Toronto, Ontario–(Newsfile Corp. – March 25, 2021) – Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), developer of the AcuVid™ Covid-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has received IRB approval and subsequently submitted to Health Canada seeking approval to conduct a clinical performance study of its AcuVidTM Covid-19 Rapid Saliva-based Antigen Test.
Therma’s clinical research organization prepared and filed the necessary documentation for the IRB and Health Canada submissions. They are now focused on readying the trial site and personnel to begin the study once the Health Canada go ahead is received.
Rob Fia, CEO, commented, “This is yet another significant milestone in moving our AcuVid™ test closer to market. We look forward to beginning the trial in Ontario, Canada as we explore other potential sites in the U.S., South America and Europe that will generate additional data to support our applications in those jurisdictions.”
Last week, the US FDA announced new guidance to streamline the approval and use of rapid Covid-19 tests in the US.
Therma Bright believes its AcuVidTM COVID-19 Rapid Antigen Saliva Test ideally meets the new March 16 FDA Guidance for test developers seeking emergency use authorization (EUA) of certain tests for screening using serial testing. Serial testing involves testing the same individual multiple times within a few days and can increase chances of detecting asymptomatic infection that might not otherwise show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission. In addition, with the recent American Rescue Bill passed by President Biden, there are opportunities to assist the U.S. and its citizens detect, contain and mitigate COVID-19 and its growing variants with Therma Bright’s “Made in the USA” AcuVidTM COVID-19 Rapid Antigen Saliva Test once approved under the Emergency Use Authorization (EUA) by the FDA.
Mr. Fia commented, “This FDA action should positively impact the approval of our test in the U.S. and accelerate the acceptance and use of AcuVidTM which is ideally suited for serial testing due to its ease of use and rapid results.”
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.
For further information, please contact:
Therma Bright Inc.
Rob Fia, CEO
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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, 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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