Therma Bright to Test AcuVid(TM) on the Highly Contagious COVID-19 Delta Variant, Company Completes Brazilian Clinical Study for Final FDA EUA Submission
Toronto, Ontario--(Newsfile Corp. - June 24, 2021) - 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, is pleased to announce that it will test the SARS-CoV-2 (COVID-19) Delta variant, first detected in India, with its AcuVid™ antigen saliva test. Governments and global health experts have expressed deep concerns that the highly contagious, fast spreading Delta variant will add to a new wave of COVID-19 viral infections globally later this summer and fall. The Delta variant has already become the dominant version of the SARS-CoV-2 (COVID-19) virus in the United Kingdom and has been detected in at least 74 other countries worldwide,
In addition, the Company has received the final 7 outstanding RT-PCR test results from the Brazilian study to match against its AcuVid™ saliva test, exceeding the minimum requirements of 30 positive/30 negative results for its FDA Emergency Use Authorization (EUA) submission. The study results will also be used for ANVISA (Brazil) and INVIMA (Colombia) submissions, as well as to further support the CE approval received in April 2021.
"We are excited that our Brazilian clinical study has now met the minimum FDA-EUA requirements for our submission to secure serial testing approval," expressed Rob Fia, Therma Bright's CEO. "In addition, we're equally excited to begin testing our AcuVid™ COVID-19 Rapid Antigen Saliva Test with the Delta variant; as we have successfully tested other fast-moving SARS-CoV-2 variants, including the P.1 and P.2 variants originally detected in Brazil and the B1.1.17 variant first detected in the UK. As always, our goal is to make our 15-minute AcuVid™ COVID-19 antigen test the leading rapid screening solution to help mitigate community spread of this virus."
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.
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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, 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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