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Last year was a pivotal year for cutting-edge diagnostic and medical device technologies developer Therma Bright Inc. (TSXV:THRM) (OTCQB:TBRIF) for many reasons.
Its flagship product, Venowave VW5, a medical compression pump that is lightweight, compact, and battery-operated, which is designed to treat and alleviate the symptoms associated with poor circulation in the lower extremities, received the permanent Healthcare Common Procedure Coding System (HCPCS) code from the U.S. Department of Health & Human Services' Centers for Medicare and Medicaid Services (CMS).
The company received the new Venowave VW5 permanent HCPCS Level II code E0683 for this first-of-its-kind solution, as well as a CMS pricing determination marking a critical milestone for the company. This FDA-designated Durable Medical Equipment (DME) device is currently the only Medicare-approved, reimbursable, mobile mechanical compression system available in the US under its HCPCS code E0683, which provides a simple and comfortable mobile treatment solution for patients needing to accelerate post-operative recovery periods while also managing longer-term pain and swelling issues.
The codes went live on October 1st, and as expected, this attracted a lot of interest from a number of potential distributors across the country. The company engaged some of these distributors in pilot tests for nationwide launches of the initial Venowave sales program to gauge Medicare/Medicaid reimbursement timelines and billing procedures as well as any rejections that occurred.
The distributors had success in the pilot trials, reaffirming the demand for Venowave. For instance, the DME Authority initially took up 25 units, which received 100% reimbursement, and later took 175 more units, which were all also reimbursed, illustrating the traction of Venowave in the market.
For context, the DME Authority provides nationally exclusive niche therapy smart devices to hospitals and physician practices with the first-ever white-glove, turn-key, technology-driven capability that delivers true “hospital to home” continuum-of-care coverage.
Following the pilot tests, Therma Bright announced it had signed a letter of intent (LOI) for a Venowave distribution program with DME Authority across the US. Through this distribution program, DME Authority would collaborate with multiple tenured and qualified network partners to establish no less than three comprehensive U.S. distribution agreements.
As outlined in the LOI, these 'Premier Distributor Partner' contracts would require a minimum foundational inventory purchase of $2 million and collectively commit to a total inventory purchase of $6 million in Venowave VW5 devices within the first six months of 2025, with a minimum equal inventory purchase requirement between Q3 and Q4, 2025.
On January 21, Therma Bright announced that it had secured a purchase order for 1,750 Venowave VW5 from the DME Authority, which would offer HCPCS code reimbursements that total about $1.43 million. This purchase order brings both companies one step closer to the outlined LOI that positions DME as a 'Premier Distributor Partner' for the company.
Earlier in the year, Therma Bright announced that it had secured an initial purchase order for 100 Venowave VW5 units from another national distribution partner called Valor Medical. The initial purchase order was based on the success of the distributor's pilot tests around the HCPCS code reimbursement program and confirmation that Venowave was indeed a superior product compared to what was in the market.
As a new national distribution partner of Therma Bright, Valor Medical looks to fill the immediate needs of its current network of medical practitioners and their patients. According to this distributor and its partners, they receive upwards of 100 doctor referrals per day for vascular compression therapy solutions and have seen great success in securing HCPCS code reimbursements within a normal 30- to 60-day timeframe.
Valor Medical and its partners intend to place orders on a regular basis, perhaps every few weeks, as they build greater awareness of the Venowave VW5 solution with their end clients. This initial purchase order for 100 Venowave VW5 units offers HCPCS code reimbursements that total a minimum of $81,955.
"We are excited to partner with Therma Bright in offering the Venowave VW5 to our national distribution network," shared Cindy Sebek Quick, Partner of Valor Medical Solutions. "This initial 100-unit purchase will fill the immediate demand of our partners, who anticipate early adoption of this special vascular compression therapy solution.”
According to a report from Straits Research, the global compression therapy market was worth about $4.18 billion in 2024 and is projected to grow to $6.72 billion by 2033, representing a CAGR of 7.30%, which bodes well for Therma Bright. With 1,850 Venowave orders in the first month of this year alone and new distribution partners in the pipeline, the company is reaffirming its position as a key player in the US compression market.
Moreover, the company’s second product is also helping position it as a key player in the medical device market and creating new potential areas for growth. Therma Bright is currently pursuing a U.S. Food and Drug Administration (FDA) 513(g) request to obtain information regarding the classification and regulatory requirements for its acoustic AI Digital Cough Technology (DCT) as a remote therapeutic monitoring solution.
The DCT platform with partner AI4LYF is focused on supporting healthcare decision-making by improving the ability to collect, organize, and display cough and respiratory data for healthcare providers, as well as epidemiologists who are public health workers that investigate respiratory patterns. The company is also looking to get reimbursement codes through CMS that allow for this type of remote therapeutic monitoring device.
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