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Posted: SEPT 2, 2008
CSMG
Technologies Subsidiary Live Tissue Connect Awarded
European Union CE Mark Certificate; Follows Recent U.S.
FDA Clearance
Corpus Christi, TX, September 2, 2008 -- CSMG Technologies,
Inc., (OTCBB: CTGI
- News),
a technology management company, announced its subsidiary,
Live Tissue Connect Technologies (LTC), has been awarded
CE Mark (Conformité Europèéne)
certification for its Bipolar Forceps by BSI Product
Services in its capacity as Notified Body for the Council
Directive 93/42/EEC.
The CE Mark allows LTC to market its forceps with the
previously CE Mark certified VAD.400 generator within
the 30 countries of the European Economic Area (EEA)
and Switzerland. This announcement follows LTC Technologies
previously announced 510(k) clearance from the FDA to
market both the aforementioned generator and forceps
in the United States.
Obtaining CE Mark certification is an extensive process
that requires evaluation of the device by the Notified
Body to ensure compliance with EU directives and standards.
To become certified, a company must have an established
quality system and must submit a technical file providing
evidence of compliance that the product meets applicable
directives and standards.
The LTC Bipolar Forceps consist of two configurations
of disposable instruments and are used exclusively with
the LTC VAD.400 generator. Its intended use is for the
application of electrosurgery in general surgery and
gynecological procedures for the sealing of arteries,
veins, and ducts. The Bipolar Forceps system is an alternative
to mechanical clamping (clips or staples) and suturing,
and can be used on veins and arteries up to 7mm diameter,
on ducts up to 2mm diameter and on tissue bundles as
large as will fit between the jaws of the instrument.
Donald S. Robbins, President and CEO of CSMG Technologies,
said, I am very pleased to announce LTC has received
this CE Mark certificate. Combined with their FDA 510(k)
clearance, LTC may now begin the process of marketing
their sealing system in both Europe and the United States.
I want to congratulate the LTC Technologies division,
headquartered in Santa Barbara, whose efforts succeeded
in securing this very important certification.
Frank D. DAmelio, President of LTC Technologies
added, We have set forth an aggressive schedule
for commercialization of LTCs technology and we
continue to execute against that plan as evidenced by
the receipt of this CE Mark certificate and our recent
FDA 510(k) clearance. In addition, achieving this CE
certification demonstrates our commitment to be a global
organization with world-wide distribution. Our sales
recruitment efforts are proceeding according to plan
and potential dealers have expressed much enthusiasm
for our technology and the opportunity to join the LTC
sales team.
Note: EEA countries include the United Kingdom, France,
Germany, Ireland, Italy, Austria, Belgium, Spain, Bulgaria,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece,
Hungary, Iceland, Liechtenstein, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia and Sweden.
About Live Tissue Connect
LTC's surgical tissue bonding/welding device is a patented
platform technology that bonds and reconnects human
soft tissue through fusion, in contrast with conventional
wound closing devices such as sutures, staples, sealant,
or glues. LTC holds approximately 31 patents and pending
patents in the U.S., Australia, Canada, European Union,
Ukraine, and other countries.
For further information on CSMG Technologies and its various subsidiaries, please visit our website at www.csmgtechinternational.com.
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CONTACT:
CSMG Technologies, Inc.
Donald S. Robbins, 361-887-7546
President and CEO
or
K. Bruce Jones, 770-955-0409
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