Landmark CREST-2 Study Published in the New England Journal of Medicine Highlights the Benefits of Carotid Artery Stenting

Rhea-AI Summary

InspireMD (Nasdaq: NSPR) welcomed publication of the CREST-2 trial in the New England Journal of Medicine on Nov 24, 2025, and presentation at SVIN and VEITH on Nov 21, 2025. CREST-2 found that adding carotid artery stenting (CAS) to medical therapy in patients with high-grade asymptomatic carotid stenosis significantly reduced the composite risk of perioperative stroke or death or ipsilateral stroke through 4 years versus intensive medical therapy alone.

The trial reported that carotid endarterectomy (CEA) did not provide a significant benefit vs medical therapy in a separate arm. InspireMD highlighted its CGuard platform, citing a 1.93% major adverse event rate through 12 months in its C-GUARDIANS trial and >b>65,000 global implants as supporting evidence.

Positive

• CREST-2: CAS reduced composite stroke/death risk through 4 years
• C-GUARDIANS: major adverse event rate 1.93% through 12 months
• Device use supported by 65,000+ global implants

Negative

• CREST-2: carotid endarterectomy (CEA) showed no significant benefit vs intensive medical therapy

Insights

Clinical trial and cardiovascular device expert

CREST-2 shows carotid artery stenting plus medical therapy reduced stroke risk versus intensive medical therapy alone over 4 years.

Business mechanism: The CREST-2 results position carotid artery stenting (CAS) as an evidence-backed therapeutic pathway for patients with high-grade asymptomatic carotid stenosis, while carotid endarterectomy did not show a significant benefit versus intensive medical therapy. This outcome creates a clearer clinical rationale for endovascular approaches and supports devices that facilitate safer CAS procedures.

Dependencies and risks: The practical upside depends on guideline revisions, payer coverage changes, clinician adoption, and real-world replication of trial outcomes; none of those implementation steps are guaranteed by publication alone. The company statements cite a 1.93% major adverse event rate through 12 months from its C-GUARDIANS pivotal trial and >65,000 global implants, which, if accurate and comparable to CREST-2 procedural performance, strengthen the device narrative but require verification in guideline and payer reviews.

What to watch (near-term): Monitor professional-society guideline updates and reimbursement decisions over the next 6–24 months and any registry or post‑market data that compare the company’s CGuard® Prime outcomes directly to CREST-2 benchmarks; changes in guideline language or coverage policy would materially affect clinical adoption within that horizon.

Carotid artery stenting combined with medical therapy demonstrated a significantly lower stroke risk compared to intensive medical therapy alone in patients with severe asymptomatic carotid stenosis

MIAMI, Nov. 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard^® Prime carotid stent system for the prevention of stroke, welcomes the recent presentation and publication of CREST-2 data which demonstrated positive clinical outcomes for carotid artery stenting (CAS) for patients with asymptomatic carotid stenosis. CREST-2 data was shown at The Society of Vascular and Interventional Neurology (SVIN) Annual Meeting and the Vascular and Endovascular Issues Techniques and Horizons (VEITH) Symposium on November 21, 2025. In conjunction, the CREST-2 study was published in the New England Journal of Medicine.

CREST-2 showed that, among patients with high-grade carotid stenosis without recent neurological symptoms, the addition of stenting led to significantly better outcomes than intensive medical management alone, as measured by a decreased risk of the composite of perioperative stroke or death or ipsilateral stroke within 4 years. In a separate arm of the same trial, carotid endarterectomy (CEA) did not achieve a significant benefit for these patients as compared to intensive medical management alone.

"The publication of CREST-2 data is an important moment for the treatment of carotid disease,” said Peter Soukas, M.D., Chief Medical Advisor of InspireMD. “These data meaningfully clarify the role of carotid stenting as a front-line treatment for patients with asymptomatic carotid stenosis, confirming the results that many of us in the field have achieved for a long time. Physicians and patients now have definitive, high-quality evidence that CAS is an effective treatment option for these patients.”

“CREST-2 validates what we have long believed – that the combination of carotid artery stenting with medical management is superior to medical therapy alone in the treatment of asymptomatic carotid disease,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The trial also highlights the value of our innovative mesh protected platform. In our C-GUARDIANS pivotal trial, CGuard demonstrated a record-low 1.93% major adverse event rate through 12 months, even when exclusively enrolling high surgical risk patients, one-quarter of whom were symptomatic. Our device is also supported by more than 65,000 global implants and extensive real-world evidence. Combined with the landmark results from the CREST-2 trial, we remain well positioned to advance the shift to an endovascular-first approach in this segment of vascular disease.”

About CREST-2
CREST-2 was a NIH sponsored independently conducted set of two parallel, observer-blinded clinical trials across 155 centers globally. The stenting trial compared intensive medical management alone (medical-therapy group) with carotid-artery stenting plus intensive medical management (stenting group); the endarterectomy trial compared intensive medical management alone (medical-therapy group) with carotid endarterectomy plus intensive medical management (endarterectomy group). The primary outcome was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke, assessed during the remaining follow-up period up to 4 years. A total of 1245 patients underwent randomization in the stenting trial and 1240 in the endarterectomy trial. The study was published in the New England Journal of Medicine on November 21, 2025. The study was neither funded nor published by InspireMD.

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 did CREST-2 report about carotid artery stenting on Nov 24, 2025 for NSPR?

CREST-2 reported that adding carotid artery stenting to intensive medical therapy significantly lowered the composite risk of perioperative stroke or death or ipsilateral stroke through 4 years.

How does the CREST-2 result affect InspireMD (NSPR) product positioning?

InspireMD said CREST-2 supports an endovascular-first approach and cited its CGuard data to position the device for asymptomatic high-grade carotid stenosis patients.

What did CREST-2 find about carotid endarterectomy (CEA) compared to medical therapy?

In a separate CREST-2 arm, CEA did not achieve a significant benefit versus intensive medical therapy.

What safety data did InspireMD cite for its CGuard device in 2025?

InspireMD cited its C-GUARDIANS pivotal trial showing a 1.93% major adverse event rate through 12 months.

When and where was CREST-2 data on carotid stenting presented in November 2025?

CREST-2 data were presented at the SVIN Annual Meeting and the VEITH Symposium on November 21, 2025.

How many global implants does InspireMD report for its mesh-protected platform?

InspireMD reported more than 65,000 global implants supporting its mesh-protected platform.