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.”