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
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forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995, as amended. our results
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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
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
+949 694 9594
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