Company to Begin Sales in Select International Markets While the U.S. FDA Reviews its 510k Application
LOS ANGELES, CA / ACCESSWIRE / November 6, 2018 / Decision Diagnostics Corp. (OTC PINK: DECN) is a 16-year-old, diabetes-focused bio-technology R&D 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 internationally launched GenSure! ("Feather") diabetes test strip, and the clinical trial in process concluded GenChoice! ("Ladybug"), the new PetSure! test strip for the diabetic testing of dogs and cats, and the panacea GenPrecis! ("Dragonfly") diabetes testing system, ready for clinical trials.
DECN reports that the CEO Keith Berman has received the concluded patient clinical trial study, managed through its partner The Bio Co., Ltd in South Korea. The study was commissioned in May 1, 2018 and was completed on October 31, 2018. During the study, medical workers at the hospital that hosted the study went on strike for approximately 45 days, causing a delay. The clinical study itself was supervised at the hospital by a credentialed professional working under the standards of the International Review Board.
Keith M. Berman, CEO of DECN commented, "The company is delighted that the patient clinical study for our impressive GenChoice! glucose test strip is now complete. This was the last step in a product development that began in earnest in December 2017. We have retained a U.S. based IRB to organize the data in a manner consistent with the expectations of the U.S. FDA and those countries using the alternative ISO standard. The data received is outstanding and exceeds all newly established standards for accuracy and precision. But most exciting is that GenChoice! will compete in a world-wide market."
Mr. Berman continued, "DECN intends to complete the configuring of the clinical report in the next 30 days, and during that time to implement its marketing plan for GenChoice! in select International markets where little or no immediate International registration is required. The clinical study will be provided to the expert firm who we previously tasked with completing our 510K application. We still anticipate filing this application in calendar year 2018. A web site for GenChoice! will go active in the coming days."
Mr. Berman concluded, "GenChoice! is an immense undertaking and achievement. Once the FDA clearance is achieved, the company intends to sell GenChoice! in retail, International and Hybrid Private label packaging. GenChoice! represents the first of several exciting new products we have in store over the next few months. Until our GenChoice! product is FDA cleared for pre-market sale, we will follow the path set by several industry leaders who launched their worldwide products initially in International markets."
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is a 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 and 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 $12 billion at-home testing 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 November 5, 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 (805) 446-2973
[email protected]
www.genultimate.com
www.petsureteststrips.com
www.genchoice.com (coming in 11/2018)
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.