Thanks for the heads up, Pluto!
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Posted On: 01/03/2018 10:13:05 AM
Thanks for the heads up, Pluto!
LOS ANGELES, CA / ACCESSWIRE / January 3, 2018 /Decision Diagnostics Corp. (OTC PINK
ECN) is a 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 new internationally launched GenSure!™ ("Feather" diabetes test strip, and the clinical trial ready GenChoice!™ ("Ladybug" diabetes test strip, as well as three other unique test strips and meters in development, including our panacea strip and meter system the highly innovative GenPrecis!™ and its first collateral asset, our GenAccord!™ multiple-egress test strip. Today, DECN previews its plans and expected outcomes for 2018.
J&J Litigation
DECN has been locked in confrontational patent litigation with two divisions of Johnson & Johnson (JNJ), almost continuously, since September 2011. The company was victorious as a Defendant in the first three suits and received a payout at their conclusion. The current lawsuit positions two divisions of DECN as plaintiffs having filed suit against J&J for infringement of the company's patented test strip technology. As anticipated, J&J has employed the identical deceptive tactics and delaying strategies they embraced during the prior litigations. They failed to affect the final outcome in the past and it is expected that they will fail once again. The company's legal positions are strong and are supported by the rulings made by higher courts in the first three cases. If necessary, the company is fully prepared, both legally and financially, to litigate until J&J has exhausted their final appeal. However, the company believes that the strength of its position will ultimately drive a negotiated settlement.
Keith Berman, CEO of Decision Diagnostics Corp., commented, "J&J, through their superior resources and "scorched earth" legal strategy, has exacted heavy tolls on our business operations. However, through this adversity, the company has discovered its footing as a legitimate competitor in a highly regulated and heavily litigious environment. We are now fortified and fully prepared to successfully engage as we introduce new products and continue to expand our base of business."
New Product Introductions
2018 is expected to become a seminal year for DECN. It begins with the marketing of its launched GenSure!™ diabetic test strip, targeted for the patient population across the developing markets. The company will then, in rapid succession, introduce three new products, the GenChoice!™ test strip for worldwide distribution, GenPrecis!™ test strip and Precise meter, and the GenAccord!™ multiple-egress test strip that capitalizes on the GenPrecis!™ "full spread electro-chemistry technology." This intense activity begins January 15, 2018 with the global introduction of the GenSure!™ test strip. Following shortly thereafter, at the end of January 2018, the commencement of clinical trials for the GenChoice! test strip should culminate with the filing of 510K application filing for market clearance with the U.S. FDA in late February. International sales of GenChoice!™ are expected to begin in March 2018.
Additionally, the company intends to finalize its testing of the GenPrecis!™ test strip by January 28, and the GenPrecis!™ Precise meter by February 28. This GenPrecis!™ test strip is now compatible with two legacy meters sold internationally.
Mr. Berman continued, "Our one overriding goal has been to create a brand that is unique and superior to what the industry has thus far produced. DECN is not, and will never be, another uninspired producer of imitation products. We are committed to being creative, nimble and aggressive throughout our current and future product line."
Hybrid Private Label Model
We have registered with the U.S. USPTO and the U.S. FDA two new product family names; Alltara!™ and Advant!™. These brands will become those licensed to big box retailers as their own exclusive private label. We anticipate registering more trade family names as our "big box" plan proceeds. The company is currently completing the private label packaging for the GenUltimate!™ product, now named Alltara!™ ultimate. This expansion is expected to be followed by Alltara!™ choice and then by Alltara!™ precis. First deliveries of Alltara!™ ultimate are expected in 2Q 2018. This brand will not be sold by any direct to patient distributors. First postings of product images, with disclaimers, if any, will be placed on the company's websites in coming days. The company will provide a full discussion of this business model in its 2017 Annual Report.
Mr. Berman concluded, "It is exhilarating when large big box retailers pursue our products for placement on their shelves. The years of litigation and struggle have been finally rewarded with the collapse of the retail barriers erected by J&J to our product placement in the retail marketplace. Now that those obstacles are crumbling, we intend to capitalize on the opportunity with our existing products and our eagerly anticipated bevy of new product introductions."
LOS ANGELES, CA / ACCESSWIRE / January 3, 2018 /Decision Diagnostics Corp. (OTC PINK
ECN) is a 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 new internationally launched GenSure!™ ("Feather" diabetes test strip, and the clinical trial ready GenChoice!™ ("Ladybug" diabetes test strip, as well as three other unique test strips and meters in development, including our panacea strip and meter system the highly innovative GenPrecis!™ and its first collateral asset, our GenAccord!™ multiple-egress test strip. Today, DECN previews its plans and expected outcomes for 2018. J&J Litigation
DECN has been locked in confrontational patent litigation with two divisions of Johnson & Johnson (JNJ), almost continuously, since September 2011. The company was victorious as a Defendant in the first three suits and received a payout at their conclusion. The current lawsuit positions two divisions of DECN as plaintiffs having filed suit against J&J for infringement of the company's patented test strip technology. As anticipated, J&J has employed the identical deceptive tactics and delaying strategies they embraced during the prior litigations. They failed to affect the final outcome in the past and it is expected that they will fail once again. The company's legal positions are strong and are supported by the rulings made by higher courts in the first three cases. If necessary, the company is fully prepared, both legally and financially, to litigate until J&J has exhausted their final appeal. However, the company believes that the strength of its position will ultimately drive a negotiated settlement.
Keith Berman, CEO of Decision Diagnostics Corp., commented, "J&J, through their superior resources and "scorched earth" legal strategy, has exacted heavy tolls on our business operations. However, through this adversity, the company has discovered its footing as a legitimate competitor in a highly regulated and heavily litigious environment. We are now fortified and fully prepared to successfully engage as we introduce new products and continue to expand our base of business."
New Product Introductions
2018 is expected to become a seminal year for DECN. It begins with the marketing of its launched GenSure!™ diabetic test strip, targeted for the patient population across the developing markets. The company will then, in rapid succession, introduce three new products, the GenChoice!™ test strip for worldwide distribution, GenPrecis!™ test strip and Precise meter, and the GenAccord!™ multiple-egress test strip that capitalizes on the GenPrecis!™ "full spread electro-chemistry technology." This intense activity begins January 15, 2018 with the global introduction of the GenSure!™ test strip. Following shortly thereafter, at the end of January 2018, the commencement of clinical trials for the GenChoice! test strip should culminate with the filing of 510K application filing for market clearance with the U.S. FDA in late February. International sales of GenChoice!™ are expected to begin in March 2018.
Additionally, the company intends to finalize its testing of the GenPrecis!™ test strip by January 28, and the GenPrecis!™ Precise meter by February 28. This GenPrecis!™ test strip is now compatible with two legacy meters sold internationally.
Mr. Berman continued, "Our one overriding goal has been to create a brand that is unique and superior to what the industry has thus far produced. DECN is not, and will never be, another uninspired producer of imitation products. We are committed to being creative, nimble and aggressive throughout our current and future product line."
Hybrid Private Label Model
We have registered with the U.S. USPTO and the U.S. FDA two new product family names; Alltara!™ and Advant!™. These brands will become those licensed to big box retailers as their own exclusive private label. We anticipate registering more trade family names as our "big box" plan proceeds. The company is currently completing the private label packaging for the GenUltimate!™ product, now named Alltara!™ ultimate. This expansion is expected to be followed by Alltara!™ choice and then by Alltara!™ precis. First deliveries of Alltara!™ ultimate are expected in 2Q 2018. This brand will not be sold by any direct to patient distributors. First postings of product images, with disclaimers, if any, will be placed on the company's websites in coming days. The company will provide a full discussion of this business model in its 2017 Annual Report.
Mr. Berman concluded, "It is exhilarating when large big box retailers pursue our products for placement on their shelves. The years of litigation and struggle have been finally rewarded with the collapse of the retail barriers erected by J&J to our product placement in the retail marketplace. Now that those obstacles are crumbling, we intend to capitalize on the opportunity with our existing products and our eagerly anticipated bevy of new product introductions."
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