LOS ANGELES, CA / ACCESSWIRE / September 13, 2017 / Decision Diagnostics Corp. (OTC PINK: DECN) ("DECN") is a manufacturer, quality plan administrator, FDA registered medical device support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate!™ diabetes test strip and now the new internationally launched GenSure!™ diabetes test strip. We are pleased to announce that our new GenSure!™ (the "Feather") diabetes test strip is available for sale in select international markets and will first be found primarily in Mexico, Central and South America, and the Far East with a target price at the international retail level at less than $0.15 per test strip, a veritable paradox.
In addition to the GenUltimate!™ and GenSure!™ products, the company is already prepared for the international pre-market launch, and the filing of a 510K application with the U.S. FDA, for its GenChoice!™ test strips, set to go into patient clinical trials in October. Although our new GenSure!™ will be available in multiple international markets, primarily in the developing world, it will not be registered, advertised or sold in the US, Puerto Rico, or U.S. territories, as a domestic market has not developed.
DECN 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 5 million diabetics worldwide. With new technology, diabetic test strips already in the final stages of development, DECN products will shortly compete on a worldwide scale with legacy manufacturers currently selling to 45+ percent of a $12 billion market.
Keith Berman, CEO of Decision Diagnostics, commented, "We have been working on GenSure!™ since May 2016, which will be manufactured by our strategic partner The Bio Co., Ltd in Korea. We could not be more satisfied with our Korean partners, who have continually delivered outstanding results with product development. Our clinical trials repeatedly point to diagnostic performance that exceeds the performance of the various predicate device platforms."
The deployment of GenSure!™ in the international and emerging markets (i.e. poorer countries) is not only business as usual for DECN, it's a tertiary revenue model and a socially responsible effort by the company to bring to light the diabetes epidemic in markets where there is very little product availability, lower education rates, and extraordinary death stats. The number of people with diabetes (those that are counted) has risen to 422 million in 2014. With the launch of our GenSure!™ product, the needs presented by the developing world are now being addressed, a business and philanthropic coup for the Company.
DECN's GenUltimate!™ glucose test strips work with the market leading Johnson & Johnson's ("J&J") LifeScan OneTouch Ultra family of glucose testing meters and the GenSure!™ test strip will also work with a family of predicate testing meters. GenSure!™ is a product designed for the developing world, where price and performance are prerequisites. The company will sell its new GenSure!™ test strip in vials of 10, 25, and 50 strips, again with the intent to keep costs lower in economically challenged markets, while maintaining internally defined net profit levels. The company is currently working on Spanish and Portuguese language TV and radio commercials that will feature GenSure!™, as well as, GenUltimate!™.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of September 12, 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
Joanne Broeders (305) 340-1000
SOURCE: Decision Diagnostics Corp.