Toronto, Ontario--(Newsfile Corp. - August 22, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer and partner in a wide-range of leading-edge, proprietary diagnostic and medical device technologies, announced today that the Company has heard back from the Centers for Medicare and Medicaid Services (CMS) on its application for the nine (9) unique permanent Current Procedural Terminology (CPT®) / Healthcare Common Procedure Coding System (HCPCS) codes.
The Centers for Medicare and Medicaid Services (CMS) has asked the Company to secure approval from the U.S. Food and Drug Administration (FDA) through an updated 510K application that the Venowave device can be used successively by multiple patients along with additional changes. These updated changes to Therma Bright's 510k application are required for securing the permanent Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes.
"We are pleased that the Centers for Medicare and Medicaid Services (CMS) has provided us time to secure a permanent code for a specific designation through an updated 510K application through the FDA. Once that is complete, we will resubmit our application for the permanent CPT® and HCPCS codes to CMS," shared Rob Fia, CEO of Therma Bright. "In the meantime, the Company continues shipping Venowave devices to its U.S. distributor network and encourages each partner to continue using the nine (9) temporary CPT® and HCPCS codes for reimbursement, which are still viable and helping Medicaid and Medicare patients receive their much-needed reimbursements."
The Company looks forward to providing more information as it becomes available on the unique permanent CPT® and HCPCS codes and on expanding its distribution partners across the U.S. for its Venowave device.
About Therma Bright Inc.
Therma Bright is a developer and partner in a wide range of leading edge, proprietary diagnostic and medical device technologies focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. Therma Bright Inc. trades on the (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com.
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
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FORWARD-LOOKING STATEMENTS
Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the commercialization and sales of Venowave and related technology as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether such results will be achieved. Actual results could differ materially from those anticipated due to several factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information, future events or otherwise, except as required under applicable securities regulations.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
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