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InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
Date:4/23/2013

enter, randomized trial, comparing both bare metal and drug eluting stents, the current therapy for STEMI patients."

The FDA trial will be known as The MASTER II (MGuard™ for Acute ST Elevation Reperfusion), the second in a series of clinical studies intended to both validate the effectiveness of the MGuard™ EPS platform, as well as achieve registration with the appropriate regulatory authorities worldwide.

InspireMD's MGuard™ EPS technology previously yielded positive results in the MASTER I findings, which revealed a statistically and clinically significant acute advantage of MGuard™ EPS with regard to ST segment resolution. As a result, MGuard™ EPS may hold the potential to lower the incidence of adverse events and prolong the survival of patients suffering from acute myocardial infarction.

About InspireMD's MGuard™ EPS Technology

In stroke and acute heart attack patients, the plaque or thrombus is unstable and often breaks up as a stent is implanted causing downstream blockages, some of which can be fatal, in a significant portion of heart attack patients.

The MGuard™ EPS stent system is integrated with a precisely engineered micro net mesh designed to prevent the unstable arterial plaque and thrombus (clots) that cause these blockages from breaking off. The mesh is designed to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard™ EPS is CE Mark approved. MGuard™ EPS, however, is not approved for sale in the U.S. by the FDA.

About InspireMD, Inc.

InspireMD is a medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard™. InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD's common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

Forward-looking Statements
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SOURCE InspireMD, Inc.
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Related medicine technology :

1. InspireMD Announces First Quarter 2012 Financial Results
2. InspireMD Announces Positive 3-Year Results from Extended MAGICAL trial
3. InspireMD to Present at Inaugural Marcum Microcap Conference on June 20th in New York
4. InspireMD to Present at Harvard Investors Group on June 27 in New York
5. InspireMD Announces Positive Results From MGuard(TM) Stent MASTER Trial for Emergency Treatment of Heart Attack Patients
6. InspireMD Reports Results For Period Ending Sept. 30, 2012
7. Positive Results of InspireMDs MASTER Trial to be Published on November 6 in Journal of American College of Cardiology
8. InspireMD to Discuss MGuard(TM) and the MASTER Randomized Trial Results at the ICI 2012 Meeting
9. InspireMD Reports Results for Period Ended Dec. 31, 2012
10. InspireMD Files Amended Registration Statement for Proposed Public Offering of Common Stock
11. InspireMD Receives CE Mark Approval for Carotid Embolic Protection Stent
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