Company
Therma Bright Inc
CVE:THRM
Therma Bright Inc, the developer of the AcuVid COVID-19 Rapid Antigen Saliva Test, is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today’s most important medical and healthcare challenges. The company’s initial breakthrough proprietary technology delivers effective, non-invasive and pain-free skincare. Therma Bright has received a Class II medical device status from the US Food & Drug Administration (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.
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Therma Bright to explore Digital Cough Technology with AI maker AI4LYF for app to detect COVID-19
"The FDA has encouraged the development of digital tests to deal with COVID-19 and potential future respiratory diseases," said CEO Rob Fia
Therma Bright receives temporary billing codes for Venowave, allowing reimbursement through Medicare and Medicaid
The new temporary billing codes will allow doctors and patients to easily order Venowave, a compact and lightweight Deep Vein Thrombosis prevention device
Therma Bright receives payment for initial Venowave orders in the US; explores global opportunities for the DVT prevention device
The biotech firm said it is currently in the process of applying for several new reimbursement codes in the US that will make it simpler and faster for doctors and patients to order the Venowave and have it covered by their medical benefits
Therma Bright updates on progress of applications to FDA and Health Canada for its AcuVid COVID-19 rapid antigen saliva test
"The FDA EUA review process is a rigorous and thorough process, as are all regulatory reviews, and therefore patience is required," said Rob Fia, CEO of Therma Bright
Therma Bright submits Health Canada application for its AcuVid COVID-19 rapid antigen saliva test for point-of-care use
The Toronto-based company said the application includes all the updated data from the company's US Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) application
Therma Bright provides update on US FDA application for its AcuVid COVID-19 rapid antigen saliva test
“Based on all the test data provided and now reformatted, along with what we hope will be our final responses to several clarify questions by FDA officials, we anticipate a successful conclusion to our EUA application," said CEO Rob Fia
Therma Bright to seek approval for its AcuVid COVID-19 rapid antigen saliva test from Health Canada
"We are also exploring other international regulatory jurisdictions where it may be advantageous for us to file and are actively seeking initial orders," said Rob Fia, CEO of Therma Bright
Therma Bright ships initial Venowave order to US distributor
“We are excited to be able to deliver products to customers in the US who have been patiently waiting for this potential life saving technology,” said the company’s CEO Rob Fia
Therma Bright submits its AcuVid COVID-19 Rapid Antigen Saliva test application for FDA Emergency Use Authorization
Since July 2021, the company's executive and development teams have worked with FDA officials, doctors, and scientists on its AcuVid EUA application requirements
Therma Bright gets recognized among 2022 TSX Venture 50 top performing stocks
"Therma Bright is honored to be placed in the TSX Venture 50 for top-performing stocks and ranked third in the Life Sciences category," said Rob Fia, CEO of Therma Bright in a statement
Therma Bright says it received patent for device for applying a topical treatment from USPTO
CEO Rob Fia said the allowed US patent application "further protects our valued intellectual property (IP) as we continue to transform innovation into wellness"
Therma Bright closes C$6M private placement with institutional investors
The Canadian medical diagnostic and device technology company said the funds will be used as working capital
Therma Bright set to raise C$6M in private placement with institutional investors
The company said net proceeds of the private placement will be used for general working capital purposes
Therma Bright says clinical study of its AcuVid COVID-19 Rapid Antigen Saliva Test successfully exceeded FDA EUA requirements
The company’s management and product development teams are currently compiling the US Clinical Performance Study results with all supplemental studies into one complete FDA EUA application for submission
Therma Bright seeks to make rapid COVID-19 antigen testing easier and less invasive
The company's self-administered AcuVid COVID-19 Rapid Antigen Saliva Test, posied to roll out in 1Q 2022, uses saliva spit instead of nasal swabs to detect the presence of COVID-19 and its variants
Therma Bright completes US Clinical Performance Study subject recruitment for its AcuVid COVID-19 Rapid Antigen Saliva Test
Therma Bright CEO Rob Fia said: “We are confident that our test will detect the relatively new stealth Omicron and are currently confirming that with our partners"
Therma Bright says its US clinical performance study underway; final results to be submitted to FDA
"Our goal is to complete this study in January 2022 within the 300 participants range per our IRB [institutional review board] Clinical Trials dashboard,” Rob Fia, CEO of Therma Bright said
Therma Bright says antibodies in its AcuVid COVID-19 Rapid Antigen Saliva Test can successfully detect Omicron variant
The Omicron variant has been detected in at least 38 countries, and early data suggests it's more contagious than the Delta variant