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InspireMD Provides Corporate Update, Plans for 2012
Date:1/23/2012

ries: Germany, Hungary, Israel, Poland, Canada, Czech Republic, France, the Netherlands, Ireland, Serbia, Brazil and South Africa. It is actively enrolling patients in 32 centers. The trial's principal investigators are Prof. Alexandre Abizaid, Prof. Dariusz Dudek and Prof. Sigmund Silber. Detailed results from the trial are expected to be submitted for presentations at interventional cardiology meetings in the second half of the year.

Plans for U.S. Registration of MGuard™ Underway

InspireMD is advancing its regulatory strategy for U.S. FDA approval for MGuard™ with a trial that is scheduled to begin in the second half of 2012. This trial will consist of patients undergoing primary revascularization for Acute Myocardial Infarction (AMI) who will be randomized to undergo PCI (Percutaneous Coronary Intervention) with either the MGuard Prime System or the comparator Abbott Vision BMS stent.

The primary efficacy endpoint will be a myocardial blush score of 3, with a successful outcome based on superiority of MGuard™ to the BMS stent. The primary safety endpoint will be non-inferiority Target Vessel Failure (TVF) with secondary endpoints including ST-segment resolution at 60 minutes and MACE at 30 days, 6 and 12 months. Dr. Donald Cutlip, Executive Director of Clinical Investigation at the Harvard Clinical Research Institute, will provide scientific leadership of the FDA Registration trial.

2011 Preliminary Shipment and Revenue Results

Unaudited preliminary shipments of the MGuard™ Coronary Stent system for 2011 increased approximately 78% compared to 2010. Unaudited preliminary revenues for 2011 were approximately $6.0 million, compared to $4.9 million in 2010, an increase of approximately 21%. These numbers have not yet been audited by PWC, InspireMD's external auditors. Final audited numbers for the year will be announced when the Company reports year-end 2011 earnings in March.  <
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Related medicine technology :

1. InspireMD Announces the Enrollment of the 1st Patient in the MGuard iMOS Registry, the Registry Will Enroll 1000 Patients
2. For the First Time, at EuroPCR, InspireMD Will Provide a Sneak Preview of the Next Generation MGuard Prime(R), a State of the Art Net Protective Cobalt Chromium Stent System
3. InspireMD Becomes a Supporting Organization in the Growing Stent for Life Initiative
4. InspireMD Boosts MGuard Production Capacity
5. InspireMD to Commence Trading as a Public Company Under Ticker Symbol "NSPR"
6. InspireMD to Participate in Benchmark Company, LLC 2011 One-On-One Investor Conference
7. InspireMD Increases Geographic Penetration; MGuard Stent is Now Available in India
8. InspireMD Promotes MGuardâ„¢ at the EuroPCR 2011 Exhibition and Conference in Paris This Week
9. InspireMD Announces Year-to-Date 2011 Progress
10. InspireMD Broadens Global Distribution Network; Signs Distributor for the Russian Federation
11. Sol J. Barer, Ph.D. Joins InspireMD Board of Directors
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