LOS ANGELES, CA--(Marketwired - Mar 4, 2015) - Decision Diagnostics Corp. (OTC PINK: DECN), the manufacturer, quality plan administrator and the exclusive worldwide sales, service and regulatory processes agent for the popular GenStrip™ 50, the FDA cleared Green Glucose Test Strip, specifically designed to work with the market leading Johnson & Johnson's LifeScan OneTouch Ultra family of glucose testing meters, today announced that despite repeated refusal of Lifescan's mediation overtures, the company was ordered to attend a mandatory, court-directed mediation on January 29, 2015. Following two separate days of these compulsory discussions at the Federal District Court for Northern California (San Francisco), which concluded on February 23, the company has again rejected Lifescan's settlement offers.
Keith Berman, Principal Executive Officer and CFO stated: "As we have repeatedly stated during this lengthy process, J&J/Lifescan will not be readily released from its legal and financial obligations stemming from its onerous actions against our product and company. A modest level of compensation will not rectify the considerable damages that they have inflicted. Our positions will be vindicated, our product fully restored and our shareholders rewarded for their patience. No company, regardless of their size, wealth or power, can willfully ignore all legal and ethical business practices. We will prevail and will be awarded appropriate reparations for our sustained damages."
The company, more importantly, is announcing that the preparation for an expected explosion of product demand following legal victory has already begun. Solicitations for interview and quotation have been circulated to various internationally certified and FDA approved manufacturers for the contract manufacture of GenStrip™ 50. The time frame for tooling creation, first article part delivery and full product production is expected to fall within a five to seven month timeframe, following the final selection of an international contract manufacturer. Concurrent to the fulfillment of supplemental GenStrip™ 50 manufacturing, that selected manufacturer will simultaneously be charged with the completion of a new product that has been under internal development for nearly a year. Several of these manufacturing candidates are currently manufacturing second generation, FDA cleared, embryonic versions of the company's (3rd generation) product concept.
William Lyons, Director of Decision Diagnostics and its subsidiary Pharma Tech Solutions, has clarified the company's direction: "Pharma Tech owns GenStrip™ 50. That ownership extends to the various interests including, the 510k, the product specifications, manufacturing and regulatory responsibility and the shared regulatory QSR. Upon our legal conquest, we will be fully prepared to assault the $ 2.5 billion worldwide J&J/Lifescan market share that they have improperly maintained through unlawful activities and anti-trust behavior. The rapidly escalating global product demand will be satisfied through our primary and, the soon to be appointed, supplemental contract manufacturer(s). We, additionally, will be launching a new product beyond the scope of our existing GenStrip™ 50 technology that is expected to have a disruptive impact in critical market segments. Our shareholders will be apprised of that product's details and progress over the coming months."
Mr. Berman concluded, "Our lack of agreement in the recent settlement discussions does not suggest that we will permit any encroachment, from those who settled, into the markets we have transformed. We maintain and will continue to maintain management control of all facets of GenStrip™ 50."
This release contains forward-looking statements about our business or financial condition that reflect our assumptions and beliefs based on information currently available. We can give no assurance that the expectations indicated by such forward-looking statements will be realized. There may be other risks and circumstances that we are unable to predict. When used in this release, words such as "believes," "expects," "forecasts," "intends," "projects," "plans," "anticipates," "estimates," "will" and similar expressions are intended to identify forward-looking statements, although there may be certain statements not accompanied by such expressions.
For further information about the Pharma Tech GenStrip™ 50, please visit the company's Web Sites: http://www.decisiondiagnostics.com or http://www.pharmatechdirect.com or http://www.new-genstrip.com.
GenStrip™ 50 test strips are a product of Pharma Tech Solutions, Inc., and are not manufactured, distributed, endorsed, or approved by nor associated with LifeScan, Inc. a Johnson & Johnson company, manufacturers and distributors of the OneTouch Ultra family of meters and OneTouch Ultra test strips.