Navigation Links
InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial

BOSTON and TEL-AVIV, Israel, April 23, 2013 /PRNewswire/ --

InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ Embolic Protection Stent (EPS), announced today that on April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). An approval with conditions indicates that the FDA concurs with the overall trial design and while minor details are being finalized, allows the company to initiate enrollment in the MASTER II IDE trial.

The multi-center, randomized trial will consist of 1,114 patients suffering from ST Elevation Myocardial Infarction (STEMI), throughout 35 sites in the U.S. and an additional 35 sites in Europe, and will support the Company's application to market its MGuard™ Prime MicroNet™ covered coronary stent system in the US.

Gregg Stone M.D ., of The Cardiovascular Research Foundation, and Jose P. S. Henriques M.D ., of the Academic Medical Center Amsterdam in the Netherlands, will serve as Principal Investigators for the trial, which will consist of two co-primary endpoints: superiority in complete ST resolution and non-inferiority in death and target vesselmyocardial infarction. In addition, a 356 patient sub-study will be conducted to assess the effect of MGuard™ EPS on vessel infarct size, as measured through cardiac Magnetic Resonance Imaging (MRI).

"Receiving this approval to commence our FDA trial is a significant milestone." commented Alan Milinazzo , InspireMD's CEO and President. Mr. Milinazzo further noted, that "This trial will provide an excellent opportunity to validate the safety and effectiveness of MGuard™ EPS in another large multi-center, randomized trial, comparing both bare metal and drug eluting stents, the current therapy for STEMI patients."

The FDA trial will be known as The MASTER II (MGuard™ for Acute ST Elevation Reperfusion), the second in a series of clinical studies intended to both validate the effectiveness of the MGuard™ EPS platform, as well as achieve registration with the appropriate regulatory authorities worldwide.

InspireMD's MGuard™ EPS technology previously yielded positive results in the MASTER I findings, which revealed a statistically and clinically significant acute advantage of MGuard™ EPS with regard to ST segment resolution. As a result, MGuard™ EPS may hold the potential to lower the incidence of adverse events and prolong the survival of patients suffering from acute myocardial infarction.

About InspireMD's MGuard™ EPS Technology

In stroke and acute heart attack patients, the plaque or thrombus is unstable and often breaks up as a stent is implanted causing downstream blockages, some of which can be fatal, in a significant portion of heart attack patients.

The MGuard™ EPS stent system is integrated with a precisely engineered micro net mesh designed to prevent the unstable arterial plaque and thrombus (clots) that cause these blockages from breaking off. The mesh is designed to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard™ EPS is CE Mark approved. MGuard™ EPS, however, is not approved for sale in the U.S. by the FDA.

About InspireMD, Inc.

InspireMD is a 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's common stock is quoted on the NYSE MKT 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 (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 (SEC), including the Company's Transition Report on Form 10-K/T and its Quarterly Reports on Form 10-Q.  Investors and security holders are urged to read these documents free of charge on the SEC's web site at The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

For additional information:

InspireMD Desk
Redington Inc.,

SOURCE InspireMD, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. InspireMD Announces First Quarter 2012 Financial Results
2. InspireMD Announces Positive 3-Year Results from Extended MAGICAL trial
3. InspireMD to Present at Inaugural Marcum Microcap Conference on June 20th in New York
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
7. Positive Results of InspireMDs MASTER Trial to be Published on November 6 in Journal of American College of Cardiology
8. InspireMD to Discuss MGuard(TM) and the MASTER Randomized Trial Results at the ICI 2012 Meeting
9. InspireMD Reports Results for Period Ended Dec. 31, 2012
10. InspireMD Files Amended Registration Statement for Proposed Public Offering of Common Stock
11. InspireMD Receives CE Mark Approval for Carotid Embolic Protection Stent
Post Your Comments:
(Date:10/8/2015)...  The National Heart, Lung and Blood Institute ... Broad Institute of MIT and Harvard to provide ... well as data to support smaller pilots in ... for Precision Medicine (TOPMed) program and serves ... which will use whole genome sequencing to drive ...
(Date:10/8/2015)... 2015 ... "Natural Language Processing Market for Health ... (Rule-Based, Statistical, & Hybrid NLP Solutions), Region ... Africa, Latin America) - Global Forecast to ... --> ) has announced the ...
(Date:10/8/2015)... Oct. 08 2015 ... "Global API Market Outlook 2020" report ... has announced the addition of the "Global ... offering. --> Research and Markets ( ... "Global API Market Outlook 2020" report ...
Breaking Medicine Technology:
... Aug. 31, 2011 BioDelivery Sciences International, Inc. (Nasdaq: ... three upcoming investor conferences.  Dr. Mark A. Sirgo, President ... where he will focus on BDSI,s product pipeline, particularly ... which data from the pivotal Phase 3 efficacy study ...
... 2011 Elbit Imaging Ltd. (NASDAQ: EMITF) ... placed an Investor Relations Presentation relating to its Sources and ... "Investor Relations - Company Presentations -Analysis of Sources and Uses." ... Imaging Ltd. operates in the following principal fields of business: ...
Cached Medicine Technology:
(Date:10/10/2015)... ... 2015 , ... Story Chaser is a one-of-a-kind app that makes ... and inspiring stories and as words drop down and users tap the corresponding word. ... and can be interacted with, making it a more engaging game. Users can use ...
(Date:10/9/2015)... ... ... Doctors on Liens has teamed up with a renowned medical practice, ... to personal injury victims. When personal injury victims suffer major, complex injuries, they ... of conditions ailing them. With the addition of this new group of doctors ...
(Date:10/9/2015)... ... ... A new health tool that helps identify if a sore throat is ... – just in time for the cold and flu season, which the Center for ... the U.S., the real start of cold/flu season is the start of the school ...
(Date:10/9/2015)... ... 2015 , ... Head Over Heels Athletic Arts gymnast, Madelyn Williams, will attend ... Ranch in Huntsville, Texas on October 17-21. , "It's very exciting to be ... and executive director, said. “It's a stepping stone into the U.S. elite system where ...
(Date:10/9/2015)... Orleans, LA (PRWEB) , ... October 09, 2015 ... ... with offices serving New Orleans and the surrounding communities, is initiating a combined ... and medical care for unwanted animals in southern Louisiana. , Animal Rescue ...
Breaking Medicine News(10 mins):
... from exposure to medications, chemicals and other agentsSAN DIEGO, ... taking cold medication or using certain cleaning products can ... A new Web site ( ) ... latest information about the potential risks of exposure to ...
... restore sight, experts suggest , , THURSDAY, March 5 (HealthDay ... in two forms of childhood blindness has been identified ... of the link between the retinal gene SPATA7 and ... because it pinpoints a new retinal metabolic disease pathway ...
... 100 property and casualty insurers closed 2008 with net ... while the top 100 life insurers suffered unprecedented unrealized ... 2008 Top 100 Performance Monitor revealed a 67.7 percent ... industry,s top property and casualty insurers, from $48.8 billion ...
... Americas, Europe and Asia to Realize New Executive ... Tokyo Stock Exchange), a leading medical diagnostics ... announced executive leadership changes at Sysmex Corporate and ... Effective April 1, 2009, Kazuya Obe will ...
... stroke and heart disease are potential complications of type ... Americans. Now research from Tel Aviv University has found ... a risk factor accelerating cognitive decline and dementia. ... TAU,s Sackler School of Medicine, found that people with ...
... 2009 Many doctors don,t offer emergency contraception ... during emergency department visits because of misinformation about ... by The Children,s Hospital of Philadelphia. , ... reduce unintended pregnancy, the study,s authors said. ...
Cached Medicine News:
Symbia T6, a True Point SPECT·CT system, combines a dual-detector variable angle gamma camera with a six slice CT scanner for advanced oncology, neurology, and cardiology applications....
... ACOM.PC turns every standard PC into ... internists, and cardiologists can use their ... access to image data thanks to ... 3 format and the compatible storage ...
... Soarian Cardiovascular Enterprise is a comprehensive ... care continuum from admission to follow-up. ... image acquisition, and diagnostic tools from ... provide a single, longitudinal clinical repository ...
... accurate lesion assessment plays a ... the appropriate stent size and ... (IC3D), a highly precise three-dimensional ... now able to quickly quantify ...
Medicine Products: