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InspireMD Announces Publication of the C-GUARDIANS Pivotal Trial Manuscript in the Journal of the American College of Cardiology (JACC)

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The CGuard® Prime Carotid Stent System demonstrated the lowest 30-day and 1-year primary endpoint ma...

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AI Summary

CGuard® Prime achieved the lowest adverse event rates in carotid stenting studies. C-GUARDIANS trial results published in JACC validate its safety and efficacy. Low 30-day DSMI rate of 0.95% indicates a promising treatment option. Innovation positions CGuard® Prime as a potential standard of care. FDA PMA-approved, targeting expansion for symptomatic and asymptomatic patients.

Sentiment Rationale

The publication of favorable trial results can attract more investors, driving up share value. Past cases show that positive clinical data can significantly impact stock prices.

Trading Thesis

Immediate investor interest may occur following publication, but long-term impacts depend on adoption rates. Historically, initial market reactions to clinical data are strong, tapering over time as adoption solidifies.

Market-Moving

  • CGuard® Prime achieved the lowest adverse event rates in carotid stenting studies.
  • C-GUARDIANS trial results published in JACC validate its safety and efficacy.
  • Low 30-day DSMI rate of 0.95% indicates a promising treatment option.

Key Facts

  • CGuard® Prime achieved the lowest adverse event rates in carotid stenting studies.
  • C-GUARDIANS trial results published in JACC validate its safety and efficacy.
  • Low 30-day DSMI rate of 0.95% indicates a promising treatment option.
  • Innovation positions CGuard® Prime as a potential standard of care.
  • FDA PMA-approved, targeting expansion for symptomatic and asymptomatic patients.

Companies Mentioned

  • ABT (ABT)
  • MDT (MDT)
  • SYK (SYK)

Research Analysis

The significance of clinical trial results heavily influences investor sentiment and stock price. Positive outcomes under peer-reviewed conditions are highly credible and could lead to market growth.

InspireMD Publishes C-GUARDIANS Trial Results in JACC

MIAMI, Jan. 12, 2026 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), a leader in carotid stent systems, has announced the publication of pivotal trial results from its C-GUARDIANS study in the Journal of the American College of Cardiology (JACC). This groundbreaking research highlights the efficacy and safety of the CGuard® Prime carotid stent system designed to prevent strokes, especially in patients with asymptomatic carotid stenosis.

Key Findings from the C-GUARDIANS Trial

The C-GUARDIANS trial demonstrated the lowest rates of disabling stroke or myocardial infarction (DSMI) in a 30-day period, alongside impressively low ipsilateral stroke rates through one year. This research underpins the safety and effectiveness of carotid artery stenting (CAS) with InspireMD's proprietary MicroNet™ covered stent.

  • 30-Day DSMI Rate: 0.95%
  • One-Year Ipsilateral Stroke Rate: 1.93%
  • Patient Cohort: 25% were symptomatic, a group historically at high risk.

The trial also reported no unexpected device-related adverse events, setting a new standard in the field of carotid stenting. These results were first presented at the VIVA conference in late 2023 and subsequently at LINC in mid-2024.

Expert Commentary

Dr. Chris Metzger, M.D., an interventional cardiologist and lead investigator of the C-GUARDIANS trial, emphasized the significance of these findings, stating, "The C-GUARDIANS results are exceptional, reflecting the lowest reported event rates in patients traditionally regarded as high-risk." He noted the implications of achieving such outcomes in a cohort that included a significant percentage of symptomatic patients.

Implications for the Interventional Community

According to Peter Soukas, M.D., Chief Medical Advisor of InspireMD, this publication represents a critical advancement in the transition towards stent-system strategies for carotid revascularization. He stated, "Clinicians are increasingly seeking validated technologies that enhance patient eligibility while maintaining excellent outcomes." The positive trial data offer strong clinical validation for broader adoption of the CGuard® Prime system.

Company Perspective

Marvin Slosman, CEO of InspireMD, commented on the publication of the trial results, indicating that peer-reviewed evidence strengthens their position in the market. "This validation highlights years of innovation and clinical rigor behind CGuard® Prime, poised to benefit thousands of U.S. patients," he said, adding that the publication's impact on physician engagement is expected to be substantial.

About the C-GUARDIANS Clinical Trial

The C-GUARDIANS trial evaluated the safety and efficacy of the CGuard® Carotid Stent System for treating carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in both the United States and Europe. The primary endpoint assessed major adverse events, including all-cause mortality, stroke, or myocardial infarction (DSMI), within 30 days post-procedure during a follow-up period lasting from 31 to 365 days.

About InspireMD, Inc.

InspireMD aims to establish its MicroNet™ technology as the industry standard for carotid stenting, ensuring exceptional acute results coupled with long-term stroke-free outcomes. The company’s stock is publicly traded on Nasdaq under the ticker symbol NSPR. For further information, visit www.inspiremd.com.

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