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 – Decision Diagnostics Corp. (OTC: 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.
