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Inspiremd Announces Positive Twelve Month Follow-Up Carenet

The following excerpt is from the company's SEC filing.

Trial Data at VEITH Symposium 2015


InspireMD, Inc.

(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today positive 12 month follow up data from its CGuard


mbolic protection Study using micro

) trial at the 42

Annual Symposium on Vascular and Endovascular Issues (VEITH) in New York. Prof. Piotr Musiałek, Co-Principal Investigator for the CARENET study, from Jagiellonian University Medical College at J ohn Paul II Hospital, Krakow, Poland, presented the 12 month follow up data, an industry first on a mesh covered carotid stent technology.

At the New Techniques, Technologies and Concepts session, Prof. Musialek presented the new data on the InspireMD CGuard

Mesh Covered Carotid Stent Program. His lecture, entitled “MicroNet Covered Embolic Prevention Carotid Stent System: From CARENET And PARADIGM Studies To Routine Clinical Practice,” focused on the CARENET 12 month results, which demonstrated zero strokes or stroke-related deaths at 12 months. Further, duplex ultrasound analysis confirmed no changes in the in-stent velocities between 6 and 12 months. This indicates no sign of vessel narrowing and is consistent with the durability of carotid artery treatment seen using CGuard

According to Prof. Musialek, previously demonstrated reduction in both the incidence and the volume of new ischemic lesions, together with the 12 month data that show minimal restenosis concern, suggests that the therapeutic benefits of the CGuard

technology may extend well beyond the acute procedural period.

Prof. Piotr Musialek commented, “It is very exciting to present the 12 month follow up data from the CGuard

CARENET study, which continues to validate the use of the MicroNet

covered CGuard

, with zero strokes at 12 months. In addition, the 12 month data showed no change in peak systolic velocity between 6 months and 12 months, suggesting no restenosis concerns. These findings, combined with the results from our recent all-comer single center PARADIGM trial, continue to show the increased therapeutic benefits of the CGuard

technology in treating patients with carotid artery disease. This technology is a game-changer in today’s practice of carotid revascularization and my colleagues and I look forward to continued use of this unique technology in routine clinical practice.”

Alan Milinazzo, CEO of InspireMD commented, “Twelve month CARENET results further validate that...