Landmark CREST-2 Study Published in the New England Journal of Medicine Highlights the Benefits of Carotid Artery Stenting
MWN-AI** Summary
The recent publication of the CREST-2 study in the New England Journal of Medicine underscores the advantages of carotid artery stenting (CAS) over intensive medical management for patients with asymptomatic carotid stenosis. Presented at the SVIN Annual Meeting and the VEITH Symposium on November 21, 2025, the data revealed that patients receiving CAS experienced significantly better outcomes, notably a reduced risk of perioperative stroke or death and ipsilateral stroke over a four-year period compared to those on medical management alone.
The trial involved two parallel studies across 155 global centers, assessing the effectiveness of stenting in addition to intensive medical management versus medical management alone in 1245 patients. Notably, another arm of the study examining carotid endarterectomy (CEA) found no significant benefits over medical management, establishing CAS as a more effective front-line treatment for this patient demographic.
InspireMD, Inc., the developer of the CGuard® Prime stent system, expressed support for the study's findings, highlighting the clarity it brings to CAS's role in treating asymptomatic carotid disease. CEO Marvin Slosman emphasized that the trial's results reinforce a long-held belief in the superiority of combining stenting with medical management. The firm's CGuard stent has demonstrated a low major adverse event rate, even in high-risk patients.
The CREST-2 study, independently funded and conducted, has set a new standard by providing robust evidence supporting endovascular approaches in vascular disease management. InspireMD plans to leverage these findings and its innovative technology as it strives towards establishing its stent as the industry benchmark for carotid interventions. Investors and stakeholders can find further information about the company and its advancements on the InspireMD website.
MWN-AI** Analysis
The publication of the CREST-2 study in the New England Journal of Medicine is a pivotal moment for InspireMD, Inc. (Nasdaq: NSPR), enhancing its position in the carotid artery stenting (CAS) market. With compelling evidence indicating that CAS, particularly utilizing InspireMD’s CGuard Prime system, yields superior outcomes compared to medical management alone for patients with asymptomatic carotid stenosis, the company stands to gain significant market traction.
As a financial analyst, investors should consider the implications of this research. The CREST-2 data not only validates InspireMD’s product but also signals a broader acceptance of endovascular treatments within vascular disease management. The company's low adverse event rate of 1.93% positions it favorably against competitors who may not have achieved such results, especially among high-risk patients.
Moreover, the shift towards an endovascular-first approach in treating carotid artery disease could result in increased demand for InspireMD’s technology as physicians are likely to pursue options that demonstrate better long-term patient outcomes. This presents potential for revenue growth, particularly if the company expands its market presence in Europe and Asia, where vascular interventions are increasingly prioritized.
Investors should monitor potential strategic partnerships or endorsements from key opinion leaders in vascular medicine, which could further bolster confidence in the CGuard Prime platform. Additionally, staying attuned to regulatory advancements and reimbursement landscape changes will be critical in assessing InspireMD’s near-term performance potential.
In summary, following the publication of the CREST-2 study, there appears to be a solid investment opportunity in InspireMD, given its innovative technology and the favorable clinical data supporting carotid artery stenting. Investors might consider this moment as a key inflection point for the stock.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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**
How does the recent CREST-2 data impact the market position of InspireMD Inc. NSPR in the carotid stenting industry, particularly regarding its CGuard Prime stent system?
What steps is InspireMD Inc. NSPR planning to take in light of CREST-2's findings to strengthen its sales and marketing strategies for the CGuard system?
With the publication of CREST-2 results, how does InspireMD Inc. NSPR aim to educate healthcare providers and patients about the benefits of carotid artery stenting over medical management alone?
What potential risks does InspireMD Inc. NSPR foresee in the competitive landscape following the positive reception of CREST-2 data in the stroke prevention market?
**MWN-AI FAQ is based on asking OpenAI questions about InspireMD Inc. (NASDAQ: NSPR).
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