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Nuwellis (NUWE)
NASDAQ:NUWE

Nuwellis (NUWE) AI Stock Analysis

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NUWE

Nuwellis

(NASDAQ:NUWE)

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Neutral 43 (OpenAI - 5.2)
Rating:43Neutral
Price Target:
$2.00
▲(13.64% Upside)
The score is held down primarily by weak financial performance (sharp TTM revenue decline, large ongoing losses, and continued negative free cash flow). Technicals also remain bearish with price below key moving averages and negative MACD. Valuation provides little support given the company is loss-making and no dividend yield is provided.
Positive Factors
Innovative Product Offering
The Aquadex SmartFlow system offers a unique ultrafiltration process, positioning Nuwellis as a leader in fluid management, crucial for heart failure care.
Strong Gross Profit Margin
A strong gross profit margin indicates efficient production and pricing strategies, supporting long-term profitability potential despite current losses.
Healthy Equity Position
A high equity ratio provides a strong buffer against liabilities, enhancing financial stability and resilience against market fluctuations.
Negative Factors
Negative Profitability
Ongoing negative profitability due to high operational costs threatens long-term viability, requiring strategic cost management to improve margins.
Negative Free Cash Flow
Persistent negative free cash flow indicates cash burn issues, potentially impacting future operations and necessitating improved cash management.
Leadership Changes
Leadership changes can disrupt strategic continuity and may affect investor confidence, necessitating a stable transition to maintain operational focus.

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

Nuwellis Business Overview & Revenue Model

Company DescriptionNuwellis, Inc., a medical device company, focuses on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy. The company's products are the Aquadex FlexFlow and Aquadex SmartFlow systems, which are indicated for the treatment of patients suffering from fluid overload who have failed diuretics. Its Aquadex FlexFlow system includes a console, disposable blood set, and catheter. The company sells its products to hospitals and clinics through its direct salesforce in the United States; and through independent specialty distributors primarily in Austria, Brazil, Czech Republic, Germany, Greece, Hong Kong, India, Israel, Italy, Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, the United Arab Emirates, and the United Kingdom. The company was formerly known as CHF Solutions, Inc. and changed its name to Nuwellis, Inc. in April 2021. Nuwellis, Inc. was founded in 1999 and is headquartered in Eden Prairie, Minnesota.
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
18
Very Negative
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
56
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
21
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
Positive
Last Price1.76
Price Trends
50DMA
2.29
Positive
100DMA
3.07
Negative
200DMA
12.97
Negative
Market Momentum
MACD
-0.08
Negative
RSI
58.39
Neutral
STOCH
58.33
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For NUWE, the sentiment is Positive. The current price of 1.76 is below the 20-day moving average (MA) of 2.01, below the 50-day MA of 2.29, and below the 200-day MA of 12.97, indicating a neutral trend. The MACD of -0.08 indicates Negative momentum. The RSI at 58.39 is Neutral, neither overbought nor oversold. The STOCH value of 58.33 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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%
47
Neutral
$9.77M-0.5120.03%-99.28%-46.16%
46
Neutral
$10.04M-0.47-220.42%-41.03%35.71%
45
Neutral
$2.54M-0.05-191.39%76.53%
43
Neutral
$3.15M-0.02-467.14%-8.93%97.80%
42
Neutral
$3.37M-0.05-173.74%82.96%82.04%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
NUWE
Nuwellis
2.37
-43.20
-94.80%
AEMD
Aethlon Medical
2.71
-54.45
-95.27%
PAVM
PAVmed
8.75
-10.59
-54.76%
VTAK
Catheter Precision
2.26
-6.58
-74.43%
BBLG
Bone Biologics
1.67
-4.08
-70.96%
HSCS
Heart Test Laboratories, Inc.
3.20
-0.12
-3.61%
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: Jan 13, 2026