Zynex Inc (NASDAQ:ZYXI) continues to expand its portfolio of innovative, non-invasive medical devices targeting pain management, rehabilitation, and pain monitoring.
The company’s flagship NexWave product is a multi-modality electrotherapy device that combines various therapeutic modalities to provide effective pain relief. It has been clinically shown to reduce pain significantly and is often prescribed for patients with chronic pain conditions.
Recently cleared by the Food and Drug Administration (FDA), Zynex’s TensWave device utilizes Transcutaneous Electrical Nerve Stimulation (TENS) therapy. It is designed to offer a portable and user-friendly solution for patients seeking drug-free pain relief.
The company is also advancing its NiCO laser pulse oximeter towards an FDA market clearance submission later this year following the completion of a key trial at Duke University.
What is Zynex’s NiCO pulse oximeter?
The NiCO pulse oximeter is an advanced medical device designed to directly measure blood oxygenation levels using precise laser technology.
Blood oxygen levels, or SpO₂, are a critical indicator of respiratory and circulatory health, reflecting how effectively oxygen is being delivered to the body’s organs and tissues.
Unlike traditional LED-based pulse oximeters that estimate oxygen levels, the NiCO device provides accurate, direct measurements, significantly reducing errors.
Why is it important?
The NiCO pulse oximeter addresses a critical issue in traditional oximetry: the potential for inaccurate readings in individuals with darker skin pigmentation.
LED-based devices have been shown to overestimate oxygen saturation in such populations, particularly at lower oxygen levels, posing risks to patient safety and care quality.
A study overseen by anesthesiologist Dr David MacLeod at Duke University confirmed that the NiCO device delivers accurate, unbiased measurements across all skin tones, addressing a critical limitation of conventional oximeters.
It reaffirmed that the NiCO device could help reduce racial disparity in clinical decision-making related to oxygen treatment and ventilation.
Next steps
Completing the Duke trial in late 2024 was a key milestone required by the FDA prior to submission of a 510(k) for clearance to market and sell the NiCO device for clinical use.
With this study complete, Zynex is focused on final testing to ensure the device's operational safety before submitting its application to the FDA, which is expected by the end of June.
Investors can also expect to see updates from the company related to its work with Medicare and the US Department of Veterans Affairs.
In December, the company announced a partnership with Veterans Affairs Medical Centers (VAMCs), the largest healthcare network in the US.
With more than $112 billion spent annually on healthcare for veterans, this collaboration will allow Zynex to expand its advanced pain management solutions to the VA’s network, which serves over 9 million veterans.
Currently, less than 1% of Zynex’s sales come from VAMCs, and this partnership provides a significant opportunity to grow in this critical market.
Zynex expects to provide more updates soon as it works closely with healthcare providers within the VA and Military Treatment Facilities to enhance care for veterans.
The company will also provide an update on its financial position and other corporate matters when it reports its fourth quarter and fiscal year financial results in early February. The company will be releasing its Q1 results at this time, too.
Management says
"We remain confident that the clinical value of NiCO's unparalleled precision, accuracy, and safety provides a game-changing solution to racial disparity as we prepare our application for FDA clearance,” Zynex Monitoring Solutions president Donald Gregg said.
“We look forward to additional milestones and announcements for NiCO pulse oximetry.”
Thomas Sandgaard, Zynex CEO and founder, described the company’s VA partnership as a significant milestone in expanding access to non-opioid pain management solutions for veterans.
"Working with the VA provides us with access to the largest healthcare network in the United States and we are honored to help enhance the quality of care for veterans nationwide,” Sandgaard said.