Toronto, Ontario–(Newsfile Corp. – September 15, 2020) – Therma Bright Inc. (TSXV: THRM) (“Therma” or the “Company”), a progressive medical device technology company, and its co-development partner, Orpheus Medica Inc. (“Orpheus”) are pleased to provide an update on the development progress of the CoviSafeTM rapid test for detecting SARS-CoV-2 in saliva.
As announced on September 3, 2020, Orpheus identified a series of polypeptides for the screening and detection of the virus (SARS-CoV-2) causing COVID-19. These polypeptides, and others, are being synthesized and when produced will be evaluated in a series of feasibility studies for the selection of the optimal candidates to ensure the best sensitivity and specificity for the SARS-CoV-2 virus. Once the optimal candidates are identified, these polypeptides will be used for testing CoviSafe™ in patient samples.
Orpheus and Therma have also entered into an agreement with a developer and manufacturer of rapid diagnostic tests to perform the feasibility studies with a short list of optimal polypeptides to be provided by Orpheus. The prototype diagnostic or screening test will then be optimized incorporating the polypeptides that exhibit the best performance in terms of sensitivity and specificity as a prototype CoviSafe™ device.
The Company has been in discussions with Health Canada regarding the process for regulatory approval for CoviSafe™. On March 18, 2020, the Government of Canada issued an Interim Order which gives Health Canada the ability to fast track approval of Covid-19 related products. Under this Order, our CoviSafe™ test will be eligible for expedited review and approval by Health Canada.
The initial application of the CoviSafe™ test will be for symptomatic patients and administered by health care professionals. As the CoviSafe™ test’s performance is validated in symptomatic patients, it will be rolled out as a screening test for monitoring large populations of healthy individuals that are asymptomatic for illness. The goal is to provide our solution for routine and widespread testing at schools, workplaces, sporting events or at home.
Mr. Rob Fia, CEO of Therma Bright, commented: “Therma Bright is proud to be an innovative Canadian company. We are impressed with Health Canada for being proactive and taking initiative to assist innovative Canadian companies with the regulatory approval process for Covid-19 solutions such as our rapid saliva test. We look forward to updating investors in the near future as we progress the development of CoviSafe™ with Orpheus Medica.”
About Therma Bright Inc.
Therma Bright is a progressive medical device technology company focused on providing consumers and medical professionals with quality medical devices that address their medical and healthcare needs. 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.
About Orpheus Medica Inc.
Orpheus Medica is a fully integrated research-driven Canadian biotech company focused on the development and commercialization of innovative diagnostic and therapeutics for unmet medical needs. Orpheus, with its fully integrated R&D infrastructure, provides strategic partners and collaborators access to its proven and proprietary discovery and development of novel biopharmaceutical products. Our team has over 15 years of proven and validated computational capabilities for analysis and optimization of single-domain antibodies and other polypeptides.
For further information, please contact:
Rob Fia, CEO
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Saeid Babaei, Chairman & CEO
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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