Approval is expected within a week, at which point Therma will submit a complete package, including the REB review, to Health Canada to conduct the clinical trial.
Toronto, Ontario--(Newsfile Corp. - March 11, 2021) - Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), a progressive medical device technology company, is pleased to announce that it has submitted an application to an independent Research Ethics Board (“REB”) for approval to conduct a clinical study with the Company’s AcuVid TM rapid antigen test for detecting SARS CoV-2 virus in saliva. Approval is expected within a week, at which point Therma will submit a complete package, including the REB review, to Health Canada to conduct the clinical trial.
The data generated from this pivotal clinical study will also be used to support Therma’s European Union CE mark submission to be initiated shortly. The CE mark will allow sales of the product in Europe and in other countries where a CE mark is required.
Mr. Rob Fia, CEO of Therma Bright, commented, “We are pleased to cross another hurdle in the process to get AcuVid TM to market. Performance of the test during the development stage has exceeded our expectations. We are in the process of seeking initial product orders, subject to final regulatory approvals and manufacturing scale up.”
Therma Bright also reported that it has received TSX-V approval to the debt settlements previously announced on January 25, 2021 and consequently has issued 145,000 common shares to settle an aggregate debt of $65,250. All securities issued in conjunction with the debt settlements are subject to a hold period expiring July 11, 2021 in accordance with applicable securities laws and the policies of the TSX-V.
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, 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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