Therma Bright Enters into Clinical Trial Agreement for its AcuVid(TM) COVID-19 Rapid Saliva-Based Antigen Test

Toronto, Ontario–(Newsfile Corp. – February 26, 2021) – Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), a progressive medical device technology company, is pleased to announce that it has entered into an agreement with a COVID-19 testing site located in the Greater Toronto Area to conduct a clinical study with the Company’s AcuVid ^TM rapid antigen test for detecting SARS-CoV-2 virus in saliva.

The testing site is located within the Greater Toronto Area that has one of the highest positivity rates in Ontario. The positivity rate around the testing center is currently at 19%. Due to the high positivity rate the Company expects to achieve the minimum number of positive samples required for regulatory approvals more quickly than other locations that were originally considered. Many of the original sites the Company was investigating for clinical trials have been experiencing lower positivity rates due to lockdowns across Canada which would have resulted in a greater expense to the Company along with longer testing periods to complete the clinical testing. The testing site will allow the Company to complete the clinical trial quickly followed by submission of the data to both the FDA and Health Canada.

With a clinical trial agreement signed, Therma Bright can seek Research Ethics Board (REB) approval and Health Canada approval for the proposed trial. Once approval is received, the site will perform the AcuVid ^TM saliva test on 100 subjects followed by a minimum of 300 subjects. The clinical trial is expected to start during the month of March. Subjects at the COVID-19 testing site will provide nasal samples for the approved lab-based PCR COVID-19 test conducted by Public Health. At the end of the trial, the results of the AcuVid^TM saliva test and PCR test will be analyzed and submitted to the FDA and Health Canada as part of the regulatory applications and will also be used to apply for a CE mark in Europe. Therma Bright is in discussions to complete additional clinical trials with the AcuVid^TM rapid saliva-based antigen test in the US and other international locations.

Therma Bright is pleased to announce it has rebranded its diagnostic test line as AcuVid^TM, which will be used for our existing COVID-19 test and any future related products. The saliva antigen test, the AcuVid ^TM SARS-CoV-2 antigen test will be the first product as the Company is currently reviewing the addition of other COVID-19 diagnostic tests to create a range of diagnostic products.

Initial results for Therma’s AcuVid^TM showed an 86% sensitivity and 100% specificity, which provides Therma Bright with a high level of confidence that the study results will satisfy the regulatory agencies requirements for saliva-based antigen tests. The minimum standard for home-use approval of rapid antigen tests is 80% sensitivity with both Health Canada under the Interim Order and the FDA under Emergency Use Authorization (“EUA”). The results achieved exceed the minimum threshold for approval with regulatory agencies.

Discussions with component suppliers and manufacturing partners have progressed with a view to produce a minimum of 1 million tests per month initially with the ability to scale up as demand increases.

Therma Bright’s goal is to provide a low-cost, scalable saliva-based test for routine and widespread testing of both symptomatic and asymptomatic individuals at home and in schools, workplaces, nursing homes, sporting events, airports and other venues where a rapid result is required. Initially the test will be used in controlled environments such as large companies, sports and music venues, nursing homes, airports, and schools where there is a health care worker or trained staff to assist with performing the test. As the regulations regarding home use become clearer and standardised, the test will be introduced as a home-use test.

Mr. Rob Fia, CEO of Therma Bright, commented:

“We are extremely pleased to have secured our first clinical test site in Ontario. Once we receive REB and Health Canada approval, the testing should be completed in short order at which point we will assemble our regulatory filing package and submit to the FDA and Health Canada. Recently, we have fielded many enquiries for our test from around the world. Our simple, easy-to-use saliva-based test is very attractive for high volume users who want a scalable low-cost solution to keep their companies operating, entertainment venues open and schools and nursing homes safe.”

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 is a progressive medical device technology company focused on providing consumers and medical professionals with quality medical devices that address their medical and healthcare needs. 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: THRM, OTCMARKETS: THRBF, FRA:JNX. For more information visit: www.thermabright.com and www.coldsores.com

For further information, please contact:

Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com

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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, manufacturing PPE and hand sanitizers and applying for government grants to support the Company’s future performance. 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.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

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.

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, manufacturing PPE and hand sanitizers and applying for government grants to support the Company’s future performance. 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.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

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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