InspireMD's CGuard® Prime Carotid Stent System Achieves Landmark Safety and Efficacy Results in C-GUARDIANS Trial Published in JACC

CGuard® Prime showed lower adverse event rates than previous studies in carotid stenting, with favorable outcomes for high-risk patients.

Quiver AI Summary

InspireMD, Inc. announced the publication of results from its C-GUARDIANS pivotal trial in the Journal of the American College of Cardiology (JACC), showcasing the CGuard® Prime Carotid Stent System's effectiveness in preventing stroke. The trial demonstrated the lowest major adverse event rates for carotid artery stenting in a pivotal study, with a 30-day disabling stroke or myocardial infarction (DSMI) rate of 0.95% and a one-year ipsilateral stroke rate of 1.93%. The study included a notable 25% of symptomatic patients and emphasized the potential of the CGuard® Prime's MicroNet™ technology as a next-generation standard of care. The trial involved 316 patients and was designed to highlight the safety and efficacy of carotid artery stenting, with the results offering strong validation for broader clinical adoption of this innovative stent system.

Potential Positives

The CGuard® Prime Carotid Stent System achieved the lowest 30-day and 1-year primary endpoint major adverse event rates in any pivotal study of carotid stenting, highlighting its effectiveness and safety.
The results from the C-GUARDIANS trial have been published in the Journal of the American College of Cardiology (JACC), a leading industry journal, enhancing the credibility and visibility of the company's product.
The study demonstrated exceptional outcomes, including a 30-day DSMI rate of just 0.95% and a one-year ipsilateral stroke rate of 1.93%, which are significant improvements, especially in high-risk patients.
The publication is expected to drive increased physician awareness and engagement, potentially leading to wider adoption and usage of the CGuard® Prime technology in clinical practice.

Potential Negatives

While the trial results are impressive, there is no indication of sales forecasts or revenue projections resulting from the publication, which raises concerns about the commercialization and financial impact of the technology.
The press release does not address any potential competition in the carotid stenting market, leaving investors uncertain about positioning against other established products.
Despite the positive results, there is no mention of the scalability of the CGuard® Prime system and whether production capacity can meet potential demand from increased physician awareness and engagement.

FAQ

What are the key findings of the C-GUARDIANS trial?

The C-GUARDIANS trial demonstrated a 30-day DSMI rate of 0.95% and a one-year ipsilateral stroke rate of 1.93%.

How does CGuard® Prime compare to other carotid stenting methods?

CGuard® Prime showed historically low event rates in high-risk patients compared to traditional carotid revascularization methods.

What is the significance of the JACC publication for CGuard® Prime?

The JACC publication validates the clinical efficacy of CGuard® Prime and enhances awareness among physicians to drive adoption.

What patient demographics were included in the C-GUARDIANS trial?

The trial enrolled 316 patients, including 25% symptomatic patients with carotid artery stenosis undergoing carotid artery stenting.

Is CGuard® Prime FDA approved?

Yes, CGuard® Prime is FDA PMA-approved for the treatment of carotid artery stenosis in the United States.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$NSPR Insider Trading Activity

$NSPR insiders have traded $NSPR stock on the open market 8 times in the past 6 months. Of those trades, 8 have been purchases and 0 have been sales.

Here’s a breakdown of recent trading of $NSPR stock by insiders over the last 6 months:

PAUL STUKA has made 5 purchases buying 54,368 shares for an estimated $109,116 and 0 sales.
GARY S ROUBIN purchased 41,322 shares for an estimated $99,999
THOMAS J KESTER purchased 30,991 shares for an estimated $74,998
MARVIN SLOSMAN (CEO and President) purchased 10,330 shares for an estimated $24,998

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We have seen 25 institutional investors add shares of $NSPR stock to their portfolio, and 8 decrease their positions in their most recent quarter.

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ABERDEEN GROUP PLC added 2,481,117 shares (+inf%) to their portfolio in Q3 2025, for an estimated $5,979,491
ROSALIND ADVISORS, INC. added 1,616,644 shares (+70.6%) to their portfolio in Q3 2025, for an estimated $3,896,112
VELAN CAPITAL INVESTMENT MANAGEMENT LP added 1,239,669 shares (+137.1%) to their portfolio in Q3 2025, for an estimated $2,987,602
PARKMAN HEALTHCARE PARTNERS LLC added 1,205,328 shares (+97.6%) to their portfolio in Q3 2025, for an estimated $2,904,840
NANTAHALA CAPITAL MANAGEMENT, LLC added 1,058,467 shares (+45.7%) to their portfolio in Q3 2025, for an estimated $2,550,905
GHISALLO CAPITAL MANAGEMENT LLC added 921,587 shares (+inf%) to their portfolio in Q3 2025, for an estimated $2,221,024
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Full Release

The CGuard ^® Prime Carotid Stent System demonstrated the lowest 30-day and 1-year primary endpoint major adverse event rates of any pivotal study of carotid stenting (CAS)

MIAMI, Jan. 12, 2026 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard ^® Prime carotid stent system for the prevention of stroke, today announced that results from the Company’s C-GUARDIANS pivotal trial have now been published in the Journal of the American College of Cardiology (JACC). 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.

As shown at VIVA in late 2023 and LINC in mid-2024, C-GUARDIANS demonstrated low rates of disabling stroke or myocardial infarction (DSMI) through 30 days and low ipsilateral stroke rates through one year, with no unexpected device-related adverse events reported. This pivotal trial showed historically low event rates in patients with obstructive carotid disease at high risk for complications with carotid endarterectomy (CEA). The cohort included 25% symptomatic patients, comparing favorably with similar patients treated with all forms of carotid revascularization in clinical trials. The published study is available here .

“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™ technology as a potential next-generation standard of care.”

“For interventionalists, the C-GUARDIANS publication marks an important step forward in the industry shift toward a stent-system approach to carotid revascularization,” said Peter Soukas, M.D., Chief Medical Advisor of InspireMD. “Clinicians are looking for proven technologies that expand patient eligibility without compromising outcomes. The trial data offer strong clinical validation for wider use of CGuard ^® Prime, and we expect the JACC publication to drive further physician awareness and engagement.”

“This publication in JACC validates years of innovation and clinical rigor behind CGuard ^® Prime, and has the potential to accelerate our ongoing efforts to bring CGuard ^® Prime to the thousands of U.S. patients who can now benefit from this breakthrough technology,” said Marvin Slosman, Chief Executive Officer of InspireMD. “With peer-reviewed evidence now published in one of the industry leading journals, we are even better positioned to drive adoption and deliver meaningful value to patients, physicians, and healthcare systems.”

CGuard ^® Prime is FDA PMA-approved for the treatment of carotid artery stenosis in the United States.

About C-GUARDIANS
The C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard ^® Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe. The trial included 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, or myocardial infarction (DSMI) through 30‐days post‐index procedure, or ipsilateral stroke from 31‐365-day follow‐up, based on the Clinical Events Committee (CEC) independent 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. The study was published in the American College of Cardiology (JACC) on December 2, 2025.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com .

Investor Contacts:
Webb Campbell
Gilmartin Group LLC
[email protected]
[email protected]