ENGLEWOOD, Colo., Aug. 15,
2022 /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 it has started enrollments in an ongoing apheresis
clinical trial with its second-generation fluid monitoring system,
the CM-1600.
The study monitors subjects during an apheresis procedure with
the predicate device, the CM-1500, and now also the CM-1600, to
refine the system's patented Relative Index in a wide array of
patient circumstances. To date, 53 subjects have been enrolled in
the study. Zynex's second generation blood and fluid monitoring
device has been introduced to the study to evaluate its sensitivity
and accuracy in the same environment. The CM-1500 was cleared by
the FDA in February of 2020 while the CM-1600 is still awaiting FDA
clearance.
"The data collected with the CM-1500 in the earlier phases of
the apheresis trial was encouraging and incredibly valuable for
improving accuracy of the CM-1600 Relative Index," said
Donald Gregg, VP of Zynex Monitoring
Systems. "We are excited to continue data acquisition with the
CM-1600 and be able to demonstrate how the device performs in a
variety of clinical settings such as apheresis donation."
The study is expected to complete enrollments in the fourth
quarter of 2022.
"We remain committed to prioritizing data collection through
clinical studies," commented Thomas
Sandgaard, CEO of Zynex. "We believe the addition of the
CM-1600 to this trial will expand the scenarios in which this
device provides novel patient monitoring capabilities and will
demonstrate its anticipated value in the marketplace."
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,
2021 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 Contact
Gilmartin Group
650 Fifth Ave., Suite 2720
New York, NY 10019
IR@zynex.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/zynex-announces-first-enrollments-in-apheresis-donation-clinical-trial-with-second-generation-fluid-monitoring-system-301605515.html
SOURCE Zynex