DECN RELEASES ITS STRATEGIC IP AND PRODUCT DEVELOPMENT INTRODUCTION PLAN WITH A SUMMARY OF 2018 ACHIEVEMENTS & 2019 EXPECTATI...
2018年12月12日 - 12:00AM
InvestorsHub NewsWire
DECN RELEASES ITS STRATEGIC IP AND
PRODUCT DEVELOPMENT INTRODUCTION PLAN WITH A SUMMARY OF 2018
ACHIEVEMENTS & 2019 EXPECTATIONS
++ IP AND
PRODUCTS STRATEGY IS PUT IN PLACE TO INCREASE REVENUES, BUILD THE
BRAND AND POSITION THE COMPANY FOR A HANDSOME SETTLEMENT OR M&A
TRANSACTION ++
LOS ANGELES, CA -- December
11, 2018 -- InvestorsHub NewsWire -- Decision Diagnostics
Corp. (OTC:PINK:
DECN) Decision Diagnostics Corp. 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 a growing brand of alternatives to legacy diabetic,
proprietary, and pet testing glucose test strips.
Decision Diagnostics is pleased to
announce and communicate significant updates for several of our
product lines including our GenChoice ("Ladybug"), GenPrecis! and
GenPrecis! Precise Meter ("Dragonfly"), the PetSure! Test Strip
("small Ladybug"), the PetUltimate! Test Strip and PetUltimate!
Avantage Meter ("Carnation"). First we'd like to discuss a major
change in the course of the development of the company’s
technologies and their introduction into the market.
In October 2018 the company’s Board of
Directors recommended a strategic adjustment in the company’s new
products plan after reviewing a report compiled by CEO Keith
Berman. The company will allocate its resources and focus its
technologies on two broad categories; or tool boxes.
The first category of commercial
technology will include products derived from the company’s
GenUltimate! tool box. Products included in that toolbox are
GenUltimate!, PetUltimate! (rebranded as GenUltimate!
4Pets), GenPrecis (rebranded as
GenUltimate! TBG) and also the company’s GenSure! product. In
addition to the test strip products, the company will introduce two
proprietary glucometers; the Avantage meter (now in production)
that will be sold in conjunction with the newly branded
GenUltimate! 4Pets, and the Precise meter
that will be sold with the newly branded GenUltimate! TBG.
GenUltimate! 4Pets will go on sale
in the U.S., Canada and Great Britain in January 2019.
The second category of commercial
technologies will be based on the company’s GenChoice! products
tool box.
Products targeted for this toolbox include the PetSure! test strip,
already available for commercial distribution, and the GenChoice!
test strip. GenChoice! has already completed patient clinical
trials with an anticipated FDA of a 510K filing on or about
December 21, 2018. A third, as yet unannounced product, will
be added to this tool box in early 2019.
Keith Berman, CEO of Decision
Diagnostics commented, "DECN is fundamentally and consistently
committed to delivering superior value. Today's announcement
demonstrates the variety of activities and progress being made
across the board on our expanding product lines. Each innovative
product launch and market advancement positions the company to
become more competitive against the Big 4 (Johnson &
Johnson/Platinum, Roche, Abbott and Bayer) in the
marketplace.
Product Development
Updates
The GenChoice! (“Ladybug”) has
completed internal testing, third party lab testing and the patient
clinical trials report (completed by an IRB). Each of these
steps are required in order to file a 510K application with the
U.S. FDA. That application is expected to be filed on or
around December 21, 2018. Additionally, the Genchoice! ("Ladybug")
International launch date of January 2, 2019 is imminent and
on schedule. GenChoice! will be sold in select international
markets while the company’s 510K filing with the U.S. FDA
progresses. Additional filings are planned in the EU, Canada and
Korea.
The PetSure! Test Strip ("small
Ladybug") product had a successful commercial launch on July 31,
2018 with distribution agreements expanding to include big box pet
supplies retailers, pet insurance carriers, and pet product
manufacturers. An advertising campaign was initiated on August 20,
2018 to support the product launch. The initial product launch
sales have been encouraging and are expected to continue to
robustly expand.
GenPrecis! and the GenPrecis! Precise
Meter ("Dragonfly") remain the company’s most exciting new product
additions and those that have the highest ceilings. Product
development and initial testing have been completed, and patient
clinical trials had been scheduled. However,the sale of J&J’s
Lifescan division to Platinum Equity, presented the company with a
unique strategic opportunity.
CEO Keith Berman presented a new
strategic plan to the company’s Board whereby the GenPrecis!
product would gain new branding and be called and sold as
GenUltimate! TBG. The GenUltimate! TBG product capitalizes on the
GenUltimate! technology foundation, but will also feature a new
technology that corrects hematocrit, the largest interfering
substance (red blood cells) in at home glucose measurements.
GenUltimate! TBG will be the company’s first complete system
product; one that includes the test strips and the meter. The TBG
product will set a new standard for glucose measurement precision
by offering precision at the +/- 8% level. This exceeds by more
than 50% the existing FDA Guidance and ISO’s latest
standards.
Mr. Berman continued, “the restructure
of our product lines into separate technology categories (or tool
boxes), and the changes made to our GenUltimate! TBG product
(formerly GenPrecis!), is a significant accomplishment. We have
long maintained that a strategic partner with a large user base was
essential to a successful launch of our GenUltimate! TBG
system. This minor strategic adjustment and shift in market
focus, enables the creation of a panacea product that may
transition us into a desirable acquisition target. DECN should no
longer be viewed by the researchers and analysts as a generic
product manufacturer selling into a declining market.”
GenUltimate!, the company’s bellwether
product will utilize the same test strip designed and manufactured
for the TBG product. They both will continue to run in an identical
manner on Lifescan’s OneTouch Ultra glucometers. Our new TBG
product will offer the same reliability and consistency while
simultaneously providing a path to better glucose results and
diabetes. That is exactly the goal that the millions of OneTouch
Ultra meter users have sought for years. All, of course, at
GenUltimate! prices. The GenUltimate! test strip will provide the
only upgrade path to OneTouch Ultra while continuing to use a test
strip that millions of worldwide OneTouch Ultra users already know
and trust.
Mr. Berman concluded, “We expect to
release an additional update next week outlining those areas not
covered completely in this discussion. This second release will
complete the summary of our 2018 and provide a pathway for our
2019. ”
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.
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 10, 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.pharmatechdirect.com
SOURCE: Decision
Diagnostics Corp.
Decision Diagnostics (CE) (USOTC:DECN)
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