Zynex Monitoring Solutions Announces First Enrollment in a Blood Loss Detection Clinical Trial for its CM-1600 Monitoring System
Zynex, Inc. (NASDAQ: ZYXI) announced the initiation of a large-scale clinical trial for its CM-1600 blood loss detection system, in partnership with ClinCept, LLC., and LifeSouth Community Blood Center. This trial aims to evaluate the device's specificity and sensitivity during whole blood donation processes, with expected enrollment of 227 subjects, set to complete by early 2023. CEO Thomas Sandgaard highlighted the importance of these trials in building trust for their patented Relative Index. The results could significantly impact clinical application and market acceptance of the CM-1600.
- Initiation of a large-scale clinical trial for the CM-1600 monitoring system.
- Partnership with ClinCept, LLC., and LifeSouth Community Blood Center.
- Expected enrollment of 227 subjects, enhancing credibility.
- Trial aims to build trust in the patented Relative Index.
- None.
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
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New York, NY 10019
IR@zynex.com
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