Zynex Announces First Enrollments in Apheresis Donation Clinical Trial with Second Generation Fluid Monitoring System
Zynex, Inc. (Nasdaq: ZYXI) has initiated enrollment in a clinical trial for its second-generation fluid monitoring system, the CM-1600, designed for apheresis procedures. The trial builds on data collected from its predicate device, the CM-1500, which received FDA clearance in February 2020. Currently, 53 subjects are participating in the study, with completion of enrollment expected by Q4 2022. Zynex aims to demonstrate the CM-1600's enhanced sensitivity and accuracy in various clinical settings to support its market value.
- Enrollment of 53 subjects in the CM-1600 clinical trial.
- Potential enhancement in accuracy and sensitivity of the CM-1600 based on CM-1500 data.
- The CM-1600 is still awaiting FDA clearance, which may delay its market introduction.
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."
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
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.
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