InspireMD Announces Regulatory and Reimbursement Approval of CGuard Embolic Prevention System in Australia

InspireMD (NYSE American:NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that its novel CGuard Embolic Prevention System (EPS) has been granted regulatory approval by the Therapeutic Goods Administration (Part of the Australian Government’s Department of Health) for commercial sale and reimbursement in Australia. Launch will commence immediately in collaboration with InspireMD’s local distribution partner, Diverse Devices of Sydney.

As quoted in the press release:

“Regulatory approval of CGuard™ EPS in Australia represents an important step toward our goal of expanding commercial availability into new territories, and the Asia-Pacific region represents a significant opportunity for our Company,” said James Barry, PhD, Chief Executive Officer of InspireMD. “With 22 million residents, Australia ranks third behind only Japan and China in terms of total healthcare spending. More significantly, however, is that Australia’s Therapeutic Goods Administration sets a very high bar in terms of regulatory and reimbursement approval of new medical devices. We believe our approval reflects not only the agency’s recognition of CGuard’s differentiating features versus conventional carotid stents, but also the need for safer treatments for carotid artery disease. We are eager to begin offering this novel technology to patients in Australia imminently.”

Aidan McEvoy, Director of Diverse Devices Pty Ltd., commented, “At Diverse Devices, we strive to bring the latest technologies to health care professionals across Australia, and we are pleased to add CGuard™ EPS to our portfolio of the most innovative stent products available on the market today.”

Click here to read the full press release.