InspireMD Announces Publication of the C-GUARDIANS Pivotal Trial Manuscript in the Journal of the American College of Cardiology (JACC)
MWN-AI** Summary
InspireMD, Inc. announced the publication of its pivotal C-GUARDIANS trial in the Journal of the American College of Cardiology (JACC), demonstrating the efficacy and safety of its CGuard® Prime Carotid Stent System, designed to prevent strokes in patients with carotid artery stenosis. The trial reported the lowest rates of major adverse events, specifically disabling stroke and myocardial infarction, both at 30 days and one year after treatment, when compared to other carotid stenting studies. Notably, the 30-day rate for disabling stroke or myocardial infarction was just 0.95%, while the one-year rate for ipsilateral stroke was 1.93%, showcasing the system’s effectiveness especially among a cohort that included 25% symptomatic patients, traditionally at higher risk.
Dr. Chris Metzger, lead investigator of the C-GUARDIANS trial, emphasized the significance of these results, which highlight the CGuard® Prime's MicroNet™ technology as a potential new standard in patient care. Peter Soukas, Chief Medical Advisor at InspireMD, indicated that the publication in JACC could advance the shift towards a stent-system approach in carotid revascularization, prompting greater acceptance among clinicians and expanding patient eligibility without compromising safety and efficacy.
CEO Marvin Slosman added that the peer-reviewed publication further validates the innovation behind CGuard® Prime, positioning the company to enhance its acceptance and utility among American patients in need of stroke prevention. The trial enrolled 316 patients across 24 sites in the U.S. and Europe, reinforcing InspireMD’s goal to set new standards in carotid stenting through advanced technology. As a publicly traded company on NASDAQ under the ticker NSPR, InspireMD is actively working to bring its solution to the healthcare market, potentially benefiting numerous patients.
MWN-AI** Analysis
InspireMD, Inc. (NSPR) recently garnered attention with the publication of the C-GUARDIANS pivotal trial manuscript in the Journal of the American College of Cardiology (JACC). The results highlight the efficacy of the CGuard® Prime Carotid Stent System, showcasing the lowest 30-day and 1-year rates of major adverse events in carotid artery stenting (CAS) reported to date. With a 30-day disabling stroke or myocardial infarction (DSMI) rate of 0.95% and a one-year ipsilateral stroke rate of 1.93%, these outcomes present a significant advancement for patients at high risk for complications.
The evidence presented reinforces the value proposition of the MicroNet™ technology. The trial included a notable 25% of symptomatic patients—an important demographic traditionally facing higher risks—with results comparable or superior to existing treatments. Such findings could reshape treatment guidelines and enable a wider adoption of InspireMD’s offerings among clinicians seeking effective solutions for carotid artery stenosis.
For investors, this publication serves as a catalyst for potential upward momentum in InspireMD's stock price. With clinical validation now established in a prestigious medical journal, we anticipate increased physician awareness and engagement driving product adoption. The positive differential in outcomes may enhance the company’s positioning within a competitive market, potentially translating into expanded market share.
Traders should closely monitor NSPR as it could experience volatility precipitated by further sampling of market responses to the assayed results. A prudent strategy could involve accumulating positions during price corrections, particularly given the long-term growth potential tied to the clinical adoption of the CGuard® Prime. Additionally, keep an eye on future updates from InspireMD which may further delineate its impact on the stroke prevention landscape. Overall, the near-term outlook appears optimistic based on the clinical validation presented.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news 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
webb@gilmartinir.com
investor-relations@inspiremd.com
FAQ**
How does the CGuard® Prime Carotid Stent System's performance in the C-GUARDIANS trial compare to existing treatments, and what implications does this have for future investments in InspireMD Inc. (NSPR)?
Given the reported low 30-day DSMI rate of 0.95%, what are the projected market opportunities for InspireMD Inc. (NSPR) as clinicians increasingly adopt the CGuard® Prime technology?
What strategies is InspireMD Inc. (NSPR) implementing to leverage the recent publication in JACC to enhance physician awareness and increase market penetration of the CGuard® Prime system?
How does InspireMD Inc. (NSPR) plan to address potential competitive pressures in the carotid stenting market following the promising results from the C-GUARDIANS trial?
**MWN-AI FAQ is based on asking OpenAI questions about InspireMD Inc. (NASDAQ: NSPR).
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