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Therma Bright's Venowave VW5 Secures FDA 510K Approval
Toronto, Ontario--(Newsfile Corp. - July 29, 2024) - Therma Bright Inc . (TSXV: THRM) (OTCQB: TB...
About this update from Therma Bright Inc.
[{"type":"text","content":"\nTherma Bright's Venowave VW5 Secures FDA 510K ApprovalToronto, Ontario--(Newsfile Corp. - July 29, 2024) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (\"Therma\" or the \"Company\"), a developer and investment partner in a wide range of leading-edge, proprietary diagnostic and medical device technologies, is pleased to announce that the Company has received the U.S. Food and Drug Administration's (FDA) approval on its 510K application request to correct the Venowave VW5 device's intended use, labeling, and description. This approval addresses the U.S. Centers for Medicare and Medicaid Services (CMS) requirement for issuing the Venowave VW5 permanent Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes.As reported, CMS asked the Company to secure approval from the FDA through an updated 510K application stating that the Venowave VW5 device could be used successively by multiple patients; a key requirement for securing the ten (10) permanent CPT® and HCPCS codes.\"With the FDA 510K application approval, as well as the CMS pricing and new HCPCS Level II code designation recommendations and review process complete, the Company expects the Venowave's permanent codes approval imminently,\" shared Rob Fia, CEO of Therma Bright. \"Our distribution partners are standing ready to begin their work to deploy our Venowave to their network of Medicare and Medicaid medical practitioners to help their patients with a variety of circulatory issues, including deep vein thrombosis (DVT) and pulmonary embolism (PE) that the Centers for Disease Control and Prevention (CDC) estimates over 900,000 U.S. citizens are impacted by every year.\"The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a waveform motion. When worn below the knee, strapped firmly to the calf, the device results in compression of the calf and consequently an increased upward volumetric displacement of venous and lymph fluid. The 2-pair unit induces improved vascular and lymphatic flow in the lower limbs. Operating with a single rechargeable 1.5 V NiMh AA battery, this 510K FDA-approved Durable Medical Equipment device enables users to receive treatment anywhere while remaining active. The Venowave VW5 assures it can withstand repeated use by successive patients.In other news, the Comp...