Send PM
Followers 33
Posts 4452
Boards Moderated 0
Alias Born 11/27/2009

Re: None

Thursday, 06/02/2022 7:53:06 AM

Thursday, June 02, 2022 7:53:06 AM

Post# of 49
$TBRIF Therma Bright Provides Update on FDA EUA Application Process For AcuVid(TM) COVID-19 Rapid Antigen Saliva Test

https://www.newsfilecorp.com/release/126235

Toronto, Ontario--(Newsfile Corp. - June 2, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive medical device technologies, is pleased to provide an update for the Company's AcuVid™ COVID-19 Rapid Antigen Saliva Test and its U.S. Food and Drug Administration's Emergency Use Authorization application process.

The Company's Executive and Product Development teams have been working with FDA officials to clarify answers to some of the EUA application questions, as well as provided some reformatting of data to better meet the EUA application template requirements. Both the follow-up answers and reformatted data have been submitted, and Therma Bright now patiently awaits a successful FDA response for Emergency Use Authorization (EUA).

On March 29, 2022, after a month of preparation of its AcuVid™ documents and test data, the Company submitted its FDA EUA application for Point of Care Use. The application submission included a great deal of detail on the AcuVid™ COVID-19 Rapid Antigen Saliva Test, including: over 490 combined test results from the U.S. and Brazilian clinical performance studies, numerous mouth- and nasal-borne viruses and bacteria cross-reactivity tests and World Health Organization's (WHO) Variants of Concern testing.

As announced on February 15, 2022, the final U.S. clinical performance study data submitted exceeded the FDA EUA minimum requirements. However, over the last few months, as the Company worked with FDA officials, irrelevant U.S. Clinical test data was removed, which was submitted in the March 29th EUA application. Upon re-calculating the clinical study results, the Therma Bright team discovered that the U.S. clinical performance study performed better than originally reported. The adjusted U.S. clinical performance study results demonstrated a stronger Positive Percent Agreement (PPA), while Negative Percent Agreement (NPA) remained relatively the same, as originally reported. This update has now been updated in the Company's EUA application.

"Our AcuVid™ COVID-19 Rapid Antigen Saliva Test performance during the height of Delta and Omicron clearly demonstrates its ability to detect this horrible COVID-19 virus quickly and effectively," shared Rob Fia, CEO of Therma Bright. "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 Emergency Use Authorization application. As reference in our recent Health Canada announcement, we plan to use the data and FDA EUA application answers to apply and secure other regulatory approvals around the world. We're excited for the back half of 2022. Therma Bright is preparing for any resurgence of COVID-19 this fall1, as announced in the press."

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.

Recent TBRIF News

Glitzy LA luxury private cigar club planned for two blocks from the Walt Disney Concert Hall Oct 4, 2022 6:15 PM

'Posh' brand funding round for all things cannabis kicks off with S.E.C. enrollment for capital raise Oct 4, 2022 5:38 PM

NFL Great, Drew Brees, to Team with Splash Beverage Corp to Promote TapouT Performance Drink SBEV Oct 4, 2022 12:34 PM

Good Gaming Inc. Announces Its Reveal Event For The Water Bear PFP, The First of Ten Species That Make Up The Genesis Collections And Their Cross Platform "Buddyverse" GMER Oct 4, 2022 9:15 AM

Quinting - a luxury Swiss watch brand partners Coinllectibles to launch Digital Ownership Tokens (DOTs) valued at more than US$450,000 at the Global Web 5.0 Conference in Singapore on 1 Nov 2022 COSG Oct 4, 2022 8:03 AM

Swifty Global Gets Swifty Gaming Off to a Flying Start and Updates its Annual Revenue Target DRCR Oct 3, 2022 10:29 AM

Branded Legacy, Inc. Products Now Featured in New Brick and Mortar Location BLEG Oct 3, 2022 9:26 AM

TNS Reports, These Four Stocks have New Developments that Could Equate to Big Catalysts INND Oct 3, 2022 8:14 AM

TNS Reports on Stocks with Potential Near-Term Catalysts in the Works SYSX Oct 3, 2022 8:08 AM

IGEN's Nimbo Tracking adds four new dealerships and 1250 vehicles across three states in Third Quarter 2022 IGN Oct 3, 2022 6:00 AM

ILUS Confirms Share Lock-Up Opportunity ILUS Sep 29, 2022 1:25 PM

ILUS Appoints Investment Bank to Assist With Up-List and Associated Acquisitions ILUS Sep 29, 2022 11:22 AM

New Break Identifies High-Grade Gold, up to 70.60 g/t Au, via Grab Sampling at Moray NBRK Sep 29, 2022 10:29 AM

Arts & Collectibles DOT Company Coinllectibles Seeing a Very Bright Future with Revenue jumping by 100% to US$8.8 Million in First Half of 2022 as compared to The Year Before COSG Sep 29, 2022 8:44 AM

Rising Star Trillion Energy Ready to Supply Much Needed European Gas TCF Sep 29, 2022 8:00 AM