DECN RECEIVES COMPLETED CLINICAL TRIAL DATA, CHARTS AND SPREADSHEETS ESSENTIAL FOR ITS IMMINENT GENCHOICE! TEST STRIP
06 Noviembre 2018 - 8:55AM
InvestorsHub NewsWire
++ COMPANY TO BEGIN SALES IN INTERNATIONAL
MARKETS WHILE THE U.S. FDA REVIEWS ITS 510K APPLICATION
++
Los Angeles, CA -- November 6, 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 clinical
trial in process concluded GenChoice! ("Ladybug"), the new PetSure!
test strip for the diabetic testing of dogs and cats, and the
panacea GenPrecis! ("Dragonfly") diabetes testing system, ready for
clinical trials.
DECN reports that the CEO Keith Berman has
received the concluded patient clinical trial study, managed
through its partner The Bio Co., Ltd in South Korea. The
study was commissioned in May 1, 2018 and was completed on October
31, 2018. During the study, medical workers at the hospital
that hosted the study went on strike for approximately 45 days,
causing a delay. The clinical study itself was supervised at
the hospital by a credentialed professional working under the
standards of the International Review
Board.
Keith M. Berman, CEO of DECN commented, “The
company is delighted that the patient clinical study for our
impressive GenChoice! glucose test strip is now complete. This was
the last step in a product development that began in earnest in
December 2017. We have retained a U.S. based IRB to organize the
data in a manner consistent with the expectations of the U.S. FDA
and those countries using the alternative ISO standard. The
data received is outstanding and exceeds all newly established
standards for accuracy and precision. But most exciting is that
GenChoice! will compete in a world-wide
market.”
Mr. Berman continued, “DECN intends to complete
the configuring of the clinical report in the next 30 days, and
during that time to implement its marketing plan for GenChoice! in
select International markets where little or no immediate
International registration is required. The clinical study
will be provided to the expert firm who we previously tasked with
completing our 510K application. We still anticipate filing this
application in calendar year 2018. A web site for GenChoice!
will go active in the coming days.”
Mr. Berman concluded, “GenChoice! is an immense
undertaking and achievement. Once the FDA clearance is
achieved, the company intends to sell GenChoice! in retail,
International and Hybrid Private label packaging. GenChoice!
represents the first of several exciting new products we have in
store over the next few months. Until our GenChoice! product is FDA
cleared for pre-market sale, we will follow the path set by several
industry leaders who launched their worldwide products initially in
International markets.”
ABOUT DECISION DIAGNOSTICS
CORP
Decision Diagnostics Corp. is a 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 and 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.
Forward-Looking
Statements:
This release contains the company's
forward-looking statements which are based on management's current
expectations and assumptions as of November 5, 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 in
11/2018)
www.pharmatechdirect.com
SOURCE: Decision Diagnostics
Corp.
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