There's a lot of things happening with this small,
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Posted On: 08/14/2018 11:57:29 AM
Re: DirkEaston #5452
There's a lot of things happening with this small, but growing DECN.
"The GenSure! ("Feather"
test strip is complete, third party tested, and clinically tested in patient trials. GenSure! is intended to be a low cost replacement strip competing mostly in the developing world. The legacy predicate device that GenSure! will compete against is unavailable for purchase in the U.S. and never has been sold. The company plans to sell GenSure! first in Mexico where upon approval by Mexican regulators, it can gain immediate traction. As such, the company has engaged an exclusive distributor for the GenSure! product. The exclusive distributor has taken on the regulatory registration process (estimated to be 90-120 days) and has inked an agreement with a large pharmacy chain and convenience store operator in Mexico, as well as several South American countries, starting with Chile. The large customer for GenSure! will also carry the company's GenUltimate! test strip. International packaging for GenSure! and GenUltimate! test strips will be 30 and 60 count boxes, a strategic deviation from the domestic business model."
"Regarding GenChoice!, both internal testing and third party lab testing has been completed on our Genchoice ("Ladybug" test strips, while clinical trials are nearing completion with an estimated time of 45 days. Genchoice ("Ladybug" is approaching an International Launch date of October 1, 2018 while our FDA 510K documentation is in process with a filing expected around October 1, 2018."
"GenPrecis and GenPrecis Precise Meter ("Dragonfly" is approaching completion of internal testing around August 31, 2018. Initial internal tests are demonstrating better results than anticipated for a product that already had set new industry precision and accuracy standards. Third party lab testing is expected to begin around August 24, 2018. Subsequently, DECN anticipates using FDA enhanced guidance to begin clinical trials around October 15, 2018."
"Our PetSure Test Strip ("small Ladybug" product had a successful commercial launch on July 31, 2018 with distribution agreements expanding to include big box retailers and pet product manufacturers. We expect to begin an advertising campaign shortly around August 20, 2018, and have been encouraged from initial launch sales which have occurred prior to any product marketing."
"DECN Packaging for PetUltimate Test Strip and PetUltimate Avantage Meter ("Carnation" is expected to be completed around August 10, 2018. The product packaging will appear on the major company Web Sites shortly thereafter. The company is seriously considering using its GenPrecis! product as a foundation for the PetUltimate! test strip. Subsequently, precision and accuracy testing along with product linearity is set to begin around September 25, 2018. We anticipate commercial sales may be launched around October 15, 2018."
"Finally, our Big Box Private Label program is proceeding with the only bottlenecks being time between sales and system processes. We anticipate providing further updates shortly as the bottlenecks are reduced and the program continues to pick up momentum."
Link
"The GenSure! ("Feather"
test strip is complete, third party tested, and clinically tested in patient trials. GenSure! is intended to be a low cost replacement strip competing mostly in the developing world. The legacy predicate device that GenSure! will compete against is unavailable for purchase in the U.S. and never has been sold. The company plans to sell GenSure! first in Mexico where upon approval by Mexican regulators, it can gain immediate traction. As such, the company has engaged an exclusive distributor for the GenSure! product. The exclusive distributor has taken on the regulatory registration process (estimated to be 90-120 days) and has inked an agreement with a large pharmacy chain and convenience store operator in Mexico, as well as several South American countries, starting with Chile. The large customer for GenSure! will also carry the company's GenUltimate! test strip. International packaging for GenSure! and GenUltimate! test strips will be 30 and 60 count boxes, a strategic deviation from the domestic business model." "Regarding GenChoice!, both internal testing and third party lab testing has been completed on our Genchoice ("Ladybug"
test strips, while clinical trials are nearing completion with an estimated time of 45 days. Genchoice ("Ladybug" is approaching an International Launch date of October 1, 2018 while our FDA 510K documentation is in process with a filing expected around October 1, 2018." "GenPrecis and GenPrecis Precise Meter ("Dragonfly"
is approaching completion of internal testing around August 31, 2018. Initial internal tests are demonstrating better results than anticipated for a product that already had set new industry precision and accuracy standards. Third party lab testing is expected to begin around August 24, 2018. Subsequently, DECN anticipates using FDA enhanced guidance to begin clinical trials around October 15, 2018." "Our PetSure Test Strip ("small Ladybug"
product had a successful commercial launch on July 31, 2018 with distribution agreements expanding to include big box retailers and pet product manufacturers. We expect to begin an advertising campaign shortly around August 20, 2018, and have been encouraged from initial launch sales which have occurred prior to any product marketing." "DECN Packaging for PetUltimate Test Strip and PetUltimate Avantage Meter ("Carnation"
is expected to be completed around August 10, 2018. The product packaging will appear on the major company Web Sites shortly thereafter. The company is seriously considering using its GenPrecis! product as a foundation for the PetUltimate! test strip. Subsequently, precision and accuracy testing along with product linearity is set to begin around September 25, 2018. We anticipate commercial sales may be launched around October 15, 2018." "Finally, our Big Box Private Label program is proceeding with the only bottlenecks being time between sales and system processes. We anticipate providing further updates shortly as the bottlenecks are reduced and the program continues to pick up momentum."
Link
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