Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) told investors that it has submitted an updated 510K application to the US Food and Drug Administration (FDA) to correct the intended use, labelling, and product description of its Venowave device.
A 510K is a premarket submission made to the FDA to demonstrate that a device to be marketed is as safe and effective as a legally marketed device that is not subject to premarket approval.
The company explained in a statement that the updated 510K will better address the US Centers for Medicare and Medicaid Services (CMS) application for permanent Current Procedural Terminology (CPT) / Healthcare Common Procedure Coding System (HCPCS) codes for Venowave.
In August, CMS asked Therma Bright to first secure approval from the FDA through an updated 510K application stating that the Venowave device can be used successively by multiple patients. The company said this was a key requirement in order to update its CMS application to secure the nine permanent codes.
“Once we secure FDA approval on our updated 510K application, our team will be ready to address the second step of updating our CMS application stating that the Venowave can be used successively by multiple patients,” CEO Rob Fia commented.
“We are cautiously optimistic that this change, along with some other minor changes, to our updated FDA application, and subsequent CMS application, will result in a positive decision on our CPT and HCPCS codes.”
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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