- Developed smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test
- Filed FDA application for Emergency Use Authorization approval to market the test
- Identifying sites to perform trials on the test for home-use applications
What Therma Bright does:
Therma Bright Inc (TSX-V:THRM, OTC:TBRIF). is the developer of the smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies.
Before the Toronto-based company joined the fight against the pandemic, Therma Bright has been providing a breakthrough proprietary technology that delivers effective, non-invasive, and pain-free skincare.
In 1997, Therma Bright received a Class II medical device status from the US Food and Drug Administration for its platform technology.
Today, the company offers four health products bases on the technology: Venowave (massage device for blood clot prevention); Bennepod (hot and cold stimulus and relief for sore muscles); Intercept (at-home cold sore prevention system); and Therozap (relief of the pain, itch, and inflammation caused by mosquito, bee, spider, mite, and jellyfish bites or stings).
Therma Bright, which is also in the research and development stage to develop a novel device for the relief of pain associated with back, knee, or other joint pain, seeks to build recurring revenue streams from its products and is incorporating intelligent technology such as artificial intelligence (AI) and the Internet of Things (IoT).
How is it doing:
Heading into the remainder of 2021, Therma Bright is shifting its focus to bringing its AcuVid COVID-19 test to market as demand for such rapid tests increases amid significant shortages.
Therma Bright's move comes as the Centers for Disease Control and Prevention (CDC) and other public health agencies recommend serial testing using rapid antigen tests, at least once per week, to help reduce transmission, especially in crowded settings such as offices, factories, schools, and large events.
In October 2021, the company filed its US Food & Drug Administration (FDA) application for Emergency Use Authorization (EUA) approval to market its AcuVid test as it continues to “monitor and interact” with the agency.
While waiting on the FDA decision, the company has ordered the needed materials and components to manufacture the first batch of its AcuVid tests in the US.
Therma Bright is securing multiple manufacturing sites in different countries to be able to meet the anticipated demand for the test in the US and elsewhere. It is also identifying and negotiating with potential customers in various jurisdictions to secure initial orders pending regulatory approval.
Moreover, the company has its eyes on one untapped testing market - at-home tests. The company is identifying sites to perform trials on the AcuVid test for home-use applications.
To help its balance sheet, the company in September 2021 uplisted from the OTC Pink Sheets to the OTCQB Venture Market under the symbol TBRIF. It also trades on the TSX Venture Exchange.
The move will give the company greater visibility within the US investment community and enhance its liquidity as it builds out its product lines as well as its US and global distribution sales channels.
Inflection points:
- Win FDA approval to market AcuVid test
- Develop at-home COVID-19 test
- Establish US and global sales channels
What the boss says:
"We continue to build manufacturing capacity for our test in anticipation of approval so that we can meet the expected huge demand for rapid testing,” said Therma Bright CEO Rob Fia in a recent statement.
“Our saliva-based test is easier to use and less intrusive than nasal swab-based tests and is ideally suited for rapid testing for all subjects."
Contact the author: patrick@proactiveinvestors.com
Follow him on Twitter @PatrickMGraham