Therma Bright's Investment Case Just Got Stronger As Approval On Permanent Insurance Codes Gets Closer

Therma Bright (TSXV:THRM) (OTCQB:TBRIF), a developer of a wide range of leading edge, proprietary diagnostic and medical device technologies that address some of today's most important medical and healthcare challenges, appears to be positioned for major growth based on one important upcoming catalyst.

For some background, Therma Bright (TSXV:THRM) (OTCQB:TBRIF) sells Venowave, a compact, battery-operated peristaltic pump that generates wave-form motion that, when worn below the knee and strapped to the calf, causes an increased upward volumetric displacement of venous and lymph fluid. The Venowave is FDA-approved for 10 indications, including: management of post-thrombotic syndrome; prevention of deep vein thrombosis (DVT/blood clots); treatment of chronic venous insufficiency; as well as other conditions related to poor circulation in the extremities. It seems that the company is set to receive a newly issued HCPCS Level II code to identify it's Venowave device, which will be instrumental in driving revenue growth. HCPCS codes are a set of health care procedure codes used in the United States to standardize the reporting of medical procedures, services and devices. These codes are essential for billing and reimbursement purposes within the Medicare and Medicaid programs and are also used by other healthcare insurers in the United States, including private insurance companies.

Additionally, a preliminary Medicare payment determination will be made for this new HCPCS code. If the Venowave is purchased outright, Medicare and Medicaid will reimburse $1,199 USD. If the unit is rented to the patient, Medicare and Medicaid will pay $78.05 USD per month for up to 13 months, for a total of $819.55 USD. These are very favourable numbers for Therma Bright when taking into account the manufacturing cost of Venowave. Additionally, private insurers such as Blue Cross Blue Shield, UnitedHealth Group, etc. also use these codes as guidelines to determine reimbursement payouts.

Why is this so important? Previously, Venowave was placed in the E0676 HCPCS code. E0676 is a miscellaneous code with no set reimbursement, meaning that when Venowave is billed for under this code, Medicare and Medicaid, as well as private insurance companies, will default to a $0 reimbursement. While it is possible to submit a package of medical necessity under this code with a detailed explanation of the patient's condition and why it should be reimbursed, the reality is that most physicians or prescribing parties will not go through this exercise as they are not reimbursed for the time and trouble it takes.

Therma Bright experienced a similar situation with the temporary codes it was approved to sell Venowave under in 2023 - Without the prescribing party submitting a package of medical necessity, Venowave by default will not be paid for. Additionally, these reimbursement issues are a barrier to prescribing parties recommending Venowave, as they are not able to tell their patients if the device will be paid for. Physicians tend to shy away from prescribing devices in these categories, as they could leave their patients with a large unexpected medical bill, reflecting badly on the prescribing party.

This new HCPCS code, combined with the preliminary payment determination, establishes a fixed payout for Venowave across public and private insurers in the United States, eliminating friction in payments as well as hesitancy by the prescribing parties in recommending the device. Therma Bright expects to receive this new HCPCS code and payment determination after the biannual CMS meeting, which was held at the end of May.

Venowave differentiates itself from other available compression products in a number of ways. Currently, pneumatic devices and simple products that squeeze the leg make up the majority of the compression market. Inexpensive portable compression devices simply squeeze and release the calf and do not actively move fluid upwards towards the heart. Sequential compression devices are proven to be very effective; however, they are not portable. Sequential compression devices have tubes attached to an air compressor, which inflates chambers in sequence, providing sequential compression. Typically, these devices can only be used while lying in bed, on a couch, or in a similar position and do not allow the patient to remain ambulatory.

Venowave combines the best of both worlds, providing sequential compression without the use of tubes or wires, allowing the patient to remain completely ambulatory while receiving treatment. Additionally, Venowave is quiet, so patients can continue to receive treatment while they are sleeping or otherwise resting.

Currently, in the United States, an estimated 25 million people are living with some form of chronic venous insufficiency. Most go untreated or rely on simple compression stockings for some form of minor relief, as proper treatment via sequential compression devices is too cumbersome and expensive. The issuance of this new HCPCS code and payment determination open up these patients to the Venowave, a new and portable form of treatment that will not cost them anything out of pocket. This market alone, along with the management of post-thrombotic syndrome and the prevention of primary thrombosis, is potentially huge.

Additionally, Therma Bright is working towards securing reimbursement for DVT prevention. While Medicare and Medicaid do not pay for DVT prevention, private insurers do. Therma Bright is confident that the issuance of this new HCPCS code and payment determination will help patients access Venowave for DVT prevention via their private health insurance, which is another huge addressable market in the United States.

During the last year, Therma Bright has been meeting with potential distributors across the United States. Many have indicated interest in the Venowave pursuant to a positive outcome with regards to the HCPCS coding. Therma Bright currently has over 2000 Venowave units in inventory, which they expect can be moved right away upon the issuance of the HCPCS code.

After these initial 2000 units are sent to distributors, placed on patients, and reimbursement received, Therma Bright conservatively estimates moving 500-1000 units per month. Given the high margin on Venowave, this will fare well for the company.

As Venowave is a high-margin product, the company is looking at the possibility of setting up a manufacturing operation in either the U.S., Canada, or Mexico, which would allow it to sell to the VA in the US. This would open up yet another large market for Venowave in the United States.

For investors who may be interested in Therma Bright, it is important to note that Venowave isn't its only product. The company also has respiratory health and consumer health product portfolios. The respiratory health product portfolio features the Digital Cough Test (DCT) app created by Therma Bright (TSXV:THRM) (OTCQB:TBRIF) and AI4LYF. The app uses artificial intelligence to detect multiple respiratory diseases by analyzing a person's cough sound and has shown a high accuracy rate. The app is currently in the process of securing a 513g FDA clearance, which will allow the company to charge for remote therapeutic monitoring (RTM) and be used for patient reimbursement. The consumer health product portfolio features devices designed for pain relief, cold sore prevention, and insect bite relief.

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