Toronto, Ontario--(Newsfile Corp. - May 6, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has entered into a distribution agreement to white label and distribute a 15-minute rapid COVID-19 antibody test for detecting IgG and IgM antibodies against SARS-CoV-2. The new product will be branded Therma Bright's AcuVid™ COVID-19 Rapid Antibody Test. This pinprick antibody blood test (i.e. serology test) uses a small amount of blood and has a 96.6% sensitivity for detecting antibodies of SARS-CoV-2 in those individuals currently infected with the virus or who have previously been infected, but went undiagnosed or were unaware of their infection. It will also aid in determining antibodies generated by those who have received a COVID-19 vaccine.
The goal of Therma Bright is to expand its AcuVid™ COVID-19 diagnostic testing product line to help meet the growing demand of the marketplace and to assist in mitigating the spread of the original novel coronavirus virus (Wuhan SARS-CoV-2) as well as the growing list of variants; including Brazilian P.1 and P.2 and the UK B.1.1.7 variants. The antibody test has received CE mark in Europe and ANVISA regulatory clearance in Brazil. Therma Bright will also seek regulatory approvals, as necessary, in other jurisdictions where it plans to sell this product.
The AcuVid™ COVID-19 Rapid Antibody Test is the perfect solution to allow people, who have been exposed to COVID-19 with mild to no symptoms (i.e. asymptomatic) to determine if they have antibodies to SARS-CoV-2. Some countries have been requiring individuals take an antibody test, in addition to an antigen test, before entering their country.
Most importantly, studies have shown the importance of antibody testing, along with serial antigen testing, in controlling and monitoring COVID-19 and vaccine effectiveness. In March 2021, FDA Guidance was provided to test developers who were seeking emergency use authorization (EUA) of certain tests that could be used for serial testing, which includes the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission. This AcuVid™ Antibody test will be Therma Bright's second rapid test for serial screening.
"We are pleased to secure this new AcuVid™ COVID-19 Rapid Antibody Test that will complement Therma Bright's AcuVid™ COVID-19 Rapid Antigen Saliva Test, as more people are infected and while the vaccine roll out continues," explained Rob Fia, CEO of Therma Bright. "The world is realizing the benefits and challenges with these COVID-19 vaccines, and this antibody test solution will aid in helping our global citizens understand if they have the SARS-CoV-2 antibodies to help them better fight the virus. We're currently in discussions to supply our new AcuVid™ COVID-19 Rapid Antibody Test to selected customers in Europe and South America."
In addition, the Company is looking at white-labeling other available government-approved COVID-19 diagnostic test solutions. This goal is three-fold (i) to help address the increased demand for serial testing solutions to mitigate community spread, (ii) to provide funding for production of the CE-approved test while awaiting FDA EUA and Health Canada approval for its premier, smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test, and (iii) to drive revenues for the business and shareholder value.
The Company also announces that it has engaged a consultant to provide services related to web and ecommerce products, including copy and design for the Company's corporate brand and setting up product page details for the commercial launch of its products, as well as creating marketing and online advertising for its products. Subject to TSXV approval, Therma Bright intends to issue up to 500,000 share purchase warrants to the consultant for the services provided, to be paid in tranches upon certain milestones being met. The warrants will be exercisable for two years and the exercise price will be determined at the time of each issue based on the volume-weighted average closing price of the Company's common shares on the TSXV for the 5 trading days immediately preceding the date of issue of the warrants.
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 (TSXV: THRM) (OTC Pink: THRBF) (FSE: 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. 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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