TEL AVIV, Israel, May 10, 2012 /PRNewswire/ -- InspireMD, Inc. (OTC BB: NSPR) (the "Company" or "InspireMD"), a medical device company focusing on the development and commercialization of its proprietary stent platform technology for use in patients with Acute Myocardial Infarctions, will host a symposium and cocktail reception at the EuroPCR meeting on Wednesday, May 16 in Paris.
Results from the EF (extended follow up) MAGICAL trial will be presented for the first time at this symposium. This is a retrospective analysis of the MAGICAL trial population with follow-up duration of 3 years. MAGICAL was a prospective, single arm study that enrolled 60 STEMI patients with less than 12 hours symptom onset. Primary endpoints were ST segment resolution, TIMI flow and Blush score. The data from the EF MAGICAL trial will be presented by the principal investigator, Dr. Dariusz Dudek from the Jagiellonian University, Krakow, Poland.
The symposium will also feature the first European presentation of the MICAMI trial, which is the first prospective randomized study with MGuard™, that demonstrated a statistically significant improvement in acute outcomes in STEMI patients when compared with traditional bare metal stents (BMS). This data was presented earlier this year in Washington, D.C. by principal investigator Dr. Dante Lindefjeld from the Pontifical Catholic University of Chile, Santiago, Chile.
The symposium "Thrombus Management in STEMI: MGuard™ Late Breaking Data" will take place at Concorde Lafayette Hotel (Grande Etoile D'Or Hall) in Paris on Wednesday May 16, from 6.30 – 8 PM.
EuroPCR is the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions. It serves as one of the leading international courses in Interventional Medicine. It will take place this year in Paris, France May 15 – 18. More than 12,000 participants from around the world are expected to attend.
About MGuard™ Coronary Stent
MGuard™ combines 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 seeks to provide 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).
MGuard™ is currently being investigated in the multi-center international MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial. This study has been designed to evaluate the MGuard™ stent compared to commercially-approved BMS or DES products in STEMI patients undergoing primary angioplasty. Preliminary top line results are expected in the third quarter of 2012. Plans for a registration study in the US are also at an advanced stage.
About InspireMD, Inc.
InspireMD is a medical device company focused 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's common stock is listed on the OTC BB under the ticker symbol "NSPR."
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 (xii) 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 April 25, 2012. 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.
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SOURCE InspireMD, Inc.