InspireMD Receives European Regulatory Approval to Resume Manufacturing and Distribution of MGuardTM Prime EPS

BOSTON, MA – InspireMD, Inc. (“InspireMD” or the “Company”), a leader in embolic protection systems (EPS), today announced that it received European regulatory approval to resume the manufacturing of its MGuard Prime EPS stent with a modified stent securement process . The Company also received approval to modify and re-deploy existing MGuard Prime EPS stents that have been returned by clinical and commercial sites worldwide.

The European regulatory approval follows a Voluntary Field Action (VFA) InspireMD implemented on April 30, 2014.

Alan Milinazzo, CEO of InspireMD, stated, “We are pleased to report the approval of our modified manufacturing process for the MGuard Prime EPS and that we can now return to commercial and clinical activities in Europe and other markets outside of the U.S. We expect production of the MGuard Prime EPS to ramp over the next several weeks, as we come back online to support our sales and clinical programs. Although we are still working on the necessary approvals to resume our MASTER II FDA trial, we can immediately begin accelerating other important clinical programs while we simultaneously reengage our commercial customers.”

InspireMD is still awaiting U.S. FDA approval of the manufacturing process changes to the MGuard Prime EPS. The Company anticipates a late Q3 or early Q4 agency review and intends to resume enrollment in its MASTER II FDA trial shortly after regulatory approval is obtained. In the meantime, the Company intends to continue focusing on site activation in order to accelerate enrollment once the study resumes.

For more information about InspireMD and its offerings, visit www.inspire-md.com.

Source: InspireMD, Inc.