The medical device industry is expanding rapidly, propelled by technological advancements and rising healthcare demands globally. According to Statista, the global medical devices market is expected to grow annually by 5.71%, reaching $673.10 billion by 2029. Key markets like the United States are significant contributors, with an anticipated $179.80 billion in medical device revenues in 2024.
Amid this growth, Therma Bright Inc. (OTCQB: TBRIF) (TSXV: THRM) has emerged as a notable player, developing cutting-edge diagnostic and medical device technologies. The company recently announced key milestones in Q2 2024, including successfully securing CAD $1,000,000 through a private placement. These funds are allocated towards developing the Digital Cough Analyzer (DCA) and increasing the company’s stake in InStatin Inc. This demonstrates strong investor confidence and 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.
A significant achievement for Therma Bright 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 addresses circulatory issues such as deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS), with the DVT treatment market expected to reach USD $1.554 billion by 2032.
Fia stated, “With the FDA 510K application approval and CMS code designation recommendations complete, we anticipate the Venowave’s permanent codes approval imminently. 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.”
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 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 pivotal for TBRIF as 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.
Therma Bright is also advancing its AI-powered Digital Cough Analyzer (DCA), positioned as a remote therapeutic monitoring solution. The DCA aims to tap into the growing global respiratory monitoring market, projected 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.
Additionally, Therma Bright continues to enhance its portfolio through strategic investments in companies developing solutions for chronic lung disease management and ischemic stroke treatment. The company's significant stakes in InStatin Inc. and Inretio are 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 deliver substantial returns for shareholders.
Therma Bright Inc. 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 enhancing its market presence and 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.
