Therma Bright (TSXV:THRM) (OTCQB:TBRIF), a developer of innovative diagnostic and medical device technologies, is poised for substantial growth due to an imminent catalyst: the expected approval of a new HCPCS Level II code for its Venowave device. This compact, battery-operated peristaltic pump is designed to improve circulation and has already received FDA approval for 10 critical indications.
The issuance of a new HCPCS code is crucial as it standardizes the reporting of medical procedures, services, and devices in the U.S. healthcare system. These codes are vital for billing and reimbursement under Medicare and Medicaid programs, as well as private insurers. The new code will allow for a reimbursement of $1,199 USD if the Venowave is purchased outright, or $78.05 USD per month for up to 13 months if rented, totaling $819.55 USD.
Previously, Venowave was classified under the E0676 HCPCS code, a miscellaneous code with no set reimbursement, leading to default $0 payouts unless a detailed package of medical necessity was submitted. This process is often avoided by prescribing parties due to the time and effort required, resulting in hesitancy to recommend the device. The new HCPCS code eliminates this barrier, providing a fixed payout and encouraging more widespread adoption.
Venowave stands out in the compression device market by offering sequential compression without tubes or wires, allowing patients to remain ambulatory while receiving treatment. This is a significant advantage over traditional pneumatic devices and compression stockings, which either lack portability or do not efficiently move fluid upwards towards the heart.
In the U.S., an estimated 25 million people suffer from Chronic Venous Insufficiency, with many relying on simple compression stockings for minor relief. The new HCPCS code will make Venowave accessible to these patients without out-of-pocket costs, addressing a substantial market. Additionally, Therma Bright is working to secure reimbursement for DVT prevention through private insurers, further expanding its market potential.
The company has been in discussions with potential distributors, who have shown interest contingent on the new HCPCS code approval. Therma Bright has over 2000 Venowave units in inventory, ready to be distributed upon code issuance, with expectations to move 500-1000 units monthly thereafter.
Given its high margin, Venowave's success could prompt Therma Bright to establish a manufacturing operation in the U.S., Canada, or Mexico, potentially opening opportunities with the U.S. Department of Veterans Affairs.
Investors should note that Venowave is just one part of Therma Bright's portfolio. The company also offers respiratory health products like the Digital Cough Test (DCT) app, developed with AI4LYF, which uses AI to detect respiratory diseases and is seeking FDA clearance. Their consumer health products include devices for pain relief, cold sore prevention, and insect bite relief.
