Nuwellis (NUWE) AI Stock Analysis

• Market Cap: $3.80M
• Dividend Yield: N/A
• Average Volume (3M): 215.70K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.01
• Revenue Growth: -7.72%
• EPS Growth: 99.54%
• Country: US
• Employees: 38
• Sector: Healthcare
• Sector Strength: 47
• Industry: Medical - Devices
• EPS (TTM): -60.99
• Shares Outstanding: 902,665
• 10 Day Avg. Volume: 179,176
• 30 Day Avg. Volume: 215,704
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: -0.55
• Enterprise Value/Revenue: -0.25
• Enterprise Value/Gross Profit: -0.42
• Enterprise Value/Ebitda: 0.53
• 1Y Price Target: $4.50
• Price Target Upside: 7.66% Upside
• Rating Consensus: Hold
• Number of Analyst Covering: 1

• Rating: 44 Neutral
• Price Target: $4.50 ▲(7.66% Upside)

Nuwellis' overall stock score is primarily impacted by its financial challenges, including ongoing losses and negative cash flows. Technical indicators suggest bearish momentum, and valuation metrics are weak due to a negative P/E ratio. While recent corporate events and strategic initiatives offer some promise, the immediate financial outlook remains concerning.

Positive Factors

Pediatric Revenue Growth

The growth in pediatric revenue indicates a strong demand in this segment, suggesting a successful market penetration and potential for sustained growth in a specialized niche.

NIH Grant for Pediatric Device

The NIH grant supports development of a pediatric therapy device, enhancing Nuwellis' product portfolio and market position in pediatric care.

FDA Clearance for New Catheter

FDA clearance for a new catheter expands Nuwellis' product offerings, potentially improving competitive positioning and market reach in the medical device sector.

Negative Factors

Revenue Decline

A significant revenue decline highlights challenges in maintaining sales momentum, which could impact long-term financial health and growth prospects.

Negative Cash Flow

Ongoing negative cash flow indicates financial strain, limiting the company's ability to invest in growth and potentially affecting operational sustainability.

Increased Operating Loss

Rising operating losses suggest inefficiencies and cost management issues, posing risks to profitability and requiring strategic adjustments for long-term viability.

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 through the sale of its medical devices and related products, which are sold to hospitals, healthcare providers, and clinics. The company's revenue model is primarily based on direct sales of its proprietary fluid management devices, as well as recurring revenue from consumables and accessories that accompany these devices. Key revenue streams include product sales, service contracts, and potential licensing agreements. Additionally, Nuwellis may benefit from partnerships with healthcare institutions and collaborations with other medical technology companies, which can enhance market reach and provide access to new customer segments.

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	8.32M	8.74M	8.86M	8.54M	7.92M	7.44M
Gross Profit	5.04M	5.68M	4.98M	4.75M	4.49M	4.06M
EBITDA	-3.96M	-5.24M	-16.36M	-4.90M	-19.06M	-16.65M
Net Income	-14.68M	-10.62M	-20.21M	-14.53M	-19.58M	-15.84M
Balance Sheet
Total Assets	9.20M	9.86M	9.77M	24.67M	30.42M	20.01M
Cash, Cash Equivalents and Short-Term Investments	4.45M	5.09M	3.80M	18.31M	24.20M	14.44M
Total Debt	438.00K	545.00K	760.00K	984.00K	1.18M	339.00K
Total Liabilities	18.16M	3.33M	6.56M	12.32M	4.47M	3.69M
Stockholders Equity	-8.96M	6.53M	3.21M	12.36M	25.95M	16.32M
Cash Flow
Free Cash Flow	-8.62M	-9.65M	-18.18M	-15.27M	-18.06M	-16.87M
Operating Cash Flow	-8.61M	-9.59M	-17.94M	-15.15M	-17.84M	-16.57M
Investing Cash Flow	-11.00K	-60.00K	330.00K	14.73M	-15.72M	-267.00K
Financing Cash Flow	12.06M	10.96M	3.68M	9.42M	27.87M	30.02M

Nuwellis Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 4.18
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Positive
• STOCH: 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 4.18 is below the 20-day moving average (MA) of 5.05, below the 50-day MA of 7.51, and below the 200-day MA of 33.29, indicating a bearish trend. The MACD of -1.01 indicates Negative momentum. The RSI at 28.18 is Positive, neither overbought nor oversold. The STOCH value of 29.62 is Neutral, 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	$8.02B	-0.31	-43.38%	2.24%	22.31%	-2.14%
NUWE	44 Neutral	$3.80M	―	-440.77%	―	-7.72%	99.54%
VTAK	44 Neutral	$3.07M	―	-179.11%	―	37.61%	68.37%
VERO	43 Neutral	$4.31M	―	-1371.21%	―	-13.90%	44.89%
SINT	42 Neutral	$12.53M	―	-195.48%	―	-40.47%	96.14%
AMIX	40 Underperform	$6.86M	―	-195.55%	―	―	65.72%
HIND	37 Underperform	$5.08M	―	-101.49%	―	-19.81%	93.32%

Nuwellis Corporate Events

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.

Nuwellis Announces At The Market Offering Agreement

On September 3, 2025, Nuwellis entered into an At The Market Offering Agreement with Ladenburg Thalmann & Co. Inc. to sell shares of its common stock, with an initial aggregate offering price of up to $4,650,000. The company is not obligated to sell any shares and will pay Ladenburg a commission of up to 3% of the gross proceeds from any sales made. This agreement allows Nuwellis flexibility in raising capital while providing Ladenburg with indemnification rights and expense reimbursements.

Nuwellis Gains FDA Clearance for New Catheter

On August 21, 2025, Nuwellis, Inc. announced that it has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). This clearance may enhance the company’s product offerings and potentially improve its market position in the medical device industry.

Nuwellis Announces Acquisition of Rendiatech, Ltd.

On August 19, 2025, Nuwellis, Inc. announced its intention to acquire Rendiatech, Ltd., an Israeli company specializing in urine flow and kidney monitoring technologies. This acquisition aims to enhance Nuwellis’ technology platform by incorporating continuous renal health monitoring, potentially offering clinicians better insights into fluid status and kidney function. The deal is expected to close in the fourth quarter of 2025, subject to due diligence, board approval, and closing conditions.

Nuwellis Approves Stock Proposals at Special Meeting

On August 4, 2025, Nuwellis, Inc. held a virtual special meeting of stockholders to discuss several key proposals. The meeting sought approval for the issuance of common stock shares, an increase in authorized shares from 100 million to 200 million, and a reverse stock split to comply with Nasdaq listing requirements. The proposals were approved by a majority vote, with the reverse split aimed at maintaining the company’s Nasdaq listing status.

Nuwellis Regains Nasdaq Compliance After Delisting Risk

Nuwellis, Inc. received a notice from Nasdaq on June 18, 2025, indicating that its stock price had fallen below $1.00 per share for 30 consecutive trading days, putting it at risk of delisting. However, by July 22, 2025, the company had resolved the issue, and Nasdaq confirmed that Nuwellis was back in compliance with listing standards, allowing its stock to continue trading on the Nasdaq Capital Market.

Nuwellis Appoints John L. Erb as CEO

On June 27, 2025, Nuwellis, Inc. appointed John L. Erb as the Chief Executive Officer and President, solidifying his leadership role after serving as interim CEO since February 2025. Mr. Erb, who has a long history with the company and extensive experience in the medical device sector, will continue to serve as Chairman of the Board. Additionally, the company announced a one-for-forty-two reverse stock split, approved by the board on June 19, 2025, to be effective on July 3, 2025, which aims to consolidate shares and adjust the stock’s market value, impacting shareholders and the company’s trading dynamics.

Nuwellis Faces Nasdaq Delisting Due to Stock Price

Nuwellis, Inc. has received a deficiency notice from Nasdaq due to its stock price falling below the minimum bid requirement of $1.00 for 30 consecutive trading days. The company, which previously conducted a reverse stock split in June 2024, is not eligible for the compliance period and faces potential delisting unless it requests a hearing. The board plans to implement another reverse stock split to regain compliance, but there is no assurance of success.

Nuwellis Completes Securities Exchange Agreement with CEO

On June 6, 2025, Nuwellis, Inc. filed a Certificate of Designation for Series F-1 Convertible Preferred Stock with the Delaware Secretary of State, authorizing the issuance of 100 shares. This new stock series is similar to the existing Series F Convertible Preferred Stock but includes a conversion limitation to prevent holders from exceeding 19.99% ownership of outstanding common stock. On June 9, 2025, Nuwellis entered into a Securities Exchange Agreement with CEO John L. Erb, exchanging 100 shares of the new Series F-1 Stock for the same number of existing Series F Stock, resulting in Mr. Erb owning 100% of the Series F-1 Stock.