Therma Bright Inc. Secures Key FDA Approvals and Strategic Investments in Medical Device Market
TL;DR
Therma Bright Inc. is positioned for potential growth in the expanding medical devices market, presenting an interesting investment opportunity.
Therma Bright Inc. has achieved significant milestones in Q2, including securing funds for developing the Digital Cough Analyzer and increasing stake in InStatin Inc.
Therma Bright Inc.'s advancements in medical device technologies have the potential to make a positive impact on the world by offering effective solutions for circulatory and respiratory health issues.
The FDA's approval of Therma Bright Inc.'s Venowave VW5 and the anticipated CMS code approvals represent pivotal achievements in the medical device industry.
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The medical device industry is witnessing rapid growth, driven by technological advancements and increasing healthcare demands. Statista projects the global medical devices market to grow annually by 5.71%, reaching $673.10 billion by 2029. The United States alone is expected to generate $179.80 billion in medical device revenues in 2024.
In this expanding market, Therma Bright Inc. (OTCQB: TBRIF) (TSXV: THRM) is gaining attention as a developer of cutting-edge diagnostic and medical device technologies. On July 3, 2024, Therma Bright announced key achievements, including securing CAD $1,000,000 through a private placement to develop its Digital Cough Analyzer (DCA) and increase its stake in InStatin Inc.
A pivotal development 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 positions the device to meet the U.S. Centers for Medicare and Medicaid Services (CMS) requirements for permanent CPT and HCPCS codes, essential for insurance reimbursements.
The Venowave VW5, which addresses circulatory issues such as deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS), is expected to significantly impact the $1.554 billion DVT treatment market by 2032. “With the FDA 510K application approval and CMS code designation recommendations complete, we anticipate the Venowave’s permanent codes approval imminently,” said CEO Rob Fia.
As of August 1, 2024, Therma Bright received positive notification from CMS regarding the pending permanent CPT and HCPCS codes for the Venowave VW5, covering ten critical health-related indications. The confirmation of these codes will enable Therma Bright to fully leverage insurance reimbursements, significantly expanding its market reach.
Therma Bright is also advancing its AI-powered Digital Cough Analyzer (DCA), aimed at the growing respiratory monitoring market, projected to nearly double to USD $2.99 billion by 2032. The company plans to work closely with the FDA on regulatory requirements for the DCA.
Additionally, Therma Bright is enhancing 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, given the projected growth of the asthma treatment and coronary stent markets to USD $30.1 billion and USD $4.8 billion by 2030 and 2029, respectively.
Therma Bright’s recent advancements, including the anticipated CMS code approvals for the Venowave VW5, underscore its potential for growth in the medical device industry. By securing key regulatory approvals and investing in innovative technologies, Therma Bright is enhancing its market presence and positioning itself for transformative success. Investors should monitor the company’s progress as it navigates this dynamic sector and drives forward with its ambitious growth strategy.
Curated from News Direct
