MIAMI, Nov. 24, 2025 — Leads & Copy — InspireMD, Inc. (Nasdaq: NSPR) has welcomed the presentation and publication of CREST-2 data, which demonstrated positive clinical outcomes for carotid artery stenting (CAS) in patients with asymptomatic carotid stenosis.
The CREST-2 data was presented 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. The study was also published in the New England Journal of Medicine.
The CREST-2 study showed that stenting, along with intensive medical management, led to better outcomes than intensive medical management alone in patients with high-grade carotid stenosis without recent neurological symptoms. The risk of perioperative stroke or death or ipsilateral stroke within four years was decreased. Carotid endarterectomy (CEA), a separate arm of the same trial, did not show a significant benefit for the same patients compared to intensive medical management alone.
Peter Soukas, M.D., Chief Medical Advisor of InspireMD, said that the publication of CREST-2 data is an important moment for treating carotid disease. He added that the data clarifies the role of carotid stenting as a front-line treatment for patients with asymptomatic carotid stenosis, confirming results achieved in the field for a long time. He noted that physicians and patients now have definitive evidence that CAS is an effective treatment for these patients.
Marvin Slosman, Chief Executive Officer of InspireMD, said that CREST-2 validates the belief that carotid artery stenting with medical management is superior to medical therapy alone in the treatment of asymptomatic carotid disease. He added that the trial also highlights the value of InspireMD’s innovative mesh protected platform.
In the 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. Slosman said that their device is also supported by more than 65,000 global implants and extensive real-world evidence. He added that combined with the landmark results from the CREST-2 trial, InspireMD remains well positioned to advance the shift to an endovascular-first approach in this segment of vascular disease.
CREST-2 was a NIH-sponsored set of two parallel, observer-blinded clinical trials across 155 centers globally. The stenting trial compared intensive medical management alone with carotid-artery stenting plus intensive medical management. The endarterectomy trial compared intensive medical management alone with carotid endarterectomy plus intensive medical management. 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 four years. A total of 1,245 patients underwent randomization in the stenting trial and 1,240 in the endarterectomy trial. The study was neither funded nor published by InspireMD.
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. For more information, please visit www.inspiremd.com.
Investor Contacts:
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
investor-relations@inspiremd.com
Source: InspireMD, Inc.
