- Therma Bright Inc. has received CE approval certification for its AcuVid™ COVID-19 Rapid Antigen Saliva Test
- The company has also secured a conditional purchase order for 100,000 units through a new global distribution partner, McWilliams Collective
- EU-CE approval enables Therma Bright to distribute its AcuVid™ COVID-19 Rapid Antigen Saliva Test throughout 27 EU member states
- Both companies are discussing a manufacturing partnership in the Americas and Europe
- Therma Bright is a progressive medical device technology company
- Therma Bright (THRM) opened trading at C$0.395 per share
Therma Bright Inc. (THRM) has received CE approval certification for its AcuVid™ COVID-19 rapid antigen saliva test.
The company has also secured a conditional purchase order for 100,000 units through a new global distribution partner, McWilliams Collective.
EU-CE approval enables Therma Bright to distribute its AcuVid™ COVID-19 Rapid Antigen Saliva Test throughout 27 member states that make up the European Union.
EU & EEA Member countries 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 essential 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 favourably 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 a great business relationship."
Before securing the CE designation, Therma Bright 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 Tests 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.
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."
Both companies are in discussions regarding a manufacturing partnership in the Americas and Europe, as part of the McWilliams 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.
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.
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.
Therma Bright Inc. (THRM) opened trading at C$0.395 per share.