DECN Announces Completion of Feasibility Testing for The Inspired Genpresis! Precision Diabetes Testing Meter and Test Strip
13 Oktober 2017 - 4:00PM
InvestorsHub NewsWire
GenPresis!™ Moved to Advanced Development,
with 1Q 2018 First to Market Release
LOS ANGELES, CA -- October 13, 2017 -- InvestorsHub
NewsWire -- Decision Diagnostics Corp. (OTC
PINK: DECN) is a manufacturer, quality plan administrator, FDA
registered medical device customer support organization, and
exclusive worldwide sales and regulatory process agent for the
GenUltimate!™ diabetes test strip, the new internationally launched
GenSure!™ "Feather" diabetes test strip, and the clinical trial
ready GenChoice!™ "Ladybug" diabetes test strip.
We are pleased to announce, today, that feasibility development
work has been completed for its GenPrecis!™ Precise ("Dragonfly")
test strip and meter system. The GenPrecis!™ product has been moved
to the advanced development phase with an anticipated completion
date set for 1Q 2018. Initial sales of the GenPrecis!™ Precise
system will take place in select international markets.
In addition to the GenUltimate!™ and GenSure!™ (for
International markets only) products, the company has prepared for
the international pre-market launch and the filing of a 510K
application with the U.S. FDA, for its GenChoice!™ test strips
which are now entering the clinical trials phase. The company's
inspired GenPrecis!™ system for diabetics will also be introduced
into select International markets in 2018 and follow the
GenChoice!™ product with another 510K application to be filed with
the U.S. FDA.
Keith Berman, CEO of Decision Diagnostics, commented, "As we
have stated previously, we view the GenPrecis!™ Precise system as a
market panacea product. The inspired technology employed in
GenPrecis!™ should breach all of the regulatory standards that
blood glucose medical devices are tasked with meeting. We
principally delayed announcement of this product for about 30 days
so that we could take the time to build in a wireless charging
feature into the GenPrecis!™ Precise meter, and create a second
design of the meter to meet the testing needs of children who have
smaller hands. The wireless charging feature represents another
innovative panacea feature built into our system."
Mr. Berman continues, "The deployment of GenPrecis!™ will mark a
seminal moment in our corporate history. GenPrecis!™ will be the
first totally proprietary system product manufactured by DECN. A
Precise product like GenPrecis!™ will mark another socially
responsible effort by the company to bring to light and to help
address the diabetes epidemic in markets where there is very little
product availability, lower education rates, and extraordinary
death stats. GenPrecis!™, on a most-likely forecast prepared for us
by a potential partner, could capture an estimated 6% market share
worldwide by 2022. "
Mr. Berman concluded, "Our Precise product will come in two
models, a version specifically developed for use by children and a
model for general commercial use. Both versions of GenPrecis!™ will
enable the company's 'Precise' technology and offer performance
well above that required by the U.S. FDA and the International ISO
organization. In conclusion, our competitive pricing will remain
evergreen in order for worldwide accessibility."
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics is the leading manufacturer and worldwide
distributor of diabetic test strips engineered to operate on legacy
glucose meters. DECN's products are designed to operate efficiently
and less expensively on certain glucose meters already in use by
almost 6 million diabetics worldwide. With the new Precise system
technology our diabetic test strips already in the final stages of
development, will operate far better than the performance standards
required by the U.S. FDA (FDA Guidance 2014) and the International
ISO organization (ISO 15197:2015). DECN is excited to share that
its products will soon challenge the competition on a worldwide
scale with legacy manufacturers currently selling to 65+ percent of
a $12 billion market.
Forward-Looking Statements:
This release contains the company's forward-looking statements
which are based on management's current expectations and
assumptions as of October 11, 2017, regarding the company's
business and performance, its prospects, current factors, the
economy, and other future conditions and forecasts of future
events, circumstances, and results.
Source: Decision Diagnostics Corp.
CONTACT
INFORMATION:
Decision Diagnostics Corp.
Keith Berman, CEO (805) 446-2973
Corporate Communications and
Regulatory Liaison
Joanne Broeders (305) 340-1000
info@decisiondiagnostics.com
www.genultimate.com
www.pharmatechdirect.com
Decision Diagnostics (CE) (USOTC:DECN)
Historical Stock Chart
Von Okt 2024 bis Nov 2024
Decision Diagnostics (CE) (USOTC:DECN)
Historical Stock Chart
Von Nov 2023 bis Nov 2024