MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) — Nuwellis, Inc. (NASDAQ:NUWE), a commercial-stage medical technology company dedicated to transforming care for fluid overload patients, today announced financial results for the second quarter ended June 30, 2025, and provided a business update.

Second Quarter 2025 and Recent Business Highlights

Nuwellis continued to advance its strategic realignment during the second quarter, sharpening focus on high-impact growth areas in pediatric and cardiac surgery care while laying the foundation for expansion in outpatient heart failure. Despite temporary revenue disruption related to an industry-wide sterilization vendor issue, the company took swift action to prioritize patient care, protect its most vulnerable populations, and ensure strong momentum entering the third quarter.

  • Revenue of $1.7 million, compared to $2.2 million in Q2 2024
  • Pediatric category remains a key driver of sustained demand
  • Executed a transition plan to outsource manufacturing to KDI Precision Manufacturing
  • Completed a $5 million gross capital raise during the quarter
  • Successfully grew to 47 pediatric centers that adopted Aquadex therapy as part of their fluid management approach with the addition of two new centers across the Southeastern United States
  • Expanded IP portfolio with granting of new U.S. patent covering the fluid bag design that passively drains once full

“While we faced a temporary headwind this quarter due to a vendor issue, our response demonstrated the strength of our operational discipline and our commitment to patients,” said John Erb, Chairman of the Board and CEO of Nuwellis. “We’re entering the second half of the year with clear priorities, a sharpened focus on our core markets, and the confidence that we’re executing on the right strategy to drive long-term growth.”

Second Quarter 2025 Financial Results

Revenue for the second quarter of 2025 was $1.7 million, compared to $2.2 million in the second quarter of 2024. The year-over-year decline was primarily due to a product backorder caused by an industry-wide sterilization delay.

Gross margin was 55.5% in Q2 2025, compared to 67.2% in Q2 2024. The margin contraction was primarily driven by under-absorption of fixed overhead because of lower production volumes.

Selling, general and administrative (SG&A) expenses were $3.2 million, which is flat to Q2 2024. Research and development (R&D) expenses totaled $675K, compared to $558K in the same period last year.

Total operating expenses for the quarter were $3.9 million, a 2% increase over prior year.

Operating loss for the quarter was $2.9 million, compared to $2.3 million in Q2 2024.

Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per basic and diluted share, compared to $7.7 million, or a loss of $791.82 per share in Q2 2024.

As of June 30, 2025, the company had $4.5 million in cash and cash equivalents and remained debt-free. Nuwellis completed a $5.0 million gross capital raise during the quarter.

Conference Call and Webcast Information

Nuwellis will host a conference call and webcast today at 9:00 AM ET to discuss its first quarter results and recent business developments.

To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, participants may dial 1-800-245-3047 (U.S.) or 1-203-518-9765 (International) and use conference ID: NUWEQ2. A replay will be available following the event.

About Nuwellis

Nuwellis, Inc. (NASDAQ:NUWE) is a commercial-stage medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company’s focus is on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, Minnesota, with a wholly owned subsidiary in Ireland. For more information, visit ir.nuwellis.com or follow us on LinkedIn or X.

About the Aquadex SmartFlow® System

The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

Forward-Looking Statements

Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding future growth and market opportunities. Forward-looking statements are based on current assumptions and expectations and involve risks and uncertainties that could cause actual results to differ materially. These risks are detailed in the Company’s filings with the Securities and Exchange Commission. Nuwellis undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

Investors:
Robert Scott
Nuwellis
Chief Financial Officer
ir@nuwellis.com

Media Contact:
Leah McMullen
Nuwellis
Director of Communications
Leah.mcmullen@nuwellis.com

 
NUWELLIS, INC. AND SUBSIDIARY

Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)

               
    June 30,
2025 
    December 31,
2024
 
    (Unaudited)          
ASSETS              
Current assets              
Cash and cash equivalents $ 4,450     $ 5,095  
Accounts receivable   1,193       1,727  
Inventories, net   2,028       1,718  
Other current assets   745       315  
Total current assets   8,416       8,855  
Property, plant and equipment, net   359       478  
Operating lease right-of-use asset   404       510  
Other assets   21       21  
TOTAL ASSETS $ 9,200     $ 9,864  
               
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)              
Current liabilities              
Accounts payable and accrued liabilities $ 3,008     $ 1,640  
Accrued compensation   561       640  
Current portion of operating lease liability   249       238  
Other current liabilities   74       41  
Total current liabilities   3,892       2,559  
Warrant liabilities   14,074       468  
Operating lease liability   189       307  
Total liabilities   18,155       3,334  
Commitments and contingencies              
               
Mezzanine Equity
Series J Convertible Preferred Stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 119 and 102, respectively
  5       2  
               
Stockholders’ equity (deficit)              
Series A junior participating preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 30,000 shares, none outstanding          
Series F convertible preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 27 and 127 shares, respectively          
Series F-1 convertible preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 34 and 0 shares, respectively          
Preferred stock as of June 30, 2025 and December 31, 2024, par value
$0.0001 per share; authorized 39,352,000 shares, none outstanding