Toronto, Ontario--(Newsfile Corp. - August 27, 2020) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that it has signed a co-development definitive agreement with Orpheus Medica Inc. ("Orpheus") or (Therma & Orpheus, the "Parties"). This agreement will allow Therma access to Orpheus' novel biological platform and the joint development of a rapid saliva test for the screening and detection of the virus (SARS-CoV-2) causing COVID-19.
Under this agreement, Therma will provide funding for the project in phases ("Phase" or "Phases") as certain developmental milestones are achieved, Therma will commit up to $300,000 for Phase 1 which will focus on the identification of anti-COVID-19 poly-peptides to be utilized in the test prototype development stage. Therma and Orpheus expect Phase 1 to take approximately 45 days to complete. Therma and Orpheus have identified several 3rd party providers to assist with the Phase 1 development path.
During Phase 2, Therma's and Orpheus' partnership with various clinical institutions will focus on clinical validation of the test prototype in up to 250 clinical samples. After Phase 2, Therma can decide to advance to Phase 3 only upon success with Phases 1 and 2. Phase 3 will include regulatory enabling studies where the Parties expect to apply for EUA approvals during Phase 3 including commercialization activities.
Upon approval by regulatory bodies of CoviSafe™, Therma and Orpheus expect to market its rapid test for use by education systems, businesses of all types, public events and other venues, sporting events or activities where a COVID-19 test is required and useful.
As stated in the Therma press release on August 20, 2020, CoviSafe™ is intended to have unique features such as high accuracy, sensitivity, and specificity while delivering results in less than 20 minutes. CoviSafe™ screens and directly detects the virus rather than its genetic material in saliva or as needed in other biological samples. It can be tested anywhere without the need for the test sample to be sent to a lab for processing by a trained technician. The test can be used alongside current testing methods in areas where laboratory access is limited or non-existent.
Additionally, Therma has negotiated terms in the co-development agreement for the right to invest in a COVID-19 therapeutic drug development program currently underway by the same management team as Orpheus' and under a separate corporate entity. Therma's participation will be by way of an equity investment to be announced at the time of investment.
Mr. Rob Fia, CEO of Therma Bright commented, "We are excited to have entered into this co-development arrangement with the Orpheus' team and its vast network of academic and clinical institution collaborators. Therma is committed to an expedited path to regulatory approval of the CoviSafe™ test by providing its expertise in medical device engineering, compliance, and regulatory affairs."
Dr. Saeid Babaei, Chairman & CEO of Orpheus Medica commented, "Orpheus can leverage the partnership with Therma by using its internal core capabilities including research and development, and clinical trial operations and validation to improve the speed, accuracy, accessibility, and affordability of COVID-19 testing, a major step in helping to prevent the spread of COVID-19. We have assembled a number of key collaborations with various industry and academic entities to innovate and accelerate our developmental timelines in addition to engaging with our trusted and established suppliers, manufacturers and service providers."
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.
Therma Bright Inc. trades on the TSXV (TSXV: THRM). For more information visit: www.thermabright.com and www.coldsores.com.
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 antibodies and peptides as well as small molecules.
For further information, please contact:
Therma Bright
Rob Fia, CEO
rfia@thermabright.com
Orpheus Medica
Saeid Babaei, Chairman & CEO
sbabaei@orpheusmed.com
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 to support the Company's future performance. 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.
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