Therma Bright Provides Update on FDA-EUA Application Process
Toronto, Ontario--(Newsfile Corp. - 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
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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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