UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 13, 2025

Nuwellis, Inc.
(Exact Name of Registrant as Specified in its Charter)

Delaware
001-35312
No. 68-0533453
(State or Other Jurisdiction of Incorporation or Organization)
(Commission File Number)
(I.R.S. Employer Identification No.)

12988 Valley View Road, Eden Prairie, MN 55344
(Address of Principal Executive Offices) (Zip Code)

(952) 345-4200
(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
NUWE
Nasdaq Capital Market

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02
Results of Operations and Financial Condition.

On May 13, 2025, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three months ended March 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.

Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits

Exhibit No. Description

Press Release, dated May 13, 2025, reporting the financial results of Nuwellis, Inc. for the three months ended March 31, 2025.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 13, 2025
NUWELLIS, INC.
   
 
By:
/s/ John L. Erb
  
 
Name:
John L. Erb
  
 
Title:
Interim President and Chief Executive Officer
  


Exhibit 99.1

Nuwellis, Inc. Announces First Quarter 2025 Financial Results and Business Highlights

Minneapolis, MN, May 13, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical device company dedicated to transforming care for fluid overload patients, today announced financial results for the first quarter ended March 31, 2025, and provided a business update.
 
First Quarter 2025 and Recent Business Highlights
 
Nuwellis continued to advance its strategic priorities during the first quarter, delivering growth in customer categories and strengthening the foundation for broader adoption of Aquadex therapy. Higher CMS reimbursement, strong pediatric performance, and disciplined expense management position the company to capitalize on both inpatient growth and emerging outpatient opportunities in 2025.
 

 •
Revenue of $1.9 million, a 3% increase over the prior-year quarter.

•
4% growth in consumables utilization year-over-year.

•
Pediatric revenue grew 38% year-over-year.

•
Operating expense reduction of $1.8 million, or 31%, compared to the prior-year quarter.

•
Effective January 1, 2025, CMS reassigned Aquadex to a higher outpatient reimbursement level, increasing the facility fee nearly four-fold to $1,639 per day.

•
Expanded outpatient opportunity pipeline, driven by favorable reimbursement and supportive clinical data.
 
“We are encouraged by the strategic progress we’re making in expanding access to Aquadex therapy, particularly as more hospitals explore outpatient use,” said John Erb, Chairman of the Board and Interim Chief Executive Officer of Nuwellis. “With higher reimbursement rates now in effect and a growing base of clinical support, we believe we are well-positioned to expand adoption across both inpatient and outpatient environments in 2025.”
 
First Quarter 2025 Financial Results
 
Revenue for the first quarter of 2025 was $1.9 million, a 3% increase compared to the same period in 2024. The year-over-year increase was driven by a 4% growth in consumables utilization and higher U.S. console sales, partially offset by a decline in international sales.
 
Gross margin for the first quarter of 2025 was 56.0%, compared to 64.1% in the prior-year quarter. The decrease primarily reflects unfavorable manufacturing variances, lower fixed overhead absorption from reduced production, and an inventory adjustment related to the FlexFlow console.
 
Selling, general, and administrative (SG&A) expenses for the first quarter of 2025 were $3.6 million, representing a 22% decrease from $4.6 million in the prior-year period, largely driven by lower headcount, compensation-related expenses, and reduced professional services.
 
Research and development (R&D) expenses were $550 thousand, compared to $1.3 million in the prior-year quarter, primarily due to reduced staffing and lower R&D project spend.
 
Total operating expenses for the quarter were $4.1 million, a 31% decrease from $5.9 million in the first quarter of 2024.
 
Operating loss improved to $3.1 million in the first quarter of 2025, compared to an operating loss of $4.7 million in the first quarter of 2024.
 
Net loss attributable to common shareholders was $3.0 million, or a loss of $0.69 per basic and diluted share, compared to a net loss of $3.8 million, or $24.11 per share, in the prior-year period.
 
As of March 31, 2025, Nuwellis had $2.6 million in cash and cash equivalents and remained debt-free.
 
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 1-800-579-2543 (U.S.) or 1-785-424-1789 (International) and use conference ID: NUWEQ1. 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:
Louisa Smith
Gilmartin Group
[email protected]
 
Media Contact:
Leah McMullen
Nuwellis
Director of Communications
[email protected]

NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)

   
March 31,
2025
    
December 31, 2024
  
   
(Unaudited)
        
ASSETS
            
Current assets
            
Cash and cash equivalents
  
$
2,557
    
$
5,095
  
Accounts receivable
    
1,540
      
1,727
  
Inventories, net
    
1,752
      
1,718
  
Other current assets
    
274
      
315
  
Total current assets
    
6,123
      
8,855
  
Property, plant and equipment, net
    
405
      
478
  
Operating lease right-of-use asset
    
457
      
510
  
Other assets
    
21
      
21
  
TOTAL ASSETS
  
$
7,006
    
$
9,864
  
                 
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
                
Current liabilities
                
Accounts payable and accrued liabilities
  
$
1,731
    
$
1,640
  
Accrued compensation
    
689
      
640
  
Current portion of operating lease liability
    
243
      
238
  
Other current liabilities
    
86
      
41
  
Total current liabilities
    
2,749
      
2,559
  
Common stock warrant liability
    
426
      
468
  
Operating lease liability
    
249
      
307
  
Total liabilities
    
3,424
      
3,334
  
Commitments and contingencies
                
                 
Mezzanine Equity
Series J Convertible Preferred Stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 110 and 102, respectively
    
4
      
2
  
Stockholders’ equity
                
Series A junior participating preferred stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 30,000 shares, none outstanding
    
—
      
—
  
Series F convertible preferred stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 127 shares
    
—
      
—
  
Preferred stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 39,352,000 shares, none outstanding
    
—
      
—
  
Common stock as of March 31, 2025 and December 31, 2024, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 4,373,968 and 4,373,968, respectively
    
—
      
—
  
Additional paid‑in capital
    
305,432
      
305,366
  
Accumulated other comprehensive income:
                
Foreign currency translation adjustment
    
(49
)
    
(47
)
Accumulated deficit
    
(301,805
)
    
(298,791
)
Total stockholders’ equity
    
3,578
      
6,528
  
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
  
$
7,006
    
$
9,864
  

NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except per share amounts and weighted average shares outstanding)

   
Three months ended
March 31
  
   
2025
    
2024
  
 Net sales  
$
1,904
    
$
1,857
  
Cost of goods sold
    
837
      
666
  
Gross profit
    
1,067
      
1,191
  
Operating expenses:
                
Selling, general and administrative
    
3,577
      
4,606
  
Research and development
    
550
      
1,334
  
Total operating expenses
    
4,127
      
5,940
  
Loss from operations
    
(3,060
)
    
(4,749
)
Other income (expense), net
    
7
      
(101
)
Change in fair value of warrant liability
    
40
      
522
  
Loss before income taxes
    
(3,013
)
    
(4,328
)
Income tax expense
    
(1
)
    
(2
)
Net loss
    
(3,014
)
    
(4,330
)
Deemed dividend attributable to Series J Convertible    Preferred Stock
    
1
       541  
Net loss attributable to common shareholders
  
$
(3,013
)
  
$
(3,789
)
                 
Basic and diluted loss per share
  
$
(0.69
)
  
$
(24.11
)
                 
Weighted average shares outstanding – basic and diluted
    
4,373,968
      
179,608
  
                 
Other comprehensive loss:
                
Net loss
  
$
(3,014
)
  
$
(4,330
)
Foreign currency translation adjustments
    
(2
)
    
(9
)
Total comprehensive loss
  
$
(3,016
)
  
$
(4,339
)

NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)

   
Three months ended
March 31
  
   
2025
 
    
2024
  
Operating Activities:
            
Net loss
  
$
(3,014
)
  
$
(4,330
)
Adjustments to reconcile net loss to cash flows used in operating activities:
                
Depreciation and amortization
    
73
      
76
  
Stock-based compensation expense
    
67
      
158
  
Change in fair value of warrant liability
    
(40
)
    
(522
)
Changes in operating assets and liabilities:
                
Accounts receivable
    
187
      
725
  
Inventory, net
    
(34
)
    
(134
)
Other current assets
     41      
21
  
Other assets and liabilities
    
45
      
(6
)
Accounts payable and accrued expenses
     139      
1,150
  
Net cash used in operating activities
    
(2,536
)
    
(2,862
)
                 
Investing Activities:
                
Purchases of property and equipment
    
—
      
(29
)
Net cash used in investing activities
    
—
      
(29
)
                 
Financing Activities:
                
Proceeds from the exercise of Series J Convertible Preferred Warrants
    
—
      
500
  
Net cash provided by financing activities
    
—
      
500
  
                 
Effect of exchange rate changes on cash
    
(2
)
    
(9
)
Net decrease in cash and cash equivalents
    
(2,538
)
    
(2,400
)
Cash and cash equivalents - beginning of period
    
5,095
      
3,800
  
Cash and cash equivalents – end of period
  
$
2,557
    
$
1,400
  








 
Supplemental cash flow information






 
Issuance of Series J Preferred Stock for exercise of Warrants
$
—

$
1,857
  
Issuance of Common Stock for conversion of Series J Preferred    Stock
$ —

$
1,535
  
Deemed dividend on Series J Preferred Stock
$ 1

$
541