K-One MediTech To Begin Production of CE approved 15-Minute Antigen Test Solution
Toronto, Ontario--(Newsfile Corp. - May 21, 2021) - Therma Bright Inc. (TSXV: THRM) ("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 that it has secured a development and manufacturing partnership with K-One MediTech to bring the Acuvid COVID-19 Rapid Antigen Saliva Test Kit to the marketplace.
K-One Meditech, an ISO 13485 certified company, is a well-established medical device manufacturer registered with the FDA to supply medical devices and products. Under this Agreement, K-One MediTech will act as the primary manufacturer in Asia to produce the AcuVid COVID-19 Rapid Antigen Saliva Test Kits. The term of the agreement will be for a two (2) year period, commencing from the first production batch of the AcuVid test kits for the Point-of-Care commercial market.
Rob Fia, CEO of Therma Bright, commented: "With our primary Asia-based manufacturing partner, K-One MediTech, in place we are ready to begin production of our CE-approved AcuVid COVID-19 Rapid Antigen Saliva Test. Therma Bright will be able to add FDA Emergency Authorization Use (FDA-EUA) and Health Canada (HC) approved kits once regulatory approvals are secured."
In April 2020, immediately following the COVID-19 pandemic global lockdown, Therma Bright and its team of talented scientists began developing its AcuVid COVID-19 Rapid Antigen Saliva Test using lateral flow technology. The Company continues to test the saliva-based solution to meet and exceed FDA-EUA and Health Canada criteria. Testing will take place in Canada, post Health Canada approval with testing currently ongoing in Brazil. The Brazilian team has not only successfully detected the original novel coronavirus Wuhan strain (SARS CoV-2), but also the Brazilian P.1 and P.2 and the UK B.1.1.7 variants with the COVID-19 Rapid Antigen Saliva Test.
In addition to selecting the manufacturing partner for Asia, the Company has also quickly pivoted during the clinical studies in Brazil to an easier, more accurate and less expensive version of AcuVid. Now the AcuVid COVID-19 Rapid Antigen Saliva Test Kit is a much simpler, easy-to-use kit that will simplify the process for medical professionals and individuals administering or taking the AcuVid test, but it also has enabled the Company to significantly reduce its cost from the first prototype version.
The K-One MediTech development and manufacturing agreement will provide services which include development, designs, concepts, formula, and manufacturing process for Therma Bright's new AcuVid Covid-19 Rapid Antigen Saliva Test. The agreement between the two companies will be deemed as works for hire, and as such, ownership of all intellectual property will remain the property of Therma Bright. K-One MediTech will be granted the primary manufacturer rights for Asia of the Company's AcuVid COVID-19 Rapid Antigen Saliva Test Kits for a period of two (2) years commencing from the 1st production batch for the commercial market.
Martin Lim, CEO of K-One MediTech, commented: "We are pleased to be selected as Therma Bright's primary manufacturer for Asia for its innovative AcuVid COVID-19 Rapid Antigen Saliva Test. This COVID-19 pandemic has devastated our communities. It has affected our loved ones with death and sickness and economic despair. Being part of a rapid testing solution, like AcuVid, can assist citizens around the world to pursue twice-weekly serial testing regiments, while awaiting vaccinations. We're honored to be a part of Therma Bright's solution."
In March 2021, FDA Guidance was provided to test developers who were seeking emergency use authorization (EUA) of certain tests that could be used for serial testing, which includes the AcuVid COVID-19 Rapid Antigen Saliva Test. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission.
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 K-One MediTech
K-One MediTech is a wholly owned subsidiary of K-One Tech. It was incorporated in 2001. Its principal business and focus are on the development and manufacturing of medical and healthcare products which includes medical devices, healthcare consumables, oral care gadgets and hospital equipment. For more information, please visit K-One MediTech at www.k-one.com.
About Therma Bright Inc.
Therma Bright, 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. 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 US FDA in 1997. Therma Bright Inc. trades on the TSXV (TSXV: THRM) (OTC Pink: THRBF) (FSE: JNX). Visit: www.thermabright.com.
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, 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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