Therma Bright Announces EU-CE Approval for AcuVid(TM) COVID-19 Rapid Antigen Saliva Test and Conditional Sale for 100,000 CE-only AcuVid(TM) Test Kits
New global distribution partner McWilliams Collective secures test kit order from European client
Toronto, Ontario–(Newsfile Corp. – April 19, 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 received CE approval certification from an EU competent authority of Belgium for its AcuVid™ COVID-19 Rapid Antigen Saliva Test, and has secured a conditional purchase order for 100,000 units through a new global distribution partner, McWilliams Collective.
EU-CE Approval: The EU-CE approval enables Therma Bright to distribute throughout 27 member states that make up the European Union. EU & EEA Member countries that have a combined population of 446,824,564. According to the European Centre for Disease Prevention and Control, as of the 1st week of April over 26.3 million cases have been reported in the EU/EEA since the global pandemic began. The EU declaration of conformity indicates that the AcuVid™ COVID-19 Rapid Antigen Saliva Test complies with all the requirements of European IVDD (in-vitro diagnostic device) legislation.
According to EU recommendations, timely and accurate COVID-19 testing is an essential part of the management of COVID-19 for slowing down the spread of the virus, supporting decisions on infection control strategies, patient management at healthcare facilities, and detecting asymptomatic cases that could spread the virus further if not isolated.
“The CE regulatory approval is a huge win for Therma Bright and our AcuVid™ COVID-19 Rapid Antigen Saliva Test. This gives our Company immediate access to the large population of citizens across the European Union,” explained Rob Fia, CEO of Therma Bright. “Securing CE approval also gives us access to the UK market and the recommendation by the European Commission favorably positions our innovative 15-minute rapid antigen saliva test to meet the tremendous demand for reliable, accurate and user-friendly tests. We are extremely pleased to partner with the team at McWilliams Collective for this initial 100,000-unit order for the European market, which we expect will be the start of great business relationship.”
Conditional Sale: Prior to securing the CE designation, the Company began working to find initial distribution partners and buyers of its AcuVid™ COVID-19 Rapid Antigen Saliva Test once CE approval was received. Through Therma Bright’s relationship with Washington DC-based Ridge Global, McWilliams Collective was identified. McWilliams Collective expressed interest in becoming a global distribution partner for North America, LATAM and EMEA regions. The 100,000 CE-approved AcuVid™ COVID-19 Rapid Antigen Saliva Test are targeted for a large European client, on the condition that the Company provides initial saliva test data with demonstrated results of 86%+ specificity and 100% sensitivity, and that production levels are met and delivered during June 2021.
Distribution Partner: McWilliams Collective has global supply relationships around the world and their Collective Supplies Strategic Business Unit provides immediate access to developed and developing regions across North America, LATAM and EMEA that are suffering from the COVID-19 global pandemic.
“We’re excited to offer this newly CE-approved AcuVid™ COVID-19 Rapid Antigen Saliva Test to our European partners,” expressed Eric McWilliams, CEO of McWilliams Collective, and Collective Supplies. “This new and innovative 15-minute rapid test will allow for faster, more accurate screening of individuals – both symptomatic and asymptomatic – to mitigate the spread of this deadly virus thereby helping to bring an end to this global pandemic. We’re excited to be part of this new offering from Therma Bright and working with them to expand their reach around the globe.”
In addition, both companies are in discussions around a manufacturing partnership in the Americas and Europe, as part of the McWilliams Collective – Collective Manufacturing Strategic Business Unit. The strategic business unit was born out of an organizational desire to research, develop and manufacture products and services that will elevate the global social conscience and well-being of all people and their communities. McWilliams Collective Manufacturing Initiatives are focusing on biomimetics, additive manufacturing, smart technologies, alternative energy technology and sustainable materials. This potential manufacturing partnership offers Therma Bright a key strategic partnership to achieve its own organizational goals by helping mitigate the spread of COVID-19 with its AcuVid™ COVID-19 Rapid Antigen Saliva Test.
“Partnering with McWilliams Collective and their strategic business units made sense for Therma Bright, as we move into manufacturing and distribution for our innovative 15-minute COVID-19 antigen saliva test kit,” added Rob Fia, CEO of Therma Bright. “As we proceed down this path together to help end the spread of COVID-19, we look forward to advancing our discussions around McWilliams Collective – Collective Manufacturing Strategic Business Unit and its capabilities for setting up manufacturing facilities in North America, LATAM and Europe.”
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) (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
McWilliams Collective LLC, and the Strategic Business Units of Collective Supplies LLC and Collective Manufacturing LLC
Eric McWilliams, CEO
Eric.mcwilliams@mcwilliamscollective.co
Follow Therma Bright on Twitter.
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.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
This press release is not an offer of the securities for sale in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful.
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