Zynex, Inc today announced that it has received clearance from the U.S. Food and Drug Administration (“FDA”) for the next generation M-Wave Neuromuscular Electrical Stimulation (“NMES”) device.
| ENGLEWOOD, Colo., Feb. 6, 2024 /PRNewswire/ -- Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today announced that it has received clearance from the U.S. Food and Drug Administration (“FDA”) for the next generation M-Wave Neuromuscular Electrical Stimulation (“NMES”) device. NMES treatments have several uses, including aiding recovery from surgery, managing chronic conditions, and even enhancing exercise performance in healthy individuals. The M-Wave replaces its predecessor, the E-Wave, which has been fundamental in NMES treatments across the U.S. since 1998. The E-Wave was the most powerful and versatile muscle stimulation device on the market for over two decades and the M-Wave builds on that history of performance with a more intuitive design and additional functionality. “The M-Wave introduces the next evolution in NMES devices, allowing for more customizable treatments within clinical and home settings,” said Thomas Sandgaard, CEO at Zynex Medical. “Our Product Management team has incorporated patient and physician feedback when designing the new M-Wave. The user-friendly interface and ease of use when designing a custom electrotherapy regimen will encourage an even broader adoption of Zynex’s therapeutic products.” The M-Wave is designed to improve the way patients manage their neuromuscular conditions. With advanced features and a user-friendly design, the M-Wave allows patients to be treated quickly in a clinical or home setting. The compact and lightweight design of the M-Wave ensures portability and easy integration into patients’ recovery routines. About Zynex, Inc. Zynex, founded in 1996, develops, manufactures, markets, and sells medical devices used for pain management and rehabilitation as well as non-invasive fluid, sepsis, and laser-based pulse oximetry monitoring systems for use in hospitals. For additional information, please visit: www.zynex.com. Safe Harbor Statement This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended. our results of operations and the plans, strategies and objectives for future operations; the timing and scope of any potential stock repurchase; and other similar statements. 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Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward looking statements. The Company makes no express or implied representation or warranty as to the completeness of forward-looking statements or, in the case of projections, as to their attainability or the accuracy and completeness of the assumptions from which they are derived. Factors that could cause actual results to materially differ from forward-looking statements include, but are not limited to, the need to obtain CE marking of new products; the acceptance of new products as well as existing products by doctors and hospitals, larger competitors with greater financial resources; the need to keep pace with technological changes; our dependence on the reimbursement for our products from health insurance companies; our dependence on third party manufacturers to produce our products on time and to our specifications’ implementation of our sales strategy including a strong direct sales force, the impact of COVID-19 on the global economy; market conditions; the timing, scope and possibility that the repurchase program may be suspended or discontinued; economic factors, such as interest rate fluctuations; and other risks described in our filings with the Securities and Exchange Commission. These and other risks are described in our filings with the Securities and Exchange Commission including but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2022 as well as our quarterly reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statements contained in this press release represent Zynex’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Zynex explicitly disclaims any obligation to update any forward-looking statements, except to the extent required by law. Investor Relations Contact:
SOURCE Zynex | ||
Company Codes: NASDAQ-NMS:ZYXI |
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