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EX-99.1 - Impact Medical Solutions, Inc. | v205884_ex99-1.htm |
8-K - Impact Medical Solutions, Inc. | v205884_8k.htm |
CE Mark
Approval of Muscle Pattern Recognition (MPR) System Announced by iTech
Medical
Back and neck pain represents one of
the greatest health problems in the European Union, with direct and indirect
treatment costs in excess of 100 billion Euros/year.
Keywords:
CE Mark approval, Europe, healthcare, biomedical, wellness, back pain, neck
pain, neurology, medical device, clinical studies, financing, commercialization,
Health Canada, chronic back pain
HUNTINGTON
BEACH, Calif., December 15, 2010 – iTech Medical, Inc.
(OTCBB:IMSU - News) (FWB:0IM - News), a medical
information technology company, announced today that it has received CE Mark
approval for the commercial sale of the Company's Muscle Pattern Recognition
(MPR) System in Europe. This approval allows for the marketing and
sale of the device in the European Union (EU) and all countries recognizing the
CE Mark. The MPR System is a non-invasive clinical assessment tool
being developed to assist in the diagnosis and treatment of back and neck pain,
one of the most common chronic conditions in the industrialized
world. On December 13, 2010, the Company reported that it had
received Health Canada approval to begin sales and marketing of the MPR System
in Canada.
“The
achievement of the CE Mark for our MPR System represents another critical
milestone in the history of iTech Medical,” said Wayne Cockburn, President &
CEO at iTech Medical.
It is
estimated that 80% of the European population will suffer back pain at some time in their
lives and in excess of one third of the European workforce suffer from low back
pain. Although many cases resolve within 2-4 weeks, many
patients will have recurring pain within 1 year following the first episode
of back pain.
“Back and
neck pain cases are one of the greatest health problems in the European Union,
with direct and indirect treatment costs in excess of 100 billion Euros a year,”
said Mr. Cockburn. “Our device has the potential to benefit a large
number of patients that suffer from neck and back pain while at the same time
reducing the costs related to diagnosing and treating this condition. We are
extremely pleased with this approval and we look forward to introducing the MPR
System in the European Community in 2011.”
The
Company stated that it is currently evaluating its marketing and distribution
strategy options, including strategic partners.
About iTech Medical -
(OTCBB:IMSU -
News)
(FWB:0IM -
News)
iTech
Medical is engaged in the research and commercial development of healthcare
information systems and technologies. To date, the Company has focused on
developing a proprietary platform called Muscle Pattern Recognition (MPR), a
unique clinical tool for the analysis of muscle function. iTech Medical is ISO
13485:2003 certified for the production and sale of surface electromyography
(sEMG) diagnostic devices for clinical use.
iTech
Medical website: www.iTechMedical.com
For a
current corporate fact sheet, visit: http://premierstocks.tv/images/company_links/imsu.pdf
About
CE Marking for Medical Devices
CE
marking is a legal requirement for medical devices intended for sale in Europe.
There are three European CE marking directives that specifically apply to
medical devices manufacturers. The MPR System was approved under the
Medical Devices Directive (MDD), which applies to all general medical devices
not covered by the other two Directives – the Active Implantable Medical Devices
Directive and the In Vitro Diagnostics Directive.
Forward-Looking
and Cautionary Statements
This news
release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 as contained in Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934
that reflect management’s current views and estimates regarding future market
conditions, company performance and financial results, business prospects, new
strategies, the competitive environment and other events. You can identify these
statements by the fact that they use words such as “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “project,” “plan,” “outlook,” and other words
and terms of similar meaning.
These
statements involve a number of risks and uncertainties that could cause actual
results to materially differ from the potential results discussed in the
forward-looking statements. Among the factors that could cause actual results
and outcomes to differ materially from those contained in such forward-looking
statements are the following: general economic conditions, acquisitions and
development of new businesses, divestitures, product availability, sales
volumes, pricing actions and promotional activities of our competitors, profit
margins, weather, changes in law or regulations, foreign currency fluctuation,
availability of suitable real estate locations, our ability to react to a
disaster recovery situation, and the impact of labor markets and new product
introductions on our overall profitability.
A further
list and description of these risks, uncertainties and other matters can be
found in the company’s annual report and other reports filed from time to time
with the Securities and Exchange Commission, including, but not limited to,
iTech Medical’s Annual Report on Form 10-K filed with the SEC on April 15,
2010. iTech Medical cautions that the foregoing list of important
factors is not complete and assumes no obligation to update any forward-looking
statements that it may make.
[Missing
Graphic Reference]Contact:
iTech
Medical, Inc.
Wayne
Cockburn, CEO
Huntington
Beach, CA
714.841.2670
Montreal,
CDA
905.505.0770
Wayne.Cockburn@iTechMedical.com
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