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

Rhea-AI Summary

InspireMD (Nasdaq: NSPR) announced publication of the C-GUARDIANS pivotal trial in JACC reporting low adverse event rates for the CGuard® Prime MicroNet™ carotid stent. The trial showed a 30-day disabling stroke or myocardial infarction (DSMI) rate of 0.95% and a 1-year ipsilateral stroke rate of 1.93% in a cohort that included 25% symptomatic patients. No unexpected device-related adverse events were reported. InspireMD highlighted that results compare favorably with prior carotid stenting pivotal studies and said the device is FDA PMA-approved for treatment of carotid artery stenosis in the U.S.

Positive

• 30-day DSMI rate of 0.95%
• 1-year ipsilateral stroke rate of 1.93%
• Cohort included 25% symptomatic patients, enhancing comparability

Negative

• None.

News Market Reaction – NSPR

-5.81%

2 alerts

-5.81% News Effect

-11.4% Trough Tracked

-$5M Valuation Impact

$76M Market Cap

0.8x Rel. Volume

On the day this news was published, NSPR declined 5.81%, reflecting a notable negative market reaction. Argus tracked a trough of -11.4% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $5M from the company's valuation, bringing the market cap to $76M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

30-day DSMI rate: 0.95% 1-year ipsilateral stroke rate: 1.93% Symptomatic patients in cohort: 25% +5 more

8 metrics

30-day DSMI rate 0.95% C-GUARDIANS pivotal trial primary endpoint

1-year ipsilateral stroke rate 1.93% C-GUARDIANS pivotal trial outcome

Symptomatic patients in cohort 25% High-risk obstructive carotid disease population

Current share price $1.72 Prior to JACC publication announcement

1-day price change -6.52% Move into the news event

52-week high $3.798 Pre-news trading range

52-week low $1.59 Pre-news trading range

Market capitalization $72,878,111 Equity value before JACC publication

Market Reality Check

Price: $1.81 Vol: Volume 47,577 is close to...

normal vol

$1.81 Last Close

Volume Volume 47,577 is close to the 20-day average of 48,694, suggesting no unusual trading activity ahead of this news. normal

Technical Price at $1.72 is trading below the 200-day moving average of $2.32, reflecting a longer-term downtrend into this publication.

Peers on Argus

NSPR fell 6.52% while close peers were mixed: BDMD -2.27%, PROF -0.94%, SERA -1....

NSPR fell 6.52% while close peers were mixed: BDMD -2.27%, PROF -0.94%, SERA -1.86%, versus ICAD +3.48% and RCEL +3.03%. Moves do not indicate a coherent sector trend.

Historical Context

5 past events · Latest: 2025-11-24 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
2025-11-24	Clinical trial data	Positive	+1.6%	CREST-2 results supported carotid stenting benefits and highlighted CGuard data.
2025-11-21	Equity compensation	Neutral	+13.5%	Inducement grants of restricted shares to new non-executive employees.
2025-11-19	Conference participation	Neutral	-2.0%	Planned fireside discussion at a major healthcare conference.
2025-11-04	Earnings release	Negative	-7.2%	Revenue growth offset by higher expenses and a larger net loss in Q3 2025.
2025-11-03	Management change	Positive	+3.6%	Appointment of a new Chief Medical Officer to advance CGuard strategy.

Pattern Detected

Recent news has often aligned with price direction: positive clinical/strategic updates tended to coincide with gains, while heavier spending and losses around earnings coincided with declines.

Recent Company History

Over the past few months, InspireMD highlighted multiple milestones around CGuard Prime and carotid stenting. A CREST-2 publication underscored benefits of carotid artery stenting, while the company advanced commercialization with conference participation and a U.S. launch. Q3 2025-11-04 results showed strong revenue growth but larger operating losses and net loss, followed by governance and insider developments, including a new Chief Medical Officer and insider share purchases. Today’s JACC C-GUARDIANS publication extends this clinical validation narrative.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-08-06

An effective Form S-3 shelf registration filed on 2025-08-06 and expiring 2028-08-06 provides InspireMD flexibility to raise capital in the future, although no usage is recorded in the provided data.

Market Pulse Summary

The stock moved -5.8% in the session following this news. The decline reflects tension between stron...

Analysis

The stock moved -5.8% in the session following this news. The decline reflects tension between strong clinical validation and a stock already trading below its 200-day moving average. The JACC publication confirms low 0.95% DSMI and 1.93% one-year stroke rates, extending a positive clinical narrative seen with CREST-2. Yet prior quarterly filings showed widened losses and going-concern language, and an unused S-3 shelf from 2025-08-06 underscores ongoing financing flexibility that some shareholders may view cautiously.

Key Terms

carotid stenting, carotid artery stenosis, myocardial infarction, ipsilateral stroke, +4 more

8 terms

carotid stenting medical

"pivotal study of carotid stenting (CAS) MIAMI, Jan. 12, 2026"

Carotid stenting is a minimally invasive procedure that opens a narrowed carotid artery in the neck by threading a thin tube to the blockage and placing a small metal mesh tube (stent) to hold the vessel open—think of propping a pinched garden hose with a tiny scaffold. It matters to investors because device sales, clinical trial results, regulatory approvals, insurance reimbursement and safety outcomes directly affect makers’ revenues, market value and legal risk in the vascular device and healthcare sectors.

carotid artery stenosis medical

"stent in patients with asymptomatic carotid stenosis. As shown at VIVA"

Carotid artery stenosis is the narrowing of the main blood vessels in the neck that deliver blood to the brain, like a pipe getting clogged by buildup. It raises the risk of stroke and often prompts medical tests, treatments or surgeries to restore blood flow. Investors track it because changes in diagnosis rates, new procedures, devices or drug approvals, and reimbursement policies can affect healthcare companies’ revenues and clinical trial prospects.

myocardial infarction medical

"demonstrated low rates of disabling stroke or myocardial infarction (DSMI)"

Myocardial infarction, commonly called a heart attack, happens when blood flow to part of the heart is suddenly blocked and heart muscle is damaged—like a garden hose being pinched so a patch of lawn starts to die. For investors, heart attacks matter because they drive demand for drugs, devices, hospitals and rehabilitation, affect health-care costs and workforce productivity, and can lead to regulatory actions, litigation or shifts in insurance and pricing that impact company earnings.

ipsilateral stroke medical

"DSMI rate of just 0.95% and a one-year ipsilateral stroke rate of 1.93%"

An ipsilateral stroke is a brain injury that causes loss of function on the same side of the body or brain as a nearby lesion, treatment site, or medical device. Think of it like damage that affects the same wing of a building where work was performed; for investors it matters because such events can signal safety risks, affect clinical trial results, increase liability or regulatory scrutiny, and influence a company’s valuation and approval prospects.

carotid endarterectomy medical

"high risk for complications with carotid endarterectomy (CEA). The cohort"

Carotid endarterectomy is an operation that removes fatty buildup (plaque) from a carotid artery in the neck to restore blood flow to the brain and reduce stroke risk. For investors, it matters because the procedure drives demand for surgical services, medical devices and hospital capacity, affects treatment costs and insurance payouts, and can influence the financial outlook of healthcare providers and makers of related products — like fixing a clogged pipe to prevent a costly flood.

pivotal trial medical

"C-GUARDIANS pivotal trial have now been published in the Journal"

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

revascularization medical

"approach to carotid revascularization,” said Peter Soukas, M.D."

Revascularization is the medical process of restoring blood flow to heart or other tissues that have been starved by narrowed or blocked vessels, often by opening or bypassing the blockage. Think of it like clearing or rerouting a clogged pipe so oxygen and nutrients can get through. Investors track revascularization because its use, outcomes, and cost affect demand for medical devices, hospital services, drug treatments, and long-term patient spending.

pma-approved regulatory

"CGuard® Prime is FDA PMA-approved for the treatment of carotid"

PMA-approved means a medical device has received Premarket Approval from the U.S. Food and Drug Administration, the most rigorous clearance for high-risk medical products. For investors, PMA approval is like a hard-won driver’s license: it allows the product to be legally sold and signals that regulators reviewed clinical evidence of safety and effectiveness, reducing regulatory risk and often supporting stronger market access and revenue potential.

AI-generated analysis. Not financial advice.

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

What were the key 30-day and 1-year results from the C-GUARDIANS trial (NSPR)?

The trial reported a 30-day DSMI rate of 0.95% and a 1-year ipsilateral stroke rate of 1.93%.

Is the CGuard Prime carotid stent FDA-approved in the United States (NSPR)?

Yes; CGuard Prime is reported as FDA PMA-approved for treatment of carotid artery stenosis in the U.S.

How much of the C-GUARDIANS trial cohort were symptomatic patients (NSPR)?

The published cohort included 25% symptomatic patients.

Where was the C-GUARDIANS pivotal trial manuscript published and when was the announcement (NSPR)?

The manuscript was published in the Journal of the American College of Cardiology (JACC) and announced on January 12, 2026.

Did the C-GUARDIANS publication report any unexpected device-related adverse events (NSPR)?

No unexpected device-related adverse events were reported in the publication.