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InspireMD Announces Enrollment of First Patients in the MGuard(TM) Acute Myocardial Infarction Clinical Trial Data Will be Used to Confirm Initial Positive Results
Date:9/23/2008

TEL AVIV, Israel, September 23 /PRNewswire/ -- InspireMD, Ltd. announced today the enrollment of the first 3 patients in its study of MGuard(TM) coronary stent in acute myocardial infarction. The GUARD Study (MGuard(TM) in Acute Myocardial Infarction Study) is designed to evaluate the safety and efficacy of MGuard(TM) in patients suffering from ST-segment elevation myocardial infarction. The first 3 patients were implanted successfully with the MGuard(TM) Coronary Stent, in the Jagiellonian University Clinic, in Krakow, Poland.

"It is very exciting for me to see this study take off and confirm our expectations," said Dr. Dariusz Dudek, the GUARD Study Chief Investigator, from Jagiellonian University in Krakow, "The MGuard(TM) represents a very innovative approach to the management of thrombus and embolization, which adversely affect the prognosis and survival rate of a large proportion of Acute MI patients. From the cases of acute MI where MGuard(TM) was implanted so far in various countries, we learned that the results were very successful and that the product has a strong efficacy and safety profile with an exceptional deliverability. I look forward to confirm these initial findings through this study."

"The successful clinical development of MGuard(TM) will benefit Acute MI patients throughout the world," said Eli Bar, CTO and VP R&D of InspireMD, "MGuard(TM) is designed to provide a comprehensive solution to the embolization threat, during and post procedure. We are confident that the GUARD Study will confirm what we have experienced so far in cath labs around the world that the product performs well and delivers extra safety to acute MI patients."

The GUARD Study is a prospective, multi center study, designed to confirm the feasibility, efficacy and safety of MGuard(TM) in acute MI patients. The GUARDS study will include 60 patients, and its primary endpoints are complete resolution of ST-segment elevation and restoration of flow through the occluded artery.

About MGuard(TM) Coronary

The MGuard(TM) Coronary stent presents a novel combination of a coronary stent merged with an embolic protection device. The embolic protection device is comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent. The protective sleeve is composed of a micron-level-fiber knitted mesh, engineered in an optimal geometric configuration and designed for utmost flexibility while retaining strength characteristics of the fiber material. The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post procedure. The MGuard(TM) Coronary stent provides long acting embolic protection, without adding complexity in deliverability. The sleeve is designed to diffuse stent pressure on the vessel wall, thereby may reduce injury and lower the likelihood of restenosis.

The MGuard(TM) Coronary's innovative concept has enjoyed an enthusiastic welcome from leading interventional cardiologists around the world.

About InspireMD

InspireMD, Ltd. is an innovative medical device company focusing on the development and commercialization of its proprietary stent platform technology, MGuard(TM). The company intends to apply its technology to develop products used in interventional cardiology and other vascular procedures. InspireMD's mission is to utilize its proprietary technology to make its products the industry standard for stents and to provide a superior solution to the key clinical issues of current stenting procedures: restenosis, embolic showers, and late thrombosis.

In addition to providing embolic protection and minimizing arterial injury, this promising technology is aimed at providing an effective and uniform drug delivery mechanism for next generation drug eluting stents. InspireMD intends to pursue applications of this technology both for bare metal and drug eluting stents in coronary, carotid and peripheral artery procedures.

Contact:

Jonina Ohayon

Marketing Director

InspireMD Ltd

Tel: +972-3-691-7691

jonina @inspire-md.com


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SOURCE InspireMD, Ltd
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