Decision Diagnostics Corp. Subsidiary Pharma Tech Enters International Markets With Conformité Européenne (CE) Mark Submiss...
28 5월 2014 - 10:20PM
Marketwired
Decision Diagnostics Corp. Subsidiary Pharma Tech Enters
International Markets With Conformité Européenne (CE) Mark
Submission
Company Also Announces Initial International Sales Endeavors
LOS ANGELES, CA--(Marketwired - May 28, 2014) - Decision
Diagnostics Corp. (OTCQB: DECN), the manufacturer of the popular
GenStrip™, the unique Green Glucose Test Strip, specifically
designed to work with the Johnson & Johnson's (NYSE: JNJ)
LifeScan Ultra family of glucose testing meters, announced today
that they have engaged a European agent to complete its submission
of Conformité Européenne (CE) Mark Technical File in order to
obtain the EU market approval for the European version of its
GenStrip™ 50 which will be marketed in Europe as the ValuPlus™
glucose sensor. CE Marking implies a medical device's compliance
with European Union (EU) legislation and directives with respect to
safety, health, environmental and consumer protection.
Keith Berman the Principal Executive Officer of DECN, commented,
"Our GenStrip™ 50 product, currently available through retailers
across the nation, is manufactured by an FDA registered and ISO
certified contract manufacturing facility that is respected
throughout the industry. We adhere to consistent and rigid quality
procedures. All of the products produced routinely exceed the
standards established by FDA. With the advent of our upcoming
Conformité Européenne (CE) Mark Technical File application, we are
enabling DECN, at a time of our choosing, to broaden our scope
internationally, a seminal achievement."
CE Marking is necessary for commercialization of a medical
device in member countries in the EU. DECN expects to receive
its CE Marking in the second quarter of 2014 and is currently
interviewing from a long list of potential distributors and other
interested parties. The company is particularly close to choosing
two distributors, and has already contracted with a third
distributor of note from Eastern Europe.
Mr. Berman concluded, "Upon receiving the CE Mark approval, our
ValuPlus™ glucose sensor will have become the world's first
internationally endorsed alternative glucose test strip designed to
work on the JNJ Lifescan family of glucose testing meters. We first
received US FDA clearance for GenStrip™ in November 2012, and are
continuing our sales efforts in a major way. We expect to announce
additional domestic and foreign sales accomplishments in the coming
weeks."
Forward Looking Statements:
This release contains forward-looking statements about our
business or financial condition that reflect our assumptions and
beliefs based on information currently available. We can give no
assurance that the expectations indicated by such forward-looking
statements will be realized. There may be other risks and
circumstances that we are unable to predict. When used in this
release, words such as "believes," "expects," "forecasts,"
"intends," "projects," "plans," "anticipates," "estimates" and
similar expressions are intended to identify forward-looking
statements, although there may be certain statements not
accompanied by such expressions.
For further information about the GenStrip 50™, please visit the
company's Web Sites: http://www.decisiondiagnostics.com/ or
http://www.pharmatechdirect.com/.
GenStrip 50™ test strips are a product of Pharmatech Solutions,
LLC and are not manufactured, distributed, endorsed, or approved by
nor associated with LifeScan®, Inc. a Johnson & Johnson®
Company, manufacturers and distributors of the OneTouch® Ultra®
Family of Meters and OneTouch® Ultra® test strips.
Contact: Decision Diagnostics Corp. Keith Berman (805) 446-2973
info@decisiondiagnostics.com
Decision Diagnostics (CE) (USOTC:DECN)
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Decision Diagnostics (CE) (USOTC:DECN)
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