Therma Bright Submits AcuVid(TM) COVID-19 Rapid Antigen Saliva Test Application for U.S. Food & Drug Administration's Emergency Use Authorization (EUA)
Toronto, Ontario--(Newsfile Corp. - March 29, 2022) - 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, is pleased to announce the submission of its U.S. Food & Drug Administration's (FDA) Emergency Use Authorization (EUA) application for its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care (POC).
"I am pleased to announce the submission of our AcuVid™ COVID-19 Rapid Antigen Saliva Test for U.S. Food & Drug Administration's Emergency Use Authorization," shared Rob Fia, CEO of Therma Bright. "Our application includes data from our U.S. clinical performance study, Brazilian clinical study, all required cross-reactivity tests, additional FDA requested cross-reactivity tests for mouth-borne viruses and bacteria, and numerous tests around World Health Organization's (WHO) Variants of Concern (VOCs), such as Delta and Omicron. Our team and partners stand ready to deliver upon receipt of FDA EUA."
Since July 2021, the Company's Executive and Development teams have worked with FDA officials, doctors and scientists on its AcuVid™ EUA application requirements. Timing on this authorization process is unknown, therefore, the Company will only notify the market upon receipt of the FDA's decision.
"With our AcuVid™ FDA EUA application submitted, the Company has begun investigating another saliva-based testing technology incorporating a robust platform for the detection for other respiratory infectious diseases affecting the lungs, as well as a novel saliva-based platform for Neuro-Vascular disorders (e.g. PTSD, head trauma/concussion)," continued Rob Fia, Therma Bright's CEO. "We'll keep the market updated on this effort, along with our business progress on our other medical devices."
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 smart-enabled 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 U.S. FDA in 1997. Therma Bright Inc. trades on the TSXV (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com.
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Therma Bright Inc.
Rob Fia, CEO
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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.
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