Zynex Submits FDA Application for its Next Generation NMES Device

Rhea-AI Summary

Zynex, Inc. (NASDAQ: ZYXI) announces the submission of a 510(k) application to the FDA for the M-Wave Neuromuscular Electrical Stimulation device. The M-Wave is set to replace the E-Wave, providing more advanced features and a user-friendly design for patients dealing with neuromuscular conditions. This submission demonstrates Zynex Medical's commitment to delivering cutting-edge medical devices.

Positive

• The submission of the 510(k) application showcases Zynex Medical's dedication to innovation and commitment to improving patients' lives. The M-Wave's advanced features and user-friendly design are likely to make it a valuable tool for healthcare professionals and an effective treatment option for patients, potentially boosting the company's market position.

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• None.

ENGLEWOOD, Colo., Nov. 13, 2023 /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 submitted a 510(k) application to the U.S. Food and Drug Administration ("FDA") for the M-Wave Neuromuscular Electrical Stimulation ("NMES") device.

The M-Wave is set to replace its predecessor, the E-Wave, which has been fundamental in NMES treatments across the U.S. since 1998. The E-Wave has helped over 17,500 patients with muscle-related issues such as drop-foot, quad rehabilitation, shoulder subluxation, and hand rehabilitation. The E-Wave has been the most powerful and versatile muscle stimulation device on the market for over two decades, and the M-Wave will be a more modern design with the same versatility and ease of use.

"We are excited to introduce the M-Wave, a device that showcases our ongoing commitment to improving the lives of patients dealing with neuromuscular conditions," said Thomas Sandgaard, CEO at Zynex Medical. "The M-Wave will be another game-changer, providing a more effective and user-friendly treatment option for patients and a valuable tool for healthcare professionals. I believe that this next-generation device will be able to build upon the need for customizable NMES treatments in clinical and home settings."

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 in a clinical or home setting with ease. The compact and lightweight design of the M-Wave ensures portability and easy integration into patients' recovery routines.

The 510(k) application submission represents a significant milestone in Zynex Medical's commitment to delivering cutting-edge medical devices. This application demonstrates the company's dedication to ensuring that patients have access to the latest innovations in medical technology.

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.

Words such as "anticipate," "believe," "continue," "could," "designed," "endeavor," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," "target," "preliminary," "will," "would" and similar expressions are intended to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. 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:
Quinn Callanan, CFA or Brian Prenoveau, CFA
MZ Group – MZ North America
ZYXI@mzgroup.us
+949 694 9594

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SOURCE Zynex

FAQ

What is the 510(k) application submission by Zynex, Inc. for?

Zynex, Inc. has submitted a 510(k) application to the FDA for the M-Wave Neuromuscular Electrical Stimulation device, which is set to replace the E-Wave.

Who is the CEO of Zynex Medical?

Thomas Sandgaard is the CEO at Zynex Medical.

How many patients has the E-Wave helped since 1998?

The E-Wave has helped over 17,500 patients with muscle-related issues such as drop-foot, quad rehabilitation, shoulder subluxation, and hand rehabilitation.

What are the key features of the M-Wave?

The M-Wave is designed to improve the way patients manage their neuromuscular conditions with advanced features and a user-friendly design, allowing treatment in clinical or home settings with ease.

What does the 510(k) application submission represent for Zynex Medical?

The 510(k) application submission represents a significant milestone in Zynex Medical's commitment to delivering cutting-edge medical devices and ensuring patients have access to the latest innovations in medical technology.