Therma Bright Submits Updated FDA 510K Application Requesting Correction of Venowave Device's Intended Use, Labeling, and Description
Therma Bright Submits Updated FDA 510K Application Requesting Correction of Venowave Device's Intended Use, Labeling, and Description
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.
安大略省多倫多-(Newsfile Corp.-2023年9月7日)-Therma Bright Inc.(TSXV：THRM)(OTCQB：TBRIF)(以下簡稱“Therma”或“公司”)今天宣佈，該公司已提交最新的美國食品和藥物管理局(FDA)510K申請，以糾正Venowave設備的預期用途。標籤和產品說明，以便更好地滿足美國醫療保險和醫療補助服務中心(CMS)對永久當前程式術語(CPT)/醫療保健通用程式編碼系統(HCPCS)代碼的申請。
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要求該公司首先通過更新的510K應用程式獲得FDA的批准，聲明Venowave設備可以被多名患者連續使用。這是該公司為了更新其CMS應用程式以確保九(9)個永久CPT和HCPCS代碼的安全而需要確保的關鍵要求。
"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. 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."
Therma Bright首席執行官羅布·菲亞分享道：“我們的團隊迅速準備好為我們的Venowave設備更新FDA 501k應用程式的第一步，特別是圍繞使用、標籤和設備描述。一旦我們確保FDA批准我們更新的510K應用程式，我們的團隊將準備好處理更新我們的CMS應用程式的第二步，聲明Venowave可以被多名患者連續使用。我們謹慎樂觀地認為，這一變化，加上對我們更新的FDA應用程式和後續的CMS應用程式的一些其他微小變化，將導致對我們的CPT和HCPCS代碼做出積極的決定。“
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.
該公司期待著在獲得唯一的永久CPT和HCPCS代碼以及擴大其Venowave設備在美國各地的分銷夥伴方面提供更多資訊。
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: .
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Therma Bright是一家領先的專有診斷和醫療設備技術的開發商和合作夥伴，致力於為消費者和醫療專業人員提供高質量的創新解決方案，以應對當今一些最重要的醫療和保健挑戰。Therma Bright Inc.在多倫多證券交易所(TSXV：THRM)(場外交易市場代碼：TBRIF)(紐約證券交易所代碼：JNX)交易。參觀：。
Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
Therma Bright Inc.
羅布·菲亞，首席執行官
郵箱：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.
前瞻性陳述
本新聞稿中的某些陳述構成“前瞻性”陳述。這些陳述涉及未來的事件，如新聞稿中描述的Venowave和相關技術的商業化和銷售。所有這些陳述都涉及大量已知和未知的風險、不確定因素和其他因素，這些風險、不確定因素和其他因素可能導致實際結果與這些前瞻性陳述明示或暗示的結果大不相同。前瞻性陳述涉及重大風險和不確定因素，不應被解讀為對未來業績或結果的保證，也不一定是能否實現此類結果的準確跡象。由於幾個因素和風險，實際結果可能與預期大不相同。儘管本新聞稿中包含的前瞻性陳述是基於公司管理層認為本新聞稿發佈之日的合理假設，但公司不能向投資者保證實際結果將與這些前瞻性陳述一致。本新聞稿中包含的前瞻性陳述是自本新聞稿發佈之日起作出的，除非適用的證券法規另有要求，否則公司不會因為新資訊、未來事件或其他原因而更新或修改任何前瞻性陳述的意圖或義務。
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多倫多證券交易所及其監管服務提供商(該術語在多倫多證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。
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