Once the clinical data has been completed and tabulated, the final results will be reported to the marketplace and the U.S. Food & Drug Administration for Emergence Use Authorization consideration.
Toronto, Ontario--(Newsfile Corp. - January 20, 2022) - 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 its U.S. Clinical Performance Study is still underway. Once the clinical data has been completed and tabulated, the final results will be reported to the marketplace and the U.S. Food & Drug Administration for Emergence Use Authorization consideration.
“We appreciate the patience of our clients, shareholders, and partners as they await the final results of our U.S Clinical Performance Study,” shared Rob Fia, CEO of Therma Bright. “Our goal is to complete this study in January 2022 within the 300 participants range per our IRB Clinical Trials dashboard. With the rapid spread of the Omicron variant, our clinics and their labs have been overwhelmed with a massive wave of COVID-19 RT PCR testing. This has caused delays in receiving these lab-based tests for several days, thus slowing down the process in matching each participant’s AcuVid™ COVID-19 Rapid Antigen Saliva Test with their specific RT PCR test. Current results are very promising, as we look to be the first COVID-19 rapid antigen saliva test to receive FDA Emergency Use Authorization.”
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.
Source: IRB Clinical Trial Dashboard: https://clinicaltrials.gov/ct2/show/record/NCT05119530?view=record
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.
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, 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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