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Nuwellis (NUWE)
NASDAQ:NUWE
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Nuwellis (NUWE) AI Stock Analysis

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NUWE

Nuwellis

(NASDAQ:NUWE)

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Neutral 45 (OpenAI - 4o)
Rating:45Neutral
Price Target:
$2.50
▲(2.88% Upside)
Nuwellis' overall stock score is primarily impacted by its weak financial performance and poor valuation metrics. While there are positive corporate developments and strategic initiatives, the immediate financial challenges and bearish technical indicators weigh heavily on the stock's attractiveness.
Positive Factors
Pediatric Revenue Growth
Strong growth in pediatric revenues indicates increasing demand and successful market penetration in a specialized segment, supporting long-term revenue stability.
New Patent Issuance
The new patent strengthens Nuwellis' IP portfolio, enhancing competitive advantage and supporting future product innovation, particularly in pediatric care.
NIH Grant for Pediatric Device
The NIH grant supports critical development of pediatric devices, potentially expanding market reach and reinforcing Nuwellis' position in pediatric healthcare solutions.
Negative Factors
Overall Revenue Decline
A significant revenue decline poses challenges for financial stability and growth, necessitating strategic adjustments to reverse the trend and sustain operations.
Gross Margin Decrease
Reduced gross margins due to lower production volumes impact profitability, highlighting the need for cost management and operational efficiency improvements.
Increased Operating Loss
Rising operating losses indicate ongoing financial strain, underscoring the necessity for strategic cost reductions and revenue enhancement to achieve profitability.

Nuwellis (NUWE) vs. SPDR S&P 500 ETF (SPY)

Nuwellis Business Overview & Revenue Model

Company DescriptionNuwellis, Inc. is a medical technology company focused on developing innovative solutions for the management of fluid overload in patients. Operating primarily in the healthcare sector, Nuwellis specializes in advanced medical devices and technologies that improve patient outcomes, particularly for those suffering from conditions like heart failure and other fluid management disorders. Their flagship product is the Aquadex SmartFlow system, which utilizes a unique ultrafiltration process to effectively remove excess fluid from the body, thereby addressing critical health challenges associated with fluid overload.
How the Company Makes MoneyNuwellis generates revenue primarily through the sale of its medical devices, particularly the Aquadex SmartFlow system and related disposables. Revenue streams include direct sales to hospitals and healthcare providers, as well as rental agreements for their devices. The company may also benefit from strategic partnerships with healthcare institutions and distributors to expand its market reach and improve product adoption. Additionally, Nuwellis could explore opportunities for reimbursement from insurance providers for the cost of its products and services, contributing to its overall revenue. Factors such as increasing demand for effective fluid management solutions and the growing prevalence of heart failure and related conditions further enhance the company's earning potential.

Nuwellis Earnings Call Summary

Earnings Call Date:Aug 14, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Mar 03, 2026
Earnings Call Sentiment Negative
The earnings call highlights several strategic initiatives and resolutions, such as pediatric revenue growth and successful transition plans, which are promising for future growth. However, the current financial performance is challenged by a significant revenue decline, reduced gross margins, and increased operating losses. While there are positive steps being taken, the immediate financial indicators present a negative outlook.
Q2-2025 Updates
Positive Updates
Pediatric Revenue Growth
Pediatric revenues increased by 23% compared to the second quarter of 2024, reflecting strong demand from established hospital customers and new centers.
Resolution of Sterilization Vendor Issue
The temporary back order issue due to a sterilization vendor was resolved in the first week of July, allowing the company to build inventory and support future sales.
Transition to KDI Precision Manufacturing
Transition to KDI Precision Manufacturing is expected to result in operational efficiencies and cost savings over the next 12 months.
Increased Reimbursement for Heart Failure
Reimbursement increased from $413 to $1,639 per day for outpatient clinics, which is expected to drive growth in the heart failure segment.
Successful Capital Raise
The company completed a $5 million gross capital raise, bolstering its financial position and supporting core growth initiatives.
Negative Updates
Overall Revenue Decline
Total revenue for the second quarter was $1.7 million, down 21% year-over-year from $2.2 million.
Gross Margin Decrease
Gross margin decreased to 55.5% from 67.2% in Q2 2024, largely due to under-absorption of fixed overhead because of lower production volumes.
Increased Operating Loss
Operating loss for Q2 was $2.9 million, compared to $2.3 million in Q2 2024.
Net Loss Attributable to Common Shareholders
Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per share, compared to $7.7 million or a loss of $791.82 per share in 2024.
Termination of REVERSE-HF Clinical Trial
The REVERSE-HF clinical trial was terminated to reallocate approximately $4 million to higher impact growth areas.
Company Guidance
During the Nuwellis Second Quarter 2025 Earnings Conference Call, management provided key guidance and insights into their strategic focus and financial performance. The company reported a revenue of $1.7 million for the second quarter, representing a 21% year-over-year decline, primarily due to a temporary back order issue with a sterilization vendor affecting approximately $400,000 in revenue. Despite this, pediatric revenues grew by 23%, while heart failure and critical care revenues saw declines of 53% and 35%, respectively. The gross margin dropped to 55.5% from 67.2% the previous year, attributed to lower production volumes. Operating expenses increased slightly by 2% to $3.9 million, resulting in an operating loss of $2.9 million. The company ended the quarter with $4.5 million in cash and remains debt-free, supported by a recent $5 million capital raise. Going forward, Nuwellis plans to focus on key growth areas in cardiac surgery, pediatrics, and outpatient heart failure, with expectations of operational efficiencies and cost savings from transitioning manufacturing to KDI Precision Manufacturing.

Nuwellis Financial Statement Overview

Summary
Nuwellis faces significant financial challenges marked by consistent losses and negative cash flows, despite stable revenue and a strong equity position. The company needs to focus on improving operational efficiency and profitability to ensure long-term sustainability.
Income Statement
45
Neutral
Nuwellis demonstrates modest revenue growth with a 2.8% increase from 2022 to 2023 and a slight decline of 1.4% in 2024. However, the company is grappling with negative profitability as evidenced by significant negative EBIT and net income margins. Despite a decent gross profit margin of approximately 64.9% for 2024, ongoing losses due to high operational costs are concerning.
Balance Sheet
50
Neutral
The company's balance sheet shows a healthy equity position with an equity ratio of 66.2% in 2024, indicating a strong buffer against liabilities. However, the debt-to-equity ratio stands at 0.08, showcasing manageable leverage but returns on equity remain negative due to sustained net losses. The stability is commendable, yet profitability remains a critical issue.
Cash Flow
40
Negative
Cash flow analysis reflects a challenging situation with negative free cash flow, although there is a marked improvement in operating cash flow from 2023 to 2024. The company's reliance on financing activities for liquidity is evident. Free cash flow growth remains negative, indicating ongoing cash burn issues which could impact future operations if not addressed.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue8.17M8.74M8.86M8.54M7.92M7.44M
Gross Profit4.97M5.83M4.98M4.75M4.49M4.06M
EBITDA-7.53M-10.53M-16.36M-4.90M-19.06M-16.65M
Net Income-16.57M-11.16M-20.21M-14.53M-19.55M-15.84M
Balance Sheet
Total Assets7.98M9.86M9.77M24.67M30.42M20.01M
Cash, Cash Equivalents and Short-Term Investments3.09M5.09M3.80M18.31M24.20M14.44M
Total Debt383.00K545.00K760.00K984.00K1.18M339.00K
Total Liabilities4.07M3.33M6.56M12.32M4.47M3.69M
Stockholders Equity3.91M6.53M3.21M12.36M25.95M16.32M
Cash Flow
Free Cash Flow-9.41M-9.65M-18.18M-15.27M-18.06M-16.87M
Operating Cash Flow-9.28M-9.59M-17.94M-15.15M-17.84M-16.57M
Investing Cash Flow-125.00K-60.00K330.00K14.73M-15.72M-267.00K
Financing Cash Flow10.60M10.96M3.68M9.42M27.87M30.02M

Nuwellis Technical Analysis

Technical Analysis Sentiment
Negative
Last Price2.43
Price Trends
50DMA
2.96
Negative
100DMA
4.82
Negative
200DMA
19.29
Negative
Market Momentum
MACD
-0.18
Negative
RSI
45.28
Neutral
STOCH
72.74
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For NUWE, the sentiment is Negative. The current price of 2.43 is below the 20-day moving average (MA) of 2.43, below the 50-day MA of 2.96, and below the 200-day MA of 19.29, indicating a bearish trend. The MACD of -0.18 indicates Negative momentum. The RSI at 45.28 is Neutral, neither overbought nor oversold. The STOCH value of 72.74 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for NUWE.

Nuwellis Risk Analysis

Nuwellis disclosed 37 risk factors in its most recent earnings report. Nuwellis reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Nuwellis Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
48
Neutral
$10.04M0.3220.03%-99.28%-46.16%
45
Neutral
$2.43M-0.08-467.14%-8.93%97.80%
41
Neutral
$3.38M-0.03-173.74%82.96%82.04%
40
Underperform
$7.07M-0.32-193.24%-66.40%65.99%
38
Underperform
$3.44M-0.07-191.39%76.53%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
NUWE
Nuwellis
2.43
-53.85
-95.68%
AEMD
Aethlon Medical
3.70
-26.51
-87.75%
PAVM
PAVmed
0.33
-0.52
-61.18%
VTAK
Catheter Precision
2.38
-4.56
-65.71%
BBLG
Bone Biologics
1.93
-5.69
-74.67%
HSCS
Heart Test Laboratories, Inc.
2.67
-1.59
-37.32%

Nuwellis Corporate Events

Executive/Board Changes
Nuwellis Appoints John L. Erb as Interim CFO
Neutral
Oct 8, 2025

On October 7, 2025, Robert B. Scott announced his resignation as Chief Financial Officer of Nuwellis, Inc., effective around October 24, 2025. His departure is not due to any disagreements with the company. The company plans to initiate a search for a new CFO. On October 8, 2025, the Board appointed John L. Erb, the current President and CEO, as interim CFO starting on the separation date. Mr. Erb has extensive experience in the medical device industry and has held various leadership roles within Nuwellis and other companies. His appointment as interim CFO is not accompanied by any additional compensation or changes to his current plans.

Product-Related AnnouncementsBusiness Operations and Strategy
Nuwellis Announces ULTRA-Peds Registry Findings
Neutral
Sep 30, 2025

On September 30, 2025, Nuwellis, Inc. announced findings from the ULTRA-Peds registry, a multi-center observational study examining the real-world use of the Aquadex System in children with acute kidney injury (AKI), fluid overload, or congenital kidney failure.

Product-Related AnnouncementsBusiness Operations and Strategy
Nuwellis Secures New Patent for Hemolysis Sensors
Positive
Sep 18, 2025

On September 18, 2025, Nuwellis, Inc. announced the issuance of a new U.S. patent related to hemolysis sensors in blood filtration systems, which supports their pediatric device, Vivian, and future innovations. This patent issuance strengthens Nuwellis’ intellectual property portfolio, potentially enhancing their market position and innovation capabilities in the medical device sector.

Product-Related AnnouncementsPrivate Placements and Financing
Nuwellis Secures NIH Grant for Pediatric Device Development
Positive
Sep 9, 2025

On September 9, 2025, Nuwellis, Inc. announced that the National Institutes of Health (NIH) awarded a multi-year grant of approximately $3 million to its partner, Koronis Biomedical Technologies Corporation. This grant will expedite the development of Vivian™, a pediatric continuous renal replacement therapy device, and enhance the company’s software and firmware, potentially strengthening its market position.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Dec 07, 2025