- Therma Bright has finalized the AcuVid™ test kit specifications and is initiating a clinical evaluation study of the product
- Therma Bright anticipates a final validation update from its Brazilian partners within the next 8-12 days
- Therma Bright’s manufacturing and sales teams continue to prepare for the production and distribution of the test
- Therma Bright Inc. is a progressive medical diagnostic and device technology company
- Therma Bright Inc. opened trading at C$0.35 per share
Therma Bright (THRM) has provided an update on the Brazilian clinical study of its innovative 15- minute COVID-19 antigen saliva test.
Following last week’s announcement on securing K-One MediTech as the Asia-based manufacturer, Therma Bright has finalized the AcuVid™ test kit specifications and is initiating a clinical evaluation study of the product. Therma Bright anticipates a full update on the progress from its Brazilian partners at Federal University of Minas Gerais within the next 8 to 12 days.
“This key clinical study requires that each tested participant take our AcuVid™ COVID-19 Rapid Antigen Saliva Test as well as a 24-hour RT-PCR test which will be used as the gold-standard comparator test,” shared Rob Fia, Therma Bright’s CEO.
“In order to ensure success in our FDA-EUA (USA), HC (Canada), ANVISA (Brazil) and INVIMA (Colombia) approval and certification, the clinical evaluations for our COVID-19 antigen test must use natural clinical specimens, in order to confirm the performance of our assay. It also requires our test solution to achieve a minimum of 30 positive and 30 negative specimens in the study. We are being vigilant and focused at exceeding these minimum requirements.”
The company looks to provide a further update upon receipt of the clinical study results. In the meantime, its manufacturing and sales teams continue to prepare for the production and distribution of the test.
Therma Bright has received TSXV approval for the previously announced debt settlement and has issued 200,000 units at a deemed price of $0.50/unit. Each unit is comprised of one common share and ½ warrant. Each whole warrant entitles the creditor to purchase one common share for two years at a price of $0.60.
Therma Bright has issued 175,000 warrants to a consultant. Each warrant entitles the consultant to purchase one common share for two years at a price of $0.45.
All of these securities are subject to a hold period expiring September 27, 2021, in accordance with applicable securities laws and the policies of the TSXV.
Therma Bright, 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.
Therma Bright Inc. opened trading at C$0.35 per share.
