Therma Bright Inc. announced the Company has submitted an updated U.S. Food and Drug Administration (FDA) 510K application to correct the Venowave device's intended use, labeling and product description in order to better address the U.S. Centers for Medicare and Medicaid Services (CMS) application for permanent Current Procedural Terminology (CPT®?) /Healthcare Common Procedure Coding System (HCPCS) codes. In late August, CMS asked the Company to first secure approval from the FDA through an updated 510K application stating that the Venowave device can be used successively by multiple patients. This was a key requirement for the Company to secure in order to update its CMS application to secure the nine (9) permanent CPT®?

and HCPCS codes. The Company looks forward to providing more information as it becomes available on the unique permanent CPT®? andHCPCS codes and on expanding its distribution partners across the U.S. for its Venowave device.