Successful completion of feasibility studies followed by engagement of nanoComposix to accelerate the development of CoviSafe™
Toronto, Ontario – 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 announce the successful completion of the initial feasibility studies with its polypeptide detection candidates for CoviSafe™.
Therma & Orpheus are also pleased to announce the engagement of nanoComposix Inc. (“nanoComposix”) to complete the development of CoviSafe™. NanoComposix is uniquely positioned to begin final development of CoviSafe™ and to assist Therma & Orpheus with defining optimal reagents and chemistries necessary to make CoviSafe™ an ultrasensitive, rapid, saliva-based, point of care lateral flow test for SARS-CoV-2 and enable final development of CoviSafe™.
NanoComposix is a global supplier of precisely engineered, highly characterized nanoparticles and provides full-service lateral flow assay development solutions for its customers. NanoComposix has more than a decade of experience incorporating novel nanoparticles and chemistry into diagnostic assays and will leverage its extensive experience in ultrasensitive, rapid, quantitative, point of care rapid tests to bring CoviSafe™ to market.
Therma & Orpheus will retain the commercial rights to the resulting CoviSafe™ rapid saliva test. The companies will work in parallel to complete development of the test prior to clinical testing for submission to Health Canada, FDA and to attain European CE marking to introduce CoviSafe™ into markets as quickly as possible.
Dr. Steven Oldenburg, Founder & CEO of nanoComposix, commented, “nanoComposix is pleased to work alongside the dynamic teams at Therma Bright and Orpheus to accelerate both the product development cycle and commercial launch of the CoviSafe™ assay.”
Rob Fia, CEO Therma Bright, commented, “We are pleased to complete the feasibility study and advance to next steps in the development of CoviSafe™. It is exciting to work with such a proactive and experienced team at nanoComposix. NanoComposix will assist Therma & Orpheus to fast track the development of CoviSafe™.”
Saied Babaei, CEO of Orpheus, commented, “With the help of nanoComposix, we will be able to accelerate our work and bring this critical test to the market quicker. We are impressed by nanoComposix’s expertise in working with Orpheus’ biological candidates to enhance sensitivity and specificity of the CoviSafe™ rapid test. We feel the addition of this strong technical team will further de-risk and accelerate the regulatory process and clinical validation of our saliva-based rapid test.”
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 to relieve 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 and Orpheus are not making any express or implied claims that its product, CoviSafe™, has the ability to eliminate or cure COVID-19 (or SARS-CoV-2 virus).
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.
NanoComposix is a San Diego, California company with the world's largest variety of metal nanoparticles for biomedical applications in life science, diagnostics, and therapeutics. GMP and ISO13485 compliant manufacturing methods produce precisely engineered and highly characterized nanoparticles that provide high levels of consistency and performance. Through the establishment of open and collaborative relationships, we rapidly generate innovative solutions to our clients’ most challenging R&D problems. NanoComposix markets their products directly and through distributors and licensing partners worldwide.