Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) Inc told investors that the Centres for Medicare and Medicaid Services (CMS) have responded to its application for nine unique permanent Current Procedural Terminology (CPT) / Healthcare Common Procedure Coding System (HCPCS) codes.
The company said in a statement that the CMS has asked it to secure US Food and Drug Administration (FDA) approval through an updated 510K application that its Venowave device can be used successively by multiple patients, along with additional changes. The updated changes to its 510K application are required to secure the permanent CPT and HCPCS codes, it added.
"Once that is complete, we will resubmit our application for the permanent CPT and HCPCS codes to CMS," Therma Bright CEO Rob Fia commented.
"In the meantime, the company continues shipping Venowave devices to its US distributor network and encourages each partner to continue using the nine temporary CPT and HCPCS codes for reimbursement, which are still viable and helping Medicaid and Medicare patients receive their much-needed reimbursements."
Venowave is a compact and lightweight Deep Vein Thrombosis (DVT) prevention pump specifically designed for use at home. The Venowave device uses a continuous wave motion to increase blood flow in the veins. The increased blood circulation helps prevent venous stasis, which is a major contributor to thrombus formation.
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