The medical devices industry is experiencing robust growth, driven by technological advancements and increasing healthcare demands worldwide. The global medical devices market is on a robust growth trajectory, with a projected annual increase of 5.71%, reaching $673.10 billion by 2029, as reported by Statista. This expansion is largely driven by key markets like the United States, which is expected to generate $179.80 billion in medical device revenues in 2024 alone. 

In this expanding market, one company gaining attention is Therma Bright Inc. (OTCQB: TBRIF) (TSXV: THRM), a developer and partner in cutting-edge diagnostic and medical device technologies.

Key Achievements and Market Positioning

On July 3, 2024, Therma Bright provided a significant market update, underscoring major milestones achieved in Q2. A critical development was the successful securing of CAD $1,000,000 through a private placement, demonstrating strong investor confidence. These funds are allocated towards developing the Digital Cough Analyzer (DCA) and increasing the company’s stake in InStatin Inc., reflecting strategic moves across multiple high-growth markets.

Therma Bright’s CEO, Rob Fia, highlighted that the proceeds would also support investor relations efforts and general working capital, emphasizing the company’s robust outlook.

Venowave VW5: FDA Approval and Anticipated CPT/HCPCS Codes

A major milestone for TBRIF in Q2 was the FDA’s approval of its 510K application for the Venowave VW5, a medical compression device designed to improve circulation in the lower extremities. This approval is pivotal as it meets the U.S. Centers for Medicare and Medicaid Services (CMS) requirement for issuing permanent CPT and HCPCS codes.

The Venowave VW5 is a lightweight, discreet device that addresses circulatory issues such as deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS). The market for DVT treatments alone is estimated to reach USD $1.554 billion by 2032, making this approval a significant achievement for Therma Bright.

“With the FDA 510K application approval and CMS code designation recommendations complete, we anticipate the Venowave’s permanent codes approval imminently,” said Fia. “Our distribution partners are ready to deploy the Venowave to Medicare and Medicaid medical practitioners, offering an effective solution for patients suffering from various circulatory issues.”

Awaiting CMS Approval: A Key Growth Catalyst

As of August 1, 2024, Therma Bright received positive notification from CMS regarding the pending permanent CPT and HCPCS codes for its Venowave VW5 device. These codes are expected to cover ten critical health-related indications, from DVT prevention to enhancing blood circulation. The confirmation of these codes, anticipated in the coming days, will enable Therma Bright to fully leverage insurance reimbursements, significantly expanding its market reach.

“We’re patiently awaiting confirmation from CMS, which is expected in a matter of days,” said Fia. “The approval of these permanent codes will be a game-changer for our distribution strategy and market penetration.”

The confirmation of these codes is a pivotal opportunity for TBRIF because it allows the Venowave VW5 to be covered by insurance, making it more accessible to patients and more attractive to healthcare providers. This expansion into the insured market can significantly boost sales, revenue, and market presence, positioning Therma Bright as a leader in the circulatory health market.

Digital Cough Analyzer (DCA) Powered by AI4LYF

Therma Bright’s advancements are not limited to circulatory health. The company is also progressing with its AI-powered Digital Cough Analyzer (DCA). Positioned as a remote therapeutic monitoring solution, the DCA is poised to tap into the growing global respiratory monitoring market, which is expected to nearly double, reaching USD $2.99 billion by 2032.

Plans are in place to work closely with the FDA on regulatory requirements, positioning the DCA as a key player in respiratory health technology.

Investments in InStatin and Inretio

TBRIF continues to enhance its portfolio through strategic investments in companies developing cutting-edge solutions in chronic lung disease management and ischemic stroke treatment. The company’s significant stakes in InStatin Inc. and Inretio are particularly noteworthy. The global markets for asthma treatment and coronary stents are projected to reach USD $30.1 billion and USD $4.8 billion by 2030 and 2029, respectively, highlighting the potential impact of these investments.

Fia expressed optimism about these ventures, noting that InStatin’s innovative solution for chronic lung conditions, including asthma and COPD, could potentially deliver returns for shareholders.

Conclusion

Therma Bright Inc. (OTCQB: TBRIF) (TSXV: THRM) stands at an important moment in the medical device industry, with its innovative approaches positioning it for potential growth. The company’s advancements, including the anticipated CMS code approvals for the Venowave VW5, underscore its ability to capitalize on opportunities. By securing key regulatory approvals and investing in cutting-edge technologies, Therma Bright is not only enhancing its market presence but also setting the stage for transformative success. As the company continues to lead with  solutions in circulatory health and respiratory monitoring, it presents an interesting investment opportunity. Savvy investors may want to closely monitor Therma Bright’s progress as it navigates this dynamic sector and drives forward with its ambitious growth strategy.

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