NEWS: Therma Bright Completes U.S. Clinical Performance Stud Therma Bright Completes U.S. Clinical Performance Study Subject Recruitment
Toronto, Ontario--(Newsfile Corp. - January 31, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, announced today that the Company has completed the U.S. Clinical Performance Study's subject recruitment effort and awaits final RT-PCR results to match against each test subject's AcuVid™ COVID-19 Rapid Antigen Saliva Test result. As stated in the January 20, 2022 release, once the clinical data has been tabulated, the final results will be filed with the U.S. Food & Drug Administration for Emergency Use Authorization (EUA) consideration.
"We appreciate the continued patience of our clients, shareholders, and partners while we await the final COVID-19 RT PCR tests from our clinic partner's labs," shared Rob Fia, CEO of Therma Bright. "The FDA closely regulates these types of scientific studies that are designed to develop evidence that support the safety and effectiveness of investigational medical devices and diagnostic tests and we are confident that our AcuVid™ U.S. Clinical Performance Study will meet the Emergency Use Authorization's (EUA) rigorous review. We will submit the U.S Clinical Performance Study data to the FDA once it is collected and tabulated."
Mr. Fia continued, "The relatively new 'stealth Omicron' variant, BA.2, has been in the news recently and although preliminary indications are that it is no more contagious or virulent than the original Omicron variant, it may become the dominant variant in certain countries in coming months. We are confident that our test will detect stealth Omicron and are currently confirming that with our partners."
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.
About Therma Bright Inc.
Therma Bright, developer of the smart-enabled 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 received a Class II medical device status from the 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 U.S. FDA in 1997. Therma Bright Inc. trades on the TSXV (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com.