Zynex Obtains FDA Clearance for New Pain Management Device
Zynex Obtains FDA Clearance for New Pain Management Device
It is important to note that the TensWave device is not intended to replace our market-leading NexWave electrotherapy device, which remains the top choice for patients seeking a comprehensive electrotherapy solution but in certain instances, can provide flexibility in dealing with patients' insurance coverage. The TensWave is a complementary product designed for those whose insurance plans exclusively cover TENS therapy.ENGLEWOOD, Colo., Sept. 3, 2024 /PRNewswire/ -- Zynex Inc. (NASDAQ: ZYXI), a leading medical technology company specializing in non-invasive medical devices for pain management and rehabilitation, today announced FDA clearance of its new TensWave device.
科羅拉多州恩格爾伍德，2024年9月3日 /美通社/ -- Zynex公司（納斯達克: ZYXI）是一家領先的醫療科技公司，專門致力於非侵入式醫療設備的疼痛管理和康復。今天宣佈其新TensWave設備獲得FDA的批准。
The TensWave device, by prescription only, builds on Zynex's strong legacy of innovation in pain management. It offers a user-friendly, portable design that can be easily integrated into patients' daily routines. The device aims to provide effective pain relief through TENS (Transcutaneous Electrical Nerve Stimulation) therapy, which has been clinically proven to reduce chronic and acute pain without needing medication.
TensWave設備只能憑處方使用，建立在Zynex在疼痛管理領域創新的強大傳統基礎之上。它採用用戶友好的便攜設計，可以輕鬆融入患者的日常生活方式。該設備旨在通過經臨床證明的TENS（經皮電神經刺激）療法，提供有效的疼痛緩解，可以減輕慢性和急性疼痛，而無需藥物。
"The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions," said Thomas Sandgaard, CEO of Zynex Medical. "We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand. It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients."
「TensWave的推出與我們致力於提供全面疼痛管理解決方案的承諾完美契合，」Zynex醫療CEO托馬斯·桑德加德說，「我們發現市場上缺乏一個符合保險報銷特定標準的高質量TENS設備，TensWave是我們對這一需求的回應。它可以補充我們的旗艦多模態設備NexWave，在這個設備上，干預電流是主要模態和開具處方的驅動力。TensWave擴展了我們的產品組合，並增強了對患者的支持。」
It is important to note that the TensWave device is not intended to replace our market-leading NexWave electrotherapy device, which remains the top choice for patients seeking a comprehensive electrotherapy solution but in certain instances, can provide flexibility in dealing with patients' insurance coverage. The TensWave is a complementary product designed for those whose insurance plans exclusively cover TENS therapy.
需要注意的是，TensWave設備並不意味着取代我們市場領先的NexWave電療設備，NexWave仍然是尋求綜合電療解決方案的患者的首選，但在某些情況下，可以在應對患者的保險覆蓋上提供靈活性。TensWave是一款補充產品，專爲那些保險計劃專門覆蓋TENS療法的人設計。
The TensWave is poised to become an essential tool for patients suffering from chronic pain conditions, offering them a safe, effective, and drug-free alternative to pain management. It complements our offerings of electrotherapy products, cervical traction, braces, cold/hot therapy and compression devices.
TensWave即將成爲患有慢性疼痛症狀的患者的重要工具，爲他們提供安全、有效和無藥物的疼痛管理選擇。它補充了我們的電療產品、頸部牽引、支架、冷/熱療法和壓縮設備。
This new product clearance by the FDA marks another milestone in Zynex's ongoing mission to improve patient outcomes through innovative medical technology.
FDA對這一新產品的批准標誌着Zynex不斷使命的又一里程碑，即通過創新的醫療科技改善患者的治療效果。
About Zynex Inc.
關於zynex公司。
Founded in 1996, Zynex develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation, as well as non-invasive monitoring systems for use in hospitals. For more information, please visit: .
成立於1996年，zynex公司開發、製造、市場推廣和銷售用於疼痛管理和康復的醫療設備，以及用於醫院的非侵入式監測系統。更多信息，請訪問：。
Safe Harbor Statement
免責聲明
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements reflect our current beliefs and expectations but are subject to various risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause such differences include, but are not limited to, the acceptance of our products by insurance providers and patients, the continued availability of reimbursement for TENS therapy, and our ability to maintain and expand our market presence. For more detailed information on the risks and uncertainties associated with our business, please refer to the filings we have made with the Securities and Exchange Commission.
本新聞稿包含根據1995年《私人證券訴訟改革法案》（The Private Securities Litigation Reform Act of 1995）進行的前瞻性聲明。這些聲明反映了我們當前的信念和期望，但是存在各種風險和不確定性，可能使實際結果與預期有所不同。可能導致這種差異的因素包括但不限於保險提供商和患者對我們產品的接受程度、TENS治療的持續報銷可用性以及我們維持和擴大市場存在的能力。有關我們業務所涉及的風險和不確定性的更詳細信息，請參閱我們向美國證券交易委員會提交的文件。
Investor Relations Contact:
Quinn Callanan, CFA or Brian Prenoveau, CFA
MZ Group – MZ North America
[email protected]
+949 694 9594
投資者關係聯繫方式：
Quinn Callanan，CFA 或 Brian Prenoveau，CFA
MZ Group – MZ North America
[email protected]
+949 694 9594
SOURCE Zynex
資訊來源：zynex
譯文內容由第三人軟體翻譯。