Zynex Submits FDA Application for its Next Generation NMES Device
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.
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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
