Therma Bright Provides Update on FDA-EUA Application Process
28 Octubre 2021 - 9:16AM
InvestorsHub NewsWire
Therma Bright Provides Update on
FDA-EUA Application Process
Toronto, Ontario, Canada
-- October 28, 2021 -- Therma Bright Inc. (TSXV: THRM, OTCQB: TBRIF) ("Therma" or the "Company"),
developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen
Saliva Test and other progressive diagnostic and medical device
technologies, announces that Therma has been in communication with
the FDA over the intervening period since the initial submission of
its AcuVid™
COVID-19 Rapid Antigen
Saliva Test.
Therma has responded to the FDA questions and suggestions and has
completed additional documentation and lab tests as required by the
FDA.
Therma
continues its active communication with the FDA and is pleased to
announce that it has identified three clinical study sites to
conduct a point-of-care clinical performance study to complement
the completed Brazilian clinical study data that was previously
shared with the FDA. This
clinical study is being conducted in the U.S. in compliance with
FDA guidance.
The study
will initiate patient screening and recruitment immediately post
securing Institutional Review Board (IRB) approval which is
expected in the coming few days. Based on current infection rates,
we expect the study to meet its primary endpoints in approximately
2-3 weeks.
Rob Fia,
CEO, commented: "We are on track to make AcuVid™ the first COVID-19
Rapid Antigen Saliva Test to receive FDA approval. Our robust bench
tests and clinical performance results, provide us with confidence
that we will be able to bring a viable solution to limit the spread
of this virus in our communities."
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, developer of the AcuVid™ COVID-19 Rapid Antigen Saliva
Test, is a progressive medical diagnostic and device technology
company focused on providing consumers and medical professionals
with quality, innovative solutions that address some of today's
most important medical and healthcare challenges. 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 FDA for its platform
technology that is indicated for the relief of the pain, itch, and
inflammation of a variety of insect bites or stings. The Company
received clearance for the above claims from the US FDA in
1997. Therma
Bright Inc. trades on the TSXV (TSXV: THRM) (OTCQB: TBRIF) (FSE:
JNX). Visit: www.thermabright.com.
Therma Bright
Inc.
Rob Fia,
CEO
rfia@thermabright.com
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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. 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
several 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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