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Therma Bright Inc. (TBRIF) is a developer and partner in a wide range of leading-edge, proprietary diagnostic and medical device technologies. The company focuses on providing consumers and medical professionals innovative solutions to address today's most important medical challenges. Therma Bright is traded on TSX Venture Exchange (THRM) and OTCQB (TBRIF). Recent achievements include receiving a cease trade order from the Ontario Securities Commission and working diligently to file required documents. Therma Bright also announced the reopening of its application for Venowave device codes and plans for a strategic review to maximize shareholder value.
Therma Bright's Venowave VW5 has secured a permanent Healthcare Common Procedure Coding System (HCPCS) code E0683 from the U.S. Centers for Medicare and Medicaid Services (CMS). This makes it the first-of-its-kind Durable Medical Equipment to receive a new HCPCS Level II designation. The device addresses deep vein thrombosis (DVT) and nine other circulatory issues.
CMS has approved a complete patient buyout option for a pair of Venowave devices with a capped reimbursement of $1199, or a rental option at $78.05 per month for 13 months. The Venowave VW5 is a compact, battery-operated peristaltic pump that improves vascular and lymphatic flow in the lower limbs. It offers advantages over compression socks, providing comfortable and effective treatment for various circulatory conditions.
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) announced that its AI-powered Digital Cough Technology (DCT) is being considered as a partner technology for a new chronic cough drug clinical trial in the US. The company, in collaboration with AI4LYF, has developed this platform to support healthcare decision-making by improving respiratory data collection and analysis.
Therma Bright is also pursuing FDA classification and regulatory requirements for its DCT as a remote therapeutic monitoring solution. The company has prepared additional materials, including user guides and data capture platforms. Furthermore, Therma Bright is exploring possibilities for CMS reimbursement code designation and federal funding for its DCT platform, while awaiting final approval on permanent CMS reimbursement codes for its Venowave VW5 solution.
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) has added Michael Raimondo to its advisory board. Raimondo, a 30-year veteran in the medical and pharmaceutical industries, brings extensive leadership experience and a track record of over $500 million in sales contracts. His initial focus will be on Venowave sales and business development.
Raimondo's expertise in sales negotiations and strategic account management is expected to boost Therma Bright's efforts in expanding its health-tech and med-tech device sales, particularly Venowave. The company is awaiting approval for patient reimbursement permanent codes from the U.S. Centers of Medicare and Medicaid (CMS) for Venowave, which could potentially benefit the 900,000 U.S. citizens who suffer from deep vein thrombosis annually.
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) has expanded its investment in InStatin, a company developing an inhaled statin solution for chronic lung conditions like asthma and COPD. This investment is part of a SAFE (Simple Agreement for Future Equity) plan, which will increase Therma's ownership stake from the current 17% at a discount to InStatin's next financing round.
InStatin is initiating preclinical studies to progress towards Phase 1 human trials. The global asthma treatment market is projected to reach USD $30.1 billion by 2030, highlighting significant market potential. Additionally, Therma Bright is in discussions regarding its investment in InVixa, which is developing inhaled statins for COVID-19 pneumonia and ARDS treatment.
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) has received positive notification from the U.S. Centers for Medicare & Medicaid Services (CMS) regarding pending permanent Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes for its Venowave VW5 device. The codes are expected to cover ten health-related and CMS reimbursable indications, including prevention of deep vein thrombosis (DVT) and management of post-thrombotic syndrome symptoms.
The company anticipates formal approval in the coming days, which could significantly impact its market opportunity. According to the CDC, over 900,000 U.S. citizens are affected by DVT and pulmonary embolism annually. Global market projections for DVT treatment alone range from USD $1.26 billion by 2028 to USD $1.554 billion by 2032.
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) has received FDA 510K approval for its Venowave VW5 device, addressing the U.S. Centers for Medicare and Medicaid Services (CMS) requirements. This approval allows the device to be used successively by multiple patients, a key factor for securing permanent CPT® and HCPCS codes. The Venowave VW5 is a compact, battery-operated peristaltic pump that improves vascular and lymphatic flow in lower limbs, targeting conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE).
With this approval, Therma Bright expects imminent issuance of permanent codes, enabling distribution partners to deploy Venowave to Medicare and Medicaid medical practitioners. The company has also engaged Outside The Box Capital Inc. for marketing and investor relations services to enhance communication with investors and expand visibility.
Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX), a developer and investment partner in diagnostic and medical device technologies, has engaged Independent Trading Group (ITG) for market-making services. This engagement, subject to regulatory approval, aims to maintain a reasonable market and improve liquidity of Therma Bright's common shares on the TSXV and other trading venues.
The agreement includes compensation of CAD $5,500 per month to ITG, with an initial one-month term that automatically renews unless terminated. Either party can terminate with 30 days' notice. ITG will not receive shares or options as compensation, and there are no performance factors in the agreement. The companies are unrelated, and ITG has no interest in Therma Bright's securities at the time of the agreement.
Therma Bright Inc. (TBRIF), a developer of medical device technologies, provided a market update.
The company successfully raised $1M CAD through a private placement, intending to invest in its Digital Cough Analyzer and InStatin Inc., along with covering debts and working capital.
The Venowave device awaits permanent HCPCS and CPT codes, potentially expanding its market reach.
Therma is working with the FDA on the regulatory requirements for its AI-powered Digital Cough Analyzer.
Investments in Inretio and InStatin show promise, with Therma holding significant stakes in both companies.
A strategic review is ongoing to explore various options to maximize shareholder value.
Therma Bright (TSXV: THRM, OTCQB: TBRIF) announced it has completed debt settlements by issuing 19,250,000 common shares at $0.01 per share, settling an aggregate debt of $192,500. These shares are subject to a hold period until October 20, 2024. CEO Rob Fia participated in the debt settlement, receiving 8,500,000 shares for $85,000 of debt, which is a related party transaction under MI 61-101. Prior to this, Fia owned 28,718,744 shares (7.2% of Therma's outstanding shares). Post-transaction, he now owns 37,218,744 shares, representing 8.8% of the total outstanding shares. On a partially diluted basis, Fia's ownership could rise to 13.3%. Fia's acquisition is for investment purposes and he may change his holdings in the future. Further details can be found on SEDAR+.
Therma Bright has completed the first tranche of its non-brokered private placement, raising $854,500 by issuing 85,450,000 units at $0.01 each. The proceeds will fund investments in Digital Cough Technology and InStatin Inc, cover management and director debts, investor relations, and general working capital. CEO Rob Fia purchased 17,500,000 units for $175,000, increasing his stake to 7.2%. Allele Communications will provide investor relations services for $7,500 per month under a new consulting agreement. The securities are subject to a hold period until October 11, 2024.
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