FYI: Yes it's still an FDA crapshoot.
Therma Bright Provides Update on FDA EUA Application Process For AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
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.
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.
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
Follow us on Twitter
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 and manufacturing 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.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
This press release is not an offer of the securities for sale in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful.
Therma Bright Provides Update on FDA EUA Application Process For AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
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.
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.
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
Follow us on Twitter
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 and manufacturing 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.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
This press release is not an offer of the securities for sale in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful.
