Report of Foreign Issuer (6-k)
December 01 2014 - 11:32AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE
ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of December 2014
Commission File Number:
001-34975
IMRIS
INC.
(Translation of registrant's name into English)
100-1370 Sony Place,
Winnipeg, Manitoba, Canada R3T 1N5
(Address of principal executive offices)
Indicate by check mark
whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
DOCUMENTS FILED AS PART OF THIS FORM 6-K
See the Exhibit Index hereto.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
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IMRIS Inc. |
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(Registrant) |
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Date: December 1, 2014 |
By: |
/s/ Jay D. Miller |
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_____________________________________ |
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Name: |
Jay D. Miller |
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Title: |
President, Chief Executive Officer and Director |
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EXHIBIT INDEX
99.1 |
News Release dated December 1, 2014 - IMRIS completes SYMBIS Surgical System human factors study |
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Exhibit 99.1
IMRIS completes SYMBIS Surgical System human factors study
18 US neurosurgeons from 9 leading institutions
validate robot usability for final 510(k) submission deliverable
MINNEAPOLIS, MN, Dec. 1, 2014 /CNW/ - IMRIS Inc. (NASDAQ: IMRS; TSX:
IM) ("IMRIS" or the "Company") today announced that the Company has successfully completed the human factors
study for the SYMBIS® Surgical System – the comprehensive validation used to support the product's 510(k)
submission to the U.S. Food and Drug Administration (FDA) on November 26.
"This is a significant step leading to our goals of merging intraoperative
imaging with robotics," said IMRIS President and CEO Jay D. Miller. "By finding ways to enhance the vision and precision
of surgery through technology, we are working towards improving the outcomes for patients with neurological disorders at lower
costs for the healthcare system."
Human factors is the science of understanding how humans interact physically
and psychologically with a device. For example, in aviation, an engineer can develop an instrument; however, if the engineer
fails to account for how a pilot uses this instrument in the cockpit, then user errors may result even if the instrument did its
job. Over the past eight years, the FDA has been actively working with companies to apply the science of human factors to medical
device development.
The human factors study provided a neurosurgeon's perspective on how well
use-related risks were mitigated by the IMRIS design team, when the SYMBIS Surgical System is used by neurosurgeons. The study
physicians were asked to perform a planned simulated procedure without any outside intervention. Throughout the study, the subject's
interaction with the system was observed for any use-related errors.
"The human factors study was not only an opportunity for IMRIS to
validate the performance of the SYMBIS System with real users," Miller added, "we also captured the voice of the customer
on how surgeons perceive the current system, as well as the future clinical applications where robotics in neurosurgery can provide
both clinical and economic value."
The SYMBIS human factors study involved a diverse group of 18 neurosurgeons
of varying demographics and range of neurosurgical experience. Subjects were recruited from nine leading neurosurgical centers
in the US – including three centers that do not currently have a VISIUS® Surgical Theatre with intraoperative
MRI (iMRI).
One of the study subjects, neurosurgeon Dr. William Broaddus of Richmond,
VA, said, "During my career, I've been fortunate to take part in the early stages of a number of new technologies that have
found valuable applications in neurosurgery. After working with the SYMBIS System as a human factors study subject, I see this
technology as an exciting platform for major advances in neurosurgical practice."
About IMRIS
IMRIS (NASDAQ: IMRS; TSX: IM) is a global leader in providing image guided therapy solutions through its VISIUS Surgical Theatre
– a revolutionary, multifunctional surgical environment that provides unmatched intraoperative vision to clinicians to assist
in decision making and enhance precision in treatment. The multi-room suites incorporate diagnostic quality high-field MR, CT and
angio modalities accessed effortlessly in the operating room setting. VISIUS Surgical Theatres serve the neurosurgical, spinal,
cardiovascular and cerebrovascular markets and have been selected by 61 leading medical institutions around the world. Learn more
by visiting www.imris.com.
SOURCE IMRIS Inc.
%CIK: 0001489161
For further information: Kevin Berger, Marketing Communications Manager,
IMRIS Inc., Tel: 763-203-6332, Email: kberger@imris.com
CO: IMRIS Inc.
CNW 06:01e 01-DEC-14
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