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.

安大略省多伦多市-（Newsfile Corp.-2023年9月7日）-Therma Bright Inc.（TSXV:THRM）（OTCJB:TBRIF）（'Therma'或'公司'），广泛的开发商和合作伙伴领先的专有诊断和医疗设备技术，今天宣布该公司已提交更新的美国。

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..

美国食品和药物管理局（FDA）510K申请纠正Venowave设备的预期用途，标签和产品描述，以便更好地解决美国医疗保险和医疗补助服务中心（CMS）永久现行程序术语（CPT®）/医疗保健通用程序编码系统（HCPCS）代码。。

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..

8月下旬，CMS要求该公司首先通过更新的510K申请获得FDA的批准，声明Venowave设备可以由多名患者连续使用。这是公司确保更新其CMS应用程序以确保九（9）个永久CPT®和HCPCS代码的关键要求。。

'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.

“我们的团队很快就为我们的Venowave设备更新了FDA 501K应用程序的第一步，特别是围绕使用，标签和设备描述，“Therma Bright首席执行官共享Rob Fia”一旦我们获得FDA对我们更新的510K应用程序的批准，我们的团队将准备好解决更新我们的CMS应用程序的第二步，说明Venowave可以由多名患者连续使用。

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.'.

我们谨慎乐观地认为，对于我们更新的FDA申请以及随后的CMS申请，这一变化以及其他一些细微变化将导致对我们的CPT®和HCPCS代码做出积极决定。

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.

该公司期待提供更多信息，因为它可用于独特的永久CPT®和HCPCS代码，并将其分销合作伙伴扩展到美国各地的Venowave设备。

About Therma Bright Inc.

关于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.

Therma Bright是广泛领先的专有诊断和医疗设备技术的开发人员和合作伙伴，致力于为消费者和医疗专业人员提供高质量，创新的解决方案，以应对当今最重要的医疗和医疗保健挑战。Therma Bright Inc。

trades on the (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: www.thermabright.com..

（TSXV:THRM）（OTCQB:TBRIF）（FSE:JNX）的贸易。访问：www.thermabright.com。。

Therma Bright Inc.

Therma Bright Inc。

Rob Fia, CEO

Rob Fia，首席执行官

rfia@thermabright.com

rfia@thermabright.com

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FORWARD-LOOKING STATEMENTS

前瞻性声明

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.

本新闻稿中的某些陈述构成“前瞻性”陈述。这些陈述涉及新闻稿中描述的未来事件，例如Venowave和相关技术的商业化和销售。所有这些陈述都涉及实质性的已知和未知风险，不确定性和其他可能导致实际结果与此类前瞻性陈述所表达或暗示的结果不同的因素。

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.

前瞻性陈述涉及重大风险和不确定性，不应将其视为对未来绩效或结果的保证，也不一定是对是否实现此类结果的准确指示。由于若干因素和风险，实际结果可能与预期的结果有很大差异。

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.

尽管本新闻稿中包含的前瞻性声明基于公司管理层认为本新闻稿发布之日的合理假设，但公司无法向投资者保证实际结果与这些前瞻性声明一致。

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..

本新闻稿中所载的前瞻性声明自本协议签署之日起生效，公司不承担任何意图或义务更新或修改任何前瞻性声明，无论是由于新信息，未来事件还是其他原因，除非另有要求适用证券法规。。

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.

TSX Venture Exchange及其监管服务提供商（如TSX Venture Exchange的政策中所定义）均不对本新闻稿的充分性或准确性承担责任。

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/179783

要查看此新闻稿的源版本，请访问https://www.newsfilecorp.com/release/179783