ENGLEWOOD, Colo., Sept. 21,
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 begun enrollments in a large-scale blood loss detection
clinical trial with its second-generation monitoring system, the
CM-1600.
The multi-site trial, first initiated with ClinCept, LLC., in
partnership with LifeSouth Community Blood Center, is designed to
determine the specificity and sensitivity of the CM-1600 in
detecting minor blood loss during a whole blood donation
procedure. Zynex Monitoring Solutions expects to continue
gaining evidence for the use and application of the CM-1600
throughout the study.
"Clinical trials are vital not only to optimizing the
performance of our device but also to building the critical body of
evidence clinicians need to gain trust in our patented Relative
Index," said Thomas Sandgaard, CEO,
Chairman and Founder.
Donald Gregg, VP of Zynex
Monitoring Solutions noted that "Zynex has a robust pipeline of
research in our development strategy, and we are excited to kick
off this trial to statistically define the sensitivity and
specificity of our device."
The trial is expected to include up to 227 subjects and will
complete enrollments in early 2023.
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-monitoring-solutions-announces-first-enrollment-in-a-blood-loss-detection-clinical-trial-for-its-cm-1600-monitoring-system-301629523.html
SOURCE Zynex