Therma Bright (TBRIF) Stock Skyrockets After Medicare and Medicaid Milestone, Enters Multi-Billion-Dollar Market

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A burgeoning name in the medical device industry, has achieved a significant breakthrough for its flagship product, the Venowave VW5. This circulation-enhancing device recently secured a crucial designation from the Centers for Medicare and Medicaid Services (CMS), positioning it for success within the expansive Medicare and Medicaid frameworks.

The Venowave VW5 has been awarded a permanent Healthcare Common Procedure Coding System (HCPCS) code, a pivotal development that could propel Therma Bright into the forefront of the deep vein thrombosis (DVT) treatment market. Industry estimates project this market to grow to $1.5 billion by 2032, offering substantial growth prospects for Therma Bright, which currently holds a modest market cap of USD $21 million.

Introducing Therma Bright: Innovating Blood Clot Prevention, and Beyond

Therma Bright, Inc., the innovative force behind the Venowave VW5, specializes in cutting-edge diagnostic and medical device technologies. While the company boasts a diverse portfolio, the Venowave VW5 is currently generating the most investor enthusiasm.

The Venowave VW5 is a device designed to be worn on the calf, where it generates wave-like motions to massage the leg and promote blood circulation. This function is critical in pushing blood back to the heart, helping to prevent blood clotting, particularly in cases of DVT—a condition that affects approximately 900,000 Americans annually, according to the CDC. Unlike traditional compression socks, which can cause discomfort and skin issues, the VW5 offers a more comfortable and effective alternative for DVT patients.

Venowave VW5 Achieves Key Medicare & Medicaid Designation

The Venowave VW5 is the first device of its kind to be classified as Durable Medical Equipment (DME) with a new HCPCS Level II code. This designation enhances the device's credibility as a treatment option and streamlines billing and reimbursement processes through Medicare and Medicaid. This is expected to increase its appeal among patients seeking treatment for DVT.

Medicare and Medicaid reimbursement is crucial for a company like Therma Bright because it opens the door to a vast and stable market of insured patients, ensuring consistent demand for their products. Securing reimbursement from these programs not only validates the effectiveness and necessity of their devices but also simplifies the purchasing process for patients and healthcare providers. For investors, this is a significant milestone as it enhances the company’s revenue potential and reduces financial risk, making Therma Bright a more attractive and reliable investment opportunity.

As per the recent announcement, patients will have the option to purchase a pair of Venowave devices outright with a capped reimbursement of $1,199. Alternatively, they can opt for a rental plan, with monthly reimbursement capped at $78.05, totaling $819.55 over 13 months. Ownership of the device will transfer to the patient after the 13th rental payment.

Strategic Distribution Partnership Secured

Shortly after receiving its new designation, Therma Bright announced a partnership with a major distributor to launch an initial sales program. This initiative aims to assess Medicare and Medicaid reimbursement timelines and billing procedures. If successful, the distributor has agreed to purchase the remaining Venowave VW5 inventory, valued at $2.38 million.

While the distributor's identity has not been disclosed, it is expected that further details will emerge as the program progresses. This partnership marks a crucial step towards establishing the VW5 as a preferred DVT treatment, particularly for patients covered by Medicare and Medicaid. Therma Bright's CEO, Rob Fia, anticipates a "significant increase" in monthly orders as a result.

Beyond DVT: Expanding the Venowave VW5's Applications

While the Venowave VW5 is already gaining attention for its role in DVT treatment, its potential applications extend far beyond. The device is capable of addressing a wide range of conditions, significantly broadening Therma Bright's total addressable market.

In addition to DVT, the VW5 can be used for:

- Managing symptoms of post-thrombotic syndrome (PTS)

- Preventing primary thrombosis

- Treating lymphedema

- Reducing post-operative pain and swelling

- Alleviating leg swelling caused by vascular insufficiency

- Treating varicose veins

- Managing chronic venous insufficiency

- Enhancing blood circulation

- Addressing intermittent claudication

All of these ailments represent blue sky for Therma Bright as each one of these very common medical issues, as they potentially become approved, would unlock a whole new category of customer for the company. 

Therma Bright's Diverse, Late-Stage Product Pipeline 

Therma Bright's diverse product portfolio is a key driver of its investor appeal, with its investment in Inretio at the forefront. 

Inretio is revolutionizing ischemic stroke treatment with its Preva® clot-retrieval device, which has recently completed its third successful human trial. This groundbreaking technology represents a significant leap in thrombectomy procedures, offering unmatched precision in restoring blood flow for stroke patients, even when traditional treatments like tPA fail. 

The Preva® device's patented protective basket design reduces the risk of embolization and minimizes the need for repeated maneuvers, positioning it as a potential game-changer in the global market for advanced clot removal solutions. As Inretio progresses towards FDA 510K designation, the success of the Preva® device underscores the strategic value of Therma Bright's investment in cutting-edge medical technologies.

With the global coronary stents market expected to reach $4.8 billion by 2029, the continued development of this device could greatly enhance Therma Bright's portfolio.

The $16 Billion COPD Market

Therma Bright is making significant strides with its investment in InStatin, a company developing innovative inhaled statin therapies for respiratory diseases like asthma and Chronic Obstructive Pulmonary Disease (COPD). Unlike traditional statin therapies that are administered orally, InStatin’s novel delivery system targets the airways and lungs directly, potentially offering a more effective treatment at lower dosages. This cutting-edge approach could revolutionize the management of these respiratory conditions, which collectively affect over 600 million people globally.

The global market for asthma and COPD treatments is substantial, with an estimated value exceeding $16 billion annually. This presents a significant growth opportunity for Therma Bright as InStatin progresses through pre-clinical stages. The unique benefits of inhaled statins—such as reduced tissue thinning and longer-lasting therapeutic effects compared to steroids—position this technology as a promising alternative in a market that has seen little innovation over the past 50 years.

With a 17% equity stake in InStatin and a 60% stake in Invixa, Therma Bright is well-positioned to capitalize on the success of these therapies.

Turn Your Head and Cough

Therma Bright has also played a pivotal role in developing the Digital Cough Test in collaboration with AI4LYF. This innovative app uses artificial intelligence to monitor various respiratory diseases through cough analysis, further diversifying Therma Bright’s product offerings.

Bringing it all Together

Therma Bright's strategic focus on both medical devices and drug therapies places the company in a unique position within the healthcare sector. The company’s flagship products—ranging from the Venowave VW5 for DVT prevention to the Preva® clot-retrieval device and inhaled statin therapies—target significant, multi-billion-dollar markets. Combined, the market opportunities across these indications surpass $22 billion globally, highlighting the substantial revenue potential for Therma Bright which pales in comparison to their tiny market value of just USD $21 Million.

What sets Therma Bright apart is its emphasis on medical devices, which typically face shorter, less expensive, and less risky development timelines compared to pharmaceutical drugs. The company's advancements with the Venowave VW5 and Preva® device, both of which are already far along in the regulatory process, partially de-risk their pipeline. This progress contrasts with the longer, more expensive, and more uncertain path often associated with drug development. 

By focusing on innovative medical devices that address large and unmet medical needs, Therma Bright is poised to potentially capture significant market share, offering a compelling growth story for investors as it continues to push the boundaries of healthcare innovation.

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