Therma Bright’s AcuVid(TM) U.S. Clinical Performance Study Successfully Exceeds U.S. Food & Drug Administration’s Emergency Use Authorization Requirements
Toronto, Ontario–(Newsfile Corp. – February 15, 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, is pleased to announce its AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care (PoC) has successfully exceeded U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) requirements for both Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). The Company’s management and product development teams are currently compiling the U.S. Clinical Performance Study results with all supplemental studies into one complete FDA EUA application for submission. This achievement places Therma Bright in a very unique leadership position as the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study.
AcuVid™ U.S. Clinical Performance Study Results
| Percent Agreement | Percentage |
| PPA (Positive Percent Agreement) | 80.3% |
| NPA (Negative Percent Agreement) | 98.0% |
In total, both the U.S. Clinical Performance Study and Brazilian Clinical Study tested over 490 patients, more than other COVID-19 rapid antigen test manufacturers prior to their FDA EUA for Point of Care (PoC). The AcuVid™ saliva test also achieved successful results on several mouth-based bacteria and viruses in additional cross-reactivity study requests from the FDA, which other EUA test manufacturers did not have to conduct.
The AcuVid™ U.S. Clinical Performance Study was conducted from December 2021 through January 2022 when Omicron B.1.1.529 variant became the dominant strain across the United States1. Similarly, when the AcuVid™ Brazilian Clinical Study was completed in July 2021, the South America county’s dominant variants were P.1 and P.2. These two clinical studies not only demonstrate, but also validate, the effectiveness of the 15-minute COVID-19 rapid antigen saliva test’s ability to detect the original SARS CoV-2 Novel Coronavirus, as well as the growing list of World Health Organization’s (WHO) Variants of Concern. Furthermore, and as stated in prior releases, the Company has begun work on its FDA EUA efforts for AcuVid™ At Home Use, and continues to work with its valued partners to improve the performance of its rapid antigen saliva test for this self-test submission.
“We are pleased with the success of our AcuVid™ U.S. Clinical Performance Study, along with our Brazilian clinical study, various cross-reactivity studies and numerous COVID-19 variant studies,” shared Rob Fia, CEO of Therma Bright. “Since July 2021, our team has worked diligently with FDA officials, doctors and scientists in our pursuit to meet all the EUA requirements. It’s our belief we have achieved all requests and requirements, and have one of the most tested pre-EUA COVID-19 rapid antigen tests for submission. Once our final FDA EUA application for Point-of Care is complete, we will submit and patiently await authorization.”
Therma Bright believes its one-of-a-kind, smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test will play a critical role in detecting and mitigating the spread of this virus and its growing list of variants, including the current Omicron B.1.1.529, which is relevant to the September 23, 2021 FDA EUA Guidance2changes for tests manufacturers to validate that their solutions detect these mutations and variants.
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.
In other news, Therma Bright announced that it has entered into a 4-month marketing and consulting contract with Toronto based marketing firm, North Equities Corp. North Equities Corp. specializes in various social media platforms and has been engaged to facilitate greater awareness and widespread dissemination of the Company’s news. Pursuant to the terms of the agreement, the Company paid North Equities $15,000 on signing of the agreement. North Equities does not currently own shares of the Company. The Company also announced that it has engaged a consultant to assist it in sourcing distribution channels for its AcuVid ™ and TheroZap™ products and to assist with branding of its AcuVid™ and TheroZap™ products. Subject to TSXV approval, as partial consideration for its services, Therma Bright intends to issue 235,000 share purchase warrants to the consultant, with each warrant being exercisable for a shares for a period of two years at an exercise price of $0.40/share.
Sources:
1 CDC: Omicron Overtook Delta as Dominant Variant. https://www.usnews.com/news/health-news/articles/2021-12-28/cdc-omicron-overtook-delta-as-dominant-variant.
2 FDA: Establishing additional Conditions of Authorization for the EUAs of Certain Molecular, Antigen and Serology IVDs related to viral mutations. https://www.fda.gov/media/152406/download.
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.
For further information, please contact:
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
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FORWARD-LOOKING STATEMENTS
Certain statements in this news release constitute “forward-looking” statements. These statements relate to future events such as development and commercialization of a rapid COVID-19 viral assay and related instrumentation, regulatory applications and manufacturing scale up as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether or not such results will be achieved. Actual results could differ materially from those anticipated due to a number of factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required under applicable securities regulations.
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