HIGHLIGHTS FROM 1st QUARTER 2017 https://www.ot
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Posted On: 05/15/2017 11:36:08 PM
HIGHLIGHTS FROM 1st QUARTER 2017
https://www.otcmarkets.com/stock/DECN/filings
The GenSure! product has completed its clinical
trials, and is currently in registration and is seeking a CE mark in the EU, and will be launched in July 2017. We have
identified International distributors for this product..
In March 2017 the company was approached by its Korean partner, The Bio Co., Ltd to design and fund a
new product which the company will call GenPrecis!. This product, when completed, will represent a major
improvement in diabetic glucose monitoring. The GenPrecis! system will be the first of its kind +/- 10% system.
Current ISO (2013) and FDA (2014) guidelines call for glucose monitoring systems to meet a +/- 15% standard,
whereby the meter and strip must be within +/- 15% in repeated samplings 95% of the time. GenUltimate! and
GenChoice! are +/- 15% test strips, but in each case 97+% of the time in repeated samplings. GenPrecis! is designed
to meet the written standards of the ISO and FDA at +/- 10%, 95% of the time – effectively setting a new standard.
The company has been funding the development of this system product, and a test strip only derivative version. The
system product will be ready for testing in September 2017 and will be registered for International sale in November
2017. However, the natural market for this product will be the U.S, and Canada where precision standards are higher
for new products.
The company entered into two international agreements in the latter part of 2016. The first agreement,
executed through the company’s exclusive Korean agent, allows for delivery of the GenUltimate! product in quantity
to the Korean market. As of this writing, the Korean partners have ordered and paid for over 65,000 pieces (units) of
GenUltimate! Another almost 20,000 pieces (units) are on order for late June 2017. The company’s second
international agreement is through a South American financier who has businesses in Bolivia and Spain. This group
has placed a single two-year (term) order for approximately $17 million in GenUltimate! product, GenUltimate!
meters and the company’s new (2017) Firefly! Lancets. Almost 11,000 pieces (units) of GenUltimate!, 3,000
GenUltimate! meters and cases of lancets have been delivered to Bolivia. In addition, the South America financier has
funded the company’s regulatory applications (through a Spanish pharmaceutical company) with the EU, to gain “CE”
marking for its GenUltimate! and GenSure! products (and later in 2017 the company’s GenChoice! and GenPrecis!
Products) in return for the Spanish distribution rights to these two products. And lastly, the South American financier
has notified the company that he and those closely associated with him wished to subscribe to a $3.25 million to $5.0
million capital investment in the company. As of this writing the company has not concluded this capital investment,
at its choice, but recently received a signed and dated a Subscription Agreement for this upcoming investment from
the financier. Among the many terms in this investment, the South American financier will not be able to convert and
sell any securities that underlie the investment vehicle for 36 months from the time of the investment.
On May 5, 2017 the company was contacted by a worldwide private label manufacturer and distributor for
the purposes of worldwide distribution of our products under their brand(s). We are in discussions with this entity
currently. This company has headquarters in the U.S. (Midwest) and France.
The company’s stock currently trades on the OTCMarkets OTC Pink Current tier of the market. The company’s shares are
DTC eligible. On May 12, 2015 the company made an application for a tier change to the OTCQX (common) tier. When the company’s
common stock fell in price beneath the $.10 threshold, and when our sponsoring broker shuttered his operation, our application went
into hiatus. Subsequently, we have been in contact with OTCMarkets and we plan to revive our application after we complete an M&A
transaction. To that end we have agreed to work with an M&A partner, a current SEC filer with a large shareholder base. We have
executed a Preliminary Agreement and are in the final stages of completing a Definitive Agreement. We anticipate closing this
transaction late in the second quarter 2017. Subsequently, the company received direct communication from OTCMarkets concerning
a new uplist program offered, beginning May 18, 2017, whereby the company might uplist within the OTCMarkets tiers as a Current
Alternative reporting company and filer. Regardless of which of these uplist paths the company’s Board of Directors decides regarding
the OTCMarkets programs, we plan to continue working through the M&A plan now in progress
At a hearing in March 2017 the Federal judge denied Lifescan’s Motion to Dismiss, granted the company’s request to allege the Doctrine
of Equivalents and set dates beginning in early April 2017 and ending in early November 2017 that could set the stage for a ruling.
Sometime in June 2017 the company expects to amend its suit a second time and name other “infringers” as well as adding additional
counts to the suit. Federal rules for patent infringement suits have changed, and these suits are now adjudicated over an 18-24 month
period. The trial judge’s ruling in mid-March seems to foot with this schedule. In addition, if the schedule set by the judge does not end
the litigation, there are five scheduled Mediations in front of a Federal Judge Magistrate pushing the process along. The company
amended its suit in April 2017, alleging patent infringement on behalf of the J&J entities under the Doctrine of Equivalents. The J&J
entities answered the amended complaint later in April, and the (next step) expert testimony has begun.
On May 5, 2017 the company was contacted by a worldwide private label manufacturer and distributor for the purposes of
worldwide distribution of our products under their brand(s). We are in discussions with this entity currently. This company has
headquarters in the U.S. (Midwest) and France.
As a part of the company’s strategic plans, we have applied (to register) for seven Trademarks with the USPTO. The company’s
Genstrip product is a registered Trademark of Shasta Technologies LLC. Our applications were filed with the USPTO in 1Q and 2Q
2015 and 3Q 2016. The company intends to use these Marks, as granted, to brand new products, rebranding of existing products, and
the establishment of a family of Marks associated with our company and its place in our industry. As December 31, 2016 the company
has received registration confirmation from the USPTO for the following Marks:
“Alltara!”
“GenUltimate!”
“GenSure!”
“GenChoice!”
“GenAccord!”
“GenCambre!”
“Firefly!”
In early May 2017 the company filed for a mark on its GenPrecis! Product.
https://www.otcmarkets.com/stock/DECN/filings
The GenSure! product has completed its clinical
trials, and is currently in registration and is seeking a CE mark in the EU, and will be launched in July 2017. We have
identified International distributors for this product..
In March 2017 the company was approached by its Korean partner, The Bio Co., Ltd to design and fund a
new product which the company will call GenPrecis!. This product, when completed, will represent a major
improvement in diabetic glucose monitoring. The GenPrecis! system will be the first of its kind +/- 10% system.
Current ISO (2013) and FDA (2014) guidelines call for glucose monitoring systems to meet a +/- 15% standard,
whereby the meter and strip must be within +/- 15% in repeated samplings 95% of the time. GenUltimate! and
GenChoice! are +/- 15% test strips, but in each case 97+% of the time in repeated samplings. GenPrecis! is designed
to meet the written standards of the ISO and FDA at +/- 10%, 95% of the time – effectively setting a new standard.
The company has been funding the development of this system product, and a test strip only derivative version. The
system product will be ready for testing in September 2017 and will be registered for International sale in November
2017. However, the natural market for this product will be the U.S, and Canada where precision standards are higher
for new products.
The company entered into two international agreements in the latter part of 2016. The first agreement,
executed through the company’s exclusive Korean agent, allows for delivery of the GenUltimate! product in quantity
to the Korean market. As of this writing, the Korean partners have ordered and paid for over 65,000 pieces (units) of
GenUltimate! Another almost 20,000 pieces (units) are on order for late June 2017. The company’s second
international agreement is through a South American financier who has businesses in Bolivia and Spain. This group
has placed a single two-year (term) order for approximately $17 million in GenUltimate! product, GenUltimate!
meters and the company’s new (2017) Firefly! Lancets. Almost 11,000 pieces (units) of GenUltimate!, 3,000
GenUltimate! meters and cases of lancets have been delivered to Bolivia. In addition, the South America financier has
funded the company’s regulatory applications (through a Spanish pharmaceutical company) with the EU, to gain “CE”
marking for its GenUltimate! and GenSure! products (and later in 2017 the company’s GenChoice! and GenPrecis!
Products) in return for the Spanish distribution rights to these two products. And lastly, the South American financier
has notified the company that he and those closely associated with him wished to subscribe to a $3.25 million to $5.0
million capital investment in the company. As of this writing the company has not concluded this capital investment,
at its choice, but recently received a signed and dated a Subscription Agreement for this upcoming investment from
the financier. Among the many terms in this investment, the South American financier will not be able to convert and
sell any securities that underlie the investment vehicle for 36 months from the time of the investment.
On May 5, 2017 the company was contacted by a worldwide private label manufacturer and distributor for
the purposes of worldwide distribution of our products under their brand(s). We are in discussions with this entity
currently. This company has headquarters in the U.S. (Midwest) and France.
The company’s stock currently trades on the OTCMarkets OTC Pink Current tier of the market. The company’s shares are
DTC eligible. On May 12, 2015 the company made an application for a tier change to the OTCQX (common) tier. When the company’s
common stock fell in price beneath the $.10 threshold, and when our sponsoring broker shuttered his operation, our application went
into hiatus. Subsequently, we have been in contact with OTCMarkets and we plan to revive our application after we complete an M&A
transaction. To that end we have agreed to work with an M&A partner, a current SEC filer with a large shareholder base. We have
executed a Preliminary Agreement and are in the final stages of completing a Definitive Agreement. We anticipate closing this
transaction late in the second quarter 2017. Subsequently, the company received direct communication from OTCMarkets concerning
a new uplist program offered, beginning May 18, 2017, whereby the company might uplist within the OTCMarkets tiers as a Current
Alternative reporting company and filer. Regardless of which of these uplist paths the company’s Board of Directors decides regarding
the OTCMarkets programs, we plan to continue working through the M&A plan now in progress
At a hearing in March 2017 the Federal judge denied Lifescan’s Motion to Dismiss, granted the company’s request to allege the Doctrine
of Equivalents and set dates beginning in early April 2017 and ending in early November 2017 that could set the stage for a ruling.
Sometime in June 2017 the company expects to amend its suit a second time and name other “infringers” as well as adding additional
counts to the suit. Federal rules for patent infringement suits have changed, and these suits are now adjudicated over an 18-24 month
period. The trial judge’s ruling in mid-March seems to foot with this schedule. In addition, if the schedule set by the judge does not end
the litigation, there are five scheduled Mediations in front of a Federal Judge Magistrate pushing the process along. The company
amended its suit in April 2017, alleging patent infringement on behalf of the J&J entities under the Doctrine of Equivalents. The J&J
entities answered the amended complaint later in April, and the (next step) expert testimony has begun.
On May 5, 2017 the company was contacted by a worldwide private label manufacturer and distributor for the purposes of
worldwide distribution of our products under their brand(s). We are in discussions with this entity currently. This company has
headquarters in the U.S. (Midwest) and France.
As a part of the company’s strategic plans, we have applied (to register) for seven Trademarks with the USPTO. The company’s
Genstrip product is a registered Trademark of Shasta Technologies LLC. Our applications were filed with the USPTO in 1Q and 2Q
2015 and 3Q 2016. The company intends to use these Marks, as granted, to brand new products, rebranding of existing products, and
the establishment of a family of Marks associated with our company and its place in our industry. As December 31, 2016 the company
has received registration confirmation from the USPTO for the following Marks:
“Alltara!”
“GenUltimate!”
“GenSure!”
“GenChoice!”
“GenAccord!”
“GenCambre!”
“Firefly!”
In early May 2017 the company filed for a mark on its GenPrecis! Product.
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