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