Jaxxm
7 meses hace
TBRIF: Therma Bright Inc., formerly known as Jenex Corporation, 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 from over 20,000 different insect stings and bites, (including bees, wasps, hornets, mosquitoes, black flies and jellyfish). The Company received approval for the above claims from FDA (United States) in 1997. (Note: 510K in the name of The Jenex Corporation is currently not licensed in the US under Therma Bright Inc. The Company expects to transfer the 510K from The Jenex Corporation to Therma Bright Inc. as it completes R&D and readies its product for commercialization.)
TherOZap™ is the next generation in pain management relief using thermal therapy for insect bites and stings. The TherOZap™ thermal relief therapy aims to reduce the inflammatory response, relieving the symptoms of pain, itch and inflammation associated with over 20,000 different insect bites and stings.
https://www.thermabright.com/thero-zap/
Eurotradr
1 año hace
Therma Bright Adds Hero LifeCare as Northeast Venowave Distribution Partner
5:31 AM ET 9/13/23 | Dow Jones
Toronto, Ontario--(Newsfile Corp. - September 13, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer and partner in a wide-range of leading-edge, proprietary diagnostic and medical device technologies, announced today the Company has signed Hero LifeCare (herolifecare.com) to be a U.S. distribution partner for marketing and selling the Venowave device.
Hero LifeCare ("Hero"), a large healthcare and emergency device and solutions company, together with its subsidiary Rapid Oxygen, manufacturers and markets innovative healthcare and emergency response products, including the R15, an FDA cleared first aid emergency oxygen device developed in conjunction with the University of Michigan and designed to be placed next to a fire extinguisher or AED. The new distributor sees the Venowave presenting sales opportunities to its current and growing customer base similar to the R15.
"We're excited to welcome Hero LifeCare as our distribution partner for our Venowave device," continued Rob Fia. "This partner has deep connections and relationships with large medical and healthcare practices, as well as direct to consumer opportunities through its e-commerce site - herolifecare.com. Hero seeks innovative health tech solutions to help their patients and customers address a variety of health-related issues and/or symptoms, which led to the meeting of our two companies. They believe the Venowave will present another innovative medical solution to their clients to further expand their product offerings and growth."
Hero LifeCare will initially use the nine (9) temporary CMS CPT(R) and HCPCS codes that other U.S. distribution partners are currently using, while the Company awaits CMS approval on the permanent CPT(R) and HCPCS.
The Company looks forward to providing more information as it becomes available on expanding its distribution partners across the U.S. for its Venowave device and the unique permanent CPT(R) and HCPCS codes process.
Mrogers23
2 años hace
$TBRIF Therma Bright, Announces Appointment of Dr. John Patton as Chairman to Investee Company InStatin Inc.
Dr. John Patton is recognized as a Leader in the Inhaled Formulation Solutions To Bring Industry Expertise To Innovative, Research-Based Pharmaceutical Firm
Toronto, Ontario--(Newsfile Corp. - March 1, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer and investor in a range of leading-edge and proprietary diagnostic and medical technologies, is pleased to announce that Dr. John Patton has joined as Chairman of InStatin Inc.("InStatin") . InStatin is a privately-held innovative, research-based pharmaceutical company specializing in inhaled therapies, which is a recent Therma Bright investment.
Read full release: https://www.newsfilecorp.com/release/156699/Therma-Bright-Announces-Appointment-of-Dr.-John-Patton-as-Chairman-to-Investee-Company-InStatin-Inc.
AveragePenny
2 años hace
$TBRIF Therma Bright Provides 2022 Year End Update
https://www.newsfilecorp.com/release/148972
Toronto, Ontario--(Newsfile Corp. - December 21, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide a summary of activities and accomplishments achieved during 2022 as outlined below.
AcuVid™
Health Canada continues to provide constructive feedback as the submission progresses through their approval process.
Due to shifting market dynamics and changing FDA requirements in the US, the Company is currently evaluating its options for US regulatory approval in discussions with the FDA and its FDA consultants.
Therma is evaluating several pathways available for US regulatory approval and market penetration including: applying under a breakthrough designation application, partnering with a diagnostic company to assist with regulatory approval, conduct additional clinical studies for in-home use, filing a full 510(k) application for AcuVid™ and develop sales relationships post approval.
AcuVid™ currently has an EU-CE mark, enabling Therma to market and sell the product in 31 countries. Therma is collaborating with an established partner to identify customers in these nations. Since the COVID-19 outbreak in 2020, the market for Covid-19 diagnostic tests has undergone a major shift. In the future, corporate buyers for employee-based testing, governments that are introducing updated testing standards, and consumers will be the key emphasis for AcuVid™ sales and marketing efforts.
Venowave
The FDA-approved Venowave product was previously sold in the US and was reimbursed under Medicare/Medicaid for only one indication. In August 2022, Therma engaged a consulting firm to apply for an expanded number of reimbursement codes for the product. The product received eight new temporary reimbursement codes greatly expanding the market for the product into other therapeutic areas and increasing the reimbursement level. Since receiving the temporary codes Therma has been working with a US distributor to identify the new market opportunities and establish reimbursement levels. The Company expects permanent codes to be issued by early 2023 when the coding committees are scheduled to meet.
The Venowave products can now be used and reimbursed for the management of the symptoms of post thrombotic syndrome (PTS), prevention of deep vein thrombosis (DVT), prevention of primary thrombosis, enhancing blood circulation, and for the treatment of intermittent claudication, lymphedema, leg swelling due to vascular insufficiency, varicose veins, and chronic venous insufficiency.
During the year, the Company also developed a new version of the product that specifically targets the hospital and clinic markets.
Therma will focus on increasing penetration for Venowave in the United States and elsewhere which represents a multi-billion dollar market opportunity. According to Coherent Market Insights, the global compression therapy market is estimated to be valued at US$ 3.336 billion in 2022 and expected to surpass US$ 5.296 billion by 2030 and expected to exhibit a CAGR of 5.9 % over the forecast period (2022-2030). The resources to be contributed by Therma are intended to help accelerate commercialization activities, as well as allow for ongoing improvements and enhancements to be made to the systems in a cost-effective manner. The goal is to establish Venowave as a leading supplier in this market segment.
Benepod
The Benepod pain relief product that uses clinically proven hot/cold contrast therapy to provide local pain relief to soft tissues and joints has been sold directly by the Company in the past. The Benepod product will be relaunched in 2023 using new digital marketing approaches to address the direct-to-consumer market for pain relief products.
InterceptCS™ and TheroZap®
Therma retained an engineering firm in mid-2022 to redesign and repackage the InterceptCS™ and Therozap® products. Both products are expected to be relaunched in 2023 to address the cold sore (InterceptCS™) and bug bite (TheroZap®) markets worldwide.
AI4LYF LLC
On November 17th, 2022, Therma announced it had entered into a letter of intent with AI4LYF LLC ("AI4LYF") for the exclusive licensing rights for a digital cough-based diagnosis screening technology. Digital Cough Test (DCT) is a groundbreaking patent-pending technology, powered by an innovative AI engine built by AI4LYF. DCT can accurately and almost instantly detect multiple respiratory diseases, including COVID-19, simply from a smartphone app, anytime, anywhere. DCT does so by digitally dissecting cough sounds into hundreds of features. The proprietary AI then analyzes these cough features to detect the subtle and peculiar signatures of specific respiratory diseases. The license rights will include the development of DCT for other respiratory diseases such as asthma, pneumonia, bronchiolitis, and chronic obstructive pulmonary disease. Therma is currently working with AI4LYF and legal counsel to finalize a definitive exclusive licensing agreement. Further development work will be conducted in 2023 with the goal of submitting for regulatory approval in late 2023 or 2024.
InStatin and InVixa
On December 1st, 2022, Therma acquired an interest in a novel patented technology that utilizes inhaled statins for the treatment of respiratory conditions including asthma, chronic obstructive pulmonary disease ("COPD"), and acute lung inflammatory diseases including those caused by COVID-19 and other causes of acute respiratory distress syndrome (ARDS).
Statins have been used in humans primarily to treat high cholesterol levels in the blood. Recently a research group at the University of California Davis (UCD) used inhaled statins to treat lung disorders with great success. A number of patents have been filed and issued on the technology. The UCD group is led by Dr. Amir Zeki, M.D., M.A.S. who is a pulmonary specialist and clinical researcher at UCD who has studied the use of statins for over 10 years. His preclinical research has shown that statins hold significant promise in the treatment of a variety of lung conditions. This approach could revolutionize the way these conditions are treated. Initial patient testing is planned to commence in 2023.
Rob Fia, CEO commented, "2022 was a busy year for Therma Bright with many accomplishments and new endeavors. However, there were many challenges during the year due to the aftermath of the Covid-19 pandemic and the changing local and global economic environments and regulatory requirements. During the year, we made our first significant sales of the Venowave product in the US and expect substantially increased sales next year because of the new reimbursement codes. We look forward to an exciting 2023 as we move our existing and new products forward. We want to thank our shareholders, employees and partners for their patience, support and efforts during an exciting year."
AveragePenny
2 años hace
$TBRIF Therma Bright Invests in the Development of Novel Treatments for COVID-19, Asthma, and Chronic Obstructive Pulmonary Disease (COPD)
https://www.newsfilecorp.com/release/146403
Toronto, Ontario--(Newsfile Corp. - December 1, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has entered into an agreement to acquire an interest in a novel technology that utilizes inhaled statins for the treatment of respiratory conditions including asthma, chronic obstructive pulmonary disease ("COPD"), and acute lung inflammatory diseases including that caused by COVID-19 and other causes of acute respiratory distress syndrome (ARDS).
Therma has entered into an agreement with 2740162 Ontario Inc., operating as August Therapeutics ("August") and Ketiko Bio Corp ("Ketiko") (collectively the "Vendors") to acquire a 25% interest in each of InStatin, Inc. and InVixa Inc., and to acquire an option to acquire additional shares in Instatin and InVixa, as described below. Therma Bright has agreed to issue 55,000,000 shares at a deemed price of $0.136364 per share for total consideration of $7,500,000.00, to the Vendors in exchange for such interests in InStatin and InVixa. The above option will additionally provide Therma with the right to earn up to 50% of InStatin and 80% of InVixa by advancing the drugs to the end of Phase 1 clinical trials for each company and eventual regulatory approval, with an investment expected to be US$5M. Additionally, the Company shall have the right to appoint one director to each of the boards of InStatin and InVixa, subject to meeting certain future funding milestones.
In connection with the acquisition, the Company will pay a finder's fee of 4,400,000 shares in its capital stock to an arm's length finder for its assistance in sourcing the transaction.
Statins have been used clinically to treat high cholesterol levels which protect patients from heart attacks and strokes for over 35 years. A research group at the University of California Davis (UCD) School of Medicine has conducted innovative laboratory research on the application of 'inhaled statins' to treat the acute and chronic respiratory inflammatory mechanisms associated with asthma, COVID-19 and other respiratory conditions with promising results.
A number of patents have been filed on the technology of inhaled delivery of statins. The UCD group is led by Dr. Amir A. Zeki, who also serves as Director of Research of the Reversible Obstructive Airway Disease (ROAD)TM Center, and Co-Director of the UC Davis Asthma Network (UCAN)TM Clinic. Dr Zeki is a pulmonary specialist and clinical researcher at UCD who has studied the use of statins for the treatment of pulmonary diseases for over 14 years. His preclinical research has shown that statins hold significant promise in the treatment of a variety of lung conditions even beyond asthma, COPD, and COVID-19. Dr. Zeki shared, "the statin drugs are a unique class of small molecules that modulate lipid and related metabolic pathways. They affect mechanisms involved in inflammation, cell proliferation and migration, cellular barrier integrity, tissue remodeling, and lung function with beneficial physiological effects. When delivered via the inhaled route, the statins are targeted to the site of disease activity for greater therapeutic benefit. We are excited that statins could be the next novel class of inhaled therapeutics."
Research has shown that 1 in 10 COVID-19 patients die within six months of being discharged from the hospital. The Office for National Statistics reported that 3 in 10 COVID-19 patients are re-admitted to hospital following breathing difficulties and COVID related acute respiratory distress syndrome.
Mr. Rob Fia, CEO of Therma Bright, commented that "this agreement brings synergy to Therma Bright's innovative COVID diagnostic testing portfolio with the addition of therapeutics to provide treatment of for COVID-19 and its complications. The Company is incredibly proud to have negotiated this interest in two promising companies and to begin the process to initiate Phase 1 clinical trials. As well, we look forward to the promise that these statin treatments provide for chronic lung diseases including asthma and COPD."
The strategic approach of repurposing approved drugs to reduce the drug development timeline and leverage the research, development and clinical work of past companies has numerous advantages to shorten the pathway toward securing regulatory approval and bringing novel solutions to patients.
It is anticipated that formal dialogue with FDA will be initiated in 2023 to discuss and agree on the clinical studies required to secure FDA approval.
AveragePenny
2 años hace
$TBRIF Therma Bright Inc. to Acquire an Exclusive License for a Patented Digital Cough Based Technology to Detect Respiratory Diseases
https://www.newsfilecorp.com/release/144580'
Toronto, Ontario--(Newsfile Corp. - November 17, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma Bright" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has entered into a letter of intent ("LOI") with AI4LYF LLC ("AI4LYF") for the exclusive licensing rights for a digital cough-based diagnosis screening technology.
Digital Cough Test (DCT) is a groundbreaking patent-pending technology, powered by an innovative AI engine built by AI4LYF. DCT is an innovative solution that can accurately and almost instantly detect multiple respiratory diseases, including COVID-19, simply from a smartphone app, anytime, anywhere. DCT does so by digitally dissecting cough sounds into hundreds of features. The proprietary AI then analyzes these cough features to detect the subtle and peculiar signatures of specific respiratory diseases. The license rights will include the development of DCT for other respiratory diseases such as asthma, pneumonia, bronchiolitis, and chronic obstructive pulmonary disease.
The DCT app records the cough when prompted by the user on the smart phone DCT app. The app then produces a positive or negative Covid test result within one minute, with an accuracy above 94%. DCT results for COVID-19 are comparable to current PCR Covid testing methods.
Therma Bright is adding this screening tool to complement its existing smart enabled diagnostic tool in the marketplace as it awaits FDA and Health Canada approval for its AcuVid™ Covid-19 Rapid Antigen Saliva Test. The Company believes DCT will drive sales of Therma Bright's diagnostic tool by channeling individuals who have screened positive using the DCT app to then seek ultimate validation with AcuVid™. In addition, the DCT technology expands Therma Bright's capability to detect other respiratory diseases with a quicker, less costly regulatory path and approval process.
The first outcome of the licensing of this technology is the clinical trial of DCT for COVID-19 diagnosis which will start in mid-January 2023 led by Therma Bright.
Upon execution of the LOI, Therma Bright advanced $200,000 and will advance an additional $65,000 on December 1, 2022. Consideration payable to acquire the exclusive license is expected to be comprised of a royalty, common shares of the Company and up to 2,000,000 warrants, with each warrant being exercisable for a common share upon payment of $0.17/share. The final terms of this transaction are currently being negotiated and a definitive agreement is expected to be signed by December 15, 2022. The Company will provide full details of the transaction upon execution of the definitive agreement. A finder's fee will be paid to an arm's length person upon execution of the definitive agreement. The finder's fee will be comprised of 500,000 shares and 500,000 three-year warrants, with each warrant being exercisable for a share upon payment of $0.17. The definitive agreement and payment of the finder's fee is subject to TSX Venture Exchange approval.
Rob Fia, CEO, commented: "We are pleased to partner with AI4LYF on this exciting new patented technology to detect respiratory disease. The market for DCT has been validated by Pfizer's recent acquisition of ResApp Health out of Australia for USD $179M. While we continue to pursue our regulatory approvals for AcuVid™ there are several advantages to DCT including: less costly development, a faster regulatory path, and instant accurate results. The FDA has encouraged the development of digital tests to deal with COVID-19 and potential future respiratory diseases."
AveragePenny
2 años hace
$TBRIF Therma Bright Receives New Billing Codes for Venowave Allowing for Reimbursement from Medicare, Medicaid, and Private Insurers
https://www.newsfilecorp.com/release/142100
Toronto, Ontario--(Newsfile Corp. - October 27, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has received new temporary PDAC (Pricing, Data Analysis and Coding) billing codes for its Venowave product giving Therma Bright immediate access to reimbursement through Medicare and Medicaid.
On September 20, 2022 Therma Bright announced that initial US sales were made under an existing reimbursement code which required preapproval from the patient's insurance provider. This resulted in longer than optimal sales cycles both for the patients, their doctors and for Therma Bright.
Therma Bright is pleased to announce that the new temporary billing codes will allow doctors and patients in the US to easily order Venowave and have it covered by Medicare, Medicaid and third-party insurers. Therma Bright has submitted an application for unique permanent HCPCS (Healthcare Common Procedure Coding System) codes to the HCPC panel for the Venowave device and related replaceable wraps. A decision on the permanent codes is expected in H1/23. Until the new permanent codes are issued Therma Bright can use the temporary codes that were issued this month to receive reimbursement. This opens the market in the US to a broader range of reimbursable applications including:
Management of the symptoms of post thrombotic syndrome (PTS)
Prevention of deep vein thrombosis (DVT)
Prevention of primary thrombosis
Treatment of lymphedema
Treatment of leg swelling due to vascular insufficiency
Treatment of varicose veins
Treatment of chronic venous insufficiency
Enhancing blood circulation
Treatment of intermittent claudication
Rob Fia, CEO stated, "Receiving these new codes is a big win for Therma Bright. These codes will significantly open up the Venowave product to a greater number of users and multiple market opportunities which will greatly increase sales in the US. We are actively working with our partners on a sales execution strategy over the next quarter."
"The Company would also like to announce that it has engaged CYFR Inc. to execute a digital marketing campaign. These campaigns will run over a three-month period partially paid in cash with up to 300,000 warrants to be issued at $0.15 per share, subject to TSXV approval. The engagement includes services related to cost-per-click advertising, content creation, web development and activation support, advertising creative development, search engine optimization and strategic digital consulting."
Therma Bright also announces that it has negotiated a debt settlement with an arm's length creditor. Pursuant to the debt settlement agreement, and subject to acceptance by the TSX Venture Exchange, the Company has agreed to settle outstanding debt of $94,000 in consideration for which it will issue 626,666 common shares at a deemed price of $0.15 per share. All shares issued in relation to this debt settlement will be subject to a hold period expiring four months + one day after the date the shares are issued, in accordance with applicable securities laws and the policies of the TSX Venture Exchange.
AveragePenny
2 años hace
$TBRIF Therma Bright Receives Payment for Initial Venowave Sales
https://www.newsfilecorp.com/release/137783
Toronto, Ontario--(Newsfile Corp. - September 20, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that the initial order of its updated Venowave product has been sold to customers in the US by our exclusive distributor, DME Authority. Therma Bright is pleased to announce it has received payment towards this initial order.
Initial US sales were made under an existing reimbursement code which required preapproval from the patient's insurance provider. This resulted in longer than optimal sales cycles both for the patients, their doctors and for Therma Bright, as well as potentially causing some patients to have to pay out of pocket for the devices. Therma Bright is currently in the process of applying for several new reimbursement codes in the US that will make it simpler and faster for doctors and patients to order the Venowave and have it covered by their medical benefits. These new codes, which should be effective in the first half of 2023 will open the market in the US to a broader range of applications and potential users and allow doctors to freely prescribe the Venowave without worrying about their patients having to pay for the devices.
Therma Bright is also exploring distributors in other parts of the world to sell the Venowave product to healthcare professionals, as well as direct to consumer.
Rob Fia stated, "We are pleased to have the first Venowave products sold to customers in the US. We are actively exploring options to expand our sales network outside of the US so that we can deliver this potentially life saving technology to patients around the world. Our distribution partner in the US is receiving extensive requests from vascular and orthopedic surgeons, as well as surgical centers for the Venowave product. The application for new billing codes will open a number of other applications for Venowave and potentially greater revenue streams for Therma Bright with payment options through Medicare and Medicaid," continued Mr. Fia. "Sequential Compression Devices, inflatable cuffs and compression therapy is a multi-billion dollar market in the United States, and Therma Bright expects to capture a measurable share of this marketplace."
The initial manufacturing and shipment challenges experienced earlier in the year appear to have improved significantly and the Company does not expect significant issues in acquiring product from our Chinese supplier going forward.
AveragePenny
2 años hace
Therma Bright (THRM.V) (OTCMKTS: $TBRIF ) Receives Update from FDA on AcuVid™ COVID-19 EUA Application
https://thestreetreports.com/therma-bright-thrm-v-otcmktstbrif-receives-update-from-fda-on-acuvid-covid-19-eua-application/
Investors are often drawn to companies that are working on the development of innovative products. There are many companies that are working on such products and one that could be of interest at this point in time is Therma Bright (THRM.V) (OTCMKTS:TBRIF).
Market Stats
On Wednesday, TBRIF stock fell 5% to $0.0551 with 11K shares, compared to its average volume of 6.3k shares. The stock moved within a range of $0.0551 – 0.0551 after opening trading at $0.0555.
The company, which is involved in developing innovative medical device technologies, is currently working on the development of the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Earlier on this week, the company provided an update with regards to the Emergency Use Authorization application it had filed for the product with the United States Food and Drug Administration.
In the update that was provided by the company earlier this week on September 12, 2022, Therma Bright noted that it had been notified by the FDA that an initial review of the application had in fact been completed. The FDA has asked for more details regarding the product.
Therma Bright announced that it was working diligently with its suppliers and strategic partners at this point in time so as to be in a position from which it can answer all the questions as clearly as possible. After the process is concluded, Therma Bright is going to work on the resubmission of the Emergency Use Authorization application, which would bear all the additional information that had been sought by the FDA. Rob Fia, who is the Chief Executive Officer of the company, spoke about the situation as well.
He noted that the company and its strategic partners were confident about the performance of the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Hence, the company was going to continue to work with the FDA in order to eventually bring the product to the United States market. He went on to add that the company would provide all the details and specific data that would be needed for the authorization process.
AveragePenny
2 años hace
$TBRIF Therma Bright Provides Update on FDA EUA Review Process
https://www.newsfilecorp.com/release/136759/Therma-Bright-Provides-Update-on-FDA-EUA-Review-Process
Toronto, Ontario--(Newsfile Corp. - September 12, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, provides an update on it AcuVid™ COVID-19 Rapid Antigen Saliva Test's Emergency Use Authorization application with the U.S. Food and Drug Administration.
The Company has received communication from the FDA which states they have completed an initial review of our AcuVid™ EUA application and have asked for additional details and questions to be addressed on our rapid saliva test solution. The Therma Bright team is working closely with its strategic partners and suppliers to comprehensively and clearly respond to the FDAs questions. Once this effort is complete, the Company will resubmit its EUA application with all the additional documentation and tests requested by FDA reviewers, including details around transport and storage of RT PCR samples, additional data on external controls used, and further validation on AcuVid's ability to detect the Omicron variant post March 1, 2022, when the variant achieved 100% overall prevalence in the U.S. State of California variant tracker (https://covid19.ca.gov/variants/), where the U.S. clinical study was performed, shows Omicron was 90.0% of all new cases on December 29, 2021 and 99.8% on February 1, 2022.
"We and our strategic partners are confident in the performance of our innovative AcuVid™ COVID-19 Rapid Antigen Saliva Test and will continue to work with FDA officials in answering their questions in order to bring our solution to the U.S. marketplace, including providing the specific data and details as needed for authorization," shared Rob Fia, CEO of Therma Bright. "In tandem, we'll continue to pursue sales where authorized, as we navigate regulatory authorization processes from around the globe."
The FDA does not provide timelines on how long approvals will take. The Company will update the market as required.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
AveragePenny
2 años hace
$TBRIF Therma Bright Provides Progress Update on FDA EUA & Health Canada Interim Order Applications for Its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
https://www.newsfilecorp.com/release/132813
Toronto, Ontario--(Newsfile Corp. - August 4, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to provide the following update for Its AcuVid™ COVID-19 Rapid Antigen Saliva Test.
Therma continues to communicate with the FDA regarding its EUA application for its AcuVid™ COVID-19 Rapid Antigen Saliva Test. As well, Therma has sought and utilized advice from Ridge Global and our FDA regulatory consultants to determine how best to accelerate the review of the AcuVid™ EUA application.
In addition to responding to the FDA's initial review and request for additional information, the Company expects to receive further feedback from the FDA once they review the submitted responses.
Health Canada's application for approval under the Interim Order is moving along expeditiously with consistent feedback and answers between Therma and Health Canada's technical and medical reviewers.
"We thank our shareholders for their continued patience and support. The FDA EUA review process is a rigorous and thorough process, as are all regulatory reviews, and therefore patience is required", commented Rob Fia, CEO of Therma Bright.
Therma is also pleased to announce that it has fielded several potential sales inquiries for the AcuVid™ COVID-19 Rapid Antigen Saliva Test. Therma is currently discussing an order utilizing its self-certification CE mark for sales into Eastern Europe and other countries where the self-certification CE mark is accepted.
AveragePenny
2 años hace
$TBRIF Therma Bright Submits Health Canada Application for Its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test for Point-of-Care (POC)
https://www.newsfilecorp.com/release/128784/Therma-Bright-Submits-Health-Canada-Application-for-Its-AcuVidTM-COVID19-Rapid-Antigen-Saliva-Test-for-PointofCare-POC
Toronto, Ontario--(Newsfile Corp. - June 23, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce the submission of its Health Canada application for the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point-of-Care Use (PoC). The HC application includes all the updated data from the Company's U.S. Food and Drug Administration's Emergency Use Authorization (EUA) application.
"We're excited with our AcuVid™ Health Canada application and the prospect of approval for our unique COVID-19 rapid antigen saliva test for point-of-care (PoC)," shared Rob Fia, CEO of Therma Bright. "While we wait for both the U.S. FDA Emergency Use Authorization (EUA) and Health Canada review and approval, our team has begun preparing other regulatory applications where we believe our AcuVid™ COVID-19 Rapid Antigen Saliva Test will be in high demand this fall when countries from around the globe expect a resurgence of Covid-19."
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
AveragePenny
2 años hace
$TBRIF Therma Bright Grants Stock Options
https://www.newsfilecorp.com/release/127190
Toronto, Ontario--(Newsfile Corp. - June 10, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive medical device technologies, announces that it has granted incentive stock options to certain directors, officers and consultants of the Company to purchase up to an aggregate of 1,475,000 common shares of the Company pursuant to the Company's share option plan. The options are exercisable for a period of three years at a price of $0.25 per share.
AveragePenny
2 años hace
$TBRIF Therma Bright Provides Update on FDA EUA Application Process For AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
https://www.newsfilecorp.com/release/126235
Toronto, Ontario--(Newsfile Corp. - June 2, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive medical device technologies, is pleased to provide an update for the Company's AcuVid™ COVID-19 Rapid Antigen Saliva Test and its U.S. Food and Drug Administration's Emergency Use Authorization application process.
The Company's Executive and Product Development teams have been working with FDA officials to clarify answers to some of the EUA application questions, as well as provided some reformatting of data to better meet the EUA application template requirements. Both the follow-up answers and reformatted data have been submitted, and Therma Bright now patiently awaits a successful FDA response for Emergency Use Authorization (EUA).
On March 29, 2022, after a month of preparation of its AcuVid™ documents and test data, the Company submitted its FDA EUA application for Point of Care Use. The application submission included a great deal of detail on the AcuVid™ COVID-19 Rapid Antigen Saliva Test, including: over 490 combined test results from the U.S. and Brazilian clinical performance studies, numerous mouth- and nasal-borne viruses and bacteria cross-reactivity tests and World Health Organization's (WHO) Variants of Concern testing.
As announced on February 15, 2022, the final U.S. clinical performance study data submitted exceeded the FDA EUA minimum requirements. However, over the last few months, as the Company worked with FDA officials, irrelevant U.S. Clinical test data was removed, which was submitted in the March 29th EUA application. Upon re-calculating the clinical study results, the Therma Bright team discovered that the U.S. clinical performance study performed better than originally reported. The adjusted U.S. clinical performance study results demonstrated a stronger Positive Percent Agreement (PPA), while Negative Percent Agreement (NPA) remained relatively the same, as originally reported. This update has now been updated in the Company's EUA application.
"Our AcuVid™ COVID-19 Rapid Antigen Saliva Test performance during the height of Delta and Omicron clearly demonstrates its ability to detect this horrible COVID-19 virus quickly and effectively," shared Rob Fia, CEO of Therma Bright. "Based on all the test data provided and now reformatted, along with what we hope will be our final responses to several clarify questions by FDA officials, we anticipate a successful conclusion to our Emergency Use Authorization application. As reference in our recent Health Canada announcement, we plan to use the data and FDA EUA application answers to apply and secure other regulatory approvals around the world. We're excited for the back half of 2022. Therma Bright is preparing for any resurgence of COVID-19 this fall1, as announced in the press."
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
AveragePenny
3 años hace
$TBRIF Therma Bright to Submit Application to Health Canada for Approval of its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
https://www.newsfilecorp.com/release/123395
Toronto, Ontario--(Newsfile Corp. - May 10, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), a progressive medical device technology company, is pleased to announce that it will submit an application to Health Canada for review of the Company's AcuVid™ COVID-19 Rapid Antigen Saliva Test for detecting SARS CoV-2 virus in saliva.
The application to Health Canada follows an application under the Emergency Use Authorization (EUA) guidelines to the U.S. Food & Drug Administration (FDA) for review of its AcuVid™ COVID-19 Rapid Antigen Saliva Test on March 29, 2022. The application to Health Canada will be made under the Interim Order issued by Health Canada. The application is substantially equivalent to the one made to FDA and uses the test performance data from the US and Brazilian clinical studies and the product manufacturing data provided to the FDA.
The FDA under its Emergency Use Authorization and Health Canada under the Interim Order recommend that candidate tests should demonstrate a minimum sensitivity of greater than 80%. The results achieved by the AcuVid™ test in clinical studies exceed the minimum threshold for approval by these regulatory agencies.
Therma Bright's goal is to provide a low-cost, scalable saliva-based antigen test for routine and widespread testing of both symptomatic and asymptomatic individuals in schools, workplaces, nursing homes, sporting events, airports and other venues where a rapid result is required.
Mr. Rob Fia, CEO of Therma Bright, commented, "We are pleased to have filed with the FDA in March and shortly with Health Canada. We are also exploring other international regulatory jurisdictions where it may be advantageous for us to file and are actively seeking initial orders, subject to final regulatory approvals. Our suppliers and contract manufacturers have been locked down and will provide sufficient capacity to fulfil the initial orders and volume orders as they develop."
"With the detection of new sub-variants of concern such as Omicron BA.4 and BA.5, it has become clear that Covid will be with us for a long time and will probably become endemic much like influenza, necessitating the need for continued vigilance and testing," added Mr. Fia.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
AveragePenny
3 años hace
$TBRIF $THRM.V Therma Bright Ships Initial Venowave Order to US Distributor
https://www.newsfilecorp.com/release/122007
Toronto, Ontario--(Newsfile Corp. - April 28, 2022) - 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, is pleased to announce that the initial order of its updated Venowave product has been shipped to its US distributor, DME Authority, LLC, from Therma's Chinese contract manufacturer. As previously announced on December 16, 2021 the initial order consists of 2,500 units, each unit consists of 2 Venowave devices, of which 500 units have been shipped by air, with the balance being shipped by sea.
Despite the challenges of material and component shortages, logistics and shipping delays and lockdowns in various parts of China, the initial order was completed and shipped recently.
Venowave is a compact and lightweight Deep Vein Thrombosis (DVT) prevention pump specifically designed for use at home. The Venowave device uses a continuous wave motion to increase blood flow in the veins. The increased blood circulation helps prevent venous stasis, which is a major contributor in thrombus formation. Specifically, the device imitates the body's venous system to counteract the pooling of blood in the lower extremities which can lead to clotting. With about 50% of DVTs beginning to form intra-operatively and 75% forming within 48 hours post-operatively, this technology is pioneering an alternative, easy to use life-saving treatment for this condition.
Rob Fia, CEO stated "We are pleased to have the first shipments of our Venowave product sent to DME Authority, our US distributor. It has been a frustrating process with all of the shortages and delays, but we are now poised to increase production and availability of the product as demand grows. We are excited to be able to deliver products to customers in the US who have been patiently waiting for this potential life saving technology."
AveragePenny
3 años hace
$TBRIF Therma Bright Submits AcuVid(TM) COVID-19 Rapid Antigen Saliva Test Application for U.S. Food & Drug Administration's Emergency Use Authorization (EUA)
https://www.newsfilecorp.com/release/118493
Toronto, Ontario--(Newsfile Corp. - March 29, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce the submission of its U.S. Food & Drug Administration's (FDA) Emergency Use Authorization (EUA) application for its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care (POC).
"I am pleased to announce the submission of our AcuVid™ COVID-19 Rapid Antigen Saliva Test for U.S. Food & Drug Administration's Emergency Use Authorization," shared Rob Fia, CEO of Therma Bright. "Our application includes data from our U.S. clinical performance study, Brazilian clinical study, all required cross-reactivity tests, additional FDA requested cross-reactivity tests for mouth-borne viruses and bacteria, and numerous tests around World Health Organization's (WHO) Variants of Concern (VOCs), such as Delta and Omicron. Our team and partners stand ready to deliver upon receipt of FDA EUA."
Since July 2021, the Company's Executive and Development teams have worked with FDA officials, doctors and scientists on its AcuVid™ EUA application requirements. Timing on this authorization process is unknown, therefore, the Company will only notify the market upon receipt of the FDA's decision.
"With our AcuVid™ FDA EUA application submitted, the Company has begun investigating another saliva-based testing technology incorporating a robust platform for the detection for other respiratory infectious diseases affecting the lungs, as well as a novel saliva-based platform for Neuro-Vascular disorders (e.g. PTSD, head trauma/concussion)," continued Rob Fia, Therma Bright's CEO. "We'll keep the market updated on this effort, along with our business progress on our other medical devices."
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
AveragePenny
3 años hace
$TBRIF Therma Bright Receives Patent for a Device for Applying a Topical Treatment from U.S. Patent & Trademark Office (USPTO)
https://www.newsfilecorp.com/release/114552
Toronto, Ontario--(Newsfile Corp. - February 23, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that on February 4, 2022 the U.S. Patent and Trademark Office allowed a U.S. patent application (US 15/787,599) which covers a device that can apply heat and antimicrobial treatment through a detachable applicator surface comprising copper or silver to provide heat conductivity and a source of antimicrobial agent. The device also includes a light source. This U.S. patent applies to both Therma Bright's InterceptCS™ Cold Sore Prevention Device and TherOZap™ Insect Bite Relief Device.
Specific to the InterceptCS™ device, this heat and antimicrobial treatment technology is combined as the solution for the prevention of cold sores. As for the TherOZap™ device, the treatment technology aims to reduce the inflammatory response, relieving the symptoms of pain, itch and inflammation associated with insect bites and stings. Furthermore, as shared in earlier press releases, the Company engaged a top Virology Research Laboratory in Canada to study the TherOZap™ technology's ability to inactivate live Zika virus in culture media and that the TherOZap™, which utilizes specialized materials, coatings and heat, was able to limit Zika virus ("ZIKV") replication in cell cultures.
"This is exciting news for Therma Bright and our TherOZap™ Insect Relief Device and InterceptCS™ Cold Sore Prevention Device," shared Rob Fia, CEO of Therma Bright. "This allowed U.S. Patent Application further protects our valued intellectual property (IP) as we continue to transform innovation into wellness."
Therma Bright is currently undergoing design upgrades to both devices and expects to complete prototyping during Q2. In addition, the Company plans to continue its research with the new TherOZap™ design on Zika and other mosquito-borne diseases during 2022.
AveragePenny
3 años hace
$TBRIF Therma Bright Receives Patent for a Device for Applying a Topical Treatment from U.S. Patent & Trademark Office (USPTO)
https://www.newsfilecorp.com/release/114552
Toronto, Ontario--(Newsfile Corp. - February 23, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that on February 4, 2022 the U.S. Patent and Trademark Office allowed a U.S. patent application (US 15/787,599) which covers a device that can apply heat and antimicrobial treatment through a detachable applicator surface comprising copper or silver to provide heat conductivity and a source of antimicrobial agent. The device also includes a light source. This U.S. patent applies to both Therma Bright's InterceptCS™ Cold Sore Prevention Device and TherOZap™ Insect Bite Relief Device.
Specific to the InterceptCS™ device, this heat and antimicrobial treatment technology is combined as the solution for the prevention of cold sores. As for the TherOZap™ device, the treatment technology aims to reduce the inflammatory response, relieving the symptoms of pain, itch and inflammation associated with insect bites and stings. Furthermore, as shared in earlier press releases, the Company engaged a top Virology Research Laboratory in Canada to study the TherOZap™ technology's ability to inactivate live Zika virus in culture media and that the TherOZap™, which utilizes specialized materials, coatings and heat, was able to limit Zika virus ("ZIKV") replication in cell cultures.
"This is exciting news for Therma Bright and our TherOZap™ Insect Relief Device and InterceptCS™ Cold Sore Prevention Device," shared Rob Fia, CEO of Therma Bright. "This allowed U.S. Patent Application further protects our valued intellectual property (IP) as we continue to transform innovation into wellness."
Therma Bright is currently undergoing design upgrades to both devices and expects to complete prototyping during Q2. In addition, the Company plans to continue its research with the new TherOZap™ design on Zika and other mosquito-borne diseases during 2022.
AveragePenny
3 años hace
$TBRIF Therma Bright Announces CAD$6 Million Private Placement with Institutional Investors
https://www.newsfilecorp.com/release/113962
Toronto, Ontario--(Newsfile Corp. - February 16, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce that it has entered into a securities purchase agreement with institutional investors for a private placement of its common shares ("Common Shares") (or Common Share equivalents) and warrants to purchase Common Shares ("Warrants") for gross proceeds of CAD$6 million (the "Private Placement"). Pursuant to the Private Placement, the Company will issue 20,000,000 Common Shares (or Common Share equivalents) and Warrants to purchase up to an aggregate of 20,000,000 Common Shares at a purchase price of CAD$0.30 per Common Share and associated Warrant. Each Warrant will entitle the holder to purchase Common Shares at an exercise price of CAD$0.375 per Common Share for a period of five years following the issuance date.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the Private Placement.
The net proceeds of the Private Placement will be used by the Company for general working capital purposes. No securities were offered or sold to Canadian residents in connection with the Private Placement. The Private Placement is expected to close on or about February 18, 2022, subject to satisfaction of customary closing conditions.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The securities referred in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, (the "U.S. Securities Act"), or any U.S. state securities laws, and such securities may not be offered or sold within the United States or to any U.S. person absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements. "United States" and "U.S. person" have the respective meanings ascribed to them in Regulation S under the U.S. Securities Act.
AveragePenny
3 años hace
$TBRIF Therma Bright's AcuVid(TM) U.S. Clinical Performance Study Successfully Exceeds U.S. Food & Drug Administration's Emergency Use Authorization Requirements
https://www.newsfilecorp.com/release/113824
Toronto, Ontario--(Newsfile Corp. - February 15, 2022) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, is pleased to announce its AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care (PoC) has successfully exceeded U.S. Food & Drug Administration's (FDA) Emergency Use Authorization (EUA) requirements for both Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). The Company's management and product development teams are currently compiling the U.S. Clinical Performance Study results with all supplemental studies into one complete FDA EUA application for submission. This achievement places Therma Bright in a very unique leadership position as the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study.
In total, both the U.S. Clinical Performance Study and Brazilian Clinical Study tested over 490 patients, more than other COVID-19 rapid antigen test manufacturers prior to their FDA EUA for Point of Care (PoC). The AcuVid™ saliva test also achieved successful results on several mouth-based bacteria and viruses in additional cross-reactivity study requests from the FDA, which other EUA test manufacturers did not have to conduct.
The AcuVid™ U.S. Clinical Performance Study was conducted from December 2021 through January 2022 when Omicron B.1.1.529 variant became the dominant strain across the United States1. Similarly, when the AcuVid™ Brazilian Clinical Study was completed in July 2021, the South America county's dominant variants were P.1 and P.2. These two clinical studies not only demonstrate, but also validate, the effectiveness of the 15-minute COVID-19 rapid antigen saliva test's ability to detect the original SARS CoV-2 Novel Coronavirus, as well as the growing list of World Health Organization's (WHO) Variants of Concern. Furthermore, and as stated in prior releases, the Company has begun work on its FDA EUA efforts for AcuVid™ At Home Use, and continues to work with its valued partners to improve the performance of its rapid antigen saliva test for this self-test submission.
"We are pleased with the success of our AcuVid™ U.S. Clinical Performance Study, along with our Brazilian clinical study, various cross-reactivity studies and numerous COVID-19 variant studies," shared Rob Fia, CEO of Therma Bright. "Since July 2021, our team has worked diligently with FDA officials, doctors and scientists in our pursuit to meet all the EUA requirements. It's our belief we have achieved all requests and requirements, and have one of the most tested pre-EUA COVID-19 rapid antigen tests for submission. Once our final FDA EUA application for Point-of Care is complete, we will submit and patiently await authorization."
Therma Bright believes its one-of-a-kind, smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test will play a critical role in detecting and mitigating the spread of this virus and its growing list of variants, including the current Omicron B.1.1.529, which is relevant to the September 23, 2021 FDA EUA Guidance2 changes for tests manufacturers to validate that their solutions detect these mutations and variants.
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
In other news, Therma Bright announced that it has entered into a 4-month marketing and consulting contract with Toronto based marketing firm, North Equities Corp. North Equities Corp. specializes in various social media platforms and has been engaged to facilitate greater awareness and widespread dissemination of the Company's news. Pursuant to the terms of the agreement, the Company paid North Equities $15,000 on signing of the agreement. North Equities does not currently own shares of the Company. The Company also announced that it has engaged a consultant to assist it in sourcing distribution channels for its AcuVid ™ and TheroZap™ products and to assist with branding of its AcuVid™ and TheroZap™ products. Subject to TSXV approval, as partial consideration for its services, Therma Bright intends to issue 235,000 share purchase warrants to the consultant, with each warrant being exercisable for a shares for a period of two years at an exercise price of $0.40/share.
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