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

als and Objectives

  • Complete the Master Trial and report results (2H, 2012) at a major interventional cardiology meeting.
  • Initiate and commence enrollment in the FDA Registration trial of MGuard™.
  • Obtain CE Mark approval for MGuard Carotid™ product. 
  • Initiate clinical study for MGuard Carotid™.
  • Expand commercial and manufacturing infrastructure in anticipation of MGuard™ demand, including the hiring of key senior executives.
  • Pursue additional registrations and distribution contracts in new countries.

MASTER Trial Enrollment on Track, Primary Endpoint Data Expected in Third Quarter

The MASTER (MGuard™ for Acute ST Elevation Reperfusion) randomized trial seeks to enroll 432 patients in a two-arm, parallel design study.  The objective is to evaluate the MGuard™ stent compared to commercially-approved BMS or DES products in achieving myocardial reperfusion in primary angioplasty for the treatment of STEMI patients. The primary endpoint is complete ST segment resolution.

Clinical follow-up will continue for one year and important secondary endpoints such as TIMI (Thrombolysis In Myocardial Infarction) flow, myocardial blush grade and MACE will be measured. Additional sub-studies for cardiac MRI and invasive angiography are planned as well. Dr. Gregg Stone, Director of Cardiovascular Research and Education, Columbia University in New York, is the study chairman.

Eli Bar, CTO and Vice President of Research and Development of InspireMD, commented: "We are pleased that enrollment in the MASTER Trial is advancing on schedule and we anticipate completing enrollment in the second quarter of 2012." He added: "The intent of the MASTER Trial is to provide additional supportive data based on a large, multi-national randomized trial."

The MASTER Trial is being conducted in 12 count
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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 MGuard™ 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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