Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, announced today that the Company has completed the U.S. Clinical Performance Study's subject recruitment effort and awaits final RT-PCR results to match against each test subject's AcuVid™ COVID-19 Rapid Antigen Saliva Test result. As stated in the January 20, 2022 release, once the clinical data has been tabulated, the final results will be filed with the U.S. Food & Drug Administration for Emergency Use Authorization (EUA) consideration.
"We appreciate the continued patience of our clients, shareholders, and partners while we await the final COVID-19 RT PCR tests from our clinic partner's labs," shared Rob Fia, CEO of Therma Bright. "The FDA closely regulates these types of scientific studies that are designed to develop evidence that support the safety and effectiveness of investigational medical devices and diagnostic tests and we are confident that our AcuVid™ U.S. Clinical Performance Study will meet the Emergency Use Authorization's (EUA) rigorous review. We will submit the U.S Clinical Performance Study data to the FDA once it is collected and tabulated."
Mr. Fia continued, "The relatively new 'stealth Omicron' variant, BA.2, has been in the news recently and although preliminary indications are that it is no more contagious or virulent than the original Omicron variant, it may become the dominant variant in certain countries in coming months. We are confident that our test will detect stealth Omicron and are currently confirming that with our partners."
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.
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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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