Company Receives 3rd Communique from FDA for Clearance of its GenChoice Test Strip, and at the Request of Agent Paragon, DECN Revives GenPrecis Line for Big Box Sales
LOS ANGELES, CA / ACCESSWIRE / April 17, 2019 / Decision Diagnostics Corp. (OTC PINK: DECN) Decision Diagnostics Corp. is a 17 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 a growing brand of glucose test strips and meters as highly accurate alternatives for legacy diabetic, proprietary, and pet testing glucose test strips.
Decision Diagnostics is pleased to announce a series of recent events, ostensibly related to the company's announcement of the completion of advanced development for its GenUltimate TBG panacea product.
Keith Berman, CEO of DECN commented, 'The company has been approached by two parties, both extremely interested in our GenUltimate! TBG product and the anticipated effect this product will have on the at-home testing industry. The approach taken by the first party would include a cash transaction followed by a 4-5 year license agreement. If this path is chosen, an exclusive arrangement would be foreseen. The second and more recent party has notified the company that their interest would be through an M&A leveraged transaction.'
Mr. Berman continued, 'Both of the parties are well heeled entities with footholds in our space. Both entities would expect standstill agreements, making the Board's decision a choice of one proposal or the other, the rejection or counter to one or the other, or perhaps a request for other parties to come forward. Current company valuation, the focal point of any offer or transaction, is believed by the Board to be extraordinarily low, and this valuation will guide all Board decisions. Shareholders and other interested parties will be notified when the Board of Directors reaches a decision.'
The company has also announced that we are in receipt of a 3rd communique from the U.S. FDA concerning our GenChoice! test strip, being reviewed by the FDA for clearance. We have answered this communique. We believe the FDA review staff is now progressing to the strongest part of our application. We have yet to see any regulatory resistance.
In addition to the above, the company similarly communicates that at the request of its agent Paragon Marketing and Sales, representing our interests in the big box arena, we have revived our GenPrecis! test strip and have rebranded the accompanying meter the GenPrecis! Re'al glucometer. The rationale behind this product revival was that all of the prospective interest in our GenUltimate! TBG product has been for exclusive rights or ownership. A transaction in this area would have deprived the overall market, and in particular the big box channel, of our highly precise product -- the future of the at-home testing market.
Mr. Berman completed his commentary, 'We are pleased with our corporate progress in the area of product development, 510K prosecution with the FDA, and our decision to market two similar products, our GenUltimate! TBG for exclusive distribution or acquisition rights, the other, GenPrecis! for private label sales. Both the GenUltimate! TBG and the GenPrecis bring a critical component of unparalled precision to an at-home testing product, and the only viable alternative to the current market interest in the 'chemistry patch' technologies. Our advantage rests on the fact that we will get to market first, and first to market matters a lot. In the next several days we will discuss how we have achieved initial success in financing our endeavors.'
The company's current portfolio of test strips includes its market established GenUltimate! and GenSure! test strips, plus its GenChoice!, GenUltimate! TBG and GenPrecis! test strips, either in regulatory review, clinical trials or advance development, its Avantage!, Precise! and Re'al! glucometers, and its PetSure! and GenUltimate! 4Pets testing products for dogs, cats and horses. The company's GenChoice! test strips are part of a current 510K prosecution process with the U.S. FDA.
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. 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 7.5 million diabetics worldwide. With new inspired technology 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.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of April 16, 2019, 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.
SOURCE: Decision Diagnostics Corp.