ENGLEWOOD, Colo. - Zynex , Inc. (NASDAQ: NASDAQ:ZYXI), a medical technology company known for noninvasive medical devices with a market capitalization of $255 million and impressive 79.7% gross margins, has announced the completion of a clinical trial for its NiCO pulse oximeter, a crucial step towards seeking FDA approval. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, suggesting potential upside for investors. Conducted under the oversight of Dr. David MacLeod at Duke University, the trial marks progress for Zynex Monitoring Solutions (ZMS) toward entering the pulse oximetry market.
The NiCO pulse oximeter is designed with laser technology to directly measure blood oxygen levels, a method Zynex claims is more precise than the LED-based estimations used by current devices. This technology is particularly significant given that LED pulse oximeters have reportedly been less accurate for individuals with darker skin pigmentation.
With the trial completed, Zynex focuses on final safety testing before submitting a 510(k) application to the FDA for the NiCO device. Donald Gregg, President of ZMS, emphasized the milestone as a turning point, with the majority of the groundwork now behind them.
Zynex's CEO, Thomas Sandgaard, expressed confidence in NiCO's potential to transform the established market with its precision and safety. The company views the product as its first entry into a mature and expanding market space.
Founded in 1996, Zynex has been developing and marketing devices for pain management and rehabilitation. It has expanded its portfolio to include non-invasive monitoring systems for hospital use. The company maintains a healthy financial position with a current ratio of 3.94, indicating strong liquidity to fund its growth initiatives. InvestingPro subscribers can access detailed financial health scores and 11 additional expert tips about Zynex's performance and outlook.
The press release also contains forward-looking statements, cautioning that actual results may differ due to various risks and uncertainties, including the need for regulatory approvals and market acceptance of new products. While the company maintains steady revenue growth of 4.2% and positive earnings per share of $0.15, investors seeking deeper insights can access comprehensive analysis through the Pro Research Report available on InvestingPro, which covers over 1,400 US stocks including Zynex.
This announcement is based on a press release statement and does not constitute an endorsement of Zynex's claims. It is a factual report on the company's recent completion of a clinical trial for its NiCO pulse oximeter as part of the FDA approval process.
In other recent news, Zynex Inc. announced steady Q3 growth in its earnings call, with a marginal increase in net revenue to $50 million and a net income of $2.4 million. The company also reported year-over-year order growth of 13% and is projecting a total revenue of $200 million for the full year of 2024. Despite a decrease in device revenue, supplies revenue rose, and the company is actively diversifying its product offerings. As part of its future expansion plans, Zynex intends to add 10 sales representatives monthly over the next 18 months. It also anticipates FDA clearance for its NiCO pulse oximeter. Analysts from various firms have noted these developments. These are the recent updates from the company.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.