Press release
Decision Diagnostics' Fundamental Genchoice! Diabetic Test Strip Moves into Formal Managed Clinical Trials and Advanced Testing for Upcoming 510k Filing with U.S. FDAPress Release | 03/13/2018
DECN Anticipates Initial International Sales of 165,000 Genchoice! Boxes Per Month as it also Readies Panacea Genprecis! System, and as Hybrid Private Label Plan Reaches Intensity
LOS ANGELES, CA / ACCESSWIRE / March 13, 2018 / 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 communicates the completion of the first stage clinical testing and the anticipated progression to IRB controlled clinical trial on March 15, 2018 for the new GenChoice! (the "Ladybug"
diabetes test strip. Within 45 days following the conclusion of these clinical trials, a 510K application for market clearance will be filed with the U.S. FDA. Necessary documentation and justifications are currently being assembled and legal and technical expertise has been engaged. Prior to FDA market clearance, GenChoice! will be exclusively distributed to select International markets after completion of the clinical trials during the month of May 2018. Management believes that the GenChoice! combination of rich features and compelling pricing will command immediate and extensive demand within those targeted international markets.
Keith Berman, CEO of Decision Diagnostics, commented, "We have made remarkable strides with the development progression of GenChoice! This process has entailed the manufacture of 138 pre-manufacture stage lots for clinical testing, bench testing, and comparative evaluation. The results of these examinations have encouraged the revision of our manufacturing forecast for International sales to 165,000 for 50 count boxes/units per month."
DECN's first product, GenUltimate! glucose test strips, are compatible with the market leading Johnson & Johnson's ("J&J" LifeScan OneTouch Ultra family of glucose testing meters. The newest products, GenSure! and GenChoice! test strips, will both now also work each with a family of predicate testing meters.
Mr. Berman continued, "DECN anticipates the GenChoice! introduction to International markets in June 2018 as a prelude to the eventual U.S. introduction. It is believed that GenChoice! will contribute $100 million in annual revenues per our pro forma financial forecast. As such, GenChoice! will temporarily become DECN's largest tertiary revenue producer and should post margins in excess of the company's successful GenUltimate! test strips, that is until our panacea product GenPrecis!, reaches the same stage of market-readiness in the next several weeks."
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 20 million diabetics worldwide. With the anticipated Fall 2018 launch of our GenPrecis Precise system technology, along with our diabetic test strips described above, 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 72+ percent of a $12 billion 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 March 7, 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.
CONTACT INFORMATION:
Decision Diagnostics Corp.
Keith Berman, CEO (805) 446-2973
info@decisiondiagnostics.com
www.genultimate.com
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.
Decision Diagnostics' Fundamental Genchoice! Diabetic Test Strip Moves into Formal Managed Clinical Trials and Advanced Testing for Upcoming 510k Filing with U.S. FDAPress Release | 03/13/2018
DECN Anticipates Initial International Sales of 165,000 Genchoice! Boxes Per Month as it also Readies Panacea Genprecis! System, and as Hybrid Private Label Plan Reaches Intensity
LOS ANGELES, CA / ACCESSWIRE / March 13, 2018 / 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 communicates the completion of the first stage clinical testing and the anticipated progression to IRB controlled clinical trial on March 15, 2018 for the new GenChoice! (the "Ladybug"
diabetes test strip. Within 45 days following the conclusion of these clinical trials, a 510K application for market clearance will be filed with the U.S. FDA. Necessary documentation and justifications are currently being assembled and legal and technical expertise has been engaged. Prior to FDA market clearance, GenChoice! will be exclusively distributed to select International markets after completion of the clinical trials during the month of May 2018. Management believes that the GenChoice! combination of rich features and compelling pricing will command immediate and extensive demand within those targeted international markets. Keith Berman, CEO of Decision Diagnostics, commented, "We have made remarkable strides with the development progression of GenChoice! This process has entailed the manufacture of 138 pre-manufacture stage lots for clinical testing, bench testing, and comparative evaluation. The results of these examinations have encouraged the revision of our manufacturing forecast for International sales to 165,000 for 50 count boxes/units per month."
DECN's first product, GenUltimate! glucose test strips, are compatible with the market leading Johnson & Johnson's ("J&J"
LifeScan OneTouch Ultra family of glucose testing meters. The newest products, GenSure! and GenChoice! test strips, will both now also work each with a family of predicate testing meters. Mr. Berman continued, "DECN anticipates the GenChoice! introduction to International markets in June 2018 as a prelude to the eventual U.S. introduction. It is believed that GenChoice! will contribute $100 million in annual revenues per our pro forma financial forecast. As such, GenChoice! will temporarily become DECN's largest tertiary revenue producer and should post margins in excess of the company's successful GenUltimate! test strips, that is until our panacea product GenPrecis!, reaches the same stage of market-readiness in the next several weeks."
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 20 million diabetics worldwide. With the anticipated Fall 2018 launch of our GenPrecis Precise system technology, along with our diabetic test strips described above, 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 72+ percent of a $12 billion 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 March 7, 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.
CONTACT INFORMATION:
Decision Diagnostics Corp.
Keith Berman, CEO (805) 446-2973
info@decisiondiagnostics.com
www.genultimate.com
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.
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