Dr. Chris Metzger, M.D., Interventional cardiologist and endovascular interventionalist at Ballad Health, and lead investigator of the C-GUARDIANS trial. "What's particularly noteworthy is that we achieved these outcomes in a cohort that included 25% symptomatic patients, a group traditionally at elevated risk. The data make a compelling case for the CGuard Prime's MicroNet(TM) technology as a potential next-generation standard of care."
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InspireMD Publishes Positive CREST-2 Data Confirming Efficacy of Carotid Stenting
- CREST-2 Study Results: InspireMD presented CREST-2 data at the SVIN Annual Meeting on November 21, 2025, showing that carotid artery stenting (CAS) significantly outperformed intensive medical management for patients with asymptomatic carotid stenosis. This finding provides crucial clinical evidence that could reshape treatment protocols for carotid disease.
- Clinical Trial Scale: The CREST-2 trial, independently conducted and NIH-sponsored, involved 155 centers globally with 1,245 patients randomized to the stenting group. Results indicated a significantly reduced risk of perioperative stroke or death over four years, underscoring the efficacy of stenting.
- Innovative Technology Advantage: InspireMD's CGuard®Prime stent demonstrated a record-low 1.93% major adverse event rate in the C-GUARDIANS trial, particularly among high-risk patients. This low event rate, combined with the positive CREST-2 results, reinforces the company's leadership in the carotid stenting market.
- Market Outlook: CEO Marvin Slosman stated that CREST-2 validates the superiority of combining stenting with medical management, indicating a shift towards an endovascular-first approach in vascular disease treatment. With growing recognition of effective treatments for asymptomatic carotid disease, InspireMD is poised for increased market share.
InspireMD to Attend the 37th Annual Healthcare Conference Hosted by Piper Sandler
Company Announcement: InspireMD, Inc. will participate in a fireside discussion at the Piper Sandler 37th Annual Healthcare Conference on December 3rd, 2025, at 12:30 pm ET.
Webcast Availability: A live audio webcast and replay of the discussion will be accessible on the company's website under the "Investor Calendar" section.
Product Focus: InspireMD is focused on its CGuard® Prime carotid stent system, which aims to prevent strokes using its proprietary MicroNet™ mesh technology.
Investor Information: InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR, and the company provides important updates for investors on its website.