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Therma Bright's Venowave VW5 Secures FDA 510K Approval

Therma Bright's Venowave VW5 Secures FDA 510K Approval

Therma Bright的Venowave VW5獲得FDA 510K批准
newsfile ·  07/29 07:55

Toronto, 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.

加拿大安大略省多倫多--(新聞稿公司-2024年7月29日)-- Therma Bright Inc.(TSXV:THRM)(OTCQB:TBRIF)(" Therma" 或 "公司"),是一家領先的診斷和醫療器械技術的開發商和投資夥伴,很高興宣佈,公司已經獲得美國食品和藥品管理局(FDA)對其51萬申請請求的批准,用於糾正Venowave VW5設備的預期使用,標籤和描述。該批准解決了美國醫療保險和醫療補助服務中心(CMS)對發放Venowave VW5永久當前操作術語(CPT)和醫療常用操作術語編碼系統(HCPCS)代碼的要求。

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.

據報道,CMS要求該公司通過更新的51萬申請獲得FDA的批准,說明Venowave VW5設備可以被多名患者連續使用;這是獲得10個永久CPt和HCPCS代碼的關鍵要求。

"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."

"隨着FDA的51萬申請批准,以及CMS定價和新的HCPCS二級代碼指定建議和審查流程完成,公司期望Venowave的永久代碼批准即將到來," Therma Bright的CEO Rob Fia分享道。"我們的分銷合作伙伴正準備開始工作,將我們的Venowave部署到他們的醫療保險和醫療補助服務中心網絡中,幫助他們的患者解決多種循環問題,包括疾病控制和預防中心(CDC)每年估計影響90萬美國公民的深靜脈血栓形成(DVT)和肺栓塞(PE)。"

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.

Venowave VW5是一系列緊湊型、電池驅動的蠕動泵,可以產生波形運動。當佩戴在膝蓋以下,緊貼小腿時,設備會導致小腿受壓,進而增加靜脈和淋巴液的向上容積排放。這種2對元件的裝置能夠在下肢誘導改善血管和淋巴流動。該設備採用單個可充電的1.5 V NiMh AA電池運行,這是一款經過FDA批准的耐用醫療設備,用戶可以在任何地方接受治療,同時保持活躍。Venowave VW5保證可以經受連續患者的反覆使用。

In other news, the Company announces that it has entered into a marketing and consulting agreement (the "OTBC Agreement") with an arm's length marketing firm, Outside The Box Capital Inc. ("OTBC") of Oakville, Ontario, to provide marketing consulting and investor relations services, including marketing services through social media channels and online media distribution.

另外,該公司宣佈已與獨立的營銷公司Outside The Box Capital Inc. ("OTBC")簽訂營銷和諮詢協議("OTBC協議"),爲多個渠道提供營銷諮詢和投資者關係服務,包括社交媒體和在線媒體分發營銷服務。

In connection with the OTBC Agreement, for a term of 3 months starting on July 26, 2024, the Company will pay OTBC a cash fee of $25,000 CAD plus applicable taxes. OTBC has no direct relationship with the Company other than as set out in this press release.

根據OTBC協議,在2024年7月26日開始的三個月期限內,公司將向OTBC支付現金費用25000 CAD加上適用稅費。除本新聞稿所述外,OTBC與公司沒有直接關係。

The Company's engagement with OTBC is another step in its efforts to enhance communication with the current investor community and expand visibility to a greater audience. OTBC specializes in various social media platforms and will be able to facilitate greater awareness and widespread dissemination of the Company's news.

公司與OTBC的合作是其增強與現有投資者社區溝通和擴大受衆範圍的努力的又一步。OTBC專注於各種社交媒體平台,將能夠促進公司新聞的更廣泛傳播和增加知名度。

About Therma Bright Inc.

Therma Bright Inc.簡介:Therma Bright是一家開發商和合作夥伴,在各種領先的專有診斷和醫療器械技術方面致力於爲消費者和醫療專業人士提供質量卓越,創新的解決方案,以應對當今最重要的醫療和醫療保健挑戰。在TSXV:THRM,OTCQB:TBRIF,FSE:JNX上交易。訪問:。

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: .

Therma Bright Inc.

Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
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FORWARD-LOOKING STATEMENTS

前瞻性聲明

Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the commercialization 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.

本新聞稿中的某些陳述構成"前瞻性"陳述。這些陳述涉及將來發生的事件,例如如新聞稿中所述的Venowave和相關技術的商業化。所有這些陳述都涉及重大的已知和未知風險、不確定性和其他因素,這些因素可能導致實際結果與此類前瞻性陳述所表達的結果有所不同。前瞻性陳述涉及重大風險和不確定性,不應將其作爲未來績效或結果的保證,並且它們不一定是是否實現此類結果的準確指標。由於多種因素和風險的影響,實際結果可能與預期的結果有所不同。儘管本新聞稿中所包含的前瞻性陳述是公司管理層在本新聞稿發佈的日期認爲合理的基礎上所作的假設,但公司不能保證投資者實際結果將與這些前瞻性陳述保持一致。本新聞稿中的前瞻性陳述是自本新聞稿發佈之日起作出的,並且公司否認任何意圖和義務,更新或修訂任何前瞻性陳述,無論是基於新信息、未來事件或其他因素,除非根據適用的證券法規定。

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或其監管服務提供者(如TSX Venture Exchange政策所定義的那樣)不接受對此新聞稿的充分性或準確性的責任。

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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