CTI Mirada Solutions Awarded FDA 510(k) Clearance to Market Scenium(TM) for Analysis of Neurological PET Scans
January 18 2005 - 12:09PM
PR Newswire (US)
CTI Mirada Solutions Awarded FDA 510(k) Clearance to Market
Scenium(TM) for Analysis of Neurological PET Scans KNOXVILLE,
Tenn., Jan. 18 /PRNewswire-FirstCall/ -- CTI Molecular Imaging,
Inc. (NASDAQ:CTMI), a leading provider of positron emission
tomography (PET) equipment, molecular biomarkers and services,
today announced that its subsidiary CTI Mirada Solutions, has been
awarded FDA 510(k) clearance to market Scenium, an innovative new
quantification tool for the analysis of neurological positron
emission tomography (PET) scans. Scenium display and analysis
software has been developed to aid clinicians in accurate
assessment and quantification of dementia and other neurological
diseases. Initially developed for use in PET studies with
fluorodeoxyglucose (FDG), Scenium has the potential to be used with
other PET molecular imaging agents in the future. The software is
organized as a series of workflows, each is specific to a
particular radiopharmaceutical and disease combination. Based on
Mirada's established image fusion techniques, Scenium enables
clinicians to compare patients' brain scans to standard normal
scans, highlighting differences in uptake. Multiple anatomical
regions are highlighted for quick assessment of an image and
quantitative comparison with other images and integration into the
current reporting workflow of the imaging center. The software will
be available as a plug-in to a wide variety of viewing
workstations, and also for use on a standard PC. "Developed in
direct response to the rapidly expanding market for quantification
software, Scenium is expected to achieve a widespread install base
during 2005, particularly with the recent approval for
reimbursement for some neurological FDG scans," commented Christian
P. Behrenbruch, president of CTI Mirada Solutions. Mirada plans to
release Scenium during spring 2005, following product optimization
based on current field trials. The software will be distributed by
CTI PETNET, as well as Mirada's OEM/PACS partners. About CTI Mirada
Solutions: Mirada Solutions Limited, a wholly owned subsidiary of
CTI Molecular Imaging, is a leading developer of software and
analytical tools for medical imaging workstations, OEM imaging
platforms and image analysis in pharmaceutical R&D. Mirada's
unique products aid in better detection, diagnosis and management
of disease through the application of powerful algorithms,
quantification tools and image analysis. Additional information is
available at http://www.mirada-solutions.com/ About CTI Molecular
Imaging: CTI Molecular Imaging, Inc. is a leading supplier of
products and services for positron emission tomography (PET), a
diagnostic imaging technology used in the detection and treatment
of cancer, cardiac disease and neurological disorders. Additional
information is available at: http://www.ctimi.com/ Certain matters
discussed in this press release constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements may be
identified by words such as "believe," "assume," "expect,"
"anticipate," "intend," "estimate" or similar expressions, and any
other statements that necessarily depend on future events.
Forward-looking statements involve a number of risks and
uncertainties and there can be no assurance that any
forward-looking statements will prove to be accurate. Various
factors could cause actual results to differ materially from those
anticipated in the forward-looking statements. CTI undertakes no
obligation to update or revise any forward-looking statements.
Further information regarding risks, uncertainties and other
factors that could adversely affect CTI or cause actual results to
differ materially from those anticipated in forward-looking
statements are included in CTI's Annual Report on Form 10-K for the
fiscal year ended September 30, 2004. "Safe Harbor" Statement under
the Private Securities Litigation Reform Act of 1995: Statements in
this press release regarding CTI Molecular Imaging, Inc.'s business
which are not historical facts are "forward-looking statements"
that involve risks and uncertainties. For a discussion of such
risks and uncertainties, which could cause actual results to differ
from those contained in the forward-looking statements, see "Risk
Factors" in the Company's Annual Report or Form 10-K for the most
recently ended fiscal year. DATASOURCE: CTI Molecular Imaging, Inc.
CONTACT: Lisa Baird of CTI Molecular Imaging, Inc.,
+1-865-218-2507; or Clare F. Jones of CTI Mirada Solutions, +44
1865 265500 Web site: http://www.mirada-solutions.com/
http://www.ctimi.com/
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