Company to Launch its GenUltimate! TBG And Genchoice! Products As Well As GenUltimate! Precis And GenUltimate! Sure in International Markets in January 2020
LOS ANGELES, CA / ACCESSWIRE / November 7, 2019 / Decision Diagnostics Corp. (OTC PINK:DECN) is an 18-year old, diabetes-focused bio-technology development 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 GenUltimate! Sure (“Feather”) and GenUltimate! Precis (“HoneyBee”) diabetes test strips for International markets, and its GenChoice! (“Ladybug”) test strip now in FDA 510(k) prosecution. The company also markets its PetSure! test strip for the diabetic testing of dogs and cats, a diagnostic specifically designed to run on the market leading Zoetis Alpha Trak meter system and the GenUltimate! 4Pets Test strip and Avantage! meter a proprietary testing product for dogs, cats and horses, and the panacea GenUltimate! TBG (“Dragonfly”) diabetes testing system and TBG Precise meter, now awaiting a clinical trial slot in Korea.
DECN announces today that on October 31, 2019 the company completed advanced development of the two versions of its GenUltimate! TBG Precise meter, by identifying and securing the last two components needed to commercialize the meter, an impedance module and a low power Bluetooth chip. The specifications for the two meters have been transferred to our contract manufacturer for these medical devices, along with a 5,000 unit order. The meters will be manufactured in China after an exhaustive process that looked at Korean, Taiwanese, and North American organizations. Cost was not the major determining issue. First deliveries of the TBG Precise meter will be in mid-December 2019 and will be initially provided to two big box accounts and our licensing partner for their field trials.
Keith Berman, CEO of DECN commented, “As many who follow DECN know, our TBG Precise meters complete the panacea GenUltimate! TBG system, and provide what our third party engineers and clinical chemists refer to as “the magic” of TGB. These meters, initially completed last July, were further developed in consultation with the leading candidate to be the worldwide licensor of our TBG products and technology. We also solicited advice from two big box accounts.”
The company’s TBG system will give diabetics a choice of two meters, the first meter a handheld appliance for diabetics that will fit the company’s business model where meters will be provided free to users. Some 85% of meters in the U.S. and Canada are provided free to diabetics by system manufacturers.
Mr. Berman continued, “GenUltimate! TBG will be the most advanced, most precise, most accurate system on the market — ever. TBG will be protected by two patents. We plan an international launch beginning January 6, 2020 in select markets. The International version of TBG will also be marketed to users of the venerable OneTouch Ultra meters, almost 2 million users worldwide. We plan a U.S. product launch just as soon as we receive 510K clearance from the U.S. FDA. We have secured a site for our TBG clinical trials at a prestigious Korean university medical center, and await approval of the clinical study from the Korean FDA.”
The company also discussed the second TBG meter which will be sold as a feature rich advanced meter, and will be directed to a special market that our Mr. Berman has researched for five years, now completing an affordable device for diabetes inflicted children. This second meter will contain features allowing for the direct connection to the Internet where the meter will be capable of relaying results directly from the diabetic user, who is expected to be at school, to the child’s parent or guardian and/or doctor. DECN intends to charge nominally for this meter. This meter is expected to be completed in January 2020. An initial order for 2,000 meters is expected to be placed shortly.
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 $15+ billion at-home testing market. The company’s GenUltimate TBG product is not yet available for sale in the United States or Puerto Rico but is expected to go on sale in select International markets in January 2020.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of November 6, 2019, 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.
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