Therma Bright Submits Updated FDA 510K Application Requesting Correction of Venowave Device's Intended Use, Labeling, and Description
- Therma Bright Inc. has submitted an updated FDA 510K application for the Venowave device, addressing the use, labeling, and device description. This is a key step in securing permanent CPT and HCPCS codes.
- None.
Toronto, Ontario--(Newsfile Corp. - September 7, 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 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.
"Our team worked quickly to prepare this first step in updating our FDA 501K application for our Venowave device, specifically around the use, labeling and device description," shared Rob Fia, CEO of Therma Bright. "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. 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."
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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