Nuwellis (NUWE) AI Stock Analysis

• Market Cap: $3.40M
• Dividend Yield: N/A
• Average Volume (3M): 289.18K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.55
• Revenue Growth: -8.93%
• EPS Growth: 97.80%
• Country: US
• Employees: 38
• Sector: Healthcare
• Sector Strength: 45
• Industry: Medical - Devices
• EPS (TTM): 0.56
• Shares Outstanding: 1,658,799
• 10 Day Avg. Volume: 82,161
• 30 Day Avg. Volume: 289,177
• PEG Ratio: 0.06
• Price to Book (P/B): 9.48
• Price to Sales (P/S): 7.08
• P/FCF Ratio: -6.41
• Enterprise Value/Market Cap: -0.62
• Enterprise Value/Revenue: -0.26
• Enterprise Value/Gross Profit: -0.42
• Enterprise Value/Ebitda: 0.28
• 1Y Price Target: $3.90
• Price Target Upside: 90.24% Upside
• Rating Consensus: Hold
• Number of Analyst Covering: 1
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 48 Neutral
• Price Target: $2.50 ▲(21.95% Upside)

Nuwellis' overall stock score is primarily impacted by its challenging financial performance, with ongoing losses and negative cash flows. While recent corporate events and strategic initiatives provide some optimism, the stock's valuation and technical indicators suggest caution. Improving operational efficiency and achieving profitability are critical for future growth.

Positive Factors

Pediatric Market Expansion

The initiation of the Aquadex program in a major children's hospital indicates growing adoption in the pediatric segment, enhancing long-term revenue potential.

Patent and Innovation

Securing patents for safety mechanisms strengthens Nuwellis' competitive edge and supports innovation, crucial for maintaining market leadership in medical devices.

Strategic Partnerships

The NIH grant for developing the Vivian device highlights strategic partnerships that can accelerate product innovation and enhance market position.

Negative Factors

Revenue Decline

A significant decline in revenue indicates challenges in market demand or operational issues, potentially impacting long-term financial health.

Gross Margin Decrease

The reduction in gross margin suggests inefficiencies in production or pricing pressures, which could affect profitability if not addressed.

Increased Operating Loss

Rising operating losses highlight ongoing financial challenges, necessitating improved cost management and revenue enhancement strategies for sustainability.

Nuwellis Business Overview & Revenue Model

Company Description

Nuwellis, 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 Money

Nuwellis 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 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

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

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

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.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	8.17M	8.74M	8.86M	8.54M	7.92M	7.44M
Gross Profit	4.97M	5.83M	4.98M	4.75M	4.49M	4.06M
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 Assets	7.98M	9.86M	9.77M	24.67M	30.42M	20.01M
Cash, Cash Equivalents and Short-Term Investments	3.09M	5.09M	3.80M	18.31M	24.20M	14.44M
Total Debt	383.00K	545.00K	760.00K	984.00K	1.18M	339.00K
Total Liabilities	4.07M	3.33M	6.56M	12.32M	4.47M	3.69M
Stockholders Equity	3.91M	6.53M	3.21M	12.36M	25.95M	16.32M
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	-60.00K	330.00K	14.73M	-15.72M	-267.00K
Financing Cash Flow	10.60M	10.96M	3.68M	9.42M	27.87M	30.02M

Nuwellis Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 2.05
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

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 2.05 is below the 20-day moving average (MA) of 2.36, below the 50-day MA of 2.67, and below the 200-day MA of 16.28, indicating a bearish trend. The MACD of -0.15 indicates Positive momentum. The RSI at 38.42 is Neutral, neither overbought nor oversold. The STOCH value of 6.12 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for NUWE.

Nuwellis Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
NUWE	48 Neutral	$3.40M	-0.02	-467.14%	―	-8.93%	97.80%
PAVM	48 Neutral	$8.91M	-0.52	20.03%	―	-99.28%	-46.16%
VTAK	43 Neutral	$3.02M	-0.04	-173.74%	―	82.96%	82.04%
HSCS	40 Underperform	$8.39M	-0.38	-220.42%	―	-41.03%	35.71%
AEMD	38 Underperform	$2.03M	-0.05	-191.39%	―	―	76.53%

Nuwellis Corporate Events

Nuwellis Appoints John L. Erb as Interim CFO

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.

Nuwellis Announces ULTRA-Peds Registry Findings

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.

Nuwellis Secures New Patent for Hemolysis Sensors

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.

Nuwellis Secures NIH Grant for Pediatric Device Development

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.