Latest news with #NiCO
Yahoo
23-05-2025
- Business
- Yahoo
Here's Why Zynex (ZYXI) Fell in Q1
Rewey Asset Management, an investment management company, released its 'RAM Smid Composite' first quarter 2025 investor letter. A copy of the letter can be downloaded here. The composite declined 6.97% in Q1 2025, trailing a 5.83% decline for the benchmark Russell 2500 Value Total Return Index. Larger-cap stocks outperformed smaller ones in 1Q25, with the Russell 3000 TR value up 1.64% and the Russell 2000 TR value down 7.74%, while the RAM Smid composite is biased towards smaller-cap stocks. The significant market theme in Q1 2025 was the uncertainty surrounding the potential negative economic effects of Trump's tariffs. In addition, please check the fund's top five holdings to know its best picks in 2025. In its first-quarter 2025 investor letter, Rewey Asset Management highlighted stocks such as Zynex, Inc. (NASDAQ:ZYXI). Zynex, Inc. (NASDAQ:ZYXI) is a medical device manufacturer. The one-month return of Zynex, Inc. (NASDAQ:ZYXI) was -6.43%, and its shares lost 78.56% of their value over the last 52 weeks. On May 22, 2025, Zynex, Inc. (NASDAQ:ZYXI) stock closed at $2.30 per share with a market capitalization of $68.189 million. Rewey Asset Management stated the following regarding Zynex, Inc. (NASDAQ:ZYXI) in its Q1 2025 investor letter: "Zynex, Inc. (NASDAQ:ZYXI) was our worst performer in the quarter, as the company announced that its top insurance payor was pausing reimbursement while it reviewed the company's shipping practices for consumable supplies. The company continues to ship consumables as requested during the review and has stated they are compliant with the relationship post an audit 2-years ago. While we did trim our position on this news, the leading pillar of our investment case, the introduction of the company's NiCO pulse laser oximeter in late 2025, remains in-tact. This pulse oximeter uses a laser to measure blood oxygen levels during surgery and is more accurate than current light-based estimated readings which are obstructed by pigment levels in skin. Leading reviews of the NiCO device have been positive, and we think it could become the standard of care." A close-up view of medical devices, electrical stimulation electrodes, and batteries. Zynex, Inc. (NASDAQ:ZYXI) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 10 hedge fund portfolios held Zynex, Inc. (NASDAQ:ZYXI) at the end of the fourth quarter compared to 10 in the third quarter. In Q1 2025, Zynex, Inc. (NASDAQ:ZYXI) reported net revenue of $26.6 million compared to $46.5 million in Q1 2024. While we acknowledge the potential of Zynex, Inc. (NASDAQ:ZYXI) as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is as promising as NVIDIA but that trades at less than 5 times its earnings, check out our report about the undervalued AI stock set for massive gains. In addition, please check out our hedge fund investor letters Q1 2025 page for more investor letters from hedge funds and other leading investors. READ NEXT: Michael Burry Is Selling These Stocks and A New Dawn Is Coming to US Stocks. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-05-2025
- Business
- Yahoo
Zynex Submits FDA Application for Its NiCO Laser Pulse Oximeter
ENGLEWOOD, Colo., May 12, 2025 /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 submitted a 510(k) application to the U.S. Food and Drug Administration ("FDA") for its NiCO™, Noninvasive CO-Oximeter device. This submission marks a historic milestone in the evolution of pulse oximetry and a major breakthrough for the Company in its mission to improve the quality of care and patient outcomes through its patient monitoring products. Pulse oximetry is one of the world's largest medical device markets and current devices on the market have long been under scrutiny for their inaccuracy and limitations. Zynex's laser technology enables oxygen levels to be measured accurately for patients with dark skin. In cases of carbon monoxide (CO) poisoning, not only are the measurements non-invasive and results instantaneous, but both oxygen and CO are measured accurately, potentially reducing the need for taking blood samples and having to wait for the lab results. Clinical studies following the COVID-19 pandemic highlighted a long-standing problem with traditional LED-based pulse oximeters dangerously misinterpreting oxygenation levels in individuals with darker skin pigmentation, and in patient populations that suffer from low oxygen perfusion1,2. In response to this pressing public health issue, the FDA issued updated pulse oximetry device recommendations earlier this year urging device manufacturers to address this issue in both existing and new technologies with expanded testing guidelines and higher overall accuracy standards. Highly precise laser technology directly measures fractional blood oxygenation levels, rather than the current LED technology which estimates functional oxygen saturation (SpO2), giving clinicians a more complete, reliable and accurate overview of the patient's real-time oxygenation status. Unlike current LED-based pulse oximeters, laser-based pulse oximetry performance is not skewed by pigments such as melanin or nail polish, resulting in highly trustworthy measurements and eliminating harmful pigmentation bias problems. The NiCO is expected to be the first product to accurately and continuously measure all four primary hemoglobin species via patented laser pulse oximetry technology, to enable earlier and more accurate detection of hypoxia and hyperoxia. Furthermore, in addition to oxygenated hemoglobin, the NiCO pulse oximeter measures the level of reduced hemoglobin, as well as dysfunctional hemoglobins (dyshemoglobins), specifically carboxyhemoglobin and methemoglobin. Dyshemoglobins can result from the ingestion of various poisons, use of various prescription medications, or due to carbon monoxide poisoning. They are unable to bind oxygen and transport it throughout the body, which is essential for life. The ability to non-invasively measure dyshemoglobins is a game changing event. "We believe NiCO is a distinct market disrupting technology and can provide significant improvements to patient care for hospital and non-hospital providers in numerous medical settings," said Donald Gregg, President of Zynex Monitoring Solutions. "Clinical studies have shown the Zynex NiCO Laser Pulse Oximeter is groundbreaking in providing more reliable, comprehensive, and accurate information about a patient's oxygen status by continuously measuring all four primary hemoglobin species. The real-time display of oxygenated hemoglobin, reduced hemoglobin, carboxyhemoglobin and methemoglobin will assist clinicians in earlier and more accurate detection of hypoxia and hyperoxia, which can save lives, lower costs, and enhance overall patient care efficiency." This FDA 510(k) application submission represents a major milestone in Zynex's commitment to delivering cutting-edge medical devices, demonstrating the Company's dedication to ensuring patients and doctors have access to the latest innovations in medical technology. The estimated accessible market for pulse oximetry monitoring is over $2.8 billion today, growing to $4.3 billion in 20273. Pulse oximeters are currently used in nearly every clinical care area in hospital and non-hospital settings. "This 510(k) submission marks a major breakthrough on the path to changing the landscape of patient monitoring," said Thomas Sandgaard, Zynex Founder and CEO. "Enormous thanks are owed to the tireless work of our tremendous Zynex Monitoring team, and the day we see NiCO in clinical care is approaching at an exciting pace." Laser pulse oximetry has the promise to revolutionize not only oxygen saturation measurements, but also the total hemoglobin testing market which is another $2-34 billion market opportunity that Zynex can pursue with laser-based technology. The NiCO submission is an exciting first step in creating a new standard for patient monitoring. 1 Sjoding MW, et al. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020; 383:2477-8.2 Gudelunas MK, et al. Low Perfusion and Missed Diagnosis of Hypoxemia by Pulse Oximetry in Darkly Pigmented Skin: A Prospective Study. Anesthesia and Analgesia. 2024;138(3):552-561.3 Markets and Markets: Pulse Oximeter Global Forecast 2022.4 Verified Market Research, GLOBAL HEMOGLOBIN MONITOR MARKET 2022-2031, and The Business Research Company, Hemoglobin Testing Global Market Report 2025. About Zynex, Inc. 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: Safe Harbor Statement This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended. our results of operations and the plans, strategies and objectives for future operations; the timing and scope of any potential stock repurchase; and other similar statements. Words such as "anticipate," "believe," "continue," "could," "designed," "endeavor," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "seek," "should," "target," "preliminary," "will," "would" and similar expressions are intended to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions. 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 first 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; market conditions; the timing, scope and possibility that the repurchase program may be suspended or discontinued; economic factors, such as interest rate fluctuations; and other risks described in our filings with the Securities and Exchange Commission. These and other risks are 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, 2024, as well as our quarterly reports on Form 10-Q and current reports on Form 8-K. Any forward-looking statements contained in this press release represent Zynex's views only as of today and should not be relied upon as representing its views as of any subsequent date. Zynex explicitly disclaims any obligation to update any forward-looking statements, except to the extent required by law. Investor Relations Contact:Dan MoorheadZynex, View original content to download multimedia: SOURCE Zynex, Inc.
Yahoo
12-03-2025
- Business
- Yahoo
Zynex Inc (ZYXI) Q4 2024 Earnings Call Highlights: Navigating Challenges and Opportunities
Net Revenue: $46 million in Q4 2024, compared to $47.3 million in Q4 2023. Device Revenue: $14.8 million in Q4 2024, down from $16.3 million in Q4 2023. Supplies Revenue: $31.2 million in Q4 2024, up from $31 million in Q4 2023. Gross Profit: $36 million or 78% of revenue in Q4 2024, compared to $37 million or 78% in Q4 2023. Sales and Marketing Expenses: $19.3 million in Q4 2024, down from $21.7 million in Q4 2023. G&A Expenses: $17.3 million in Q4 2024, up from $13 million in Q4 2023. Net Loss: $615,000 or $0.02 per share in Q4 2024, compared to net income of $1.2 million or $0.04 per share in Q4 2023. Adjusted EBITDA: $584,000 in Q4 2024, compared to $9.9 million in Q4 2023. Cash Flows from Operations: $2.4 million in Q4 2024 and $12.7 million for the full year. Cash Balance: $39.6 million at the end of Q4 2024, up 5% from Q3's balance of $37.6 million. Working Capital: $58.3 million as of December 31, 2024. Sales Force: Reduced from approximately 475 to 330 people by the end of 2024. Revenue per Sales Rep: Increased 22% to $490,000 on average in 2024. Projected Q1 2025 Revenue: Approximately $30 million. Projected Q1 2025 Net Loss: Between $9 million and $10 million. Warning! GuruFocus has detected 4 Warning Signs with ZYXI. Release Date: March 11, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Zynex Inc (NASDAQ:ZYXI) reported a 4% increase in revenue for 2024, with order growth of 16% for the year. The company has diversified its revenue streams by adding new products, including internally developed and private label products. Positive test results for the NiCO pulse oximeter were received from trials at Duke University and the University of California, San Francisco. Zynex Inc (NASDAQ:ZYXI) has restructured its sales force, resulting in a 22% increase in revenue per sales representative. The company has a strong cash position with $39.6 million on the balance sheet, up 5% from the previous quarter. TRICARE has temporarily suspended payments to Zynex Inc (NASDAQ:ZYXI), affecting 20% to 25% of the company's revenue. The company reported a net loss of $615,000 in Q4 2024 compared to a net income of $1.2 million in Q4 2023. Adjusted EBITDA for Q4 2024 was significantly lower at $584,000 compared to $9.9 million in Q4 2023. The FDA submission for the NiCO pulse oximeter has been delayed into 2025, impacting potential revenue generation. Zynex Inc (NASDAQ:ZYXI) has reduced its workforce by 15%, primarily affecting corporate office employees, to manage costs amid revenue uncertainties. Q: Could you give us a sense of what was accomplished in the fourth quarter regarding the 15% staff reduction and how it will affect your OpEx lines? A: Daniel Moorhead, CFO, explained that less than half of the $30 million-plus in annual savings was achieved during 2024, with the rest implemented in Q1 2025. Sales expenses are expected to decrease by $1-2 million, and G&A expenses will also see a similar reduction. Q: Could you elaborate on the commercial path to market for the NiCO pulse oximeter? A: Donald Gregg, President of Zynex Monitoring Solutions, stated that they are considering multiple strategies, including direct sales, partnerships, and indirect sales through 1099 organizations. They are prepared to execute these plans upon FDA clearance. Q: What was the nature of the 2022 audit by TRICARE related to billing practices, and why didn't you have visibility into TRICARE's actions? A: Anna Lucsok, COO, mentioned that the audit was a routine post-payment audit with standard adjustments. The lack of visibility into TRICARE's recent actions is due to unclear communication from TRICARE regarding specific issues. Q: Why don't you have visibility into sales for 2025, given that 75% of your business is still being reimbursed? A: Thomas Sandgaard, CEO, explained that the uncertainty with TRICARE, which represents a significant portion of revenue, makes it difficult to provide guidance. They are confident in resolving the issue but are taking a conservative approach until more clarity is obtained. Q: What is your plan for the April meeting with TRICARE, and have they requested specific information? A: Anna Lucsok, COO, stated that TRICARE has provided vague guidance, but Zynex plans to present data on compliance with policies and refer to the 2022 audit findings. They aim to clarify and resolve the issues during the meeting. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
