Therma Bright provides update on the 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 AcuVid ™ COVID -19 Rapid Antigen Saliva Test and other advanced diagnostic and medical device technologies, announces that Therma has been in contact with the FDA during the period since the initial submission of its AcuVid ™ COVID-19 Rapid Antigen Saliva Test. Therma responded to questions and suggestions from the FDA and completed additional documentation and laboratory tests required by the FDA.
Therma continues to actively communicate 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 data from completed Brazilian clinical studies that have previously shared with the FDA. This clinical study is being conducted in the United States in accordance with FDA guidelines.
The study will begin screening and recruiting patients immediately after obtaining Institutional Review Board (IRB) approval, which is expected in the coming 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 antigen rapid saliva test to receive FDA approval. a viable solution to limit the spread of this virus in our communities. “
Therma Bright makes no express or implied representation 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 medical diagnostics and progressive device technology company focused on providing consumers and healthcare professionals with innovative, quality solutions that meet some of today’s most significant medical and health challenges. The company’s first proprietary technology delivers effective, non-invasive and pain-free skin care. Therma Bright has received Class II medical device status from the FDA for its platform technology which is indicated for the relief of pain, itching and inflammation from a variety of insect bites. The Company received US FDA clearance for the above claims in 1997. Therma Bright Inc. is listed on the TSX Venture Exchange (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com.
FORWARD-LOOKING STATEMENTS Certain statements contained in this press release constitute “forward-looking” statements. These statements relate to future events such as the development and commercialization of a rapid COVID-19 viral test and associated instrumentation. as described in the press release. All of these statements involve substantial risks, uncertainties and other known and unknown factors which may cause actual results to vary from those expressed or implied by these forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be interpreted as guarantees of future performance or results, and they do not necessarily constitute precise indications as to whether or not such results will be obtained. Actual results could differ materially from those anticipated due to several factors and risks. Although the forward-looking statements contained in this press release are based on what the management of the Company considers to be reasonable assumptions at the date of this press 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 does not constitute an offer to sell the securities in the United States. The securities have not been registered under the US Securities Act of 1933, as amended, and may not be offered or sold in the United States without registration or an exemption from registration. This press release does not constitute an offer to sell or the solicitation of an offer to buy and there will be no sale of securities in any state in which such an offer, solicitation or sale would be illegal.
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