Toronto, Ontario--(Newsfile Corp. - June 17, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the AcuVid™ COVID-19 Rapid Antigen Saliva Test and a progressive medical device technology company, is pleased to provide an update on the exceptional performance of its AcuVid™ COVID-19 Rapid Antigen Saliva Test's Brazilian Clinical Study, conducted in Minas Gerais, Brazil.
"The ongoing clinical study for our AcuVid™ COVID-19 Rapid Antigen Saliva Test has performed extremely well," expressed Therma's CEO Rob Fia. "As of June 16th, 63 subjects were enrolled and provided a nasal swab for a RT-PCR test and a saliva sample for the AcuVid™ test. Of the 63, RT-PCR results were received for 56 subjects, with 28 positive and 28 negative results. The RT-PCR results for the other 7 subjects will be received in the coming days. The AcuVid™ test demonstrated a 100% specificity for the RT-PCR negative samples. Of the 28 positive RT-PCR results, the AcuVid™ test had a 100% sensitivity for RT-PCR results with a Ct values below 27."
Currently, the Company is waiting on final results from 7 additional test subjects from the 63 total valid individuals in the clinical study, and who provided both a nasal swab for a RT-PCR test and a saliva sample. The RT-PCR and Ct results for the remaining 7 test subjects will be matched against their AcuVid™ rapid test. The Company anticipates achieving the 30 positive/30 negative requirements for FDA Emergency Use Authorization (EUA) application and will submit when all final results are received, and final documentation is ready. Furthermore, Therma plans to continue the clinical study in Brazil beyond the initial requirements, should any regulatory body require additional test data of the AcuVid™ COVID-19 Rapid Antigen Saliva Test.
"We're extremely pleased with the performance of the AcuVid™ test and its 100% sensitivity for Ct values below 27, as well as the 100% specificity," shared Dr. Ricardo Fujiwara, the Principal Investigator for the study at the Federal University of Minas Gerais. "Patients with Ct values below 27 are usually in the early phases of this viral infection and are the most contagious. Not only is it important, but also critical, to identify these patients as quickly and accurately as possible to mitigate spread, and this COVID-19 saliva test will do just that! Overall, the first 56 clinical test results are impressive and demonstrate the reliability, ease of use and accuracy of Therma Bright's AcuVid™ test. Furthermore, our clinical staff and test subjects found this rapid saliva test far easier to administer and much better tolerated than the standard nasal swab tests."
The AcuVid™ COVID-19 Rapid Antigen Saliva Test was specifically designed to allow individuals to 'self-collect' their own saliva in a collection tube. This self-collection process greatly lowers the COVID-19 infection/transmission risk posed to healthcare workers responsible for sample collection and testing. Moreover, in a future version of the AcuVid™ test, the saliva collection tube will make it easier for individuals to perform the self-testing in a home environment and better contain their saliva sample and test cartridge in a safe disposable package.
The ongoing Brazilian AcuVid™ clinical study is an all-comers design for subjects, both symptomatic and asymptomatic who present at the COVID-19 testing clinic at the University hospital. Each subject first provides a nasal swab for a standard ANVISA-approved high sensitivity RT-PCR test and then provides a saliva sample for use with the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Results from the AcuVid™ test are recorded and later compared to the respective RT-PCR test results post-lab work, which takes a day or two and includes the Ct value.
"This is a significant achievement for Therma Bright and our AcuVid™ COVID-19 Rapid Antigen Saliva Test," further expressed Therma's CEO Rob Fia, "Not only will this clinical data be used for our FDA EUA application submission, but we will also be submitting this clinical data in our Health Canada, ANVISA (Brazil) and INVIMA (Colombia) filings, as well as it will be used to further support our recent CE approval received in April 2021."
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
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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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