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.