Zynex Monitoring Announces First Enrollment in an Apheresis Blood Donation Clinical Trial for its Fluid Monitoring System
Zynex, Inc. (NASDAQ: ZYXI) has initiated enrollments in a clinical trial for its fluid monitoring system, CM-1500, aimed at enhancing performance characterization during apheresis blood donation. Conducted at Vitalant Research Institute, the trial will monitor changes in the device's patented Relative Index. The CM-1500 received FDA clearance in February 2020, and the company is focused on building clinical evidence for this technology. Zynex is also preparing for the next-generation device (CM-1600) FDA submission, reinforcing its commitment to innovate in non-invasive monitoring solutions.
- Enrollment in a clinical trial for CM-1500 initiated to enhance performance characterization.
- FDA clearance for CM-1500 obtained in February 2020, supporting its market potential.
- Focus on developing the next-generation device (CM-1600) for FDA submission.
- None.
ENGLEWOOD, Colo., Jan. 11, 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 reported it has started enrollments in a clinical trial aimed at further characterizing the performance of its fluid monitoring system, CM-1500. The study, conducted at Vitalant Research Institute (the research arm of Vitalant, the nation's largest independent, nonprofit blood services provider), tracks changes in the device's patented Relative Index during apheresis blood donation procedures. The company obtained FDA clearance of the fluid monitoring system in February 2020.
"We are excited to continue innovating the portfolio of clinical evidence to support the performance of our non-invasive fluid monitoring technology," said Donald Gregg, VP of Zynex Monitoring Solutions. "We believe this technology is fulfilling an unmet need to manage fluid and blood loss across the clinical care continuum."
The CM-1500 is a non-invasive monitor intended to monitor patients' fluid balance in hospitals and surgical centers. The company's focus in 2021 has been on the clinical evidence supporting the CM-1500 and preparing the next generation device (CM-1600) for submission to the FDA.
Thomas Sandgaard, CEO, Chairman and Founder said: "We believe our Relative Index can be the future of patient fluid monitoring. We're excited to participate in more studies, like this one, to validate the Relative Index and our technology. We look forward to more research throughout 2022 as we continue innovating our technology for the CM-1600."
About Zynex, Inc.
Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation as well as developing noninvasive patient fluid, pulse oximetry and sepsis monitoring systems. 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.
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.
Contact: Zynex, Inc. (800) 495-6670
Investor Relations Contact:
Gilmartin Group
Investor Relations Counsel
ir@zynex.com
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SOURCE Zynex
FAQ
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