DECN RECEIVES CLINICAL TRIALS REPORT, ANTICIPATES FILING ITS FDA 510K APPLICATION FOR ITS GENCHOICE! TEST STRIP ON 12/21/2018
04 Dezember 2018 - 4:00PM
InvestorsHub NewsWire
++ DECN TO LAUNCH GENCHOICE! PRODUCT IN SELECT
INTERNATIONAL MARKETS JANUARY 2, 2019 AND TO FILE FOR CE MARK IN
THE EU AND HEALTH CANADA APPROVAL IN EARLY 2019
++
Los
Angeles, CA -- December 4, 2018 -- InvestorsHub NewsWire --
Decision Diagnostics Corp. (OTC
PINK: DECN) is a 16 year old, diabetes-focused bio-technology
R&D firm, manufacturer, quality plan administrator, FDA
registered medical device customer support organization, and
exclusive worldwide sales and regulatory process agent for the
GenUltimate! ("Sunshine") diabetes test strip, the internationally
launched GenSure! ("Feather") diabetes test strip, and the
GenChoice! ("Ladybug") which is now in the process of completing
its 510K application for filing with the U.S. FDA, the market ready
PetSure! test strip for the diabetic testing of dogs and cats, the
market ready GenUltimate! 4Pets system (new) also for the diabetic
testing of dogs and cats, and the panacea GenPrecis! ("Dragonfly")
diabetes testing system, ready for clinical
trials.
Keith
Berman, CEO of Decision Diagnostics stated, “The receipt of the
completed report from the company’s IRB is an important event for
the company. It indicates that we have reached a milestone
for our GenChoice! product where we now have proven technology that
meets or exceeds all FDA and ISO (international) standards.
We anticipate filing the 510K application with the FDA for their
review on December 21, 2018.”
Mr.
Berman continued, “We view GenChoice! as the first necessary
advance of our business model where our
“Gen” brand will become the low priced
but high quality alternative for a number of legacy glucose test
strips. GenChoice is the second of four anticipated
alternative test strips for the legacy systems that account for
approximately 71% of the U.S. market, and at even higher levels in
the EU. We plan to launch GenChoice! in select International
markets on January 2, 2019. We will update our web sites with
images of the GenChoice! international packaging in the next
several weeks.”
Mr.
Berman concluded, “In the next 10 days, we also intend to discuss a
major advance to our GenPrecis! test strip and meter, allowing us,
hopefully, to shorten the time for U.S. FDA clearance which will
evolve our panacea product to become a savior product for one of
the legacy system companies. Please stay tuned for this upcoming
announcement.”
ABOUT DECISION DIAGNOSTICS
CORP
Decision Diagnostics Corp. 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 7.5 million diabetics
worldwide. With new inspired technology diabetic test strips
already in the final stages of development, DECN products compete
on a worldwide scale with legacy manufacturers currently selling to
71+ percent of a $12 billion at-home testing market.
Wall Street Reporter CEO
Interview:
Short Link:
http://www.wallstreetreporter.com/2018/11/decision-diagnostics-otc-decn-game-changer-products-for-25-billion-diabetes-monitoring-market/
Wall Street
Reporter (Est. 1843) is the leading financial news provider,
focused on giving investors direct access to CEO’s of
promising, publicly-traded companies, and market
experts.
Wall Street
Reporter’s global investor audience consists primarily of hedge
fund managers, investment advisors, analysts, investment bankers,
and self-directed individual investors managing over $2 trillion in
capital worldwide.
Forward-Looking
Statements:
This
release contains the company's forward-looking statements which are
based on management's current expectations and assumptions as of
December 3, 2018, 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.
CONTACT
INFORMATION:
Decision Diagnostics
Corp.
Keith Berman (805) 446-2973
info@decisiondiagnostics.com
www.genultimate.com
www.petsureteststrips.com
www.genchoice.com (coming
later in 12/2018)
www.pharmatechdirect.com
SOURCE: Decision Diagnostics
Corp.
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