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InspireMD Reports Fourth Quarter and Fiscal Year 2013 Results
Date:9/17/2013

and strategic partnership activities in key international markets.  In terms of the U.S. market, we already began enrollment for our FDA-intended MASTER II trial.  And as we expand our current clinical activities for the Coronary market, we continue to bolster our product pipeline with advances for the Carotid and Peripheral Vasculature target indications," concluded Mr. Milinazzo.

Operational Overview  In fiscal year 2013, the Company announced superior results from the MASTER trial for its MGuard Embolic Protection Stent (EPS).The findings show the novel MGuard EPS provides a significant acute advantage in reducing ST segment elevation versus traditional bare metal and drug eluting stents. As a result, MGuard may hold the potential to prolong the survival of heart attack victims, as evidenced by the 30-day and 6-month data. 

The MASTER trial is an important study for InspireMD, as it is the first large, randomized clinical trial for the MGuard to date. As such, the results have gained much more credence among those in the medical community. The 12-month follow up results for the MASTER trial, scheduled to be released on October 29th, are expected to be an important data point for physicians evaluating the MGuard, as the first year is an important period for evaluating a patient that has received a stent during a heart attack. 

The results disclosed thus far from the MASTER trial have allowed the Company to begin the transition to a new commercial strategy in countries where the MGuard has received regulatory clearance.  This includes setting up the support structure for a direct sales team in certain European countries and advancing discussions with new strategic partners.  The Company recently entered into an agreement with Healthlink Europe, a medical device support services and distribution company, to provide logistical and customer support for InspireMD's commercial operations and clinical
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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
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