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TheStreet Open House

IMRIS Receives Australian Regulatory Clearance For Intraoperative CT Solution

VISIUS iCT listing expands availability of state-of-the-art imaging with low dose management accessed effortlessly in the OR

MINNEAPOLIS, MN, Feb. 26, 2014 /PRNewswire/ - IMRIS Inc. (NASDAQ: IMRS; TSX: IM) ("IMRIS" or the "Company") today announced that it has obtained Therapeutic Goods Administration (TGA) regulatory listing for VISIUS ® iCT, the first and only ceiling-mounted intraoperative computed tomography, allowing for sales and marketing in Australia.

"This is another step in our overall global launch following US and European approvals. VISIUS iCT offers the highest image quality of competing intraoperative systems along with market leading dose management capabilities," said Jay D. Miller, IMRIS CEO and President. "As procedures become less invasive, the need for better visualization with advanced imaging during procedures and low radiation exposure increases. With this unique solution, surgeons can confirm implant placements, fusion and other complex procedure results while still in the OR."

Market research shows that Australia is the second fastest growing spinal implant market behind China in the Asia Pacific region with a compounded annual growth rate of 8.4 percent since 2003. Australia is also the third largest contributor of medical imaging equipment sales in the area.

The Company currently has two Australian customers with VISIUS intraoperative MRI (iMRI) installations at Royal Children's Hospital in Melbourne and Canberra Hospital in Canberra. In 2013, IMRIS established an office in Singapore to increase focus on the growing Asia Pacific market.

IMRIS received U.S. Food and Drug Administration (FDA) 510(k) and CE mark clearance for VISIUS iCT in July 2013. The Company now has several systems sold to major US neurosciences centers.

VISIUS iCT provides personalized dose management together with diagnostic quality imaging during surgical procedures to assist surgeons in critical decision support and procedure guidance. The 64-slice scanner effortlessly moves into and out of the operating room (OR) in about 30 seconds during surgery using ceiling-mounted rails to ease workflow. In addition, IMRIS offers a configuration where the scanner can travel into two ORs to allow the hospital to use it for more patients.

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