TEL AVIV, Israel, July 26, 2011 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) (“Inspire” or the “Company”), the developer of the MGuard mesh protective stent system, announced today that the first patient has been enrolled in the MASTER (MGuard for Acute ST Elevation Reperfusion) Randomized Trial, a multinational randomized controlled trial designed to demonstrate MGuard Coronary Stent’s superiority over standard care for STEMI (heart attack) patients. The patient was enrolled in the Department of Haemodynamics and Angiocardiography, headed by Dr. Krystrof Zmudka, at the Krakow Specialist Hospital - John Paul II in Krakow, Poland.
The MASTER Randomized Trial will enroll 432 patients in a two-arm, parallel design, with the objective to demonstrate superiority of the MGuard stent over commercially-approved bare-metal stents (BMS) or drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI). The primary endpoint is complete ST segment resolution. Clinical follow-up will continue for one year and other important secondary endpoints such as TIMI flow, myocardial blush grade and MACE (major adverse cardiac events) rate will be measured. Sub studies for cardiac MRI and invasive angiography are planned as well. Dr. Gregg Stone, Director of Cardiovascular Research and Education from Columbia University in New York, is the study chairman.
Mr. Eli Bar, CTO and Vice President of Research and Development of InspireMD, commented, “The enrollment of the first patient in the MASTER Trial is a significant milestone for InspireMD. Previous non-randomized trials have demonstrated the safety and efficacy of MGuard in heart attack patients. The importance of the MASTER Trial is validation of these results, in a large, randomized trial. I am confident that the successful completion of the MASTER Trial will be an important step towards making MGuard the standard of care in treatment of heart attack patients.”
The MASTER randomized trial will be carried out in 50 centers throughout Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Poland and South Africa. The trial’s principal investigators are Dr. Alexandre Abizaid, Dr. Dariusz Dudek and Prof. Sigmund Silber.
About MGuard Coronary Stent
MGuard presents a novel combination of a coronary stent merged with an embolic protection specifically designed for acute MI patients. The embolic protection is comprised of an ultra-thin polymer micron net that wraps the stent. The MGuard stent provides outstanding and lifelong embolic protection, without affecting deliverability. MGuard is CE Mark approved. Mesh-based protection is now recommended for use in the recent Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC).
About InspireMD Inc.
InspireMD is an innovative 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 is traded on the over-the-counter bulletin board (OTC BB) under the ticker symbol “NSPR”.
Forward-looking Statements:
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multi-national companies, (v) product liability claims, (vi) our limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (viii) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers for certain product components, (xi) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xi) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission, including the Company’s Registration Statement on Form S-1 filed with the SEC on June 16, 2011. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Company Contact:
www.inspire-md.com
Jonina Ohayon
Marketing Director
jonina@inspire-md.com
OTC BB: NSPR
Investor Contact:
Jeffrey Stanlis
Partner, Hayden IR
jeff@haydenir.com
(602) 476-1821
SOURCE InspireMD
