Therma Bright Provides Progress Update on FDA EUA & Health Canada Interim Order Applications for Its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
Toronto, Ontario--(Newsfile Corp. - August 4, 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, is pleased to provide the following update for Its AcuVid™ COVID-19 Rapid Antigen Saliva Test.
Therma continues to communicate with the FDA regarding its EUA application for its AcuVid™ COVID-19 Rapid Antigen Saliva Test. As well, Therma has sought and utilized advice from Ridge Global and our FDA regulatory consultants to determine how best to accelerate the review of the AcuVid™ EUA application.
In addition to responding to the FDA's initial review and request for additional information, the Company expects to receive further feedback from the FDA once they review the submitted responses.
Health Canada's application for approval under the Interim Order is moving along expeditiously with consistent feedback and answers between Therma and Health Canada's technical and medical reviewers.
"We thank our shareholders for their continued patience and support. The FDA EUA review process is a rigorous and thorough process, as are all regulatory reviews, and therefore patience is required", commented Rob Fia, CEO of Therma Bright.
Therma is also pleased to announce that it has fielded several potential sales inquiries for the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Therma is currently discussing an order utilizing its self-certification CE mark for sales into Eastern Europe and other countries where the self-certification CE mark is accepted.
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.
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. 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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