Datametrex AI Limited (the
“
Company” or “
Datametrex”)
(
TSXV: DM, FSE: D4G, OTC: DTMXF) is pleased to
announce that it has secured non-exclusive rights to COVID-19 test
kits with Health Canada (“
HC”) approval, Kingdom
of Saudi Arabia, Saudi Food & Drug Authority
(
“SFDA”) approval, and CE marking certification
(“
CE”) for European Economic Area
(
“EEA”) countries, which covers the 27 member
states of the EU, the 4 members of EFTA, plus Turkey and the United
Kingdom under Brexit.
The latest, and fourth kit to be added by
Datametrex to distribute is the 1copy™ COVID-19 qPCR Multi Kit
(“qPCR kit”), which is Health Canada approved with
Authorization Reference Number 312777, Device ID 1020660 and Model
No. M22MD100. It is a nucleic test kit providing results in less
than two hours that verifies the RdRp gene for SARS-CoV-2 with
real-time qPCR kit via a nasopharyngeal swab and oropharyngeal
swab, specifically targeting the E gene sequences of COVID-19. The
kits are made by 1drop Inc. (“1drop”) in South
Korea, and are immediately ready for sales orders in Canada.
1drop is located in South Korea and is a medical
technology spin-off from Samsung Electronic’s C-Lab program. The
C-Lab is an internal incubation program within Samsung that first
started in 2012 to help inspire a more creative company culture.
1drop already has more than five products approved in Europe in the
past 18 month under the CE marking certification. “CBC News
reported that Canada lost almost two million jobs during the month
of April as the impact of COVID-19 according to Stats Canada’s
release on May 8, 2020. The team has been working around the clock
to identify and source high quality test kits from South Korea for
Canada. We are thrilled to have secured the rights to sell kits
from 1drop, Health Canada approved manufacturer. We will be able to
start filling orders immediately and are looking forward to help
flatten the curve and get Canadians back to work safely,” says
Marshall Gunter, CEO of the Company.
The Company’s ability to fulfill any purchase
order for COVID-19 test kits is subject to the availability of
inventory at the time of order. Due to the extraordinarily high
demand for COVID-19 tests, there is volatility in the supply chain,
and available supply may fluctuate on a daily basis.
Datametrex anticipates that it will have little
or no upfront costs associated with importing and selling these
test kits. Assuming these test kits are purchased by the Canadian
Government, the manufacturer will ship the test kits directly to
the Canadian government or hospitals, and Datametrex will not be
involved in the shipping, warehousing, or distribution process.
The Company did not pay consideration to the
manufacturer to obtain sales rights.
The Company granted 16,500,000 incentive stock
options to its directors, officers, employees and consultants in
accordance with the Company's Stock Option Plan. These stock
options have an exercise price of $0.17 and expire on June 30,
2022. All options will be subject to a vesting schedule, with
25% immediately vesting and 25% vesting on the three, six and nine
month anniversaries of the grant date.
About CE Marking
CE marking is a certification mark that
indicates conformity with health, safety, and environmental
protection standards for products sold within the European Economic
Area (EEA). The CE marking is also found on products sold outside
the EEA that have been manufactured to EEA standards. This makes
the CE marking recognizable worldwide even to people who are not
familiar with the European Economic Area (the 27 member states of
the EU, the 4 members of European Free Trade Association
(“EFTA”), plus Turkey and United Kingdom). CE
marking also supports fair competition by holding all companies
accountable to the same rules. For more information please consult
the European Commission website at: CE marking
About Kingdom of Saudi Arabia, Saudi
Food & Drug Authority (“SFDA”)
The Saudi Food & Drug Authority (SFDA) is
the government agency that regulates drugs and medical devices in
Saudi Arabia. It is also in charge of biological and chemical
substances, as well as electronic products. The agency was
established under the Council of Ministers and functions under the
Council of Ministers as an independent body that reports to the
President of Council of Ministers.
SFDA is in charge of overseeing the safety,
security and effectiveness of medical devices, ensuring their
accuracy, and controlling and supervising manufacturing facilities,
as well as overseeing the importation and registration of these
products.
A list of regulations can be found here on SFDA
website.
About 1drop Inc.
1drop is located in Jungwon-gu, South Korea, and
was incorporated in 2017 following a technology spin-off from
Samsung Electronic’s C-Lab program. Samsung Electronic’s C-Lab,
located in South Korea is an internal incubation program that first
started in 2012 to help inspire a more creative company culture.
1drop already had more than five products approved in Europe in the
past 18 month under CE marking is a certification.
For more information please consult the website
at: 1drop
About Datametrex
Datametrex AI Limited is a technology focused
company with exposure to Artificial Intelligence and Machine
Learning through its wholly owned subsidiary, Nexalogy
(www.nexalogy.com). Additional information on Datametrex is
available at www.datametrex.com
For further information, please
contact:
Marshall Gunter – CEOPhone: (514) 295-2300Email:
mgunter@datametrex.com
Neither the TSX Venture Exchange nor it's
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
Forward-Looking Statements
This news release contains “forward-looking
information” within the meaning of applicable securities
laws. All statements contained herein that are not clearly
historical in nature may constitute forward-looking information. In
some cases, forward-looking information can be identified by words
or phrases such as “may”, “will”, “expect”, “likely”, “should”,
“would”, “plan”, “anticipate”, “intend”, “potential”, “proposed”,
“estimate”, “believe” or the negative of these terms, or other
similar words, expressions and grammatical variations thereof, or
statements that certain events or conditions “may” or “will”
happen, or by discussions of strategy.
Readers are cautioned to consider these and
other factors, uncertainties and potential events carefully and not
to put undue reliance on forward-looking information. The
forward-looking information contained herein is made as of the date
of this press release and is based on the beliefs, estimates,
expectations and opinions of management on the date such
forward-looking information is made. The Company undertakes no
obligation to update or revise any forward-looking information,
whether as a result of new information, estimates or opinions,
future events or results or otherwise or to explain any material
difference between subsequent actual events and such
forward-looking information, except as required by applicable
law.
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