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.”