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.
Today, the company is thrilled to announce that our new GenChoice!™ (the "Ladybug") diabetes test strip has completed its advanced development phase, has begun pre-clinical testing and will begin its clinical trials in Pennsylvania and California in November. The company expects to file its 510K application for U.S. FDA clearance in January 2018. In the meantime, the company will test market its new GenChoice!™ test strip in select International markets.
Keith Berman, CEO of Decision Diagnostics, commented, "We entered advanced development of the GenChoice!™ in November 2016. We have set an initial manufacturing forecast at 150,000 for 50 count boxes/units per month beginning in February 2018, and we intend to sell our GenChoice!™ in alternative packages of 25 count, 50 count, and 100 count boxes/units."
DECN's first product, GenUltimate!™ glucose test strips, work with the market leading Johnson & Johnson's ("J&J") LifeScan OneTouch Ultra family of glucose testing meters and our GenSure!™ and GenChoice!™ test strips will also work each with a family of predicate testing meters. The company sells its GenUltimate!™ test strips in vials of 50, and 100 strips, its new GenSure!™ test strip in vials of 10, 25, and 50 strips, and it's now much anticipated GenChoice!™ test strips will be sold in vials of 25, 50, and 100 strips. The prices will remain evergreen in order to maintain worldwide accessibility per our socially responsible corporate undertaking.
Mr. Berman continued, "DECN anticipates utilizing select International markets as an early dry run for eventual U.S. sales and envisions the product generating over $100 million in annual revenues per our pro forma financials which we will post as soon as we complete the clinicals. GenChoice!™ will become DECN's largest tertiary revenue producer and should generate margins in excess of the company's successful GenUltimate!™ test strips. As stated previously the number of people with diabetes (those that are counted) has risen to 422 million worldwide in 2014. With the early 2018 launch of our GenChoice!™ product, we now have three legacy products, representing another step in our 'Gen' branding efforts, and a business coup for the Company."
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 October 9, 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, CEO (805) 446-2973
Corporate Communications and Regulatory Liaison
Joanne Broeders (305) 340-1000
SOURCE: Decision Diagnostics Corp.