Therma Bright Provides Update on FDA EUA Review Process
Toronto, Ontario--(Newsfile Corp. - September 12, 2022) - 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, provides an update on it AcuVid™ COVID-19 Rapid Antigen Saliva Test's Emergency Use Authorization application with the U.S. Food and Drug Administration.
The Company has received communication from the FDA which states they have completed an initial review of our AcuVid™ EUA application and have asked for additional details and questions to be addressed on our rapid saliva test solution. The Therma Bright team is working closely with its strategic partners and suppliers to comprehensively and clearly respond to the FDAs questions. Once this effort is complete, the Company will resubmit its EUA application with all the additional documentation and tests requested by FDA reviewers, including details around transport and storage of RT PCR samples, additional data on external controls used, and further validation on AcuVid's ability to detect the Omicron variant post March 1, 2022, when the variant achieved 100% overall prevalence in the U.S. State of California variant tracker (https://covid19.ca.gov/variants/), where the U.S. clinical study was performed, shows Omicron was 90.0% of all new cases on December 29, 2021 and 99.8% on February 1, 2022.
"We and our strategic partners are confident in the performance of our innovative AcuVid™ COVID-19 Rapid Antigen Saliva Test and will continue to work with FDA officials in answering their questions in order to bring our solution to the U.S. marketplace, including providing the specific data and details as needed for authorization," shared Rob Fia, CEO of Therma Bright. "In tandem, we'll continue to pursue sales where authorized, as we navigate regulatory authorization processes from around the globe."
The FDA does not provide timelines on how long approvals will take. The Company will update the market as required.
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.
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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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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