FDA approves IMRIS’ VISIUS Surgical Theatre that integrates high-field MR scanners

IMRIS Inc. (NASDAQ: IMRS; TSX: IM) ("IMRIS" or the "Company") today announced US Food and Drug Administration clearance of the newest generation VISIUS^® Surgical Theatre which integrates Siemens' latest high-field MR scanners.

The new core imaging technology based on Siemens Aera 1.5T(tesla) and Skyra 3.0T technology helps IMRIS deliver better image quality with higher signal-to-noise ratio, faster 3D image acquisition, and improved ease-of-use and workflow during neurosurgical procedures using intraoperative MRI (iMRI).

"These high-field intraoperative scanner options will give a hospital's clinical team imaging applications and image quality that increase productivity," said IMRIS President and CEO Jay D. Miller. "We are bringing the latest and unequaled imaging technology into the operating room where it can make the most difference - during the surgery. IMRIS systems have been used in over 13,000 cases worldwide to improve outcomes in brain tumor and epilepsy surgeries in particular."

The addition of these MR systems expands the industry-leading 1.5T and 3.0T MRI choices hospitals have when considering the unique, ceiling-mounted IMRIS solution for intraoperative imaging which brings the MRI to the patient during the procedure.

The first installation of this new generation VISIUS Surgical Theatre will be a four-room hybrid operating room suite, known as the Center for Surgical Innovation (CSI) at Dartmouth-Hitchcock Medical Center in Lebanon, NH. "Surgeons are too often limited by what they cannot see - anatomy that is difficult to reach or diseases that are not visible to the naked eye," says Sohail Mirza MD, medical director of CSI and chair of orthopedics at Dartmouth-Hitchcock. "The advanced integration of state-of-the-art imaging tools in CSI will allow surgeons and engineers to innovate like never before, rapidly developing, testing, and validating new surgical tools and techniques, with the goal of achieving better, safer, and, in some cases, less-costly care for patients everywhere."

The Dartmouth-Hitchcock installation will also include a VISIUS intraoperative CT (iCT), which utilizes the technology of the 64-slice Siemens SOMATOM^® Definition AS scanner, making it the only operating suite in the world with both VISIUS iMRI and iCT modalities able to serve multiple operating rooms (ORs) without moving the patient.

Inside a VISIUS Surgical Theatre equipped with either high-field iMRI or iCT, surgeons have on-demand access to real-time data and state-of-the-art imaging, during the procedure from the OR table. The Company also designs and manufactures proprietary head fixation devices, imaging coils, and OR tables for use in this unique and multifunctional intraoperative environment.