Therma Bright
Provides Update on FDA-EUA Application Process
Toronto, Ontario --
InvestorsHub NewsWire -- September 1, 2021 -
Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of its
smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test
and other progressive diagnostic and medical device technologies,
is pleased to provide an update on its AcuVid™ Saliva Test with the
US Food & Drug Administration's Emergency Use Authorization
(EUA) application.
"During the past
30 days, the Therma Bright team has been actively engaged with
officials at the FDA around our first-of-its-kind
AcuVid™ COVID-19 Rapid Antigen Saliva Test and our successful
clinical study results," expressed Rob
Fia, CEO of Therma Bright. "The
team, with support from our US development partners,
have successfully completed and submitted additional research
and documentation requested
by the FDA, and we now await for
the Administration to complete its review for Emergency Use
Authorization."
To
date, all the COVID-19 rapid antigen tests that have been
FDA-EUA approved are
nasal swab tests. The Company expects its saliva-based COVID-19
antigen test to become the first rapid test to receive FDA-EUA
approval.
As
AcuVid™ is
an innovative, leading-edge rapid saliva test
solution, additional
information was required for the FDA-EUA review process.
In addition, the Company
has also amended its CE application for the AcuVid™ Saliva Test
with the new saliva collection and testing process and has
received CE final
approval certification from
the EU
competent authority of Belgium.
The Company also reports
that it has received TSXV approval to the debt settlement
previously announced August 12, 2021 and has consequently issued
118,750 common shares at a deemed price of $0.40/share. These
shares are subject to a hold period expiring January 1, 2022, in
accordance with applicable securities laws and the policies of the
TSXV.
Therma Bright advises
that it has also issued 325,000 warrants to a consultant for
services rendered pursuant to a securities for services agreement
previously announced April 22, 2021. Each warrant entitles the
consultant to purchase one common share for two years at a price of
$0.41. All of these securities are subject to a hold period
expiring January 1, 2022, in accordance with applicable securities
laws and the policies of the TSXV.
The Company has also
agreed to issue 200,000 bonus shares in relation to the execution
of an agreement relating to the sale and distribution of antibody
testing kits.
Based on the Company's
current market price, these shares will be issued at a deemed price
of $0.36/share.
The issuance of these
bonus shares is subject to approval from the TSXV.
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) (OTC Pink:
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 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.
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