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 Aprilover 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.


More Posts

contact us