SOURCE: Decision Diagnostics Corp.

Decision Diagnostics Corp.

February 09, 2016 09:20 ET

Decision Diagnostics Conveys Opportunities and Potential Following Landmark Circuit Court Ruling Against Diabetes Testing Division of Johnson & Johnson

Federal Circuit Court's Rule 36 Affirmation Positions DECN to Achieve Significant Market Penetration

LOS ANGELES, CA--(Marketwired - Feb 9, 2016) - Decision Diagnostics Corp. (OTC PINK: DECN), the manufacturer, quality plan administrator and the exclusive worldwide sales, service and regulatory processes agent for GenStrip™ 50 and the GenUltimate™ glucose test strip, both designed to work with the market leading Johnson & Johnson's ("J&J") LifeScan OneTouch Ultra family of glucose testing meters, and the in-development GenSure™ glucose test strip targeted to the developing world markets, today relays a summary of the arguably illegitimate J&J/Lifescan lawsuit impact on DECN business activity, its current status and future expectations.

Corporate annual revenue generation approximated $15+ million from 2009-2012 from existing business activities, prior to the comprehensive 2012-2013 Medicare reimbursement reductions for at-home testing supplies. In 2012 the company assumed total program management of the Genstrip blood glucose test strip; including all regulatory activity directed towards FDA 510k market clearance. Concurrent to this transition, and prior to regulatory approval and Genstrip product introduction, J&J/Lifescan commenced its campaign of litigation, threats and intimidation to prevent the introduction of Genstrip to the diabetic patient population. They collectively filed patent infringement and trademark infringement lawsuits.

The FDA 510k market clearance in November, 2012, activated an intensive product launch and initiated an order wave that deluged manufacturing and overwhelmed capacity. Agreements were quickly executed with mass merchandisers, drug chains and grocery retailers. However, internal expectations for meteoric product growth and rapid revenue escalation were abruptly interrupted by lower court judges, persuaded by J&J/Lifescan assertions of false health risks and their own financial impairment, to enter two preliminary injunctions preventing the continued sale of Genstrip. Prior to the reversal of those injunctions by a rational Federal Circuit Court of Appeals panel, J&J/Lifescan expanded its scorched earth strategy through a communication campaign targeting all existing and prospective Genstrip customers. Each of these accounts received notifications, replete with distortions, suspect legal opinions and an explicit threat to employ the full financial power of the $75 billion corporate giant to sue any commercial Genstrip purchaser for patent infringement. This totally disingenuous, yet highly successful, campaign effectively neutralized the company's marketing plans for the Genstrip product through all second and third party sellers.

Keith Berman, Principal Executive of Decision Diagnostics commented, "We entered 2013 poised to capture a considerable share of the J&J/Lifescan $2+ billion test strip market. Although expecting J&J/Lifescan to make every effort to protect their market monopoly, we did not anticipate the breath of faithless tactics that they would employ to remove our looming threat to their cash cow franchise. Our only option was to repel their attacks and to pursue vindication through unconditional legal victory. We had been counseled that J&J/Lifescan frequently filed baseless lawsuits characterized by unfounded accusations, delaying tactics and often supported by incapable or fraudulent expert witnesses; forcing smaller undercapitalized competitors to capitulate under the weight of staggering legal defense costs. "

The company and its Pharma Tech Solutions subsidiary won, and won unconditionally. As announced, that ruling initiated a company legal claim and the aggressive pursuit of a court mandated J&J/Lifescan $12.7 million bond posted in the event that the imposed injunction was reversed or proven to be invalid. Additional legal pursuit against J&J/Lifescan will be activated for the extensive damages their improper behavior and anti-trust activities have inflicted on the company.

The multiple and final legal victories now reopens the gateway to the rapid business expansion curtailed by the J&J/Lifescan legal assaults and their campaign of threat and intimidation. During the Genstrip legal hiatus from the market, the company has been intensely preparing for the product re-launch. It now is engaged in conversations with multiple national retailers to re-embrace the functional and financial superiority of GenStrip that they found so compelling in 2013.

Mr. Berman continued, "We are energized and reborn. Wasted years, lost opportunity and unnecessary expense are now behind us. We have won so conclusively that the Federal Circuit Court took the uncommon step of awarding us court costs in their Rule 36 decision. That award punctuated their decision and emphasized their conviction in the ruling. We would like to thank all of our shareholders who have supported our efforts and fought the battle with us. We are fully committed to shortly rewarding their patience, investment and encouragement."

The company has also packed the last several years with the planning and development of a suite of new products that it will begin releasing in 2016. Those additions to the family of diagnostic testing products and devices include:

  • GenUltimate test strip targeted for sale to GPOs, major chain pharmacies, private label sales and mega-distributors.
  • GenSure test strip, a product for international sales to the developing world markets and which will initially feature a test strip and shortly followed by the release of a test meter.
  • The Discretion product line of glucose meter systems empowered by Internet radio devices, designed for remote glucose monitoring of diabetes inflicted school-aged, children

Mr. Berman concluded, "Here we are once again after 3+ years; poised to distribute to the millions of diabetic patients a superior and significantly less expensive test strip that have been denied due to the legal and business harassment of J&J/Lifescan. This time we will not be deterred. Rapid growth will be fulfilled and supported by our contract domestic manufacturer and our newly engaged supplemental international manufacturer.

Forward-Looking Statements:
This release contains the Company's forward-looking statements which are based on management's current expectations and assumptions as of February 9, 2016, 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.

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