IoT II
3年前
Toronto, Ontario, Canada -- October 4, 2021 -- InvestorsHub NewsWire -- Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company and developer of the AcuVid™ Covid-19 Rapid Antigen Saliva Test, provides the following update for its AcuVidTM Covid-19 Rapid Saliva Antigen Test.
Therma Bright filed its application for EUA approval to market its AcuVid™ Covid-19 Rapid Antigen Saliva Test with the US FDA on as previously reported on July 22nd and September 1st, 2021. Therma continues to monitor and interact with the US FDA as necessary regarding our active submission.
Therma Bright has ordered sufficient materials and components to manufacture the first batch of AcuVid™ tests in the US. At the same time, Therma is securing multiple manufacturing sites in different countries to be able to meet the anticipated demand for our test in the US and elsewhere.
Therma is identifying and negotiating with potential customers in various jurisdictions to secure initial orders pending regulatory approval.
In September the Centers for Disease Control and Prevention (CDC) stated that they expect shortages of rapid tests as demand increases. The CDC, and other bodies, recommend serial testing using rapid antigen tests at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission, especially in congregant settings such as workplaces, schools and large events.
Therma is currently identifying sites to perform trials on the AcuVid™ test for home use applications. The results from these trials will be used to file for approval to market the AcuVid™ Covid-19 Rapid Antigen Saliva Test for home use by non-healthcare professionals. This should greatly expand the market for our test. Once a site is identified, Therma expects to report back to shareholders on the expected date to complete the home use clinical study.
~ Blue ~
4年前
Therma Bright and Orpheus Medica Advance CoviSafe(TM) Rapid Saliva Test to Formal Product Developmental Phase
Successful Completion of the feasibility Studies followed by engagement of nanoComposix to accelerate the development of CoviSafe(TM)
Toronto, Ontario--(Newsfile Corp. - October 21, 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 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.
NanoComposix is a global supplier of the widest variety of precisely engineered, highly characterized nanoparticles and provides full-service lateral flow assay development solutions for its medical device customers. nanoComposix has more than a decade of experience building precisely engineered and highly characterized nanomaterials for thousands of customers worldwide.
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.
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."
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 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).
Therma Bright Inc. trades on the TSXV (TSXV: THRM) (FSE: JNX). 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 single-domain antibodies and other polypeptides.
About NanoComposix
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.
For further information, please contact:
Therma Bright
Rob Fia, CEO
rfia@thermabright.com
Follow us on Twitter: @bright_therma
https://www.newsfilecorp.com/release/66571/Therma-Bright-and-Orpheus-Medica-Advance-CoviSafeTM-Rapid-Saliva-Test-to-Formal-Product-Developmental-Phase
~ Blue ~
4年前
THRM big news out: Therma Bright and Orpheus Identify Novel Biological Detection Molecules for COVID-19 Rapid Test
Toronto, Ontario--(Newsfile Corp. - September 3, 2020) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that its co-development partner, Orpheus Medica Inc. ("Orpheus") has identified a series of polypeptides for the screening and detection of the virus (SARS-CoV-2) causing COVID-19.
The research carried out by Orpheus and its academic collaborators has resulted in several high-quality polypeptides that recognize the COVID-19 virus with clear distinction from other coronavirus types such as SARS or MERS. These biological molecules will form the basis of the CoviSafe™ that is being developed to screen and detect the proteins of the virus rather than its genetic material. Therma and Orpheus expect to provide additional test formats where the user can test and differentiate between COVID-19 and seasonal flu symptoms.
Recently, Health Canada announced that it will be taking applications for home testing devices for screening purposes for COVID-19.
See National Post: https://nationalpost.com/pmn/health-pmn/health-canada-changes-course-on-covid-testing-at-home
CoviSafe™ is a screening test designed to monitor large populations of healthy individuals that are asymptomatic for the COVID-19 illness. CoviSafe™ can also be used as a diagnostic test to investigate individuals with COVID-like symptoms. CoviSafe™ will have a number of quality control features to avoid misuse or misinterpretation of home-based test results, which address a number of Health Canada's concerns as outlined in the article by the National Post. Therma and Orpheus will be carrying out field evaluation testing to determine test performance in different settings. The goal is to provide our solution for routine and widespread testing at schools, workplaces, sporting events or at home.
Dr. Saeid Babaei, Chairman & CEO of Orpheus commented: "We are excited to identify and validate the first series of our polypeptides in collaboration with our academic partners in a timely fashion. The detection molecules discovered to-date have already been validated in a COVID-19 model in the laboratory. Our plan is to further validate these results on the device platform as the next step in coming weeks."
Mr. Rob Fia, CEO of Therma Bright, commented: "We believe that CoviSafe™ can be developed as a low cost, saliva-based solution, that produces fast and accurate results for use at point of care or home, school, business or sporting event applications. We are excited for the potential to incorporate features that identify whether someone has COVID-19 or the seasonal flu. Therma and Orpheus believe this goal is the game changer that the world is looking for to get back to normalcy."
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 single-domain antibodies and other polypeptides.
For further information, please contact:
Therma Bright
Rob Fia, CEO
rfia@thermabright.com
Orpheus Medica.
Saeid Babaei, Chairman & CEO
sbabaei@orpheusmed.com
https://www.newsfilecorp.com/release/63161/Therma-Bright-and-Orpheus-Identify-Novel-Biological-Detection-Molecules-for-COVID19-Rapid-Test
~ Blue ~
4年前
Amazing news~ Therma Bright Enters into Co-Development Agreement with Orpheus Medica's COVID-19 Rapid Saliva Test, CoviSafe™Toronto,
August 27 2020 - 09:45AM
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Therma Bright Enters into Co-Development Agreement with Orpheus Medica's COVID-19 Rapid Saliva Test, CoviSafe™
Toronto, Ontario – August 27, 2020 – InvestorsHub NewsWire -- 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
~ Blue ~
4年前
Great News from Bioworld about THRM's Covid Test
The pilot project is aimed at med-tech companies that have filed a new or existing patent application for an invention supporting the health-related response to COVID-19 and with fewer than than 50 employees. A case in point: Orpheus Medica Inc., a Mississauga, Ontario-based biotech company with 12 experts busy developing a rapid saliva test for detecting the SARS-CoV-2 strain that causes the COVID-19 virus. Investors as well as small- and medium-sized enterprises (SMEs) are paying attention.
“The first thing an investor will ask about your technology is ‘Do you have a patent on it?’” Orpheus Medica chairman and CEO Saeid Babaei told BioWorld. “So with an accelerated process of review, that provides a lot more assurance for SMEs anxious to track their investments.”
https://www.bioworld.com/articles/496431-canadas-patent-office-speeding-examination-of-covid-19-med-tech-applications-cutting-company-costs
--------------------------------------------------
THRM ~ Rapid Test for COVID-19 Virus in Saliva - CoviSafe(TM)
Toronto, Ontario--(Newsfile Corp. - July 16, 2020) - Therma Bright Inc. (TSXV: THRM), ("Therma" or the "Company"), a progressive medical device technology company, is pleased to provide an update on its project with Orpheus Medica to develop a rapid test to detect COVID-19 virus in saliva - the CoviSafeTM.
The project will integrate Orpheus' novel biologics platform, coupled with third party rapid detection and portable device technology, to develop a reliable palm-sized test for screening of COVID-19 virus in saliva. Orpheus and its academic collaborators have already spent over $500,000 on the development of a series of novel antibody and peptide-based detection molecules, identified through its existing intellectual property, know-how and infrastructure.
The proposed COVID-19 rapid saliva test is intended to have unique features such as high sensitivity, accuracy and specificity while delivering results in less than 20 minutes. Orpheus has substantial experience developing rapid tests, including roadside THC drug screening kits for saliva and other biological samples. The design and development of the fundamental components of the proposed test have already begun, which may allow Therma and Orpheus to deliver a solution to the Canadian and global markets.
The parties' arrangement is subject to completion of due diligence and successful negotiation of comprehensive terms and conditions of a definitive development project agreement. The parties' arrangement is subject to acceptance by the TSX Venture Exchange.
Mr. Rob Fia, CEO of Therma Bright commented, "We are pleased with the level of interest in this project by the investor community. As a result, we have posted a new presentation on our website, www.thermabright.com/therma-orpheus/ which provides additional information on the project, the market opportunity and preliminary details on the CoviSafeTM product. I am also able to report that we are moving forward with our fundraising efforts and due diligence and expect to finalize the definitive agreements within the 30-day period, as reported on July 7, 2020.
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 privately held 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 30 years of combined experience in developing disruptive and cutting-edge technologies based on deployment of an advanced Artificial Intelligence, machine and deep learning processes combined with biological and small molecules platforms leading to optimal drug candidate selection.
For further information, please contact:
Therma Bright
Rob Fia, CEO
rfia@thermabright.com
Orpheus Medica
Saeid Babaei, Chairman & CEO
sbabaei@orpheusmed.com
https://finance.yahoo.com/news/therma-bright-provides-orpheus-medica-103300282.html
janetcanada
4年前
THRM - This stock is trading so well......I am very happy!!!.....
Recent News
Therma Bright Increases Private Placement to $1,250,000 Due to Increased Demand
Toronto, Ontario--(Newsfile Corp. - July 22, 2020) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that further to its news release of July 20, 2020, it has received interest above the previously announced private placement of up to...
2020-07-22 6:00 AM ET
Therma Bright Announces up to $1,000,000 Private Placement Financing with Insider Participation and Debt Settlements
Toronto, Ontario--(Newsfile Corp. - July 20, 2020) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that it proposes to undertake a non-brokered private placement (the "Private Placement") of up to 13,333,334 units ("Units") at a price of...
2020-07-20 6:00 AM ET
janetcanada
4年前
Good morning Blue, looks really Interesting and Promising!.....
*From TSXV....
Thursday, July 16, 2020
Therma Bright Provides Update on Orpheus Medica Rapid Test for COVID-19 Virus in Saliva - CoviSafe(TM)
- Newsfile , 6:34 AM EDT
Thursday, July 9, 2020
Therma Bright Completes Due Diligence to Acquire Medical Device Technology from Saringer Life Science Technologies Inc.
- Newsfile , 7:15 AM EDT
Tuesday, July 7, 2020
Therma Bright Enters Into a Binding Letter of Intent with Orpheus Medica to Develop a Rapid Test to Detect COVID-19 Virus in Saliva
- Newsfile , 6:01 AM EDT
Thank you!
janet
~ Blue ~
4年前
THRM huge news out: Rapid Test for COVID-19 Virus in Saliva - CoviSafe(TM)
Toronto, Ontario--(Newsfile Corp. - July 16, 2020) - Therma Bright Inc. (TSXV: THRM), ("Therma" or the "Company"), a progressive medical device technology company, is pleased to provide an update on its project with Orpheus Medica to develop a rapid test to detect COVID-19 virus in saliva - the CoviSafeTM.
The project will integrate Orpheus' novel biologics platform, coupled with third party rapid detection and portable device technology, to develop a reliable palm-sized test for screening of COVID-19 virus in saliva. Orpheus and its academic collaborators have already spent over $500,000 on the development of a series of novel antibody and peptide-based detection molecules, identified through its existing intellectual property, know-how and infrastructure.
The proposed COVID-19 rapid saliva test is intended to have unique features such as high sensitivity, accuracy and specificity while delivering results in less than 20 minutes. Orpheus has substantial experience developing rapid tests, including roadside THC drug screening kits for saliva and other biological samples. The design and development of the fundamental components of the proposed test have already begun, which may allow Therma and Orpheus to deliver a solution to the Canadian and global markets.
The parties' arrangement is subject to completion of due diligence and successful negotiation of comprehensive terms and conditions of a definitive development project agreement. The parties' arrangement is subject to acceptance by the TSX Venture Exchange.
Mr. Rob Fia, CEO of Therma Bright commented, "We are pleased with the level of interest in this project by the investor community. As a result, we have posted a new presentation on our website, www.thermabright.com/therma-orpheus/ which provides additional information on the project, the market opportunity and preliminary details on the CoviSafeTM product. I am also able to report that we are moving forward with our fundraising efforts and due diligence and expect to finalize the definitive agreements within the 30-day period, as reported on July 7, 2020.
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 privately held 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 30 years of combined experience in developing disruptive and cutting-edge technologies based on deployment of an advanced Artificial Intelligence, machine and deep learning processes combined with biological and small molecules platforms leading to optimal drug candidate selection.
For further information, please contact:
Therma Bright
Rob Fia, CEO
rfia@thermabright.com
Orpheus Medica
Saeid Babaei, Chairman & CEO
sbabaei@orpheusmed.com
https://finance.yahoo.com/news/therma-bright-provides-orpheus-medica-103300282.html
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