Therma Bright Provides Update for its AcuVid™ COVID-19 Rapid Antigen Saliva Test
October 04 2021 - 9:59AM
InvestorsHub NewsWire
Therma Bright Provides
Update for its AcuVid™ COVID-19 Rapid Antigen Saliva
Test
Toronto, Ontario,
Canada -- October 4, 2021 -- InvestorsHub NewsWire -- Therma Bright
Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive
medical device technology company and developer of the AcuVid™
Covid-19 Rapid Antigen Saliva Test, provides the following update
for its AcuVidTM Covid-19 Rapid
Saliva Antigen
Test.
-
Therma Bright filed
its application for EUA approval to market its
AcuVid™ Covid-19 Rapid Antigen Saliva Test with the US FDA
on as previously reported on July 22nd and September
1st, 2021. Therma continues
to monitor and interact with the
US FDA as necessary regarding our active
submission.
-
Therma Bright has ordered sufficient materials and
components to manufacture the first batch of
AcuVid™ tests in the US. At the same
time, Therma is securing multiple manufacturing sites in different
countries to be able to meet the anticipated demand for our test in
the US and
elsewhere.
-
Therma is identifying
and negotiating with potential customers in various jurisdictions
to secure initial orders pending regulatory
approval.
-
In September the Centers for Disease Control and
Prevention (CDC) stated that they expect shortages of rapid tests
as demand increases. The CDC, and other bodies,
recommend serial testing using rapid antigen tests at least once
per week, along with other mitigation measures, such as masking and
social distancing, to reduce disease transmission, especially in
congregant settings such as workplaces, schools and large
events.
-
Therma is currently
identifying sites to perform trials on the
AcuVid™ test for home use applications. The results from
these trials will be used to file for approval to market the
AcuVid™ Covid-19 Rapid Antigen Saliva Test for home use by
non-healthcare professionals. This should greatly expand the market
for our test. Once a site is identified, Therma expects to
report back to shareholders on the expected date to complete the
home use clinical
study.
Rob Fia, CEO of Therma Bright, commented, "We
continue to build manufacturing capacity for our test in
anticipation of approval so that we can meet the expected huge
demand for rapid testing. Our saliva-based test is easier to use
and less intrusive than nasal swab-based tests and is ideally
suited for rapid testing for all
subjects."
Therma Bright is not making any express or implied
claims that its test product has the ability to eliminate or cure
COVID-19 or the SARS-CoV-2
virus.
About Therma Bright
Inc.
Therma Bright is a progressive medical device
technology company focused on providing consumers and medical
professionals with quality medical devices that address their
medical and healthcare needs. The Company's initial breakthrough
proprietary technology delivers effective, non-invasive and
pain-free skincare. Therma Bright received a Class II medical
device status from the US FDA in 1997 for its platform technology
that is indicated for the relief of the pain, itch, and
inflammation of a variety of insect bites or
stings.
Therma Bright Inc. trades on the TSXV:THRM,
OTCQB:THRBF, FRA:JNX. For more information
visit: www.thermabright.com
and www.coldsores.com
For further information, please
contact:
Therma Bright Inc.
Rob Fia,
CEO
rfia@thermabright.com
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Twitter:
FORWARD LOOKING
STATEMENTS
Certain statements in this news release constitute
"forward-looking" statements. These statements relate to future
events such as development and commercialization of a rapid
COVID-19 viral assay and related instrumentation, regulatory
applications and manufacturing scale up as described in the news
release. All such statements involve substantial known and unknown
risks, uncertainties and other factors which may cause the actual
results to vary from those expressed or implied by such
forward-looking statements. Forward-looking statements involve
significant risks and uncertainties, they should not be read as
guarantees of future performance or results, and they will not
necessarily be accurate indications of whether or not such results
will be achieved. Actual results could differ materially from those
anticipated due to a number of factors and risks. Although
the forward-looking statements contained in this news release are
based upon what management of the Company believes are reasonable
assumptions on the date of this news release, the Company cannot
assure investors that actual results will be consistent with these
forward-looking statements. The forward-looking statements
contained in this press release are made as of the date hereof and
the Company disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new
information, future events or otherwise, except as required under
applicable securities
regulations.
Neither the TSX Venture Exchange nor its 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 press
release.
This press release is not an offer of the securities
for sale in the United States. The securities have not been
registered under the U.S. Securities Act of 1933, as amended, and
may not be offered or sold in the United States absent registration
or an exemption from registration. This press release shall not
constitute an offer to sell or the solicitation of an offer to buy
nor shall there be any sale of the securities in any state in which
such offer, solicitation or sale would be
unlawful.
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