GenPresis!™ Moved to Advanced Development, with 1Q 2018 First to Market Release
LOS ANGELES, CA / ACCESSWIRE / October 12, 2017 / Decision Diagnostics Corp. (OTC PINK: DECN) is a manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate!™ diabetes test strip, the new internationally launched GenSure!™ "Feather" diabetes test strip, and the clinical trial ready GenChoice!™ "Ladybug" diabetes test strip.
We are pleased to announce, today, that feasibility development work has been completed for its GenPrecis!™ Precise ("Dragonfly") test strip and meter system. The GenPrecis!™ product has been moved to the advanced development phase with an anticipated completion date set for 1Q 2018. Initial sales of the GenPrecis!™ Precise system will take place in select international markets.
In addition to the GenUltimate!™ and GenSure!™ (for International markets only) products, the company has prepared for the international pre-market launch and the filing of a 510K application with the U.S. FDA, for its GenChoice!™ test strips which are now entering the clinical trials phase. The company's inspired GenPrecis!™ system for diabetics will also be introduced into select International markets in 2018 and follow the GenChoice!™ product with another 510K application to be filed with the U.S. FDA.
Keith Berman, CEO of Decision Diagnostics, commented, "As we have stated previously, we view the GenPrecis!™ Precise system as a market panacea product. The inspired technology employed in GenPrecis!™ should breach all of the regulatory standards that blood glucose medical devices are tasked with meeting. We principally delayed announcement of this product for about 30 days so that we could take the time to build in a wireless charging feature into the GenPrecis!™ Precise meter, and create a second design of the meter to meet the testing needs of children who have smaller hands. The wireless charging feature represents another innovative panacea feature built into our system."
Mr. Berman continues, "The deployment of GenPrecis!™ will mark a seminal moment in our corporate history. GenPrecis!™ will be the first totally proprietary system product manufactured by DECN. A Precise product like GenPrecis!™ will mark another socially responsible effort by the company to bring to light and to help address the diabetes epidemic in markets where there is very little product availability, lower education rates, and extraordinary death stats. GenPrecis!™, on a most-likely forecast prepared for us by a potential partner, could capture an estimated 6% market share worldwide by 2022. "
Mr. Berman concluded, "Our Precise product will come in two models, a version specifically developed for use by children and a model for general commercial use. Both versions of GenPrecis!™ will enable the company's 'Precise' technology and offer performance well above that required by the U.S. FDA and the International ISO organization. In conclusion, our competitive pricing will remain evergreen in order for worldwide accessibility."
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics 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 6 million diabetics worldwide. With the new Precise system technology our diabetic test strips already in the final stages of development, will operate far better than the performance standards required by the U.S. FDA (FDA Guidance 2014) and the International ISO organization (ISO 15197:2015). DECN is excited to share that its products will soon challenge the competition on a worldwide scale with legacy manufacturers currently selling to 65+ percent of a $12 billion market.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of September 8, 2017, 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.
Decision Diagnostics Corp.
Keith Berman (805) 446-2973
Corporate Communications and Regulatory Liaison
Joanne Broeders (305) 340-1000
SOURCE: Decision Diagnostics Corp.