InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuardT 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 MGuardT Prime MicroNetT 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 MGuardT 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 MGuardT 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 (MGuardT for Acute ST Elevation Reperfusion), the second in a series of clinical studies intended to both validate the effectiveness of the MGuardT EPS platform, as well as achieve registration with the appropriate regulatory authorities worldwide.
InspireMD's MGuardT EPS technology previously yielded positive results in the MASTER I findings, which revealed a statistically and clinically significant acute advantage of MGuardT EPS with regard to ST segment resolution. As a result, MGuardT 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 MGuardT 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 MGuardT 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. MGuardT EPS is CE Mark approved. MGuardT 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, MGuardT.
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.