Zynex Monitoring Announces First Enrollment in a Hemodialysis Clinical Trial for its Fluid Monitoring System
Zynex (NASDAQ: ZYXI) has commenced enrollments for a hemodialysis clinical trial using its CM-1500 fluid monitoring system, which received FDA clearance in February 2020. Conducted at DaVita Clinical Research clinics, the trial aims to assess changes in the device's patented Relative Index during hemodialysis. This initiative seeks to refine Zynex's medical technology and advance its monitoring division. The study targets operating and recovery rooms where fluid balance is crucial, expected to complete enrollments by Q1 2022.
- Initiated hemodialysis clinical trial for CM-1500 fluid monitoring system.
- Device received FDA clearance in February 2020.
- Targets critical healthcare settings like operating and recovery rooms.
- None.
ENGLEWOOD, Colo., Dec. 20, 2021 /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 reported it has started enrollments in a hemodialysis clinical trial with its fluid monitoring system, CM-1500. The study, conducted at DaVita Clinical Research clinics, is aimed at further characterizing changes in the device's patented Relative Index during hemodialysis procedures where a large volume of fluid is removed from patients. The company obtained FDA clearance of the fluid monitoring system in February 2020. The CM-1500 is a non-invasive monitor intended to monitor patients' fluid balance in hospitals and surgical centers.
"Engaging in these trials will not only refine our devices and technology but will also push the monitoring division forward to better serve patients across the world. We're excited to take this next step in innovating the clinical value that our technology provides hospitals and surgical centers", said Thomas Sandgaard, CEO, Chairman and Founder.
Zynex Monitoring Solutions expects to initially target operating rooms and surgeries that typically display substantial blood loss, as well as recovery rooms and intensive care units where internal bleedings are more common and difficult to detect until serious complications occur.
Donald Gregg, VP of Zynex Monitoring Solutions said: "Investing in clinical evidence is critically important to clearly articulate how our device performs in multiple care settings, and the hemodialysis population is of particular interest due to the controlled setting and known volume removed from patients on a regular basis."
The study is expected to complete enrollments in the first quarter of 2022.
About Zynex, Inc.
Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation. Zynex also has a fluid monitoring system for use in hospitals and surgery centers. 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, 2020 as well as our quarterly reports on Form 10-Q and current reports on Form 8-K.
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Contact: Zynex, Inc. (800) 495-6670
Investor Relations Contact:
Gilmartin Group
Investor Relations Counsel
ir@zynexmed.com
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