ENGLEWOOD, Colo., Dec. 5, 2024
/PRNewswire/ -- Zynex, Inc. (NASDAQ: ZYXI) ("Zynex", "ZMS", "we" or
the "Company"), an innovative medical technology company
specializing in the manufacture and sale of noninvasive medical
devices for pain management, rehabilitation, and patient
monitoring, today announced that it has completed its clinical
verification trial for their NiCO™ pulse oximeter overseen by
anesthesiologist Dr. David MacLeod
at Duke University.
Trial completion is a key milestone required by the FDA prior to
submission of a 510(k) for clearance to market and sell the NiCO
device for clinical use. With the completion of this study, Zynex
now turns to final testing to ensure the operational safety of the
device prior to 510(k) submission.
Zynex's NiCO pulse oximeter utilizes highly precise laser
technology to measure blood oxygenation levels directly, as opposed
to current pulse oximeter products, which only estimate oxygenation
levels using LEDs. LED pulse oximeters have been shown to
mismeasure oxygen levels in several populations, most prominently
in individuals with darker skin pigmentation.
Zynex Monitoring Solutions' NiCO product line is a strategic
investment for Zynex to enter the multi-billion dollar pulse
oximetry market with entirely new pulse oximetry technology. The
Company is confident that the clinical value of NiCO's unparalleled
precision, accuracy, and safety will provide the right entry into
this market space.
"The completion of our verification study is a pivotal event for
Zynex Monitoring and the result of an enormous team effort. The
bulk of the hard work is behind us at this point as we turn to
submit NiCO for FDA clearance officially," said Donald Gregg, President of Zynex Monitoring
Solutions.
"NiCO will be the first Zynex monitoring product to enter a
mature and growing market whose entry will be enabled by its
game-changing capabilities. We are excited to finally have all the
required clinical studies behind us as we prepare our application
for FDA clearance," added Thomas
Sandgaard, Founder and CEO of Zynex.
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 release contains
forward-looking statements within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995.
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 and other risks 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,
2023 as well as our quarterly reports on Form 10-Q and current
reports on Form 8-K.
Any forward-looking statement made by us in this release is
based only on information currently available to us and speaks only
as of the date on which it is made. We undertake no obligation to
publicly update any forward-looking statement, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
Investor Relations Contact:
Brian Prenoveau, CFA
MZ Group – MZ North America
ZYXI@mzgroup.us
+561 489 5315
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SOURCE Zynex, Inc.